TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Delivery of Self-management Through a Peer-support Telehealth Intervention in Patients With Cardiovascular Disease: The Healing Circles Project
Brief Summary: Heart disease is a leading cause of death and disability in Canada. Providing social and peer supports has been proven to help patients manage their health and stay out of the hospital. The use of telehealth has opened up a wider possibility of patients receiving peer support while staying in their homes and communities. The investigators plan to study a new application for supporting patients through peer support. The application can be accessed by smartphone, tablet and desktop/laptop computer. Over two years, the investigators anticipate that the application (Healing Circles) will improve patient self care and reduce hospitalizations.


Options:
A: Hospital admissions for any cause (Twelve months)
B: Mortality rate (10-year)
C: Recruitment (Baseline); Dropout (24 weeks); Satisfaction with intervention (12 weeks); Number of contacts (24 weeks); Content of contacts (24 weeks); CR attendance (12 weeks); CR attendance (24 weeks); Change in Health-related Quality of Life (Baseline to 24 weeks); Change in Self-efficacy (Baseline to 24 weeks); Change in symptoms of anxiety and depression (Baseline to 24 weeks); Change in dietary quality (Baseline to 24 weeks); Change in physical activity (Baseline to 24 weeks)
D: Changes from baseline in patient self-management (Health Education Impact Questionnaire v3.0) every 6 months until study end. (At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Repetitive Transcranial Magnetic Stimulation for Depression After Basal Ganglia Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness of repetitive transcranial magnetic stimulation(rTMS) in treating depression after basal ganglia ischemic stroke and to examine whether such effects are related to restoration of white matter integrity.Sixty-six participants will be recruited from three centers and randomized with a 1:1 ratio to receive active rTMS treatment or sham rTMS treatment in addition to routine supportive treatments.The data of neuropsychological tests and MRI will be collected at 0, 2 and 4 weeks after the commencement of the treatment.


Options:
A: Occurrence rate of depression (3 months)
B: Treatment response (Week 4 after tenth day of tDCS)
C: Number of Participants With Adverse Events (After Day 1 of rTMS treatment); Number of Participants With Adverse Events (After Day 2 of rTMS treatment); Number of Participants With Adverse Events (After Day 3 of rTMS treatment); Number of Participants With Adverse Events (After Day 4 of rTMS treatment); Number of Participants With Adverse Events (3 months following neurostimulation); Number of Participants With Adverse Events (6 months following neurostimulation); Number of Participants With Adverse Events (12 months following neurostimulation); Depressive Symptoms as Rated by the Hamilton Depression Rating Scale (Depressive symptoms will be quantified before the rTMS stimulation protocol); Depressive Symptoms as Rated by the Hamilton Depression Rating Scale (Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation.); Depressive Symptoms as Rated by the Hamilton Depression Rating Scale (Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol.); Depressive Symptoms as Rated by the Hamilton Depression Rating Scale (Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol.); Depressive Symptoms as Rated by the Hamilton Depression Rating Scale (Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol.)
D: response rate (baseline, 2nd and 4th week); remission rate (baseline, 2nd and 4th week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Repetitive Transcranial Magnetic Stimulation for Depression After Basal Ganglia Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness of repetitive transcranial magnetic stimulation(rTMS) in treating depression after basal ganglia ischemic stroke and to examine whether such effects are related to restoration of white matter integrity.Sixty-six participants will be recruited from three centers and randomized with a 1:1 ratio to receive active rTMS treatment or sham rTMS treatment in addition to routine supportive treatments.The data of neuropsychological tests and MRI will be collected at 0, 2 and 4 weeks after the commencement of the treatment.


Options:
A: response rate (baseline, 2nd and 4th week); remission rate (baseline, 2nd and 4th week)
B: Occurrence rate of depression (3 months)
C: TMS Symptom Checklist (Adminstered at testing session, 2-4 years after intervention.)
D: Treatment response (Week 4 after tenth day of tDCS)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Strategies for Blood Pressure Control in the Setting of Acute Ischemic Stroke to Reduce Cerebral Hemorrhage After Thrombectomy: Systolic Blood Pressure Target of Less Than 130 mmHg vs Less Than 185 mmHg, for 24 Hours Following Reperfusion, in Patients With Cerebral Infarction Due to Occlusion of the Anterior Circulation
Brief Summary: A randomized, multicenter study comparing two strategies: 1 / standard management of systolic blood pressure according to international recommendations (systolic blood pressure \<185 mm Hg) versus 2 / intensive blood pressure management Systolic with a target \<130 mm Hg.


