TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Fecal Microbiota Transplantation (FMT) for the Treatment of Recurrent C. Difficile Associated Diarrhea (RCDAD) Via Retention Enema or Oral Route
Brief Summary: The objective of the study is to investigate the safety of a frozen or lyophilized inoculum administered, respectively, by retention enema or capsules in patients with recurrent C. difficile associated diarrhea (RCDAD).

This is a single center, randomized, parallel assignment, open label safety study conducted in subjects with RCDAD. Fifty subjects will be enrolled in the study and randomized at 1:1 ratio to receive frozen filtered intestinal bacteria via retention enema or lyophilized donor intestinal bacteria. All subjects will be followed for a total of 3 years after study completion.

Donors will be enrolled and screened at the laboratory in the Center for Infectious Diseases at University of Texas School of Public Health (UT-SPH). The donors will come from a variety of places, including the UT-SPH. At least 20 donors will be screened to recruit at least 15 qualified donors.

Recipients may self-refer but must have a physician who agrees to accept care of the patient following fecal microbiota transplantation (FMT). Subjects consenting to treatment at Baylor St. Luke's Medical Center (BSLMC) and the UT-SPH must be willing to self-pay for the FMT in the amount of $1,500. There will be no insurance accepted. Subjects undergoing retention enema will be treated as outpatients at either at BSLMC, Kelsey-Seybold Clinic, or at the Memorial Hermann in the Texas Medical Center. All subjects taking capsules with lyophilized intestinal bacteria will be seen at UT-SPH. Once the procedure is completed, the recipient's care will be returned to their physician. At least 75 recipients will be screened to recruit 50 qualified recipients.

The primary endpoint is to evaluate the safety of FMT by rectal or oral routes with secondary endpoint related to efficacy prevention of RCDAD. In order to monitor any health effects for safety, participants will be contacted pre- and 7, 14, 30 days, then monthly basis for the first 90 days after FMT and quarterly till 3 years after FMT. The following procedures will be completed: review recipient diary with the recipient to ensure that the following information is recorded correctly and a fresh stool sample will be collected from recipient, tested for C. difficile toxins and an aliquot (2mL) stored at -80C for microbiome analysis. Recipients will be contacted by phone for their diarrhea status on monthly basis till 90 days after FMT, then on quarterly basis till 3 years after FMT.


Options:
A: Safety as Assessed by Number of Participants With Any Adverse Events (AE)s (6 months after the procedure)
B: Change in subjective symptom score (at 0 and 3 months)
C: Cure of C. difficile infection (8 weeks)
D: Clinical Cure (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Atopic Dermatitis and ALLergies in Children
Brief Summary: The primary objective is of the PreventADALL study is to test if primary prevention of allergic diseases is possible by simple and low cost strategies, and secondary to asses the impact of xenobiotic exposure and microbiota in and on the body and the environment on allergic disease development.

The secondary objective is an exploratory focus to investigate early life risk factors for development of non-communicable diseases, including asthma and allergic diseases as well as for diseases that may share common risk factors, including cardiovascular disease, obesity and diabetes.

Design: A multi-national population-based prospective birth cohort with a factorial designed randomized controlled intervention trial of two clinical interventions; skin care 0-9 months and early food introduction by 3-4 months, thereafter observation only.

Recruitment in three cities (Oslo, Ostfold and Stockholm) of approximately 2500 mother-child pairs is done in two steps; first pregnant women are recruited and enrolled at the 18-weeks ultrasound investigation (n=approximately 2700) and thereafter their new-born babies are included.

Randomization into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township".

Visits for biological and environmental sampling, observations and investigations will be at the relevant pediatric departments (at 3-6-12-24-36 months of age) and through childhood into adulthood thereafter, provided sufficient funding.


Options:
A: Atopic dermatitis (AD) (AD 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding); Food allergy to any intervention allergen (0-36 months, assessed first at 36 months, with follow-up investigations at intervals up to year 2044, provided funding)
B: Trans Epidermal Water Loss(TEWL) (first 7 days of life)
C: Proportion of eligible families screened who are willing and able to be randomised. (Before birth)
D: Cumulative incidence of provider-diagnosed AD (up to 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Atopic Dermatitis and ALLergies in Children
Brief Summary: The primary objective is of the PreventADALL study is to test if primary prevention of allergic diseases is possible by simple and low cost strategies, and secondary to asses the impact of xenobiotic exposure and microbiota in and on the body and the environment on allergic disease development.

The secondary objective is an exploratory focus to investigate early life risk factors for development of non-communicable diseases, including asthma and allergic diseases as well as for diseases that may share common risk factors, including cardiovascular disease, obesity and diabetes.

