TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Direct Current Stimulation Versus Sham for Treatment of Fibromyalgia: a Double Blinded Randomized Controlled Trial
Brief Summary: The aim of this study is to assess the effectiveness of transcranial direct current stimulation (tDCS) in treating fibromyalgia.

Participants will be randomly assigned to one of the two groups: Group I (Intervention group) tDCS (2mA for 25 minutes on 5 consecutive days/week for 2 weeks with the anode centered over M1 bilaterally Anodal tDCS for 20 minutes at 1.5 mA (15 s ramp in and 15 s ramp out) will be applied daily for 10 consecutive days (5 sessions/week) . The anodal electrode (24 cm² with current density of 0.08 mA (2mA/24 cm²) will be placed over the left primary motor area in group I, and the reference electrode (24 cm² will be fixed over the contralateral arm (extracephalic).

Daily tDCS was given to prolong and stabilize these long-lasting after-effects. Group II will receive sham tDCS will be applied using the above described parameters in group I. For sham tDCS, the placement of the electrodes, current intensity, and ramp time was identical to real tDCS stimulation group; however, the stimulation lasted only for 30 Sec. However, since none of the patients have been experienced tDCS previously, they were unaware of which stimulation is real and which sham is. The investigator responsible for delivering tDCS had no contact with the patients. All study participants will be followed up by the same evaluation sheet and by an evaluator who are blinded to the type of intervention she /he has received.Evaluation will be done pre assessment, post 5 sessions, post 10 sessions, post one month and post 2 months by using wide spread pain index (WPI) \& symptoms severity of fibromyalgia, measuring visual analogue scale (VAS), Depression and anxiety will be assessed using Hamilton Depression Scale (HDS) and anxiety scale, pain sensitivity threshold by using Electronic Von Frey unit EVF4 . Determination of human beta-endorphin level before start sessions and after end 10 sessions.


Options:
A: Changes in the Visual Analog Scale for Phantom Limb Pain (4 weeks)
B: Pain severity (up to three months after the end of treatment)
C: Analgesic efficiency (36 months)
D: Change in pain Scores as measured by the Visual Analog Scale (2 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aim of the present study was to determine the effects of fortified soy milk with L. planetarium A7 on a cytokine receptor, an adipokine and renal function biomarkers in type II diabetic patients with nephropathy.


Options:
A: Plasma level of p-cresol sulfate (8 weeks)
B: inflammatory adipokine- Progranulin (PGRN) (8 week); cytokine receptor -soluble tumor necrosis factor receptor 1 (sTNFR1), (8 week); serum levels of Neutrophil gelatinase-associated lipocalin (NGAL) (8 week); cystatin C (Cys- C) (8 week)
C: Indoxyl Sulfate concentration (Through study completion, an average of 60 days)
D: Uremic toxicity evaluated by serum and urinary levels of p-cresyl sulfate and indoxyl sulfate (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Carbamazepine and Oxcarbazepine on Serum Neuron-specific Enolase and S100B in Focal Seizures
Brief Summary: The present study has been planned to assess the level of serum neuron-specific enolase (NSE) in focal seizures and its changes after antiepileptic therapy.


Options:
A: The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase (112 days)
B: Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject (6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject); Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject (6 consecutive months (26 consecutive weeks) of treatment); Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) (Duration of the Treatment Phase (up to 113 weeks)); Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) (Duration of the Treatment Phase (up to 113 weeks)); Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks) (Duration of the Treatment Phase (up to 113 weeks))
C: Serum neuron-specific enolase (NSE) and S100B (Change from baseline over 4 weeks)
D: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b Study of JCAR014, Autologous T Cells Engineered to Express a CD19-Specific Chimeric Antigen Receptor, in Combination With Durvalumab (MEDI4736) for Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Brief Summary: This phase Ib trial studies whether anti-CD19-chimeric antigen receptor (CAR) lentiviral vector-transduced autologous T cells (JCAR014) and durvalumab are safe in combination and can work together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). JCAR014 is made of each patient's immune cells (T cells) that have a new gene added to them in a laboratory, which programs them to kill lymphoma cells. Durvalumab is a type of drug called a monoclonal antibody, targeted to PD-L1 that may help immune cells attack cancer cells more effectively and thus help JCAR014 work better.


