TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise-based Motivational Interviewing for Fibromyalgia
Brief Summary: Fibromyalgia (FMS), defined as the presence of both chronic widespread pain and the finding of 11/18 tender points on examination, affects 2% of the general population. Drug therapy for FMS is largely symptomatic as there is not yet a complete understanding of the pathogenesis of the disease. In the past 17 years, supervised aerobic exercise has emerged as an important treatment modality to improve pain, aerobic capacity, function, and well-being. Individuals who are able to adhere to exercise almost always maintain the symptomatic benefits of exercise. Unfortunately, the rate of exercise adherence six months after the completion of a well-structured supervised exercise program is disappointingly low. Furthermore, although the efficacy of supervised aerobic exercise in the research setting is well documented, the applicability of such intervention in the clinic setting is doubtful. Therefore, we propose to conduct the Research to Encourage Exercise for Fibromyalgia (REEF), a randomized attention-controlled trial whose primary aim is to evaluate the efficacy of telephone-delivered motivational interviewing (MI) to encourage exercise, in improving exercise adherence and self-report physical function (co-primary outcome measures) for FMS patients. REEF will enroll 200 FMS patients, randomizing them to either the MI group or the attention-control (AC) group. Participants from each group will receive a total of 6 telephone calls within a 12-week period. Prior to the phone calls, participants from both groups will receive an individualized exercise prescription and 2 supervised exercise training sessions to get them started on an exercise program. All subjects will undergo comprehensive outcome assessment at baseline, week 12, week 24, and week 36. The secondary aim of this proposal is to determine the mediators between MI and improvement in self-report physical function. The proposed research is significant because our focus is the promotion of adherence to an exercise program, of adequate intensity, in order to maximize functioning and well-being for patients with FMS. The use of a predominantly home-based exercise program and telephone-delivered MI by a trained licensed practice nurse (LPN) could potentially make the proposed intervention more accessible to the greater majority of FMS patients. Furthermore, if proven efficacious, MI could readily be applied to other chronically painful conditions (e.g. chronic back pain).


Options:
A: Aim 1: Test the feasibility and subject acceptability of a potentially objective tool (NFR) for measuring pain severity. (Baseline, Week 9, and Week 12)
B: Measure the effects of exercise-based MI intervention improving exercise adherence. (This is a five year study, each subject will participate in a 9-month study sequence)
C: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)
D: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Comparison of the Effect of Frequent Oral Dosing Versus Constant IV Infusion of Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers
Brief Summary: Patients with bleeding ulcers identified by endoscopy will be randomly assigned to receive an acid-blocking drug (called a proton pump inhibitor \[PPI\]) either by mouth every 3 hours for 24 hours or intravenously (IV) by constant infusion for 24 hours. A pH probe in the stomach will be used to determine intragastric pH (a measure of the acid production in the stomach) at baseline and during the 24 hours of therapy. The purpose of the study is to determine if the continuous intravenous administration of the drug provides better reduction of acid in the stomach than the oral administration.


Options:
A: Intragastric pH > 6 (24 hours)
B: rate of initial hemostasis and the rate of recurrent bleeding (72hr)
C: Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers (30 days after endoscopic therapy)
D: Re-bleeding within 14 days in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness in Type 2 Diabetes Patient With Metabolic Syndrome (Randomized, Double-Blind, Placebo-Controled, Cross-Over Study)
Brief Summary: Cilostazol is an antiplatelet agent used to reduce the symptoms of intermittent claudication. Cilostazol inhibits phosphodiesterase III (PDE III), which causes it to be a vasodilator and inhibitor of platelet aggregation. Recently there were report of beneficial effect of cilostazol like vasodilation, lipid metabolism, and cytokine production. But there were few clinical studies that support these effects of cilostazol. The purpose of this study is to evaluate the vasodilatory and anti-inflammatory effect of cilostazol presented by PWV and plasma adipocytokines.


Options:
A: Change From Baseline in Peak Walking Time (PWT) at Day 180 (Baseline, Day 180)
B: The effect on pulse wave velocity (PWV) (8 weeks)
C: Improvement in peak walking time at 26 weeks (26 Weeks)
D: Adherence to medication (One year after surgical or endovascular treatment for Intermittent Claudication)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)
Brief Summary: The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (At Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16 (At Week 16)
B: Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase (Baseline and Week 16 of the placebo-controlled phase)
C: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)
D: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)
Brief Summary: The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)
B: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)
C: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
D: The changes in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the carotid artery and ascending aorta in patients randomized to adalimumab as compared to patients randomized to standard non-systemic therapy. (Day -10 to -1, Day 105)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)
Brief Summary: The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.


Options:
A: Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis (12 weeks)
B: Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 (Week 24)
C: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)
D: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)
Brief Summary: The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12 (Week 12); Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12)
B: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)
C: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)
D: Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 (Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)
Brief Summary: The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.


Options:
A: Aortic Vascular Inflammation as Measured by FDG-PET/CT (baseline, 12 weeks)
B: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)
C: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 (12 Weeks)
D: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improved Delivery of Cardiovascular Preventive Care (IDOCC) Through Outreach Facilitation
Brief Summary: The aim of the proposed study is to implement and evaluate Outreach Facilitation as a means to increase the uptake of evidence-based practice for secondary prevention and management of patients with established CVD and cardiovascular risk factors, in primary care practices throughout the Champlain LHIN. This initiative centers on the use of an Outreach Facilitation Model, in which skilled health professionals known as facilitators (Practice Change Consultants) serve as an expert resource to primary care practices in three areas: a) practice performance assessment, feedback, and consensus building towards goal setting and implementation; b) clinical, technical, organizational resources and practical advice; and c) encouragement to face and move through the challenges associated with implementing system change.