Design: A multi-national population-based prospective birth cohort with a factorial designed randomized controlled intervention trial of two clinical interventions; skin care 0-9 months and early food introduction by 3-4 months, thereafter observation only.

Recruitment in three cities (Oslo, Ostfold and Stockholm) of approximately 2500 mother-child pairs is done in two steps; first pregnant women are recruited and enrolled at the 18-weeks ultrasound investigation (n=approximately 2700) and thereafter their new-born babies are included.

Randomization into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township".

Visits for biological and environmental sampling, observations and investigations will be at the relevant pediatric departments (at 3-6-12-24-36 months of age) and through childhood into adulthood thereafter, provided sufficient funding.


Options:
A: Proportion of eligible families screened who are willing and able to be randomised. (Before birth)
B: Presence of eczema (12 months of age.); Confirmed diagnosis of food allergy at 12 months (52 weeks). (12 months of age)
C: Cumulative incidence of provider-diagnosed AD (up to 24 months)
D: Atopic dermatitis (AD) (AD 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding); Food allergy to any intervention allergen (0-36 months, assessed first at 36 months, with follow-up investigations at intervals up to year 2044, provided funding)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multi-Center, Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Clinical Study to Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.


Options:
A: SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo (2 weeks)
B: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6 (Baseline, Week 6)
C: Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. (Baseline and 4 weeks); Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM. (Baseline and 4 weeks)
D: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8 (Baseline and week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone for Prophylaxis of Acute Mountain Sickness in Patients With Chronic Obstructive Pulmonary Disease Travelling to Altitude
Brief Summary: Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing acute mountain sickness in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.


Options:
A: incidence of acute mountain sickness (2 days)
B: Acute mountain sickness, cumulative incidence (day 3 at 3200 m)
C: Acute mountain sickness score (At 3230m and 4,130m(Annapurna base camp))
D: acute mountain sickness (during ascent)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabetes Mellitus
Brief Summary: Primary Objective:

Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (\<8% if age \>=65 years or with defined comorbidities or otherwise \<7%) at 6 months without documented symptomatic (Blood Glucose \<=70 mg/deciliter \[mg/dL\]) and/or severe hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive participants with type 2 diabetes initiating basal insulin therapy in a real world setting.

Secondary Objectives:

Compare Toujeo to other commercially available basal insulins at 6 months after initiating insulin therapy in a real world setting in terms of:

* Participant persistence with assigned basal insulin therapy.
* Risk of hypoglycemia including the incidence and rate of documented symptomatic and severe hypoglycemia.
* Changes in HbA1c, fasting plasma glucose, body weight
* Differences in participant and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs) and (DTSQc), Hypoglycemia Patient Questionnaire, and participant and provider reported Global Effectiveness Scale (GES).
* Healthcare resource utilization including hospitalizations and emergency department or other provider visits and healthcare costs.


Options:
A: The percentage of patients with a 3-step or greater progression in the patient; level recoded integer ETDRS retinopathy scale
B: HbA1c (Recorded at baseline (week 0), week 12, week 24 and week 36)
C: Health Assessment, Patient treatment satisfaction and Quality-of-Life (At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint))
D: Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia (Baseline to Month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Prediction Rule for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
Brief Summary: The aim of the study is to investigate the effect of aerobic exercise on chronic neck pain. The study will be double blind randomized controlled trial . 120 patients with neck pain will be recruited for the study and divided into a research group and control group. The research group will receive neck exercise program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders) and the control group will receive only neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. In addition, clinical prediction rule (CPR) for identifying patients with neck pain who will respond better to an aerobic treatment program will be defined.


Options:
A: Change in Neck pain intensity as measured by Visual Analog Scale (Change from baseline neck pain intensity at 4 weeks)
B: Numeric pain rating scale (NPRS) (Baseline); Numeric pain rating scale (NPRS) (post 3 weeks); Pain pressure threshold (baseline); Pain pressure threshold (post 3 weeks); Thoracic ROM (Baseline); Thoracic ROM (post 3 weeks)
C: Global Rating of Change (GROC) scale (following 6 weeks of treatment, 3 months and 6 months)
D: Neck Disability Index (NDI) (baseline and post intervention 2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of MElatonin on Depression, Anxiety, CIrcadian and Sleep Disturbances in Patients After Acute Myocardial Syndrome
Brief Summary: The objective of the study is to investigate whether prophylactic treatment with melatonin has an effect on depressive symptoms. Secondarily melatonin's effect on anxiety, sleep and circadian disturbances will be investigated.

