TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Background: Surveys have shown that antipsychotic drug combinations are frequently prescribed. Amisulpride, an atypical antipsychotic agent, has low incidence of extrapyramidal symptom (EPS) but with high cost compared to sulpiride. The objective of the study is to compare the efficacy and safety of the 800-mg/d amisulpride and 400-mg/d amisulpride plus 800-mg sulpiride in the treatment of acute psychotic exacerbations of schizophrenia.

Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia are randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus sulpiride (800 mg/d).The hypothesis is that the two treatment groups have the similar efficacy and safety, but different cost.


Options:
A: Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.; The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
B: change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores (The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).)
C: Brief Psychiatric Rating Scale (BPRS) Total Score (Baseline); Brief Psychiatric Rating Scale (BPRS) Total Score (Endpoint (12 weeks)); Scale for the Assessment of Negative Symptoms (SANS) (baseline); Scale for the Assessment of Negative Symptoms (SANS) (Endpoint (12 weeks))
D: PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods. (48 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Background: Surveys have shown that antipsychotic drug combinations are frequently prescribed. Amisulpride, an atypical antipsychotic agent, has low incidence of extrapyramidal symptom (EPS) but with high cost compared to sulpiride. The objective of the study is to compare the efficacy and safety of the 800-mg/d amisulpride and 400-mg/d amisulpride plus 800-mg sulpiride in the treatment of acute psychotic exacerbations of schizophrenia.

Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia are randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus sulpiride (800 mg/d).The hypothesis is that the two treatment groups have the similar efficacy and safety, but different cost.


Options:
A: change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores (The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).)
B: Number Who Discontinued Medication Within First 6 Study Months (Measured at Six Months)
C: For 100 subjects with incomplete response to adequate treatment with clozapine, the primary objective is to determine if risperidone augmentation of clozapine is superior to augmentation with placebo, using the outcome measure of total PANSS score
D: Risperidone effectiveness is measured by time to relapse within the 52 week period.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing Tobacco Use Treatment Guidelines in Dental Public Health Clinics
Brief Summary: System level strategies for implementing tobacco use treatment guidelines exist but are insufficiently put into practice, particularly in dental care settings. Closing the gap between research and practice is stymied by the limited research on systems changes necessary to implement tobacco treatment in routine dental care. Drawing from a burgeoning dissemination science literature, the proposed study compares the cumulative benefit of the following three systems-level strategies: 1) staff training and clinical reminders, 2) provider feedback and 3) pay-for- performance (financial incentives), that have been widely endorsed by a 2001 Institute of Medicine Report, "Crossing the Quality Chasm" (IOM 2011) and the 2008 PHS Guidelines (Fiore 2007, Fiore 2008, IOM 2011).

The investigators propose a 3-arm cluster randomized controlled trial that will analyze the implementation process and compare the cost and effectiveness of three implementation strategies: 1) Staff training and CBP in implementing PHS Guidelines; 2) CBP + provider performance feedback (PF) and 3) CBP + PF + Pay-for-performance (provider reimbursement for tobacco cessation treatment delivery). Guided by Organizational Change Theory and the Theory of Planned Behavior (Ajzen 1991, Damschroder 2009, Greenhalgh 2004, Solberg 2007) the investigators will identify multi-level factors that facilitate or impede the implementation process in dental clinics. Our primary outcome is improvement in provider delivery of tobacco cessation treatment found through extensive meta-analysis (Fiore 2008) to be an essential determinant of patient cessation outcomes. Our secondary outcome will be post-intervention patient-reported quit rates. In addition to examining the comparative effectiveness of the three implementation strategies, the investigators will use a mixed methods approach to examine implementation processes (Aim 2) to assess the degree to which the interventions are integrated into practice as intended and to clarify the mechanisms through which the intervention influences provider behavior.


