TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE
Brief Summary: To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting.


Options:
A: Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays (1 year); Completion of Screening Protocol in Both Trial Arms (1 year); Discontinuation of Contact Precautions in Both Trial Arms (1 year)
B: N/A
C: Number of ICU Patients Who Acquire VRE or MRSA (9 months)
D: Bacterial colony counts and the frequency with which methicillin-resistant Staphylococcus aureus was found over time (8 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE
Brief Summary: To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting.


Options:
A: Clinical: Primary blood stream infections and culture negative sepsis (Six Months); Microbiologic: Skin colonization from environment and endotracheal secretions (Six Months)
B: The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing (7 days after recieved 2% chlorhexidine wipes)
C: Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tennessee Connections for Better Birth Outcomes
Brief Summary: Women with a history of a prior preterm birth (PTB) have a high probability of a recurrent preterm birth. Some risk factors and health behaviors that contribute to PTB may be amenable to intervention. Home visitation is a promising method to deliver evidence based interventions. We evaluated a system of care designed to reduce preterm births and hospital length of stay in a sample of pregnant women with a history of a PTB. All participants (N = 211) received standard prenatal care. Intervention participants (N = 109) also received home visits by certified nurse-midwives guided by protocols for specific risk factors (e.g., depressive symptoms, abuse, smoking). Data was collected via multiple methods and sources including intervention fidelity assessments. Average age was 27.6 years. Racial breakdown mirrored local demographics. Most women had a partner, a high school education, and Medicaid. Enhanced prenatal care by nurse-midwife home visits may limit some risk factors and shorten intrapartum length of stay for women with a prior PTB. This study contributes to knowledge about evidence-based home visit interventions directed at risk factors associated with PTB.


Options:
A: Reduction in perinatal and neonatal mortality (3 years)
B: Mean change in Edinburgh Postpartum Depression Scale (EPDS) Scores from baseline to post intervention and 1-month follow-up (Post-treatment and 1-month follow-up and an equivalent time frame for the TAU group)
C: Sexual behavior risk (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Lab tested STDs (Measured at 3rd trimester); Rapid repeat pregnancy (Measured at Months 6 and 12 postpartum); Low birthweight (Measured at delivery); Preterm labor (Measured at delivery); Breastfeeding (Measured at Months 6 and 12 postpartum)
D: Infant Gestational Age (Time of delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
Brief Summary: This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Options:
A: Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip (One Year (at baseline and one year))
B: Change in degree of arterial stiffness measured by pulse wave velocity (18 months); Changes in vascular calcification on CT scans of superficial femoral artery and aorta (18 months)
C: Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) (Baseline and 9 months)
D: extent of aortic and coronary artery calcification with and without the use of alendronate; bone mineral density with and without the use of alendronate

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Perspectives and Testing Uptake With Abbreviated Versus Standard HIV Consenting in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial
Brief Summary: The purpose of the study is to determine whether an abbreviated pretest/post-test CDC recommended counseling is as equally acceptable to prenatal patients as the standard strategy using prenatal care nurses and medical providers at San Francisco General Hospital \[SFGH\]).


Options:
A: Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale) (same day as HIV test counseling (cross-sectional study))
B: Hopkins Symptom Checklist-25 (HSCL-25) (Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment)
C: Percentage of Cancer Screening Tests Completed - Intention to Treat (8 months); Percentage of Cancer Screening Tests Completed - As Treated (8 Months)
D: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Perspectives and Testing Uptake With Abbreviated Versus Standard HIV Consenting in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial
Brief Summary: The purpose of the study is to determine whether an abbreviated pretest/post-test CDC recommended counseling is as equally acceptable to prenatal patients as the standard strategy using prenatal care nurses and medical providers at San Francisco General Hospital \[SFGH\]).


Options:
A: Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale) (same day as HIV test counseling (cross-sectional study))
B: Change from baseline in asthma knowledge at 2 months, measured by QCALF score (Visit 1 (baseline) and visit 2 (2-month follow-up)); Change from baseline in decisional conflict at 2 months, measured by DCS score (Visit 1 (baseline) and visit 2 (2-month follow-up))
C: Contraceptive Continuation (4 and 7 months post-enrollment)
D: Reach of Intervention (Baseline 2 (post-education: average 3 days after enrollment)); Effectiveness of Intervention: Knowledge (Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)); Adoption of Intervention (At time of intervention phase start); Implementation of Intervention (Baseline 2 (post-education: average 3 days after enrollment)); Maintenance of Intervention (6 months after study enrollment end date); Effectiveness of Intervention: Values-Choice Concordance (Baseline 1 (enrollment) and 1 Month Follow-Up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II,Multicenter,Randomized,Double-blind,Cross-over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-induced Nausea and Vomiting in Asian Population
Brief Summary: The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.


