TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: "Collaborative Assessment and Management of Suicidality" (CAMS) in Comparison to "Treatment as Usual" (TAU) for Suicidal Patients: a Randomized Controlled Trial
Brief Summary: Although suicide risk is highly prevalent among the patient population in mental health care, remarkably little research exists on effective treatments. Among a small set of novel approaches, CAMS is particularly promising. The investigators compare CAMS to TAU in a randomized controlled trial at four departments in Vestre Viken Hospital Trust, hypothesizing CAMS to be the superior approach. Primary outcome measures are suicidal ideation and suicide attempts, with secondary outcome measures including general symptoms of mental health problems. Changes in the outcome measures are compared between the two groups from baseline to 6 and 12 months after patients are included in the study. The study has the potential to impact the science of treating suicidal individuals and it could benefit the general public by establishing CAMS as an effective clinical approach for rapidly reducing suicide risk.


Options:
A: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)
B: Perceived Stress Scale (PSS) (Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))
C: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
D: Suicide Attempts (Assessed bimonthly)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: "Collaborative Assessment and Management of Suicidality" (CAMS) in Comparison to "Treatment as Usual" (TAU) for Suicidal Patients: a Randomized Controlled Trial
Brief Summary: Although suicide risk is highly prevalent among the patient population in mental health care, remarkably little research exists on effective treatments. Among a small set of novel approaches, CAMS is particularly promising. The investigators compare CAMS to TAU in a randomized controlled trial at four departments in Vestre Viken Hospital Trust, hypothesizing CAMS to be the superior approach. Primary outcome measures are suicidal ideation and suicide attempts, with secondary outcome measures including general symptoms of mental health problems. Changes in the outcome measures are compared between the two groups from baseline to 6 and 12 months after patients are included in the study. The study has the potential to impact the science of treating suicidal individuals and it could benefit the general public by establishing CAMS as an effective clinical approach for rapidly reducing suicide risk.


Options:
A: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)
B: MHS heavy use (2 years)
C: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)
D: Parasuicidal behaviour (intermittent)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Meditation Intervention for the Treatment of Depression and Anxiety Symptoms in Patients Undergoing Dialysis: A Randomized Control Trial
Brief Summary: This study examines the use of brief meditation interventions for patients with symptoms of anxiety and depression who are undergoing dialysis. Half of the participants will receive meditation interventions 3 times a week, while the other half will receive treatment as usual. This study will examine whether meditation is feasible and whether it has any effect on reducing symptoms of anxiety or depression.


Options:
A: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)
B: Proportion of participants screened as eligible who enroll (34 months); Proportion of participants who enrolled who completed the 8 week-trial (34 months); Tolerability of Meditation Intervention on a 10-point Likert scale (8 weeks)
C: Percent change in left ventricular volume index (LVVI) at Week 96.
D: Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage: A Randomized Controlled Trial.
Brief Summary: The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.


Options:
A: Number of surgical evacuation in each group (during de study)
B: Cervical Dilation in Women Following Exposure to Either Ripening Agent (3-4 hours after placement of ripening agent)
C: Success rate of abortion (24 hours); Interval to abortion (24 hours)
D: Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection (7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage: A Randomized Controlled Trial.
Brief Summary: The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.


Options:
A: Complete evacuation (six weeks after initial treatment)
B: Efficacy defined as complete abortion without recourse to surgical abortion. (2 weeks)
C: Complete abortion (30 days)
D: Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection (7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Randomized, Controlled, Single Blind Study to Evaluate the Haemostatic Efficacy and Safety of Topically Applied TT-173 in Patients Undergoing Knee Arthroplasty
Brief Summary: The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the total blood loss associated with the total knee arthroplasty.


Options:
A: total blood loss (2 day)
B: Fall in post-operative hemoglobin level after total knee replacement (First 7 days after surgery)
C: Blood transfusion rate (participants will be followed for the duration of hospital stay, an expected average of 5 days)
D: The volume of postoperative blood loss in the drain (48 hours after the operation); Changes from baseline hemoglobin concentrations (48 hours after the operation); unit of blood transfusion (48 hours after the operation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fast-track Surgery After Gynaecological Oncological Surgery
Brief Summary: Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now.

The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction.

The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.


