TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Very Brief Smoking Reduction Intervention in Smokers Who Having no Intention to Quit: Study Protocol for a Randomized Controlled Trial
Brief Summary: A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be proposed in outpatient department clinics of People's Liberation Army General Hospital in Beijing, China. Smoking reduction intervention arm (SRI) consisting of a very brief face-to-face individual smoking reduction intervention lasted about one minute, and five follow-up interventions lasted for about minute each. Control arm (EDA) consisting of a very brief face-to-face individual exercise and dietetic advices lasted for the same intervention time as SRI, and also five follow-up interventions lasted for one minute each with different intervention contents.


Options:
A: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
B: smoking cessation (52 weeks)
C: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)
D: self-reported 7-day point prevalence quit rate (at 12 months follow-up); prolonged abstinence quit rate (at 12 months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Intervention for Victimized Perinatal Women With Mental Illness (Phase 1)
Brief Summary: The study developed and assessed an innovative, high-reach, easily implementable, low-cost computer-delivered intervention (Reach out for a Safe Environment; ROSE Program) that addressed known barriers in early identification and intervention with perinatal women with IPV seeking treatment for mental illness.


Options:
A: Composite Abuse Scale (CAS)-CAS Victimization Total Score (Assessed at baseline, and again three months later); Safety Behavior Checklist (SBC) (Assessed at baseline, and again three months later); Effectiveness in Obtaining Resources Scale (EOR) (Assessed at baseline, and again three months later)
B: Posttraumatic Diagnostic Scale (PDS/PSS-I). (Symptoms will be assessed at pre-treatment-point and post-treatment-point (up to 6-month follow-ups)); The Patient Health Questionnaire-9 (PHQ-9) (At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups); The Hopkins Symptom Checklist-25 (HSCL-25) (At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups); Perceived Stress Scale-4 (At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups)
C: Change in partner violence victimization (summary score) (baseline to 12 months); Change in reproductive coercion (summary score) (baseline to12 months)
D: Evidence of change in incidence and frequency of intimate partner physical assault and psychological aggression assessed by questionnaires and clinical interviews. (Change determined by assessments pre and post treatment, 6 months, 12 months, and 18 months following treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Intervention for Victimized Perinatal Women With Mental Illness (Phase 1)
Brief Summary: The study developed and assessed an innovative, high-reach, easily implementable, low-cost computer-delivered intervention (Reach out for a Safe Environment; ROSE Program) that addressed known barriers in early identification and intervention with perinatal women with IPV seeking treatment for mental illness.


Options:
A: Drug abstinence
B: Change in Percent Drinking Days on The Time Line Follow-Back (Participants will report on drinking during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.); Change in number of standard drinks per drinking day on The Time Line Follow-Back (Participants will report on drinking during the 30 days prior to initiation of the study, and ever day until completion of study visits, approximately six weeks.); Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5) (Baseline and after completion of study visits, approximately six weeks.); Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders (Baseline and after completion of study visits, approximately six weeks.)
C: Change in PTSD Checklist (PCL-M) score from baseline to end of treatment (approximately 2 weeks)
D: Composite Abuse Scale (CAS)-CAS Victimization Total Score (Assessed at baseline, and again three months later); Safety Behavior Checklist (SBC) (Assessed at baseline, and again three months later); Effectiveness in Obtaining Resources Scale (EOR) (Assessed at baseline, and again three months later)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine
Brief Summary: This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The primary study hypotheses are that pembrolizumab (MK-3475) prolongs progression free survival (PFS) and overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.

As of 20-March-2016, enrollment will be limited to PD-L1 positive participants.


Options:
A: Overall survival (Up to study completion (estimated time frame: 30 months), every 2 weeks in principle)
B: Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants (Up to 30 months (through database cut-off date of 26 Oct 2017)); Overall Survival (OS) in PD-L1 Positive Participants (Up to 30 months (through database cut-off date of 26 Oct 2017))
C: In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet. (Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization)
D: Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)); Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)); Overall Survival (OS) in All Participants (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to evaluate a patient-centered diabetes self-management mobile application (app), which was developed with feedback from both patients and healthcare providers. During the 12 month randomized control trial, participants in the intervention group will be provided with a mobile phone and commercial home medical devices, such as a weight scale, glucometer and activity monitor. The measurements taken from the medical devices will wirelessly transfer to the mobile phone, where the app will assess the data and provide patients with actionable self-management knowledge. The proposed intervention may be helpful in increasing adherence to recommended self-care practices, improving self-efficacy, and enhancing the overall patient experience.


Options:
A: Weight loss (18-months)
B: Change in HbA1c from baseline to 12 months (Baseline, 3, 6, 9 and 12 months)
C: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)
D: Change in Glycemic Control (HbA1c) (6 months (baseline to 6 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom: A Randomise Controlled Trial
Brief Summary: The purpose of this study is to determine the feasibility and effectiveness of a CBT-based internet intervention for adults with tinnitus in the United Kingdom


Options:
A: Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005) (Last session)
B: The Tinnitus Functional Index (Assessed at baseline and 8 weeks post-intervention)
C: Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) (At baseline and 3, 8 and 12 months follow-up)
D: Tinnitus Functional Index (TFI) (Change will be assessed at 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2). The change will be assessed at every test moment.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis
Brief Summary: The purpose of this study is to examine the effect of nutritional supplementation during hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover design.


