TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Recombinant Human Activated Factor VII as Salvage Therapy in Women With Severe Postpartum Hemorrhage
Brief Summary: The aim of this clinical research project is to evaluate the use of the recombinant human activated factor VII (rhFVIIa), given as a salvage therapy, in women with a dramatic postpartum hemorrhage still ongoing after all the currently available medical and surgical treatments. We are going to compare its early use, before elective surgery or arterial embolization, to its late use, after embolization or surgery, before salvage hysterectomy.


Options:
A: Clinical parameters: intensity of the hemorrhage, before and one hour after the end of the rhuFVIIa infusion (use of a graduated blood collector bag device). (1 hour); Any transfusion (number of units and volume) of red blood cells, platelet or fresh frozen plasma. Haemodynamics-related parameters (non-invasive arterial pressure,heart rate, diuresis,..). (7 Hours); Biological parameters:packed red cell volume, hemoglobin, etc. (12 hours); Therapeutic interventions aiming at controlling postpartum hemorrhage: selective arterial embolization, ligation of hypogastric arteries, hysterectomy. (Day 1)
B: Incidense of transfusion with allogenic blood products (During hospital stay or until 6 weeks postintervention)
C: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)
D: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Studies on Safety and Efficacy of Zinc-ORS Compared to ORS Alone in Hospitalized Children With Severe and Complicated Acute Diarrhea
Brief Summary: Three-hundred-and-fifty-two males aged 1-36 months with acute non-dysenteric diarrhoea and no systemic illness will be enrolled in this clinical trial. Eligible children will be stratified by their age (1up to 5 months, 6-35 months). Within the two age strata the patients will be randomized to receive zinc-ORS (fortified with 40 mg elemental zinc as zinc gluconate per litre) or standard WHO ORS. The major outcome measures will be stool output and duration of diarrhea. The safety of administering zinc will be determined by examining the effect of zinc ingestion on vomiting, sodium and potassium homeostasis, plasma zinc and copper, and iron stores and concentration of serum transferrin receptor.


Options:
A: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)
B: To evaluate innate and adaptive immune response.; Future occurrence of acute diarrhoea, ARI and impetigo.
C: Immune failure (For at least 6 months)
D: Stool output (g/kg/24h); Duration of diarrhoea (days).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Pregabalin for the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Brief Summary: The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.


Options:
A: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
B: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))
C: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score (6 weeks)
D: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
Brief Summary: We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks


Options:
A: Cohen-Mansfield (2 weeks)
B: Neuropsychiatric Inventory Nursing Home Version (Screening, Baseline, 1 month, 2 months, 3 months); Clinical Global Impression of Change (Baseline, 1 month, 2 months, 3 months)
C: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (Baseline to week 24); Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) (Week 24)
D: The primary outcome is safety as measured by adverse events, laboratory tests, vital signs, weight, physical exam and electrocardiogram

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
Brief Summary: We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks


Options:
A: N/A
B: Cohen-Mansfield Agitation Inventory - long form (CMAI) (CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12.)
C: NeuroBehavior Rating Scale-- Agitation (9 weeks); Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC) (Baseline to 9 weeks)
D: Cohen-Mansfield (2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
Brief Summary: We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks


Options:
A: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (Baseline to week 24); Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) (Week 24)
B: stride length by gait analysis with an optoelectronic system (VICON®) (3 months of treatment)
C: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
D: Cohen-Mansfield (2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Double-Blind Placebo Controlled Study on Influenza Vaccination in Prevention From Coronary Events in Patients With Coronary Artery Disease Confirmed by Angiography
Brief Summary: Background: Influenza vaccination is recommended in patients (pts) with cardiovascular disease, however there is a shortage of clinical studies proving its protective effect on clinical course of coronary artery disease (CAD). The aim of the study was to evaluate the effect of influenza vaccination on the incidence of coronary events in pts with CAD confirmed by coronary angiography.


Options:
A: Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. (After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))); Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups. (At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study)
B: 1.Variations in INR value and in OAT weekly dosage after IV
C: cardiovascular death (12 months)
D: Incidence ratio for acute MI (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% & 0.01% Atropine Treatment In Controlling Progression of Myopia In Children
Brief Summary: The purpose of this study is to find an optimal dose of atropine for preventing the rapid progression of myopia in children by comparing the efficacy, safety and functional impact of binocular treatment with 0.5%, 0.1% and 0.01% atropine and to develop a treatment regimen for the routine management of childhood myopia.


Options:
A: Spherical equivalent refraction determined by cycloplegic autorefraction
B: Myopia progression, measured by cycloplegic autorefraction (Every 6 months)
C: the progression of myopia degree, axial length elongation of eye
D: Cycloplegic autorefraction (Baseline, 6, 12, 18, and 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% & 0.01% Atropine Treatment In Controlling Progression of Myopia In Children
Brief Summary: The purpose of this study is to find an optimal dose of atropine for preventing the rapid progression of myopia in children by comparing the efficacy, safety and functional impact of binocular treatment with 0.5%, 0.1% and 0.01% atropine and to develop a treatment regimen for the routine management of childhood myopia.


