TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomised, Double-blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Three Doses of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (1.25, 2.5 and 5.0 Mcg Once Daily) Versus Placebo in Patients With Moderate Persistent Asthma.
Brief Summary: Rationale for the current trial is to evaluate the efficacy and safety of three doses (1.25 µg, 2.5 µg and 5.0 µg ex mouthpiece) of tiotropium inhalation solution in patients with moderate persistent asthma who are still symptomatic despite regular maintenance therapy with inhaled corticosteroids (ICS).

The data collected in the present trial will provide useful information to health care providers and patients regarding the efficacy and safety of a once daily inhalation of three different doses of tiotropium solution delivered by the Respimat® inhaler in addition to inhaled corticosteroids in the treatment of not fully controlled moderate asthma in comparison to placebo. The Pharmacokinetics (PK) of tiotropium is well established in COPD patients. However, there is currently no PK data available for the 3 doses of tiotropium being tested in this trial in patients with moderate persistent asthma. Tiotropium is a once daily drug. Hence, the rationale for blood and urine sampling for PK analysis over 24 hours in a subset of patients is to confirm the PK of the 3 doses in moderate asthma patients. Rationale for the 24-hour pulmonary function test sub-investigation is to demonstrate that a once daily dosing of tiotropium inhalation solution is effective and safe in the treatment of moderate persistent asthma.


Options:
A: Number of Patients With Drug-related Adverse Events (after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409)
B: Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response (10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration)
C: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)
D: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Antibiotic Treatment of Recurrent Episode of Asthma in Children - a Randomised, Case-controlled Study Within the COPSAC2010 Cohort (Asthma Begins in Childhood)
Brief Summary: Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to viral infection. The current study will examine whether treatment of asthmatic exacerbations with macrolide antibiotics - in the abscence of clear clinical bacterial infection which would in any case precipitate antibiotic treatment - has an effect on either the particular episode, or subsequently. Macrolide antibiotics are chosen for ease of administration ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.


Options:
A: Progression to Clinically Significant Lower Respiratory Tract Symptoms (14 days after initiation of APRIL therapy); OCELOT: Pediatric Respiratory Assessment Measure (36-72 hours after initiation of OCELOT therapy)
B: Juniper Asthma Control Questionnaire (ACQ) Results (Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome)
C: Symptom scoring (1 to 3 years of age); Duration in days of each asthmatic episode from randomisation start (1 to 3 years of age)
D: Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antibiotic Treatment of Recurrent Episode of Asthma in Children - a Randomised, Case-controlled Study Within the COPSAC2010 Cohort (Asthma Begins in Childhood)
Brief Summary: Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to viral infection. The current study will examine whether treatment of asthmatic exacerbations with macrolide antibiotics - in the abscence of clear clinical bacterial infection which would in any case precipitate antibiotic treatment - has an effect on either the particular episode, or subsequently. Macrolide antibiotics are chosen for ease of administration ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.


Options:
A: Diary card summary symptom score (10 days after randomisation)
B: Symptom scoring (1 to 3 years of age); Duration in days of each asthmatic episode from randomisation start (1 to 3 years of age)
C: Patient's daily diary summary symptom scores/Morning diary PEFR (During the Study Conduct)
D: Peak expiratory flow rate. (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Antibiotic Treatment of Recurrent Episode of Asthma in Children - a Randomised, Case-controlled Study Within the COPSAC2010 Cohort (Asthma Begins in Childhood)
Brief Summary: Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to viral infection. The current study will examine whether treatment of asthmatic exacerbations with macrolide antibiotics - in the abscence of clear clinical bacterial infection which would in any case precipitate antibiotic treatment - has an effect on either the particular episode, or subsequently. Macrolide antibiotics are chosen for ease of administration ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.


Options:
A: Comparison of number of participants with very good partial response or better response after three courses of VCD combined with clarithromycin or placebo (10 weeks)
B: Presence of malaria parasites on thick blood smear or Rapid Diagnostic Test (RDT) in children 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Fraction of isolates of pneumococcus exhibiting macrolide resistance by nasopharyngeal swabs in children 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 36 months); Prevalence of macrolide resistance in the stool as determined by genetic determinants or phenotypic testing (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Fraction of conjunctival swabs yielding ocular chlamydia in children 1-60 months (24 months); Height over time in children aged 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Weight for Height over time in children aged 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months)
C: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
D: Symptom scoring (1 to 3 years of age); Duration in days of each asthmatic episode from randomisation start (1 to 3 years of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of LitramineTM in Reducing Body Weight in Overweight and Obese Subjects
Brief Summary: Preparations that bind to nutritional fat and inhibit its absorption could be decisively meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after eating. Such effects are supposed to facilitate adherence to energy-restricted diets. The medical device to be investigated contains a patented formula of fibre complex having a high ability to bind to dietary fat.

