TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The ACTonHEART Study: a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy in Cardiac Patients
Brief Summary: The study will determine whether a brief intervention program based on Acceptance and Commitment Therapy can be effective for the reduction of modifiable risk factors and improvement of psychological well-being in patients referred to cardiac rehabilitation


Options:
A: Changes in Body Mass Index (BMI) measured by Bio-electrical Impedance Analysis (TANITA) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in eating habits estimated by 24h recall and PREDIMED questionnaire (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in the level of physical exercise estimated by the International Physical Activity Questionnaire (IPAQ) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in emotional eating estimated by the Dutch Eating Behaviour Questionnaire (DEBQ) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in the quality of life estimated by the Impact of Weight in the Quality of Life-Lite Questionnaire (IWQOL-Lite) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in weight self-stigma estimated by the Weight Self-Stigma Questionnaire (WSSQ) (Pretreatment-Posttreatment (5 months)-7 months follow-up)
B: Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress) (baseline, 12 weeks and 24 weeks)
C: Success meeting recruitment goals (20 patients within 3-4 months) (4-month recruitment window); Willingness to participate in study (>10% of eligible) (4-month recuitment window); Adherence rate (≥70% attendance, 7 of 10 classes) (12-weeks); Retention (≤25% drop-out) (6-months)
D: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The ACTonHEART Study: a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy in Cardiac Patients
Brief Summary: The study will determine whether a brief intervention program based on Acceptance and Commitment Therapy can be effective for the reduction of modifiable risk factors and improvement of psychological well-being in patients referred to cardiac rehabilitation


Options:
A: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)
B: Smoking Abstinence (End of Treatment (8 weeks))
C: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)
D: 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))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The ACTonHEART Study: a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy in Cardiac Patients
Brief Summary: The study will determine whether a brief intervention program based on Acceptance and Commitment Therapy can be effective for the reduction of modifiable risk factors and improvement of psychological well-being in patients referred to cardiac rehabilitation


Options:
A: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)
B: Depressive Symptom Reduction (Change from depression at baseline to depression at 6-months); Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) (6 months after randomization)
C: Stage of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Process of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Decisional balance for coronary heart disease patients with depression (2 - days (T0) before discharge.); Self-efficacy for coronary heart disease patients with depression: scale (2 - days (T0) before discharge.); Hamilton Rating Scale for Depression (2 - days (T0) before discharge.)
D: Hamilton Rating Scale for Depression (HAM-D-17) (12 weeks post-randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Letrozole-metformin-pioglitazone Versus Combined Clomiphene Citrate-metformin-pioglitazone in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome
Brief Summary: Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.


Options:
A: Ovulation (6 weeks after starting the intervention)
B: Live birth rate (Up to 18 months)
C: Live Birth (as few as 5 months, up to 16 months)
D: Ovulation Rate (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Letrozole-metformin-pioglitazone Versus Combined Clomiphene Citrate-metformin-pioglitazone in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome
Brief Summary: Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.


Options:
A: Live birth rate (Up to 14 months)
B: ongoing pregnancy (3 months)
C: Ovulation Rate (3 months)
D: Ovulation (6 weeks after starting the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabiliation-Aftercare for an Optimal Transfer Into Autonomous Daily Life (RENATA) - an eHealth Intervention Study
Brief Summary: Persons undergoing cardiac rehabilitation often have difficulties transferring the learned health behaviors into their daily routine which decreases their health status. Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption. The aim of this study is, to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation in Germany, the Netherlands and China. The primary goal of the study is to analyze the effectiveness of a rehabilitation aftercare program with regard to the level of physical activity and nutrition.


Options:
A: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)
B: Participation in Cardiac Rehabilitation (12 Months)
C: Change in total volume of weekly active energy expenditure (3 and 6 months)
D: Change in dietary and physical activity behavior (self-report) (Baseline to 8 weeks later)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabiliation-Aftercare for an Optimal Transfer Into Autonomous Daily Life (RENATA) - an eHealth Intervention Study
Brief Summary: Persons undergoing cardiac rehabilitation often have difficulties transferring the learned health behaviors into their daily routine which decreases their health status. Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption. The aim of this study is, to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation in Germany, the Netherlands and China. The primary goal of the study is to analyze the effectiveness of a rehabilitation aftercare program with regard to the level of physical activity and nutrition.


