TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist
Brief Summary: This multicenter cluster-randomized trial will evaluate the impact of Crew Resource Management training on the occurrence of postoperative complications and the adherence to a surgical safety checklist, among a large sample of French surgical departments.


Options:
A: Self-reported, unprotected (without condoms) anal or vaginal sex with HIV-negative and unknown-status persons.
B: The proportion of patients with a non-severe non-malarial illness prescribed a recommended antimalarial drug in a new consultation. (1year)
C: Occurrence of any major postoperative complication during hospitalization (during the two phases of the study : 18 months)
D: General practitioners'adherence to treatment recommendations (3-6 months after end of intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Double Blind Trial to Study the Efficacy of G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease
Brief Summary: Study Design

50 patients will be enrolled and randomized into patients (Group IA) and controls (Group I B)

Investigations:

Hematology CBC, Prothrombin time and INR Peripheral smear, Retics Biochemistry Liver function testing, AFP Kidney function testing Etiology of chronic liver disease Infectious etiology: total antiHBc, anti HCV, HCV RNA, HBV DNA Non infectious etiology: Autoimmune markers, copper studies, iron studies, HOMA IR, FBS Etiology of decompensation Variceal bleed Infection ( blood culture, urine culture, sputum culture, chest xray) Surgery Drugs Alcohol intake Ascitic fluid analysis UGI endoscopy Imaging USG abdomen with Doppler for spleno-portal axis CECT- Triple phase upper abdomen Liver regenerative potential efficacy testing Histology ( by transjugular liver biopsy) Liver Dendritic cells ( CD11c, CD40, CD 54, CD 123, BDCA 2 staining) by flow cytometry CD 34+ cells, CD 45+ cells and CD 133+ cells measurement in hepatic venous blood, peripheral blood and liver biopsy by flow cytometry Markers of proliferation like Ki- 67, proliferating cell nuclear antigen (PCNA) in liver biopsy Markers of angiogenesis like VEGF, v WF in hepatic venous blood Measurement of Hepatic venous pressure gradient ( HVPG)


Options:
A: mobilization of CD34 cells in the peripheral blood (1 month)
B: transplant free survival at 1 year (3 Months)
C: Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8) (Day 1, Day 8, Day 29, and Day 90)
D: Transplant-free survival up to 90 days (death or transplant count as events) (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Project Fit:a School- and Community-based Intervention to Address Physical Activity and Healthy Eating Among Low-income Elementary School Children
Brief Summary: Project FIT is a collaboration between the public school system, local health systems, physicians, neighborhood associations, businesses, faith-based leaders, community agencies and university researchers to develop a multi-faceted approach to promote physical activity and healthy eating toward the general goal of preventing and reducing childhood obesity among children in Grand Rapids, MI, USA. There are four overall components to Project FIT: school, community, social marketing, and school staff wellness - all that focus on: 1) increasing access to safe and affordable physical activity and nutrition education opportunities in the schools and surrounding neighborhoods; 2) improving the affordability and availability of nutritious food in the neighborhoods surrounding the schools; 3) improving the knowledge, self-efficacy, attitudes and behaviors regarding nutrition and physical activity among school staff, parents and students; 4) impacting the 'culture' of the schools and neighborhoods to incorporate healthful values; and 5) encouraging dialogue among all community partners to leverage existing programs and introduce new ones.


Options:
A: Time to Service Disengagement (12 months)
B: HIV-1 seroincidence; HSV2 seroprevalence
C: Mean SCL-20 depression scores (6 & 12 months post-baseline); Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline (6 & 12 months post-baseline); Complete depression remission defined as SCL-20 score less than 0.5. (6 & 12 months post-baseline)
D: Physical activity measured by pedometer. (2 years); Healthy eating index quantified by the Food Frequency Questionnaire. (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: S0927: A Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness In Women With Early Stage Breast Cancer, Phase III
Brief Summary: RATIONALE: An omega-3 fatty acid-enriched nutritional supplement may help improve muscle and bone pain and stiffness caused by hormone therapy in patients with breast cancer.

PURPOSE: This randomized phase III trial is studying omega-3 fatty acid supplements in treating muscle and bone pain and stiffness in patients with stage I, stage II, or stage III breast cancer receiving hormone therapy.


Options:
A: Disease free survival. (Up to end of year 2015)
B: Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale (baseline to 6 months); Change in Hand Grip Strength (baseline to 6 months)
C: Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score (12 weeks post-registration)
D: Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Intervention Effectiveness in Improving Psychosocial and Economic Well-being of Sexual Violence Survivors in DRC
Brief Summary: The Democratic Republic of the Congo (DRC) has become synonymous with sexual violence by armed groups within the last 2 decades. Reportedly, tens of thousands of women and girls have been raped, sexually assaulted, attacked and abducted in the Eastern Provinces including North and South Kivu, targeted by armed groups with unparalleled levels of brutality.

