TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Arthroscopic Partial Meniscectomy or Exercise Therapy as Treatment of Degenerative Meniscus Tears in Middle-aged Patients. A Randomized, Controlled Trial
Brief Summary: This study is conducted as a collaboration between NAR, Orthopedic Department, Oslo University Hospital,Ullevaal, Hjelp24Nimi Oslo, Martina Hansens Hospital Norway, and University of Southern Denmark, Odense, Denmark.

The investigators hypothesize that exercise is more effective than arthroscopic partial meniscectomy: a) on self-reported outcomes, functional performance and muscle strength in middle-aged patients subsequent to arthroscopic partial meniscectomy for a degenerative meniscus tear, and b) in preventing further development of knee osteoarthritis (OA).


Options:
A: KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale (12 month)
B: The Lysholm Knee Score (One year); Pain After Exercise (VAS) (One year); WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool) (One year)
C: KOOS4 - Change From Baseline (24 months); Peak Torque Knee Extension - Change From Baseline (at 3 months); Peak Torque Knee Flexion - Change From Baseline (3 months); Knee Osteoarthritis Incidence (5 years); Radiographic Progression (the Osteoarthritis Research Society International [OARSI] Atlas) [Time Frame: At 10 Years] (10 years)
D: the Knee Injury and Osteoarthritis Outcome Score (KOOS4) (Primary endpoint: Change from baseline to 12 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: ACTIVITAL: Health Promotion Intervention in Ecuadorian Adolescents to Promote Healthy Dietary and Physical Activity Patterns.
Brief Summary: Worldwide, low-income and middle-income countries are undergoing rapid demographic and nutritional changes. Populations tend to move from their traditional food habits towards dietary patterns characterized by a more energy-dense diet, while urbanization and technology (work, transport) play a role in the reduction of their physical activity. This shift towards energy-dense diets and lower levels of physical activity are key determinants of chronic diseases. Nowadays, childhood overweight and obesity are becoming a major threat to public health all in low-income and middle-income countries. Clearly, not properly addressing this health problem will only aggravate the already enormous impact of chronic diseases on the social and economic development of these countries. This study aims to develop a culturally relevant school-based prevention intervention among Ecuadorian adolescents (11-13 years old) in Cuenca. The intervention will target behavioural nutrition and physical activity. Intervention strategies will be developed based on theoretical behavioural change models integrated in two complementary frameworks, i.e. (i) the Intervention Mapping protocol, and (ii) the Comprehensive Participatory Planning and Evaluation protocol.

The study includes two phases:

1. A formative research, which will be conducted in order to understand the causality of the school environment and unhealthy eating and low physical activity levels in school-going adolescents, aged 12-13 years old.
2. A paired, cluster-randomized controlled trial including 1400 adolescents (12-13 years old) from 10 pairs of schools (i.e. clusters). Within each pair of clusters, one cluster will be randomly assigned to the intervention and the other to the control group.


Options:
A: Behavioural determinants of physical activity and nutrition by determinant questionnaire (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Physical activity, physical fitness and sedentarity (questionnaire and accelerometer) (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Food intake by 24h recall (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)
B: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
C: BMI (6 months)
D: Percent Body Fat (Baseline and One year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Trial of Subcutaneous Methylnaltrexone in the Treatment of Severe Opioid-induced Constipation in Cancer Patients
Brief Summary: The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving opioid-induced constipation in cancer patients at various stages of disease.


Options:
A: Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit (4 weeks and a 6 month open label); Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used (4 weeks and a 6 month open label)
B: Assess the efficacy of Targinact® treatment (12 weeks)
C: Efficacy of SC MNTX compared with placebo in inducing laxation (29 days)
D: Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone (4 hours after the dose of subcutaneous methylnaltrexone)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Trial of Subcutaneous Methylnaltrexone in the Treatment of Severe Opioid-induced Constipation in Cancer Patients
Brief Summary: The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving opioid-induced constipation in cancer patients at various stages of disease.


Options:
A: Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit (4 weeks and a 6 month open label); Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used (4 weeks and a 6 month open label)
B: Efficacy of SC MNTX compared with placebo in inducing laxation (29 days)
C: Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3) (4weeks)
D: Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone (4 hours after the dose of subcutaneous methylnaltrexone)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Ventilated Patients With Nosocomial Pneumonia Due to Gram Negative Organisms
Brief Summary: This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).


Options:
A: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
B: Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1 (Day 1)
C: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
D: Clinical Cure Rate at the End-of-treatment (EOT) Visit (End-of-treatment (Day 10 or Day 11))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A One Year Prospective, Randomized, Double Blind Interventional Study to Assess Tolerability, Quality of Life and Immunomodulation With Interferon Beta Combined With Vitamin D in Patients With Relapsing Remitting Multiple Sclerosis
Brief Summary: The investigators hypothesize that vitamin D supplementation may ameliorate interferon beta-induced flu-like symptoms, owing to reduced release and activity of the cytokines that are in correlation with this adverse event. Vitamin D supplementation may also positively affect injection site reactions due to its immunomodulatory effects. Vitamin D may also augment the therapeutic efficacy of interferon beta among multiple sclerosis (MS) patients. Vitamin D intake may influence melatonin levels of MS patients as they share the same nuclear receptor.


