TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information
Brief Summary: Two of AHRQ 's consumer-focused guides, "Pills for Type 2 Diabetes" and "Premixed Insulin for Type 2 Diabetes" could be of great use to underserved ethnic and racial minority adults. The presentation of content and delivery mechanisms of these Guides, however, needs to be modified to increase their use and impact among these difficult-to-reach populations.

To achieve this goal, a long-standing collaboration among African American and Latino community organizations, health care centers and systems, public health organizations, and academics (the REACH Detroit Partnership) is joining with leading experts in the development of personally and culturally tailored health decision aids (University of Michigan's Center for Health Communications Research \[CHCR\] and Center for Behavioral and Decision Sciences in Medicine \[CBDSM\]).

The investigators will develop and evaluate a computer tailored online diabetes medication decision aid that will enable community health workers (CHWs) to provide personalized patient education materials to underserved diabetic African American and Latino adults in Detroit, Michigan.


Options:
A: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
B: Proportion of clinical failure by day 7 compared among the 3 study arms. (10 months)
C: Changes in decisional conflict (baseline and 3 month post intervention)
D: Contraception Use Self-efficacy Scale Score (Aim 1b) (Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)); Contraception Use Self-efficacy Scale Score (Aim 1c) (Baseline, 3 months, 6 months); Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b) (Baseline, 3 months, 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information
Brief Summary: Two of AHRQ 's consumer-focused guides, "Pills for Type 2 Diabetes" and "Premixed Insulin for Type 2 Diabetes" could be of great use to underserved ethnic and racial minority adults. The presentation of content and delivery mechanisms of these Guides, however, needs to be modified to increase their use and impact among these difficult-to-reach populations.

To achieve this goal, a long-standing collaboration among African American and Latino community organizations, health care centers and systems, public health organizations, and academics (the REACH Detroit Partnership) is joining with leading experts in the development of personally and culturally tailored health decision aids (University of Michigan's Center for Health Communications Research \[CHCR\] and Center for Behavioral and Decision Sciences in Medicine \[CBDSM\]).

The investigators will develop and evaluate a computer tailored online diabetes medication decision aid that will enable community health workers (CHWs) to provide personalized patient education materials to underserved diabetic African American and Latino adults in Detroit, Michigan.


Options:
A: HbA1c (6 months)
B: Changes in decisional conflict (baseline and 3 month post intervention)
C: Program satisfaction, behavioral and emotional outcomes. (3, 6, 9, 12 months after implementation of intervention)
D: Self-Care Behaviors; Glycemic control (HbA1c); fitness

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Thirty-six-Month Immunogenicity Evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 45 Years and Male Subjects Aged 9 to 15 Years
Brief Summary: The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male subjects aged 9 to 15 years.


Options:
A: Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen. (From Month 6 up to Month 48)
B: Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))
C: Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).); Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms (Within 7 days (Day 0-6) after vaccination.); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (Within 7 days (Day 0-6) after vaccination.)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Clinic-based Interventions to Promote Early Initiation and Exclusive Breastfeeding Through 6 Months After Birth in Kinshasa, Democratic Republic of Congo
Brief Summary: A cluster-randomized controlled trial will be conducted in the Democratic Republic of Congo to compare rates of early initiation and exclusive breastfeeding between mothers who give birth in hospitals with the current standard of care, mothers who give birth in hospitals that have implemented the first nine steps of the Baby-Friendly Hospital Initiative, and mothers who give birth in hospitals that have implemented all ten steps of the Baby-Friendly Hospital Initiative, with the 10th step being the provision of breastfeeding support during well-child clinic visits.


Options:
A: Early initiation of breastfeeding (Within 1 hour of birth); Exclusive breastfeeding rate (up to 6 months after birth)
B: Neonatal mortality rate
C: The rate of exclusive breastfeeding at 3 months post-birth. (3 months post birth)
D: Reduction in the prevalence and degree of obesity at age 3 years (3 years); Improvement in infant diet composition (1-3 years); Improvement in infant lifestyle behaviors associated with increased risk of obesity. (1-3 years); Improvement in parent feeding knowledge, attitudes, styles and practices (1-3 years); Reduction in infant and child excess weight gain (1-3 years); Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention (2-5 years); Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention (2-5 years); Feasibility process measures: (2-5 years); Participant engagement (2-5 years); Participant satisfaction (2-5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Clinic-based Interventions to Promote Early Initiation and Exclusive Breastfeeding Through 6 Months After Birth in Kinshasa, Democratic Republic of Congo
Brief Summary: A cluster-randomized controlled trial will be conducted in the Democratic Republic of Congo to compare rates of early initiation and exclusive breastfeeding between mothers who give birth in hospitals with the current standard of care, mothers who give birth in hospitals that have implemented the first nine steps of the Baby-Friendly Hospital Initiative, and mothers who give birth in hospitals that have implemented all ten steps of the Baby-Friendly Hospital Initiative, with the 10th step being the provision of breastfeeding support during well-child clinic visits.