Options:
A: Change in dietary and physical activity behavior (self-report) (Baseline to 8 weeks later)
B: Women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out. (90 days)
C: Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits) (Measured at Months 6 and 12)
D: Surgical Failure (6 months and 1, 2, 3, 4, and 5 years); Recruitment Into E-OPTIMAL (At 24 Months post OPTIMAL Treatment); Retention in E-OPTIMAL (3, 4, and 5 Years Post OPTIMAL Treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabiliation-Aftercare for an Optimal Transfer Into Autonomous Daily Life (RENATA) - an eHealth Intervention Study
Brief Summary: Persons undergoing cardiac rehabilitation often have difficulties transferring the learned health behaviors into their daily routine which decreases their health status. Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption. The aim of this study is, to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation in Germany, the Netherlands and China. The primary goal of the study is to analyze the effectiveness of a rehabilitation aftercare program with regard to the level of physical activity and nutrition.


Options:
A: Change in dietary and physical activity behavior (self-report) (Baseline to 8 weeks later)
B: Phase 1: patient who've received interventions based on evidence proportion informed by the indicators (9 months); Phase 2: increase of prescription of evidence based treatment in clinical practice (6 months)
C: Change in individual anaerobic threshold according to lactate kinetics during spiroergometry (6 months)
D: Total steps (last 30 days of intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-arm Phase IIB Randomised, Double Blind Placebo-controlled Clinical Trial Comparing the Efficacy of Three Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis.
Brief Summary: Multiple sclerosis (MS) is a disabling and progressive neurological disease that affects approximately 100,000 people in the UK. Many patients with MS experience two phases of disease; early MS (also called relapsing remitting MS, RRMS) and late MS (also called secondary progressive MS (SPMS). Early MS is due to inflammation of the nerves and the insulation (called myelin) that surrounds the nerves. Early MS is often characterised by periods of "attacks" interspersed with periods of "remission" with no or low disease symptoms. Late or progressive MS, which affects the majority of patients and typically emerges after 10-15 years of disease, results from actual nerve death (also called neurodegeneration). The progressive stage of disease results not in individual attacks but slow, cumulative and irreversible disability affecting walking, balance, vision, cognition, pain control, bladder and bowel function. Critically, and unlike early disease, there is no proven treatment for the late stage of MS. This is therefore an urgent and major unmet health need. MS-SMART directly addresses this need and will evaluate in this clinical trial three drugs (fluoxetine, riluzole or amiloride), all of which have shown some promise in MS, and in particular in SPMS. The trial is randomised and blinded. Randomisation means patients can get any one of the three active drugs or the inactive placebo/dummy; blinded means that neither patients nor the doctors will know which drug or placebo patients are receiving. Randomisation and blinding are standard approaches in clinical trials to ensure unbiased testing of drugs. All patients in MS-SMART will have periodic MRI (magnetic resonance imaging) brain scans and after 96 weeks these will be analysed. We will then compare the scans of each drug to the placebo or dummy to see if any of the drugs slow the rate of brain shrinkage that normally occurs in SPMS. This measured change in brain size is the primary (major) outcome of MS-SMART.


Options:
A: Pressure Pain Threshold. (Difference between baseline (prior to treatment) compared with 10 weeks of 60 mg/daily duloxetine compared with placebo)
B: Change in Mean Pain Severity Score From Baseline to 13 Weeks (Baseline and 13 weeks)
C: MRI-derived Percentage Brain Volume Change (PBVC). (2 years)
D: Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS). (Baseline and 9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke
Brief Summary: Stroke is the most serious disabling condition in the United States and the developed world. Novel stroke rehabilitation approaches, such as task-specific training, have shown promise in improving an individual's recovery in the rehabilitation setting; however, evidence suggests that these improvements are not generalized or transferred to the home, community, or work settings. Thus, these interventions usually do not impact overall health and participation outcomes. This research study seeks to improve task-specific training as a stroke rehabilitation approach by integrating it with evidence-based cognitive-oriented strategies which have shown great promise as a way to address the limitations of task-specific training. The new treatment protocol is called Cognitive-Oriented Strategy Training Augmented Rehabilitation, or COSTAR. The hypothesis of this study is that COSTAR will result in more efficient functional skill acquisition, better long-term retention of skills learned, and generalization and transfer of skills learned to home, community, and work settings.


