TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Combined Anodal TDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke
Brief Summary: Recent work showed that application of peripheral nerve and cortical stimulation independently can induce 10-15 % improvement in motor performance in patients with chronic stroke.

The purpose of this study was to compare in post-stroke hemiplegic patients the effect on motor recovery of one session of anodal transcranial direct current stimulation to the ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the same peripheral nerve stimulation combined with sham tDCS.

Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability of Ipsilesional M1(TMS) Follow-up: 30 days


Options:
A: Motor learning improvement with tDCS (Improvement on motor learning were recorded from baseline to 4 weeks after the intervention)
B: Jebsen-Taylor Hand Function Test (Baseline, Treatment days 1,5,10, Follow Up); Motor Activity Log Rating Scale (Baseline, Treatment Days 1,5,10 and Follow Up); Beck Depression Inventory (Baseline, Treatment days 1,5,10 and Follow up); Visual Analogue Scale for Anxiety (Baseline, Treatment days 1,5,10 and Follow Up)
C: Will include the accuracy (defined as the difference between the straight line connecting the origin and the target and the line followed by the subject) during reaching. One of the additional outcomes is the time to complete a reaching task.
D: Jebsen Taylor test (5-15-30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Combined Anodal TDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke
Brief Summary: Recent work showed that application of peripheral nerve and cortical stimulation independently can induce 10-15 % improvement in motor performance in patients with chronic stroke.

The purpose of this study was to compare in post-stroke hemiplegic patients the effect on motor recovery of one session of anodal transcranial direct current stimulation to the ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the same peripheral nerve stimulation combined with sham tDCS.

Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability of Ipsilesional M1(TMS) Follow-up: 30 days


Options:
A: Jebsen Taylor test (5-15-30 days)
B: Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke (assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.)
C: Upper Extremity Fugl-Meyer-Assessment (UEFMA) (1-7 days after the end of the intervention)
D: Change in Behavioural Inattention Test (BIT) (6 months post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Type 2 Diabetes Secondary Prevention Trial at the Reunion Island
Brief Summary: Three hundred and ninety height diabetic patients were educated during a week of hospitalisation (nutritional and physical-activity advices). After that, they were randomized in two groups : frequent follow-up (each three month) by educational nurses and dieteticians, versus no follow-up (control group). All patients were evaluated one year after their inclusion,by HbA1c (primary outcome), anthropometry, other cardiovascular risk factors, nutritionnal and physical-activity behaviours.


Options:
A: Hemoglobin A1c
B: Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg (4 months)
C: %HbA1c (at inclusion and at one year)
D: Pt. 1 Dilated Fundus Exam (DFE) (6-month follow-up assessment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis
Brief Summary: The purpose of this study is to determine whether milnacipran reduces widespread, non-joint pain in patients with rheumatoid arthritis (RA). The investigators will conduct a double-blind randomized crossover trial in subjects with RA to test the hypothesis that milnacipran improves widespread, non-joint pain. The investigators will also use data from the trial to determine whether response to milnacipran is associated with pain-modulating mechanisms from the central nervous system. The investigators hypothesize that response to milnacipran will be greater among patients with impaired central pain mechanisms than among patients with intact central pain modulating mechanisms.


Options:
A: Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits (at end of treatment, 15 weeks from baseline assessment)
B: Brief Pain Inventory (BPI) Change (Baseline to 6 weeks)
C: Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score (Baseline, 12 weeks)
D: Change from baseline in the endpoint mean pain score (14 weeks); Fibromyalgia Impact Questionnaire (14 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
Brief Summary: Approximately 60,000 premature infants are born each year who weigh less than 1,500 grams,many of whom sustain brain damage because of their prematurity. This study is designed to evaluate the long-term developmental effects of one promising neuroprotective treatment,erythropoietin (Epo), when given in the neonatal period. Using detailed neurodevelopmental testing and state-of-the-art brain imaging, we hope to determine whether this is an effective treatment to prevent brain injury associated with prematurity, and to lay the groundwork for further studies to improve the developmental outcome of infants delivered prematurely.