Options:
A: To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post). (prior to and approximately 12 months following each site's enrollment in the study); Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation (June 2013-June 2017)
B: Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months (6 months)
C: 6 Month Self-reported Abstinence From Smoking (6 months)
D: smoking status (six month followup)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing Tobacco Use Treatment Guidelines in Dental Public Health Clinics
Brief Summary: System level strategies for implementing tobacco use treatment guidelines exist but are insufficiently put into practice, particularly in dental care settings. Closing the gap between research and practice is stymied by the limited research on systems changes necessary to implement tobacco treatment in routine dental care. Drawing from a burgeoning dissemination science literature, the proposed study compares the cumulative benefit of the following three systems-level strategies: 1) staff training and clinical reminders, 2) provider feedback and 3) pay-for- performance (financial incentives), that have been widely endorsed by a 2001 Institute of Medicine Report, "Crossing the Quality Chasm" (IOM 2011) and the 2008 PHS Guidelines (Fiore 2007, Fiore 2008, IOM 2011).

The investigators propose a 3-arm cluster randomized controlled trial that will analyze the implementation process and compare the cost and effectiveness of three implementation strategies: 1) Staff training and CBP in implementing PHS Guidelines; 2) CBP + provider performance feedback (PF) and 3) CBP + PF + Pay-for-performance (provider reimbursement for tobacco cessation treatment delivery). Guided by Organizational Change Theory and the Theory of Planned Behavior (Ajzen 1991, Damschroder 2009, Greenhalgh 2004, Solberg 2007) the investigators will identify multi-level factors that facilitate or impede the implementation process in dental clinics. Our primary outcome is improvement in provider delivery of tobacco cessation treatment found through extensive meta-analysis (Fiore 2008) to be an essential determinant of patient cessation outcomes. Our secondary outcome will be post-intervention patient-reported quit rates. In addition to examining the comparative effectiveness of the three implementation strategies, the investigators will use a mixed methods approach to examine implementation processes (Aim 2) to assess the degree to which the interventions are integrated into practice as intended and to clarify the mechanisms through which the intervention influences provider behavior.


Options:
A: Our primary outcome measures are patient-reported provider delivered tobacco screening and tobacco cessation advice. (Baseline, 8-months post-intervention, and 24-months post-intervention)
B: Patient report (Within 3 days of the dental encounter)
C: To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post). (prior to and approximately 12 months following each site's enrollment in the study); Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation (June 2013-June 2017)
D: Point prevalence abstinence

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Using a YMCA Exercise Program to Enhance Nicotine Dependence Treatment for Women
Brief Summary: Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be an efficacious treatment component in combating nicotine dependence, especially among women for whom concerns about weight gain during smoking cessation are an obstacle to successful quitting. In previous trials of women smokers, the investigators program of cognitive behavioral smoking cessation treatment (CBT) plus regular aerobic exercise was more efficacious than CBT plus equal contact time. Recognizing the program's successes, Commit to Quit (CTQ) was recently designated an Effective Program by the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Effective Programs. Thus, the Commit to Quit program is well poised for a larger trial in a community setting where it has the potential to reach a large number of female smokers in a setting in which it can be sustained. In response to PA-03-126, Behavioral Therapies Development Program, the investigators propose a Stage III study in which they will conduct a trial to test the investigators CTQ smoking cessation program in the community setting of the local YMCAs. As stated in the PA, Stage III research is aimed at understanding if and how an efficacious therapy may be transported to the community. The investigators propose a randomized controlled clinical trial to take place in the YMCA setting and delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a program of regular exercise to CBT smoking cessation treatment plus contact control. In order to promote transportability to the YMCA, the investigators will use the YMCA's existing Personal Fitness Program, which is similar to the investigators CTQ exercise program, in that it is guided by trained staff and requires participants to exercise 3 times per week. If the exercise condition is found to be more efficacious than contact control when delivered at the YMCA by YMCA staff, then the investigators will be well positioned to partner with the YMCA to pursue widespread, national dissemination of this program.


Options:
A: smoking cessation (12 months)
B: Smoking Cue Reactivity on Quit Day (4-weeks)
C: TC/HDL ratio (one year)
D: Salivary Cotinine (12 months posttreatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Open Label Study Evaluating the Coverage by Teleconsultation Versus Standard Follow-up of Renal Transplant Patients According to a Risk Score of Early Graft Failure (KTFS)
Brief Summary: The main objective of this study is to optimize the coverage of renal transplant patients thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney Transplant Failure Score), associated with teleconsultations.