Options:
A: Favourable outcome (day 90)
B: Final Infarct Volume (36 (+/-12) hrs after treatment initiation); Utility-weighted Modified Rankin Score (90 days after treatment initiation)
C: Rate of patients with intracranial hemorrhagic complications (Scan performed between 24 and 36 hours after thrombectomy)
D: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure
Brief Summary: This study evaluates whether tailored, peripheral ultrafiltration complementary to low-dose diuretics is associated with a reduction in cardiovascular mortality in 90 days after randomization and heart failure events in 90 days after discharge than usual care including stepped intravenous diuretics in acutely decompensated chronic heart failure with fluid overload (not fully responsive to diuretic therapy).


Options:
A: Change in Serum Creatinine (Change from Baseline to Day 4); Change in Weight (Change from Baseline to Day 4)
B: Changes in a composite clinical-lab score (Baseline and 96 h after randomization,precisely:48 h after end of the last UF session in the intervention arm;24 h after end of 72 h infusional drug treatment in the control arm)
C: Cardiac death and rehospitalization for HF (180 days)
D: Heart Failure (HF) Event (in 90 days after discharge); Cardiovascular Death up to 90 Days After Randomization. (in 90 days after discharge)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Ekso Improve Motor Function and Neuroplasticity in Pazients Affected by Chronic Stroke? A Rondomized Pilot Study
Brief Summary: The use of neurorobotic devices into gait rehabilitative programs, including Ekso, is reported to increase the engagement and motivation of the patients while actively performing a task, and to shape the sensory-motor plasticity (SMP) and its balance between the primary motor areas (M1), and the fronto-parietal network (FPN) connectivity, thus contributing to successful gait rehabilitation. Aim of our study was to assess whether Ekso would foster the recovery of deteriorated FPN connectivity and SMP patterns involved in limb coordination during walking in a sample of patients with hemiparesis due to stroke.

Twenty outpatients were consecutively included in this study according to the following inclusion criteria: (i) age ≥55 years; (ii) a first-ever ischemic supra-tentorial stroke (confirmed by MRI scan) at least 6 months before their enrollment; (iii) an unilateral hemiparesis, with a Muscle Research Council -MCR- score ≤3; (iv) ability to follow verbal instructions, with a Mini-Mental State Examination (MMSE) \>24; (v) a Modified Ashworth Scale (MAS) score ≤2; (vi) no severe bone or joint disease; and (vii) no history of concomitant neurodegenerative diseases or brain surgery.

Patients were randomly assigned to the experimental (Ekso gait training -EGT) of control group (conventional overground gait training -OGT- at a velocity matched to the Ekso gait training).


Options:
A: The time required to climb Up and Down 9 stairs (seconds) (1 day)
B: Change in 10 Meter Walk Test From Baseline in Gait Speed (Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up))
C: Motricity Index (Six months)
D: 6-minute Walk Test (3-month follow-up); Functional Ambulation Category (3-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Culture-sensitive Emotion Regulation Group Therapy for Traumatized Refugees: A Randomized Controlled Trial
Brief Summary: There is a lack of studies on treatment effect in traumatised refugees. Recent findings indicate that emotion regulation deficits play a key role in PTSD also among traumatized refugees and highlight the importance and potential directions for the development of an emotion regulation training for refugees. In this study, the investigators therefore want to examine the effectiveness of a new, transdiagnostic, cultural-sensitive group therapy, which systematically teaches specific emotion regulation strategies. Participants will be randomly assigned to either the emotion regulation training, delivered in group format or a wait list control condition. The study takes place in cooperation with REFUGIO Munich, which is a treatment centre specialised in the treatment of traumatised refugees. Clinicians will deliver the treatment to traumatized asylum seekers and refugees that report difficulties in emotion regulation. The investigators will examine if refugees and asylum seekers in the intervention group will show improvements in psychological symptoms, social functioning as well as in emotion regulation in comparison to a wait list control group which will receive the treatment after the intervention group has completed. The group therapy covers 14 sessions and has a cognitive-behavioural background. It focuses on conveying strategies to cope with intense feelings and the patients should gain a sense of self-efficacy and control over their trauma-relevant feelings and symptoms. Qualified interpreters will be used in the assessments as well as group therapies.


