TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: ARTSS-2: A Pilot, Phase 2b, Randomized, Multi-center Trial of Argatroban in Combination With Recombinant Tissue Plasminogen Activator for Acute Stroke
Brief Summary: Randomized controlled clinical trial to estimate overall treatment benefit (improvement in disability) among stroke patients treated with rt-PA who are randomized to also receive either low-dose Argatroban, high-dose Argatroban or neither.


Options:
A: percentage of patients with new stroke (ischemic or hemorrhage) (90 days)
B: Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period. (From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.)
C: Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism) (10 ± 4 days following acute ischemic stroke)
D: Number of Participants With 0 or 1 on Modified Rankin Scale (90 days); Number of Participants With Symptomatic Intracranial Hemorrhage Within 48 Hours of tPA Administration (48-hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
Brief Summary: Objectives

To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions:

1. To determine whether there is a difference in rates of breastfeeding continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.
2. To determine whether there is a difference in infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills.
3. To determine whether there is a difference in birth control method continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.

Hypothesis

Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will cause a differential in continuation of breastfeeding: 35% continuation in the combined pill group vs. 60% in the progestin-only pill group at 8 weeks.


Options:
A: IUD Usage Rate at 6 Months (6 months after delivery)
B: Evaluation of infant weight, height and size of the tibial (women and children will be evaluated at time frame from day 42 through day 64 post-partum)
C: Time to Lactogenesis Stage II (5 days postpartum)
D: Number of Participants Who Continued to Breastfeed at 6 Months (Baseline to Week 8, Week 8, 2-6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions in Peru, Tanzania, Senegal, Vietnam, Indonesia, and India
Brief Summary: This study consists of an impact evaluation (IE) of the Scaling up Handwashing with Soap (HWWS) and Total Sanitation and Sanitation Marketing (TSSM) projects of the Water and Sanitation Program (WSP) of the World Bank. The objective of this study is to estimate the causal impact of the HWWS and TSSM interventions on the health and welfare of the rural poor in six developing countries: Peru, Tanzania, Senegal, Vietnam, Indonesia, and India. The IE will assess the impact of exposure to the HWWS and TSSM promotion on individual-level hygiene and sanitation practices, and on the health and welfare of children 0-5 years old. By introducing exogenous variation in handwashing and sanitation practices (through exposure to the HWWS and TSSM promotion), the IE will also answer a number of important questions related to the effect of the intended behavioral change (handwashing and improved sanitation) on health and welfare, thus providing information on the extent to which these behaviors alter intended development outcomes. This study uses a cluster-randomized experimental design, whereby the geographic units called clusters (e.g. village, commune, ward, depending on administrative structure of country) are randomly assigned to receive certain components of the Handwashing and Sanitation interventions in the case of treatment arms, and no Handwashing or Sanitation intervention in the case of control arms. . The final sample for the evaluation will consist of approximately 14,000 households, randomly selected, with at least one child between 0 and 24 months of age at baseline. Data will be collected from these 14,000 households (approximately 54,781 subjects) through household surveys, anthropometric measurements, blood and stool samples, direct observations of behaviors, and community surveys. The data collected will be analyzed using a differences in differences approach, where possible, and the results will be disseminated to country officials and others stakeholders.


Options:
A: Duration of diarrhea (within the first 72 hours during hospitalization)
B: Diarrhoea (<5s) (21 months)
C: Change in target behaviour: zinc use (six weeks post-intervention); Change in target behaviour: correct ORS preparation (six weeks post-intervention); Change in target behaviour: Exclusive breastfeeding (six weeks post-intervention); Change in target behaviour: Handwashing with soap (six weeks post-intervention)
D: Diarrhea in Children Under 5 (one year after the intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions in Peru, Tanzania, Senegal, Vietnam, Indonesia, and India
Brief Summary: This study consists of an impact evaluation (IE) of the Scaling up Handwashing with Soap (HWWS) and Total Sanitation and Sanitation Marketing (TSSM) projects of the Water and Sanitation Program (WSP) of the World Bank. The objective of this study is to estimate the causal impact of the HWWS and TSSM interventions on the health and welfare of the rural poor in six developing countries: Peru, Tanzania, Senegal, Vietnam, Indonesia, and India. The IE will assess the impact of exposure to the HWWS and TSSM promotion on individual-level hygiene and sanitation practices, and on the health and welfare of children 0-5 years old. By introducing exogenous variation in handwashing and sanitation practices (through exposure to the HWWS and TSSM promotion), the IE will also answer a number of important questions related to the effect of the intended behavioral change (handwashing and improved sanitation) on health and welfare, thus providing information on the extent to which these behaviors alter intended development outcomes. This study uses a cluster-randomized experimental design, whereby the geographic units called clusters (e.g. village, commune, ward, depending on administrative structure of country) are randomly assigned to receive certain components of the Handwashing and Sanitation interventions in the case of treatment arms, and no Handwashing or Sanitation intervention in the case of control arms. . The final sample for the evaluation will consist of approximately 14,000 households, randomly selected, with at least one child between 0 and 24 months of age at baseline. Data will be collected from these 14,000 households (approximately 54,781 subjects) through household surveys, anthropometric measurements, blood and stool samples, direct observations of behaviors, and community surveys. The data collected will be analyzed using a differences in differences approach, where possible, and the results will be disseminated to country officials and others stakeholders.