Options:
A: N/A
B: Changes in Cycloplegic Autorefraction in One Year. (One year)
C: Changes in uncorrected visual acuity (Baseline, Month 6, Month 12)
D: Spherical equivalent refraction determined by cycloplegic autorefraction

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled Trial of D-Cycloserine and Exposure Therapy for Combat-PTSD
Brief Summary: The primary aim of this project is to examine whether administration of D-Cycloserine (DCS), a partial N-methyl-D-aspartate (NMDA) receptor agonist that has been shown to facilitate fear extinction, enhances the therapeutic benefit of exposure-based cognitive behavioral therapy (CBT) in OEF/OIF veterans with PTSD.


Options:
A: Snake Questionnaire (SNAQ) (2 weeks)
B: Clinician Administered PTSD Scale-IV (Pre Intervention); Clinician Administered PTSD Scale-IV (Post Intervention); Clinician Administered PTSD Scale-IV (3 month follow-up); Clinician Administered PTSD Scale-IV (6 month follow-up)
C: Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). (Baseline, Mid-Treatment, Post-treatment)
D: Acrophobia Questionnaire With Avoidance (AAVQ) (2 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: To Compare the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
Brief Summary: The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.


Options:
A: To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ,Ⅴ, Ⅲ+Ⅴand Ⅳ+Ⅴ LN. (24 weeks)
B: Induction Phase: Number of Patients Showing Treatment Response (24 weeks); Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval (From the start of the Maintenance Phase to Month 36)
C: remission rate (month 6)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Patients With Chronic Critical Limb Ischemia: a Randomized, Placebo-controlled Clinical Trial
Brief Summary: The purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and to relate the stem cell function with clinical outcome.


Options:
A: N/A
B: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)
C: Angiographic evaluation of angiogenesis and vasculogenesis at target limb (3 months)
D: major amputation (six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Patients With Chronic Critical Limb Ischemia: a Randomized, Placebo-controlled Clinical Trial
Brief Summary: The purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and to relate the stem cell function with clinical outcome.


Options:
A: major amputation (six months)
B: Ankle brachial index (6 months)
C: Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months (Baseline, 3 months)
D: Survival without major amputation (6 months after implantation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PDA+: A Personal Digital Assistant for Obesity Treatment
Brief Summary: The purpose of this study is to determine whether including a PDA decision support tool plus distance support enhances the outcomes attainable by the MOVE2! (Managing Obesity for Veterans Everywhere) standard care alone. Primary hypotheses are that obese patients with chronic pain who are randomized to MOVE2! + PDA + Support will a) lose more weight by 6 months, b) show greater maintenance of weight loss at 12 months, and c) display greater reduction in pain intensity and pain-related disability than those randomized to Standard Care. Secondary hypotheses are that MOVE2! + PDA + Support, compared to Standard Care will result in: a) improved quality of life, b) greater treatment adherence, and c) reduced care utilization.


Options:
A: Percentage of Days App Used Over 12 Weeks (12 weeks); Usability (12 weeks); Acceptability (12 weeks); Burden (12 weeks)
B: Weight loss (3 months, 6 months, 12 months)
C: Change in Body Mass Index z-score (youth) (Baseline, 3 months, 6 months); Change in health behaviour knowledge (youth) (Baseline, 3 months, 6 months); Change in objective dietary behaviour (youth) (Baseline, 3 months, 6 months); Change in number of daily steps (youth) (Baseline, 3 months, 6 months); Change in screen behaviour (youth) (Baseline, 3 months, 6 months)
D: Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I) (baseline, 3, 6, 9, and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: PDA+: A Personal Digital Assistant for Obesity Treatment
Brief Summary: The purpose of this study is to determine whether including a PDA decision support tool plus distance support enhances the outcomes attainable by the MOVE2! (Managing Obesity for Veterans Everywhere) standard care alone. Primary hypotheses are that obese patients with chronic pain who are randomized to MOVE2! + PDA + Support will a) lose more weight by 6 months, b) show greater maintenance of weight loss at 12 months, and c) display greater reduction in pain intensity and pain-related disability than those randomized to Standard Care. Secondary hypotheses are that MOVE2! + PDA + Support, compared to Standard Care will result in: a) improved quality of life, b) greater treatment adherence, and c) reduced care utilization.


