TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: 1/2-Multi-site Study: Varenicline Treatment of Alcohol Dependent Smokers
Brief Summary: The purpose of this study is to determine whether varenicline is effective in the treatment of alcohol dependence in smokers.


Options:
A: Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment (weeks 9-12); Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment (weeks 13-16); Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment (8 weeks)
B: The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks. (5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date)
C: Smoking abstinence (one year)
D: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh
Brief Summary: The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access to preventive as well as curative health services, and good prenatal care. The proposed research is on the possible options for providing a nutritious diet, realizing the constraints of poverty and food insecurity faced by care givers whose children are at risk of developing or confirmed to be suffering from moderate malnutrition. Even when people are not typically food insecure but consume a relatively monotonous diet with few good-quality foods, they also have to have options for dietary improvement, and especially the possibility of ready-to-use complementary food supplements (RUCFS) for young children. This proposed research on development of RUCFS will pave the way for programmatic considerations for expansion of the use of new complementary food supplements for preventing malnutrition among young children in Bangladesh.


Options:
A: Acceptability of at least one Ready -to-Use Complementary Food supplement (7 days)
B: Postpartum weight loss between delivery and 28 weeks (between delivery and 28 weeks); Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.) (birth to 28 weeks); Exclusive breastfeeding and breastfeeding cessation by 28 weeks (birth to 28 weeks)
C: Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age (After 24 months of program implementation); Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months) (monthly from study inclusion at 6 months to 23 months of age and at study endline); Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm (Monthly from study inclusion at 6 months to 23 months of age); Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted) (monthly from study inclusion at 6 months to 23 months of age and at study endline)
D: 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))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-based Pulmonary Rehabilitation in COPD
Brief Summary: Pulmonary rehabilitation consists of a multidisciplinary program of care for patients with chronic respiratory disease, which currently encompasses numerous features and physical training methods aimed at maintaining stability clinic for people with Chronic Obstructive Pulmonary Disease (COPD), especially in patients who, even with optimized clinical treatment, continue their decline and symptomatic physical functions and 8 so that these social. goals are achieved the patient with COPD should integrate into a program of RP assiduous and with accompanying several times per week, for several months, which for a number of factors is not always possible. For this reason, it is the research of methodology of RP that hold their effectiveness, but with greater flexibility and viability to people with COPD. On this basis, this study aims to investigate the effectiveness of a program of RP semi-domiciliar in which the patient suffering from COPD can receive guidance and training in person, to develop it partially in own domicile.


Options:
A: Combined number of hospitalizations and emergency department presentations (Two years)
B: The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records. (1 year)
C: Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR) (At baseline, after one year follow-up, and after two years follow-up)
D: Change from baseline of functional capacity and quality of life after Home-based rehab (After two months of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Interests of Strengthening Isokinetic Upper Extremity Hemiparetic Sequelae in Patients
Brief Summary: Stroke (CVA) is the leading cause of death and the leading cause of disability in developed countries as in developing countries (WHO, 2000). In the aftermath of a stroke, patients keep a permanent disability in 75% of cases and only one quarter of them is able to resume work. The post stroke sequelae are sensory-motor and cognitive.

According to literature data, 75-83% of patients who survive a stroke learn to walk only 25 to 45% recover use of their upper limb in activities of daily living (Friedman, 1990).

The existence of a phase called "plateau" in motor recovery after stroke has been suggested (Colautti, 2001). This would occur beyond the 4 th month and would correspond to a phase where the rehabilitation techniques used in the subacute phase are deemed less effective. Recently, Page (2004) speculated that this plateau phase is rather the consequence of adaptation to the type of patient follow-up training and not that of a limit to the possibilities of recovery. In an observational study on the recovery of upper limb conducted over a period of 4 years, Broeks (2004) showed a possible recovery beyond 16 weeks post stroke. The results of studies on different techniques for rehabilitation of chronic stroke patients tend to confirm the hypothesis of page. Therefore, varying the training parameters (type, intensity, frequency) could improve the functional capabilities of these patients, even at a distance of stroke.

Strength training is part of the management of hemiparetic patients. The results of several studies show an improvement in muscle strength and functional ability to walk after a building program isokinetic lower limb (Sharp, 1997).

The objective of our project is to evaluate the effectiveness of a building program of isokinetic muscle on the paretic limb motor recovery in hemiparetic patients over 6 months of a stroke.


Options:
A: Change in the Reintegration to Normal Living Index (RNL) from baseline (baseline, 12 weeks, 24 weeks)
B: Change from baseline in Cognitive Function at 3 months (Baseline, Month 3); Change from baseline in Functional Performance at 3 months (Baseline, Month 3); Change from baseline in Muscle Function at 3 months (Baseline, Month 3)
C: Aerobic capacity (Baseline,3month)
D: upper limb motor function (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 of Mom Power: Attachment Based Parenting and Self-Care Skills Program
Brief Summary: Mom Power is a weekly attachment based parenting program aimed to increase parenting and self-care skills for families.


