TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Study on the Effectiveness of Cupping Massage for Home Use in Chronic Neck Pain [Randomisierte Kontrollierte Studie Zur Wirksamkeit Der Schröpfkopfmassage Als Heimanwendung Bei Chronischen Nackenschmerzen]
Brief Summary: The purpose of this randomized controlled study is to determine the effectiveness of cupping massage as home use for patients with chronic nonspecific neck pain compared to relaxation exercise.


Options:
A: Pain Intensity (T2 (84 days))
B: Pain intensity (at T2 (Day 25))
C: Change in Neck pain intensity as measured by Visual Analog Scale (Change from baseline neck pain intensity at 4 weeks)
D: Pain intensity (week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol).
Brief Summary: Previous research that utilises single sessions of transcranial direct current stimulation (tDCS) have demonstrated functional improvements. However these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. In these studies, tDCS is typically applied with the goal of adaptively enhancing functional activation of pathologically under-active tissue or suppressing pathologically over-active tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can improve learning/memory functions in healthy controls. The goal of this study is to test if the application of tDCS could enhance learning and/or memory for physiotherapy rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions of tDCS.

This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.


Options:
A: Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT) (1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.)
B: Gait Speed ("6 weeks")
C: Change scores of Fugl-Meyer Assessment (FMA) (Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks); Change scores of Wolf Motor Function Test (WMFT) (Baseline, 2 weeks, and 4 weeks); Change scores of Motor Activity Log (MAL) (Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks); Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0) (Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks); Change scores of Revised Nottingham Sensory Assessment (rNSA) (Baseline, and 4 weeks)
D: 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.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol).
Brief Summary: Previous research that utilises single sessions of transcranial direct current stimulation (tDCS) have demonstrated functional improvements. However these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. In these studies, tDCS is typically applied with the goal of adaptively enhancing functional activation of pathologically under-active tissue or suppressing pathologically over-active tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can improve learning/memory functions in healthy controls. The goal of this study is to test if the application of tDCS could enhance learning and/or memory for physiotherapy rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions of tDCS.

This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.


Options:
A: Upper Extremity Fugl-Meyer-Assessment (UEFMA) (1-7 days after the end of the intervention)
B: Change of Fugl-Meyer assessment (FMA) score (Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention)
C: Postural control (After 5 days)
D: 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.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use.
Brief Summary: The aim of this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus.


Options:
A: Fasting Intact Proinsulin (Change from baseline at 24 weeks)
B: Weight change (6 months)
C: Body weight loss (after 26 weeks of treatment)
D: Health Assessment, Patient treatment satisfaction and Quality-of-Life (At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: 5-Fluorouracil Versus Capecitabine as Perioperative Treatment for Locally Advanced Rectal Cancer. a Randomized Phase III Trial
Brief Summary: This study compares capecitabine with standard 5-FU in the perioperative treatment of locally advanced rectal cancer.


Options:
A: To compare the combination of S-1 and oxaliplatin to the combination of capecitabine and oxaliplatin in terms of progression free survival in patients previously untreated by systemic therapy for advanced or metastatic colorectal carcinoma. (9 months)
B: Overall survival (5-year)
C: N/A
D: Overall survival (Assessed until 1.5 years after the last patient enrolment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Exercise Training in Primary Sjogren´s Syndrome, Myositis and Takayasu's Arteritis
Brief Summary: Exercise may improve physical capacity and health parameters in Primary Syndrome´s Sjogren, Myositis and Takayasu's Arteritis.

Therefore, this study aims to investigate the role of an exercise training program in patients with Primary Syndrome´s Sjogren, Myositis and Takayasu's Arteritis.


Options:
A: Canadian Occupational Performance Measure (COPM) (3 months)
B: Efficacy based on VO2,max (10 weeks)
C: Aerobic Capacity (Twelve weeks); Muscle strength (Twelve weeks); Quality of life (Twelve weeks)
D: DM1-Activ (Baseline and 10 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Brief Summary: Background/Aims:

The investigators explored the therapeutic effects of probiotics in patients with AH.

Methods:

Between September 2010 and April 2012, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline and again after therapy.


Options:
A: The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein) (2 months)
B: Time To The First Breakthrough Overt HE Episode (Baseline up to 6 Months (168 days))
C: High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk) (2 months)
D: Liver Enzymes(ALT) (7 days after probiotics)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double Blind Comparison of Atosiban in Patients Undergoing in Vitro Fertilization Treatment
Brief Summary: The hypothesis of this randomized double blind study is that the live birth rates are significantly higher after the use of atosiban prior to the embryo transfer in patients undergoing in vitro fertilization (IVF) treatment. This study aims to compare the live birth rates of IVF treatment between patients receiving atosiban and placebo prior to the transfer.


Options:
A: Intra-uterine pregnancy with fetal heart beat at 10 weeks (10 weeks post ET day)
B: live birth rate (9 months)
C: PRIMARY OUTCOME MEASURE:IMPLANTATION RATE; (9 MONTHS)
D: EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat (about 6 weeks post ET day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as good as the pill. The investigators will compare OCP vs oral estrogens to plan the initiation of IVF cycles.