Options:
A: Change in Difficulties in Emotion Regulation (baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)); Change in General Health (baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment))
B: Recovery from Common Mental Disorder (defined by ICD10) (6 months)
C: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
D: Change in body pain index using Body Pain Inventory (At recruitment, right before and after the intervention and 12 weeks afterwards); Change in Impact of Events Scale (At recruitment, right before and after the intervention and 12 weeks afterwards)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing Standing Desks in Primary and Secondary Schools to Reduce Sedentary Time: Effect and Process Evaluation.
Brief Summary: Since sedentary time is related to various health outcomes and is already highly prevalent in childhood and adolescence, effective strategies are needed to tackle this health problem. Children and adolescents spend the majority of the day in a classroom while sitting at a desk. Therefore, the classroom is an important setting for implementing specific strategies to reduce sedentary time.

One of the strategies that gained more attention during the past years is replacing traditional desks and chairs with standing desks.

This project evaluates the implementation of standing desks in primary and secondary schools via a clustered randomized controlled trial using an intervention and control condition. Effects on sedentary time during in class, sedentary activities during leisure time, breaks in sedentary time, and related determinants (secondary outcomes) are evaluated.

Next to effect evaluation, it is also equally important to evaluate how teachers and pupils perceive this change in the classroom environment. Both groups need to be positive in order to obtain the adoption and sustainability. Therefore, focus groups with pupils and interviews with teachers are conducted, with a specific focus on the perceived barriers. Moreover, the process evaluation is conducted quantitatively as well by using questionnaires in pupils and teachers.

The project results will lead to recommendations on how to broadly implement standing desks into primary and secondary schools.


Options:
A: Change in the prevalence of overweight and obesity (Baseline, Month 9)
B: Blood pressure (6 months)
C: Change in body mass index (BMI). (Baseline through Follow-up: Grades 5-6-7-8)
D: Decrease in children's sedentary time during school hours (One schoolyear)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Closed Versus Open Abdomen in the Surgical Treatment of Severe Secondary Peritonitis: a Randomized Controlled Clinical Trial
Brief Summary: This is a prospective randomized clinical study. The study will comprise the randomized decision to either A) primarily close the fascia after laparotomy for intra-abdominal infection (CLOSED); or B) leave the fascia open after laparotomy and apply a temporary abdominal closure (TAC) device (OPEN) with a vacuum drain.

Although debatable, both procedures (CLOSED or OPEN abdomen) are acceptable based on current suggested standard of care. Thus, high quality data to direct clinical decision making in this highly lethal condition is urgently required.


Options:
A: The numbers of participants who are survival in hospital stay (90 days after participants enrolled in the study)
B: Fascial Closure Rate (Until hospital discharge Aprox 60 days)
C: Indications to open abdomen (Enrollment); Techniques to perform open abdomen (Enrollment); Management of open abdomen (Visit 2); Definitive closure techniques (Visit 4)
D: Systemic inflammatory marker levels and peritoneal fluid inflammatory marker levels (admission to dicharge, expected average of hospital stay 4 weeks.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants: a Randomized Controlled Trial of a Revised Algorithm
Brief Summary: Two-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (Continous positive airway pressure (CPAP) or Non-invasive Ventilation (NIV) or Invasive Ventilation (IV)). Routine manual control (RMC) of the fraction of inspired oxygen (FiO2) will be tested against RMC supported by closed-loop automatic control (CLAC) with "slow"-algorithm and RMC supported by CLAC with "fast"-algorithm.

The primary hypothesis is, that the use of the "faster" algorithm results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the faster algorithm is equally effective as the slower algorithm to maintain the SpO2 in the target range.