Options:
A: Number of Transfusions During Hospitalization (From birth to 36 weeks gestational age); Composite Cognitive Score at 18-22 Months Corrected Age (18-22 months)
B: Full Scale IQ, Performance IQ, Verbal IQ, Executive Function (42-48 months and 66-72 months)
C: Mental developmental index (Bayley II) and motor, visual and hearing impairment (at age of 24 months corrected for prematurity.)
D: Death or Neurodevelopment Impairment (18-22 Months Corrected Age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
Brief Summary: Approximately 60,000 premature infants are born each year who weigh less than 1,500 grams,many of whom sustain brain damage because of their prematurity. This study is designed to evaluate the long-term developmental effects of one promising neuroprotective treatment,erythropoietin (Epo), when given in the neonatal period. Using detailed neurodevelopmental testing and state-of-the-art brain imaging, we hope to determine whether this is an effective treatment to prevent brain injury associated with prematurity, and to lay the groundwork for further studies to improve the developmental outcome of infants delivered prematurely.


Options:
A: Death or Neurodevelopment Impairment (18-22 Months Corrected Age)
B: Mental developmental index (Bayley II) and motor, visual and hearing impairment (at age of 24 months corrected for prematurity.)
C: The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day). (one month); Time to stop parentral nutrition (one month); Day of onset of weight gain (one month); Duration of hospitalization (2 months)
D: Full Scale IQ, Performance IQ, Verbal IQ, Executive Function (42-48 months and 66-72 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.


Options:
A: Percentage improvement of PASI from baseline to Week 16 (Week 16)
B: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
C: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16)
D: PASI 75 (16 weeks); Physician Global Assessment, PGA (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.


Options:
A: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)
B: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.
C: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
D: Change in PASI score from baseline in the two groups (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.


Options:
A: Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 (from week 0 to week 12)
B: Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo (Baseline, Week 16 and Week 52 or 68)
C: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.


Options:
A: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
B: Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52. (Baseline, Week 52)
C: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of Pf-03049423 In Subjects With Ischemic Stroke
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following multiple dose administration to subjects with ischemic stroke. The study will also evaluate the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following 90 days of therapy. The study will also explore the relationship between PF-03049423 concentration and blood pressure.


Options:
A: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
B: Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (Up to 90 days); Major Hemorrhage (Up to 90 days)
C: Comparison of the frequency of mRS 0, 1, 2 at 90 days (at 90 days)
D: Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2) (Day 1 (Baseline) up to Day 90); Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern (Part 1* and 2) (Day 1 (Baseline) up to follow-up (28 days after Day 90)); Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern (Part 1* and 2) (Day 1 (Baseline) to Day 90); Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2) (Day 1 (Baseline) up to Day 90); Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2) (Day 1 (Baseline) up to Day 90); Number of Participants With Suicidal Behavior and/or Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Part 1* and 2) (Day 7 (Baseline) up to follow up (28 days after Day 90)); Percentage of Participants With Modified Rankin Scale (mRS) Less Than or Equal to (<=2) at Day 90 (Part 2) (Day 90)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Atorvastatin on the NO-system in Patients With Type 2 Diabetes and Nephropathy
Brief Summary: It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in patients with type 2 diabetes with nephropathy.


Options:
A: The primary outcome is the time to occurrence of a major; cardiovascular event, defined as the composite outcome of the; following clinical endpoints; CHD death; Non-fatal/Non-procedure related MI; Resuscitated cardiac arrest or fatal/non-fatal stroke
B: Raw Urine Osmolality value at 12 week follow-up, adjusted for baseline (UOsm in mOsm/Kg) (12 weeks follow-up)
C: 24-hour urinary protein excretion rate, at the end of 6 months treatment phase (At 0, 2,3,4,5,6,7,8,9,10 months.)
D: Fractional excretion of sodium (5 days treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Treatment Versus Optimal Medical Treatment of Atherosclerotic Renal Artery for Preserving Renal Function of the Ischemic Kidney.
Brief Summary: Renal atherosclerotic stenosis (RAS) is a prevalent cause of secondary hypertension (HT). Since there are still uncertainties as to whether and in what patients revascularization by means of percutaneous renal angioplasty (PTRAS) should be pursued, we designed a study exploiting an optimized patient selection strategy and using hard experimental endpoints to unravel these uncertainties.

Primary objective: to determine if revascularization by means of PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate in the ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan.

