TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: Study Protocol for a Randomized, Placebo-controlled Trial
Brief Summary: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide. So far, available therapies offer little or no proven benefit to CP/CPPS. The investigators design and implement this study is to assess efficacy of acupuncture therapy performed in the CP/CPPS .


Options:
A: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))
B: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
C: Six point drop in NIH-CPSI total Score
D: NIH-CPSI total score and change from baseline (baseline, week 1-8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Supported Discharge for Improving Functional Outcomes After Stroke
Brief Summary: The purpose of this pragmatic study is to investigate whether implementation of a comprehensive post-acute stroke service model that integrates Early Supported Discharge (ESD) and Transitional Care Management (TCM) for stroke survivors discharged home improves functional outcomes post-stroke, reduces caregiver stress, and reduces readmission rates.


Options:
A: Stroke Impact Scale (SIS-16) (post-stroke day 90)
B: percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications (participants will be followed for the duration of hospital stay, an expected average of 2 weeks); a composite measure score of performance measures (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
C: Difference in the percentage of patients who Door-to-Needle Time≤60min (Up to 24 hours)
D: functional gain as measured by motor FIM score (One year post team training intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Trial of Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency: if You Don't Tell, They Won't Know
Brief Summary: The current study was a double blind randomised controlled trial that compared radiofrequency ablation (RFA) versus conventional surgery (CS) in patients who served as their own controls and who had intact great saphenous veins (GSVs).


Options:
A: Number of Participants With Complete Closure of the Target Vein at 3 Months (3 months)
B: Occlusion rate (One year after the treatment); Freedom from reflux (One year after the treatment); Disease-specific quality of life (One year after the treatment); Occlusion rate (three years after the treatment); Freedom from reflux (three years after the treatment); Disease-specific quality of life (three years after the treatment); Occlusion rate (five years after the treatment); Freedom from reflux (five years after the treatment); Disease-specific quality of life (five years after the treatment)
C: cumulative probability of recurrent varicose vein within 24 months after treatment (24 months)
D: Change in intensity of hyper pigmentation using a scale of 0 to 10 (One week, one month and six months after surgery); Change in extension of hematoma using a scale of 0 to 10 (One week, one month and six months after surgery); Change in aesthetic results using a scale of 0 to 10 (One week, one month and six months after surgery); Change in pain levels using a scale of 0 to 10 (One week, one month and six months after surgery); Change in intensity of skin burns using a scale of 0 to 10 (One week, one month and six months after surgery); Change in presence of sensitivity alteration (One week, one month and six months after surgery); Change in presence of thrombophlebitis (One week, one month and six months after surgery); Change in presence of resection or occlusion of the great saphenous vein (One month, six months and 12 months after surgery); Change in presence of reflux in the sapheno-femoral junction and in the great saphenous vein (One month, six months and 12 months after surgery); Change in presence of complications (One month, six months and 12 months after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Individualized Management Based on Mobile Phone Platform in Diabetic Patients
Brief Summary: The purpose of this study was to explore a model suitable for the individualized diabetic management based on the mobile application coaching and demonstrate its effect among the diabetic mellitus population.


Options:
A: Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply. (12 months for each participant)
B: Hemoglobin A1c (6 months)
C: change in glycated hemoglobin levels (six months)
D: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled, Open-Label, Phase II-III Trial to Evaluate the Safety and Efficacy of Regimens Containing Bedaquiline and Pretomanid for the Treatment of Adult Patients With Pulmonary Multidrug Resistant Tuberculosis
Brief Summary: TB PRACTECAL is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary multi drug-resistant TB (MDR-TB).


Options:
A: Cure rate (6 months)
B: Stage 1:Percentage of patients with culture conversion in liquid media at 8 weeks post randomisation. (8 weeks post randomisation); Stage 1: Percentage of patients who discontinue treatment for any reason or die (8 weeks post randomisation); Stage 2: Percentage of patients with an unfavourable outcome (failure, death, recurrence, loss to follow-up) (72 weeks post-randomisation)
C: Number of Patients Converted to Sputum Culture Negative in Each Arm, With Data Censored at 4 Months. (Sputum smear conversion or max 4 months after the start of Linezolid therapy.)
D: Cumulative rate of serious adverse events - SAEs (measured as the number of SAEs per person days) during the period of study therapy and the four weeks of post-study therapy follow-up. (the period of study therapy (generally 16 weeks) plus the four weeks of post-study therapy follow-up.); Proportion of patients in each arm who complete 80% of the proposed regimen (90 doses) within 18 weeks of treatment initiation. (within 18 weeks of treatment initiation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multi-center Phase III Clinical Study to Assess the Efficacy and Safety of Surufatinib Compared to Placebo in Patients With Advanced Pancreatic Neuroendocrine Tumors
Brief Summary: A randomized, double-blind, placebo controlled, multi-center Phase III study to assess the efficacy of Surufatinib 300 mg once a day in treating advanced pancreatic neuroendocrine tumors.


