TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Acupuncture for Non-emergent Acute Musculoskeletal Pain and Primary Headache in an Emergency Department Setting: a Parallel, Randomized, Controlled Pilot Trial
Brief Summary: Acupuncture is widely used for managing acute and chronic pain conditions. In the context of an emergency department (ED), patients often present with non-emergent acute pain symptoms. This may result in a delayed triage process and inefficient emergent management. An integrative patient-care approach in emergency departments has been explored that may improve patient satisfaction and promote efficient use of healthcare resources for non-emergent patients in the ED. This implies there is a potential role for acupuncture in such contexts. The aim of this pilot study is to assess the effectiveness and safety of acupuncture as an add-on intervention for patients with non-emergent acute musculoskeletal pain and primary headaches in an ED setting.

Hypotheses of this study are as follows:

1. A single session of add-on acupuncture, with standard ED management, can reduce pain levels in non-emergent acute pain, compared to standard ED management alone.
2. A single session of add-on acupuncture to standard ED management can reduce additional consumption of healthcare resources for management of non-emergent acute pain, compared to standard ED management alone.

This study aimed to include 40 participants, 20 in the acupuncture plus standard ED management group and 20 in the standard ED management alone group.


Options:
A: Pain Scores on the Visual Analogue Scale(VAS) (7 week)
B: Visual Analogue Scale for bothersomeness (Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up)
C: Immediate reduction in pain intensity (at ED discharge (within 3 hours from ED admission))
D: Days with pain (Change from baseline to follow-up after 16 weeks); Physical functioning (Change from baseline to follow-up after 16 weeks); Role physical (Change from baseline to follow-up after 16 weeks); Bodily pain (Change from baseline to follow-up after 16 weeks); General health (Change from baseline to follow-up after 16 weeks); Vitality (Change from baseline to follow-up after 16 weeks); Social functioning (Change from baseline to follow-up after 16 weeks); Role emotional (Change from baseline to follow-up after 16 weeks); Mental health (Change from baseline to follow-up after 16 weeks); Disability (Change from baseline to follow-up after 16 weeks); Stress (Change from baseline to follow-up after 16 weeks); Well-being (Change from baseline to follow-up after 16 weeks); Use of prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of non-prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of conventional care (Change from baseline to follow-up after 16 weeks); Use of complementary care (Change from baseline to follow-up after 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefit and Tolerability of a Probiotic Product in Subjects With Increased Susceptibility to Common Cold
Brief Summary: The objective of this study is to assess the benefit and tolerability of a probiotic product in subjects with increased susceptibility to common cold.


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: Common infections in children
C: The mean number of episodes and duration of acute diarrheal disease (24 weeks)
D: Severity of cold symptoms (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Predictive Value of AMH (AMH=Anti Müllerian Hormone ) in IVF (IVF=In Vitro Fertilization ); a Prospective Randomized Controlled Trial
Brief Summary: The primary aim of this trial is to compare two groups of women undergoing IVF (IVF=in vitro fertilisation ) treatment, to investigate if assessment of AMH (AMH=Anti-Müllerian hormone ), in addition to assessment of maternal age, AFC (AFC=antral follicle count ) and BMI (BMI=body mass index ) gives a more optimal COH (COH=controlled ovarian stimulation than does assessment of only age, AFC and BMI, measured as number of patients obtaining 5-12 oocytes during COH.


Options:
A: Ongoing Pregnancy Rate (10-11 weeks after blastocyst transfer); Ongoing Implantation Rate (10-11 weeks after blastocyst transfer)
B: Live birth rate (12 months)
C: Number of oocytes retrieved (End of stimulation (max 16 days after investigational medicinal product (IMP) start))
D: Number of patients obtaining 5-12 oocytes during COH (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Predictive Value of AMH (AMH=Anti Müllerian Hormone ) in IVF (IVF=In Vitro Fertilization ); a Prospective Randomized Controlled Trial
Brief Summary: The primary aim of this trial is to compare two groups of women undergoing IVF (IVF=in vitro fertilisation ) treatment, to investigate if assessment of AMH (AMH=Anti-Müllerian hormone ), in addition to assessment of maternal age, AFC (AFC=antral follicle count ) and BMI (BMI=body mass index ) gives a more optimal COH (COH=controlled ovarian stimulation than does assessment of only age, AFC and BMI, measured as number of patients obtaining 5-12 oocytes during COH.


