TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcranial Direct Current Stimulation in Older Persons With Knee Pain: Randomized Pilot Study
Brief Summary: The purpose of this research is to study the effects of Transcranial Direct Current Stimulation (tDCS) on clinical pain, mobility disability, and pain sensitivity to gain a better understanding of the factors that cause pain and disability in people with knee osteoarthritis (OA). In particular, people from different ethnic and racial groups may experience OA pain differently which is why the focus will be on older Asian Americans and non-Hispanic whites. It is important to find a reason for such difference so that a better treatment can be found for all OA patients. In addition, the research study will examine if there is any ethnic differences in pain and mobility disability. The investigator hypothesize that Asian Americans will report greater pain and mobility disability than non-Hispanic whites, and that active tDCS will result in improvement in pain and disability compared to sham tDCS.


Options:
A: Analgesic efficiency (36 months)
B: Numeric Rating Scale (NRS) for Pain (baseline); Numeric Rating Scale (NRS) for Pain (day 5); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (baseline); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (day 5); Six-minute Walk Test (baseline); Six-minute Walk Test (day 5); Short Physical Performance Battery (SPPB) (baseline); Short Physical Performance Battery (SPPB) (day 5); Heat Pain Threshold (baseline); Heat Pain Threshold (day 5); Heat Pain Tolerance (baseline); Heat Pain Tolerance (day 5); Pressure Pain Threshold (baseline); Pressure Pain Threshold (day 5); Punctate Mechanical Pain Sensitivity (baseline); Punctate Mechanical Pain Sensitivity (day 5); Conditioned Pain Modulation (CPM) (baseline); Conditioned Pain Modulation (CPM) (day 5)
C: Change in Pain Scale (Measured for approximately 6 months)
D: Change From Baseline in Visual Analogue Scale (VAS) for Pain Change From Baseline (On a weekly basis: 1) Day 1 (first day of tDCS). 2) Day 8 (after first week with post 5 consecutive sessions of tDCS followed by 2 consecutive days without tDCS). 3) Day 15 (after second week post another 5 sessions of tDCS followed by 2 consecutive days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment: An Efficacy Study
Brief Summary: This study aims to investigate and compare the intervention effects of combining exercise and cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly with mild cognitive impairment. The investigators hypothesize that (1) both sequential and dual-task training can induce greater improvements in the outcome measures than single mode of training; (2) the improvement in cognitive functions and other outcomes may differ between the groups.


Options:
A: overall cognition (2 Monhths)
B: Aggregate Cognitive Performance (Baseline to 10 weeks)
C: the change in cortical thickness between the baseline and the post-intervention assessment. (between the baseline and the post-intervention assessment (12 week training))
D: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment: An Efficacy Study
Brief Summary: This study aims to investigate and compare the intervention effects of combining exercise and cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly with mild cognitive impairment. The investigators hypothesize that (1) both sequential and dual-task training can induce greater improvements in the outcome measures than single mode of training; (2) the improvement in cognitive functions and other outcomes may differ between the groups.


Options:
A: Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests. (Changes from baseline at 4 months in z-scores.)
B: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
C: Global cognitive functioning (26 weeks)
D: Useful Field of View Test (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment: An Efficacy Study
Brief Summary: This study aims to investigate and compare the intervention effects of combining exercise and cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly with mild cognitive impairment. The investigators hypothesize that (1) both sequential and dual-task training can induce greater improvements in the outcome measures than single mode of training; (2) the improvement in cognitive functions and other outcomes may differ between the groups.


Options:
A: STROOP-Negative Priming (Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks); ODDBALL (Change from Baseline oddball task at 15 weeks and 30 weeks); N-BACK (Change from Baseline N-back task at 15 weeks and 30 weeks); CORSI BLOCK (Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks)
B: Useful Field of View Test (12 months)
C: Global cognitive functioning (26 weeks)
D: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment: An Efficacy Study
Brief Summary: This study aims to investigate and compare the intervention effects of combining exercise and cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly with mild cognitive impairment. The investigators hypothesize that (1) both sequential and dual-task training can induce greater improvements in the outcome measures than single mode of training; (2) the improvement in cognitive functions and other outcomes may differ between the groups.