Options:
A: Proportion of Patients Alive and Progression-free at 6 Months (6 months)
B: Progression Free Survival (PFS) (7 months after the last patient enrolled)
C: Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology (Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010)
D: Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review (Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Evaluation of the King Vision Video Laryngoscope aBlade System in Children
Brief Summary: The purpose of this study is to determine whether the Ambu KingVision videolaryngoscope performs as well as direct laryngoscopy for intubating small children and infants.


Options:
A: Number of Participants With Success in the First Attempt (at the time of intubation)
B: Success rate (5 minutes)
C: Time to Intubation (Assessed intraoperatively at time of intubation)
D: Endotracheal intubation success rate. (5 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SWITCH: EffectS of Non-nutritive sWeetened Beverages on appetITe During aCtive weigHt Loss
Brief Summary: The effects of non-nutritive sweetened (NNS) beverages on weight management and psychological indices of appetitive behaviour have not been assessed in both weight loss and maintained weight loss phases over the long term to determine whether NNS beverages may assist in efforts to lose weight and maintain weight loss and how this affects appetite expression (satiety, food choice, craving, ease of dieting etc.). Thus the present research will determine the impact of NNS beverages as compared to water on weight loss and weight loss maintenance, satiation, satiety, cravings for sweet, exercise efforts and mood state across both a period of weight-loss as well as a weight-maintenance phase. To determine if the effects of NNS on appetite are beneficial or detrimental to successful weight management, the study will also systematically compare the effects of NNS beverages, water and caloric beverages (CBs) on appetite (hunger, satiety, liking and wanting) and energy intake (including food choice and caloric compensation) across the whole day during active weight management in a subset of participants.


Options:
A: Initial change in weight (52 weeks)
B: This investigation is an equivalency trial to determine whether weight loss differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers at 12 weeks. (Data will be measured at 12 weeks.)
C: Weight change (0, 3, 6 months)
D: Body Weight (kg) (Six months); MR spectroscopy (Six months); Magnetic resonance imaging (Six months); Dual-energy X-ray absorptiometry (DEXA) scan (Six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Integrated-Delivery-of-Care Approach to Improve Patient Outcomes, Safety, Well-Being After Orthopaedic Trauma
Brief Summary: Orthopedic trauma is an unforeseen life-changing event. Nearly 2.8 million Americans sustain traumatic orthopedic injuries such as major fractures or amputation each year. Injury is treated in the hospital by physicians who medically stabilize and reconstruct the patient. Upon completion of their hospital stay, patients are discharged to begin their reintegration back into home and community activities. Despite high surgical success and survivorship rates, these injuries often result in poor quality of life (QOL)-related outcomes in otherwise healthy people. Fifty to ninety percent of patients develop severe psychological distress such as post-traumatic stress syndrome, depression or anxiety. Patients are often not provided the comprehensive support care and resources that are necessary to cope successfully with psychological stress and reintegrate into purposeful living. This is a major problem because high distress levels predict poor physical function, use of pain medications and low QOL. Survivors often cannot return to work, have persistent pain and experience social isolation. Distress worsens the self-perceptions of functional gain and efficacy and decreases personal fulfillment. Lingering psychological distress contributes to the development of other health problems and rebuilding of life is negatively impacted. The lack of psychosocial support contributes to injury re-occurrence, injury recidivism, re-hospitalizations and longer hospitalization stays, and higher personal and societal health care costs.

There is currently a lack of comparative efficacy research to determine which delivery approach produces greater improvements in the outcomes that are most desired by patients, specifically, functional QOL and emotional well-being. The proposed research will directly compare these delivery-of-care approaches and measure the patient-reported outcomes that are considered important to patients.


Options:
A: Post-traumatic Stress Disorder (chronic) by CAPS scores. (Four months, seven months, 14 moths, two years)
B: Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. (Change from baseline at weeks 2, 6 and 12)
C: Diagnosis of Post Traumatic Stress Disorder (3 months post critical illness)
D: PTSD Symptom Scale- I (PSS) (Measured 4 and 12 weeks post-trauma)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Clinical Trial for a Stepwise Progression in the Treatment of Cardiogenic Shock
Brief Summary: The purpose of this study is to evaluate efficacy and safety of i.v. adrenaline infusion as an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock, including ventricular mechanical support.


Options:
A: Survival at 60 days (60 days)
B: Responder Analysis - Peak Oxygen Uptake (Peak VO2) (Baseline to 6 months); Responder Analysis - Six (6) Minute Walk (6MW) Distance (Baseline to 6 months); Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score (baseline to 6 months); Number of Participant Deaths (12 months)
C: Left ventricular ejection fraction (LVEF) on day 30 (30 days)
D: Cardiac index (within 1 hour after device implantation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: GLP-1 Restores Altered Insulin and Glucagon Secretion in Post-transplantation Diabetes Mellitus
Brief Summary: Post-transplantation diabetes mellitus (PTDM) develops in 10-15 % of all renal transplant recipients within 10 weeks after transplantation, and has been associated with increased risk of cardiovascular disease and impaired patient survival. PTDM is primarily believed to be a variant of type 2 diabetes mellitus (T2DM), but the pathophysiology underlying the impaired glucose metabolism in renal transplant recipients with PTDM is unclear and some aspects are still poorly investigated. Hyperglycemic clamp investigations with concomitant infusion of glucagon-like peptide-1 (GLP-1) are warranted for a thorough characterization of the α-cell and β-cell function.

