TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures
Brief Summary: Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation randomized controlled trial (RCT) among CVS employees. The investigators will be able to determine the comparative and absolute efficacy and effectiveness of 4 different incentive structures that are each grounded in behavioral economic principles. Additionally, the investigators will measure rates of and reasons for acceptance of each incentive structure, and examine participant characteristics that modify the efficacy and acceptance of different incentive structures.


Options:
A: verified abstinence 6 months (6 months)
B: Salivary cotinine or anabasine testing (metabolites of nicotine) (at 6 months following the patient selected target quit date.)
C: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)
D: Cigarette smoking abstinence. (Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Study of Topical Rapamycin to Erase Angiofibromas in TSC-Multicenter Evaluation of a Novel Therapy
Brief Summary: The study is a multi-center prospective, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of a topically applied formulation of rapamycin to cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to their angiofibromas for six months.

The primary goal of this study is to evaluate the efficacy of the topical medication for reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study is to confirm the safety of the topical medication.


Options:
A: Change From Baseline in the Facial Angiofibroma Grading Scale (AGS) Score (baseline, 6 months)
B: Objective Response Rate (On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks.)
C: longest diameter of renal angiomyolipomas assessed by MRI scan, toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (assessments at baseline and 2,6,12 and 24 months); toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events (throughout study)
D: Rapamycin level (6 months); Complete blood count (6 months); Total cholesterol (6 months); Dermatologic sensitivity at site of application (pain, erythema, edema, pruritis) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Craniosacral Therapy on Chronic Neck Pain: A Randomized Controlled Trial
Brief Summary: The purpose of this randomized controlled trial is to determinate the efficacy and safety of Craniosacral Therapy in the treatment of chronic unspecific neck pain.


Options:
A: Neck Pain (Baseline)
B: Pain Pressure Threshold (6 sessions)
C: Pain intensity (week 8)
D: The intensity of cervical pain (Baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study
Brief Summary: The investigators examined whether a combined therapy with low-dose spironolactone plus metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary Syndrome (PCOS) patients.


Options:
A: To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women (twelve months)
B: Live birth rate
C: Serum testosterone
D: Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study (six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Non-invasive Ventilation Versus Long-term Oxygen Therapy in COPD Survivors of Acute Hypercapnic Respiratory Failure. A Multicenter Randomized Controlled Trial
Brief Summary: Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed to treat acute respiratory failure but little information is available about the benefits of home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure surviving an acute hypercapnic respiratory failure. The purpose of this study is to determine whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an episode of acute hypoxemic respiratory failure (AHRF) treated by Non-invasive ventilation (NIV).


Options:
A: Acute hypercapnic respiratory failure episode (up to 102 weeks)
B: Health related quality of life measured by the Chronic Respiratory Questionnaire
C: Severe Respiratory Insufficiency (SRI) Questionnaire (1 year)
D: Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Efficacy of Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation - a Single Centre, Randomized, Double-blind, Placebo-controlled Study (the AnPAF Study)
Brief Summary: The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial was to assess clinical efficacy of antazoline in rapid conversion of atrial fibrillation during observation sinus rhythm.


Options:
A: recurrence of atrial fibrillation (6 month)
B: The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.
C: Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus (1.5 hour)
D: Death from any cause or adjudicated hospitalization for worsening heart failure (Until study cut-off date)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
Brief Summary: The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.

The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.


Options:
A: Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes (within 3 minutes)
B: Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization (Intraoperative, 4 minutes following randomization)
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: Proportion of patients with hemostasis 3 minutes after application of the haemostat product (3 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
Brief Summary: The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.

The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.


Options:
A: Proportion of patients with hemostasis 3 minutes after application of the haemostat product (3 minutes)
B: Intraoperative blood loss (End of operation)
C: Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS). (Intra-operative)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
Brief Summary: The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.

The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.


Options:
A: Attainment of hemostasis at following randomization.
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: Blood loss (milliliters) (intraoperative (from skin incision to skin closure))
D: Success in achieving hemostasis.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients With Autoimmune Disease
Brief Summary: This is a study to evaluate the safety and immunogenicity of V212 vaccine in adults with autoimmune disease, including participants with rheumatoid arthritis, psoriatic arthritis, psoriasis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, and other similar diseases. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at approximately 28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.


