TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Preventive Efficacy of an Algorithm Taking Place After Suicide Attempts Among Attempters Admitted to Hospital in the French Overseas Territories
Brief Summary: In France, suicide behaviours are a major public health concern that triggered the creation in 2013 of a National Observatory of Suicide. In continental France, the "Algos" protocol was found to be effective for the prevention of suicide attempts reiterations. This protocol is based on a procedure that keeps telephone and postal contacts with the suicide attempter and allows, via an algorithm, to assess the risk of suicide attempt recurrence, in order to intervene if necessary. Nevertheless, Algos does not involve primary care health practitioners, who could add a substantial additional efficacy, especially if they intervene downstream and in supplement to Algos. In addition, this kind of protocol has never been evaluated in the French overseas territories.


Options:
A: Existence of a suicide (6 months); Existence of a suicide (13 months)
B: Acceptability- attendance rates (Five weeks); Safety- adverse experiences (Five weeks); Feasibility - completion rate of assessments (Five weeks)
C: Suicide Events (Measured after 6 months of treatment)
D: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Preventive Efficacy of an Algorithm Taking Place After Suicide Attempts Among Attempters Admitted to Hospital in the French Overseas Territories
Brief Summary: In France, suicide behaviours are a major public health concern that triggered the creation in 2013 of a National Observatory of Suicide. In continental France, the "Algos" protocol was found to be effective for the prevention of suicide attempts reiterations. This protocol is based on a procedure that keeps telephone and postal contacts with the suicide attempter and allows, via an algorithm, to assess the risk of suicide attempt recurrence, in order to intervene if necessary. Nevertheless, Algos does not involve primary care health practitioners, who could add a substantial additional efficacy, especially if they intervene downstream and in supplement to Algos. In addition, this kind of protocol has never been evaluated in the French overseas territories.


Options:
A: Suicidal thoughts or attempts (Measured at Year 2)
B: Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr (Screening, 6 weeks, 24 weeks)
C: Time to Fatal or Non-fatal Suicide Attempt or Self-Harm (18 Months after randomization)
D: Existence of a suicide (6 months); Existence of a suicide (13 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial: Single Versus Multiple-infusion Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection
Brief Summary: Fecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves satisfactory cure rates of recurrent CDI). However, several retrospective studies show that severe clinical picture of recurrent CDI is a risk factor for the failure of single-infusion FMT, suggesting that multiple fecal infusions are required to cure this condition.

This is an open-label randomized clinical trial aiming to assess if multiple-infusion FMT is more effective than single-infusion FMT in curing severe CDI


Options:
A: Safety (up to 6 mo post FMT)
B: Cure of C. difficile infection (8 weeks)
C: Clinical Cure (8 weeks)
D: Global cure rate at 10 weeks (10 weeks after enrolment); Time to clinical cure (Through study completion, an average of 18 months); Time to global cure (Through study completion, an average of 18 months); Cure rate at 2 weeks (2 weeks after enrolment); Cure rate at 4 weeks (4 weeks after enrolment); Treatment failure rate (Through study completion, an average of 18 months); Recurrence rate 8 weeks after clinical cure (8 weeks after clinical cure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Comparison of Effectiveness of Facemask Preoxygenation and Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) in Bariatric Patients Undergoing General Anaesthesia
Brief Summary: The purpose of the study is to compare effectiveness of different methods of achieving pre-oxygenation in bariatric patients. The investigators intend to compare facemask pre-oxygenation with a high-flow humidified nasal oxygen.

The primary outcome measure of interest is time to desaturation to 92% or 18 minutes of apnoea.