The primary objective of the present study is to investigate whether hyperglucagonemia is present in renal transplant recipients with PTDM. Furthermore, the investigators aim to examine the insulinotropic and glucagon suppressive effects of GLP-1 (compared to placebo) in PTDM patients during fasting glycemia and during hyperglycemic conditions (hyperglycemic clamp), respectively.


Options:
A: Concentration of glucagon during fasting glycemia and during hyperglycemic conditions measured in picomoles per liter (4 weeks)
B: OGTT-derived 2-hour blood glucose level (4 weeks after start of Empagliflozin treatment)
C: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (Time from randomisation up to end of follow-up (scheduled at week 109))
D: To assess whether monotherapy with Vildagliptin improve glycemic control in kidney transplanted patients with newly diagnosed NODAT as judged in OGTT 3 months after treatment start compared to placebo. (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically fruit and vegetable consumption. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with a control condition in which no rewards are offered. Study participants will provide reports of their fruit and vegetable consumption each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their fruit and vegetable consumption. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards.


Options:
A: Fruit and Vegetable Consumption, servings per week (3 weeks); Perceived Behavioral Control scale score (3 weeks); Attitudes scale score (3 weeks); Intrinsic Motivation scale score (3 weeks); Fruit and vegetable consumption, servings per week (5 weeks); Perceived Behavioral Control scale score (5 weeks); Attitudes scale score (5 weeks); Intrinsic Motivation scale score (5 weeks)
B: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
C: Change in physical activity (Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention)
D: Child anthropometry (Baseline. Up to 12 months. Up to 24 months.); Child food intake (Baseline. Up to 12 months. Up to 24 months.); Child health (Baseline. Up to 12 months. Up to 24 months.); Distribution of food intake within the household (Baseline. Up to 12 months. Up to 24 months.); Household food security (Baseline. Up to 12 months. Up to 24 months.); Maternal nutrition knowledge (Baseline. Up to 12 months. Up to 24 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically fruit and vegetable consumption. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with a control condition in which no rewards are offered. Study participants will provide reports of their fruit and vegetable consumption each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their fruit and vegetable consumption. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards.


Options:
A: Change in intake of the target vegetable (Change in intake of the target vegetable from Baseline to day 14)
B: Change from Baseline in physical activity level of children at 1 and 4 months (After 1 and 4 months); Change from Baseline in sedentary behavior of children at 1 and 4 months (After 1 and 4 months); Change from Baseline in healthy diet of children at 1 and 4 months (After 1 and 4 months)
C: 1 Year change in insulin resistance via HOMA-IR (Change during first year); 2 year change in insulin resistance via HOMA-IR (Change during 2 years)
D: Fruit and Vegetable Consumption, servings per week (3 weeks); Perceived Behavioral Control scale score (3 weeks); Attitudes scale score (3 weeks); Intrinsic Motivation scale score (3 weeks); Fruit and vegetable consumption, servings per week (5 weeks); Perceived Behavioral Control scale score (5 weeks); Attitudes scale score (5 weeks); Intrinsic Motivation scale score (5 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically fruit and vegetable consumption. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with a control condition in which no rewards are offered. Study participants will provide reports of their fruit and vegetable consumption each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their fruit and vegetable consumption. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards.


Options:
A: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
B: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
C: BMI and aerobic fitness (1 schoolyear)
D: Fruit and Vegetable Consumption, servings per week (3 weeks); Perceived Behavioral Control scale score (3 weeks); Attitudes scale score (3 weeks); Intrinsic Motivation scale score (3 weeks); Fruit and vegetable consumption, servings per week (5 weeks); Perceived Behavioral Control scale score (5 weeks); Attitudes scale score (5 weeks); Intrinsic Motivation scale score (5 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to peripheral muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major limitation of daily activity and quality of life. Technologies likes' neuromuscular electrical stimulation (NMES) are currently being adapted and tested to support exercise training.

The investigators hypothesized that functional electrical stimulation cycling improves VO2 and aerobic capacities during exercise compared to endurance training.


Options:
A: Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity) (1 week)
B: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)
C: oxygen uptake (VO2) (during 30 minutes exercise)
D: VE/VCO2 slope (Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: B-slim, a Multi-source Digital Super Coach for Sustainable Weight Loss
Brief Summary: The purpose of this study is to carry out a field trial to evaluate the effectiveness and added value of the b-SLIM digital Super Coach in a convenient sample of overweight and obese adults.


Options:
A: weight reduction (at 6 months)
B: Weight maintenance 12 months after weight loss intervention (15 months)
C: Weight Loss (Omron Weight Balance) (12 weeks)
D: Weight loss (3 months, 6 months, 12 months)

Answer: C