Options:
A: Change Between the Value of the SF-36 Physical Function Score at 12 Months Minus Value at Baseline to Measure the Change in Health-related Quality of Life and Function (Baseline (pre-randomization) and 12 months)
B: Change From Baseline in Performance Quality Rating Scale (PQRS) (A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline))
C: Canadian Occupational Performance Measure (COPM) (Change from baseline to post-intervention (12 weeks)); Performance Quality Rating Scale (PQRS) (Change from baseline to post-intervention (12 weeks))
D: Number of persons having cognitively declined at 24 months (24 months after randomization); Cognitive decline measured on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 24 months (24 months after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimising Rehabilitation Outcomes in Frail Older Adults: Effects of Increasing the Amount of Physical Activity
Brief Summary: The main aim of this study is to investigate whether increasing the amount of physical activity in frail older people during hospital based rehabilitation is associated with better mobility outcomes compared to usual care. A second aim is to investigate whether this physical activity intervention is associated with improvements in health related quality of life. Finally we plan to investigate whether increasing the amount of physical activity during rehabilitation is cost effective, measured from a health system perspective, compared with usual care.

Older people receiving inpatient rehabilitation will be randomly assigned to an intervention group, who will receive extra physical activity on weekdays and weekends or a control group, who will receive additional activities based on social interaction. The activity sessions will be individualized to the particular participant. Both groups of people will be assessed at baseline, discharge from hospital and at 6 months following discharge. The intervention group will be provided with one or two extra sessions on weekdays and two extra sessions on weekends for the duration of their rehabilitation stay. To account for the extra physiotherapy time that the intervention group receives, the people in the control group will spend the same amount of time performing other activities, such as cards, board games or reading, whilst seated. To ensure the safety of the participants in this study, each physical activity session will be supervised by either a physiotherapist or allied health assistant.

Hypothesis 1: The primary hypothesis is that, compared with usual care, increasing the amount of physical activity in frail older people during rehabilitation will lead to more optimal mobility at discharge, as measured by gait speed.

Secondary hypotheses are that, compared with usual care, increasing the amount of physical activity during rehabilitation will:

Hypothesis 2: lead to significantly greater improvements in mobility and function both at discharge and six months following discharge.

Hypothesis 3: lead to better quality of life six months following hospital discharge, measured using the EuroQol Health (EQ5D) Questionnaire and the EuroQol-Visual Analogue Scale (EQ-VAS).

Hypothesis 4: be cost effective compared to usual care


Options:
A: Gait Velocity (Discharge (Average Duration of Hospital Stay is 3 weeks))
B: Length of Stay (At time of discharge from hospital (an expected average of 8 days post admission))
C: Proportion of residents receiving at least one antipsychotic medication after 12 months (12 months)
D: Successful medication discontinuation (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in CC-resistant Patients With Polycystic Ovary Syndrome
Brief Summary: Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10 (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university hospital and private practice setting. One hundred ten infertile women with PCOS resistant to CC were randomized to either combined CC/CoQ10 (51 patients, 82 cycles) or CC 150 mg/day alone (50 patients, 71 cycles) for ovulation induction in patients with CC-resistant PCOS.

Main outcome measures: Number of follicles, serum E2, serum P, endometrial thickness, pregnancy rate (PR) and miscarriage rate.


Options:
A: Whole body insulin action (3 months)
B: 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)
C: Pregnancy rate (6 months follow-up)
D: Number of ovulating patients (1-2 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in CC-resistant Patients With Polycystic Ovary Syndrome
Brief Summary: Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10 (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university hospital and private practice setting. One hundred ten infertile women with PCOS resistant to CC were randomized to either combined CC/CoQ10 (51 patients, 82 cycles) or CC 150 mg/day alone (50 patients, 71 cycles) for ovulation induction in patients with CC-resistant PCOS.

Main outcome measures: Number of follicles, serum E2, serum P, endometrial thickness, pregnancy rate (PR) and miscarriage rate.


Options:
A: pregnancy rate (3 momths)
B: Number of ovulating patients (1-2 months)
C: 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)
D: Pregnancy rate (6 months follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Week, Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Irritability Associated With Autistic Disorder
Brief Summary: This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.


Options:
A: Children's Psychiatric Rating Scale (Weekly)
B: Change From Baseline at Week 24 on the Vineland Adaptive Behavior Scales (Vineland-II) Two-domain Composite (2DC) Score. (Week 24)
C: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (Baseline to 6 Weeks)
D: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Week, Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Irritability Associated With Autistic Disorder
Brief Summary: This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.


Options:
A: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) (Baseline (Visit 1) to week 12)
B: Change From Baseline in Social Communication Deficits as Measured by Social Responsiveness Scale 2 (SRS-2) (Baseline, Week 12); Percentage of Participants with Suicidality, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) (Baseline up to Week 12); Percentage of Participants With Adverse Events (From Baseline up to Week 18)
C: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (Baseline to 6 Weeks)
D: hyperactivity, impulsiveness, and distractibility

Answer: C