Options:
A: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
B: cognition: MMSE, ADAS-cog. (month 0, 6, 12)
C: Global cognitive functioning (26 weeks)
D: the change in cortical thickness between the baseline and the post-intervention assessment. (between the baseline and the post-intervention assessment (12 week training))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation
Brief Summary: Delayed graft function (DGF) is defined as requirement for dialysis in the first week following kidney transplantation. DGF is a common complication occurring in 39% of the deceased donor renal transplants at the investigators' institution with significant cost and outcome implications. The 3 major risk factors for DGF are donor graft characteristics, recipient factors and perioperative management. The most easily modifiable of these factors is perioperative management, in particular intraoperative fluid therapy. The investigators propose to compare the amount of fluid administered using the current standard of care with the fluid administered when optimizing the cardiac output (CO) using Esophageal Doppler Monitoring (EDM) to guide fluid therapy. EDM measures blood flow in the descending aorta, optimizing stroke volume (SV) and cardiac output (CO) by indicating when fluid administration fails to produce an increase in CO.


Options:
A: Composite endpoint of death or major postoperative complications (30 days after randomization)
B: The primary outcome measure is the duration of postoperative hospital stay. (at days 1,2, and 5, as well as at ICU discharge, and hospital discharge.)
C: complications until 30 days after surgery according to the zurich classification (30 days postoperative)
D: The volume of crystalloid solutions administered intraoperatively. (Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Pain Relief Between Adductor Canal Block and Femoral Nerve Block in Total Knee Arthroplasty in General Anesthesia
Brief Summary: This study aims to compare the effectiveness of adductor canal block and femoral nerve block in total knee arthroplasty in general anesthesia. Two block techniques were proved safe and effective in pain control after total knee arthroplasty. But some authors insist that quadriceps muscle power was decreased by femoral nerve block. The study design is a double-blind randomized controlled trial. Fifty patients planed to undergo simultaneously bilateral total knee arthroplasty are randomised to receive ultrasound-guided femoral nerve block on one leg and adductor canal block on the other, in addition to combined general anaesthesia. The primary outcome was comparative postoperative pain in either extremity at four, eight, 12, 24, 72 hours and 7days postoperatively. Secondary comparative outcomes included motor strength by cybex test.


Options:
A: the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo (0-6 hours)
B: Changes in Visual pain scale (Changes from the baseline visual pain scale to 1 week after surgery)
C: Morphine Equivalents (12 hours postoperatively and 20 hours after placement of catheter)
D: Timed Up and Go test (2-3 days post srugery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Microbleeds and Genetic Risk Factors to Predict the Risk of Intracranial Haemorrhage in Patients Treated With Anticoagulation Following Cardioembolic Stroke Due to Atrial Fibrillation
Brief Summary: Study I: CROMIS-2 (AF) Prospective cohort study of patients anticoagulated after cardioembolic stroke An observational inception cohort study (n=1425) of patients throughout the United Kingdom (UK) - (79 hospitals) started on best practice oral anticoagulant (without prior use) for presumed cardioembolic ischaemic stroke due to non-valvular AF with follow up for the occurrence of intracerebral haemorrhage (ICH) and ischaemic stroke for an average of two years. The main baseline exposures (risk factors of interest) are the presence of cerebral microbleeds (CMBs) on magnetic resonance imaging (MRI), and genetic polymorphisms in candidate genes with potential functional relevance to ICH risk.

Study II: CROMIS-2 (ICH) Observational and genetics study of intracerebral haemorrhage The investigators will also recruit 600 patients admitted to participating centres with ICH (with a target of at least 300 anticoagulant-related ICH cases) and collect DNA to increase the power of the genetic studies. The investigators will collect clinical and imaging data from these ICH cases to investigate risk factors associated with anticoagulant-related ICH compared to non anticoagulant-related ICH.


