TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Polycystic Ovary Syndrome (PCOS) - The Female Metabolic Syndrome Genes And Processes In The Aetiology And Pathogenesis Of PCOS And Identification Of New Treatment Strategies
Brief Summary: Hypothesis:

The overall hypothesis is that women with PCOS, both obese and non-obese, have larger adipocytes, altered metabolism and signs of inflammation in adipose tissue and that these changes are associated with high sympathetic nerve activity, hyperandrogenism hyperinsulinaemia, insulin resistance with progression to type II diabetes and cardiovascular disease (CVD) as well as psychological distress and reduced quality of life. Physical exercise and electro-acupuncture decrease high concentrations of androgens, induce regulare menstrual pattern, inhibits high sympathetic activity and restore the PCOS induced disturbances.


Options:
A: To measure if physical exercise and electro-acupuncture restores endocrine, neuroendocrine, metabolic and immunological disturbances related to sympathetic nerve activity as well as psychological distress and improve quality of life in women with PCOS. (One year)
B: Weight loss (One year)
C: Body mass index,Normalization of menses,Pregnancy,Hirsutism,Waist to hip ratio, Testosterone, Androstenedione, DHEAS,Progesterone, FSH, LH,Glucose, OGTT,Insulinemia,Total HDL and LDL Cholesterol, Triglycerides,Uric acid, Prostate specific antigen (4 months)
D: insulin resistance (10 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MEASURES OF GAIT AND SELF-REPORTED PAIN IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE: A RANDOMIZED, SINGLE-BLIND WASHOUT, DOUBLE-BLIND TREATMENT, DOUBLE DUMMY CROSS-OVER PILOT TRIAL USING PLACEBO, OXYCODONE AND CELECOXIB (A9011030)
Brief Summary: The Purpose of this trial is to evaluate the use of a cross-over trial design in an osteoarthritis population. We will determine the inter- and intra-subject variability in osteoarthritis (OA) endpoints and evaluate if efficacy can be detected by measuring OA endpoints following treatment with 2 different types of analgesics in a crossover study of this design.


Options:
A: Change From Baseline in Knee Pain Intensity Measured by Numeric Rating Scale (NRS) at Week 12 (Baseline, Week 12); Change From Baseline in Knee Pain Intensity Measured by Visual Analog Scale (VAS) at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Pain Subscale Score at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Physical Function Subscale Score at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Stiffness Subscale Score at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Total Score at Week 12 (Baseline, Week 12); Change From Baseline in Knee Adduction Moment at Week 12 (Baseline, Week 12); Change From Baseline in Quadriceps Inhibition at Week 12 (Baseline, Week 12); Change From Baseline in Peak Ground Reaction Force at Week 12 (Baseline, Week 12); Change From Baseline in Total Ground Reaction Force at Week 12 (Baseline, Week 12); Change From Baseline in Stride Length at Week 12 (Baseline, Week 12); Change From Baseline in Walking Speed at Week 12 (Baseline, Week 12); Change From Baseline in Cadence at Week 12 (Baseline, Week 12); Change From Baseline in Patient Global Assessment of Arthritic Condition (PGAAC) Score at Week 12 (Baseline, Week 12)
B: 5-Day Sum of Pain Intensity Difference (SPID5) (Day 1 to Day 5); Spontaneous Bowel Movements Per Week (SBMs/Week) (Week 1 to Week 2)
C: Number of Participants With Treatment-emergent Adverse Events (TEAE) (52 weeks)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigating the Effect of Intra-operative Infiltration With Local Anaesthesia on the Development of Chronic Postoperative Pain After Inguinal Hernia Repair. A Randomized Placebo Controlled Triple Blinded and Group Sequential Study Design
Brief Summary: The effect of intraoperative infiltration of the operation site with bupivacain on the development of chronic pain is the object of our trial. We hypothesize that the occurrence of chronic pain in the goup of patients receiving the infiltration will be 50% less than in the placebo group receiving normal saline. The study is a randomized controlled triple blinded trial with a sequential study design.


Options:
A: The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period. (24 hours)
B: opiate consumption (hospital discharge/ days 0-7)
C: occurrence of chronic pain (3 months)
D: Evaluation of chronic postsurgical pain. (After 3 and 12 months of surgery.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigating the Effect of Intra-operative Infiltration With Local Anaesthesia on the Development of Chronic Postoperative Pain After Inguinal Hernia Repair. A Randomized Placebo Controlled Triple Blinded and Group Sequential Study Design
Brief Summary: The effect of intraoperative infiltration of the operation site with bupivacain on the development of chronic pain is the object of our trial. We hypothesize that the occurrence of chronic pain in the goup of patients receiving the infiltration will be 50% less than in the placebo group receiving normal saline. The study is a randomized controlled triple blinded trial with a sequential study design.