Access to services in North and South Kivu-both emergency and longer term care-remains a major challenge. Limited services as well as the potential stigma of seeking services mean that many survivors have never received adequate care. Results of a preliminary study found many survivors have substantially reduced ability to function, including reduced ability to perform basic tasks and activities related to earning, self care, caring for family, and contributing to their communities. These survivors also describe high rates of mental health and social problems including mood disorders, anxiety, withdrawal, and stigmatization and rejection by family and community.

While social and economic development in conflict affected areas like DRC relies on populations who are ready and able to work, the psychological effects of conflict may mean that a percentage of the population living in these low-resource areas are less able to engage in economic opportunities even when they are available. However, there is little data on the best strategy to deal with this.

This study will be run as two parallel randomized impact evaluations to investigate the impacts of two different intervention programs to be implemented as part of standard programming of the collaborating NGO. The first study will focus on the impact of IRC's social-economic intervention, Village Savings and Loans Associations (VSLA) compared to a wait-control sample. The VSLA impact evaluation study will be conducted in communities served by 9 community-based organization (CBO) partners. The second study will focus on the impact of a mental health intervention, Cognitive Processing Therapy (CPT) compared to a wait-control sample. The CPT impact evaluation study will be conducted in communities serviced by NGO partners currently providing psychosocial support. As an exploratory investigation, the researchers will follow the CPT program with the VSLA program to look at the effect of receiving a mental health intervention prior to the VSLA on rates of retention and impact.


Options:
A: Viral load suppression (12 months); Patient Health Questionnaire 9 (PHQ-9) response (6 months)
B: Severity of mental health symptoms (previous 4 weeks)
C: Mental health symptoms (6 weeks); Idiographic problems (6 weeks)
D: Depressive symptom change (baseline, 3-, 6-, and 12-month follow up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Intervention Effectiveness in Improving Psychosocial and Economic Well-being of Sexual Violence Survivors in DRC
Brief Summary: The Democratic Republic of the Congo (DRC) has become synonymous with sexual violence by armed groups within the last 2 decades. Reportedly, tens of thousands of women and girls have been raped, sexually assaulted, attacked and abducted in the Eastern Provinces including North and South Kivu, targeted by armed groups with unparalleled levels of brutality.

Access to services in North and South Kivu-both emergency and longer term care-remains a major challenge. Limited services as well as the potential stigma of seeking services mean that many survivors have never received adequate care. Results of a preliminary study found many survivors have substantially reduced ability to function, including reduced ability to perform basic tasks and activities related to earning, self care, caring for family, and contributing to their communities. These survivors also describe high rates of mental health and social problems including mood disorders, anxiety, withdrawal, and stigmatization and rejection by family and community.

While social and economic development in conflict affected areas like DRC relies on populations who are ready and able to work, the psychological effects of conflict may mean that a percentage of the population living in these low-resource areas are less able to engage in economic opportunities even when they are available. However, there is little data on the best strategy to deal with this.

This study will be run as two parallel randomized impact evaluations to investigate the impacts of two different intervention programs to be implemented as part of standard programming of the collaborating NGO. The first study will focus on the impact of IRC's social-economic intervention, Village Savings and Loans Associations (VSLA) compared to a wait-control sample. The VSLA impact evaluation study will be conducted in communities served by 9 community-based organization (CBO) partners. The second study will focus on the impact of a mental health intervention, Cognitive Processing Therapy (CPT) compared to a wait-control sample. The CPT impact evaluation study will be conducted in communities serviced by NGO partners currently providing psychosocial support. As an exploratory investigation, the researchers will follow the CPT program with the VSLA program to look at the effect of receiving a mental health intervention prior to the VSLA on rates of retention and impact.


Options:
A: Severity of mental health symptoms (previous 4 weeks)
B: Clinician Administered PTSD Scale (before treatment, 1 month after, 6 months after)
C: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) (4 & 9 months after completion of treatment)
D: Harvard Trauma Questionnaire (HTQ) (Change from baseline after aprox. 6 months treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates (ZEUS) Study
Brief Summary: To prospectively evaluate in a multicenter open label trial whether the use of zotarolimus-eluting ENDEAVOR Stent implantation in patients at low restenosis or at high bleeding or thrombotic risk will decrease the incidence of 12-month major adverse cardiac events (MACE) including overall death, any myocardial infarction (MI) or any target vessel revascularization (TVR).


Options:
A: Major adverse cardiac events (MACEs) in the overall population, defined as the composite of cardiac death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months (30 days, 6 months, 1,2 and 5 years)
B: MACE (12 months)
C: ST segment resolution (90 min); Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up). (immediately after and at 8 month follow up)
D: target vessel failure (30 days and one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)
Brief Summary: This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.