Options:
A: Count of Participants Who Experienced Adverse Events (28 days post last infusion of Durvalumab, up to 1 year); Dose Limiting Toxicity (DLT) Rates (28 days post first infusion of Durvalumab (for participants in Group 1) or 28 days post infusion of JCAR (for participants in Group 2)); Highest Treatment Dose Administered on Study (28 days); Maximum JCAR014 Cmax by Flow Cytometry (Up to 12 months); Area Under the Curve (AUC) of JCAR014 by Flow Cytometry (Up to 28 days); Maximum JCAR014 Cmax in Blood by Quantitative Polymerase Chain Reaction (qPCR) Analysis (Up to 12 months); AUC of JCAR014 Cells by qPCR Analysis (Up to 28 days); Time to Loss of JCAR014 Detection in Blood by qPCR Analysis (Up to 12 months, +/- 30 days)
B: Overall Response Rate (ORR) (From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months))
C: Death Within 8 Weeks of the Study Cell Infusion Thought to be Definitely or Probably Related to Chimeric Antigen Receptor (CAR) T Cell Therapy (Within 8 weeks of the study cell infusion); Dose Limiting Toxicities (30 days); Objective Response Rate of Complete Response and Partial Response (Up to 1 year); Overall Survival (Up to 1 year); Progression Free Survival (Up to 1 year)
D: Occurrence of study related adverse events (Until week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Oxygenation by 100% Oxygen Via High Flow Nasal Cannula During Apnea in Adult Elective Surgical ENT Patients
Brief Summary: Oxygenation with high-flow nasal cannula with 100% oxygen has only been evaluated in a limited number of studies. Although data are convincing it is of importance to evaluate this new concept in our department before implementing it into clinical practice.

The general purpose of this project is to evaluate a new ventilation strategy during ENT-surgery based on oxygenation with high-flow nasal cannula with 100% oxygen with focus on gas exchange.


Options:
A: Following the induction of general anaesthesia and muscle relaxation, the time (minutes and seconds) to peripheral oxygen saturations (SpO2) of 92%. Comparing pre-oxygenation with standard face mask oxygen or THRIVE technique. (Eighteen (18) minutes maximum)
B: Change in arterial carbon dioxide (pCO2) (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes); Change in arterial pH (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes); Change in arterial oxygen tension (pO2) (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes)
C: Lowest noninvasive oxygenation value (Within 3 hours, beginning from the administration of the sedation or the neuromuscular blocker till the placement of the endotracheal tube); First pass success rate (With in 3 hours of the start of procedure for placement of endotracheal tube)
D: Reintubation (within 72 hours after extubation or at ICU discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Research Study Comparing Online Pulmonary Rehabilitation 'myPR' Versus Conventional Pulmonary Rehabilitation for Patients With COPD
Brief Summary: Over time, patients with COPD (Chronic Obstructive Pulmonary Disease) develop progressive symptoms of breathlessness, which can limit day-to-day activities and tolerance to exercise. Pulmonary Rehabilitation (PR) is an established intervention in the management of COPD and is a structured programme of exercise training and education. Pulmonary Rehabilitation encourages and enables patients to improve their exercise capacity incrementally over the course of a six-week programme. An established evidence base has placed PR at the centre of interventions for COPD and its provision is mandated by NICE as a key pillar of integrated care.

Currently, the provision of PR in the NHS is limited to group sessions run over an established protocol of 6 weeks. Whilst this has been demonstrated to improve exercise capacity, access to PR classes can be problematic for some patients. Also, staff and facility resources limit delivering the programme at scale. An online PR programme developed by my mhealth known as 'myPR', in consultation with patients and physiotherapy experts, offers an alternative provision of this important intervention.

