TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Double-Blinded Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor Between 24 to 32 6/7 Weeks' Gestation
Brief Summary: Primary Hypothesis:

Acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 6/7 weeks' gestation.


Options:
A: Number of Participants With Preterm Birth (Less than 37 weeks of gestation)
B: Duration of labor (48 hours)
C: Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization (Two weeks after enrolled and randomized, up to 37 weeks of pregnancy)
D: Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of OT-551 Antioxidant Eye Drop in Participants With Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration
Brief Summary: Othera Pharmaceuticals' Othera (OT)-551 antioxidant eye drop has the potential for chronic treatment of the dry form of age-related macular degeneration. This pilot study of up to 10 eye drop tolerant participants with bilateral geographic atrophy is designed to characterize the effect of 0.45% concentration of OT-551 eye drops given 3 times a day on the progression of geographic atrophy area over a two-year period. Participants will have one eye randomized to receive the eye drop and the fellow eye will be observed only.


Options:
A: Change of geographic atrophy size to baseline (24 months)
B: The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants. (2 years)
C: RT-PCR for influenza A virus in nasal secretion (2 days)
D: Growth of Geographic Atrophy (6 months); Decrease in Drusen Volume (6 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of OT-551 Antioxidant Eye Drop in Participants With Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration
Brief Summary: Othera Pharmaceuticals' Othera (OT)-551 antioxidant eye drop has the potential for chronic treatment of the dry form of age-related macular degeneration. This pilot study of up to 10 eye drop tolerant participants with bilateral geographic atrophy is designed to characterize the effect of 0.45% concentration of OT-551 eye drops given 3 times a day on the progression of geographic atrophy area over a two-year period. Participants will have one eye randomized to receive the eye drop and the fellow eye will be observed only.


Options:
A: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
B: Retinal blood flow (in total 8x on 2 study days)
C: The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants. (2 years)
D: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Patient-initiated Famciclovir 1000 mg b.i.d. x 1 Day to Valacyclovir 500 mg b.i.d. x 3 Days in Immunocompetent Adults With Recurrent Genital Herpes
Brief Summary: This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).


Options:
A: Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions (72 hours after initiation of study medication up to Day 20)
B: Serologically confirmed HIV infection (Throughout study)
C: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. (15 weeks)
D: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir. (11 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tube Versus Trabeculectomy (TVT) Study
Brief Summary: The purpose of the Tube Versus Trabeculectomy (TVT) Study is to compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous ocular surgery.


Options:
A: Mean IOP at 6 months (6 months); Surgical complication rates (intraoperative and postoperative up to 12 months)
B: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure (12 months); Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure (24 months)
C: Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. (Baseline and 24 months)
D: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tube Versus Trabeculectomy (TVT) Study
Brief Summary: The purpose of the Tube Versus Trabeculectomy (TVT) Study is to compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous ocular surgery.


Options:
A: N/A
B: Progression-Free Survival (Assessed every 3 months for 2 years, then every 6 months for 3 years)
C: N/A
D: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tube Versus Trabeculectomy (TVT) Study
Brief Summary: The purpose of the Tube Versus Trabeculectomy (TVT) Study is to compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous ocular surgery.


Options:
A: Efficacy (24 months)
B: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure (12 months); Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure (24 months)
C: Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit. (12 months)
D: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tube Versus Trabeculectomy (TVT) Study
Brief Summary: The purpose of the Tube Versus Trabeculectomy (TVT) Study is to compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous ocular surgery.


Options:
A: Mean IOP at 6 months (6 months); Surgical complication rates (intraoperative and postoperative up to 12 months)
B: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)
C: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure (12 months); Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure (24 months)
D: Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data (Baseline; Month 24 postoperative)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
Brief Summary: The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V® arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston Scientific.

TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.


