TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study Of Pregabalin In The Treatment Of Fibromyalgia With Concurrent Antidepressant Therapy For Comorbid Depression (Protocol A0081275)
Brief Summary: The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.


Options:
A: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
B: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
C: Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.
D: Mean NRS Pain Score at End of Period. (End of each period, at Weeks 6 and 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Exercise Training on Endothelial Function, Inflammation, Arterial Stiffness and Autonomic Function in Coronary Artery Disease Patients
Brief Summary: The main purposes of this study is to analyze, in a randomized controlled trial, the effects of an exercise-based cardiac rehabilitation program (i) on biomarkers of endothelial function, (ii) on biomarkers of inflammation, (iii) on autonomic function, and (iv) on arterial stiffness in coronary artery disease patients (CAD). Additionally, the investigators aim to analyze the (v) contribution of age and the changes in traditional risk factors to the modification of the endothelial dysfunction and inflammation, and (vi) the contribution of the changes in inflammatory and endothelial function biomarkers to the modification of autonomic function and arterial stiffness.

The investigators hypothesize that exercise training will improve the autonomic function, arterial stiffness and mitigate the endothelial dysfunction and inflammation in CAD patients even in the absence of significant changes in traditional risk factors. Thus, the investigators expect with the present study to promote, develop and expand the knowledge in this field by assessing the impact of exercise on a pool of markers that provide a wide picture of the pathophysiological processes underlying CAD.


Options:
A: Change in VO2peak (day1); Change in VO2peak (month 2 + 14 days); Change in VO2peak (month 4 + 14 days)
B: Autonomic Function (Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program)
C: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke
D: Escore of combined risk factor control (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Timing of the Decision on Surgical Intervention for Buruli Ulcer Patients Treated With Rifampicin/Streptomycin
Brief Summary: SUMMARY

Rationale: Buruli ulcer, caused by Mycobacterium ulcerans, is an ulcerative disease endemic in West Africa. It often leads to functional limitations. Treatment was by extensive surgery, until in 2005 gradually antibiotic treatment for eight weeks with rifampicin and streptomycin was added. Observation of Buruli ulcer lesions of limited size during antibiotic treatment showed that during treatment there is a paradoxical increase of the lesion, with a decrease of the lesion after week 14. Current WHO protocols advise to decide whether surgery is needed four weeks after the start of antibiotics. This might be too early in the healing process. The investigators hypothesize that delay in surgery is safe, and that it results in a reduction of the number of surgical interventions.

Objectives:

Primary Objective of this study is to compare the need for surgical treatment in standard timing of surgery at the end of eight weeks antimicrobial treatment with a policy to postpone surgical treatment until week 14.

Secondary Objectives are to study whether postponing surgery leads to less extensive surgery and a change in frequency of functional limitations;

Study design:

Patients will be randomized for surgery at week 8 after start of antibiotic treatment and week 14 after start of treatment. Reasons for treating doctors to decide to intervene with surgery will be according to current clinical practice and will be clearly defined in this protocol. Standard care of eight weeks of rifampicin and streptomycin will be given. All patients will be followed and lesional size using acetate sheet recordings will be used during follow-up.

Study population: Patients with a clinical picture of Buruli ulcer disease confirmed by diagnostic tests in the districts covered by the Buruli ulcer centers in Lalo and Allada, Benin. Patients who are pregnant, have a contraindication for general anaesthesia and children below three years old will be excluded. 130 Patients in each treatment arm will be included to detect a difference in percentage of patients needing surgery of 20 percent.

Main study parameters/endpoints: Primary outcome measure is the number of patients healed without surgery. Secondary outcome measures are the extent of surgery by measurement of lesional size, functional limitations after the end of treatment and one year after the start of treatment and the duration of admission.


Options:
A: healing without recurrence and without debridement surgery at 12 months follow-up after start of treatment (12 months follow-up after start of treatment)
B: healing without recurrence and without excision surgery (12 months after start of treatment)
C: Unsatisfactory clinical outcome at week 96 after randomisation (96 weeks)
D: Healing without surgical intervention (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tuberculosis in HIV-infected Patients Managed in Health Centres in Ethiopia - Identification of a Screening Algorithm for Active Tuberculosis and Determination of Outcome of Combined Antituberculosis and Antiretroviral Treatment
Brief Summary: Background: Increased access to antiretroviral therapy (ART) in Africa will require decentralization to primary health care. For this purpose, adapted methods for management of patients co-infected with tuberculosis (TB) and HIV are needed. Improved detection of TB in patients starting ART, and assessment of co-administration of ART and TB treatment are priorities in this field.

Aims: To identify clinical predictors of TB in patients starting ART, and to construct screening algorithms for TB in this population; to assess ART outcomes in patients receiving TB treatment at health centre level.

Work plan: The project is performed in health centres providing ART in Ethiopia. A cohort of HIV positive patients initiating ART is prospectively followed. Baseline characteristics are registered; blood samples for CD4 cells, HIV RNA and immunological markers are collected, as well as sputum for TB culture and PCR. During ART, clinical data, CD4 cell counts and HIV RNA levels are followed. Patients with TB are compared to those without TB with regard to ART outcome. Baseline factors associated with TB will be used to construct TB screening algorithms.

