TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pessary as Adjunctive Therapy to Cerclage for the Prevention of Preterm Birth
Brief Summary: Cervical cerclage was devised in the 1950's for women with prior early preterm births (PTB) who developed a dilated cervix detected by manual exam in the second trimester. In contemporary practice, there are three possible indications for cerclage. History-indicated cerclage (HIC) is defined as a cerclage placed usually between 12-15 weeks based solely on poor prior obstetrical history, e.g. multiple second trimester losses due to painless dilatation. Ultrasound-indicated cerclage (UIC) is defined as a cerclage placed usually between 16-23 weeks for transvaginal ultrasound (TVU) cervical length (CL) \< 25mm in a woman with a prior spontaneous PTB. Physical-exam indicated is defined as a cerclage placed usually between 16-23 weeks because of cervical dilatation of 1 or more centimeters detected on physical (manual) examination.

Randomized trials and meta-analysis of these have shown that UIC is associated with significant reduction in PTB and improved neonatal outcome, whereas evidence of efficacy for history-indicated cerclage and physical exam-indicated cerclage is limited. In the United States, the national data shows that the rate of cerclage has decreased in the last few years. The indications of placement of cerclage have recently changed, and so it is important to evaluate how many women are getting this procedure. With the recent completion of clinical trials, it is plausible that obstetricians and perinatologists may have become more selective in terms of the best candidates for cerclage.

The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB as adjuctive therapy in women with UIC


Options:
A: Gestational age of delivery (<37 weeks)
B: Delivery before than 37 weeks gestation (Up to 37 weeks gestation)
C: Preterm delivery (Less than 34 weeks gestation)
D: Gestational Latency Achieved Between Cerclage Placement and Time of Delivery (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Planning Treatment for Oesophago-gastric Cancer: a Randomised Maintenance Therapy Trial
Brief Summary: To evaluate the efficacy of maintenance therapies following completion of standard first-line chemotherapy in patients with locally advanced or metastatic HER-2 positive or HER-2 negative oesophago-gastric adenocarcinomas.


Options:
A: Progression-free Survival (Treatment will continue until disease progression or intolerable toxicity, up to 2 years)
B: Progression Free Survival (PFS) (5 years)
C: Overall Survival (OS) (2.5 years)
D: Overall Survival (OS)- Phase 3 (Date of randomization until death (up to 2 years 3 months)); Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study) (Date of randomization until death (up to 1 year))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind Randomized Controlled Clinical Trial of 3 Days Versus 5 Days Amoxicillin Dispersible Tablets for Chest-indrawing Childhood Pneumonia Among Children 2-59 Months of Age Presenting to Kamuzu Central Hospital in Lilongwe, Malawi
Brief Summary: This clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT.


Options:
A: Cumulative incidence of recurrent wheezing confirmed by physicians (two years)
B: Proportion of children failing treatment (4 days)
C: Proportion of children failing treatment (6 days)
D: Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization (From study Day 0 through study Day 150)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: DIRECT (DIsulfiram REsponse as add-on to ChemoTherapy in Recurrent) Glioblastoma: A Randomized Controlled Trial
Brief Summary: Disulfiram (Antabuse®) is a well-tolerated, cheap, generic drug that has been in use since the 1950s to treat alcoholism. There is now an increasing amount of independent preclinical data to support disulfiram as an anticancer agent. The potency of disulfiram as an anticancer agent seems strengthened by copper.

The investigators aim is to investigate disulfiram and copper-supplement as add-on treatment in glioblastoma patients with recurrence receiving alkylating chemotherapy.


Options:
A: Groups 1 and 2: Progression-free survival rate (6 months post-Day 1); Group 2C: Objective Response Rate (Every 8 weeks from Day 1 through progression or initiation of other anti-cancer therapy)
B: Overall survival (From date of study entry until the date of death from any cause (up to 10 years))
C: Progression Free Survival (up to 142 weeks)
D: Survival 6 mo (Proportion of alive participants at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Influence of a Virtual Reality Environment on Pain Perception During Exercises for Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial
Brief Summary: Immersion in a virtual reality environment has been shown to reduce pain during a variety of painful medical procedures, such as wound care for burn patients and dental care. Often, serious games are used to distract patients from this painful procedures. Recently, serious games have also been developed for patients with low back pain. Because patients with low back pain frequently experience pain during exercises, the investigators hypothesize that exercising with serious games can reduce the pain intensity and the time spent thinking of pain during exercises. To test this hypothesis, the investigators will conduct a randomized controlled trial where two groups will be compared: the experimental group will perform one session of exercises with serious games, while the control group will perform one session of the same exercises without the serious games.