Options:
A: total morphine consumption (7 days after surgery)
B: Pain, Cumulative Visual Analog Score, 1st Follow Up (about 4 to 5 weeks after surgery); Pain, Cumulative Visual Analog Score, Final Follow up (about 18 to 20 weeks after surgery)
C: occurrence of chronic pain (3 months)
D: The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period. (24 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigating the Effect of Intra-operative Infiltration With Local Anaesthesia on the Development of Chronic Postoperative Pain After Inguinal Hernia Repair. A Randomized Placebo Controlled Triple Blinded and Group Sequential Study Design
Brief Summary: The effect of intraoperative infiltration of the operation site with bupivacain on the development of chronic pain is the object of our trial. We hypothesize that the occurrence of chronic pain in the goup of patients receiving the infiltration will be 50% less than in the placebo group receiving normal saline. The study is a randomized controlled triple blinded trial with a sequential study design.


Options:
A: Average Pain Score at Rest (48 hours); Average Pain Score With Coughing the First Morning Following Surgery (First morning following surgery); Average Pain Score With Coughing on Second Morning After Surgery (Second morning after surgery)
B: occurrence of chronic pain (3 months)
C: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)
D: The primary aim of this study was to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay. (April, 2007)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events
Brief Summary: The purpose of REAL-LATE (Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated with Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between clopidogrel use and long-term rates of cardiac death or MI after DES implantation in real-world practice and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.


Options:
A: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
B: Occurrence of myocardial infarction,stroke or cardiovascular death.
C: The composite of cardiac death or MI in the intent-to-treat population (1 year after randomization)
D: Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) (randomization through 48 hours after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events
Brief Summary: The purpose of REAL-LATE (Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated with Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between clopidogrel use and long-term rates of cardiac death or MI after DES implantation in real-world practice and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.


Options:
A: The composite of cardiac death or MI in the intent-to-treat population (1 year after randomization)
B: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
C: MACE events (6 months)
D: Occurrence of myocardial infarction,stroke or cardiovascular death.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair.
Brief Summary: The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.


Options:
A: Number of Subjects With Breast Implant Rupture (12 to 24 months post surgery)
B: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours (0 to 72 hours)
C: Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores (0-24 hours)
D: Total Opioid Burden (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner); Health Economic Benefits (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefit (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety, Efficacy, and Comparative Systemic Bioavailability of a Single Administration of SKY0402 Via Local Infiltration for Prolonged Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty.
Brief Summary: Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty


Options:
A: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4 (0 to 96 hours)
B: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours (0 to 72 hours)
C: Total Opioid Burden (Wound closure to time hospital discharge order written or Day 30, whichever is sooner); Health Economic Benefits - Total Cost of Hospitalization (Wound closure to time hospital discharge order written or Day 30, whichever is sooner.); Health Economic Benefits - Length of Stay (Up to Day 30)
D: Number of Subjects With Breast Implant Rupture (12 to 24 months post surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 36 Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant in Patients With Type 2 Diabetes
Brief Summary: A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients.


Options:
A: Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo (Baseline and 12 Weeks)
B: Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging.
C: change in percent atheroma volume at 12 months intravascular ultrasonography (12 months)
D: Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared With Sham in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion
Brief Summary: This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to central retinal vein occlusion (CRVO); 392 patients with CRVO were enrolled at 95 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).


Options:
A: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months (Baseline and 6 months)
B: N/A
C: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months (Baseline and 6 months)
D: Proportion of eyes with an improvement of more than 15 letters (approximately > 3 lines of visual acuity gain) after one year as compared to baseline

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared With Sham in Subjects With Macular Edema Secondary to Branch Retinal Vein Occlusion
Brief Summary: This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to branch retinal vein occlusion (BRVO); 397 patients with BRVO were enrolled at 93 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).


Options:
A: N/A
B: Integrity of retinal layers (End of study)
C: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months (Baseline and 6 months)
D: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months (Baseline and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Brief Summary: RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.