Options:
A: Percentage of Subjects With Disease Activity Free Status up to Week 48 (Up to Week 48)
B: Measure: the proportion of patients with P-PTH< 20 ng/l and S-OH(D)2 > 85 nmol/l at 6 and 12 months (one year)
C: The effects of two doses of vitamin D and placebo therapy on the change in the frequency of CD4 T cell subsets and cytokine responses of PBMC over 24 weeks of therapy from baseline. (This outcome measure will be assessed at baseline and at 24 weeks.)
D: Occurrence and severity of Interferon beta related Flu Like Symptoms and Injection Site Reactions. (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.
Brief Summary: The purpose of the clinical trial is to investigate whether low carbohydrate diet is better than the traditional diabetic diet in the treatment of patients with diabetes mellitus type 2, for blood sugar and body weight.


Options:
A: Hemoglobin A1c (22 weeks)
B: Laboratory findings and body composition (2 years)
C: Death, all-cause (Up to 7 years)
D: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.
Brief Summary: The purpose of the clinical trial is to investigate whether low carbohydrate diet is better than the traditional diabetic diet in the treatment of patients with diabetes mellitus type 2, for blood sugar and body weight.


Options:
A: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
B: Laboratory findings and body composition (2 years)
C: Hemoglobin A1c (22 weeks)
D: Hemoglobin A1c (Every sixth month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.
Brief Summary: The purpose of the clinical trial is to investigate whether low carbohydrate diet is better than the traditional diabetic diet in the treatment of patients with diabetes mellitus type 2, for blood sugar and body weight.


Options:
A: N/A
B: Laboratory findings and body composition (2 years)
C: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
D: Breast Cancer Recurrence (Lifetime)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.
Brief Summary: The purpose of the clinical trial is to investigate whether low carbohydrate diet is better than the traditional diabetic diet in the treatment of patients with diabetes mellitus type 2, for blood sugar and body weight.


Options:
A: Laboratory findings and body composition (2 years)
B: Lipid Analysis (June 2012); Body Weight Analysis (November 2011); Glycemic Control Analysis (June 2012); Blood Pressure (BP) Analysis (January 2012); Uric Acid Analysis (February 2012); "Catalytic" Fructose Across Cardiometabolic Endpoints Analysis (January 2012); Non-Alcoholic Fatty Liver (NAFL) Analysis (June 2012)
C: Change in body weight from baseline (4 weeks)
D: Physical Activity Energy Expenditure (kJ/Day or kcal/Day) (7 days (across 12 weeks) - Primary outcome at week 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.
Brief Summary: The purpose of the clinical trial is to investigate whether low carbohydrate diet is better than the traditional diabetic diet in the treatment of patients with diabetes mellitus type 2, for blood sugar and body weight.


Options:
A: Laboratory findings and body composition (2 years)
B: Breast Cancer Recurrence (Lifetime)
C: weight loss
D: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.
Brief Summary: The purpose of the clinical trial is to investigate whether low carbohydrate diet is better than the traditional diabetic diet in the treatment of patients with diabetes mellitus type 2, for blood sugar and body weight.


Options:
A: To assess the prevalence and 6-year progression rate of subclinical atherosclerotic disease in a population aged 40-54 years using basic and advanced cardiovascular imaging techniques. (20 years)
B: Hemoglobin A1c (baseline to 16 weeks)
C: Laboratory findings and body composition (2 years)
D: Change in body weight and lipid profile of diets with different protein composition in overweight and obese women.. (After 3 months of intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study Comparing Two Different Sirolimus-based Transition Regimens in African-American Renal Transplant Recipients
Brief Summary: This study's focus is to compare the level effectiveness and safety of regimens involving Sirolimus, Cellcept and steroid to Prograf, Sirolimus and steroid in African-American recipients of kidney transplants.


