TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study
Brief Summary: The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.


Options:
A: angiographic binary re-restenosis (12 months)
B: angiographic binary restenosis (12 months)
C: Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure (12 months post index procedure); Percentage of Participants With Primary Patency of the Target Lesion at 12 Months Post Index Procedure (12 months post index procedure)
D: Primary Patency (12 Month); Primary Safety Composite (12 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study
Brief Summary: The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.


Options:
A: Freedom From Target Lesion Revascularization (TLR) (6 months); Freedom From Major Adverse Events (MAE) (30 days)
B: Primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) and without target lesion revascularization (TLR) within 12 months. (1 year); Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure (30 days)
C: primary patency rate (6 months)
D: angiographic binary re-restenosis (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of the Effect of a Conjoint Analysis Based Values Clarification Exercise, Rating and Ranking Exercise, and Balance Sheet for Colorectal Cancer Screening and Prostate Cancer Screening Decision Making
Brief Summary: Participants will be recruited from the United States and Australia to take an online survey about colon cancer screening or prostate cancer screening. Individuals selected for both the prostate cancer survey and the colon cancer study will be randomized to take one of three survey types - balance sheet, rating and ranking or conjoint analysis. These surveys will help participants clarify their values and opinions about screening options for colon cancer or prostate cancer. Participants' responses to the online survey are measured at one point in time - the time at which the participant takes the survey.


Options:
A: Participant-reported most important attribute from survey (1 day)
B: Physical Activity (6 months)
C: Test if Chest Pain Choice Safely Improves Patient Knowledge. (Directly following intervention (on day 1))
D: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery
Brief Summary: The investigators have previously shown that elective vascular surgery is a high-risk operation with an anticipated risk of either death or heart attack of 15%. This study is testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior to the operation is safe, feasible and reduces the incidence of an adverse, perioperative cardiac complication.


Options:
A: occurrence of a pulmonary complication (Before the 48 hours after the beginning surgery); occurrence of a kidney complication (During the 8 days after surgery); occurrence of a pulmonary complication (During the 8 days after surgery); occurrence of a pulmonary complication (During the 48 hours after initial extubation)
B: Troponin I Elevation Above the Upper Reference Limit (URL) (Within 3 days of the vascular operation)
C: Carotide-femoral pulse velocity (24 h); Augmentation index (24 h)
D: Peak post-operative troponin (ng/L) (At 6-12, 24, 48, 72h)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Brain Morphometries in OA Patients Treated With Duloxetine
Brief Summary: This study aims to determine in people with knee Osteoarthritis (OA) if relief of pain after treatment with either duloxetine or placebo is associated with changes in brain anatomy.


Options:
A: Change in Brain Gray Matter Volume (16 weeks compared to baseline)
B: Pain reduction (16 weeks)
C: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)
D: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Brain Morphometries in OA Patients Treated With Duloxetine
Brief Summary: This study aims to determine in people with knee Osteoarthritis (OA) if relief of pain after treatment with either duloxetine or placebo is associated with changes in brain anatomy.


Options:
A: Brain Regional Gray Matter Density (2 weeks)
B: Change in Brain Gray Matter Volume (16 weeks compared to baseline)
C: Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score (Baseline, Week 13)
D: Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores (Baseline, Week 13)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CopenHeartVR - A Randomized Clinical Trial Investigating the Effect of Integrated Rehabilitation Versus Usual Care Without Physical Exercise After Heart Valve Surgery.
Brief Summary: The aim of the study is to investigate the effect of an integrated rehabilitation programme, consisting of physical exercise training and psycho-educational consultations, for patients after heart valve surgery.

The hypothesis is that integrated rehabilitation can improve physical capacity measured by V02 peak, self-rated mental health and life quality by validated questionnaires such as SF-36, and other objective parameters such as cardiac-specific biomarkers and echocardiographic measurements.


Options:
A: Improvement in mean daily number of steps (Improvement between baseline (during the last preoperative month) and first 3 (and 12) months after discharge.)
B: Change in physical capacity (1,4,12 months)
C: Change of peak oxygen uptake (Baseline to 8 weeks)
D: Proportion of patients willing to undertake cardiac rehabilitation following TAVR. (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blinded Placebo-Controlled Trial on the Routine Use of Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
Brief Summary: This is a randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy (MRM) for breast care.