Options:
A: median length of stay (participants will be followed for the duration of hospital stay, an expected average of 2 weeks.)
B: Length of Hospitalization Post-operation (up to 12 months); The Total Cost (RMB) (12 month)
C: Disease free survival (4.5 years from surgery)
D: Shorter Length Of Hospitalization (LOH) (Up to 4 weeks after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery
Brief Summary: Observational cohort study examining the perioperative course of copeptin in patients undergoing elevated-risk surgery.


Options:
A: perioperative copeptin concentrations (perioperative from induction of anesthesia to the third postoperative day); composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE) (12 months); myocardial injury in non-cardiac surgery (MINS) (3 postoperative days)
B: Prospective validation of the prognostic potential of a score system based on the presence/absence of three risk factors (VH mutational status, Zap-70 and CD38 expression) on Progression Free Survival (PFS ). (6 months)
C: Deaths in one year after non-cardiac surgery in patients with and without PMI (1 year)
D: Major Adverse Cardiac and Cerebrovascular Events (MACCEs) (up to 90 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D to Prevent Severe Asthma Exacerbations
Brief Summary: This study will determine whether vitamin D3 prevents severe asthma attacks in children who have a serum vitamin D (25(OH)D) level \<30 ng/ml and who are being treated with inhaled corticosteroids for asthma. Half the participants will receive vitamin D3 at a dose of 4,000 IU/day, and the other half will receive placebo.


Options:
A: Days to a Severe Asthma Exacerbation (48 weeks)
B: Time to first upper respiratory tract infection (One year); Time to first severe asthma exacerbation (One year)
C: Change From Baseline in Serum 25OHD (During the 7-month follow-up period)
D: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial on Central Venous Catheterization Techniques in Neonates: Seldinger Versus Modified Seldinger
Brief Summary: The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the Seldinger and modified Seldinger technique for ultrasound-guided central venous catheterization in neonates.


Options:
A: Only one attempt at arterial puncture was necessary (yes/no) (Day 0 - end of procedure)
B: First successful central venous catheterization rate (Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes)
C: Successful rate without extra vascular damage (Through study completion, an average of 1 year.)
D: Time to Successful Radial Arterial Catheterization (up to 5 minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial
Brief Summary: Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial.

Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS.

Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.


Options:
A: Proportion of patients with events of stroke or death (at 30 days after randomization)
B: the target vessel stroke event (within 30 days after stenting)
C: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
D: Rate of Stroke or Death Among Participants (within 72 hours of the procedure)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial
Brief Summary: Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial.

Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS.

Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.


Options:
A: Proportion of patients with events of stroke or death (at 30 days after randomization)
B: stroke or death within 30 days after enrollment, any stroke in the territory of the symptomatic intracranial artery beyond 30 days through 12 months (12 months)
C: Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment. (Mean length of follow-up was 2.4 years)
D: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maxigesic IV Bunionectomy Study- A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group and Placebo-Controlled Study
Brief Summary: The purpose of the study is to determine the clinical efficacy and safety of Maxigesic IV, acetaminophen IV, Ibuprofen IV versus placebo IV for the treatment of acute postoperative pain after bunionectomy


Options:
A: Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery (24 Hours)
B: the amount of morphine administered (during the first 24 hours)
C: Summed Pain Intensity Difference (SPID)-Calculated From the Pain Intensity Scores Recorded on a 100mm Long Scale With Anchors for "no Pain" (0 mm) and "Worst Pain Imaginable" (100 mm). (48 hours after the first dose)
D: Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour) (mean pain score over 48 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Open-label, Multicentre Phase-II Trial to Evaluate Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by Ofatumumab and Ibrutinib Followed by Ibrutinib and Ofatumumab Maintenance in CLL Patients
Brief Summary: A prospective, open-label, multicentre phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by ofatumumab and ibrutinib followed by ibrutinib and ofatumumab maintenance in CLL patients.


Options:
A: Primary Analysis: Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 30 (Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]).); Final Analysis: PFS Based on Investigator Assessment - Kaplan Meier Landmark Estimates at Month 48 (Month 48 (Median follow-up time was 44.6 months at the time of the final analysis [data cutoff date: 17 October 2019]).)
B: Arm A: Percentage of Complete Responses (7 months); Arm B: Treatment-free Survival at 18 Months (18 months)
C: Overall response rate (ORR) (84 days after first dose of last induction cycle)
D: Overall response rate (ORR) (84 days after first dose of last induction cycle)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 29-day, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of GSK1278863 in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Switched From a Stable Dose of an Erythropoiesis-stimulating Agent
Brief Summary: GSK1278863 is an orally available, hypoxia-inducible factor - prolyl hydroxylase inhibitor, currently being investigated as a treatment for anemia associated with chronic kidney disease. GSK1278863 has been given as a once daily regimen in clinical studies to date. However, physicians in countries that use a three-times weekly hemodialysis schedule prefer to give the anemia medicine at the same time as the dialysis session. This study will test how well GSK1278863 can maintain hemoglobin levels when given three-times weekly, for 29 days.

