TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Gonadotropin Ovarian Stimulation for Intrauterine Insemination: a Pilot Randomized Controlled Study
Brief Summary: It is well known that implantation of the developing blastocyst occurs during the luteal phase of the menstrual cycle when the endometrium is under the direct influence of Progesterone (P).Several prospective randomized controlled trials have evaluated the benefits of luteal phase P support in ovulation induction cycles and a recent review and meta-analysis demonstrated that it may be of benefit to patients undergoing ovulation induction with gonadotropins in intrauterine insemination (IUI) cycles. Until now, injectable P was offered only in an oil-base solution owing to the insoluble properties of the molecule, which made the IM route mandatory. A recent publication, however, demonstrated the efficacy of a new P formulation that could be a game changer. The aim of the present pilot trial will be to compare the efficacy and tolerability of 25 mg/d of the new SC P with 90 mg/d of vaginal gel P for luteal phase support (LPS) in COH and IUI cycles.


Options:
A: Ongoing Pregnancy Rate (10 weeks after treatment start)
B: Clinical pregnancy (8 weeks after IUI)
C: Frequency of Moderate to Severe OHSS. (From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test)
D: Number of cumulus-oocyte-complexes retrieved (1 cycle)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Novel Protocol for Postpartum Magnesium Sulfate in Severe Preeclampsia When the Woman Received Less That 8 Hours Before Delivery. Six Versus Twenty-four Hours Postpartum
Brief Summary: There are huge doubts as to how long to keep postpartum magnesium sulfate. Studies demonstrating the usefulness for 24, 12 or 6 hours are of little evidence and do not take into account the use of magnesium sulphate before delivery. Termination of pregnancy is the best option to prevent eclampsia and magnesium sulphate has proven effective, but do not know the minimum effective dose.The investigators believe that if the patient has received less than 8 continuous hours of magnesium sulphate before delivery, maintain magnesium sulfate for 6 hours is as effective as keeping it for 24 hours.


Options:
A: Maternal Serum Magnesium Level at 4 Hours After Administration (4 hours)
B: Need to continue therapy for another 12 hours. (24 hours)
C: completed course of treatment (24 hours postpartum)
D: Seizure (Eclampsia) (72 hours postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Anaesthetic Strategy During Endovascular Therapy: General Anaesthesia or Conscious Sedation ?
Brief Summary: Patients suffering a stroke with a large vessel occlusion is often treated intra veneous thrombolyse and on top of that also intra arterial therapy. It is unknown what form of anaestesia is best during intra arterial therapy. The investigators will randomize these patients between general anaestesia and local anaestesia. Outcome will be growth of the ischemic lesion as judged on an MRI scan.


Options:
A: modified Rankin score (post-procedural 30 days)
B: Score on the modified Rankin scale (3 months)
C: modified rankin score（mRS） (post-procedural 90 days)
D: Growth of DWI lesion (48-72 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Electroencephalography Study of the Effects of Psychostimulants on Dynamic Patterns of Cognitive Task-based Functional Connectivity in Youths With Attention Deficit Hyperactivity Disorder
Brief Summary: In the current study, we will administer three widely administered cognitive tasks while simultaneously measuring electroencephalography (EEG) in ADHD patients before and after methylphenidate immediate release (IR) treatment compared to placebo. In addition we will compare the effective connectivity dynamics to normal subjects. Using this novel network analysis approach, we will attempt to address the currently limited cognitive network literature. We will attempt to map the connectivity between the discrete brain regions during the execution of the tasks before and after treatment with methylphenidate IR. Comparison with healthy control subjects will enable us to determine whether the direction of methylphenidate induced changes in brain functioning (in youths with ADHD) will be toward or away from normal connectivity patterns. We will also examine whether network patterns differ between the healthy controls and the ADHD patients.


Options:
A: Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP)-Combined Scores During the Full-Day Laboratory Classroom (Full-day Classroom - 13 hrs)
B: Baseline Complex Network connectivity before treatment - using electrodes signal correlation (P-value) (0 minutes); Baseline Complex Network connectivity after treatment - using electrodes signal correlation (P-value) (90 minutes)
C: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks); Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint (DB baseline, DB endpoint)
D: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Intensity Interval Training for thE Rehabilitation of Geriatric Patients - a Feasibility Pilot studY.
Brief Summary: This is a pilot study for evaluating the feasibility of using High Intensity Interval Training in geriatric hospitalized patients compared to the standard current rehabilitation practice.


Options:
A: Proportion of patients who complete the rehabilitation program (2 weeks)
B: Falls (18 months); Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers (During hospital stay)
C: Glittre test (up to 9 months)
D: Length of Stay (At time of discharge from hospital (an expected average of 8 days post admission))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women
Brief Summary: The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors.