Options:
A: Time to the first occurrence of cerebral hemorrhage (time since randomization; follow-up period is 1.0 to 5.5 years); Time to the first occurence of composite cardiovascular events (time since randomization; follow-up period is 1.0 to 5.5 years)
B: BP Study: Efficacy (3 months from randomisation); BP Study: Feasibility (3 months from randomisation); BP Study: Safety (3 months from randomisation); Imaging Study: Efficacy (12 months from randomisation); Imaging Study: Safety (12 months from randomisation)
C: Symptomatic intracranial haemorrhage (24 months)
D: Recurrent Stroke (Average of 6 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Perineal Muscle Training Versus Usual Prenatal Care in the Incidence of Avulsion of the Levator Ani Muscle at First Birth of Mexican Women: Randomized Control Trial
Brief Summary: Levator Ani Muscle (LAM) avulsion occurs in 13-36% of women having their first birth. These damages by palpation and ultrasound of the pelvic floor can be detected. Avulsion of the LAM results in decreased muscle strength of the pelvic floor, enlarge the genital hiatus and promotes pelvic organ prolapse. The perineal muscle training is a proposal to combine the perineal massage with pelvic floor exercises in order to prepare the LAM in the last weeks before delivery, to withstand stretching which will be submitted during childbirth. No studies in the world that have explored the effect of the perineal muscle training on the avulsion of MEA.

Objective: To quantify the proportion of primiparous that result with avulsion of LAM after their first birth among those performing perineal muscle training from week 33 of gestation and those with usual prenatal care.


Options:
A: Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) (From Baseline to 6 Weeks); Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) (Change from 6 weeks to 12 weeks); Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) (Baseline to 12 weeks)
B: Evaluation of subjective cure (At the end of 3 months of supervised treatment)
C: Difference in Incontinence Impact Questionnaire (IIQ-7) scores (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Difference in Overactive Bladder Symptom Score (OABSS) (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Urogenital Distress Inventory (UDI-6) scores (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Differences in daytime frequency (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); incontinence episodes (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Nocturia (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group)
D: Levator ani muscle avulsion (six weeks after childbith)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief Summary: To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation


Options:
A: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)
B: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
C: Maximum Observed Concentration (Cmax) of VX-659, TEZ, and IVA (Day 1 and Day 15); Observed Pre-Dose Concentration (Ctrough) of VX-659, TEZ, and IVA (Day 8 and Day 15); Area Under the Concentration Versus Time Curve From Time 0 to 6 Hours (AUC0-6h) of VX-659, TEZ, and IVA (Day 1 and Day 15)
D: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief Summary: To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation


Options:
A: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
B: Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 105 (Study 105)); Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs (Day 1 up to Week 105 (Study 105))
C: Safety and Tolerability of N91115 (21 Days); Pharmacokinetics: Day 1 AUClast (Day 1); Pharmacokinetics: AUCtau Day 14 (Day 14); Pharmacokinetics: Day 1 Plasma Cmax Values (Day 1); Pharmacokinetics: Plasma Cmax Values on Day 14 (Day 14)
D: Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24 (Day 1, Through Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief Summary: To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation


Options:
A: Number of Subjects With Adverse Events (Combined Part 1 and Part 2) (Baseline to Follow-up); Number of Adverse Events (Combined Part 1 and Part 2) (Baseline to Follow-up)
B: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
C: Changes in the Sino-nasal-outcome test SNOT-20 adapt CF (days 1, 29, 57 and 85)
D: Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches) (day 1, 29, 57 and 85)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief Summary: To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation


Options:
A: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
B: Number of Participants With Treatment-Emergent Adverse Events (First administration (Day 1) through Follow-up (Day 43))
C: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12 (Baseline, Through Week 12)
D: Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 105 (Study 105)); Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs (Day 1 up to Week 105 (Study 105))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief Summary: To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation


Options:
A: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
B: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline through Week 100)
C: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in treatment period up to safety follow-up (up to 28 days)); Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)); Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29)
D: Safety and Tolerability (Over 7 treatment days and 7 days of follow-up)

Answer: A