Options:
A: Antibody levels after vaccination.
B: N/A
C: Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) (Baseline and ~28 days after Vaccination 4 (~Day 118)); GMFR in VZV Antibody Response Measured by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay (Baseline and ~28 days after Vaccination 4 (~Day 118)); Percentage of Participants With a Serious Adverse Event (Up to ~28 days after Vaccination 4 (~Day 118))
D: Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series (One month after the 3-dose infant series (7 months of age)); Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose (1 Month After the Toddler Dose); Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series (One Month After the Infant Series (7 months of age)); Percentage of Participants Reporting Pre-specified Systemic Events (Within 7 days after each dose); Percentage of Participants Reporting Pre-specified Local Reactions (Within 7 days after each dose)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Health Partnership Program for Cancer Patients
Brief Summary: The Objectives of this study is

1. To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of participating in tailored program (Health Partnership Program) for 24 weeks
2. To evaluate the efficacy for quality of life, life satisfaction, health leadership, anxiety, depression, impact of event, social support, cancer belief as a result of participating in tailored program (Health Partnership Program) for 24 weeks
3. To assess the efficacy of such intervention compared with usual care in cancer patients


Options:
A: Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI) (baseline, 3month, 6month, and 12month)
B: Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) (6 months)
C: Weight loss (2 years)
D: Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) (baseline, 3, 6, and 12 months); Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Health Partnership Program for Cancer Patients
Brief Summary: The Objectives of this study is

1. To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of participating in tailored program (Health Partnership Program) for 24 weeks
2. To evaluate the efficacy for quality of life, life satisfaction, health leadership, anxiety, depression, impact of event, social support, cancer belief as a result of participating in tailored program (Health Partnership Program) for 24 weeks
3. To assess the efficacy of such intervention compared with usual care in cancer patients


Options:
A: The primary end point of the study was the maximum grade of acute graft versus host (GVH) disease observed in the recipient.
B: Health related quality of life (Change from Baseline HRQoL at 6 months)
C: Mental condition (from baseline until 6 months)
D: Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI) (baseline, 3month, 6month, and 12month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Study for Evaluation of the Insulin Resistance, Lipid Metabolism and Sub Clinical Cardiovascular Disease in Women Who Initiate the Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method With in Follow-up for Two Years
Brief Summary: Objective:

The purpose of this study is to determine the etiology of the weight increase in Depot-medroxyprogesterone Acetate (DMPA) users.

Method:

Prospective study with 100 women, aged 18-40 years old and BMI \< 30kg/m², paired with users of a non hormonal method follow for two years. Will be included only women who never used DMPA. There will be evaluated habit, blood pressure, anthropometric measure, distribution of corporal fat, lipids profile and glycemia parameters every six months. Thirty women and their control group will performed a euglycemic-hyperinsulinemic clamp to evaluate the resistance of insulin, adiponectin,neuropeptide Y, apolipoprotein A/B and arterial evaluation with ultrasound, intimal and media measure. Anova analysis for repeated samples. The metabolic alterations should elucidate the etiology, and the beginning of the sub clinical cardiovascular disease should be shown/discarded with the arterial evaluation.


Options:
A: insulin resistance (12 months)
B: Prostate-specific antigen (PSA) (3 months)
C: Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS (Participants will receive counseling before admission and at 12 months after)
D: LNG Steady State at Baseline and Then Post-randomization (baseline (2 months) and post-randomization (4 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Suicidal and Self-Injurious Adolescents With Emotional Dysregulation
Brief Summary: Suicide is the third leading cause of death among adolescents in the US yet there is a paucity of research on effective treatments for this population. The primary aim of the research described in this application is to evaluate the efficacy of dialectical behavior therapy (DBT) for suicidal adolescents. DBT has an empirical track record with suicidal adults of reducing the incidence, frequency and medical risk of suicide attempts and non-suicidal self-injuries among individuals meeting criteria for borderline personality disorder (BPD). While DBT is widely used in the community with suicidal adolescents, particularly those with difficulties characteristic of BPD such as poor emotion regulation and impulse control, no randomized trial of DBT with suicidal adolescents has ever been conducted. And, while non-randomized trials indicate that the intervention is both safe and effective, without a randomized trial the investigators simply do not know whether DBT for suicidal adolescents is efficacious or not. Given the severity of the problem and the lack of alternative treatments for high risk adolescents, addressing this question is of great importance. The second aim of the research is to analyze mediators of reduced suicidal and self-injurious behaviors in adolescents. 170 adolescents at two sites (Seattle and Los Angeles) will be randomized to DBT or Individual and Supportive Group Therapy (IGST). Both treatments include 6 months of individual and group treatment and adolescents and a parent complete 5 assessments over a 1-year period.


