TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Diabetes Care in General Practice Study: Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus
Brief Summary: The aims of a concluding 14-year follow-up study are:

* To investigate what long-term effect the project model for structured, personalized diabetes care has on 1) the patients' mortality and development of diabetic complications, 2) the patients' use of services from the primary and secondary sector, 3) the patients' self-rated health and motivation, and 4) the doctor-patient relationship.


Options:
A: Rate of Change in Hemoglobin A1c (12 month period)
B: Hemoglobin A1c (6 months)
C: HbA1c (12 months)
D: Mortality (From diabetes diagnosis until median14 year after study start); Diabetic retinopathy (at 6 year and 14 year after study start); Urinary albumin concentration (at 6 year and 14 year after study start); Myocardial infarction (From diabetes diagnosis until median14 year after study start); Stroke (From diabetes diagnosis until median14 year after study start)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia
Brief Summary: Randomized controlled multi-center study with three arms including 200 patients with low risk endometrial hyperplasia. After confirmed diagnosis the patients will receive one of the following treatments:

1. Provera (Medroxyprogesterone (MPA)/progestin) 10 mg per oral treatment for 6 months 10 day each cycle,
2. MPA 10 mg continuously for 6 months,
3. Mirena (Levonorgestrel) impregnated IUD for 6 months.


Options:
A: Pathological response rate (From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months); Pathological response time (From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months)
B: Pathologic Response (6-12 months); Pregnancy Rate (7-144 months); Live Birth Rate (16-144 months)
C: Regression and remission rate of endometrial hyperplasia (3 month)
D: Regression of hyperplasia related to treatment arm after 6 months of therapy (Six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Open Label Study Comparing the Efficacy of Chloroquine/Primaquine, Chloroquine and Artesunate in the Treatment of Vivax Malaria Along the Thai-Burmese Border
Brief Summary: This is a randomised open label trial with follow up for 1 year. 660 adults and children above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either chloroquine, artesunate, or chloroquine/primaquine therapy. Participants will be screened on the day of inclusion then followed weekly for 8 visits and every 4 weeks until week 52. The primary objective of the study is to compare the efficacy of the WHO and Thai Ministry of Public Health recommended radical curative regimen of chloroquine and primaquine with the currently used monotherapy regimens of chloroquine and artesunate along the Thai-Burmese border.


Options:
A: Pharmacokinetic Parameters of Primaquine and Carboxyprimaquine in breast milk. Area Under Curve (AUC) (13 Days. Time Frame: predose, 0,1,2,3,4,6,8,12,24,72 hours; Day 7, Day 13 post-dose)
B: The first recurrence of Plasmodium vivax malaria (Day 28)
C: Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate (28 Days)
D: Recurrence of P. vivax (52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial for the Optimal Timing of HIV Therapy After Cryptococcal Meningitis
Brief Summary: The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital discharge results in superior survival compared to standard initiation of ART started as an outpatient.


Options:
A: Mortality (2 years)
B: Survival (18 weeks)
C: Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug (Day 100); Number of Dose-limiting Toxicities Attributed to Treatment Regimens (Day 100)
D: Mortality (26 weeks from study entry)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial for the Optimal Timing of HIV Therapy After Cryptococcal Meningitis
Brief Summary: The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital discharge results in superior survival compared to standard initiation of ART started as an outpatient.


Options:
A: Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality (full follow-up, 9.3 years)
B: Mortality (26 weeks from study entry)
C: Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48
D: Mortality (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial for the Optimal Timing of HIV Therapy After Cryptococcal Meningitis
Brief Summary: The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital discharge results in superior survival compared to standard initiation of ART started as an outpatient.


Options:
A: Percent of Participants Who Survived Without AIDS Progression. (Through week 48)
B: Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. (1 month and 12 months after testing)
C: Mortality (26 weeks from study entry)
D: Linkage to care (90 days); Viral suppression (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride
Brief Summary: The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.


Options:
A: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 (Week 24)
B: Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52 (Baseline and Week 52); Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days (Baseline and Week 76+10 days); Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days (Week 52+10 days and Week 76+10 days)
C: Change from baseline in HbA1c at 24 weeks
D: Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Elective Induction of Nulliparous Labor: A Randomized Clinical Trial
Brief Summary: Primary outcome: to evaluate the effect of elective induction of labor (IOL), at 39 weeks gestation, on cesarean delivery rates in nulliparous women compared to expectant management (EM).

