TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Lactobacillus Rhamnosus (LGG®) on the Defence Against Pathogens in the Upper Respiratory Tract in Healthy Children - a Single-center, Randomized, Double-blind, Placebo-controlled Study With 16 Weeks Intervention.
Brief Summary: This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. The study will investigate the effect of daily intake of a probiotic on Upper Respiratory Tract Infections (URTI) during a 16-week intervention.


Options:
A: Number of Participants With Positive Blood Culture for L Reuteri (Participants are followed an average of 36 days); Mean Daily Temperature (Study days 1-5, 8,12, 15, 18, 28, and 36)
B: Severity of cold symptoms (3 months)
C: The mean number of episodes and duration of acute diarrheal disease (24 weeks)
D: The incidence of URTI (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension
Brief Summary: This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.


Options:
A: Severity of Pruritis, as measured by a visual analogue scale (3 months)
B: Decrease symptom burden (8 weeks)
C: Severity of Pruritis as measured by a visual analogue scale (VAS) (3 months)
D: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12 (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Verify the Safety and Effectiveness of the Cerclage Pessary in the Prevention and Treatment of High-risk Preterm Pregnancy
Brief Summary: Verify the safety and effectiveness of the cerclage pessary in the prevention and treatment of high-risk preterm pregnancy.


Options:
A: Children's survival without neurodevelopmental disability at the age of 3 years (assessment of the newborn at age of 3 years (corrected age for prematurity))
B: preterm birth before 34 weeks of gestation rate in singleton pregnancies (up to 20 weeks from recruitment); preterm birth before 32 weeks of gestation rate in twin pregnancies (up to 20 weeks from recruitment)
C: Child's birth and survival（rate） (34+0 weeks)
D: Recruitment feasibility (Up to 24 weeks (18 to 42 weeks of gestation))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on the Effect of the Universal Decontamination With Daily Bathing With 4% Chlorhexidine Gluconate on the Incidence of Hospital Acquired Infections in Intensive Care Units
Brief Summary: The study will assess the utility of 4% chlorhexidine gluconate (CHG) daily bathing to reduce hospital acquired infections in patients admitted to intensive care units. One group will be daily bathed with 4% CHG and the other group with standard soap.


Options:
A: Colonization with MRSA, VRE and ESBL (On admission); Colonization with MRSA, VRE and ESBL (During ICU stay)
B: hospital acquired infections incidence (infections occured 48 hours after admission to ICU/PC-ICU)
C: Main Outcome: Patients With Nosocomial MRSA Clinical Cultures (The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.)
D: Bacteremia (participants were followed for the duration of ICU stay, median stay 3 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Integrated Health System Leading, Managing and Governing for Result Model Towards Institutional Delivery Among Staff of Health Facilities in Northwest Ethiopia
Brief Summary: The need for leading people, managing work, and governing organizations never changed over the civilization paths of society. However, people in every pole of the globe observe: over-led and under-managed, over-managed and under-governed, and even out of these organizations. These disparities have remained worse in the health system of developing countries like Ethiopia.

To date, Ethiopia put a goal of ending preventable child and maternal death, in achieving universal healthcare by 2035. Nevertheless, the investment on integrated leadership, management and governance is limited.

Therefore, this study hypothesize that institutional delivery are expressively linked with integrated health system leading, managing and governing for results model among health facilities staff in northwest Ethiopia?


Options:
A: Institutional delivery (Up to six months)
B: Percentage of adherence of opportunities for hand hygiene (march 2008, october 2008, may 2009, november 2009)
C: Supportive leadership behaviour questionnaire for assessing head nurses performance (10 months)
D: Change in experience of group leadership (2 weeks before and 6 months after the education); Relevance and experience of the education in group leadership (After completed intervention, intervention has an expected average duration of 12 weeks.); Change in experience of group leadership and relevance and experience of the education in group leadership (6 months after the education)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline on Vaginal Bacteria Colony Counts in Pregnant Women
Brief Summary: The purpose of this study is to see whether chlorhexidine is superior to povidine-iodine vaginal antisepsis at reducing bacteria colony counts in pregnant women by comparing three groups: vaginal washing with chlorhexidine-alcohol, vaginal washing with povidine-iodine, and vaginal washing with saline alone.