The MEDACIS trial is a randomised, placebo-controlled, double-blinded multicenter trial investigating the effect of 25 mg exogenous melatonin (intervention group) against placebo (control group) and the study is designed as a parallel group superiority trial.


Options:
A: Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 14.); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 28); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 42); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 56); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 70); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 84)
B: Feasibility - enrollment of 1-2 participants per month (One year)
C: Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) (Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28)
D: Depression (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?
Brief Summary: To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma.


Options:
A: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))
B: Forced Expiratory Volume in the first second (FEV1 %) predicted value (2 years)
C: Pediatric Asthma Quality of Life Questionnaire (PAQLQ) (9 months post camp); Asthma Control Questions (9 months post camp)
D: Change in asthma control from baseline at 3 months (3 months); Change in asthma control from baseline at 6 months (6 months); Change in asthma control from baseline at 9 months (9 months); Change in asthma control from baseline at 12 months (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?
Brief Summary: To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma.


Options:
A: Medication Adherence (12 months)
B: Change in asthma control from baseline at 3 months (3 months); Change in asthma control from baseline at 6 months (6 months); Change in asthma control from baseline at 9 months (9 months); Change in asthma control from baseline at 12 months (12 months)
C: Objective Adherence to ICS (Baseline); Change in objective adherence to ICS (Change from baseline in objective adherence to ICS at 1 month); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control); Feasibility, Acceptability and Usability of the Text Messaging Website (At time of text messaging intervention); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 1 month after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 2 months after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 3 months after receiving text messages)
D: Adherence rate (at three months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?
Brief Summary: To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma.


Options:
A: N/A
B: Medication Adherence (12 months)
C: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)
D: Change in asthma control from baseline at 3 months (3 months); Change in asthma control from baseline at 6 months (6 months); Change in asthma control from baseline at 9 months (9 months); Change in asthma control from baseline at 12 months (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Subcutaneous Insulin Glargine Versus NPH Insulin in Patients With Chronic Kidney Disease Stages III and IV: Randomized Controlled Trial.
Brief Summary: Chronic kidney disease (CKD) is one of the most common microvascular complications of diabetes mellitus, and it is the leading cause of end stage renal disease on developed countries. The CKD diagnosis and its progression require re-evaluation of hypoglycemic therapy and constant dosing adjustments, in order to optimize glycemic control and minimize its side effects. Long acting insulin analogs and its pharmacokinetics have not been studied through different stages of kidney disease and there is no consensus defining the appropriate dosing adjustment based on the glomerular filtration rate (GFR). This research project will compare the glycemic response to intensive insulin treatment with NPH insulin and basal insulin analog (insulin glargine) in type 2 diabetes (DM 2) patients with CKD stages 3 and 4. Patients and methods - Inclusion Criteria: DM 2 patients with CKD secondary to diabetic nephropathy and GFR of 15-59 ml/min/1.73m². Exclusion Criteria: Patients with systemic neoplasia, HIV, CKD or nephropathy from other etiologies, severe psychiatric disorders and pregnant women. Study design: This study consists of a randomized, cross-over, open-label controlled clinical trial. Patients will be randomly divided into two groups: GROUP 1 - insulin analog glargine once a day and GROUP 2 - NPH human insulin, three applications per day, both group will be treated with insulin lispro at mealtime. The laboratory tests will be performed at baseline and 12, 24, 36 and 48 weeks after the study start. During routine medical appointments will be analyzed self- monitoring of capillary blood glucose (SMBG) and the hypoglycemia score. After 24 weeks the basal insulin will be changed, i.e. patients using NPH insulin will receive insulin glargine and patients on insulin glargine will be changed to NPH insulin. A CGMS will be carried out at 24 and 48 weeks. Methodology: The metabolic profile will be evaluated throughout SMBG; biochemical, hormonal and hematological measurements; hypoglycemia score and CGMS. Statistical analysis will be performed using comparative descriptive analyzes, such as chi-square distribution, t-test and non-parametric tests. Analyze of data CGMS will include the area under the curve and the related statistic. Finally, logistic regression models will be adopted to evaluate the effect of the treatment on the several variables in question.


Options:
A: The change in liver fat content and visceral fat mass (After 26 weeks of treatment)
B: Glycemic variability (24 weeks)
C: Change in Glycosylated Haemoglobin (HbA1c) at Month 7 (week 0, month 7)
D: Difference in A1c Levels (baseline and 24 weeks); Number of Hypoglycemic Events (between 1rst and 24 weeks of each treatment arm)

Answer: D