Recruitment of the cohort was completed in March 2013; follow-up for determination of long term outcome of ART will be continued until 2016.

Significance: These studies give insight into TB-HIV co-infection at primary health care level in a Sub-Saharan region, and may impact future guidelines for management of such patients.


Options:
A: Time to TB treatment initiation (8 weeks follow up)
B: Retention in care with viral suppression (48 weeks after HIV testing)
C: Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis. (Two years); Comparison of ART outcome in patients taking concomitant anti-tuberculosis therapy and those only taking ART. (Three years)
D: Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy (2 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tuberculosis in HIV-infected Patients Managed in Health Centres in Ethiopia - Identification of a Screening Algorithm for Active Tuberculosis and Determination of Outcome of Combined Antituberculosis and Antiretroviral Treatment
Brief Summary: Background: Increased access to antiretroviral therapy (ART) in Africa will require decentralization to primary health care. For this purpose, adapted methods for management of patients co-infected with tuberculosis (TB) and HIV are needed. Improved detection of TB in patients starting ART, and assessment of co-administration of ART and TB treatment are priorities in this field.

Aims: To identify clinical predictors of TB in patients starting ART, and to construct screening algorithms for TB in this population; to assess ART outcomes in patients receiving TB treatment at health centre level.

Work plan: The project is performed in health centres providing ART in Ethiopia. A cohort of HIV positive patients initiating ART is prospectively followed. Baseline characteristics are registered; blood samples for CD4 cells, HIV RNA and immunological markers are collected, as well as sputum for TB culture and PCR. During ART, clinical data, CD4 cell counts and HIV RNA levels are followed. Patients with TB are compared to those without TB with regard to ART outcome. Baseline factors associated with TB will be used to construct TB screening algorithms.

Recruitment of the cohort was completed in March 2013; follow-up for determination of long term outcome of ART will be continued until 2016.

Significance: These studies give insight into TB-HIV co-infection at primary health care level in a Sub-Saharan region, and may impact future guidelines for management of such patients.


Options:
A: All-cause mortality 12 weeks after inclusion (12 weeks)
B: Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis. (Two years); Comparison of ART outcome in patients taking concomitant anti-tuberculosis therapy and those only taking ART. (Three years)
C: All-cause mortality (8 weeks)
D: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tuberculosis in HIV-infected Patients Managed in Health Centres in Ethiopia - Identification of a Screening Algorithm for Active Tuberculosis and Determination of Outcome of Combined Antituberculosis and Antiretroviral Treatment
Brief Summary: Background: Increased access to antiretroviral therapy (ART) in Africa will require decentralization to primary health care. For this purpose, adapted methods for management of patients co-infected with tuberculosis (TB) and HIV are needed. Improved detection of TB in patients starting ART, and assessment of co-administration of ART and TB treatment are priorities in this field.

Aims: To identify clinical predictors of TB in patients starting ART, and to construct screening algorithms for TB in this population; to assess ART outcomes in patients receiving TB treatment at health centre level.

Work plan: The project is performed in health centres providing ART in Ethiopia. A cohort of HIV positive patients initiating ART is prospectively followed. Baseline characteristics are registered; blood samples for CD4 cells, HIV RNA and immunological markers are collected, as well as sputum for TB culture and PCR. During ART, clinical data, CD4 cell counts and HIV RNA levels are followed. Patients with TB are compared to those without TB with regard to ART outcome. Baseline factors associated with TB will be used to construct TB screening algorithms.

Recruitment of the cohort was completed in March 2013; follow-up for determination of long term outcome of ART will be continued until 2016.

Significance: These studies give insight into TB-HIV co-infection at primary health care level in a Sub-Saharan region, and may impact future guidelines for management of such patients.


Options:
A: Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis. (Two years); Comparison of ART outcome in patients taking concomitant anti-tuberculosis therapy and those only taking ART. (Three years)
B: Time-to-treatment initiation (Up to 48 days after enrollment)
C: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)
D: Notification Rate Ratio (October 2012 (up to 2 years)); Costs Per Detected Case (October 2012 (up to 2 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maneuvers to Decrease Upper and Shoulder Pain After Gynecologic Laparoscopic Surgery
Brief Summary: Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. In some cases, it has been reported to last more than 72 hours after surgery.

The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to C4. Therefore, the investigators should try to do is that if the investigators could reduce carbon dioxide retention in the pelvic cavity.

This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.


Options:
A: Intensity of shoulder pain (48 hours after discharge)
B: The degree of shoulder pain after gynecologic laparoscopy (During the first 24hours after surgery; 1,6, 12, 24hr)
C: The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery (The first 48 hours after the surgery)
D: Shoulder Pain (within 14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy: A Randomized, Placebo-controlled, 2x2 Factorial, Double Blind Trial of Candesartan and Metoprolol
Brief Summary: Women treated for breast cancer are at increased risk for cardiovascular disease, including heart failure. In this study, by using magnetic resonance imaging (MRI), the investigators want to assess if heart failure medications such as beta blockers and angiotensin receptor blockers can prevent cardiac dysfunction during early breast cancer therapy.


