TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus
Brief Summary: Objective:

* To improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and by helping primary care professionals to improve health care provided to patients.
* To assess the effectiveness and cost-effectiveness of two complex interventions (education and behavioural modification, independently and conjointly, for primary health care teams (PHCT) and patients and their relatives) to improve the health results in people with T2DM.

Methodology:

Design: Randomized clinical trial. Setting: Basic healthcare district in Canary Islands. Spain. Subjects: Patients with T2DM, 18-65 years old, without complications. Main measures: HbA1c, rate of patients with properly controlled T2DM. Sample: 2328 patients, 582 per arm. Intervention: G1: Interventions on the patients: Educational and habit modification group program. G2: Intervention on the PHCT: a) Educative intervention to improve the knowledge about the disease and their abilities; b) Computer-based clinical decision support system; c) Feedback of results. G3: Interventions on the patients and the PHCT. G4: Control group. Patients receive only the usual care.


Options:
A: Impact of mHealth app on rate of uninsured persons who are at risk and attend a first visit with a health professional at a local government primary care clinic. (6 weeks)
B: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)
C: Composite endpoint death and cardiovascular events (1-year after randomization); Hospitalization (1-year after randomization); Composite endpoint death and broader cardiovascular events (1-year after randomization)
D: Change in Glycosylated hemoglobin (HbA1c) (Baseline and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Solitaire™ FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Clinical Trial
Brief Summary: The primary study objective is to determine if subjects experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS) than those subjects treated with IV t-PA alone


Options:
A: Number of Participants With Angiographic Revascularization of the Occluded Target Vessel (At immediate post-procedure); Number of Device-related Serious Adverse Events (Within 24 hours post-procedure); Number of Procedure-related Serious Adverse Event (Within 24 hours post-procedure)
B: Complete recanalization percentage (Immediately after the revascularization procedure is completed)
C: Perfect reperfusion rate (24 hours)
D: 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Solitaire™ FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Clinical Trial
Brief Summary: The primary study objective is to determine if subjects experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS) than those subjects treated with IV t-PA alone


Options:
A: Feasibility of enrolling 12 subjects with major vessel occlusion within 1 year and random 1:1 assignment to treatment with IV (N=6) and IA (N=6) IA Activase using the following criteria: Time to clinical and radiological assessments (3 years); Time to IA Activase treatment (3 years); Preliminary safety assessment: 24 hour symptomatic ICH (3 years); Resources utilized and risk-benefit of IA Activase treatment. (3 years)
B: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
C: clinical (efficacy): favorable modified Rankin Score (less than or equal to 2) (3 months); Rate of symptomatic intracranial hemorrhage (24 hours)
D: 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Solitaire™ FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Clinical Trial
Brief Summary: The primary study objective is to determine if subjects experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS) than those subjects treated with IV t-PA alone


Options:
A: 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). (90 days)
B: Shift in the mRS score, defined by a proportional odds model. (90 days)
C: To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months. (3 months)
D: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable COPD
Brief Summary: Skeletal muscle dysfunction impairs exercise capacity, quality of life and prognosis in chronic obstructive pulmonary disease (COPD). The purpose of this prospective randomized controlled study was to evaluate effects of Neuromuscular electrical stimulation (NMES) plus quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training (control group) on muscle function, exercise capacity, health related quality of life, activities of daily living, and self-efficacy in patients with COPD who are eligible and able to participate in endurance training.


Options:
A: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)
B: VE/VCO2 slope (Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.)
C: Incremental shuttle walk test (10 weeks)
D: Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks (Baseline and 12 weeks post-intervention); Change From Baseline in Quadriceps Strength at 12 Weeks (Baseline and 12 weeks following the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable COPD
Brief Summary: Skeletal muscle dysfunction impairs exercise capacity, quality of life and prognosis in chronic obstructive pulmonary disease (COPD). The purpose of this prospective randomized controlled study was to evaluate effects of Neuromuscular electrical stimulation (NMES) plus quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training (control group) on muscle function, exercise capacity, health related quality of life, activities of daily living, and self-efficacy in patients with COPD who are eligible and able to participate in endurance training.