Options:
A: Number of serious adverse events (2 years)
B: Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7) (Baseline recruitment/screening)
C: Combined endpoint achievement of target blood pressure and proteinuria (one year); Cumulative duration of hospitalization in short-stay for 1 year (one year); Cumulative duration of unplanned short stay for 1 year (One year); Survival (One Year)
D: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: LIFT: Lifestyle Interventions For Two (Member of the LIFE Moms Consortium)
Brief Summary: This randomized, controlled trial is proposed to study the effect, in a cohort of racially and ethnically diverse group of overweight and obese pregnant women, of an Intensive Lifestyle Intervention (ILI) which utilize cognitive behavioral strategies to help participants achieve and maintain changes in dietary intake and physical activity habits compared to Usual Care (UC) on gestational weight gain (GWG), infant fatness, and mothers' post-delivery weight retention. The hypothesis is that the percent body fat at birth will be significantly less in offspring from ILI mothers than UC mothers.


Options:
A: Gestational weight gain (36 weeks)
B: Maternal Weight Change (baseline to 2 weeks post partum)
C: Number of at risk participants developing GDM during pregnancy
D: Infant Percent Fat at Birth (Within 24 hours of birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The DIPAK 1 Study: A Randomised, Controlled Clinical Trial Assessing the Efficacy of Lanreotide to Halt Disease Progression in ADPKD
Brief Summary: Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive cyst formation in both kidneys, in most patients leading to end stage renal disease. It is the most common hereditary renal disease with a prevalence of approximately 1 in 1,000 persons. The majority of patients also have progressive cyst formation in the liver, leading to pain, gastrointestinal discomfort and sometimes the need for liver transplantation. At present there is no proven therapeutic intervention to slow the rate of disease progression in human ADPKD. The development of renoprotective treatments that are well tolerated, is therefore of major importance.

In this respect, somatostatin analogues are promising for especially polycystic liver disease, but also for the renal phenotype. However, the studies that have been performed thus far with these agents, were underpowered and of too short duration to reach a definitive conclusion on the potential reno- and hepatoprotective efficacy of somatostatin analogues. Therefore, the present study is designed as a randomised clinical trial with sufficient duration of follow-up to investigate whether the somatostatin analogue Lanreotide slows progression of polycystic kidney and liver disease in ADPKD-patients.

To this end, 300 ADPKD patients, aged 18-60years, with an eGFR 30-60 ml/min/1.73 m2) will be randomized 1:1 to standard care or monthly subcutaneous lanreotide injections on top off standard care. These 300 subjects will go through 15 study visits in 3 years and 1 follow up visit. During these visits, questionnaires will be filled in, physical examinations will be performed, blood will be drawn and urine collected. After study completion, rate of renal function decline in lanreotide treated subjects will be compared to that of subject who received standard care.


Options:
A: renal volume measured by high resolution magnetic resolution imaging (1.5 yrs)
B: Change in renal function (serial eGFR measurements from month 3 until end of treatment visit (month 30))
C: Change over baseline of the total kidney volume at 1 and 3 years follow-up (estimated by gadolinium contrast enhanced and T2-weighted magnetic resonance imaging, MRI). (Basal, 1 and 3 years follow-up)
D: Study A: Percent Annual Change in Total Kidney Volume (Baseline and 2-, 4- and 5-year follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women
Brief Summary: This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.


Options:
A: Combined incidence of HIV-1 and HIV-2
B: HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm. (24 months); All Adverse Events (24 months)
C: Effectiveness (30 months); Safety (30 months)
D: Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial. (minimum of 12 months and a maximum of 14 months per participant); The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks). (minimum of 12 months and a maximum of 14 months per participant)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Hyperimmune Intravenous Immunoglobulin Treatment for Severe H1N1 2009 Infection
Brief Summary: Treatment with hyperimmune intravenous immunoglobulin (H-IVIG), derived from convalescent plasma from patients recovered from H1N1 2009 influenza A infection, for patients with severe H1N1 2009 infection will decrease mortality, reduce viral load, and shorten the length of stay in ICU and hospital.