Options:
A: Change in arterial carbon dioxide (pCO2) (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes); Change in arterial pH (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes); Change in arterial oxygen tension (pO2) (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes)
B: Expired fraction of oxygen at the end of intubation (2 minutes)
C: Measurement of safe apnea time (Maximum up to 6 minutes)
D: Following the induction of general anaesthesia and muscle relaxation, the time (minutes and seconds) to peripheral oxygen saturations (SpO2) of 92%. Comparing pre-oxygenation with standard face mask oxygen or THRIVE technique. (Eighteen (18) minutes maximum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Traumatic Musculoskeletal Pain in the Emergency Department: A Double-Blinded, Randomized, Controlled Trial
Brief Summary: * Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with acute traumatic musculoskeletal pain.
* The objective of the study is compare the efficacy of intravenous dexketoprofen with paracetamol in the treatment of acute traumatic musculoskeletal pain.


Options:
A: Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores (2 hours)
B: Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm (60 minutes post-analgesia)
C: Decrement of the pain on VAS (Baseline and 60 minutes)
D: analgesic efficacy both at rest and with movement (72 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Decrease in Sympathetic Tone in OSA Patients: Is CPAP More Effective Than APAP ?
Brief Summary: The present study aims to compare muscle sympathetic neural activity by microneurography after one month treatment of fixed versus auto-adjusting CPAP treatment and its impact on arterial blood pressure


Options:
A: subjective sleepiness and other OSAS symptoms (3 months, 1 year, 2 years); quality of life (3 months, 1 year, 2 years); percentage of withdrawal and cross-over to other CPAP mode (3 months, 1 year, 2 years); objective vigilance (3 months, 1 year, 2 years); blood pressure (3 months, 1 year, 2 years); cost/utility ratios (3 months, 1 year, 2 years)
B: proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. (90 days)
C: Apnea-Hypopnea Index (Baseline and 180 Days)
D: Sympathetic tone (MSNA) (Change from baseline after one month of intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of Intracytoplasmic Sperm Injection Versus Conventional in Vitro Fertilization in Couples With Non-male Factor Infertility: a Randomized Controlled Trial
Brief Summary: Conventionally, ICSI was initially developed and has been shown to be an effective treatment for male factor infertility. It is increasingly being used for patients without a male factor diagnosis, despite the lack of clinical evidence to support its use. Moreover, ICSI is an invasive and expensive procedure. This multi-center, randomized, controlled, parallel-group trial will be conducted to compare the effectiveness of ICSI versus conventional IVF in infertile couples scheduled for IVF treatment, in whom the male partner has normal sperm.


Options:
A: Ploidy state: euploid or aneuploid (7 days)
B: Cumulative live birth rate from first live birth episode of a study cycle (Minimum follow-up time is one year after inclusion)
C: Ongoing pregnancy leading to live birth after the first cycle with embryo transfer (After 22 weeks of gestation)
D: Ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle. (At 12 weeks of gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
Brief Summary: Military sexual trauma (MST) is a common duty-related stressor which occurs among one in four female Veterans and is associated with substantial concerns about social isolation and high rates of PTSD. Women with MST also experience numerous person-level barriers to care including the desire to avoid male-dominated VA clinics, transportation difficulties and childcare responsibilities. Treatment programs that address the social and mental health needs of this population and acknowledge barriers to care that disproportionately affect women are lacking. The proposed study will use a hybrid effectiveness-implementation design to evaluate the in-home delivery of a gender-sensitive, evidence-based coping skills program to improve social and role functioning as well as reduce PTSD and will prioritize enrolling rural women in a representative manner. If the program is found to be successful at improving social functioning and PTSD, and in reducing barriers to care, it will provide a tremendous benefit to women Veterans with MST, particularly those in rural areas.


