TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Robot-Assisted Upper Limb Rehabilitation in Stroke
Brief Summary: This project consists of two parts: Robotic Rehabilitation Trials, and Study of Outcome Predictors and Clinimetric Attributes. In the first part of study, the investigators aim to (1) investigate the treatment effects of robot-assisted therapy (RAT) in patients with stroke on various outcomes, (2) test the dose-response relations by using two different intensities (higher versus lower intensity RAT), and (3) investigate the effects of the training intensity on a biomarker of oxidative stress. Treatment outcomes will encompass the spectrum of functioning including motor ability, motor control strategies, basic/extended daily functions, mobility, community reintegration, quality of life, and biomarker (8-OHdG). In the second part of study, the purposes are to define the appropriate populations for RAT and to examine the clinimetric properties of clinical measures relevant for use in robotic rehabilitation research. the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions. Finally, the investigators will examine and compare the clinimetric properties (e.g., validity and responsiveness) of the clinical measures of rehabilitation outcome to inform selection of test instruments that may detect clinically meaningful change after rehabilitation therapy.


Options:
A: Korean-Montreal Cognitive Assessment (K-MoCA) (Change of K-MoCa after intensive cognitive rehabilitation for 4 weeks)
B: Fugl-Meyer Assessment (before and after intervention)
C: Wolf Motor Function Test (WMFT) Log-transformed Time (Baseline to 1 year post-randomization); Wolf Motor Function Test Time (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS) Hand Function Subscale Score. (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization) (Baseline to 1 year post-randomization)
D: Disability (three months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Co-Bedding as a Comfort Measure for Twins Undergoing Painful Procedures
Brief Summary: A rising number of preterm twins, at high risk of undergoing repeated medical procedures often without adequate pain relief, are being admitted to Neonatal Intensive Care Units. Skin-to-skin contact between mothers and their infants during painful procedures has been shown to decrease pain and help them stabilize more quickly afterwards. The main question of this study is whether the contact of a twin could provide a similar form of comfort. Sixty-four twin pairs will have an equal chance of undergoing a medically necessary heel stick while being cared for together (co-bedding) or separately. Primary outcome will be physiologic and behavioral pain response. If found to be beneficial, changes to neonatal care practices to include co-bedding may help twins tolerate and recover from painful procedures. Findings will help care providers make recommendations for at risk twins experiencing procedural pain and add to existing theoretical models with respect to the exact mechanism of comfort through touch.


Options:
A: Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP) (before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection)
B: To measure analgesic effectiveness of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with sucrose, during routine immunizations at 2 and 4 month well child visits. (every 15 sec)
C: Pain response(Premature Infant Pain Profile (PIPP) (Baseline until completion of heelstick)
D: recovery after inguinal hernia surgery = time to restore normal activities after surgery (one week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Co-Bedding as a Comfort Measure for Twins Undergoing Painful Procedures
Brief Summary: A rising number of preterm twins, at high risk of undergoing repeated medical procedures often without adequate pain relief, are being admitted to Neonatal Intensive Care Units. Skin-to-skin contact between mothers and their infants during painful procedures has been shown to decrease pain and help them stabilize more quickly afterwards. The main question of this study is whether the contact of a twin could provide a similar form of comfort. Sixty-four twin pairs will have an equal chance of undergoing a medically necessary heel stick while being cared for together (co-bedding) or separately. Primary outcome will be physiologic and behavioral pain response. If found to be beneficial, changes to neonatal care practices to include co-bedding may help twins tolerate and recover from painful procedures. Findings will help care providers make recommendations for at risk twins experiencing procedural pain and add to existing theoretical models with respect to the exact mechanism of comfort through touch.