Options:
A: Feasibility via recruitment rate (Screening to enrollment (Week 1)); Feasibility via retention rate (sessions completed/dropout rate) (Week 1 (NET Session 1) to Week 6 (NET Session 6)); Feasibility via retention rate (completion of follow-up questionnaires) (1 Week Post-treatment (Post-treatment Evaluation), 1 Month Post-treatment (Post-treatment Evaluation), 1 Month Post-partum (Follow-up Evaluation)); Acceptability of the NET intervention via participant satisfaction (1 Week Post-treatment (Post-treatment evaluation)); Acceptability of the NET intervention via participant expectancy (Week 1 (NET Session 1) , Week 2, Week 3, Week 4, Week 5, Week 6 (NET Sessions 6)); Acceptability of the NET intervention via perceived benefit (1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)); Acceptability of the NET intervention via qualitative feedback (Upon study completion (up to 10 months) or upon early withdrawal from intervention); Change in Symptoms of PTSD (Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation))
B: PTSD symptom severity (16 weeks)
C: PTSD Checklist (PCL-5) (1 Year); Generalized Anxiety Disorder (GAD-7) (1 Year); Patient Health Questionnaire (PHQ-9) (2 years); Brief Child Abuse Potential Inventory (BCAP) (1 Year); Working Model of the Child Interview (WMCI) (1 year); Infant Toddler Social-Emotional Assessment (ITSEA) (1 Year)
D: Psychopathology (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre Randomised Control Trial of Point-of-treatment (Clinic-based) Xpert MTB/RIF Assay
Brief Summary: Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. Xpert can detect TB genetic material in sputum samples as well as test for genetic resistance to rifampicin providing results within 2 hours. Xpert received WHO endorsement in December 2010. There is limited data on the impact of Xpert on time-to-treatment and TB-related patient morbidity in primary care clinics. No studies have yet evaluated Xpert performed at the point-of-treatment (POT) i.e. in primary care clinic location. The investigators hypothesize that one sputum GeneXpert MTB/RIF assay performed at the POT will improve time-to-diagnosis, time-to-treatment and TB related patient morbidity for patients with suspected TB presenting to primary level TB clinics in high HIV prevalent settings.


Options:
A: Retention in care with viral suppression (48 weeks after HIV testing)
B: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)
C: increase TB case detection (6 months)
D: Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis. (week 0); Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis. (week 0); Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. (week 0)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre Randomised Control Trial of Point-of-treatment (Clinic-based) Xpert MTB/RIF Assay
Brief Summary: Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. Xpert can detect TB genetic material in sputum samples as well as test for genetic resistance to rifampicin providing results within 2 hours. Xpert received WHO endorsement in December 2010. There is limited data on the impact of Xpert on time-to-treatment and TB-related patient morbidity in primary care clinics. No studies have yet evaluated Xpert performed at the point-of-treatment (POT) i.e. in primary care clinic location. The investigators hypothesize that one sputum GeneXpert MTB/RIF assay performed at the POT will improve time-to-diagnosis, time-to-treatment and TB related patient morbidity for patients with suspected TB presenting to primary level TB clinics in high HIV prevalent settings.


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: All-cause mortality (8 weeks)
C: All-cause mortality 12 weeks after inclusion (12 weeks)
D: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre Randomised Control Trial of Point-of-treatment (Clinic-based) Xpert MTB/RIF Assay
Brief Summary: Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. Xpert can detect TB genetic material in sputum samples as well as test for genetic resistance to rifampicin providing results within 2 hours. Xpert received WHO endorsement in December 2010. There is limited data on the impact of Xpert on time-to-treatment and TB-related patient morbidity in primary care clinics. No studies have yet evaluated Xpert performed at the point-of-treatment (POT) i.e. in primary care clinic location. The investigators hypothesize that one sputum GeneXpert MTB/RIF assay performed at the POT will improve time-to-diagnosis, time-to-treatment and TB related patient morbidity for patients with suspected TB presenting to primary level TB clinics in high HIV prevalent settings.


Options:
A: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)
B: Rates of TB treatment initiation (48 hours)
C: All-cause mortality (8 weeks)
D: Survival of newly-diagnosed HIV-infected patients at 1 year (4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre Randomised Control Trial of Point-of-treatment (Clinic-based) Xpert MTB/RIF Assay
Brief Summary: Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. Xpert can detect TB genetic material in sputum samples as well as test for genetic resistance to rifampicin providing results within 2 hours. Xpert received WHO endorsement in December 2010. There is limited data on the impact of Xpert on time-to-treatment and TB-related patient morbidity in primary care clinics. No studies have yet evaluated Xpert performed at the point-of-treatment (POT) i.e. in primary care clinic location. The investigators hypothesize that one sputum GeneXpert MTB/RIF assay performed at the POT will improve time-to-diagnosis, time-to-treatment and TB related patient morbidity for patients with suspected TB presenting to primary level TB clinics in high HIV prevalent settings.


Options:
A: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)
B: All-cause Mortality (6 months post-HAART initiation)
C: All-cause mortality (8 weeks)
D: All-cause mortality and incidence of invasive bacterial infections (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Eicosapentaenoic Acid (EPA)/ Docosahexaenoic Acid (DHA) Supplementation on Cognitive Control in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Brief Summary: Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD) receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary intervention. Cognitive control functions are measured with functional Magnetic Resonance Imaging (MRI) before and after the intervention. Behavioural change is monitored with behavioural scales.