Options:
A: Back-related function (6 months); Pain (6 months)
B: Average pain intensity during exercises using the numeric pain rating scale (Day 1); Time spent thinking of the pain using a numeric rating scale (Day 1)
C: Selfrated function, symptoms and pain-rating (8 weeks, 6 month, 12 month)
D: Sickness absence days (Low back (LB) specific, other than LB, total) (6, 12, 24, 36, 48 months); Low back pain (VAS) (0, 3, 6, 12, 24 months); Disability (Roland Morris 18) (0, 3, 6, 12, 24 months); Quality of Life (15-D) (0, 3, 6, 12, 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The immediate post cesarean section IUD insertion is a further step towards spreading more compliance to females in developing countries, with rapid increase in population size


Options:
A: neonatal growth (12 months)
B: Time (6 months)
C: Time to Lactogenesis Stage II (5 days postpartum)
D: Expulsion rate (6 months); The percentage of females seeking contraception (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial Assessing The Impact Of An Intermittent Energy Restricted Diet On Weight Loss, Insulin Sensitivity and Heart Rate Variability In Men and Women With Central Obesity
Brief Summary: An intermittent energy restricted (IER) diet may modify cardio-metabolic disease risk factors compared to an energy-matched continuous energy restricted (CER) diet. A randomised controlled parallel design trial will determine the impact of a short-term IER diet (2 consecutive days of very low calorie diet (VLCD), 5 days moderate energy restriction each week for a 4 week period), compared to a CER diet, on insulin sensitivity in healthy (disease-free) subjects with central obesity.


Options:
A: Change in body weight (Baseline and weeks 2, 4 and 8)
B: Change in Total Body Weight (in kg) at 3 months compared to baseline (Baseline to 3 months)
C: Revised QUICKI (RQUICKI) (Baseline); RQUICKI (day 29); RQUICKI (day 31)
D: Blood biomarkers (After two weeks, 3 and 6 months); Blood biomarkers (After two weeks, 3 and 6 months); Blood biomarker (After two weeks, 3 and 6 months); Blood biomarker (After two weeks, 3 and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Right Hemisphere Stroke
Brief Summary: Spatial neglect is a common attention disorder after right hemisphere stroke and is associated with decreased independence and quality of life. Despite its high prevalence in the stroke population, there is currently no standard of care for the treatment of neglect. Prism adaptation (PA) is a promising rehabilitation technique, however incorporation into clinical care has been limited likely due to the lack of standardized procedures. The investigators have developed a computerized PA technique designed to better engage patients and assist clinicians. In this study the investigators aim to evaluate the feasibility and effectiveness of the computerized PA procedure in a typical health care setting, with the hypothesis that the PA procedure will improve patient's neglect symptoms.


Options:
A: Change in Behavioural Inattention Test (BIT) (6 months post intervention)
B: Change in Sunnybrook Neglect Assessment Procedure (SNAP) (Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start))
C: Neglect symptom severity (neuropsychological test performance) (Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)); Neglect-related functional disability (Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22))
D: Change in the result of Fugl-Meyer assessment for UE motor function (baseline, endpoint (6 weeks) and follow up (18 weeks)); Change in the result of Modified Ashworth scale (MAS) (baseline, endpoint (6 weeks) and follow up (18 weeks)); Change in the result of Box and blocks test (baseline, endpoint (6 weeks) and follow up (18 weeks)); Change in the result of Semmes-Weinstein monofilament (SWM) test (baseline, endpoint (6 weeks) and follow up (18 weeks)); Change in the result of Motor Activity Log (baseline, endpoint (6 weeks) and follow up (18 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Three-armed Randomised Controlled Trial of Non-participants in an Organised Cervical Cancer Screening Programme
Brief Summary: The trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening.


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: Change in Cardiorespiratory Fitness from Baseline (Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Three-armed Randomised Controlled Trial of Non-participants in an Organised Cervical Cancer Screening Programme
Brief Summary: The trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening.


Options:
A: 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)
B: Adherence to cervical cancer screening (step1) (Up to 20 months)
C: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
D: Clinical effectiveness measures (Third year); Costs measures (Third year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)
Brief Summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)


Options:
A: The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year. (Baseline, 6 months, 12 months)
B: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)
C: Occurrence of clinically relevant calcium disturbances (patients are followed for 8 weeks); Occurrence of clinically relevant acid-base disturbances (patients are followed for 8 weeks)
D: Levels of Fatigue (9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)
Brief Summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)


Options:
A: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)
B: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period (Baseline and week 12 to 16)
C: Mean Hemoglobin (Hb) change from baseline to average levels from Week 28 to Week 52. (Minimum of 52 weeks and maximum of up to 3 years after last subject is randomized); Proportion of subjects who achieve a Hb response during the first 24 weeks of treatment. (Week 0 to Week 24); The incidence of cardiovascular and cerebrovascular events within 52 weeks. (Week 0 to Week 52)
D: Maximum change in hemoglobin by Week 9 from baseline (Week 9)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania
Brief Summary: The purpose of this study is to determine whether motivational text messages and/or travel vouchers are effective in increasing cervical cancer screening rates in urban and rural regions of Northern Tanzania.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
C: Adherence to PrEP (Baseline to Week 48)
D: Self-reported completion of a full course of PEP medications and receipt of a final HIV test result from their nPEP provider 12 weeks after the index exposure (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania
Brief Summary: The purpose of this study is to determine whether motivational text messages and/or travel vouchers are effective in increasing cervical cancer screening rates in urban and rural regions of Northern Tanzania.