Options:
A: Number of patients obtaining 5-12 oocytes during COH (2 years)
B: Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage); Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage)
C: Number of Oocytes Retrieved (Day of oocyte retrieval (up to Day 18 after start of stimulation))
D: Number of metaphase II oocytes retrieved during the course of one treatment cycle (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-blind, Phase II Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgeries
Brief Summary: This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal surgical procedures.


Options:
A: A composite of life-threatening bleeding, major bleeding, and critical organ bleeding (30 days after randomization); A composite of MINS, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism. (30 days after randomization); For patients in the blood pressure management arm: A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest. (30 days after randomization)
B: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
C: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection (Within 5 minutes)
D: Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS (From start of treatment until 5 minutes after treatment start)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, 8-week Comparing Safety and Tolerability of Switching From Generic Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) to Three Different Dose Initiation Strategies With Vilazodone
Brief Summary: This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10 mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S. FDA for the treatment of major depressive disorder in adults. The purpose of this study is to evaluate the efficacy (how well the drug works), safety (the side effects), and tolerability (how well tolerated) of Vilazodone in preventing relapse or recurrence of depression. As vilazodone is not approved by the United States Food and Drug Administration (FDA) to prevent the recurrence of depression, for the purposes of this study it is considered investigational. The word "investigational" means that the study drug is still being tested in research studies and has not been approved for this use by the FDA.


Options:
A: Suicide completion and acts of deliberate self harm (DSH) will constitute the composite primary outcome (One year)
B: Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period (Baseline (Week 8)); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period (Baseline (Week 8) to Week 16)
C: Change in Total MADRS Scores From Baseline to Week 8 (Baseline, Week 8); Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS) (Baseline, week 9); Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX) (Baseline, Weeks 8)
D: Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set (Baseline and Week 14); Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol (Baseline and Week 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing the Impact of Low-Touch Devices on Medication Adherence
Brief Summary: The aim of this study is to determine whether adherence to oral maintenance medications differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox, or none of these devices, with the hypothesis that low-touch devices improve adherence over control and that the increase in adherence is agnostic across devices.


Options:
A: Lung function (FEV1, FVC, FEF25-75)
B: Optimal medication adherence to all cardiovascular or non-depression chronic disease medications (12 months)
C: Medication Adherence (12 Months)
D: Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls. (baseline and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Program to Prevent the Risk of Antisocial Behavior and Attacks of Patients or Attendant on Healthcare Workers in an Ophthalmic Emergency Unit.
Brief Summary: At the hospital, the attacks against health professionals are becoming commonplace, making working conditions difficult. The ophthalmological emergencies are a perfect testing ground to evaluate the effectiveness of a series of original actions to prevent the occurrence of violence against healthcare workers. The main objective is to measure the impact of an integrated prevention of the occurrence of antisocial behavior or attacks against the healthcare workers.

The prevention program combines five interventions (steps): 1) a computer sorting algorithm and specific screens for calling patients in waiting rooms, 2) a clear signage to direct patients between waiting rooms, treatment rooms and administrative et medical offices, 3) Posts information on the activity of emergency services displayed on screens, in the waiting rooms, 4) a mediator/go-between/conciliator, 5) and a dummy surveillance camera.