Therefore, the rationale for this study is to confirm that Litramine's proven fat binding capacity to increase fat excretion and modulate the feeling of satiety will translate into measurable reduction in body weight. A double blind, randomized, placebocontrolled design has been chosen to assess the efficacy and safety of Litramine in overweight and obese subjects on a energy-restricted diet.


Options:
A: Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c. (0-26 weeks)
B: Body weight (24 weeks)
C: weight loss (kg) (after 12 weeks)
D: Change in BMI from baseline (18 months and 36 months); Change in Insulin resistance from baseline (3; 6; 9; 12; 15; 18; 24; 30 and 36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Infant Feeding Experience of New Mothers - a Descriptive Pilot Study.
Brief Summary: Characterize a population-based sample of first-time expectant mothers with regards to maternal metabolic health and their infant feeding experience.


Options:
A: Early lactation difficulties (1 year)
B: a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II (within the first two weeks postpartum)
C: Peak Change in Milk Output (baseline and 4 weeks post-intervention)
D: success of continuing breastfeeding; amount of supplementation used

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cash Transfer for the Prevention of HIV in Young South African Women
Brief Summary: Cash transfers to young women for staying in school and its effect on acquiring HIV


Options:
A: Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year (1 year); Change From Baseline in CD4 Count at 1 Year (1 year)
B: Weight Change From Baseline to 24 Weeks (24 weeks)
C: Cumulative incidence of child wasting (3-monthly until 24 months after inclusion); Incremental cost-effectiveness ratio (24 months after inclusion)
D: HIV Incidence (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Nursing Intervention to Prevent Poor Psychosocial Outcomes in Living Donors
Brief Summary: The purpose of this study is to evaluate the potential effectiveness of a psychosocial intervention based on the principles of motivational interviewing. The novel intervention will assist living donor candidates to think through any remaining concerns or questions that they may have about living donation. If the intervention is effective, it may help to prevent post-donation problems related to psychological and health outcomes.


Options:
A: Donor registration status at 7 days (7 days)
B: Knowledge about Living Kidney Donation (3 weeks)
C: Proportion of signed donor cards (One day)
D: psychological distress (6 weeks post-donation); somatic/physical health perceptions (6 weeks post-donation); interpersonal relationship quality and distress (6 weeks post-donation); quality of life (6 weeks post-donation); psychological distress (3 months post-donation); somatic/physical health perceptions (3 months post-donation); interpersonal relationship quality and distress (3 months post-donation); quality of life (3 months post-donation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to assess whether 4-months of interval-walking exercise training improves glycemic control in individuals with type 2 diabetes mellitus. The effects of interval-walking training will be compared to continuous-walking exercise in a randomised, controlled trial design. Changes in glycemic control will be examined using oral glucose tolerance tests (OGTT) with stable isotope methodology. In addition, insulin sensitivity and secretion will be examined using glucose clamps combined with glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).


Options:
A: Glycemic Control (0 and 4 months)
B: Attendance (12 months); Recruitment rate (12 months); Retention rate (12 months); The appropriateness and practicality of the designed intervention in the proposed settings (12 months); The acceptability of the intervention by participants and willingness to participate (12 months); The assessment rate of questionnaires (12 months); The appropriateness of statistical methods of data analysis (12 months); Likely required sample size for the future pilot trial (12 months); The effect size will be calculated for loneliness (12 months); The effect size will be calculated for social support (12 months); The effect size will be calculated for social networks (12 months); The effect size will be calculated for depression (12 months); The effect size will be calculated for anxiety (12 months); The effect size will be calculated for self-efficacy for exercise (12 months); The effect size will be calculated for satisfaction with level of social contacts (12 months); The effect size will be calculated for expected outcomes and barriers for exercise (12 months)
C: Physical activity level (At the begining of the intervention and after 9 months.); Cardiovascular risk. (At the begining of the intervention and after 9 months); Biochemical analysis. (At the begining of the intervention and after 9 months.); Antropometric measurements. (At the begining of the intervention and after 9 months.); Frequency of food consumption (At the begining of the intervention and after 9 months.); Health related quality of life (At the begining of the intervention and after 9 months.)
D: To reduce risk factors related to metabolic syndrome

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Intracoronary Transplantation in Myocardial Infarction and Other Heart Diseases.
Brief Summary: The purpose of this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Heart failure patients underwent PCI treatment after AMI and with informed consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected; echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be reversed in heart failure patients.


Options:
A: Change in global left ventricular function (measured by quantitative left ventricular angiography)
B: Heart function (one year)
C: Change in global left ventricular function in quantitative LV angiography after 4 months. (baseline to 4 months)
D: Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year) (after 3 months and 1 year of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intradialytic Protein Supplementation & Exercise Training in Dialysis Patients.
Brief Summary: Chronic kidney disease (CKD) patients receiving hemodialysis treatment (CKD stage 5) suffer from a variety of co-morbid diseases, many of which may be mechanistically linked. Protein malnutrition, muscle catabolism and wasting are especially common, and these lead to reduced muscle strength, declines in physical function, and low levels of physical activity. Physical inactivity exacerbates these functional declines, and also promotes cardiovascular disease (CVD) and bone disorders. This cycle of disease and disability greatly reduces quality of life (QOL) and increases mortality rates in dialysis patients.