Options:
A: Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen (0 to 120 hours in the first cycle of chemotherapy)
B: Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting) (0-24h, 24-120h , 0-120h following chemotherapy)
C: Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy. (120 hours); Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen (120 hours)
D: To compare fosaprepitant dimeglumine, palonosetron, and dexamethasone with palonosetron, dexamethasone, and placebo with respect to efficacy; the proportion of subjects with no vomiting during five weeks of radiotherapy and concomitant weekly cisplatin. (35 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Effect of Insulin Detemir Versus Insulin NPH Both With Insulin Aspart on Weight Change in Overweight and Obese Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Europe. The purpose of the trial is to investigate the effect of insulin detemir on weight change in overweight and obese patients with type 2 diabetes.


Options:
A: 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))
B: The change in liver fat content and visceral fat mass (After 26 weeks of treatment)
C: Body weight loss (after 26 weeks of treatment)
D: Difference in A1c Levels (baseline and 24 weeks); Number of Hypoglycemic Events (between 1rst and 24 weeks of each treatment arm)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Effect of Insulin Detemir Versus Insulin NPH Both With Insulin Aspart on Weight Change in Overweight and Obese Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Europe. The purpose of the trial is to investigate the effect of insulin detemir on weight change in overweight and obese patients with type 2 diabetes.


Options:
A: Change in HbA1c (percentage %) (Baseline to 6 months)
B: Body weight loss (after 26 weeks of treatment)
C: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization: A Randomized Clinical Trial
Brief Summary: Recently a clinical prediction rule (CPR) has been developed that identifies patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust manipulation and an active range of motion exercise. Although the initial predictor variables identified during the development of a thoracic spine manipulation CPR seem to have adequate face validity, there is no guarantee that these factors will persist in a different group of patients, even ones with similar characteristics as those used in the initial exploratory study. The purpose of this follow-up study in which patients will be randomly assigned to receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic exercise alone will be to investigate the validity of the previously developed CPR. If the CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine thrust manipulation should experience improved outcomes compared to patients who are negative on the CPR and receive thoracic spine manipulation, and compared to patients who are positive on the CPR but receive the intervention believed to be effective for another subgroup of patients with neck pain.


Options:
A: Patient-rated pain (0-11 box scale) (short term = 12 weeks; long term = 52 weeks)
B: Patient-rated pain (0-10 scale, 11 box) (short term = 12 weeks; long term = 52 weeks)
C: Neck Disability Index (4 weeks, 6 months)
D: Neck Pain (Up to 10 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization: A Randomized Clinical Trial
Brief Summary: Recently a clinical prediction rule (CPR) has been developed that identifies patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust manipulation and an active range of motion exercise. Although the initial predictor variables identified during the development of a thoracic spine manipulation CPR seem to have adequate face validity, there is no guarantee that these factors will persist in a different group of patients, even ones with similar characteristics as those used in the initial exploratory study. The purpose of this follow-up study in which patients will be randomly assigned to receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic exercise alone will be to investigate the validity of the previously developed CPR. If the CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine thrust manipulation should experience improved outcomes compared to patients who are negative on the CPR and receive thoracic spine manipulation, and compared to patients who are positive on the CPR but receive the intervention believed to be effective for another subgroup of patients with neck pain.


Options:
A: Reduction in number of days per month with headache and shoulders pain after 6 months.Proportion of subjects with more than 4 days with headache and shoulder pain at the baseline that will have reduction in pain frequency of more than 50%, after 6 months (6 months)
B: Neck Disability Index (4 weeks, 6 months)
C: Neck Pain (Up to 10 months)
D: Neck/shoulder pain (December 2010)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Multi-Center, Double-Blind, Randomized, Parallel-Group Study, Followed by a 12 Month Extension Study, of the Efficacy and Safety of LCP-AtorFen in Subjects With Dyslipidemia
Brief Summary: The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.


Options:
A: Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment. (8 weeks)
B: Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 (Baseline (Week 6), Week 12)
C: Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels. (16 weeks)
D: Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy (baseline(randomization) to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Study: Evaluation of the Safety and Efficacy of Brivaracetam in Subjects (≥ 16 to 70 Years Old) Suffering From Localization-related or Generalized Epilepsy.
Brief Summary: This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.