This is an interrupted time series study. All patients admitted to the ophthalmological emergency unit of a university hospital located in Lyon, France, are included in the study, from June 2013 to Sept 2015


Options:
A: Yale-Brown Obsessive Compulsive Scale (YBOCS): to measure repetitive behaviors (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Aberrant Behavior Checklist (ABC): to measure aggression and irritability (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Clinical Global Impression - Improvement (CGI-I): to measure global functioning (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks)
B: N/A
C: Proportion of patients (or their attendants) who committed a rudeness/incivility or aggression or violence against healthcare workers. (Patients will be followed for the duration of the ophthalmic emergency unit stay, an expected average of 2 hours.)
D: Clinical Global Impression - Severity (Week 12); Clinical Global Impression - Improvement (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of the Use of a Mobile Tool Added to a Standard Intervention in Improving Lifestyles in Adults
Brief Summary: Objectives: To develop and validate a mobile tool for use in Smartphone supports as a first step, and to evaluate the effect of adding this new tool of information and communication technologies (ICT), to a standardized intervention to increase adherence to nutritional recommendations of the Mediterranean diet and increase physical activity as primary endpoint. Analyze adherence and intervention results from a gender perspective. Methodology: Multicenter, randomized double-blind, clinical trial with two parallel group, aimed at assessing the effects of adding an TIC tool, developed for the Smartphone application (intervention), in support of behavioral and educational recommendations (control) in the increased physical activity and adaptation to the Mediterranean dietary pattern. Population: 1215 included subjects younger than 70 years from the project EVIDENT who agree to participate. Measurement and interventions: Physical activity will be assessed with the accelerometer and the 7-PAR day and adaptation to the Mediterranean diet with a questionnaire of adherence and a food frequency survey. It will also assess vascular structure and function, central blood pressure, Augmentation index, pulse rate and of carotid intima-media thickness. The counsel to adaptation the Mediterranean diet (based on the project PREDIMED) and exercise (based on PEPAF project), will be common to both groups. The intervention group will be added training and use of an application on a Smartphone designed to promote healthy eating and increased physical activity.


Options:
A: Mean Change in Weight by Randomized Group (Observed means from baseline weight and at 6 months)
B: Patients' subjective assessment of usability of the PRECIOUS system (At the end of the test (Session 5, week 12)); Satisfaction with the PRECIOUS system (At the end of the test (Session 5, week 12)); User's acceptance of the PRECIOUS system (At the end of the test (Session 5, week 12)); Effectiveness of the PRECIOUS system (At the end of the test (Session 5, week 12))
C: Mediterranean diet compliance (1 year)
D: Weight loss (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure Compliance: The Greek Experience
Brief Summary: The purpose of this study was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.


Options:
A: Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms (Mean of 6- and 12-months); Difference in CPAP Adherence by Active Treatment Arm (6-months); Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) (Mean of 6- and 12-months); Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms (12-months); Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms (6-months); Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) (12-months); Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) (6-months)
B: Short term CPAP Compliance (3 months); Intermediate CPAP Compliance (1 year)
C: Effect of intensive intervention on CPAP adherence (24 months)
D: Apnea-Hypopnea Index (Baseline and 180 Days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Single-blind Study of Effects of Pectin on Flora Intestinal Colonization and Maintenance After Fecal Transplantation to Patients With Inflammatory Bowel Disease
Brief Summary: The purpose of this study is to evaluate the effect and safety of pectin and fecal microbiota transplantation on patients with inflammatory bowel disease. The investigators hypothesize that patients who take pectin can promote the migration of probiotics in intestine engraftment, reduce pathogenic agents'adhesion to intestinal mucosa, cut down the inflammation, and to maintain intestinal flora diversity and steady state in a long time.


Options:
A: Clinical Response (4 weeks following GMT Treatment)
B: co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score (at 12 weeks after treatment.)
C: diversity and steady state of the stool (6 months)
D: Feasibility (Composite Measure) (30 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Single-blind Study of Effects of Pectin on Flora Intestinal Colonization and Maintenance After Fecal Transplantation to Patients With Inflammatory Bowel Disease
Brief Summary: The purpose of this study is to evaluate the effect and safety of pectin and fecal microbiota transplantation on patients with inflammatory bowel disease. The investigators hypothesize that patients who take pectin can promote the migration of probiotics in intestine engraftment, reduce pathogenic agents'adhesion to intestinal mucosa, cut down the inflammation, and to maintain intestinal flora diversity and steady state in a long time.