Secondary outcomes: to evaluate differences in the mean number of clinic visits/antepartum tests avoided with IOL, to compare the differences in utilization of inpatient resources (mean duration of inpatient stay, mean duration of labor), and to evaluate the effect of IOL on the risk of urinary/anal incontinence and sexual dysfunction as analyzed using previously validated measurements. We will evaluate differences in the rate of cervical change once active labor is diagnosed, and the time from completion of active labor, defined as complete dilation and complete effacement, to the delivery of fetus (definition of second stage of active labor). Furthermore, other secondary outcomes to be evaluated include comparisons between IOL and EM in regards to the occurence of chorioamnionitis, stillbirth, operative vaginal delivery, and meconium stained amniotic fluid. An evaluation of the predictive value of cervical length and Bishop score for vaginal delivery will also be examined.


Options:
A: Number of Participants With a Need for Cesarean Delivery (Induction to delivery)
B: Cesarean Birth Rate (39 weeks gestation)
C: To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a (2 years)
D: feasibility of randomised Induction of Labour Trial in Out-patient setting (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Elective Induction of Nulliparous Labor: A Randomized Clinical Trial
Brief Summary: Primary outcome: to evaluate the effect of elective induction of labor (IOL), at 39 weeks gestation, on cesarean delivery rates in nulliparous women compared to expectant management (EM).

Secondary outcomes: to evaluate differences in the mean number of clinic visits/antepartum tests avoided with IOL, to compare the differences in utilization of inpatient resources (mean duration of inpatient stay, mean duration of labor), and to evaluate the effect of IOL on the risk of urinary/anal incontinence and sexual dysfunction as analyzed using previously validated measurements. We will evaluate differences in the rate of cervical change once active labor is diagnosed, and the time from completion of active labor, defined as complete dilation and complete effacement, to the delivery of fetus (definition of second stage of active labor). Furthermore, other secondary outcomes to be evaluated include comparisons between IOL and EM in regards to the occurence of chorioamnionitis, stillbirth, operative vaginal delivery, and meconium stained amniotic fluid. An evaluation of the predictive value of cervical length and Bishop score for vaginal delivery will also be examined.


Options:
A: Caesarean section rate for non-reassuring fetal status. (Up to 2 days after cervical ripening)
B: Time from the start of labor induction to delivery
C: Time From Induction of Labor Until Delivery (Time from induction to delivery (average 14.2 hours))
D: Cesarean Birth Rate (39 weeks gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage: Evidence of Kinematic Study
Brief Summary: This research centers on the comparison of the immediate efficacy (right after therapy) and the maintained efficacy (3 months and 6 months) between "Modified Constraint-Induced Movement Therapy" (mCIMT) group and control group at different age.


Options:
A: Hand function assessment (Pretest, posttest)
B: Kinematics of reach (Change from Baseline to Post intervention (1 month), and 6 months later); Somatosensory processing measurement by ERP (Change from Baseline to Post intervention (1 month), and 6 months later); Bayley Scales of Infant and Toddler Development (Bayley III) - 3rd Edition (Change from Baseline to Post intervention (1 month), and 6 months later)
C: N/A
D: Bruininks-Oseretsky Test of Motor Proficiency (BOTMP) (4 weeks (post-treatment), 12 week, 24 week); Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ) (4 weeks (post-treatment), 12 week, 24 week); Kinematic analysis (4 weeks (post-treatment), 12 week, 24 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial
Brief Summary: The purpose of this study is to assess the efficacy of a disease management programme (DMP) for very old patients with HF and significant co-morbidity.

METHODS: A multicenter randomized trial will be conducted with 700 patients with heart failure, aged over 75 years, admitted to the acute-care units of the Geriatrics Departments in 8 hospitals. Patients will be randomly allocated to a DMP or to conventional usual-care. Randomization will be stratified by hospital and performed with concealment of the allocation list.

The DMP will be conducted by a case manager, and will include three main components:

1. patient education to improve disease' knowledge and self-care
2. monitoring of clinical status
3. therapeutic adherence. Main statistical analyses will be performed according to the intention-to-treat principle, and will use Cox regression models to examine the association of a DMP with hospital readmission, quality-of-life, and mortality over 12 months.


Options:
A: Hospital admissions for any cause (Twelve months)
B: Adherence (Change in baseline adherence at 3 month and 6 month)
C: 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)
D: Mortality or readmission (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial
Brief Summary: The purpose of this study is to assess the efficacy of a disease management programme (DMP) for very old patients with HF and significant co-morbidity.

METHODS: A multicenter randomized trial will be conducted with 700 patients with heart failure, aged over 75 years, admitted to the acute-care units of the Geriatrics Departments in 8 hospitals. Patients will be randomly allocated to a DMP or to conventional usual-care. Randomization will be stratified by hospital and performed with concealment of the allocation list.

The DMP will be conducted by a case manager, and will include three main components:

1. patient education to improve disease' knowledge and self-care
2. monitoring of clinical status
3. therapeutic adherence. Main statistical analyses will be performed according to the intention-to-treat principle, and will use Cox regression models to examine the association of a DMP with hospital readmission, quality-of-life, and mortality over 12 months.