Options:
A: Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity) (1 week)
B: oxygen uptake (VO2) (during 30 minutes exercise)
C: VE/VCO2 slope (Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.)
D: Incremental shuttle walk test (10 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Robot-aided Therapy in Acute Stroke Patients for the Upper Limb Rehabilitation With Long-term Follow-up.
Brief Summary: Numerous studies showed that ascertaining the effectiveness of rehabilitative interventions on conditions leading to long-term disability, such as stroke, is a complex task because the outcome depends on many interacting factors. Several studies underline the importance of brain plasticity and its therapeutic potential in neurological disorders. Accredited theories of cortical reorganization after brain lesion endorse the use of early, intensive, repetitive, and context-related exercise as optimal strategies to promote motor relearning and minimize motor deficit. The use of robotic systems in upper limb motor rehabilitation programs has been already demonstrated to provide safe and intensive treatment to subjects with motor impairments due to a neurological injury: several studies showed the advantages of robotic therapy on chronic post-stroke patients, even if no consistent influence on functional abilities was found and evidence of better results providing intensive treatments, both robotic and conventional rehabilitative techniques, was found. Recent development and recent trial in robot-assisted rehabilitation has shown the great potential of robotic devices for delivering repetitive training, thus facilitating a high intensity and a large dose of training during sub-acute and chronic phases of stroke rehabilitation. The proposed project, through a randomized controlled observer-blind multicenter trial is aimed at evaluating the effectiveness of robot-assisted therapy as additional treatment to the standard physical therapy in the early phase after stroke onset and evaluating in conjunction with EEG and EMG recordings the effects of the rehabilitative treatments in a quantitative, measurable way, by providing reliable and objective methods for measuring functional recovery after stroke.


Options:
A: Fugl-Meyer (FM-SEC and FM-WH) (7 months); Motor-Functional Independence Measure (m-FIM) (7 months); Frenchay Arm Test (FA-T) (7 months)
B: Change from Baseline in Fugl-Meyer Scale at 28 weeks. (at inclusion, week 4 and week 28); Change from Baseline in Box and Block Test at 28 weeks. (at inclusion, week 4 and week 28.)
C: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment (Baseline to Final Training (6 weeks))
D: Wolf Motor Function Test (8 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for the Treatment of Gastrointestinal Haemorrhage: an International Randomised, Double Blind Placebo Controlled Trial
Brief Summary: Severe bleeding in the digestive system is a common symptom of many diseases. Each year, about 50,000 people end up in British hospitals because of this problem and about 5,000 of them die. The most common cause of this bleeding is stomach ulcers. In sub-Saharan Africa, schistosomiasis (parasitic worms) is responsible for about 130,000 deaths from stomach bleeding each year. From previous research in other bleeding conditions such as surgery and trauma, we know that a drug called tranexamic acid can reduce bleeding and save lives. We now want to do the HALT-IT trial to see if giving tranexamic acid can save lives and if there are any complications in people with severe bleeding from the digestive system.


Options:
A: Bleeding Scores (intra-operatively and up to 24 hours postoperatively)
B: Incidense of transfusion with allogenic blood products (During hospital stay or until 6 weeks postintervention)
C: The primary outcome is death from haemorrhage (within 5 days of randomisation)
D: Total units of allogeneic blood products (Up to 24 hours after investigational medicinal product (IMP) administration)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for the Treatment of Gastrointestinal Haemorrhage: an International Randomised, Double Blind Placebo Controlled Trial
Brief Summary: Severe bleeding in the digestive system is a common symptom of many diseases. Each year, about 50,000 people end up in British hospitals because of this problem and about 5,000 of them die. The most common cause of this bleeding is stomach ulcers. In sub-Saharan Africa, schistosomiasis (parasitic worms) is responsible for about 130,000 deaths from stomach bleeding each year. From previous research in other bleeding conditions such as surgery and trauma, we know that a drug called tranexamic acid can reduce bleeding and save lives. We now want to do the HALT-IT trial to see if giving tranexamic acid can save lives and if there are any complications in people with severe bleeding from the digestive system.


Options:
A: The primary outcome is death from haemorrhage (within 5 days of randomisation)
B: blood transfusion rate (two years)
C: Analgesic demand (Postoperative 24 hours); Stone clearance (3 months)
D: The change in urine NGAL/Cr value (2 hours preoperative and 2 hours postoperatively)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Preconditioning and Cerebral Small Vessel Disease
Brief Summary: The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a beneficial effect on outcomes of cerebral small vessel disease (CSV).


Options:
A: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
B: changes in brain lesions (0-24 months)
C: In-hospital death (Postoperative 30 days); Myocardial infarction (Postoperative 30 days); Stroke (Postoperative 30 days); Respiratory failure (Postoperative 30 days); Renal dysfunction (Postoperative 30 days); Renal failure (Postoperative 30 days); Cardiogenic shock (Postoperative 30 days); Gastrointestinal complication (Postoperative 30 days)
D: Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. (February 2012)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare the tolerability and acceptability of a formulation containing Hypertonic saline 7% (HS) alone and a formulation containing HS and Hyaluronic acid 0.1% in a population of Cystic Fibrosis (CF) patients who already showed poor tolerance to HS.


Options:
A: Comparison of the judgement on global pleasure of the inhalation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the symptom cough between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of saltiness between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of throat irritation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.)
B: Percent Mucociliary Clearance at 60 Minutes (60 minutes)
C: Interview #1 (to be conducted at the time of enrollment (post SIMPLIFY study)); Interview #2 (to be conducted 4 months following the date of the first interview)
D: Number of patients in both treatment groups with adverse events (AEs) and serious adverse events (SAEs) (during the 52 week treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare the tolerability and acceptability of a formulation containing Hypertonic saline 7% (HS) alone and a formulation containing HS and Hyaluronic acid 0.1% in a population of Cystic Fibrosis (CF) patients who already showed poor tolerance to HS.


