TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Vascular calcification and endothelial dysfunction (ED) contribute to the development of cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification in CKD patients while the exact mechanism has not been clarified.

This study was designed to investigate the effect of short-term sevelamer treatment on both serum fetuin-A concentrations and ED seen in CKD patients.


Options:
A: N/A
B: Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) (4 weeks)
C: FGF23 serum level (Change over 2 weeks of treatment)
D: Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-blind, Placebo- and Active-control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee.
Brief Summary: The purpose of this study is to evaluate whether tapentadol (CG5503) prolonged-release (PR) tablets at doses of 100-250 mg twice daily provide a better pain relief in patients with moderate to severe chronic pain due to osteoarthritis of the knee than a placebo (a medication without active substance). In addition the tolerability of CG5503 PR will be assessed. One third of the patients will receive CG5503 and one third will receive placebo. For further comparison one third of the patients will receive oxycodone controlled release (CR) at doses of 20-50 mg twice daily which is an active approved pain medication. Please note that tapentadol ER (Extended Release) and tapentadol PR (Prolonged Release) are identical and used interchangeably. This is due to United States of America and European naming conventions.


Options:
A: Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS). (Change from baseline over the 12 week Maintenance Period)
B: Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12. (Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).)
C: Number of Participants With Treatment-emergent Adverse Events (TEAE) (52 weeks)
D: Number of Participants That Responded to Treatment (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Indocin Versus Nifedipine for Preterm Labor Tocolysis - A Randomized Double-Blinded Clinical Trial
Brief Summary: Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor. This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral indomethacin for preterm labor tocolysis in an effort to identify which drug is most effective.

Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used.


Options:
A: Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization (Two weeks after enrolled and randomized, up to 37 weeks of pregnancy)
B: delivery within 48 hours (48 hours after enrollment)
C: Time of Delivery (Delivery)
D: Duration of labor (48 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: S. Japonicum and Pregnancy Outcomes: A Randomized, Double Blind, Placebo Controlled Trial (RCT)
Brief Summary: The purpose of the study is to understand whether the drug praziquantel (PZQ) is safe for the mother and developing baby when the mother has schistosomiasis (a type of worm) infection, and whether the drug may improve the mother's and baby's health. The usual practice is to wait until after a mother has finished breast feeding before giving the medicine. Approximately 375 infected pregnant women, ages 18 and over, in endemic villages in Leyte, The Philippines will participate. Study volunteers 12-16 weeks pregnant will be given PZQ or an inactive pill (placebo) and stay in the hospital overnight. Small blood samples will be collected before and after the medication is taken. Three stool and urine samples will be taken during a total of 7 study visits. An ultrasound image (picture or outline of the unborn baby) will be performed. When the baby is born, a small blood sample will be taken. Mother and baby will be followed for up to 8 months before the baby is born and 1 month after.


Options:
A: STH transmission interruption (5 years (Three years of drug administration and two years of surveillance))
B: Mean Newborn Birth Weight (Within 24 hours of delivery.)
C: Reduction of egg excretion (6 weeks after second IPTp)
D: Mean (± standard deviation) weight gain (kg) (Change between birth and six months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study
Brief Summary: The purpose of this study is to determine whether a short group intervention programe aiming at lifestyle changes at a local health centre can improve risk factors for cardiovascular disease


Options:
A: HbA1c level (Final (before 2 years follow-up))
B: weight loss (3 months); Weight loss (1 year)
C: The primary outcome being measured is the level of activity monitored by the activity monitor. Control and Intervention subjects will be encouraged to wear the activity monitor on a daily basis for the 12 week course of the study. (12 weeks)
D: Changes in anthropometry (BMI, waist and hip cf) (3 years); Maximal oxygen uptake (VO2max) (3 years); Health-related quality of life (EQ 5D, SF-36) (3 years); Self-reported physical activity (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study
Brief Summary: The purpose of this study is to determine whether a short group intervention programe aiming at lifestyle changes at a local health centre can improve risk factors for cardiovascular disease


Options:
A: Framingham Risk Score (15 months)
B: body weight
C: Changes in anthropometry (BMI, waist and hip cf) (3 years); Maximal oxygen uptake (VO2max) (3 years); Health-related quality of life (EQ 5D, SF-36) (3 years); Self-reported physical activity (3 years)
D: weight change at 18 months (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Respiratory muscle strength is used as an outcome measure in intervention studies. There are reference values for respiratory muscle strength in 'healthy' people but not in those with bronchiectasis disease. The aim of this study is to investigate the reliability of respiratory muscle strength measurements and identify reference values for those with stable moderate to severe bronchiectasis disease.


Options:
A: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)
B: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. (8 weeks)
C: Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire (July 2011)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
Brief Summary: The purpose of this randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric Cutaneous caused by L. Viannia species in Colombia.


Options:
A: Final Clinical Cure for Index Lesions (Initial clinical cure by day 63 and no relapse by day 168)
B: The primary outcome measure will be the proportion of "Therapeutic Failures" diagnosed during the final (week 26) visit or before, according to defined clinical criteria. (26 weeks (6 months)); Evidence of clinical or laboratory toxicity during the treatment period. (During the treatment period (20 or 28 days))
C: Proportion and severity of local adverse events of Anfoleish or Vehicle when applied three or two times per day. (At the end of treatment (Day 28)); Clinical cure rates in two regimens of Anfoleish: Three times a day and Two times a day (Day 90)
D: Occurrence of dose-limiting toxicity; Adverse events

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).