The study aims to compare this online PR programme to conventional face-to-face PR as currently delivered by the NHS. The study aims to recruit 106 patients referred for PR from Portsmouth Hospital and local Participant Identification Centres.They will then be assessed for suitability onto PR, consented and randomised onto an arm of the study. 36 will undertake a conventional PR programme as reflected in the NHS, and 70 the online PR programme known as 'myPR'. Pre and post programme measurements including walking distance and quality of life questionnaires will then be compared between each arm of the trial, to ensure that the online PR is not inferior to the conventional face-to-face PR.


Options:
A: Number of Participants with Hospital Readmission at 6 months (6 months)
B: Dyspnea with ADL (3, 6, and 12 months); Exercise and functional performance (3, 6, and 12 months); Exercise adherence (3, 6, and 12 months); Acute COPD exacerbations (3, 6, and 12 months)
C: Six Minute Walk Distance (6 weeks); COPD Assesment Tool (CAT) (6 weeks)
D: Change in 6-Minute Walk Test Distance (6MWT) (baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Research Study Comparing Online Pulmonary Rehabilitation 'myPR' Versus Conventional Pulmonary Rehabilitation for Patients With COPD
Brief Summary: Over time, patients with COPD (Chronic Obstructive Pulmonary Disease) develop progressive symptoms of breathlessness, which can limit day-to-day activities and tolerance to exercise. Pulmonary Rehabilitation (PR) is an established intervention in the management of COPD and is a structured programme of exercise training and education. Pulmonary Rehabilitation encourages and enables patients to improve their exercise capacity incrementally over the course of a six-week programme. An established evidence base has placed PR at the centre of interventions for COPD and its provision is mandated by NICE as a key pillar of integrated care.

Currently, the provision of PR in the NHS is limited to group sessions run over an established protocol of 6 weeks. Whilst this has been demonstrated to improve exercise capacity, access to PR classes can be problematic for some patients. Also, staff and facility resources limit delivering the programme at scale. An online PR programme developed by my mhealth known as 'myPR', in consultation with patients and physiotherapy experts, offers an alternative provision of this important intervention.

The study aims to compare this online PR programme to conventional face-to-face PR as currently delivered by the NHS. The study aims to recruit 106 patients referred for PR from Portsmouth Hospital and local Participant Identification Centres.They will then be assessed for suitability onto PR, consented and randomised onto an arm of the study. 36 will undertake a conventional PR programme as reflected in the NHS, and 70 the online PR programme known as 'myPR'. Pre and post programme measurements including walking distance and quality of life questionnaires will then be compared between each arm of the trial, to ensure that the online PR is not inferior to the conventional face-to-face PR.


Options:
A: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)
B: Six Minute Walk Distance (6 weeks); COPD Assesment Tool (CAT) (6 weeks)
C: Changes in EQ ED From Baseline to 3 Months Endpoint (Baseline and change at 3 months); Changes in the Symptom Burden of Disease From Baseline to 3 Months (Baseline with change at 3 months); Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint (Baseline and change at 3 months); Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint (Baseline and change at 3 months)
D: Measure of physical activity (Change from Baseline to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Supplementation With Resistant Starch in the Profile of the Intestinal Tract and Cardiovascular Markers in Patients With Chronic Kidney Disease
Brief Summary: The objective of this study is to assess whether supplementation with resistant starch from the rice-flour coffee developed by EMBRAPA, as well as from an already industrialized product (Hi-Maize of Ingredion®) could modulate the intestinal microbiota of patients with CKD ( both patients under conservative treatment, such as dialysis treatment), as well as exerting a beneficial effect with respect to reducing levels of inflammatory markers of oxidative stress, uremic toxins and in addition, markers of cardiovascular disease.