Options:
A: Clinical Global Impression (CGI) (Day 0); Suicide Intent Scale (Day 0); Montgomery-Asberg depression rating scale (Day 0)
B: Reduced Self-harm (3 months)
C: Suicide Events (1 year)
D: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Suicidal and Self-Injurious Adolescents With Emotional Dysregulation
Brief Summary: Suicide is the third leading cause of death among adolescents in the US yet there is a paucity of research on effective treatments for this population. The primary aim of the research described in this application is to evaluate the efficacy of dialectical behavior therapy (DBT) for suicidal adolescents. DBT has an empirical track record with suicidal adults of reducing the incidence, frequency and medical risk of suicide attempts and non-suicidal self-injuries among individuals meeting criteria for borderline personality disorder (BPD). While DBT is widely used in the community with suicidal adolescents, particularly those with difficulties characteristic of BPD such as poor emotion regulation and impulse control, no randomized trial of DBT with suicidal adolescents has ever been conducted. And, while non-randomized trials indicate that the intervention is both safe and effective, without a randomized trial the investigators simply do not know whether DBT for suicidal adolescents is efficacious or not. Given the severity of the problem and the lack of alternative treatments for high risk adolescents, addressing this question is of great importance. The second aim of the research is to analyze mediators of reduced suicidal and self-injurious behaviors in adolescents. 170 adolescents at two sites (Seattle and Los Angeles) will be randomized to DBT or Individual and Supportive Group Therapy (IGST). Both treatments include 6 months of individual and group treatment and adolescents and a parent complete 5 assessments over a 1-year period.


Options:
A: Suicidal thoughts or attempts (Measured at Year 2)
B: Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up (24 months)
C: Suicide Events (1 year)
D: Change in Beck Scale for Suicide Ideation (BSS) score (Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Subcutaneous Abdominal Wound Healing Impairment After Surgery Without Fascial Dehiscence by Vacuum Assisted Closure™(SAWHI-V.A.C.® Study) Versus Standard Conventional Wound Therapy
Brief Summary: This clinical study is performed in several German, Dutch and Belgian hospitals to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) for the treatment of postsurgical abdominal wound healing impairments after surgery. Therefore the underlying layer of fibrous tissue that permeates the internal organs must be intact.

Main outcome measure is the time until complete wound closure that sustained for a minimum of 14 days. Furthermore the therapy options will be examined regarding several other clinical, safety, patient reported and economic parameters.

Patients will be assigned equally and by chance to both treatment groups. Study participants as well as the attending doctors and nurses will be informed about the assignment to the respective treatment arm.

The primary outcome measure and some of the secondary parameters like reappearance of the wound and the development of the wound size over time, examined within an active study treatment time of 42 days, will be photographed and analysed under the use of a central computer system. The central analysing personal will not be informed about patient details or therapy allocation.

Patients with at first closed belly wounds with wound healing disorder in the postoperative course after surgery without an opening of the underlying layer of fibrous tissue are eligible to be included in the trial if the diagnosis of a wound healing impairment in the postoperative course is manifested as a wound with spontaneous dehiscence, a wound that requires an active reopening of the suture by the treating physician or a wound that cannot be closed by primary intention and requires further treatment to achieve permanent closure.

Study participants will be selected and enrolled within clinical surgical departments which provide the respective personal, structural and scientific background for the conduction of the trial project.

Trial therapy will be started in-hospital and may be continued in ambulatory care. It is very important to examine the therapy options also in the ambulant care setting thus study participants with good health who are able to continue the specific wound treatment in ambulant should be transferred to the ambulant service as soon as possible.


Options:
A: Early Complications of Vascular Zone (2 weeks)
B: Time to Complete Wound Closure (42 days)
C: Surgical Site Infection (30 days)
D: Post-operative wound infection (6 weeks post-operative)

Answer: B