Options:
A: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)
B: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
C: Immunization coverage (12 months); Timeliness of receipt of scheduled immunization (12 months)
D: The primary outcome will measure the number of children who got vaccinated for routine immunization scheduled at 6, 10 and 14 weeks of life (Vaccination status at 20th week of life of the particpants)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania
Brief Summary: The purpose of this study is to determine whether motivational text messages and/or travel vouchers are effective in increasing cervical cancer screening rates in urban and rural regions of Northern Tanzania.


Options:
A: Intention to treat analysis (13 months)
B: Adherence to cervical cancer screening (step1) (Up to 20 months)
C: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
D: Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study (4-months post-encouragement)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania
Brief Summary: The purpose of this study is to determine whether motivational text messages and/or travel vouchers are effective in increasing cervical cancer screening rates in urban and rural regions of Northern Tanzania.


Options:
A: Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA) (assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported); Self-report Leisure-time MVPA (assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported)
B: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
C: Number of Participants Completing a Self-sampling Test (2 to 6 months)
D: 1. ADEs; 2. duration of ameliorable medication side effects; 3. health goal adherence rates; 4. diabetes outcomes; 5. familial risk factor documentation rates; 6. user satisfaction surveys; 7. user metrics

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania
Brief Summary: The purpose of this study is to determine whether motivational text messages and/or travel vouchers are effective in increasing cervical cancer screening rates in urban and rural regions of Northern Tanzania.


Options:
A: Adherence to PrEP (Baseline to Week 48)
B: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)
C: Change from Baseline HIV-1 Viral Load at 48 weeks (48 weeks)
D: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke
Brief Summary: The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke


Options:
A: Walking ability - Functional Ambulation Category (Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks))
B: Change in 10 Meter Walk Test From Baseline in Gait Speed (Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up))
C: Change From Baseline in Berg Balance Scale at 4 Weeks (Baseline and 4 weeks from baseline)
D: 6-minute Walk Test (3-month follow-up); Functional Ambulation Category (3-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Obstetric Perineal Trauma, Pelvic Floor Symptoms and Early Physiotherapy Intervention
Brief Summary: The main objective is to investigate effects of perineal trauma at birth on women´s health and whether early physiotherapy improves pelvic floor strength. This will be achieved by an acknowledged/validated questionnaire sent electronically 6 weeks after first delivery. Women with symptomes of urinary incontinence according to the questionnaire will be offered participation in a single-blinded randomized intervention study to compare outcome after targeted physiotherapy with conventional advice and support. Intervention encompasses weekly pelvic floor training for 12 weeks. Pelvic strength will be measured and symptom information collected before and after intervention and 12 months postpartum in both groups.

Pelvic floor problems after delivery are common and often persistent, including urinary/fecal incontinence, pelvic organ prolapse and sexual problems. Such symptoms reduce QoL and handicap women in multiple ways, physically, psychologically and socially. More knowledge of whether interventions and guidelines in this field can improve health and QoL is required.


Options:
A: Change in the number of incontinent episodes (6 months)
B: Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire (16 weeks)
C: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)
D: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Establishing the Effect(s) and Safety of Fluoxetine Initiated in the Acute Phase of Stroke
Brief Summary: The purpose of this study is to investigate whether routine administration of fluoxetine 20mg once daily in the 6 months initiated during the acute stroke improves the patient's functional outcome.

EFFECTS is an investigator lead Sweden-based, multicenter, parallel group, double blind placebo controlled trial with broad entry criteria and follow up at 6 and 12 months.

EFFECTS managed to recruit its anticipated numbers of 1,500 participants between 20th October 2014 and 28th June 2019. Data will be unblinded when the 6-months follow-up is completed, and the primary outcome is due to report on May 2020.


Options:
A: Functional status, measured with the modified Rankin scale. (6 months)
B: Feasibility of recruitment (ability to recruit dyads) (Baseline); Feasibility of intervention delivery (ability to deliver intervention to dyads) (Feasibility of program delivery will be measured at 6 weeks); Credibility and expectancy questionnaire (Baseline); Client Satisfaction Questionnaire (post intervention (6 weeks after baseline))
C: Hamilton Rating Scale for Depression (HRSD) (1 year post-treatment)
D: General Health Questionnaire (GHQ 28) (T2 (6 months poststroke))

Answer: A