Options:
A: Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer. (3 months)
B: Stimulated ln (TNF-a) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-6) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-1b) (Immediately post-treatment and 3 months post-treatment); MFSI-SF Fatigue (Immediately post-treatment and 3 months post-treatment); Vitality, SF-36 (Immediately post-treatment and 3 months post-treatment); CES-D (Immediately post-treatment and 3 months post-treatment)
C: Quality of life (Participants will be followed over 8 weeks)
D: Patient perception and pattern of change (3 months of training followed by 6 and 12 months of no formal training)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Brief Summary: RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.


Options:
A: Bone mass-lumbar spine and hip (DEXA) (baseline, 12 months)
B: Percent interlimb difference, change over 12 months. (Baseline and 12 months)
C: Stimulated ln (TNF-a) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-6) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-1b) (Immediately post-treatment and 3 months post-treatment); MFSI-SF Fatigue (Immediately post-treatment and 3 months post-treatment); Vitality, SF-36 (Immediately post-treatment and 3 months post-treatment); CES-D (Immediately post-treatment and 3 months post-treatment)
D: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Brief Summary: RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.


Options:
A: Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL) (Baseline to up to 6 months); Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months); Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months)
B: Stimulated ln (TNF-a) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-6) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-1b) (Immediately post-treatment and 3 months post-treatment); MFSI-SF Fatigue (Immediately post-treatment and 3 months post-treatment); Vitality, SF-36 (Immediately post-treatment and 3 months post-treatment); CES-D (Immediately post-treatment and 3 months post-treatment)
C: Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) (2-24 months after surgery, chemotherapy, and/or radiation therapy)
D: quality of life, fatigue, and body weight (baseline, 6 months, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Community-based Obesity and Diabetes Prevention Program on Pregnant Outcomes in Pregnant Women
Brief Summary: The general goal of the present study is to assess the impact of a community-based exercise and dietary intervention in pregnant women living in urban areas during and after their pregnancy on the reduction of the risks of both diabetes and obesity in mothers and their offspring.

We hypothesize that a community-based lifestyle intervention program during and after gestation may improve pregnancy outcomes in terms of reducing the risk of developing obesity or type 2 DM in mothers and their children.


Options:
A: Excessive weight gain during pregnancy (2007-2023)
B: Maternal Weight Change (baseline to 2 weeks post partum)
C: Child body mass standard deviation score (On average 2.9 years of age)
D: Maternal weight gain in pregnancy (Measured at the time of delivery); Weight of the newborn (Measured at the time of delivery); Maternal fasting serum glucose level (Measured at gestational week 30); Incidence of operative delivery, both cesarean section and operative vaginal delivery (Assessed following delivery); Maternal body composition (Measured at 36 weeks of gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Community-based Obesity and Diabetes Prevention Program on Pregnant Outcomes in Pregnant Women
Brief Summary: The general goal of the present study is to assess the impact of a community-based exercise and dietary intervention in pregnant women living in urban areas during and after their pregnancy on the reduction of the risks of both diabetes and obesity in mothers and their offspring.

We hypothesize that a community-based lifestyle intervention program during and after gestation may improve pregnancy outcomes in terms of reducing the risk of developing obesity or type 2 DM in mothers and their children.


Options:
A: Gestational weight gain (4 years)
B: Diet; Physical Activity
C: Postpartum weight retention (no more than 1.5 years)
D: Excessive weight gain during pregnancy (2007-2023)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Non-Inferiority Trial of Sulfadoxine-Pyrimethamine Plus Artesunate Compared to Chloroquine for the Treatment of Vivax Malaria in Eastern Afghanistan.
Brief Summary: The purpose of this study was to determine whether the proposed first line treatment for falciparum malaria in this region (sulfadoxine-pyrimethamine + artesunate) would be no worse a treatment for vivax malaria that the standard vivax treatment of chloroquine. In areas where vivax and falciparum malaria co-exist misdiagnosis of vivax malaria as falciparum is not unlikely; it is important to know whether adequate treatment will be received in these cases.


Options:
A: Incidence of symptomatic malaria (due to any Plasmodium species) from 3 - 15 months of age (15 months); Incidence of symptomatic P. falciparum malaria from 3 - 15 months of age (15 months); Incidence of symptomatic P. vivax malaria from 3-15 months of age (!5 months)
B: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
C: Proportion of patients with parasitological cure up to day 28 after treatment (defined as clearance of circulating vivax parasites by day 7 and absence until end of follow-up).
D: Crude Cure Rate on Day 14 (Day 14)

Answer: C