Options:
A: Change from Baseline Triglyceride/HDL cholesterol ratio at 3 months, 6 months and 3 months after the trial (baseline,3 months, 6 months and 3 months after the trial)
B: Highly sensitive C-reactive protein (hs CRP) level (4 weeks); Total anti-oxidant capacity (4 weeks); Blood urea level (4 weeks)
C: Change in gut microbiota profile measured by denaturing gradient gel electrophoresis after supplementation of resistance starch treatment (Change from Baseline microbiota gut at 6 weeks); Change in cytokines plasma levels measured by ELISA after supplementation of resistance starch (Change from Baseline inflammation at 6 weeks)
D: Change in blood uremic toxin, indoxyl sulphate, between treatments (between endpoints of each experimental period (week 8 to week 18)); Change in blood uremic toxin, p-cresyl sulphate, between treatments (between endpoints of each experimental period (week 8 to week 18))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Additional Trunk Exercises on Gait Performance: a Randomised Controlled Trial
Brief Summary: The aim of SWEAT² study is to further explore the effects of additional customized trunk exercises on clinical and biomechanical gait performance. Despite of the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. The findings of this study might lead to new scientific insights in the importance of the trunk during gait rehabilitation in people suffering from stroke submitted to a rehabilitation hospital.


Options:
A: Change response time during a novel motor task. (Baseline, After Intervention (2 weeks), 30-day follow-up); Wolf Motor Function Task Rate (Baseline, After Intervention (2 weeks), 30-day follow-up)
B: Changes in cortical excitability measures (Measured for approximately 6 weeks)
C: Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months)
D: The change in Tinetti Performance Oriented Mobility Assessment (week 0, week 5, and week 9)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Additional Trunk Exercises on Gait Performance: a Randomised Controlled Trial
Brief Summary: The aim of SWEAT² study is to further explore the effects of additional customized trunk exercises on clinical and biomechanical gait performance. Despite of the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. The findings of this study might lead to new scientific insights in the importance of the trunk during gait rehabilitation in people suffering from stroke submitted to a rehabilitation hospital.


Options:
A: Systolic Blood Pressure (12 months)
B: The change in Tinetti Performance Oriented Mobility Assessment (week 0, week 5, and week 9)
C: Motor Assessment Scale (18 months after inclusion)
D: Aerobic capacity (Baseline,3month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Additional Trunk Exercises on Gait Performance: a Randomised Controlled Trial
Brief Summary: The aim of SWEAT² study is to further explore the effects of additional customized trunk exercises on clinical and biomechanical gait performance. Despite of the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. The findings of this study might lead to new scientific insights in the importance of the trunk during gait rehabilitation in people suffering from stroke submitted to a rehabilitation hospital.


Options:
A: The change in Tinetti Performance Oriented Mobility Assessment (week 0, week 5, and week 9)
B: Barthel Index (up to 6 months)
C: Recruitment (Through study completion, an average of 1.5 months.); Retention (Through study completion, an average of 1.5 months.); Participation (Through study completion, an average of 1.5 months.); Adherence (Through study completion, an average of 1.5 months.); Acceptability and enjoyment (Through study completion, an average of 1.5 months.); Safety and Adverse events (Through study completion, an average of 1.5 months.); Device development or modifications (Through study completion, an average of 1.5 months.); Fatigue (Through study completion, an average of 1.5 months.); Patient Global Impression of Change (Through study completion, an average of 1.5 months.)
D: Timed get up and go (eight weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)
Brief Summary: This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.


Options:
A: Response Rate (approximately 18 months); Overall Survival Phase 3 Interim Analysis (Approximately 18 months); Overall Survival (18 months)
B: Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs) (Dose Escalation: Baseline up to Week 3); Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (Ovarian Cancer Efficacy Expansion: Baseline up to Day 620); Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931); Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871); Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (HNSCC Efficacy Expansion: Baseline up to Day 1072)
C: Survival (24 months)
D: Overall Survival (OS) (From randomization to the date of death (Up to 40 Months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Comparison of Once-daily Fixed combiNation vErsus freE-drug cOmbination of Three aNtihypertensive Agents in arteriaL hYpertension (the ONE&ONLY Trial)
Brief Summary: Randomized comparison of once-daily fixed combiNation versus free-drug combination of three antihypertensive agents in arterial hypertension


Options:
A: Reduction of the Estimated 10-year Total Cardiovascular Risk Score (Six months)
B: Profile of Pharmacokinetics (0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose)
C: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability. (18 months); Adherence to treatment measured by the Morisky-Green questionnaire (18 months); Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. (18 months); Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) (18 months)
D: Number of patients who reach target blood pressure (From baseline to the end of the 3-month study period)

Answer: D