Secondary objectives: to determine if the two treatments are equivalent in lowering blood pressure (BP), preserving overall renal function and regressing damage in the target organs of hypertension.

Design: prospective multicenter randomized, unblinded two-arm study.

Eligible patients will have clinical and/or radiological evidence of unilateral or bilateral RAS, defined by stenosis of the proximal portion of the renal artery and its main bifurcations at angioCT. Duplex scan will exclude nephroangiosclerosis as the latter could bias the assessment of the outcome of revascularization.

Inclusion criteria. RAS affecting the main renal artery or its major branches at angio-CT either \> 70% or, if \< 70 with post-stenotic dilatation.

Renal function will be assessed with 99mTc-DTPA renal scintigraphy.

Sample size (30 patients per arm) was calculated to have a 90% power to detect a difference in means of GFR in the vascularized (or control untreated kidney) of 7.5 ml/min.

Arms

1. Revascularization: digital scan angiography and PTA with stenting of the renal artery at the ostium or at truncular level, plus optimal medical therapy.
2. Medical therapy: the drug regimen that had been optimized during the run-in period.

Experimental endpoints:

The absolute value of GFR assessed by 99TcDTPA in the ischemic kidney will be used as quantitative variable and compared between groups at each time point. A categorical definition of kidney loss, defined as a GFR in the ischemic kidney of \< 5 ml/min, will be also used and the rate of achievement of such endpoint will be compared.

Duration: 5 years.


Options:
A: Glomerular filtration rate in the ischemic kidney after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment. (24 months)
B: Difference between treatments in change of estimated glomerular filtration rate (eGFR) (12 months)
C: Dialysis; Death; Doubling of creatinine
D: Progressive renal function loss (= reduction in estimated Cr clearance by >20%) after 2 yrs follow-up, with an extended follow-up of 5 yrs

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Metformin on the Ovarian Response to Gonadotropins for in Vitro Fertilization Treatment in Patients With Polycystic Ovary Syndrome and Predictors of Poor Ovarian Response
Brief Summary: Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking.

On the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF cycles.


Options:
A: To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women (Vaginal ultrasound in pregnancy week 7)
B: Rate of cancellation due to low ovarian response (one month)
C: Total number of retrieved oocytes (Two weeks Metformin treatment)
D: Live birth rate (End of pregnancy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Metformin on the Ovarian Response to Gonadotropins for in Vitro Fertilization Treatment in Patients With Polycystic Ovary Syndrome and Predictors of Poor Ovarian Response
Brief Summary: Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking.

On the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF cycles.


Options:
A: Live birth rate
B: Rate of cancellation due to low ovarian response (one month)
C: Body mass index,Normalization of menses,Pregnancy,Hirsutism,Waist to hip ratio, Testosterone, Androstenedione, DHEAS,Progesterone, FSH, LH,Glucose, OGTT,Insulinemia,Total HDL and LDL Cholesterol, Triglycerides,Uric acid, Prostate specific antigen (4 months)
D: Clinical pregnancy (within 6 calendar months of randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Translating Habituation Research to Interventions for Pediatric Obesity
Brief Summary: The purpose of this center grant is to translate basic behavioral science on habituation theory into clinical intervention using a vertical hierarchical approach from laboratory studies to field studies to the clinical intervention to improve weight loss outcomes in pediatric obesity treatment.


Options:
A: Number of Targeted Products Selected Relative to Others (up to 8 months)
B: Change of Child Body Composition (Baseline to 6 months); Change Parent Body Composition (Baseline to 6 months)
C: Energy density of the diet (Weeks 0 and 13)
D: Overweight and obesity according to IOTF references (0-1-2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Translating Habituation Research to Interventions for Pediatric Obesity
Brief Summary: The purpose of this center grant is to translate basic behavioral science on habituation theory into clinical intervention using a vertical hierarchical approach from laboratory studies to field studies to the clinical intervention to improve weight loss outcomes in pediatric obesity treatment.


Options:
A: Energy density of the diet (Weeks 0 and 13)
B: Change of Child Body Composition (Baseline to 6 months); Change Parent Body Composition (Baseline to 6 months)
C: Intake of vegetables and fruit (One month)
D: 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)

Answer: B