Options:
A: Number of Participants With Clinical Response at Week 6 (Baseline, Week 6)
B: Remission without steroids, immunosuppressives and without colectomy (week 16)
C: Clinical and Endoscopic Remission. (8 weeks)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).


Options:
A: 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)
B: Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point (Week 10)
C: Proportion of Participants With Clinical Remission Per Mayo Score at Week 8 (Week 8)
D: Number of Participants With Clinical Response at Week 6 (Baseline, Week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).


Options:
A: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8 .
B: Number of Participants With Clinical Response at Week 6 (Baseline, Week 6)
C: 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)
D: Remission defined as a decrease in Mayo score to ≤ 2 points at week 4 (week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Cognitive Deficits Associated With Schizophrenia
Brief Summary: The primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia


Options:
A: cognition (six weeks)
B: Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests. (8 weeks)
C: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint (Baseline and Endpoint (Week 24 or last observation after baseline))
D: Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (Baseline and 4 weeks (or last observation after Baseline))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Teledermatology on Health Services Outcomes in the VA
Brief Summary: This study compares store and forward teledermatology with the conventional clinic-based consult process. Our primary objective is to determine whether the mean change in quality of life, as rated by the subscale scores and composite score on the Skindex-16 differs between the store and forward and conventional care modalities.


Options:
A: Safety and quality of health care (1 year)
B: Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score (Baseline to Month 9); Skindex-16 Change Scores Baseline to Month 3 - Composite Score (Baseline to Month 3); Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score (Baseline to Month 9); Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score (Baseline to Month 3); Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score (Baseline to Month 9); Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score (Baseline to Month 3); Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores (Baseline to Month 9); Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score (Baseline to Month 3)
C: Proportion of Participants that Receive Annual Eye Exam (Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study))
D: Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe
Brief Summary: This trial will address the question of whether early application of the Non-pneumatic Anti-Shock Garment (NASG) at the Satellite Health Facility (SHF) level before transport to a Referral Hospital (RH) will decrease maternal mortality and morbidity. The available evidence indicates that the NASG substantially decreases blood loss, but there is no evidence that its application will reduce extreme adverse outcomes. It is also not known if possible side effects associated with NASG use might outweigh potential benefits. This study would rigorously test the effectiveness of the NASG using an experimental design with adequate power to detect statistically significant decreases in morbidity and mortality.


Options:
A: Frequency of mortalities and frequency of severe morbidities combined as extreme adverse outcomes (during hospital stay)
B: Total measured blood loss (time frame is approximately 24 hours, until the balloon catheter is removed from the uterus)
C: Amount of blood loss (mL) (8 months)
D: Maternal death due to PPH or invasive procedures due to PPH (After delivery and before discharge from facility (usually within 48 hours after delivery)); Treatment of postpartum infection among women diagnosed with PPH (Within 4 weeks after delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.


Options:
A: Change in Mayo Score, Safety (At week 8)
B: Clinical Response at Week 8 Based on Mayo Score (Eight week treatment period)
C: Percentage of Participants With Clinical Response (Week 8)
D: Number of Participants in Clinical Response Through Week 54 (Induction Baseline, Week 0 through Week 54)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.


Options:
A: Percentage of Participants In Remission at Week 52 (Week 52)
B: Number of Participants in Clinical Response Through Week 54 (Induction Baseline, Week 0 through Week 54)
C: Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition) (Week 8); Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition) (Week 8); Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition) (Week 44); Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition) (Week 44)
D: Percentage of Participants With Remission at Week 8 (Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation Compared With Traditional Primary Care Concerning Sick-listing and Health-care Visits. A Randomized Controlled Trial, 18-month Follow-up
Brief Summary: BACKGROUND

Non-specific back and neck pain (BNP) dominates sick-listing. A program of cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month follow-up, with traditional primary care concerning sick-listing and health-care visits.

METHODS

After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (= full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were randomized to a rehabilitation center or continued health-center care. Outcome measures were Return-to-work (=the proportion who regained work ability for at least 30 consecutive days), the proportion with Work ability at different time points, Total sick-listing (expressed in whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months and corresponding six-month periods. For the analyses were used t-test, z-test, generalized estimating equations and a mixed, linear model.


Options:
A: Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing. (within 12 months)
B: Sickness leave (2008-2020)
C: Modified Von Korff Pain Scale for low back pain (baseline 1&2, 6, 12, 18, 24, 39, 52 weeks); Modified Von Korff Disability Scale (baseline 1&2, 6, 12, 18, 24, 39, 52 weeks)
D: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation Compared With Traditional Primary Care Concerning Sick-listing and Health-care Visits. A Randomized Controlled Trial, 18-month Follow-up
Brief Summary: BACKGROUND

Non-specific back and neck pain (BNP) dominates sick-listing. A program of cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month follow-up, with traditional primary care concerning sick-listing and health-care visits.

METHODS

After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (= full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were randomized to a rehabilitation center or continued health-center care. Outcome measures were Return-to-work (=the proportion who regained work ability for at least 30 consecutive days), the proportion with Work ability at different time points, Total sick-listing (expressed in whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months and corresponding six-month periods. For the analyses were used t-test, z-test, generalized estimating equations and a mixed, linear model.


Options:
A: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)
B: Brief Pain Inventory Interference (Measured at Year 1); HSCL-20 Depression Severity (Measured at Year 1)
C: Oswestry Disability Index; Cost-effectiveness (full economic analysis)
D: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year

Answer: A