Options:
A: Diarrhoea (<5s) (21 months)
B: Incidence of Diarrhea (2 weeks)
C: Diarrhea in Children Under 5 (one year after the intervention)
D: Infant length at 18 months (18 months of age. Protocol and Statistical Analysis Plan are available at https://osf.io/w93hy.); Infant hemoglobin at 18 months (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions in Peru, Tanzania, Senegal, Vietnam, Indonesia, and India
Brief Summary: This study consists of an impact evaluation (IE) of the Scaling up Handwashing with Soap (HWWS) and Total Sanitation and Sanitation Marketing (TSSM) projects of the Water and Sanitation Program (WSP) of the World Bank. The objective of this study is to estimate the causal impact of the HWWS and TSSM interventions on the health and welfare of the rural poor in six developing countries: Peru, Tanzania, Senegal, Vietnam, Indonesia, and India. The IE will assess the impact of exposure to the HWWS and TSSM promotion on individual-level hygiene and sanitation practices, and on the health and welfare of children 0-5 years old. By introducing exogenous variation in handwashing and sanitation practices (through exposure to the HWWS and TSSM promotion), the IE will also answer a number of important questions related to the effect of the intended behavioral change (handwashing and improved sanitation) on health and welfare, thus providing information on the extent to which these behaviors alter intended development outcomes. This study uses a cluster-randomized experimental design, whereby the geographic units called clusters (e.g. village, commune, ward, depending on administrative structure of country) are randomly assigned to receive certain components of the Handwashing and Sanitation interventions in the case of treatment arms, and no Handwashing or Sanitation intervention in the case of control arms. . The final sample for the evaluation will consist of approximately 14,000 households, randomly selected, with at least one child between 0 and 24 months of age at baseline. Data will be collected from these 14,000 households (approximately 54,781 subjects) through household surveys, anthropometric measurements, blood and stool samples, direct observations of behaviors, and community surveys. The data collected will be analyzed using a differences in differences approach, where possible, and the results will be disseminated to country officials and others stakeholders.


Options:
A: Reported diarrhoea in children <5 years (7-day recall, assessed 4 times during 3-month follow-up rounds)
B: Diarrhea in Children Under 5 (one year after the intervention)
C: childhood mortality rate at age 1-6
D: Reduction in hookworm prevalence and intensity of infection in intervention arm (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions in Peru, Tanzania, Senegal, Vietnam, Indonesia, and India
Brief Summary: This study consists of an impact evaluation (IE) of the Scaling up Handwashing with Soap (HWWS) and Total Sanitation and Sanitation Marketing (TSSM) projects of the Water and Sanitation Program (WSP) of the World Bank. The objective of this study is to estimate the causal impact of the HWWS and TSSM interventions on the health and welfare of the rural poor in six developing countries: Peru, Tanzania, Senegal, Vietnam, Indonesia, and India. The IE will assess the impact of exposure to the HWWS and TSSM promotion on individual-level hygiene and sanitation practices, and on the health and welfare of children 0-5 years old. By introducing exogenous variation in handwashing and sanitation practices (through exposure to the HWWS and TSSM promotion), the IE will also answer a number of important questions related to the effect of the intended behavioral change (handwashing and improved sanitation) on health and welfare, thus providing information on the extent to which these behaviors alter intended development outcomes. This study uses a cluster-randomized experimental design, whereby the geographic units called clusters (e.g. village, commune, ward, depending on administrative structure of country) are randomly assigned to receive certain components of the Handwashing and Sanitation interventions in the case of treatment arms, and no Handwashing or Sanitation intervention in the case of control arms. . The final sample for the evaluation will consist of approximately 14,000 households, randomly selected, with at least one child between 0 and 24 months of age at baseline. Data will be collected from these 14,000 households (approximately 54,781 subjects) through household surveys, anthropometric measurements, blood and stool samples, direct observations of behaviors, and community surveys. The data collected will be analyzed using a differences in differences approach, where possible, and the results will be disseminated to country officials and others stakeholders.