Options:
A: Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication (During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2))
B: Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period (Week 2 to the end of the Treatment Period (Week 16)); Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period (Baseline (Week 0) to the end of the Treatment Period (Week 16))
C: Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (12 week Treatment Period); 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (Baseline to 12 week Treatment Period)
D: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) (From Entry Visit (Month 0) until the Last Visit (up to 84 months)); Percentage of Participants Who Withdrew Due to Adverse Events (AEs) (From Entry Visit (Month 0) until the Last Visit (up to 84 months)); Percentage of Participants With at Least One Serious Adverse Event (SAE) (From Entry Visit (Month 0) until the Last Visit (up to 84 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Study: Evaluation of the Safety and Efficacy of Brivaracetam in Subjects (≥ 16 to 70 Years Old) Suffering From Localization-related or Generalized Epilepsy.
Brief Summary: This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.


Options:
A: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (From Baseline to 12-week Treatment Period)
B: Partial onset seizure frequency (Type I) per week over the 7-week maintenance period (7-week maintenance period)
C: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (Baseline to 12-week Treatment Period)
D: Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period (Week 2 to the end of the Treatment Period (Week 16)); Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period (Baseline (Week 0) to the end of the Treatment Period (Week 16))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-blind-placebo-controlled and Open-label-Sevelamer Hydrochloride-controlled, Dose-ranging Study for ASP1585 in Patients With Chronic Kidney Disease(CKD) and Hyperphosphatemia on Hemodialysis
Brief Summary: To evaluate the superiority to placebo, dose-responsibility and safety.


Options:
A: Change in serum phosphorus (4 weeks)
B: FGF23 serum level (Change over 2 weeks of treatment)
C: serum phosphorus (change from baseline to mean during 2 weeks active therapy)
D: Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) (4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MK-0777 for the Treatment of Cognitive Impairments in Patients With Schizophrenia
Brief Summary: Patients with schizophrenia are characterized by a broad range of neurocognitive abnormalities. These include impairments in attention, including abnormalities in sensory gating; executive function; visual and verbal learning and memory; working memory; processing speed; and social cognition (Nuechterlein et al, 2004). These impairments are major determinants of poor functional outcome in patients with schizophrenia (Green, 1996; Green et al, 2004). Conventional antipsychotics have limited effects on these impairments. Second generation antipsychotics may have modest benefits for cognitive function, but whether this represents a direct cognitive enhancing effect has not been established. Regardless, patients continue to exhibit pronounced cognitive impairments despite adequate second generation antipsychotic treatment. Adjunctive pharmacotherapy may offer a viable approach for the treatment of cognitive impairments. Adjunctive agents can be used to modulate specific neurotransmitter systems that are hypothesized to be involved in the pharmacology of cognitive functions.

The standard of care for schizophrenia is antipsychotic medications to treat psychotic symptoms. However, cognitive impairments remain and these impairments have been found to be significantly associated with the poor psychosocial function observed in patients with schizophrenia. There is a considerable preclinical rationale for the use of drugs that act at the Gamma-amino-buyric acid (GABA) α2 subunit as adjunctive treatments to target cognitive impairments. MK-0777 GEM (Merck-0777 Gel Extrusion Module) formulation provides an opportunity to directly test this mechanism.

The purpose of the proposed study is to examine the efficacy and safety of two doses of MK (Merck) -0777 GEM, 3 mg BID (twice daily) and 8 mg BID (twice daily), in the treatment of cognitive impairments in patients with schizophrenia. Secondary goals are to determine whether MK-0777 has beneficial effects on measures of functional capacity and patient self-report of cognitive function.


Options:
A: To determine if a mGlu2/3 agonist (LY2140023) dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score (28 days)
B: Composite MATRICS Consensus Cognitive Battery Score (4 weeks)
C: Positive and Negative Syndrome Scale (PANSS) total score (over 4 weeks of treatment)
D: The change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Memantine Versus Donepezil in Mild to Moderate Alzheimer's Disease. A Randomized Trial With Magnetic Resonance Spectroscopy.
Brief Summary: It is well known that in the brain of the patients with Alzheimer's disease there is a glutamatergic hyperstimulation leading to neuronal death. Memantine is a low affinity antagonist of NMDA glutamate receptors. The use of this drug in the early phases of the disease could provide neuroprotective effects and delay of progression. The effects of memantine should be compared to those of donepezil, which is the most prescribed anticholinesterase drug.


Options:
A: Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. (6 months)
B: Cohen Mansfield Agitation Inventory
C: Change From Baseline to Week 24 in SIB Total Score (Baseline and Week 24); Overall Change From Baseline in Modified CIBIC+ to Week 24 (Baseline and Week 24)
D: Change in cognition and function after 24 weeks.

Answer: A