Options:
A: Lung function (FEV1, FVC, FEF25-75)
B: Wet sputum production (45 minutes)
C: Changes in the Sino-nasal-outcome test SNOT-20 adapt CF (days 1, 29, 57 and 85)
D: Comparison of the judgement on global pleasure of the inhalation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the symptom cough between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of saltiness between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of throat irritation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure
Brief Summary: The purpose of this study is to determine the efficacy of the Heart Failure Exercise and Resistance Training (HEART) Camp behavioral exercise training intervention on long-term adherence to exercise at 18 months in patients with heart failure. The central hypothesis is that the HEART Camp intervention group (HC) will have significantly better adherence to exercise at 18 months.


Options:
A: Cardiac Rehabilitation Enrollment (12 weeks after patient is discharged from hospital)
B: Hospital admissions for any cause (Twelve months)
C: Adherence (Change in baseline adherence at 3 month and 6 month)
D: Adherence to exercise. (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
Brief Summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).


Options:
A: Progression-free survival (PFS) based on independent review committee (up to 6 years)
B: Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study (Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months)); Percentage of Participants With Best Overall Response in Phase II of the Study (by Cutoff Date: 31 March 2012 (within 3 years, 4 months))
C: Percentage of Participants With Overall Response At the End of Induction Period (Randomization to clinical cutoff: 01 September 2011 (Up to 70 days))
D: Progression-Free Survival (Randomization to End of Study (up to 60 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Blood Pressure and Endothelial Function Pregnancy After Acute and Daily Consumption Flavanol-rich Chocolate Among Healthy Pregnant Women: a Pilot Randomized Controlled Trial
Brief Summary: The purpose of this study is to to test the feasibility of design methods and procedures for later use on a larger scale and to examine the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function and blood pressure in healthy pregnant women.


Options:
A: An improvement of endothelial function as measured by flow-mediated dilation (FMD) (1 month)
B: endothelial function (acute (2 hours), chronic (2 and 4 weeks))
C: Endothelial function (Time points: day 0 [baseline], and day 30 each 0 and 2h.)
D: Changes in endothelial function and blood pressure (within the first 12 weeks of chocolate intake (week 12 and baseline))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Core Stabilization Enhance Neuromuscular Control and Functional Status of the Upper Extremity?
Brief Summary: The purpose of the study is to determine the effects of the addition of core stabilization exercises to a traditional upper extremity rehabilitation program in upper extremity injuries.


Options:
A: Gross Motor Function Measure, Sitting Section (2 months)
B: health of children (Pediatric Quality of Life Inventory) (changes from baseline at one and two months.)
C: Upper extremity functional status (30 minutes)
D: Gross Motor Function Measure-66 (GMFM) (Basline and Post Intervention); 600 Yard Walk-Run Test (Baseline and Post Intervention); 30 Second Walk Test (Basline and Post Intervention); Knee Flexor and Knee Extensor Torque (Basline and Post Intervention); Pediatric Quality of Life Inventory (PedsQL) (Basline and Post Intervention); Pediatric Outcomes Data Collection Instrument (PODCI) (Basline and Post Intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Comparing Efficacy of 8 Weeks Treatment With Clarithromycin and Rifampicin Versus Streptomycin and Rifampicin for Buruli Ulcer (M. Ulcerans Infection)
Brief Summary: This is a WHO-sponsored trial.

Combination therapy with streptomycin and rifampicin has been the standard antibiotic treatment for M. ulcerans infection since 2004. In March 2010, a WHO Technical Advisory Group recommended that a trial be carried out to develop a fully oral treatment for the disease. Although the current treatment is effective, injection with streptomycin is a problem. Several small observational studies (published and unpublished) have shown that a fully oral treatment is promising.

This WHO sponsored study will be a randomized, controlled open label non-inferiority phase II/III, multi-centre trial (1 centre in Benin and 4 centres in Ghana), with two parallel treatment groups. The ultimate goal is to search for an effective alternative treatment to the current standard WHO-recommended therapy for all forms of Buruli ulcer, which includes injections of streptomycin with inherent logistic, operational and safety disadvantages.

Financial and material support:

1. American Leprosy Missions, USA
2. Raoul Follereau Foundation, France
3. MAP International, USA
4. Sanofi, France
5. 7th Framework Programme of the European Union: BuruliVac project (241500)
6. Aranz Medical Limited, New Zealand


Options:
A: healing without recurrence and without debridement surgery at 12 months follow-up after start of treatment (12 months follow-up after start of treatment)
B: Unsatisfactory clinical outcome at week 96 after randomisation (96 weeks)
C: Healing without surgical intervention (one year)
D: healing without recurrence and without excision surgery (12 months after start of treatment)

Answer: D