Options:
A: Viral load (6 months post-randomization)
B: Adherence (Change from baseline at 6 months)
C: Contraception Use Self-efficacy Scale Score (Aim 1b) (Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)); Contraception Use Self-efficacy Scale Score (Aim 1c) (Baseline, 3 months, 6 months); Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b) (Baseline, 3 months, 6 months)
D: Self-reported completion of a full course of PEP medications and receipt of a final HIV test result from their nPEP provider 12 weeks after the index exposure (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women
Brief Summary: The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors.


Options:
A: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
B: Neonatal death (28 days)
C: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
D: Viral load (6 months post-randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women
Brief Summary: The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors.


Options:
A: Viral load (6 months post-randomization)
B: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
C: Rate of Premature birth (before 37 weeks gestation)
D: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women
Brief Summary: The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors.


Options:
A: Vaccines received (Electronic Health Record) (up to a year of follow up)
B: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
C: Exclusive breastfeeding duration (Six months)
D: Viral load (6 months post-randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE
Brief Summary: General objective:

To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users.

Design A multicenter single-blind randomized study with 1 year of follow-up. The effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users will be assessed.

Patients will be randomly assigned to one of two treatments:

1. Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse + pharmacological treatment
2. Control group (N=50): standard treatment: psychoeducation + pharmacological treatment


Options:
A: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
B: Percent days abstinent from alcohol (12, 24, 36, and 48 weeks)
C: Cannabis use reduction in the follow-up (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up.); Improvement in the development of psychotic disorder (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up); Changes in the components of the endogenous cannabinoid system (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up); Normalizing the possible alterations in the endogenous cannabinoid system (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up)
D: Global Assessment of Function (9 months and 21 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone Consultation as a Substitute for Routine Out-patient Face-to-face Consultation for Children With Inflammatory Bowel Disease: Randomised Controlled Trial and Economic Evaluation.
Brief Summary: Inflammatory bowel disease (IBD) refers to two chronic diseases (Crohn's disease and ulcerative colitis) that affect the intestines. The number of new cases of IBD in people younger than 16 years old has been increasing in the United Kingdom (UK), and is currently estimated to be 700 new cases every year. There is no cure for IBD and patients experience episodes of flareups in between periods of wellbeing.

Traditionally, children with IBD are asked to attend regular hospital appointments. This means that, even if they are well, they have to get to the hospital and this can involve travelling long distances.

Telephone consultations have been shown to be beneficial in some areas of medicine but this approach has not been well studied in children. The aims of this study are to determine whether telephone consultations would improve quality of life, patient satisfaction, proportion of consultations attended and whether they would be safe and reduce costs for patients and the National Health Service (NHS). Investigators plan a randomised controlled trial involving 92 participants recruited from amongst the 250 children and adolescents aged between 8 and 16 years who attend the regional paediatric IBD centre in Manchester. Half will be assigned to telephone consultations, and half to face to face consultations. The study would have the approval of the local ethics committee and participants would have provided written consent. Investigators will compare outcomes in the two groups over 2 years. If telephone consultations prove to be effective, the NHS could offer children with IBD the choice of either telephone consultation or face to face consultation for their outpatient followup. Those who are doing well would not have to make unnecessary journeys to the hospital. This would free up clinic spaces and allow patients who are unwell, and new patients to be seen more quickly, thus reducing waiting


Options:
A: Changes in the paediatric IBD-specific health-related quality of life (QOL) scores. (6 monthly over 2 years)
B: Clinical Remission (6 months); Clinical Remission (6 months)
C: Adherence (beginning at baseline - week 20)
D: Improvement in Quality Indicators (adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations) (up to 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO Plan)
Brief Summary: Chicago is an epicenter for asthma health disparities in the U.S., with African-American children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of these disparities is the high rate of visits to the Emergency Department (ED) for uncontrolled asthma. Clinical uncertainties regarding the real-world effectiveness of guideline recommendations for ED discharge and strategies to reduce environmental triggers at home contribute to practice variation and poor adherence to guidelines. The CHICAGO Plan tests both ED- and home-level interventions to improve clinically meaningful outcomes in a minority pediatric ED population with uncontrolled asthma.


Options:
A: Practice-level colon cancer screening rate (12-months post baseline)
B: Change in Child Body Mass Index (BMI) Z-score (Post intervention (9 months after baseline))
C: Access to specialty services- Referral time (6 month post-enrollment); Access to specialty services- Travel (6 month post-enrollment); Access to specialty services- Missed school/work (6 month post enrollment); Access to specialty services- Out of pocket cost (6 month post-enrollment); Access to specialty services- Visits (6 month post-enrollment)
D: PROMIS Asthma Impact Scale (v1.0, SF8a) (Baseline and 6 months after index ED discharge); PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a) (Baseline and 6 months after index ED discharge)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV-infected Women Exposed to Gender Based Violence in Kenya
Brief Summary: The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence. This pilot study will provide data on the efficacy trends, acceptability and feasibility of our IPT intervention and will generate preliminary findings for an R01-funded intervention to test the intervention's efficacy for remediating the effects of GBV trauma on mental health and HIV-related outcomes.

Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU alone.

Hypothesis 2: IPT+TAU will be acceptable and feasible.


Options:
A: Severity of mental health symptoms (previous 4 weeks)
B: Depression, PTSD (Change from 0-12 weeks, 12-24 weeks and 24-36 weeks)
C: Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores (2 weeks post-treatment)
D: Change in Clinician Administered PTSD Scale; Re-experiencing (Baseline, Week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV-infected Women Exposed to Gender Based Violence in Kenya
Brief Summary: The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence. This pilot study will provide data on the efficacy trends, acceptability and feasibility of our IPT intervention and will generate preliminary findings for an R01-funded intervention to test the intervention's efficacy for remediating the effects of GBV trauma on mental health and HIV-related outcomes.

Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU alone.

Hypothesis 2: IPT+TAU will be acceptable and feasible.


Options:
A: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)
B: Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale (9 months)
C: Depression, PTSD (Change from 0-12 weeks, 12-24 weeks and 24-36 weeks)
D: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Care for Somatoform Vertigo/Dizziness - From Diagnostics to Therapy
Brief Summary: The purpose of this study is to evaluate the efficacy of a manualised, multimodal group psychotherapy, based on integrative psychotherapy (IPT) and tailored to somatoform vertigo/dizziness (SVD) subgroups of mental disorders, compared to self-help groups (SHGs) in patients with SVD. The investigators hypothesise that patients who received IPT will demonstrate greater improvement concerning their vertigo-related handicap compared to patients from the SHGs. The investigators will also analyse the cost-effectiveness of experimental and control intervention.


Options:
A: Self-reported measures of dizziness (Measured at beseline, 12 weeks and 1 year.)
B: Dizziness Handicap Inventory (DHI) (3 min); 6 m walking test preferred velocity (5 min)
C: Vertigo-related quality of life (Improvement at follow-up (12 months after treatment))
D: Change from before and after treatment in the severity of dizziness on Visual Analog scale (VAS). (before and after treatment (4 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Hyperoxia on Organ Dysfunction and Outcome in Critically Ill Patients With SIRS
Brief Summary: Objectives:

1. To study the short- and long-term effect of two different PaO2 targets on circulatory status, organ dysfunction and outcome in patient admitted to the ICU with Systemic Inflammatory Response Syndrome (SIRS) criteria.
2. To study underlying mechanisms of hyperoxia by determining differences in oxidative stress response between the hyperoxic and the normoxic patients.

Study design:

Randomized, prospective multicentre clinical trial

Study population:

Patients admitted to the Intensive Care unit with ≥ 2 positive SIRS-criteria and an expected ICU stay of more than 48 hours

Intervention:

Group 1: target PaO2 120 (105 - 135) mmHg (high-normal)

Group 2: target PaO2 75 (60 - 90) mmHg (low-normal)

Primary endpoints:

The primary endpoint will be cumulative daily delta SOFA score (CDDS) from day 1 to day 14.


Options:
A: all-cause mortality (day 28)
B: Death (Day 28)
C: Surgical wound infection (14 days after surgery)
D: Daily Delta Sequential Organ Failure Assessment Score (14 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Determination of Antifungal Activity of Loceryl Nail Lacquer 5% When Used Concomitantly With a Cosmetic Nail Varnish Compared to a Loceryl Nail Lacquer (NL) 5% Alone in Treatment of Toenail Distal Subungual Onychomycosis
Brief Summary: The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis.

The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.


Options:
A: Percentage of patients who achieve clinical cure (52 weeks)
B: Change from baseline in area of infected nail (9 months)
C: Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail (After 30, 60, 120 and 180 days of treatment)
D: Measurement of Antifungal Activity of Loceryl Nail Lacquer (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Feasibility of Delivering an Introductory Education Program to Patients Admitted to Hospital With an Acute Exacerbation of COPD - a Pilot Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine if it is effective and feasible to provide a chronic obstructive pulmonary disease (COPD) education program to patients admitted with an acute exacerbation of COPD.


Options:
A: Evaluation of effects (T1: Initial evaluation; T2: after three months; T3: one year after T1)
B: Change from baseline in disease specific knowledge (This primary outcome measure will be collected prior to randomization and approximately four weeks after admission); Change from baseline in information needs (This primary outcome measure will be collected prior to randomization and approximately four weeks after admission)
C: COPD Assessment Test (CAT) (1 Year)
D: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)

Answer: B