TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Calcific Tendinitis of the Rotator Cuff - a Multi-centre, Randomized and Sham Controlled Trial (KALK Study)
Brief Summary: The purpose of this study is to determine whether the combination of removal of the calcification in calcific tendinitis of the shoulder (supraspinatus and/or infraspinatus tendon) by aspiration with a needle and syringe (barbotage) and a corticosteroid injection is more effective than corticosteroid or sham injection alone.


Options:
A: Shoulder Pain and Disability Index (SPADI) (Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months)
B: Shoulder Pain and Disability Index (Baseline and 11 weeks); Participant perceived global rating of change post treatment (11 weeks)
C: Oxford Shoulder Score (6 months post randomisation)
D: Oxford Shoulder Score (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial
Brief Summary: The aim of this study is to clarify the efficacy of the endovascular treatment for acute ischemic stroke patients with large vessel occlusion and are not respond to intravenous recombinant tissue plasminogen activator (rt-PA) therapy.


Options:
A: Final Infarct Volume (36 (+/-12) hrs after treatment initiation); Utility-weighted Modified Rankin Score (90 days after treatment initiation)
B: Level of disability (90 days (3 months))
C: Combined death and disability (90 days)
D: Assessment of modified Rankin Scale shift analysis at 90 days after onset (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial
Brief Summary: The aim of this study is to clarify the efficacy of the endovascular treatment for acute ischemic stroke patients with large vessel occlusion and are not respond to intravenous recombinant tissue plasminogen activator (rt-PA) therapy.


Options:
A: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
B: Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS) (90 days)
C: Assessment of modified Rankin Scale shift analysis at 90 days after onset (90 days)
D: Modified Rankin Scale (mRS) 0-1 (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Physical Exercise Program on Fetoplacental Growth: a Randomized Controlled Trial
Brief Summary: The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth.


Options:
A: Prematurity (Women will be interviewed at hospital soon after birth (up to 2 days after delivering))
B: pain (6 weeks); Disability (6 weeks); Pelvic Floor Muscle activity (6 weeks); Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness (6 weeks); Multifidus muscle thickness and crass section area(S1 level) (6 weeks)
C: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))
D: Placental weight (At delivery); Fetal birth weight (At delivery); Change from baseline in maternal gestational weight (38-42 weeks of gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Physical Exercise Program on Fetoplacental Growth: a Randomized Controlled Trial
Brief Summary: The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth.


Options:
A: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)
B: Incidence of fecal and/or flatal incontinence (3 months (1st trimester)); Incidence of fecal and/or flatal incontinence (6 months (2nd trimester)); Incidence of fecal and/or flatal incontinence (9 months (3rd trimester))
C: Placental weight (At delivery); Fetal birth weight (At delivery); Change from baseline in maternal gestational weight (38-42 weeks of gestation)
D: Levator ani muscle avulsion (six weeks after childbith)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in the Cardiac Rehabilitation Pathway: A Single-blind Randomised Controlled Trial
Brief Summary: Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and quality of life, and reduce the risk of further cardiac events. Depression and anxiety (distress) are common among CR patients: 37% of patents have significant anxiety and/or depressive symptoms. Distressed patients are at greater risk of death, further cardiac events and poorer quality of life than those without distress and they use more healthcare. Available drug and psychological treatments have only small effects on distress and quality of life, and no effects on physical health. Therefore, it is essential that more effective treatments for depression and anxiety are integrated into CR services. Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention (metacognitive therapy) that reduces this style of thinking alleviates depression and anxiety in mental health settings. The investigators aim to conduct a pilot trial of the group intervention and in work stream 2 the investigators will undertake a full-scale trial to evaluate whether adding the group intervention to standard CR is more effective at alleviating anxiety and depression than standard CR alone.