Options:
A: Cognitive control task - functional MRI (change over 16 week intervention period (pre/post))
B: Seizure occurence (Measured between Weeks 1 and 4); Clinical administered scores on the ADHD Rating Scale IV Parent Version (Measured between Weeks 1 and 4)
C: Conners Rating Scale - School Version (change from baseline in conners raiting scale at 15 weeks)
D: Change in ADHD RS-IV total score (Baseline, month 4, and month 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes Mellitus and Moderate to Severe Renal Impairment
Brief Summary: This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of LX4211 following once daily oral administration in subjects with type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment.


Options:
A: Change from baseline in postprandial glucose (baseline to 7 days)
B: Change From Baseline in Hemoglobin A1 (A1C) at Week 24 (Baseline, Week 24)
C: Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) (From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).)
D: Adjusted Mean Change in HbA1c Levels (Baseline to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hemoglobin and Iron Recovery Study
Brief Summary: The purpose of this study is to investigate the effect of daily iron supplements after blood donation on time to recovery of hemoglobin and iron stores. The study will also determine whether the effect of iron supplements on time to recovery is different in men and women, in older vs. younger donors (\<60 years old vs. at least 60 years old) and in donors with replete vs. diminished pre-donation iron stores.


Options:
A: Time to recovery of hemoglobin after blood donation (Up to 24 weeks after blood donation)
B: Duration of diarrhea (within the first 72 hours during hospitalization)
C: Anemia (6 months following the start of the intervention)
D: gastrointestinal symptoms (14 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: How Can Health Care Help Female Breastcancer Patients Reduce Their Stress Symptoms? A Randomized Intervention Study With Stepped-care
Brief Summary: The purpose of this study within Caring sciences is to identify women with breast cancer who have stress symptoms and to offer these women appropriate care to reduce stress and increase well-being. This will be achieved by

1. Studying the prevalence of stress related symptoms in female patients with breast cancer
2. Testing the use of two short screening instruments to identify women at risk for developing long-standing stress symptoms
3. Studying the level and intensity of stress management interventions required to achieve increased well-being, using a stepped-care approach.
4. Studying the effects of interventions based on cognitive behavior therapy, delivered individually or in a group format.

The hypothesis is that half of the individuals assigned to a low intensity intervention will be significantly improved after treatment. For individuals who continue to have symptoms after low intensity treatment it is hypothesized that continued treatment in a group setting with high intensity interventions will be more cost-effective. In addition the assumption is that reduction of stress symptoms in women with breast cancer will lead to a reduction in socio-economic costs.


Options:
A: Psychosocial aspect (Changes in psychosocial aspects from baseline to 12 months post diagnosis)
B: Pain (From baseline until 6 months)
C: Stress (20 months)
D: Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality; Physical:cortisol levels (stress hormone)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial
Brief Summary: The objective of this study is to conduct a prospective randomized controlled trial of robotic-assisted versus conventional laparoscopy for the treatment of endometriosis.


Options:
A: postoperative pain measured by a 10 point numeric rating scale (around one week)
B: Number of harvested lymph nodes (2 years)
C: Operative Time (1st 24 hours)
D: Primary outcome: operative time from incision to closure. (Primary outcome: will be obtained immediately at the end of each procedure.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial
Brief Summary: The objective of this study is to conduct a prospective randomized controlled trial of robotic-assisted versus conventional laparoscopy for the treatment of endometriosis.


Options:
A: Operative Time (1st 24 hours)
B: Primary outcome: operative time from incision to closure. (Primary outcome: will be obtained immediately at the end of each procedure.)
C: Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy (6 Weeks)
D: Disease free survival (5 years from surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study
Brief Summary: The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.


Options:
A: Late lumen loss of vessel segment following dilatation after 6 months
B: Target Lesion Percent Stenosis (at 1 Year)
C: MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) (6 months)
D: angiographic binary restenosis (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Subsequent Healthcare Use Associated With Early Physical Therapy Access Compared With a Stepped Usual Care Approach for Treatment of Low Back Pain.
Brief Summary: The primary purpose of this study is to compare the effectiveness of two management strategies for patients with a recent onset of low back pain (LBP). One is based on usual care and the other is based on early access to physical therapy following a pragmatic treatment-based classification approach. The secondary purposes are to compare the subsequent healthcare utilization associated with two management strategies as well as to evaluate the importance of psychosocial factors on outcomes within both groups of treatment. The overall hypothesis guiding the study is that the additional initial treatment expense incurred by early implementation will result in superior short-term clinical effectiveness, and will be more cost-effective in the long-term due to reduced healthcare utilization. We will also explore the importance of psychosocial factors on outcomes within both treatment groups, which may provide insights for further improving treatment strategies.


Options:
A: Number of Days on Sick Leave (12 MONTHS)
B: Modified Oswestry Disability Index (12 months)
C: Muscle activity onset in transversus abdominal muscle (1 year)
D: Pain Scores (Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up)

Answer: B