Options:
A: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
B: Doubling of Interstitium or Any ESRD (Baseline to 5 years)
C: Postoperative Atrial Fibrillation (Measured from admission to the ICU until discharge from hospital)
D: Change in left ventricular ejection fraction, as assessed by cardiac MRI (Baseline and end of study (up to 72 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti
Brief Summary: The purpose of this quasi-experimental study is to evaluate the effectiveness of an infant feeding intervention in improving growth and anemia outcomes among HIV-exposed infants 6-12 months of age.


Options:
A: Change in prevalence of growth faltering during the intervention (end of intervention (approximately 12 months of age)); Change in prevalence of growth faltering post-intervention (Six-months post-intervention (approximately 18 months of age))
B: Weight gain during the 12-month follow-up (in grams)
C: child nutritional status (Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo)
D: Incidence of severe stunting (Length-for-age Z score < -3) (1 year after enrolment); Incidence of serious and non-serious adverse events (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants
Brief Summary: Premature babies are at risk for bleeding in their brains, which can result in developmental delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical cord immediately after birth is standard, but delaying this procedure allows more of the baby's blood to move from the placenta into the baby and prevents head bleeds. However, a delay in clamping the umbilical cord is not usually done in very premature babies, because it would delay their treatment and they could get cold. Milking the umbilical cord is another way to give premature babies more of their own blood while avoiding a delay in treatment. Umbilical cord milking has been shown to improve blood pressure, decrease the need for blood transfusions, and increase the amount of urine made in the first few days of life.


Options:
A: Superior Vena Cava Flow (6 hours)
B: Hematologic status at 6 months of age; Iron status at 6 months of age
C: Superior Vena Cava Flow (<12 hours of life)
D: Hemoglobin (8 months plus/minus one month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Breast Cancer and Exercise Trial in Alberta: The BETA Trial
Brief Summary: The Breast Cancer and Exercise Trial (BETA Trial) is a randomized controlled trial aimed at understanding what dose (or volume) of exercise will best reduce the risk for breast cancer, particularly among women who are between the ages of 50-74. The primary aim is to compare the effects of a high versus moderate volume exercise intervention on specific biological intermediate endpoints for breast cancer in a group of previously inactive postmenopausal women


Options:
A: Change in sitting time (During 7 days. Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention)); Change in minutes spent in sedentary behaviour (During 7 days. Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention)); Change in total activity counts per minute (During 7 days. Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention))
B: Body Fat (36 Months)
C: Energy Intake (Phase I and Phase II)
D: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
Brief Summary: Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of pain and disability among adults. Many adults with OA have significant pain and functional limitations, even though they receive some medical care for their OA. Efforts are needed to help adults improve OA-related outcomes. This study will examine three different approaches for helping adults manage their OA-related symptoms. The study will compare a patient-based intervention (involving exercise, weight management, and cognitive behavioral pain management), a provider-based intervention (involving provision of patient-specific recommendations for care, based on evidence-based guidelines), and a combination of the two interventions, relative to usual care among patients with hip and/or knee osteoarthritis. The interventions are relatively low cost and easy to disseminate, with the patient component being telephone based. This study will provide novel, valuable information of the effectiveness (and cost-effectiveness) of these three interventions in the context of real-world clinical settings.


Options:
A: Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) from Baseline to 12-months. (Baseline and 12-months); Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 18-months post Baseline. (post Baseline,18-months); Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 24-months post Baseline. (post Baseline, 24-months)
B: Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) (12-months)
C: EQ5D (At baseline and at follow-up after 6 months); Arthritis self-efficacy scale (At baseline and at follow up after 6 months); One-leg rising from sitting to standing (At baseline and at follow up after 6 months); Grip Ability Test (At baseline and at follow up after 6 months)
D: Pain (Baseline and 12-month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Blood Transfusion With Intravenous Iron in Gynecologic Cancer Patients Receiving Platinum Based Chemotherapy
Brief Summary: Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron?


Options:
A: Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP) (from week 5 to EOTP)
B: Red blood cell (RBC) transfusion rate (6 months)
C: Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP) (from week 5 to EOTP)
D: Progression-free Survival (PFS) Rate at 3 Years (Assessed every 3 months until progression up to 4 years and 8 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-label Clinical Investigation to Evaluate the Safety and Efficacy of Glucosanol in Maintaining Body Weight Loss in Overweight and Obese Subjects
Brief Summary: To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.


Options:
A: N/A
B: Body weight (24 weeks)
C: The primary outcome measure that will be used to test the study hypothesis is change in Body Mass Index (BMI). The mean change from baseline in individual BMIs between the two groups will be compared at two time-points; at week 52 and week 100.
D: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at 6 Months (Baseline and 6 months); Change From Baseline in Fibrinogen at 6 Months (Baseline and 6 months); Change From Baseline in Interleukin 6 (IL-6) at 6 Months (Baseline and 6 months); Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at 6 Months (Baseline and 6 months)

Answer: B