Options:
A: Clinician Assessed Severity of PTSD (Baseline, 16, 24 and 32 weeks)
B: Impact of Events Scale-Revised 'IESR' (Change from Baseline PTSD symptomology at up to 5 months); The Psychology Experiment Building Language 'PEBL' Test (Change from Baseline neuropsychological functioning at up to 5 months); Generalized Anxiety Disorder 7 (GAD-7) Scale (Change from Baseline anxiety levels at up to 5 months); Patient Health Questionnaire 9 (PHQ-9) Scale (Change from Baseline depression levels at up to 5 months); Weekly Problems Rating Scale (Change from Baseline emotional and behavioural functioning at up to 5 months); Rosenberg Self-Esteem Scale 'RSES' (Change from Baseline levels of self-worth at up to 5 months); The Valued Living Questionnaire 'VLQ' (Change from Baseline quality of life issues at up to 5 months)
C: PTSD Checklist (PCL) (Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment)
D: Change in Number of Health Risks (Two months); Change in Number of Health Risks (Four months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
Brief Summary: Military sexual trauma (MST) is a common duty-related stressor which occurs among one in four female Veterans and is associated with substantial concerns about social isolation and high rates of PTSD. Women with MST also experience numerous person-level barriers to care including the desire to avoid male-dominated VA clinics, transportation difficulties and childcare responsibilities. Treatment programs that address the social and mental health needs of this population and acknowledge barriers to care that disproportionately affect women are lacking. The proposed study will use a hybrid effectiveness-implementation design to evaluate the in-home delivery of a gender-sensitive, evidence-based coping skills program to improve social and role functioning as well as reduce PTSD and will prioritize enrolling rural women in a representative manner. If the program is found to be successful at improving social functioning and PTSD, and in reducing barriers to care, it will provide a tremendous benefit to women Veterans with MST, particularly those in rural areas.


Options:
A: Change in telomerase activity (pre-intervention (baseline) and post-intervention (5.5 months later))
B: Clinician Assessed Severity of PTSD (Baseline, 16, 24 and 32 weeks)
C: Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores (2 weeks post-treatment)
D: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients
Brief Summary: A number of studies for clinical pathway (CP) after hip fracture have been suggested to improve post-fracture outcome. However, CP is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation specialists. Thus, we developed Fragility fracture integrated rehabilitation management (FIRM), a new standardized guideline and the multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and conducted a prospective study to evaluate the effects of FIRM compared to conventional rehabilitation.


Options:
A: Relational Coordination (For average period of 3 months)
B: Change in the performance-based Short physical performance battery (SPPB) (Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery)
C: Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation (0, 3 month, 6 month, 12 month)
D: Self-rated degree of patient participation in rehabilitation (At discharge from in-patienten rehabilitation, on average 14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
Brief Summary: We compared the effectiveness of three active vision therapy approaches for convergence insufficiency (CI). Patients with eligible criteria and symptomatic CI were included in a prospective study and randomly allocated into three groups. In the home-based vision orthoptic therapy (HBVOT) group, patients were trained to do the pencil push-ups procedure 15 minutes per day, five days a week. In the office-based vision orthoptic therapy (OBVOT) group, 60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed. For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.


Options:
A: Symptom score on the Convergence Insufficiency Symptom Survey
B: Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey (12 weeks)
C: symptomatic convergence insufficiency (one month)
D: Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU (12 weeks after randomization (baseline)); Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P (12-weeks after randomization (baseline))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Subcutaneous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Not on Dialysis
Brief Summary: The aim of this study was to compare and evaluate efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia not on dialysis.


Options:
A: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))
B: Changed amount of mean hemoglobin level in evaluation period compared to the baseline (([Mean of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 0])); Mean administration dose in evaluation period: Mean dose administered in Weeks 20 - 24 (Weeks 20 - 24)
C: hemoglobin variability (2 years)
D: Hemoglobin response rate (Weeks 1-24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery :a Multicenter Randomised, Double Blind Placebo Controlled Trial (TRAAP2)
Brief Summary: The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).


Options:
A: Bleeding (between inclusion (T0) and 6 hours after inclusion (T360).)
B: Number of patients receiving study intervention (At time of delivery)
C: postpartum hemorrhage (day 2)
D: Incidence of PPH (24 hours after birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Prospective Clinical Trial to Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
Brief Summary: This trial is multicenter prospective study to evaluate clinical efficacy of respiratory rehabilitation personalized mobile services for respiratory disease.