Options:
A: Surgical Site infection (365 days after the procedure)
B: Surgical Site Infection (as defined by the Centers for Disease Control and Prevention) (Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days)
C: Drainage volume (7 days)
D: Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group). (1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, Placebo-controlled, 6 Treatment, 4 Period, Incomplete Cross-over Trial to Characterise the 24-hour Lung Function Profiles of Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg, 5/5 µg), Tiotropium (2.5 µg, 5 µg) and Olodaterol (5 µg) (Oral Inhalation, Delivered by the Respimat® Inhaler) After 6 Weeks Once Daily Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM]
Brief Summary: The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.


Options:
A: Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks (Baseline and Weeks 2 to 52)
B: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169. (1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.); Trough FEV1 Response on Day 170. (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170); Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) (Day 169)
C: Change From Baseline in Morning Pre-dose Trough FEV1 (At Week 24)
D: Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment. (day 1 and week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Comparison of a Low Fat or Low Carbohydrate Dietary Pattern for Weight Loss and Impact on Biomarkers Associated With Breast Cancer Risk in Overweight and Obese Premenopausal Women: Lifestyle Eating and Fitness
Brief Summary: The primary specific aim of this study was to determine if overweight and obese premenopausal women can lose weight and if long term weight loss impacts biomarkers associated with breast cancer risk.


Options:
A: Number of women who lose weight when following 1 of 2 different calorie-restricted diets (18 months)
B: Change in body weight (measured at Year 2)
C: Dietary intake (6 month)
D: body weight (prior to and after 4, 8, and 12 months of dieting)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: EVALUATION OF THE EFFICACY OF NOVEL IBUPROFEN ACETAMINOPHEN COMBINATION FORMULATIONS IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN
Brief Summary: This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.


Options:
A: Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing. (6 hours)
B: Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8) (From 0 hour up to 8 hours post-dose)
C: The visual analog scale (VAS) was used to measures levels of pain. (8 hours-time)
D: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) (0 to 8 hours); Time to Onset of Meaningful Relief (0 to 8 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Treatment in Opioid Dependent Chronic Back Pain Patients
Brief Summary: Chronic pain patients are treated with prescription opioids and many exhibit opioid addiction. Currently, there are no evidence-based guidelines to better manage patients with chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and methadone treatment in these patients. The investigators hypothesize that both buprenorphine and methadone treatment will reduce pain and addiction behaviors and increase functioning in these patients.


Options:
A: percentage of subjects abstinent from all opioids through the final day of detoxification (up to 12-week trial)
B: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 (12 weeks); The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment (12 weeks in Phase 2 period (i.e., 24 weeks into the study))
C: Analgesia (6 months)
D: Time to Relapse (Intent to Treat Population) (Weeks 3-24); Time to Relapse (Per Protocol Population) (Weeks 3-24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical and Immunological Study of Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata: A Randomized Controlled Clinical Trial
Brief Summary: Alopecia areata (AA) is a disease of the hair follicles with multifactorial etiology and a strong component of autoimmune origin. It is characterized by non-scarring hair loss on the scalp or any hair-bearing surface.

Various therapeutic agents have been described for the treatment of AA, but none are curative or preventive. The aim of AA treatment is to suppress the activity of the disease. Phototherapy in the form of topical psoralen and ultraviolet A (PUVA) has been a well documented therapy for AA since 1978.

A more recent technique of topical PUVA, namely phototoxic PUVA, has been adopted in two previous studies. Sessions were carried out once every 3 months, and a higher efficacy with more encouraging response rates in comparison to the conventional PUVA therapy has been documented. This assumed upper hand over the conventional PUVA might be due to increasing the amount of UV reaching the hair follicle cells and the surrounding inflammatory cells. Also it has been suggested that it might play a role as a powerful initiating agent of suppression through direct action at the DNA level. However, still the exact effect of this treatment has not been fully clarified.


Options:
A: Treatment success (After six months from onset of treatment)
B: Change in scalp surface area affected over time (24 weeks)
C: Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 (Week 36)
D: Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 (Baseline and 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Service members and veterans often experience symptoms of psychological trauma following combat deployments. While efforts are being made in the military and at the Veteran's Affairs to meet the large number of soldiers and veterans experiencing symptoms of psychological trauma, there remains a need to evaluate new treatments, particularly those that are designed to be brief in length.

A new therapy, known as Accelerated Resolution Therapy (ART), is a type of psychological therapy that is designed for rapid resolution of symptoms of psychological trauma. This approach uses a combination of talking and sets of eye movements guided by the therapist. During therapy, this interactive personal guidance is thought to be helpful in resolving problems (such as bad memories).