Options:
A: Clinical Status at Day 7 (Day 7)
B: Time to Normalization of Respiratory Status (Primary Efficacy Population) (Measured from Day 0 through Day 28)
C: Mortality (From date of randomization until the date of death from any cause during hospitalization, assessed up to 6 months)
D: Number of Patients in Each of 6 Clinical Status Categories on Day 7 (Assessed on Day 7)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Hyperimmune Intravenous Immunoglobulin Treatment for Severe H1N1 2009 Infection
Brief Summary: Treatment with hyperimmune intravenous immunoglobulin (H-IVIG), derived from convalescent plasma from patients recovered from H1N1 2009 influenza A infection, for patients with severe H1N1 2009 infection will decrease mortality, reduce viral load, and shorten the length of stay in ICU and hospital.


Options:
A: Overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first (until hospital discharge or a maximum of 60 days whichever comes first)
B: Mortality (From date of randomization until the date of death from any cause during hospitalization, assessed up to 6 months)
C: Clinical status during follow-up at 30th day (30th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma))
D: Number of Participants Who Were Intubated or Died (Day 30)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Hyperimmune Intravenous Immunoglobulin Treatment for Severe H1N1 2009 Infection
Brief Summary: Treatment with hyperimmune intravenous immunoglobulin (H-IVIG), derived from convalescent plasma from patients recovered from H1N1 2009 influenza A infection, for patients with severe H1N1 2009 infection will decrease mortality, reduce viral load, and shorten the length of stay in ICU and hospital.


Options:
A: Mortality (From date of randomization until the date of death from any cause during hospitalization, assessed up to 6 months)
B: N/A
C: Time to Normalization of Respiratory Status (Primary Efficacy Population) (Measured from Day 0 through Day 28)
D: death (within 7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The HEP-OKS Pilot Study - a Randomized Controlled Trial of Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients
Brief Summary: Spatial neglect represents one of the major cognitive disorders following stroke. Patients patients fail to be aware of objects or people to their left and orientate instead to their right side. Enduring neglect has been found to be a poor prognostic indicator for functional independence following stroke. Despite some promising experimental accounts there are no established treatments for this condition.

The aim of this study is to test whether a combined treatment with hemifield eye patching (HEP) and optokinetic stimulation (OKS) can permanently reduce neglect behaviour and improve functional outcome in patients with hemispatial neglect following stroke.

The investigators hypothesise that the treatment with HEP and OKS will lead to a greater reduction of neglect scoring in the neglect test battery as well as a greater improvement in functional independence scores as compared to the spontaneous clinical course of the usual-care control group.


Options:
A: Total "dose" of intervention received as a proportion of the scheduled time (10 days over a 2 week period)
B: Overall Proportion Saying "Yes" to Real Prism Glasses (Evaluated after 4 weeks of wearing each type of prism glasses)
C: Participant enrollment, recruitment and retention. (Ongoing for18 months after start of recruitment.)
D: Total score in a neglect test battery (Change from baseline at Day 8 (post-treatment)); Functional independence score (Change from baseline at Day 8 (post-treatment))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The HEP-OKS Pilot Study - a Randomized Controlled Trial of Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients
Brief Summary: Spatial neglect represents one of the major cognitive disorders following stroke. Patients patients fail to be aware of objects or people to their left and orientate instead to their right side. Enduring neglect has been found to be a poor prognostic indicator for functional independence following stroke. Despite some promising experimental accounts there are no established treatments for this condition.

The aim of this study is to test whether a combined treatment with hemifield eye patching (HEP) and optokinetic stimulation (OKS) can permanently reduce neglect behaviour and improve functional outcome in patients with hemispatial neglect following stroke.

The investigators hypothesise that the treatment with HEP and OKS will lead to a greater reduction of neglect scoring in the neglect test battery as well as a greater improvement in functional independence scores as compared to the spontaneous clinical course of the usual-care control group.


Options:
A: Wolf Motor Function test (immediately before and immediately after treatment); Fugl-Meyer Assessment (immediately before and immediately after treatment)
B: Total score in a neglect test battery (Change from baseline at Day 8 (post-treatment)); Functional independence score (Change from baseline at Day 8 (post-treatment))
C: Change in Upper Extremity Fugl Meyer Assessment (6 weeks from baseline); Percentage of Sessions With Adverse Events (Post treatment (6 weeks from baseline).)
D: Safety of the intervention as assessed by frequency of adverse events (2 weeks)

Answer: B