Options:
A: The rate of exclusive breastfeeding at 3 months post-birth. (3 months post birth)
B: Breastfeeding intensity at 1,3, and 6 months (1,3, and 6 months after birth of the baby)
C: Early initiation of breastfeeding (Within 1 hour of birth); Exclusive breastfeeding rate (up to 6 months after birth)
D: Breastfeeding Initiation (Three days postpartum); Positive parenting behavior (Parent Child Observation Guide) (4 months postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion
Brief Summary: Antagonists of the vascular endothelial growth factor (VEGF) pathway are effective in treating macular edema resulting from retinal vein occlusion (RVO). In the eye, the two most widely used anti-VEGF agents are ranibizumab and bevacizumab. Only ranibizumab has been FDA-approved for the treatment of macular edema from RVO, however bevacizumab has been used off-label by many ophthalmologists with good success. Furthermore, the cost of bevacizumab is less than one-tenth the cost of ranibizumab. Here the investigators conduct a six month randomized, prospective interventional trial comparing the effectiveness of ranibizumab with bevacizumab in the treatment of macular edema from RVO. Primary outcome measures are change in central retinal thickness. Secondary measures are change in visual acuity from baseline and change in angiographic properties of macular lesions from baseline after treatment.


Options:
A: The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit (Change from baseline to 12 months)
B: Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) (Baseline, 6 Months)
C: change in central retinal thickness (six months compared to baseline)
D: Changes in best spectacle-corrected visual acuity (BSCVA) (from baseline to month 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Carbetocin at Elective Cesarean Delivery: A Dose Finding Study (Part 2)
Brief Summary: Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.


Options:
A: Need for additional treatment after initial PPH study treatment (all additional interventions recorded following initial uterotonic treatment)
B: Uterine tone (2 minutes)
C: Immediate hemodynamic effects of carbetocin and oxytocin (1 day)
D: the amount of blood loss in third and fourth stages of labor (The end of the delivery to 2 hours after birth.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Carbetocin at Elective Cesarean Delivery: A Dose Finding Study (Part 2)
Brief Summary: Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.


Options:
A: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment (baseline to discharge (2 - 3 days)); Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage (Initial hospital discharge (2-3 days)); Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors (baseline to discharge (2-3 days))
B: postpartum bleeding in the third stage of labour (participants will be followed for the duration of hospital stay, an expected average of 48 hours)
C: Estimated Blood loss (24 hours)
D: Uterine tone (2 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery
Brief Summary: This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown three months following urinary fistula repair surgery. The study will be conducted among 507 women with simple fistula presenting at 8 study sites in Sub-Saharan Africa for fistula repair surgery.


Options:
A: Post-operative urinary retention requiring re-catheterisation (14 days following urethral catheter removal)
B: Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test. (3 months)
C: The incidence of acute urinary retention (within the 30 days after surgery)
D: Urinary retention (6 hours after discharge from PACU)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Mailed Nicotine Replacement Therapy to Canadian Smokers
Brief Summary: This study will examine the efficacy of mailed distribution of free Nicotine Replacement Therapy to smokers. Telephone numbers will be randomly selected from across Canada in order to recruit adult smokers interested in completing a smoking survey and willing to be interviewed again in 8 weeks and 6 months time. Study participants will be asked about their smoking history and a hypothetical question: would they be interested in receiving the nicotine patch if this were to be provided to them free of charge? Participants expressing interest will be randomly assigned to one of two groups. One group will be offered the opportunity to actually receive a program of 5 weeks of the nicotine patch for free right away and the other group will not be offered the free nicotine patches. The proportions of smokers in the two groups who quit smoking by the 6-month interview will be compared.