Options:
A: Pain Process Outcomes (pain assessment) (T1 (Baseline)); Factors Influencing Sustainability: The Alberta Context Tool (ACT) (T1 (Baseline)); Pain Process Outcomes (pain assessment) (T2 (12 months following the implementation of the Booster)); Pain Process Outcomes (pain assessment) (T3 (24 months following the implementation of the Booster)); Factors Influencing Sustainability: The Alberta Context Tool (ACT) (T2 (12 months following the implementation of the Booster)); Factors Influencing Sustainability: The Alberta Context Tool (ACT) (T3 (24 months following the implementation of the Booster)); Pain Process Outcomes (pain management) (T1 (Baseline)); Pain Process Outcomes (pain management) (T2 (12 months following the implementation of the Booster)); Pain Process Outcomes (pain management) (T3 (24 months following the implementation of the Booster))
B: Visual Analogue Scale (sevral minutes before and after BTX injections)
C: Pain response(Premature Infant Pain Profile (PIPP) (Baseline until completion of heelstick)
D: The primary outcome: Feasibility and acceptability of study procedure (after the study completion (4 months after the baseline survey))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Vitamin D Supplementation on Host Immunity to Mycobacterium Tuberculosis and Response to Treatment: Building Translational Research Capacity in Nutrition and Infectious Diseases in the Republic of Georgia
Brief Summary: Tuberculosis bacterium (TB) is a germ that can infect any part of the human body, especially the lungs. Vitamin D is a hormone present in humans that regulates blood electrolytes such as calcium and phosphate. There is new information that links vitamin D to the functioning of our immune system. The purpose of the study is to find out how vitamin D affects the immune system of patients with TB. We want to find out if correcting low vitamin D levels, in addition to getting standard therapy for TB, will help the immune system fight off TB infection more effectively.

The study will be done at the Georgia National Center for Tuberculosis and Lung Diseases (NCTBLD) in Tbilisi, Republic of Georgia. 220 patients with tuberculosis and 80 family members or household contacts of patients with tuberculosis will be participating in this study. TB patients, already receiving standard TB therapy, will be randomly assigned to either receive the Vitamin D pill or a placebo for a total of sixteen weeks. Neither the subject nor the investigator will know whether the subject has received the Vitamin D or the inactive placebo.The subject will orally consume the Vitamin D/placebo tablet 3 times a week for the 1st 8 weeks (while in hospital) and then once every other week for the last 8 weeks( during out-patient visits to the hospital).

The main study hypothesis is that Vitamin D supplementation helps patients with tuberculosis, who are on standard anti TB antibiotic therapy, get better faster.


Options:
A: Time to sputum culture conversion
B: proportion of patients who successfully complete TB treatment and achieve cure.
C: The primary outcome for this intent-to-treat trial is the time to Mycobacterium tuberculosis sputum culture conversion to negative (Up to 16 weeks from therapy start date)
D: Proportion of pulmonary TB patients who are culture negative at 1 month (1 month); Difference in improvement in composite clinical endpoint comprising weight, cough clearance and FEV1 at 2 months. (2 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Educational Videos to Improve Patient Decision Making and Racial Disparities in the Implantation of Implantable Cardioverter Defibrillators (ICDs)
Brief Summary: The investigators will examine whether an educational video increases patient knowledge about heart failure and the risk of sudden cardiac arrest and leads to greater satisfaction with information provided as compared to usual care. Additionally, the investigators will look at whether racial concordance (physician and patient being of the same race) improves satisfaction with the patient's treatment decision and disease knowledge. Our hypothesis is that a video in which participants are of the same race as the patient will provide better education and more satisfaction with the treatment decision and may lead to more patients choosing ICD therapy.


Options:
A: Incidence choice for eSET (after embryo transfer)
B: The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.
C: Decisional Conflict (Baseline to 6 months); Decisional Satisfaction (Baseline to 6 months); Satisfaction with Preparation for Decision Making (Baseline to 1 month)
D: Decision to Receive an ICD (1 week post intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Educational Videos to Improve Patient Decision Making and Racial Disparities in the Implantation of Implantable Cardioverter Defibrillators (ICDs)
Brief Summary: The investigators will examine whether an educational video increases patient knowledge about heart failure and the risk of sudden cardiac arrest and leads to greater satisfaction with information provided as compared to usual care. Additionally, the investigators will look at whether racial concordance (physician and patient being of the same race) improves satisfaction with the patient's treatment decision and disease knowledge. Our hypothesis is that a video in which participants are of the same race as the patient will provide better education and more satisfaction with the treatment decision and may lead to more patients choosing ICD therapy.


Options:
A: Decision to Receive an ICD (1 week post intervention)
B: Decisional conflict (within 1 week after consult)
C: Glycosylated Hemoglobin (HbA1c): (baseline and at the end of 12 months post index date)
D: Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale) (same day as HIV test counseling (cross-sectional study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
Brief Summary: This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.