Options:
A: net muscle protein balance (10 hours)
B: Change in serum albumin (16 weeks)
C: Changes in beat-to-beat systolic blood pressure (Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks)
D: Number of patients who correct the state of protein energy wasting in intervention group compared to a control group (at 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Timing of Pessary Care
Brief Summary: This is a prospective trial to investigate optimal timing of care for vaginal pessaries. A vaginal pessary is a silicone device that is placed in the vagina to support the pelvic organs of a woman who has pelvic organ prolapse. Some women are willing and able to remove their own pessary on a regular basis. In women who are either unwilling or unable to remove their own pessary, complete pessary care is provided in the urogynecology office. Complete pessary care involves regular removal and cleaning of the pessary with a vaginal examination. In our practice, the investigators typically remove vaginal pessaries and examine the vagina every 3 months in patients for whom the investigators provide complete pessary care. Interval of pessary removal varies widely between practitioners. In the literature, removal intervals vary from weekly to yearly. In this study, the investigators will randomize participants to pessary care with removal every 12 weeks or every 24 weeks.


Options:
A: vaginal epithelial abnormalities (Routine group: change from baseline in vaginal epithelial abnormalities at 12 weeks, 24 weeks, 36 weeks, 48 weeks. Extended group: change from baseline in vaginal epithelial abnormalities at 24 weeks, 48 weeks)
B: Evaluate the histopathological effects on endometrium after each treatment (48 days); Compare the endometrial thickness measured by ultrassound after each treatment (48 days)
C: Vaginal Dryness (6 months)
D: Vaginal infections (60 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Care Health Education Intervened by Social Networking on Mobile Phone Compared With Usual Care to Improve Maternal and Neonatal Outcomes: Randomized Controlled Trial
Brief Summary: The purpose of the study is to determine whether social networking on mobile phone in antenatal care health education is effective in the improvement of maternal and neonatal outcomes compared with usual antenatal care.


Options:
A: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
B: Adherence to PrEP (Baseline to Week 48)
C: Rate of Premature birth (before 37 weeks gestation)
D: ANC (Assess the recommend number of ANC (4 ANC) coverage 18 months after intervention); PNC (Assess the recommend number of PNC (3 ANC) coverage 18 months after intervention); Contraceptive prevalence rate (CPR) (Assess the Contraceptive prevalence rate (CPR) at the end of intervention of 18 months.); EPI coverage (Assess the EPI vaccination coverage at the end of the intervention of 18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Care Health Education Intervened by Social Networking on Mobile Phone Compared With Usual Care to Improve Maternal and Neonatal Outcomes: Randomized Controlled Trial
Brief Summary: The purpose of the study is to determine whether social networking on mobile phone in antenatal care health education is effective in the improvement of maternal and neonatal outcomes compared with usual antenatal care.


Options:
A: Measles vaccination coverage (10 months)
B: Rate of Premature birth (before 37 weeks gestation)
C: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)
D: Overall MEMS Adherence to Antiretroviral Medication (6 weeks); MEMS Adherence to Antiretroviral Medication Based on Dose Timing (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Care Health Education Intervened by Social Networking on Mobile Phone Compared With Usual Care to Improve Maternal and Neonatal Outcomes: Randomized Controlled Trial
Brief Summary: The purpose of the study is to determine whether social networking on mobile phone in antenatal care health education is effective in the improvement of maternal and neonatal outcomes compared with usual antenatal care.


Options:
A: Immunization coverage (12 months); Timeliness of receipt of scheduled immunization (12 months)
B: Rate of Premature birth (before 37 weeks gestation)
C: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
D: Immunization Rate (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Care Health Education Intervened by Social Networking on Mobile Phone Compared With Usual Care to Improve Maternal and Neonatal Outcomes: Randomized Controlled Trial
Brief Summary: The purpose of the study is to determine whether social networking on mobile phone in antenatal care health education is effective in the improvement of maternal and neonatal outcomes compared with usual antenatal care.


Options:
A: Exclusive breastfeeding duration (Six months)
B: Rate of Premature birth (before 37 weeks gestation)
C: Change in average monthly number of infant DBS HIV tests (Baseline and 6 mos (endline)); Change in average monthly number of maternal postpartum HIV tests (Baseline and 6 mos (endline)); Change in average monthly number of DPT1 doses administered (Baseline and 6 mos (endline))
D: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Care Health Education Intervened by Social Networking on Mobile Phone Compared With Usual Care to Improve Maternal and Neonatal Outcomes: Randomized Controlled Trial
Brief Summary: The purpose of the study is to determine whether social networking on mobile phone in antenatal care health education is effective in the improvement of maternal and neonatal outcomes compared with usual antenatal care.