Options:
A: Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) measurements
B: Smoking cessation (6 month follow-up)
C: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)
D: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: China Salt Substitute Study in Tibet: Efficacy of Salt Substitute in Reducing Blood Pressure in Hypertensive Adults
Brief Summary: The study was a single-blind randomized controlled trial conducted between February and August 2009 in two townships (Yangbajing and Gongtang) of Dangxiong County, an area at 4300 meters altitude in Tibet. A brief baseline survey and assessment for eligibility was performed before randomization. A total of 282 residents with known hypertension (systolic blood pressure ≥ 140mmHg) were recruited and randomly assigned to intervention or control with stratification by gender and baseline blood pressure. The intervention group received 6-month's supply of salt substitute (68% sodium chloride, 22% potassium chloride and 10% magnesium sulfate heptahydrate) and the control group 6-month's supply of regular salt (100% sodium chloride). After 3-month's intervention, the ones with a blood pressure above 140 mmHg / 90 mmHg will be given low-dose diuretic for further anti-hypertensive therapy. The study hypothesis is that salt-substitute will greatly reduce blood pressure in treated patients when compared to controls. Blood pressure levels were measured at baseline and followed up by trained observers using an automated sphygmomanometer and brief survey on level of compliance, amount of salt consumed, and reasons for non-compliance.


Options:
A: Stroke (5 years)
B: Systolic/diastolic blood pressure (mmHg) (Three years)
C: Change in Baseline Mean Systolic Blood Pressure (mmHg) at 6 months ((Baseline compared to 6 months after start of intervention))
D: Absolute difference between systolic blood pressure values determined with an oscillometric cuff device and an iPhone 4s (Delta mmHg) (1 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The THERAPY Trial: The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke
Brief Summary: The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not work very well in cases where the stroke is caused by a large vessel occlusion. The hypothesis being tested is to determine if the addition of a treatment by a mechanical thrombectomy device like the Penumbra System can improve the clinical outcome of the patient over just using IV rtPA alone.


Options:
A: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
B: The Modified Rankin Scale Score (at 90 days post-stroke)
C: To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months. (3 months)
D: Good Functional Outcome as Defined by a Modified Rankin Score of 0-2 (90 days); Incidence of All Serious Adverse Events (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of Clinical Utility of Combination Tocolysis in Preterm Labor
Brief Summary: The purpose of this study is to compare the tocolytic efficacy, effectiveness and safety of Atosiban in comparison with the combination of Atosiban and Nifedipine together.


Options:
A: The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor. (3-5 days after delivery)
B: Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Participants will be followed for the duration of pregnancy, an expected average of 10 weeks); Number of women undelivered 48 hrs and seven days of initiation of therapy (Participants who are not delivered within seven days of initiation of therapy); Number of Babies with Adverse Events as a Measure of Safety and Tolerability (participants will be followed for the duration of hospital stay, an expected average of 7 weeks)
C: Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours (48 hours after the randomization)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Individually Tailored Elastic Compression Therapy After Deep Venous Thrombosis in Relation to the Incidence of Post Thrombotic Syndrome, a Randomized Multicenter Trial
Brief Summary: In the Netherlands, 25.000 patients each year are diagnosed with Deep Venous Thrombosis (DVT). Elastic compression stocking (ECS) therapy reduces the incidence of post thrombotic syndrome (PTS) following DVT from 50% without ECS to 20-30% after ECS therapy for two years. It is however unclear whether all patients benefit to the same extent from this therapy or what the optimal duration of ECS therapy for individual patients should be. ECS therapy is not only costly, inconvenient and demanding but sometimes also even debilitating. Substantial costs could be saved by tailoring therapy to individual needs and as a result the quality of life for individual patients can be expected to improve.

This study aims to assess the costs and effects of tailoring the duration of ECS therapy after DVT to individual patients needs.

ECS therapy with a standard duration of 24 months will be compared with tailored ECS therapy, following an initial therapeutic period of 6 months, in patients with acute proximal DVT. The primary outcome is the percentage of patients with PTS at two year follow-up.

This is a multi-center, randomized, allocation concealed, single-blinded clinical trial.


Options:
A: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
B: The occurrence of PTS at 24 months after the event of acute DVT (At 24 months after the event of the acute DVT)
C: N/A
D: Patency after 6 months (6 months); Post-thrombotic syndrome after 2 years (yrs) (2 years)

Answer: B