Options:
A: change from baseline in Modified Medical Research Council dyspnea score (12 weeks); change from baseline in COPD Assessment Test(CAT) score (12 weeks); change from baseline in real distance walked for 6 minutes (12 weeks)
B: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations
C: 6 Minutes Walk Test (9 weeks)
D: COPD Assessment Test (CAT) (Baseline and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Prospective Clinical Trial to Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
Brief Summary: This trial is multicenter prospective study to evaluate clinical efficacy of respiratory rehabilitation personalized mobile services for respiratory disease.


Options:
A: Number of exacerbations (12 months)
B: Treatment Adherence (10 months)
C: Change in 6-Minute Walk Test Distance (6MWT) (baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))
D: change from baseline in Modified Medical Research Council dyspnea score (12 weeks); change from baseline in COPD Assessment Test(CAT) score (12 weeks); change from baseline in real distance walked for 6 minutes (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Prospective Clinical Trial to Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
Brief Summary: This trial is multicenter prospective study to evaluate clinical efficacy of respiratory rehabilitation personalized mobile services for respiratory disease.


Options:
A: change from baseline in Modified Medical Research Council dyspnea score (12 weeks); change from baseline in COPD Assessment Test(CAT) score (12 weeks); change from baseline in real distance walked for 6 minutes (12 weeks)
B: Quadriceps Muscle Strength Testing Change (measured at baseline and at ten weeks); Six Minute Walk Test (measured at baseline and at ten weeks); Health-related Quality of Life Assessments Change (measured at baseline and ten weeks); Participant Satisfaction Survey (measured at ten weeks (study completion))
C: Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. (4 years)
D: Six Minute Walk Distance (6 weeks); COPD Assesment Tool (CAT) (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
Brief Summary: Inguinal lymph node dissection (ILND) is indicated following metastatic malignant melanoma, and is associated with a high-complication rate, of which many begin with the formation of seroma and ends in complicated wound healing, reoperation, multiple outpatient visits and re-hospitalization. Prevention of seroma may therefore lead to a reduction of many of the preceding complications and improve patient quality-of-life. The aim of this study is to evaluate the efficacy and oncological safety of prophylactic negative pressure wound therapy following ILND in melanoma patients.


Options:
A: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)
B: Early Complications of Vascular Zone (2 weeks)
C: Number of participants with seroma (3 months)
D: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
Brief Summary: Inguinal lymph node dissection (ILND) is indicated following metastatic malignant melanoma, and is associated with a high-complication rate, of which many begin with the formation of seroma and ends in complicated wound healing, reoperation, multiple outpatient visits and re-hospitalization. Prevention of seroma may therefore lead to a reduction of many of the preceding complications and improve patient quality-of-life. The aim of this study is to evaluate the efficacy and oncological safety of prophylactic negative pressure wound therapy following ILND in melanoma patients.


Options:
A: Number of Participants With Wound Complications (Four weeks after cesarean section)
B: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)
C: Number of participants with seroma (3 months)
D: Surgical Site Infection (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
Brief Summary: Inguinal lymph node dissection (ILND) is indicated following metastatic malignant melanoma, and is associated with a high-complication rate, of which many begin with the formation of seroma and ends in complicated wound healing, reoperation, multiple outpatient visits and re-hospitalization. Prevention of seroma may therefore lead to a reduction of many of the preceding complications and improve patient quality-of-life. The aim of this study is to evaluate the efficacy and oncological safety of prophylactic negative pressure wound therapy following ILND in melanoma patients.


Options:
A: Number of participants with seroma (3 months)
B: questionnaire (1 YEAR)
C: Early Complications of Vascular Zone (2 weeks)
D: superficial site infection via southampton scoring system (higher score - worse outcome) (5 days); Wound Dehisence (5 days)

Answer: A