Options:
A: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))
B: Measles vaccination coverage (10 months)
C: Initiation of Long acting reversible contraception method (6 months)
D: Rate of Premature birth (before 37 weeks gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rectal Preserving Treatment for Early Rectal Cancer. A Multi-centred Randomised Trial of Radical Surgery Versus Adjuvant Chemoradiotherapy After Local Excision for Early Rectal Cancers
Brief Summary: Current therapy for early colorectal cancer is radical Total Mesorectal Excision (TME). Colorectal surgical resections are accompanied with high morbidity of up to 33% and 90 days mortality of up to 9% in the fragile elderly patients as is seen in the results of the Dutch Surgical Colorectal Audit (DSCA) of 2013. Additionally, rectal cancer surgery is associated with substantial loss of health related quality of life due to defecation disorders, incontinence, sexual dysfunction and stoma related morbidity. These disadvantages are acceptable when radical surgery is the only option for cure. Advances in technology enabled the development of local excision of early rectal cancer with precise endoluminal microsurgery or local endoscopic excision resulting in a significant decrease in short- and long term morbidity. However current evidence is of inadequate quality to conclude on the oncologic safety of local treatment for early rectal cancer. Imaging can predict outcome and tailors treatment in more advanced cancer but fails in early cancer. Pathological assessment of the excised tumor tissue provides the optimal information on tumor stage, tumor characteristics and tumor differentiation, thereby it enables to predict the risk of recurrence after local treatment alone. For early rectal cancers, with a low risk on recurrence based on favourable tumor characteristics local excision is seen as safe and these patients do not require an additional treatment. However, for patients with early rectal cancer with a higher risk on recurrence based on tumor characteristics there is no consensus on the additional treatment after local excision. According to the National guideline these patients receive a TME procedure. However, for this subgroup of patients local treatment followed by chemoradiotherapy might also be oncological safe. Current evidence is of inadequate quality to be conclusive. For this subgroup of patients with early rectal cancer with high risk tumorcharacteristics the TESAR trial is designed, in which patiens will be randomised after local endoluminal excision between an additional TME-procedure (standard) and adjuvant chemoradiotherapy. Primary endpoint of the study will be local recurrence at 3 three year follow-up.


Options:
A: oncological result in term of local and/or systematic recurrence (3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, 54, 60 months after operation)
B: Recurrence free at 3 year follow-up (3 year)
C: Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after (24 months)
D: Phase II (Feasibility study) Primary Outcome: Recruitment Rate (24 Months); Phase III Primary Outcome: Organ Preservation (30 Months from start day of (chemo)radiotherapy treatment.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Fish Oil Supplementation in Women With Gestational Diabetes on Insulin Like Growth Factor-1 DNA Methylation in Newborns
Brief Summary: Gestational diabetes is the development of diabetes during pregnancy. Left untreated, gestational diabetes and preeclampsia can lead to serious -- or even fatal -- complications for both mother and child. Some evidence suggesting omega-3 fatty acids might help protect women from two serious pregnancy complications -- gestational diabetes and preeclampsia. Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA), help a pregnant woman give her developing baby every advantage in life starting in-utero. Recent studies suggested that the biologic processes underlying the observed associations may involve epigenetic changes, specifically DNA methylation. In this study the investigators aimed to examine the effect of fish oil supplementation in women with gestational diabetes mellitus on newborn outcomes and insulin like growth factor 1 DNA methylation.


Options:
A: Birth size (1 year)
B: Primary outcome is measuring of infant CNS maturity to 18 months of age (18 months)
C: percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood (labour)
D: Decreased inflammation during human pregnancy (enrollment (8-16 weeks) to delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption
Brief Summary: Acetazolamide improves central sleep apnea related to opium consumption.


Options:
A: The Central Apnea-hypopnea Index (one night); Respiratory Arousal Index (one night)
B: exercise capacity (1 week); Quality of Life (1 week)
C: The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI) (6 months); Freedom From Related Serious Adverse Events Within 12 Months (12 months)
D: Changes in Central Apnea Index (baseline and six days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Upper Extremity Aerobic Exercise Training on Functional Exercise Capacity in Patients With Pulmonary Arterial Hypertension
Brief Summary: Decreased exercise capacity, peripheral muscle strength and quality of life and increased dyspnea and fatigue perception is prevalent in patients with pulmonary arterial hypertension. It was demonstrated exercise training has beneficial effects in patients with pulmonary arterial hypertension. However, no study investigated the effects of upper extremity aerobic exercise training, therefore effects of upper extremity aerobic exercise training on outcomes in patients with pulmonary arterial hypertension.


Options:
A: Change in the 6-minute walking distance (after 3 weeks and after 15 weeks compared to baseline.); Quality of life (SF-36) (baseline and 15 weeks)
B: distance walked in 6 minutes (baseline - 15 weeks afterwards); change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire (baseline - 15 weeks afterwards)
C: Six minute walking distance (3 months); New York Heart Association (NYHA) functional class (3 months)
D: Functional exercise capacity (Oxygen consumption measurement during test) (6 weeks)

Answer: D