Options:
A: N/A
B: We will be measuring patients' response by the clinical scoring criteria of the Hidradenitis Suppurativa European Research Group (HISERG) scale. (6 months); Examining histologic changes at various time points following 1064 nm Nd:YAG laser treatment of hidradenitis suppurativa. (6 months.)
C: Percentage of Participants Achieving Clinical Response at Week 16 (Baseline, Week 16)
D: Physician global assessment of HS of clear or mild at week 12 (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial
Brief Summary: Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.


Options:
A: Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment (from week 9 to week 48)
B: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
C: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
D: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial
Brief Summary: Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.


Options:
A: N/A
B: Anamnestic and biochemical* validated smoking cessation (12 months after inclusion)
C: Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment (from week 9 to week 48)
D: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Strattera and Behavior Therapy on the School and Home Functioning of Elementary School Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there is only one published study specifically designed to evaluate its efficacy in school settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3 mg/kg, significantly reduced teacher rated ADHD symptoms (Weiss et al., 2005). However, children are typically referred for treatment because of "real life" problems in functioning, not symptoms (Pelham, Fabiano, \& Massetti, 2005). While ATX has been found to produce functional improvements at home, the Weiss study found limited results in this area at school.

Furthermore, almost no research has examined the effects of combining ATX and behavior therapy (BT). In the MTA, adding BT to stimulants improved teacher ratings of hyperactivity/impulsivity and increased the number of subjects reaching optimal response (Swanson et al., 2001). Therefore, it is possible that the addition of BT to ATX may improve functional performance in the classroom. The effects of combined therapy may be even larger for ATX as monotherapy with nonstimulants produces smaller effect sizes than with stimulants.

Objective: The primary objective was to evaluate the effects of ATX alone and in combination with BT on the school functioning of 56 children ages 6-12 with ADHD. Outcomes were assessed using traditional symptoms measures as well as functional measures of academic and behavioral improvements in the classroom.


Options:
A: Rule Violations During Direct Classroom Observation at Endpoint (Week 8) (Endpoint (Week 8))
B: Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe (measured at week 12 (endpoint))
C: change in ADHD-rating scale (baseline,after the training (12week))
D: ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.) (3 month); ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.) (6 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-bound Fibrin Sealant During Liver Resection (ESSCALIVER)
Brief Summary: This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres. The primary objective of this study is to show that the collagen based haemostatic device Sangustop® is not inferior to a carrier-bound fibrin sealant (Tachosil®) in achieving haemostasis after hepatic resection.


Options:
A: Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS). (Intra-operative)
B: Proportion of patients with hemostasis 3 minutes after application of the haemostat product (3 minutes)
C: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection (Within 5 minutes)
D: Receipt of blood transfusion(s) (7 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-bound Fibrin Sealant During Liver Resection (ESSCALIVER)
Brief Summary: This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres. The primary objective of this study is to show that the collagen based haemostatic device Sangustop® is not inferior to a carrier-bound fibrin sealant (Tachosil®) in achieving haemostasis after hepatic resection.


Options:
A: To determine if ANH reduces the requirement for allogeneic red cell transfusions in patients undergoing major hepatic resection or pancreaticoduodenectomy compared to standard intraoperative management (All patients will have their blood checked every 30 minutes during surgery)
B: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection (Within 5 minutes)
C: Intraoperative blood loss (2.5 hours)
D: Proportion of patients with hemostasis 3 minutes after application of the haemostat product (3 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).
Brief Summary: This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process


Options:
A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
B: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)
C: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)
D: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) (Baseline, Day 29); Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29) (Baseline, Day 29); Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier (Baseline, Day 29)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).
Brief Summary: This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process


Options:
A: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)
B: Clinically Significant Laboratory Abnormalities. (28 Days)
C: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
D: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) (Baseline, Day 29); Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29) (Baseline, Day 29); Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier (Baseline, Day 29)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Buzzy: An Integration of Vibration, Cold, and Distraction for Pediatric Needle Pain Relief
Brief Summary: A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.


Options:
A: Faces Pain Scale-Revised (FPS-R) (5 minute)
B: Visual Analogue Scale (sevral minutes before and after BTX injections)
C: Venham's clinical rating scale (Within 1 hour of procedure)
D: Child pain intensity (2 minutes after completion of the immunization series.)

Answer: A