Options:
A: Mortality or readmission (one year)
B: Combined number of hospitalizations and emergency department presentations (Two years)
C: disease-specific health-related quality of life (HRQoL) (two years)
D: Adverse events (Evaluation at 12 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial
Brief Summary: The purpose of this study is to assess the efficacy of a disease management programme (DMP) for very old patients with HF and significant co-morbidity.

METHODS: A multicenter randomized trial will be conducted with 700 patients with heart failure, aged over 75 years, admitted to the acute-care units of the Geriatrics Departments in 8 hospitals. Patients will be randomly allocated to a DMP or to conventional usual-care. Randomization will be stratified by hospital and performed with concealment of the allocation list.

The DMP will be conducted by a case manager, and will include three main components:

1. patient education to improve disease' knowledge and self-care
2. monitoring of clinical status
3. therapeutic adherence. Main statistical analyses will be performed according to the intention-to-treat principle, and will use Cox regression models to examine the association of a DMP with hospital readmission, quality-of-life, and mortality over 12 months.


Options:
A: Mortality or readmission (one year)
B: Drug Related Problems (DRP) (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Mortality (6-month after inclusion); Average length of the hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Readmissions (6-month after inclusion); Average cost of hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days)
C: N/A
D: Forced expiratory volume 1 second (FEV1) (16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial
Brief Summary: The purpose of this study is to assess the efficacy of a disease management programme (DMP) for very old patients with HF and significant co-morbidity.

METHODS: A multicenter randomized trial will be conducted with 700 patients with heart failure, aged over 75 years, admitted to the acute-care units of the Geriatrics Departments in 8 hospitals. Patients will be randomly allocated to a DMP or to conventional usual-care. Randomization will be stratified by hospital and performed with concealment of the allocation list.

The DMP will be conducted by a case manager, and will include three main components:

1. patient education to improve disease' knowledge and self-care
2. monitoring of clinical status
3. therapeutic adherence. Main statistical analyses will be performed according to the intention-to-treat principle, and will use Cox regression models to examine the association of a DMP with hospital readmission, quality-of-life, and mortality over 12 months.


Options:
A: The combined number of hospital admissions and ED visits for a COPD exacerbation (6-month follow-up period)
B: Hospitalization-free Survival - Time to Event (From randomization until date of first hospitalization for COPD, assessed up to 26 months); Hazard Ratio for First COPD Hospitalization (26 months)
C: Mortality or readmission (one year)
D: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Observational Study to Assess the Long-Term Follow-Up of Subjects Who Had Participated in SKY0402 Breast Augmentation Studies
Brief Summary: A history and physical focused on clinical sequelae of breast implant rupture was completed by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon shell.


Options:
A: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours (0 to 72 hours)
B: Total Opioid Burden (Wound closure to time hospital discharge order written or Day 30, whichever is sooner); Health Economic Benefit (Wound closure to time hospital discharge order written or Day 30, whichever is sooner.)
C: Time to First Use of Supplemental Pain Medication (Through 96 hours postdose)
D: Number of Subjects With Breast Implant Rupture (12 to 24 months post surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes
Brief Summary: The primary objective of this study is to evaluate the impact of substance-abuse treatment as usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or methamphetamine dependence.


Options:
A: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)
B: Smoking Abstinence (12 weeks); Smoking Abstinence (2 weeks)
C: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)
D: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes
Brief Summary: The primary objective of this study is to evaluate the impact of substance-abuse treatment as usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or methamphetamine dependence.


Options:
A: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)
B: Smoking Status at 6 Months (6 months after enrollment)
C: Longest duration of abstinence (Week 24)
D: Salivary cotinine or anabasine testing (metabolites of nicotine) (at 6 months following the patient selected target quit date.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes
Brief Summary: The primary objective of this study is to evaluate the impact of substance-abuse treatment as usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or methamphetamine dependence.


Options:
A: Continuous smoking abstinence since target quit date until last visit before delivery. (Last 6 months of pregnancy)
B: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)
C: Smoking abstinence at 12 months post-enrollment (12 months)
D: Percent negative CO readings; Percent negative cotinine readings; Longest period of continuous abstinence

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes
Brief Summary: The primary objective of this study is to evaluate the impact of substance-abuse treatment as usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or methamphetamine dependence.


Options:
A: Urinalysis results negative for methamphetamine over 10 weeks (10 weeks); Adverse events (10 weeks); Compliance (10 weeks); Retention (10 weeks)
B: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
C: Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use (weekly for 14 weeks of trial or for length of participation); ADHD Symptoms Based on ADHD Rating Scale (measured once per week for 14 weeks or length of study participation)
D: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)

Answer: D