Options:
A: Number of Patients With Surgical Site Infection (4 weeks after cesarean delivery)
B: rates of endometritis (2.5 years)
C: Post-intervention Aerobic Bacterial Colony Counts (From intervention to 7 days post); Post-intervention Anaerobic Bacterial Colony Counts (From intervention to 7 days post)
D: Number of Subjects with post cesarean endometritis (48 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Hospital Medication Expertise on the Rate of Unplanned Hospitalizations at 3 Months of Patients Residing in Nursing Homes (EPAD)
Brief Summary: The use of drugs in the elderly population remains a major public health problem worldwide. Technological advances and the development of new drugs have helped to extend life expectancy. However, the complex process of aging, resulting in changes in physiological functions, may affect the pharmacodynamics and kinetics of medications taken by the elderly. In addition, polypharmacy, due to multiple comorbidities, may also lead to an increased risk of drug or field interaction and the use of potentially inappropriate drugs (PID), increasing the risk of drug iatrogenic use in older users.

With a view to optimizing drug prescriptions and preventing drug iatrogenic disease in the elderly, and in the context of a university-based research and teaching approach, the AP-HM pharmacy initiated the setting up of clinical pharmacy activities for patients at high iatrogenic risk.

The contribution of clinical pharmacists to mobile geriatric teams who carry out more than 2,200 geriatric assessments a year, is a way to optimize the efficiency of the medication management of the elderly person hospitalized out of hospital. geriatric service and EHPAD. TIn order to promote the physician-pharmacist action synergy observed in practice, the investigators decided to integrate the pharmaceutical evaluation with the geriatric evaluation. This new cooperation makes it possible to improve the knowledge of the treatments taken by the patients, to raise awareness on the observance of the treatments and to facilitate the administration of the drugs, to reduce the risks of iatrogenic medicinal increase the acceptance of therapeutic interventions by the health care team. Indeed, the first results show that the mobile team's medico-pharmaceutical interventions have a much higher acceptance rate than medical or pharmaceutical interventions alone.

However, the economic context and the human resources allocated do not make it possible to ensure an efficient service throughout the territory and in particular in nursing homes outside the city where the CHU is located. In order to increase the number of evaluations, the investigators propose to develop a tele-expertise of a medico-pharmaceutical hospital team (MPHT) and evaluate the impact for patients residing in nursing homes in the context of a high-level study.


Options:
A: number of unplanned hospitalizations (6 months)
B: Successful medication discontinuation (4 months)
C: Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers) (Interview performed 30-35 days post-discharge.)
D: Neuropsychiatric symptoms (9 months); Quality of life (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Outcomes and Response/Remission Efficacy of Convulsive Therapies for Bipolar Depression: the CORRECT-BD Trial
Brief Summary: This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Bipolar Disorder (BD). Research indicates that the prevalence of treatment resistance in bipolar depression is twice that of unipolar depression. The limited effectiveness of current treatments for bipolar depression coupled with the medical and economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.


Options:
A: changes of The Positive and Negative Syndrome Scale (PANSS) (At baseline, 4-week, 8-week)
B: Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24 (HRSD-24) (7 weeks); Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT) (7 weeks)
C: Score on rating scale that corresponds to diagnosis: i) Hamilton Rating Scale for Depression, 24-item (HRSD-24); or ii) Yale-Brown Obsessive Compulsive Scale (Y-BOCS); or iii) Brief Psychiatric Rating Scale (BPRS) (Change from baseline in HRSD-24 / Y-BOCS / BPRS at date of symptom remission or date of the 24th treatment, whichever comes first, assessed up to 12 weeks); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 1 month after final treatment); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 2 months after final treatment); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 3 months after final treatment); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 6 months after final treatment)
D: Remission (score </= 10) on the Hamilton Rating Scale for Depression - 24 (HRSD-24) (Greater than 8 treatments (2.5 weeks)); Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT) (Greater than 8 treatments (2.5 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB IN COMBINATION WITH CHEMOTHERAPY FOLLOWED BY MAINTENANCE THERAPY OF AVELUMAB IN COMBINATION WITH THE POLY (ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OVARIAN CANCER (JAVELIN OVARIAN PARP100)
Brief Summary: JAVELIN Ovarian PARP 100 (B9991030) is an open-label, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III study, and the decision was based on several factors, including previous announced interim results from JAVELIN Ovarian 100 study (B9991010). Patients who remain in B9991030 study will continue receiving their randomized treatment assigned and will be monitored for appropriate safety assessments until treatment discontinuation.