Options:
A: Death (4 months); Death (8 months); Death (12 months); Death (16 months); Death (20 months); Death (24 months); Death (3 years); Death (4 years); Stroke/Systemic embolism (SE) (4 months); Stroke/Systemic embolism (SE) (8 months); Stroke/Systemic embolism (SE) (12 months); Stroke/Systemic embolism (SE) (16 months); Stroke/Systemic embolism (SE) (20 months); Stroke/Systemic embolism (SE) (24 months); Stroke/Systemic embolism (SE) (3 years); Stroke/Systemic embolism (SE) (4 years); Major bleeding (4 months); Major bleeding (8 months); Major bleeding (12 months); Major bleeding (16 months); Major bleeding (20 months); Major bleeding (24 months); Major bleeding (3 years); Major bleeding (4 years)
B: Mental Stress Induced Elevation in "Double Product" by Math Stress Task (Immediate to 6 months post intervention); Mental Stress Induced Elevation in Double Product by Math Stress Task (3 months post intervention); Mental Stress Induced Elevation in "Double Product" by Anger-recall Task (Immediate to 6 months post intervention)
C: Changes from baseline to 18 months in depressive symptoms (HADS-D) (18 months)
D: Change in Hospital Anxiety and Depression Scale (HADS) (Baseline pre treatment, four-month post baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia
Brief Summary: Behavioral symptoms that commonly occur with dementia are associated with increased health care utilization and can lead to challenges for the person living with dementia and their caregivers. Caregivers need knowledge and skills to monitor these behaviors, to identify what triggers them, and to learn how to use proven, practical medication-free strategies to prevent and manage the behaviors. The purpose of this study is to develop and test the WeCareAdvisor, a customized, internet-based computer tool for family caregivers that helps them to assess, manage and track behavioral symptoms and their contributing factors (e.g., pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free behavior management. This study is a collaboration between researchers at the University of Michigan and Johns Hopkins University.


Options:
A: Effects of the WeCareAdvisor Tool on Caregiver Upset (4 weeks); Effect of the WeCareAdvisor Tool on Caregiver Confidence (4 weeks)
B: Depressive Symptoms (Change from baseline through study completion, an average of about 5 months)
C: Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12) (3 months)
D: Parental Self-Efficacy (baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Innovative Caregiver Tool to Assess and Manage Behavioral Symptoms of Dementia
Brief Summary: Behavioral symptoms that commonly occur with dementia are associated with increased health care utilization and can lead to challenges for the person living with dementia and their caregivers. Caregivers need knowledge and skills to monitor these behaviors, to identify what triggers them, and to learn how to use proven, practical medication-free strategies to prevent and manage the behaviors. The purpose of this study is to develop and test the WeCareAdvisor, a customized, internet-based computer tool for family caregivers that helps them to assess, manage and track behavioral symptoms and their contributing factors (e.g., pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free behavior management. This study is a collaboration between researchers at the University of Michigan and Johns Hopkins University.


Options:
A: Effects of the WeCareAdvisor Tool on Caregiver Upset (4 weeks); Effect of the WeCareAdvisor Tool on Caregiver Confidence (4 weeks)
B: Depressive Symptoms (Change from baseline through study completion, an average of about 5 months)
C: Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977) (Baseline and weeks 6 and 10; 3-months and 6-months post)
D: Caregiver Burden Inventory (one year); Proportion of days spent at home by the AD patient in the past year (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Brief Summary: This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.


Options:
A: Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Percentage of Participants Who Died of Any Cause in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)); Overall Survival (OS) in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months))
B: Progression Free Survival (PFS) (From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 3 years)
C: Progression Free Survival (2 3/4 years)
D: Progression free survival (Randomization until earliest date of disease progression (according RECIST 1.1 criteria) or death, an expected average of one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Brief Summary: This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.


Options:
A: Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Percentage of Participants Who Died of Any Cause in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)); Overall Survival (OS) in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months))
B: Objective Response Rate (ORR) - Percentage of Participants With Objective Response (Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.)
C: Progression Free Survival (PFS) (Randomization to Measured Progressive Disease or Date of Death From Any Cause (Up to 67 Months))
D: Progression Free Survival (PFS): First-Line Participants (Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)); Progression Free Survival (PFS): Second-Line Participants (Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Transitional Care Program Involving an Advanced Practice Nurse on 30-Day Hospital Readmissions for Elderly Patients Discharged From a Short Stay Geriatric Ward (PROUST Study)
Brief Summary: In France, it has be estimated that the hospital readmission rate within 30 days of patients aged 75 or older is 14% (IC95% \[12.0-16.7\]), nearly a quarter being avoidable. There is evidence that interventions "bridging" the transition from hospital to home involving a dedicated professional (usually nurses) would be most effective in reducing the risk of readmission, but the level of evidence of current studies is low. Our study aims to assess the impact of a program of transitional care from hospital to home for people of 75 years old or more admitted to acute care.


Options:
A: NIHSS Stroke Scale, relapse rate (360 days)
B: drug related problems (DRP) (7 days after patient discharge)
C: 30-Day unscheduled hospital readmission or emergency visit rate after the index hospital discharge. (Within 30 days after hospital discharge.)
D: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)
Brief Summary: Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).