This study will describe the relationship between hemoglobin and GSK1278863 given three-times weekly. The data from this study will allow for conversion of once daily doses to three-times weekly doses.


Options:
A: US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue Therapy (Baseline (Day 1, Week 0), Weeks 28 to 52); Ex-U.S. Submission: Mean Hb Change From Baseline to the Average Weeks 28 to 36, Without Having Received Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period for Participants Enrolled Under the Original Protocol (Baseline (Day 1, Week 0), Weeks 28 to 36)
B: Number of subjects with adverse events (15 days); Vital signs and 12 lead ECGs (15 days); Cmax (maximum concentration) (15 days); tmax (time to reach maximum concentration) (15 days); t1/2 (elimination half-life) (15 days); AUC (area under the concentration-time curve) (15 days); AR (accumulation ratio) (15 days); RBC (red blood cell) count (15 days); Hgb (hemoglobin) (15 days); TSAT (transferrin saturation) (15 days); serum ferritin (15 days)
C: Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks (Weeks 1 to 20); Part 1 (ESA Treated): Percentage of Participants who Achieved Mean Hb ≥100 g/L Averaged Over Weeks 17 to 21 Visits (Weeks 17 to 21); Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits (Weeks 33 to 37)
D: Change From Baseline in Hgb Levels at Day 29 (Baseline and Day 29)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed: An Open Label Randomized Controlled Trial.
Brief Summary: All patients with non variceal bleed who are admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent.


Options:
A: Occurrence of a composite endpoint (90 days)
B: Amount of FFP (Fresh Frozen Plasma) transfusion in both groups (42 days)
C: Adherence to the study protocol (up to 28 days)
D: Physical Fatigue (on day 3 postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Post-operative Regional Analgesia Rather Than Systemic Analgesia to Decrease the Incidence of Post-operative Delirium After Acute Hip Fracture Surgery? A Prospective Randomized-controlled Double-blinded Pilot Study.
Brief Summary: Post operative delirium is common after hip fracture surgery and is associated with increased length of hospital stay, delayed recovery and increased mortality. Postoperative delirium can also decrease a patient's quality of life and increase treatment costs. Anesthesia and pain relief (analgesia) treatments may also influence the incidence of delirium, but more research is needed into which techniques are effective in improving patient outcomes, care and decreasing costs. This pilot study compares the addition of regional analgesia as part of general anesthesia to determine the incidence of delirium following hip surgery. This is a collaborative study involving anesthesia, orthopedic surgery and geriatrics in the improvement of patient care.


Options:
A: Interleukin-6 Concentration in Peripheral Blood. (Before, 24 and 72 hours after the surgery); Changes in Cognitive Function (Before, 24,48,72,96 and 120 hours after the surgery)
B: Pain level (Pre operatively); Pain medication requirement (Pre operatively); Pain level (Four hours after surgery); Pain medication requirement (Four hours after surgery); Pain level (One day after surgery); Pain medication requirement (One day after surgery); Pain level (Two days after surgery); Pain medication requirement (Two days after surgery); Pain level (Three days after surgery); Pain medication requirement (Three days after surgery)
C: The incidence of post-operative delirium after hip fracture surgery (immeidately to 5 days post operatively)
D: Acute complications during insertion of regional anesthesia (at the day of insertion, day zero)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate the effect of preoperative remote ischaemic preconditioning (RIPC) on organ damage and the functional characteristics of arteries in patients undergoing vascular surgery. In addition, we investigate the connection between RIPC and changes in the functional characteristics of arteries and low molecular weight metabolites.


Options:
A: Incidence of AKI within the 7 days after the surgery (Within 7 days after the surgery)
B: Carotide-femoral pulse velocity (24 h); Augmentation index (24 h)
C: Serum troponin levels (3 days)
D: Troponin I Elevation Above the Upper Reference Limit (URL) (Within 3 days of the vascular operation)

Answer: B