Options:
A: Progression-free Survival (Participants With Newly Diagnosed Advanced Ovarian Cancer With Defects in DDR+） (At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by Blinded Independent Central Review (BICR) regardless of initiation of new anti-cancer therapy)
B: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)
C: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
D: Percentage of Participants with Complete Resection After IDS (After IDS (approximately 4 months from randomization)); Percentage of Participants with Different CC Scores After IDS (After IDS (approximately 4 months from randomization))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB IN COMBINATION WITH CHEMOTHERAPY FOLLOWED BY MAINTENANCE THERAPY OF AVELUMAB IN COMBINATION WITH THE POLY (ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OVARIAN CANCER (JAVELIN OVARIAN PARP100)
Brief Summary: JAVELIN Ovarian PARP 100 (B9991030) is an open-label, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III study, and the decision was based on several factors, including previous announced interim results from JAVELIN Ovarian 100 study (B9991010). Patients who remain in B9991030 study will continue receiving their randomized treatment assigned and will be monitored for appropriate safety assessments until treatment discontinuation.


Options:
A: Progression-Free Survival (PFS) (Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months))
B: To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up)); To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up).)
C: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
D: Progression-free Survival (Participants With Newly Diagnosed Advanced Ovarian Cancer With Defects in DDR+） (At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by Blinded Independent Central Review (BICR) regardless of initiation of new anti-cancer therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of a Resilience Intervention for Critical Care Nurses
Brief Summary: The Corporate Athlete® Resilience (CAR) Training Program is a 1-day training program that uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.

The purpose of this RCT is to determine whether the CAR Training Program has significant impact on nurses' resilience and stress mindset in their personal lives and their working environment. Knowledge from this study can be applied to interventions in the future to improve resilience behavior.


Options:
A: Job satisfaction (baseline to 3 month)
B: Stress Mindset Measure - General (SMM-G) (Change from Baseline SMM-G score at 6-months post CAR Training)
C: Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI) (five weeks); quality of life questionnaire (5 weeks); psychophysiological measures (heart rate and heart rate variability indexes) (5 weeks)
D: Presence of job stain evaluated by the French version of the Karasek scale (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of a Resilience Intervention for Critical Care Nurses
Brief Summary: The Corporate Athlete® Resilience (CAR) Training Program is a 1-day training program that uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.

The purpose of this RCT is to determine whether the CAR Training Program has significant impact on nurses' resilience and stress mindset in their personal lives and their working environment. Knowledge from this study can be applied to interventions in the future to improve resilience behavior.


Options:
A: Stress Mindset Measure - General (SMM-G) (Change from Baseline SMM-G score at 6-months post CAR Training)
B: Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale (Data collected before the program starts and one months after the end of the program and six months); Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months); Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months)
C: Pre-/post-intervention changes in mRNA transcript abundance across the entire transcriptome of circulating immune cells in the intervention group relative to the control group. (6 weeks); Pre-/post-intervention changes in IL-6 (6 weeks); Pre-/post-intervention changes in IL-8 (6 weeks); Pre-/post-intervention changes in IL-10 (6 weeks); Pre-/post-intervention changes in TNF-α (6 weeks); Pre-/post-intervention changes in IFN-γ (6 weeks); Pre-/post-intervention changes in peripheral blood mononuclear cell (PBMC) telomerase activity (6 weeks)
D: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of a Resilience Intervention for Critical Care Nurses
Brief Summary: The Corporate Athlete® Resilience (CAR) Training Program is a 1-day training program that uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.

The purpose of this RCT is to determine whether the CAR Training Program has significant impact on nurses' resilience and stress mindset in their personal lives and their working environment. Knowledge from this study can be applied to interventions in the future to improve resilience behavior.


Options:
A: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
B: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)
C: Stress Mindset Measure - General (SMM-G) (Change from Baseline SMM-G score at 6-months post CAR Training)
D: Score of the Borderline Personality Disorder Severity Index (BPDSI) - The BPDSI is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorder (BPD) during the last three months. (Changes from baseline to 3, 6 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of a Resilience Intervention for Critical Care Nurses
Brief Summary: The Corporate Athlete® Resilience (CAR) Training Program is a 1-day training program that uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.

The purpose of this RCT is to determine whether the CAR Training Program has significant impact on nurses' resilience and stress mindset in their personal lives and their working environment. Knowledge from this study can be applied to interventions in the future to improve resilience behavior.


Options:
A: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
B: Stress Mindset Measure - General (SMM-G) (Change from Baseline SMM-G score at 6-months post CAR Training)
C: Change in Aggression (baseline, post-intervention (week 8), 3-month followup, 6-month followup)
D: Job satisfaction (baseline to 3 month)

Answer: B