Options:
A: Reduction in total cholesterol in the entire SHCS population (18 months)
B: Discussion with provider about CHD risk reduction; Stated plans for CHD risk reduction
C: Quality of care process index = ∑ of recommended services received by patient/ ∑ of the recommended services for which the patient was eligible (5 years)
D: Proportion of patients treated appropriately with respect to lipid-lowering therapy within four months after lipid testing (Measured at 2 years); Rate of appropriate treatment among patients with high blood pressure (Measured at 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improved Delivery of Cardiovascular Preventive Care (IDOCC) Through Outreach Facilitation
Brief Summary: The aim of the proposed study is to implement and evaluate Outreach Facilitation as a means to increase the uptake of evidence-based practice for secondary prevention and management of patients with established CVD and cardiovascular risk factors, in primary care practices throughout the Champlain LHIN. This initiative centers on the use of an Outreach Facilitation Model, in which skilled health professionals known as facilitators (Practice Change Consultants) serve as an expert resource to primary care practices in three areas: a) practice performance assessment, feedback, and consensus building towards goal setting and implementation; b) clinical, technical, organizational resources and practical advice; and c) encouragement to face and move through the challenges associated with implementing system change.


Options:
A: Change in stigmatizing attitudes, as measured by the Social Distance questionnaire (Baseline, post-training (immediately after 10-day training curriculum), +4 months, + 16 months)
B: Quality of care process index = ∑ of recommended services received by patient/ ∑ of the recommended services for which the patient was eligible (5 years)
C: Time-to-first HF rehospitalization or death during the 12-months post-discharge (12-months after discharge); Improvement in an opportunity-based composite score of adherence to quality metrics for HF. (Baseline to 12 months post discharge)
D: Change in uptake of shared decision-making from the patients' perspective (All clinics: baseline, 8 months, 16 months, 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain: A Randomized Clinical Trial
Brief Summary: A pulmonary recruitment maneuver at the end of surgery reduced shoulder pain as well as nausea and vomiting after laparoscopic surgery.


Options:
A: Intensity of shoulder pain (48 hours after discharge)
B: The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery (The first 48 hours after the surgery)
C: pain scores at varying time points pot operatively (48 hours)
D: Shoulder Pain (within 14 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
Brief Summary: Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin.


Options:
A: The First 3-point Major Adverse Cardiovascular Events (3P-MACE) (From randomization until individual day of trial completion, up to 432 weeks)
B: Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52 (Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis)
C: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 (Baseline and Week 52); Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104 (Baseline and Week 104)
D: Hemoglobin A1c (HbA1c) Change From Baseline to Week 52 (Baseline to 52 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients : A Prospective Randomized Double Blind Placebo Controlled Trial
Brief Summary: The purpose of this study is to determine whether simvastatin is effective in the improvement of IVF-ICSI outcome in Pcos patients.


Options:
A: Serum testosterone
B: Brachial Artery Flow-mediated Dilation (FMD) (baseline and 6 weeks)
C: ivf-et outcomes (14-20 days)
D: serum testosterone

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-arm, Open Label Multicenter Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of C.E.R.A. for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia
Brief Summary: This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Options:
A: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP (EEP (Week 16 to Week 24))
B: Median Time to First Cardiovascular Event (Up to 4 years)
C: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) (Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24)
D: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis
Brief Summary: PRIMARY HYPOTHESIS:

Compared with intensive medical therapy alone, intracranial angioplasty and stenting combined with intensive medical therapy will decrease the risk of the primary endpoint by 35% over a mean follow-up of two years in high-risk patients patients with 70% - 99% intracranial stenosis who had a transient ischemic attack (TIA) or stroke within 30 days prior to enrollment) with symptomatic stenosis of a major intracranial artery.

SUMMARY:

The best treatment for prevention of another stroke or TIA in patients with narrowing of one of the arteries in the brain is uncertain. A common treatment is the use of anti-clotting medications to prevent blood clots from forming in the narrowed vessel. There are a variety of medicines used for this purpose. These medications are usually taken for the rest of a patient's life.

However, a treatment that has been used successfully together with anti-clotting medications in patients with narrowing of the blood vessels of the heart is now being studied in the blood vessels of the brain. This treatment is called stenting.

Recent research has also indicated a benefit in prevention of recurring stroke by Intensive Medical Therapy, which is defined as treating risk factors for stroke like high blood pressure, elevated LDL (low density lipids - the "bad" form of cholesterol) and diabetes. The purpose of this study is to compare the safety and effectiveness of either Intensive Medical Therapy PLUS Stenting or Intensive Medical Therapy ONLY in preventing stroke, heart attacks or death.

The study will enroll patients over a 5 year period. Each participant will be involved in the study for a minimum of 1 year and a maximum of 3 years.

Fifty different medical centers in the United States are part of this study. Both the Clinical Coordinating Center and the Statistical Coordinating Center for the entire study will be located at Emory University.


Options:
A: stroke or death within 30 days after enrollment, any stroke in the territory of the symptomatic intracranial artery beyond 30 days through 12 months (12 months)
B: Rate of Stroke or Death Among Participants (within 72 hours of the procedure)
C: Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment. (Mean length of follow-up was 2.4 years)
D: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)

Answer: C