The purpose of this study is to:

1. Evaluate how effective ART is in treating symptoms of psychological trauma among non-active duty veterans who served in Operation Iraqi Freedom and Operation Enduring Freedom in Iraq and in Afghanistan or other combat conflicts.
2. Learn if there is improvement in symptoms of psychological trauma (such as bad memories, anxiety, depression, and guilt) after receiving Accelerated Resolution Therapy (ART).


Options:
A: Change of Points on Impact of event scale before and after Lifespan Integration treatment after a sexual trauma (3 weeks)
B: Change in PTSD Checklist (PCL-M) score from baseline to end of treatment (approximately 2 weeks)
C: Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores (2 weeks post-treatment)
D: PTSD Checklist (PCL) (Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Lengths of Treatment in Early-onset Ventilated Associated Pneumonia
Brief Summary: The duration of treatment of community acquired pulmonary infection varies between 5 and 14 days according to the authors (22), or even 3 days with new drugs having long half-life (2). For nosocomial pulmonary infection, treatment durations are not standardized (5). It is simply mentioned the concept of "usual" treatment of at least 15 days. However, recent studies used 10 days of treatment without significant decrease in the rate of healing compared to usual treatment. It is essential to clarify the optimal duration of antibiotic treatment. Indeed, any excessive extension of treatment may increase the occurrence of adverse effects (renal toxicities, hepatic...), and induce resistance of bacteria to antibiotics (selection pressure), colonization of the patient by Multiresistant bacteria and an increase in the cost of treatment


Options:
A: 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)
B: Cure of respiratory infection (21 days after inclusion)
C: Clinical Cure Rate at the End-of-treatment (EOT) Visit (End-of-treatment (Day 10 or Day 11))
D: mortality/survival (28 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose Study
Brief Summary: This study will evaluate the long-term efficacy and safety of low dose oral methylprednisolone compared to matching placebo, on a background of routine RAS inhibitor therapy, in preventing kidney events in patients with IgA nephropathy and features suggesting a high risk of progression.


Options:
A: Serum creatinine; 24 hour urinary protein excretion
B: Patients reaching full clinical remission of their disease (at the end of the 3 year study period.); GFR loss of 15 ml/min or higher from baseline GFR (at the end of the 3 year study period)
C: Change from baseline in urine protein creatinine ratio (9 months)
D: Progressive kidney failure (1-6 years); primary outcome for low dose cohort (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Validation of a Structured Training and Assessment Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery. A Randomized Controlled Study
Brief Summary: This study describes the development and validation of a structured training and assessment curriculum (STAC) for a basic laparoscopic procedure. The investigators hypothesized that residents trained using the STAC curriculum would demonstrate superior technical skills in the operating room compared to residents that were trained using a traditional curriculum.


Options:
A: Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation (3 months)
B: Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS) (4-6 weeks post-intervention)
C: Transfer of Skills to Clinical Colonoscopy (less than 2 weeks)
D: Technical skills (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.
Brief Summary: A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.

Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance.

Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.


Options:
A: Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event (Randomization to event or last known date if no event (up to approximately 52 months)); Time From Randomization to the First Component Event of MACE (Randomization to event or last known date if no event (up to approximately 52 months))
B: Lean body mass (approximately three years)
C: Changes in Physical Performance Measured by an Exercise Testing Regimen (baseline and 6 months)
D: Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12 (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A School-based Internet Obesity Prevention Program for Adolescents
Brief Summary: Compare the effect of the HEALT\[e\]TEEN program and a HEALTH\[e\]TEEN plus coping skills training delivered to high school students on BMI, nutrition and physical activity behaviors, and self-efficacy over 6 months.


Options:
A: Overweight and obesity according to IOTF references (0-1-2 years)
B: Change in Weight Status (baseline and 2 year follow-up)
C: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
D: BMI (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A School-based Internet Obesity Prevention Program for Adolescents
Brief Summary: Compare the effect of the HEALT\[e\]TEEN program and a HEALTH\[e\]TEEN plus coping skills training delivered to high school students on BMI, nutrition and physical activity behaviors, and self-efficacy over 6 months.


Options:
A: BMI (6 months)
B: 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)
C: Student: SSB Change From Baseline to 7-months (All Participants) (Baseline and 7-months)
D: Change in Body Mass Index (Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months)

Answer: A