Options:
A: Equivalence of graft survival at month 12
B: GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation
C: Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection (12 months)
D: Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH) (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Clinic Test of Youth Anxiety and Depression Study
Brief Summary: Structured, manualized treatments have been developed for numerous mental health problems and disorders among children and adolescents, and a number of these have shown strong beneficial effects in clinical trials. Such findings have led to proposals that the empirically supported treatments be used to improve outcomes of conventional clinic treatment, which some research suggests may not be very effective. But can these lab-tested treatments actually work in service-oriented clinics with referred youth? Available evidence cannot tell us, because the therapists, conditions, and clientele in the laboratory efficacy tests tend to differ so markedly from those of clinical practice. To assess the clinical potential of efficacy-tested treatments, we need effectiveness research that tests these treatments in the crucible of clinical practice. To help begin this process, the proposed research focuses on a specific treatment program for a specific cluster of disorders: Kendall's (1994) cognitive-behavioral "Coping Cat" program for child and adolescent anxiety disorders. The program has shown unusually positive effects across a series of clinical trials in the U.S. and Australia, but it has never been tested in real-world clinical conditions. The proposed study will test the effectiveness of the treatment with clinic-referred youth, treated in community clinics, with the treatment carried out by clinic staff therapists. Some 128 youth, aged 9-14, referred for anxiety and diagnosed with anxiety disorders, will be randomly assigned to receive either the usual treatment in the clinic, or the Kendall program, carried out by clinic staff who have been trained to proficiency. Therapists for the two treatment conditions will also be chosen randomly, from a pool of volunteers. Outcome assessment at immediate post-treatment, 1-year, and 2-year follow-ups, will test effects across many outcomes. It is hypothesized that outcomes for youths treated using the cognitive-behavioral treatment will be superior to those treated using usual care.


Options:
A: Clinical Global Impression - Improvement Scale (Measured at Week 12)
B: Pediatric Anxiety Rating Scale. (Post-treatment, which is an average of 16 weeks after Baseline)
C: N/A
D: Clinical Global Impression Scale Improvement and Severity (After 12 weeks of treatment); Pediatric Anxiety Rating Scale (After 12 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).


Options:
A: Rate of moderate/severe exacerbations over a 52 week treatment period.
B: Change from baseline in trough FEV1 (Forced expiratory volume in one second) (after 12 weeks); Change from baseline in FEV1 2 hours post inhalation (after 12 weeks)
C: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
D: Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Phase II Clinical Trial to Evaluate Efficacy and Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme Patients After Complete Surgical Resection With Fluorescence Microscope
Brief Summary: 1. Primary outcome measure:

   a.Evaluation of the treatment impact on progression-free survival.
2. Secondary outcome measures:

   1. Safety evaluation.

      * Direct effects attributable cell obtaining and administration.
      * Adverse events during treatment.
      * Neurological deterioration quantified using the NIH Stroke Scale.
      * Autoimmune phenomena.
   2. Evaluation of impact on other efficiency clinical parameters.

      * Overall survival.
      * Quality of life measured with EORTC questionnaire.
   3. Study of specific immune response and correlates with clinical outcome.

      * Delayed hypersensitivity.
      * Humoral response to autologous tumor cells/tumoral lysate.
      * Cellular response (proliferation, cytokine production, specific cytotoxicity).
   4. Cell line characterization and correlate the final product with clinical efficacy.

      * Phenotypic studies.


Options:
A: Evaluation of the treatment impact on progression-free survival (5 years)
B: 6 Month Progression-free Survival (First day of treatment until progression or until 6 months mark)
C: Overall survival (12 months)
D: Progression Free Survival (PFS) time (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy
Brief Summary: This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.


Options:
A: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment (Baseline and 52 weeks); Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment (Baseline and 76 weeks)
B: Incidence of liver inflammation or injury greater than 3 times the upper limit of normal, as monitored by serum alanine aminotransaminase elevation. (At All Visits)
C: The First 3-point Major Adverse Cardiovascular Events (3P-MACE) (From randomization until individual day of trial completion, up to 432 weeks)
D: Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. (From week 0 to week 52.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Coumadin in Preventing Periprocedural Thrombo-Embolism as a Complication of Radio Frequency Catheter Ablation in High-risk Atrial Fibrillation Patients
Brief Summary: This study aims to explore the risk of periprocedural thromboembolic events in continuous versus interrupted Coumadin therapy in a large, randomized high-risk patient population undergoing radio-frequency catheter ablation for atrial fibrillation.


Options:
A: Number of Patients With Clinically-Significant Bleeding (Randomization to 1 month post catheter ablation); Number of Patients With Thrombotic Events (Randomization to 1 month post catheter ablation)
B: Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure. (Up to 6 years)
C: therapeutic ACT retention rate during procedure (2 years)
D: Absence of thromboembolic events 48 hours post-ablation (48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Micro Dose Gonadotropin-Releasing Hormone (GnRH) Agonist Flare up & Flare Protocol in Poor Responders in Assisted Reproductive Technology (ART) Cycle
Brief Summary: About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments have been suggested for increasing pregnancy rate. In this study, the investigators will compare the outcome of Microflare protocol and Flare up regimen in poor responders.


Options:
A: Number of metaphase II oocytes retrieved during the course of one treatment cycle (2 years)
B: Live birth rate (12 months)
C: Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles (Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose)
D: Number of mature follicles in the study and control group.

Answer: B