Options:
A: proportion of time spent in extreme saturation ( less than or equal to 80%) (Through study completion, an average of 8 weeks)
B: Proportion of time with SpO2 spent within set target range (Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.)
C: Proportion of time with SpO2 within target range (16 hours); Proportion of Time with SpO2 within target range (16 hours)
D: Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) (18-21 months corrected for prematurity)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomised Controlled Trial of M-health Enabled, Nurse Care Coordinator Led Intervention to Improve Management of Hypertension in India: m-Power Heart Project
Brief Summary: This study evaluates the effect of a mobile health technology enabled trained nurse led intervention on control of blood pressure among patients with hypertension seeking care in the community health centres in the southern state of Andhra Pradesh, India. half the community health centres will receive the intervention and the other half will receive the routine care.


Options:
A: 60 day Medication Adherence (60 days); 120 day medication adherence (120 days)
B: Blood Pressure (one year)
C: Difference in the mean systolic blood pressure (12 months)
D: Medication Adherence (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N-Acetylcysteine Versus L-carnitine in Clomiphene Citrate Resistant Pcos Women. a Randomized Controlled Trial
Brief Summary: N-Acetylcysteine and L-carnitine were used in pcos patients


Options:
A: Determine the cost-effectiveness of fast track to IVF versus conventional infertility treatment by conducting a randomized clinical trial to compare success rates and costs, as well as the associated complications of treatment. (at end of study)
B: Pregnancy rate (6 months follow-up)
C: pregnancy rate (3 momths)
D: Whole body insulin action (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Demonstration of the Effectiveness of Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism Spectrum Disorder With Severe Injurious Behavior.
Brief Summary: Severe injurious behaviors in children with autism spectrum disorder are challenging. First line treatment approaches include behavioral techniques but pharmacotherapy is frequently required despite frequent adverse effects in youths.

Therapeutic body wraps has been reported in small series or case reports, but has never been assessed in the context of a randomized controlled trial.

The present study is an exploratory, multicenter, randomized, controlled, open label with blinded outcome assessment (PROBE design) trial of the effect of wet versus dry therapeutic body wraps in children presenting with autism spectrum disorder and severe injurious behavior.


Options:
A: Aberrant Behavior Checklist (ABC) irritability score (Baseline and 3 months)
B: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
C: Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality (3-month period); Major Bleedings (3 months)
D: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Demonstration of the Effectiveness of Treatment by Therapeutic Body Wraps in Children and Adolescents Suffering From Autism Spectrum Disorder With Severe Injurious Behavior.
Brief Summary: Severe injurious behaviors in children with autism spectrum disorder are challenging. First line treatment approaches include behavioral techniques but pharmacotherapy is frequently required despite frequent adverse effects in youths.

Therapeutic body wraps has been reported in small series or case reports, but has never been assessed in the context of a randomized controlled trial.

The present study is an exploratory, multicenter, randomized, controlled, open label with blinded outcome assessment (PROBE design) trial of the effect of wet versus dry therapeutic body wraps in children presenting with autism spectrum disorder and severe injurious behavior.


Options:
A: Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality (3-month period); Major Bleedings (3 months)
B: Aberrant Behavior Checklist (ABC) irritability score (Baseline and 3 months)
C: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
D: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Shortened Time Interval to Postpartum Visit in Improving Postpartum Attendance
Brief Summary: Due to potential to improve family planning, clinicians are increasingly interested in shortening the time to postpartum visits, but lack an evidence base to change policy.There are no studies that have examined the effectiveness of shortened interval to postpartum visit on attendance rate, contraception use, and rapid repeat of pregnancy (RROP). With this research, the investigators propose to conduct a randomized controlled trial (RCT) to examine the effect of reduced time interval to postpartum visit (3-4 weeks rather than 6-8 weeks) on postpartum visit attendance rate, contraceptive use, and RROP.


Options:
A: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)
B: Postpartum Clinic Attendance (assessed at 12 weeks postpartum)
C: Parents breastfeeding self efficacy (7 days post partum)
D: DSS Investigated and Substantiated Child Maltreatment Rates (0 - 12 Years of Child Age)

Answer: B