Options:
A: Incidence of Diarrhea (2 weeks)
B: Diarrhoea (<5s) (21 months)
C: Change in Latrine Usage Rate (Baseline, Post-Intervention (Up to 1 Year))
D: Diarrhea in Children Under 5 (one year after the intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
Brief Summary: This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.


Options:
A: Number of Participants With Remission Based on Modified Mayo Score at Month 6 (Month 6)
B: Percentage of Participants In Remission at Week 52 (Week 52)
C: Percentage of Participants With Remission at Week 8 (Week 8)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
Brief Summary: This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.


Options:
A: Number of Participants in Clinical Response Through Week 54 (Induction Baseline, Week 0 through Week 54)
B: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
C: Clinical response (8 weeks)
D: Percentage of Participants With Remission at Week 8 (Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effectiveness of Physical Therapy Program to Treat Rotator Cuff Disorders Among Nursing Professionals According to Indicators of Quality of Life and Job Satisfaction
Brief Summary: The program of stretching, strengthening and proprioception is more effective than stretching and strengthening program in nursing, with rotator cuff disorder, according to indicators of quality of life and job satisfaction.


Options:
A: Shoulder Pain and Disability Index (SPADI) (Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months)
B: Constant-Murley shoulder assessment (Baseline and change after three months of exercises, 3 month follow-up); Constant_Murley shoulder assessment (Change from baseline to the 12-month follow-up)
C: Indicators of quality of life (WORC - Western Ontario Rotator Cuff The Index) (This scale is applied one day before and one day after the application of physical therapy intervention programs)
D: Shoulder Pain and Disability Index (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0993 Study.
Brief Summary: Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).


Options:
A: Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase (Week 31 through Week 109)
B: The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.
C: Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) (Up to 3.5 Years (Duration of the Treatment Phase)); Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years) (Up to 3.5 Years (Duration of the Treatment Phase)); Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years) (Up to 3.5 Years (Duration of the Treatment Phase))
D: Percentage of Subjects With a Treatment Failure (Week 0 (First Dose) to Week 50)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease
Brief Summary: The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.


Options:
A: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments (Baseline, Week 10); Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments (Baseline, Week 10)
B: Clinical remission (CDAI score of <150) (Week 11)
C: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (6 weeks)
D: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Exploratory Phase IIa, Randomized, Open-Label Trial to Investigate the Efficacy and Safety of 12 Weeks or 24 Weeks of TMC435 in Combination With PSI-7977 (GS7977) With Or Without Ribavirin in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Subjects
Brief Summary: The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977 (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1 hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or are HCV treatment-naive (patients who never received treatment for HCV infection).


Options:
A: Percentage of Participants Experiencing Treatment Emergent Adverse Events (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline (Baseline; Days 4, 5, 6, 7, 8, 10, and 17)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses (12 weeks after last dose of study drug)
C: Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) (Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks))
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Exploratory Phase IIa, Randomized, Open-Label Trial to Investigate the Efficacy and Safety of 12 Weeks or 24 Weeks of TMC435 in Combination With PSI-7977 (GS7977) With Or Without Ribavirin in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Subjects
Brief Summary: The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977 (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1 hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or are HCV treatment-naive (patients who never received treatment for HCV infection).


Options:
A: Proportion of Participants With Sustained Virologic Response 12 (SVR-12) (12 weeks post-therapy)
B: Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) (Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks))
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug (Up to 12 weeks)
D: Part 1: Rapid Virological Response (RVR) (4 weeks); Part 2: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 52 weeks); Part 3 and 4: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 36 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Citrasate Dialysate on Heparin Dose: A Randomized Cross Over Trial in Hemodialysis Patients.
Brief Summary: An alternative to systemic heparin anticoagulation for HD is citrate dialysate (CD). CD contains a small amount of citric acid rather than acetic acid as the acidifying agent. The use of citrasate may lead to lower heparin requirements in hemodialysis. This is a randomized, double blinded, two-period crossover trial in HD patients to compare the effect of citrasate dialysis (CD) and usual acetic-acid based dialysate (AD) on heparin dose.


Options:
A: Safety and Tolerability - evaluated by reviewing frequency and severity of Adverse events (including bleeding events) and use of concomitant medications, changes in vital signs and laboratory evaluations for all patients (For the PK Cohort: Patients will be followed for 72 days. For Cohorts A and B: Patients will be followed for 162 days.)
B: The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD (2 weeks after CD exposure, 2 weeks after AD exposure)
C: Patency of hemodialysis circuit (20 weeks)
D: Levels of osteoprotegerin after administration of UFH or LMWH used as anticoagulant therapy for hemodialysis (during and after dialysis sessions)

Answer: B