Options:
A: live birth rate (10 months for group A, 12 months for group B)
B: Implantation rate (20 days after the embryo transfer)
C: clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity (12 weeks after embryo transfer)
D: Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) (Assessed at least 10 weeks after embryo transfer (up to 1 year)); Mean Number of Oocytes Retrieved (Up to 36 hours after administration of hCG (up to 1 year))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial Testing the Incremental Effect of Strategies That Raise Awareness, Acceptance and Performance of Identification and Brief Intervention Programmes for Harmful Alcohol Consumption in Primary Health Care
Brief Summary: The overall objective is to study if training and support, financial reimbursement and referral to an internet based brief intervention programme, singly or in combination, may increase implementation of evidence based methods of identification and brief intervention for excessive alcohol consumption in routine primary health care.


Options:
A: Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. (Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months)
B: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
C: Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care (5 months); Number of brief interventions for excessive alcohol consumption delivered in primary health care settings (5 months)
D: proportion of negative breath samples submitted (Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke
Brief Summary: A multi-centric initiative to study safety,feasibility and efficacy of using intravenous autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This phase of study is visualised as phase 2 study and will aim to determine dose response gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for autologous stem cell therapy in patient with acute ischamic stroke.


Options:
A: Functional Independence Measure (6 months)
B: Incidence of adverse events (1 year)
C: frequency of dose limiting adverse events (7 days); Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI) (90 days)
D: Barthel index score (six month post randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound
Brief Summary: Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails to sample the cancer cells. The fanning technique is a method where the needle moves in multiple directions within a mass and therefore there is a better chance of the cancer cells being sampled compared to the standard technique where the needle moves in only one direction. The diagnostic performance of both these techniques has not been compared in a randomized fashion.


Options:
A: Diagnostic accuracy (2 months)
B: Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts (Within 6 months after the end of Follow-up period); Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes (Within one year after the end of the follow-up period)
C: accessing the rate for procurement of the histologic core (up to 5 minuites after endoscopic ultrasound-guided fine needle biopsy)
D: Assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE) (From the date of imaging until follow up for 6 months to two years.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic surgery. There are no prospective studies comparing outcomes between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic surgery - liberal or restrictive


Options:
A: Methodology of the pilot study (up to 30 days)
B: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))
C: Randomization Rate (12 months)
D: Composite end-point of mortality and severe complication (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic surgery. There are no prospective studies comparing outcomes between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic surgery - liberal or restrictive


Options:
A: Composite end-point of mortality and severe complication (30 days)
B: Mortality (90 day)
C: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
D: Occurrence of a composite endpoint (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic surgery. There are no prospective studies comparing outcomes between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic surgery - liberal or restrictive


Options:
A: Composite end-point of mortality and severe complication (30 days)
B: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
C: A Composite of In-hospital Postoperative Morbidity and Mortality (After surgery until hosptal discharge)
D: Reduce red-cell transfusion packs (60 days after hospital discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Temozolomid (One Week on/One Week Off) Versus Strahlentherapie in Der Primärtherapie Anaplastischer Astrozytome Und Glioblastome Bei älteren Patienten: Eine Randomisierte Phase III-Studie (Methvsalem)
Brief Summary: The study aims to optimize the treatment of elderly subjects (\> 65) with anaplastic astrocytoma and glioblastoma. Current treatment policies tend to be no more than palliative. There is no consensus as to how radical the surgery should be. Involved-field radiotherapy is the treatment most likely to be accepted apart from supportive and palliative measures. The role of chemotherapy is barely defined. Study data available to date does not suggest that this patient population would benefit from combined radiochemotherapy. The aim of the study is to verify the hypothesis that first-line chemotherapy with one week on/one week off temozolomide is not inferior to extended-field radiotherapy in the first-line treatment of anaplastic astrocytoma and glioblastoma in the elderly (\> 65 age group). The primary endpoint is median survival, as life expectancy is limited to several months. Secondary endpoints are response rates in both arms (CR, PR, MacDonald et al. 1990), median progression-free survival, 1-year and 2-year survival rates, definition of MGMT as molecular genetic prognostic or predictive markers, and quality of life. Theoretically, it should be possible to preserve quality of life in the first-line chemotherapy arm of the study.


Options:
A: Overall Survival (7 years)
B: Progression free survival (PFS) at 12 months (1 year)
C: Overall survival (From the date of randomization to 18 months or to the date of death from any cause)
D: Overall survival (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Temozolomid (One Week on/One Week Off) Versus Strahlentherapie in Der Primärtherapie Anaplastischer Astrozytome Und Glioblastome Bei älteren Patienten: Eine Randomisierte Phase III-Studie (Methvsalem)
Brief Summary: The study aims to optimize the treatment of elderly subjects (\> 65) with anaplastic astrocytoma and glioblastoma. Current treatment policies tend to be no more than palliative. There is no consensus as to how radical the surgery should be. Involved-field radiotherapy is the treatment most likely to be accepted apart from supportive and palliative measures. The role of chemotherapy is barely defined. Study data available to date does not suggest that this patient population would benefit from combined radiochemotherapy. The aim of the study is to verify the hypothesis that first-line chemotherapy with one week on/one week off temozolomide is not inferior to extended-field radiotherapy in the first-line treatment of anaplastic astrocytoma and glioblastoma in the elderly (\> 65 age group). The primary endpoint is median survival, as life expectancy is limited to several months. Secondary endpoints are response rates in both arms (CR, PR, MacDonald et al. 1990), median progression-free survival, 1-year and 2-year survival rates, definition of MGMT as molecular genetic prognostic or predictive markers, and quality of life. Theoretically, it should be possible to preserve quality of life in the first-line chemotherapy arm of the study.


Options:
A: Evaluation of the treatment impact on progression-free survival (5 years)
B: Overall survival (12 months)
C: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)
D: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)

Answer: B