Options:
A: Target Lesion Failure (12 months)
B: Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent (6 months)
C: Ischemia Driven Target Lesion Failure (TLF) (1 year)
D: target vessel failure (30 days and one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Parallel, Randomized, Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention of Mother-to-Child HIV Transmission
Brief Summary: A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has been shown to be an effective way of reducing the risk of mother-to-child transmission (MTCT) of HIV. The purpose of this study was to compare the effectiveness of a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral regimen versus a protease inhibitor (PI)-based regimen in HIV infected infants who had or had not been exposed to SD NVP for prevention of MTCT.

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\>\> A five year follow up has been added to the study.


Options:
A: Trough concentration of LPV and pharmacokinetic parameters (Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96); Recurrent treatment-related Grade 3 and non-life threatening Grade 4 toxicity or single occurence of life-threatening Grade 4 toxicity (Throughout study)
B: Virologic suppression at 6 months after randomization
C: Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment (Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010))
D: Time to Failure of First Line Therapy or Death (From date of randomization up to failure of first-line therapy or death from any cause, whichever came first, assessed up to 4.8 years); Number of Participants Who Experienced Immunological Failure Defined as Failure of CD4% to Reach 20% or CD4% Falls Below 20% on Two Occasions, Within 4 Weeks, at Any Time After the First 24 Weeks of Therapy (Initial Therapy or Restart) (This outcome was assessed from the date of randomization to immunological failure. Immunological failure was assessed in the entire study duration of 4.8 years.); Number of Participants Who Experienced Regimen-limiting ART Drug Toxicity (Regimen limiting drug toxicity was monitored from randomization up to the entire study duration of 4.8 years.); Number of Participants Who Experienced Clinical Failure (Defined as Development of Severe CDC Stage B or Stage C Disease.) on Therapy. (Clinical failure on therapy was assessed at each visit for the entire study duration of 4.8 years.); Number of Participants Who Experienced Virological Failure Defined as Confirmed HIV-1 RNA Value of at Least 10,000 Copies Per/ml Recorded on Two Consecutive Separate Occasions After 24 Weeks of Treatment (Initial Therapy or Restart) (Virological failure was assessed from randomization through the entire study duration of 4.8 years.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine and Smoking Cessation in Schizophrenia
Brief Summary: Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.


Options:
A: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
B: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
C: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
D: seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (end of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine and Smoking Cessation in Schizophrenia
Brief Summary: Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.


Options:
A: Quit Rate (4 months)
B: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
C: seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (end of treatment)
D: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine and Smoking Cessation in Schizophrenia
Brief Summary: Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.


Options:
A: effectiveness (2 years)
B: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)
C: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
D: seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (end of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine and Smoking Cessation in Schizophrenia
Brief Summary: Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.


Options:
A: seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (end of treatment)
B: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
C: 7-Day Point-Prevalence Abstinence (12 months)
D: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine and Smoking Cessation in Schizophrenia
Brief Summary: Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)
C: A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. (2 years)
D: seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (end of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Auto-Continuous Positive Airway Pressure Device(Auto-CPAP) With Conventional Fixed CPAP in Chinese Patients With Obstructive Sleep Apnea (OSA)
Brief Summary: AutoCPAP would lead to better compliance than FixCPAP


Options:
A: objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.) (3 months)
B: proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. (90 days)
C: To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.; To compare the clinical efficacy of auto-CPAP and fixed CPAP in terms of pressure level to abolish OSA, Epworth sleepiness scale and quality of life questionnaire.; To compare patient acceptance of the different type of treatment.
D: Clinical blood pressure (Before treatment, 4 months after treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis.
Brief Summary: The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest (From Day 169 to Day 729); Short-term Period: Number of Participants With ACR 20 Response at Day 169 (At Day 169 from Baseline)
B: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16); Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16)
C: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)
D: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis.
Brief Summary: The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
B: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)
C: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)
D: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis.
Brief Summary: The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)
B: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26
C: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
D: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis.
Brief Summary: The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
B: Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) (Week 12); Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1) (Week 12); Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1) (Up to Week 12); Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1) (Up to Week 12)
C: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)
D: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)

Answer: D