Options:
A: durability of clinical remission (One year)
B: diversity and steady state of the stool (6 months)
C: Recurrence of CDI up to 8 Weeks (Up to Week 8)
D: The primary outcome of the randomized trial is remission of UC defined as a Mayo score < 3 with an endoscopic Mayo score = 0 at the end of the trial Transplant Therapy in Ulcerative Colitis (9 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition After Birth (COSGOD) - a Prospective Two-centre Randomized Controlled Pilot Feasibility Study
Brief Summary: Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS 5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery and respiratory support based on both measurements in preterm neonates during the first 15 minutes after birth.

Patients: Preterm neonates \<34+0 weeks of gestation born via caesarean section and/or who require respiratory support will be eligible for the study.

Design: A prospective two-centre randomized controlled pilot feasibility study

Methods: Study group: Pulse oximetry will be used to measure SpO2 and heart rate as routine non-invasive monitoring in the first minutes of resuscitation. In addition during the first 15 minutes NIRS measurements will be recorded. crSO2 measurements in addition SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth. Control group: Only SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth.

Hypothesis: Supplemental oxygen support and respiratory support guided by crSO2 and SpO2 measurements will reduce the time in % minutes of crSO2 \<10th or \>90th centile in preterm neonates during the first 15 minutes after birth

Outcome Parameter: Primary outcome parameter will be duration in % minute of crSO2 \<10th or \>90th centile.


Options:
A: change of medical management elicited by cerebral oxygenation out of range (0-72 hours of life)
B: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
C: Cerebral tissue oxygen saturation (crSO2) (15 minutes)
D: The burden of hypo- and hyperoxia (0-72 hours of life)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Harmonic Scalpel Reduce Operating Time and Blood Loss in Patients Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma? A Prospective, Randomized Trial.
Brief Summary: The harmonic scalpel is a tool that may reduce operative blood loss. Some studies also indicate it may result in faster surgery. A recently published randomized study from our group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer any reduction in OR time. The present study investigates the utility of the harmonic scalpel in resections involving removal of oral cavity tissues as well as the neck. Oral cavity resections are especially prone to blood loss and we believe the harmonic scalpel will confer benefits in this type of surgery, potentially reducing the need for blood transfusion.


Options:
A: blood loss (intraoperative)
B: Spinal accessary nerve function (2 years)
C: Overall Survival (5 years)
D: Overall survival

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Harmonic Scalpel Reduce Operating Time and Blood Loss in Patients Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma? A Prospective, Randomized Trial.
Brief Summary: The harmonic scalpel is a tool that may reduce operative blood loss. Some studies also indicate it may result in faster surgery. A recently published randomized study from our group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer any reduction in OR time. The present study investigates the utility of the harmonic scalpel in resections involving removal of oral cavity tissues as well as the neck. Oral cavity resections are especially prone to blood loss and we believe the harmonic scalpel will confer benefits in this type of surgery, potentially reducing the need for blood transfusion.


Options:
A: Recurrence-free survival (5 years)
B: blood loss (intraoperative)
C: Overall Survival (5 years)
D: Opreation Duration (1 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast
Brief Summary: Main adverse events of Roflumilast are weight loss, loss of appetite, insomnia, headache, diarrhea, vomiting, and nausea. Although the majority of these adverse reactions were mild or moderate. They occurred mainly at the beginning of therapy and mostly resolved with continued treatment around for two weeks according to experiences of clinicians. These adverse events occur more often in Roflumilast 500 μg than 250 μg, having negative impact on compliance of patients at the early stage of treatments.

Thus, investigators aim to compare the drop-out rates between the usual dosage (Roflumilast 500 μg once daily) and the dose escalation (Roflumilast 250 μg once daily for 4 weeks and then escalating dose of 500 μg once daily).


Options:
A: Medicines adherence (Change in adherence from 6 weeks to 10 weeks and 26 weeks); Cost effectiveness (6 months); Operation of the NMS (1 year from first recruited patient)
B: Hospital readmission within 30 days of discharge (30 days)
C: medication(Roflumilas) history taking (16 weeks)
D: Readmission rate (6 month)

Answer: C