Options:
A: Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I) (baseline, 3, 6, 9, and 12 months)
B: Difference in Number of Patients Who Reached Target Blood Pressure (6 months); Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months (baseline and 6 months)
C: Feasibility (7 months)
D: Comparison of HbA1c mean between the 3 groups (at 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extending HIV Care Beyond the Rural Health Center
Brief Summary: The objective of this application is to develop and assess a system which uses non-clinician extenders to provide selected aspects of HIV care in rural western Kenya. The plan is to train persons living with HIV/AIDS (PLWAs) to undertake this role as Community Care Coordinators. Our central hypothesis, is that PLWAs can be effective members of the health care team and that their involvement in community-based HIV care will facilitate patient access to services and improve outcomes. As such our two specific aims are: 1) To develop a sustainable system to extend HIV care into the community and to train the individuals necessary to support such a system (Community Care Coordinators). 2) To determine the impact of Community Care Coordinators on patient adherence (to drugs and to clinic visits), clinical outcomes (i.e. viral load responses \[an individuals level of circulating HIV virus\], inter-current opportunistic infections, hospitalization, drop out from the program, change to second line therapy and mortality) and patient perception of stigma. This study will provide invaluable data on the use of non-clinician care extenders for providing HIV care in resource poor settings. As such, knowledge gained from this study will assist in developing a model for non-clinician centered HIV care systems elsewhere in sub-Saharan Africa.


Options:
A: Lost to Follow-up (12 months)
B: Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm). (96 weeks)
C: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study); All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study)
D: Virologic suppression at 6 months (6 months); Virologic failure at all time intervals from ART initiation (these primary outcomes added to expanded trial protocol November 2007) (Typically every 24 weeks); Adherence measured by pill counts (this primary outcome added to expanded trial protocol November 2007) (Typically weekly to monthly)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extending HIV Care Beyond the Rural Health Center
Brief Summary: The objective of this application is to develop and assess a system which uses non-clinician extenders to provide selected aspects of HIV care in rural western Kenya. The plan is to train persons living with HIV/AIDS (PLWAs) to undertake this role as Community Care Coordinators. Our central hypothesis, is that PLWAs can be effective members of the health care team and that their involvement in community-based HIV care will facilitate patient access to services and improve outcomes. As such our two specific aims are: 1) To develop a sustainable system to extend HIV care into the community and to train the individuals necessary to support such a system (Community Care Coordinators). 2) To determine the impact of Community Care Coordinators on patient adherence (to drugs and to clinic visits), clinical outcomes (i.e. viral load responses \[an individuals level of circulating HIV virus\], inter-current opportunistic infections, hospitalization, drop out from the program, change to second line therapy and mortality) and patient perception of stigma. This study will provide invaluable data on the use of non-clinician care extenders for providing HIV care in resource poor settings. As such, knowledge gained from this study will assist in developing a model for non-clinician centered HIV care systems elsewhere in sub-Saharan Africa.


Options:
A: Blood glucose control with changes in Glycated hemoglobin (HbA1c) values (At the baseline and at the end of the intervention (3 months))
B: Clinician Detection (probable, sub-clinical, confirmed) of major depression or generalized anxiety or post-traumatic stress disorder or alcohol dependence (Day 1); Patient discussion on mental health (Day 1)
C: Lost to Follow-up (12 months)
D: healing time for leg ulcer and/or diabetes related foot ulcer (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Manualized Treatment for Veterans With Military Sexual Trauma
Brief Summary: The purpose of this study is to evaluate the effectiveness of Cognitive Processing Therapy (CPT) versus Present-Centered Therapy (PCT) in treating current post-traumatic stress symptoms associated with sexual assault that occurred while veterans were serving in the military.


Options:
A: Clinician Assessed Severity of PTSD (Baseline, 16, 24 and 32 weeks)
B: Alcohol Use Interview (Past month); Alcohol Use Self-Report (Past month); Posttraumatic Stress Disorder Severity (PTSD) Interview (Past two weeks); Posttraumatic Stress Disorder Severity (PTSD) Self-Report (Past two weeks)
C: Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores (2 weeks post-treatment)
D: PTSD Checklist (PCL) (Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Manualized Treatment for Veterans With Military Sexual Trauma
Brief Summary: The purpose of this study is to evaluate the effectiveness of Cognitive Processing Therapy (CPT) versus Present-Centered Therapy (PCT) in treating current post-traumatic stress symptoms associated with sexual assault that occurred while veterans were serving in the military.


Options:
A: summing totals of 17 DSM-IV symptoms (10 weeks)
B: PTSD Checklist (PCL) (Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment)
C: Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment (Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE)
D: Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) (Baseline, weekly during treatment, posttreatment, 6-month and 12-month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Manualized Treatment for Veterans With Military Sexual Trauma
Brief Summary: The purpose of this study is to evaluate the effectiveness of Cognitive Processing Therapy (CPT) versus Present-Centered Therapy (PCT) in treating current post-traumatic stress symptoms associated with sexual assault that occurred while veterans were serving in the military.


Options:
A: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
B: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
C: condom use (4.5 months)
D: PTSD Checklist (PCL) (Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment)

Answer: D