Options:
A: Progression free survival (up to 18 months)
B: Progression-free Survival by Independent Review Committee (Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years)
C: Number of Participants With Progression-free Survival Incidence at Week 24 (Week 24)
D: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (every 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Males, Antioxidants, and Infertility (MOXI) Trial
Brief Summary: The objective of the Males, Antioxidants, and Infertility (MOXI) Trial is to examine whether treatment of infertile males with an antioxidant formulation improves male fertility. The central hypothesis is that treatment of infertile males with antioxidants will improve sperm structure and function, resulting in higher fertilization rates and improved embryo development, leading to higher pregnancy and live birth rates. Findings from this research will be significant in that they will likely lead to an effective, non-hormonal treatment modality for male infertility. An effective treatment for men would also reduce the treatment burden on the female partner, lower costs, and provide effective alternatives to couples with religious or ethical contraindications to ART (Assisted Reproductive Technology). If antioxidants do not improve pregnancy rates, but do improve sperm motility and DNA integrity, they could allow for couples with male factor infertility to use less intensive therapies such as intrauterine insemination. Male fertility specialists currently prescribe antioxidants based on the limited data supporting their use. A negative finding, lack of any benefit, would also alter current treatment of infertile males.


Options:
A: Live Birth (At delivery); Semen Volume (6 months); Sperm Concentration (6 months); Sperm Motility (6 months); Sperm Morphology (6 months); DNA Fragmentation Index (6 months); Total Motile Sperm Count (6 months)
B: DFI_3 (Change in DNA Fragmentation Index from Baseline to 3 months); DFI_6 (Change in DNA Fragmentation Index from Baseline to 6 months)
C: semen quality (150 days); sperm motility (150 days); sperm morphology (150 days); sperm concentration (150 days); total sperm count (150 days); semen volume (150 days)
D: Live Birth Rate (up to 15 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain: a Randomized Controlled Trial
Brief Summary: Background: The use of low-dose continuous infusion of S(+)-ketamine combined with target-controlled intravenous anesthesia with remifentanil and propofol may be related to the control of postoperative pain and of opioid-induced hyperalgesia. The present study aimed to evaluate the efficacy of continuous infusion of S(+)-ketamine given intraoperatively in the control of postoperative pain compared to placebo.


Options:
A: pain score (4 hours)
B: Pain at 24 hour postoperatively (at 24 hour postoperatively)
C: To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural (24 months)
D: Morphine consumption (12 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone-Delivered Interventions for Smoking Cessation
Brief Summary: The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).


Options:
A: Number of Participants With Smoking Abstinence (4 weeks post quit day (one week following the end of treatment)); Smoking Abstinence (26 weeks post quit day); Smoking Abstinence (4 weeks post quit day (one week following the end of treatment))
B: 30 day point prevalence abstinence (12 months)
C: Smoking behavior (6 months)
D: Self-reported quit rate for the past 7 days (6-month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Different Montages of Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke Patients: a Randomized Controlled Trial
Brief Summary: Transcranial direct current stimulation (tDCS) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose of this study was to compare the effectiveness of three different montages of tDCS (anodal, cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in acute stroke patients.


Options:
A: 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)
B: Subjective Index of Physical and Social Outcome (SIPSO) (Change from baseline to 3 months.); Nottingham Extended Activities of Daily Living (NEADL) (Change from baseline to 3 months.)
C: Four Square Step Test (Change from Baseline in Risk of Falls at 3 months)
D: Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs) (After one year of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Different Montages of Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke Patients: a Randomized Controlled Trial
Brief Summary: Transcranial direct current stimulation (tDCS) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose of this study was to compare the effectiveness of three different montages of tDCS (anodal, cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in acute stroke patients.


Options:
A: Four Square Step Test (Change from Baseline in Risk of Falls at 3 months)
B: Upper Extremity Component of Fugl-Meyer Assessment (week 0, week 2, week 4)
C: Behavioural Inattention Test (BIT) (Assessed at the recruitment interview (week 0) and at the exit interview (8 weeks after the intervention)); Neglect Test Battery (Assessed at 2 separate pre-intervention baseline sessions at least 1 week apart. Re-assessed following the intervention at intervals of 1, 2, 4 and 8 weeks.)
D: Motor learning improvement with tDCS (Improvement on motor learning were recorded from baseline to 4 weeks after the intervention)

Answer: A