Many factors contribute to the development of these co-morbidities. Chronic inflammation is believed to be a cause and a consequence of the protein malnutrition, CVD and bone disorders in dialysis patients. In addition, abnormalities in mineral metabolism resulting from the deficit in kidney function promote the loss of mineral from bone and the deposition of mineral in the vasculature, a process termed vascular calcification (VC). VC is associated with a variety of CVD-related disorders, including arterial stiffness, increases in arterial wall intima-media thickness (IMT), left ventricular hypertrophy (LVH), and declines in cardiac function. As a result of these abnormalities, cardiovascular events are 10 to 30 times greater in dialysis patients than in age- and sex-matched subjects in the general population.


Options:
A: Serum albumin (Change from baseline serum albumin at 6 months of the study); Body mass index (BMI) (Change from BMI at 6 months of the study)
B: Examine the effects of intradialytic oral protein supplementation and exercise training on physical function. (12 months)
C: Mortality (Intervention discontinued on April 13, 2020 due to Covid-related prohibition on eating in facilities. Event follow-up concluded on August 13, 2020. Follow-up time varied among participants, with the maximum of approximately 3.5 years.)
D: Changes in beat-to-beat systolic blood pressure (Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double Blind, Placebo Controlled, Single IV Dose Parallel Efficacy and Safety Study of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder
Brief Summary: The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.


Options:
A: Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose (Last Observation Carried Forward [LOCF] Data): Double-blind (DB) Treatment Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2)); Change From Baseline in Clinical Global Impression-Severity of Suicidality - Revised (CGI-SS-R) Scale at 24 Hours Post First Dose (LOCF Data): DB Treatment Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2))
B: Change in depression score (14 days)
C: Hamilton Rating Scale for Depression - 6 Items (A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1, & 3)
D: Change in 24 item Hamilton Depression Rating Scale (HAMD) scores. Safety measures: UKU scale, vital signs assessments, laboratory parameters (SMA-20, CBC, UA) (6 weeks); Change in Hamilton Rating Scale for Anxiety (HAMA) scores. (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Phase. Cord Blood Serum in the Treatment of Ocular Surface Diseases
Brief Summary: Human autologous serum (AS) eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing, due to their growth factor (GF) content. Umbilical cord serum (UCS) contains even higher GF concentrations and the objective of the study was to prove whether UCS eye drops

1. are effective in the healing of corneal epithelial defects.
2. ameliorate the painful subjective symptoms


Options:
A: To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears. (5 weeks)
B: Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L (Single visit); Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm (Single visit); Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds (Single visit); Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 (Single visit); Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 (Single visit); Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 (Single visit); Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 (Single visit)
C: Corneal epithelial damage evaluated by fluorescein staining (micron meter squares) with digital photos (28 days treatment)
D: C Corneal fluorescein staining (up to 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
Brief Summary: Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most of the patients with fibromyalgia complain of either non-restorative sleep or complaints of disturbed sleep due to pain. The study aimed at examining the effects of milnacipran on sleep disturbance in patients with fibromyalgia. The study is a randomized, double-blind, placebo controlled, two way crossover polysomnography (PSG) study to explore the effects of milnacipran on sleep disturbance. Patients received either milnacipran 50 mg twice a day (BID) or matching placebo.


Options:
A: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)
B: Number of Awakenings After Sleep Onset (NAASO) (4-Week maintenance treatment with milnacipran and placebo); Sleep Efficiency (SE) (4-Week maintenance treatment with milnacipran and placebo); Wake After Sleep Onset (WASO) (4-Week maintenance treatment with milnacipran and placebo)
C: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
D: Change from baseline in the endpoint mean pain score (14 weeks); Fibromyalgia Impact Questionnaire (14 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
Brief Summary: Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most of the patients with fibromyalgia complain of either non-restorative sleep or complaints of disturbed sleep due to pain. The study aimed at examining the effects of milnacipran on sleep disturbance in patients with fibromyalgia. The study is a randomized, double-blind, placebo controlled, two way crossover polysomnography (PSG) study to explore the effects of milnacipran on sleep disturbance. Patients received either milnacipran 50 mg twice a day (BID) or matching placebo.


Options:
A: Number of Awakenings After Sleep Onset (NAASO) (4-Week maintenance treatment with milnacipran and placebo); Sleep Efficiency (SE) (4-Week maintenance treatment with milnacipran and placebo); Wake After Sleep Onset (WASO) (4-Week maintenance treatment with milnacipran and placebo)
B: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
C: Mean two-week sleep log estimate of post-treatment sleep continuity (An average of two-weeks post-treatment)
D: Percent days abstinent from alcohol (PDA) (12 and 24 weeks)

Answer: A