Options:
A: Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group (At 1 month post-Dose 2 (Month 3)); Antibody Concentrations Against Glycoprotein E (Anti-gE) (At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)); Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens (At 1 month post-Dose 1 (Month 1)); Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens (At 1 month post-Dose 1 (Month 1))
B: Reduce burden of illness due to herpes zoster (HZ) (Incidence of postherpetic neuralgia (PHN), where PHN is defined as HZ-associated pain greater than or equal to 3 persisting or appearing more than 30 days after the onset of the HZ rash)
C: Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations (One month after dose 2, at Month 3); Number of Subjects With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) (During the 30-day (Days 0-29) period after each dose.); Number of Subjects With Any and Related Serious Adverse Events (SAEs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)); Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3))
D: Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies (Baseline and 6 weeks following vaccine administration); Number of Participants Reporting an Adverse Experience (AE) (Up to 42 days following vaccine administration); Number of Participants Reporting a Serious Adverse Experience (SAE) (Up to 42 days following vaccine administration); Number of Participants Reporting a Serious Adverse Experience (Within 5 days after the blood draw at approximately 20 months following vaccine administration); Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) (Up to 5 days following vaccine administration); Number of Participants Reporting Systemic Adverse Experiences (Up to 42 days following vaccine administration); Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) (Up to 42 days following vaccine administration)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)
Brief Summary: This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.


Options:
A: Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value (At Month 3)
B: Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies (Baseline and 6 weeks following vaccine administration); Number of Participants Reporting an Adverse Experience (AE) (Up to 42 days following vaccine administration); Number of Participants Reporting a Serious Adverse Experience (SAE) (Up to 42 days following vaccine administration); Number of Participants Reporting a Serious Adverse Experience (Within 5 days after the blood draw at approximately 20 months following vaccine administration); Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) (Up to 5 days following vaccine administration); Number of Participants Reporting Systemic Adverse Experiences (Up to 42 days following vaccine administration); Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) (Up to 42 days following vaccine administration)
C: Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) (Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)); Anti-gE Antibody Concentrations (Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)); Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations (At two months after Dose 1 (M2) and one month after Dose 2 (M3)); Descriptive Statistics of Anti-gE Antibody Concentrations (Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3)); Number of Subjects With Solicited Local Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses); Number of Subjects With Solicited General Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses); Mean Number of Days With Local Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D)); Mean Number of Days With General Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D)); Number of Subjects With Potential Immune-Mediated Disorders (pIMDs) (From Month 0 to Month 3); Number of Subjects With Unsolicited Adverse Events (AEs) (Within 30 days (Days 0-29) post vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (From Month 0 to Month 3)
D: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases (During the entire study period (3 to 5 year period following Day 0))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Atopic Dermatitis
Brief Summary: The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).


Options:
A: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (Baseline up to end of study (up to Day 85))
B: Change in EASI Scores (Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm))
C: Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Day 29 (Day 29); Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) (AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36); Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29 (Baseline, Day 29); Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29 (Baseline, Day 29)
D: Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 (Baseline to Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SUPERvised Exercise Therapy (SET) or Immediate Percutaneous Transluminal Angioplasty (PTA) for Intermittent Claudication (IC) in Patients With an Iliac Artery Obstruction: A Randomized Controlled Trial. SUPER Study
Brief Summary: The purpose of our study is to compare the clinical effectiveness and cost-effectiveness of two treatment strategies of Intermittent Claudication (IC) due to an iliac artery obstruction: to start with SUPERvised Exercise Therapy (SET) and deferred Percutaneous Transluminal Angioplasty (PTA) in case of SET failure, or immediate PTA.

It is our hypothesis that PTA as first line treatment is more effective than SET as first line treatment with regard to maximum walking distance, quality of life and costs after one year.


Options:
A: Disease specific Quality of Life (12 months); Maximum Walking Distance (12 months)
B: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)
C: Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD) (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment); Ankle brachial pressure indices(ABPI) measured at rest and post exercise (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment)
D: Health Related Quality of Life (HRQOL) (24 months with intermistic analysis at 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SUPERvised Exercise Therapy (SET) or Immediate Percutaneous Transluminal Angioplasty (PTA) for Intermittent Claudication (IC) in Patients With an Iliac Artery Obstruction: A Randomized Controlled Trial. SUPER Study
Brief Summary: The purpose of our study is to compare the clinical effectiveness and cost-effectiveness of two treatment strategies of Intermittent Claudication (IC) due to an iliac artery obstruction: to start with SUPERvised Exercise Therapy (SET) and deferred Percutaneous Transluminal Angioplasty (PTA) in case of SET failure, or immediate PTA.

It is our hypothesis that PTA as first line treatment is more effective than SET as first line treatment with regard to maximum walking distance, quality of life and costs after one year.


Options:
A: Quality of Life (1 year)
B: maximal walking distance
C: maximum walking distance (one year)
D: Disease specific Quality of Life (12 months); Maximum Walking Distance (12 months)

Answer: D