TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individuals 65 and Over With Chronic Mechanical Low Back Pain
Brief Summary: The purpose of this randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.


Options:
A: Five Times Sit-to-stand (5XSTS) (Change from Baseline sit-to-stand at 3 and 6 months)
B: Patient-rated pain (0-11 box scale) (short term = 12 weeks; long term = 52 weeks)
C: Pain Intensity (5 weeks after randomization); Disability (Five weeks after randomization)
D: Change in pain Intensity (Baseline and 6 weeks after beginning treatment.); Change in functional disability (Baseline and 6 weeks after beginning treatment.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individuals 65 and Over With Chronic Mechanical Low Back Pain
Brief Summary: The purpose of this randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.


Options:
A: N/A
B: Manual Examination of the Cervical Spine; Pressure algometry; Thermal stimulation; Perceived effect; HIT-6
C: Global Perceived Effect (GPE), Neck disability index (NDI-DV ) (0-3-7-13-26-52 weeks)
D: Patient-rated pain (0-11 box scale) (short term = 12 weeks; long term = 52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Manipulation, Exercise, and Self-Care for Low Back Pain
Brief Summary: The broad, long term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and to increase our understanding of this important condition. The primary aim is to examine the relative efficacy of chiropractic spinal manipulation, rehabilitative exercise, and self-care education in terms of patient-rated outcomes in the short and long term for non-acute low back pain.


Options:
A: Timed Get-Up-And Go (Change from baseline to 12-week follow-up); PROMIS Health Assessment Questionnaire (Change from baseline to 12-week follow-up)
B: Pain (12 months); Disability (12 months)
C: Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
D: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Manipulation, Exercise, and Self-Care for Low Back Pain
Brief Summary: The broad, long term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and to increase our understanding of this important condition. The primary aim is to examine the relative efficacy of chiropractic spinal manipulation, rehabilitative exercise, and self-care education in terms of patient-rated outcomes in the short and long term for non-acute low back pain.


Options:
A: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)
B: Pain (visual analogical scale and McGill pain questionnaire) (Six weeks); Functional disability (Oswestry disability questionnaire) (Six weeks); TrA muscle activation capacity (Pressure Biofeedback Unit = PBU) (Six weeks)
C: Selfrated function, symptoms and pain-rating (8 weeks, 6 month, 12 month)
D: Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Manipulation, Exercise, and Self-Care for Low Back Pain
Brief Summary: The broad, long term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and to increase our understanding of this important condition. The primary aim is to examine the relative efficacy of chiropractic spinal manipulation, rehabilitative exercise, and self-care education in terms of patient-rated outcomes in the short and long term for non-acute low back pain.


Options:
A: Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
B: Pain (6 weeks); Functional Disability (6 weeks)
C: Muscle activity onset in transversus abdominal muscle (1 year)
D: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Manipulation, Exercise, and Self-Care for Neck Pain
Brief Summary: The purpose of this study is to compare three treatments for neck pain: 1) rehabilitative exercise, 2) chiropractic spinal manipulation combined with rehabilitative exercise, and 3) self-care education.


Options:
A: Global Perceived Effect (GPE), Neck disability index (NDI-DV ) (0-3-7-13-26-52 weeks)
B: Neck Pain (Up to 10 months)
C: Patient rated pain(0-10 scale,11 box) (short term = 12 weeks; long term = 52 weeks)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease
Brief Summary: This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.


Options:
A: Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline (12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w)
B: Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12 (Baseline and Week 12)
C: Canadian Occupational Performance Measure (COPM) (3 months)
D: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease
Brief Summary: This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.


Options:
A: secondary influenza infection (7 days)
B: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (24 weeks)
C: To characterize the pharmacokinetics of amantadine following twice daily administration alone or in combination with twice daily oseltamivir in healthy volunteers.; To characterize the pharmacokinetics of oseltamivir following twice daily administration alone or in combination with twice daily amantadine in healthy volunteers.
D: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days
Brief Summary: This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%


Options:
A: Rate of successful abortion (2 weeks after mifepristone administration)
B: successful menstrual regulation without the need for a surgical evacuation (14 days)
C: Proportion of women who select home-use of mifepristone (1-2 weeks); Satisfaction with Method (1-2 weeks)
D: complete abortion rate (5 weeks after treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days
Brief Summary: This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%


Options:
A: complete abortion rate (5 weeks after treatment)
B: Complete abortion (14 days)
C: Number of surgical evacuation in each group (during de study)
D: feasibility (3 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, Multicenter Trial to Evaluate Continuation Rates, Side Effects and Acceptability of NuvaRing Versus OrthoEvra
Brief Summary: This is an open-label prospective, multicenter, randomized trial to compare continuation rates into the fourth cycle of women using either the NuvaRing or OrthoEvra. Five hundred women will be recruited at 9 centers nationwide to be randomly assigned to use either the NuvaRing or OrthoEvra for four months. Women must either be on the pill or have recently stopped the pill and be relatively satisfied with oral contraceptive use to qualify for enrollment. Two visits and two phone calls will be required.


Options:
A: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
B: Adherence Rate (Rate of Perfect Method Use) (For the first 3 months)
C: N/A
D: continuation into the fourth cycle (four months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Safety and Effectiveness of OROS (Methylphenidate HCl) in Children With ADHD
Brief Summary: The purpose of this study is to evaluate the long-term safety and effectiveness of OROSÂ® Methylphenidate HCl (a central nervous system stimulant) in children with attention deficit hyperactivity disorder (ADHD).


Options:
A: Psychopathology: improvement on PANSS positive scale (PANSS 'Positive and Negative Syndrome Scale') (12 weeks)
B: Executive function test (seven to ten weeks)
C: Incidence of adverse events; Changes in physical examinations, clinical laboratory tests, vital signs, sleep quality, appetite, and tics
D: Cigarette Smoking (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lopinavir/Ritonavir/Combivir vs. Abacavir/Zidovudine/Lamivudine for Virologic Efficacy and the Prevention of Mother-to-Child HIV Transmission Among Breastfeeding Women With CD4 Counts Greater Than or Equal to 200 Cells/mm3 in Botswana
Brief Summary: Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child transmission (MTCT) of HIV in developed countries. However, little is known of the effectiveness of such regimens in developing countries, such as Botswana. This study will determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV) is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected pregnant women in Botswana.


Options:
A: The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint. (48 Weeks)
B: HIV PCR (1 month)
C: Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.
D: Number of Participants With Virologic Suppression (Throughout study, including breastfeeding, assessed up to 24 months); Number of HIV+ Infants (Throughout study, including breastfeeding, assessed up to 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lopinavir/Ritonavir/Combivir vs. Abacavir/Zidovudine/Lamivudine for Virologic Efficacy and the Prevention of Mother-to-Child HIV Transmission Among Breastfeeding Women With CD4 Counts Greater Than or Equal to 200 Cells/mm3 in Botswana
Brief Summary: Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child transmission (MTCT) of HIV in developed countries. However, little is known of the effectiveness of such regimens in developing countries, such as Botswana. This study will determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV) is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected pregnant women in Botswana.


Options:
A: 1. To estimate the cumulative risk of infant infection at 6 weeks, 9 months, and 18 months of age among breast fed infants. The anticipated outcome is a transmission rate of <6% at 6 weeks and <8% at 18 months of age. (6 weeks, 9 months, 18 months)
B: HIV infection detected by 4 months among children with no evidence of HIV infection at birth. (24 months of age); Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
C: Rate of HIV infection in infants born to study participants in each arm of the study (At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18); Safety and tolerance of HIVIGLOB given to pregnant women at 36-37 weeks gestation and neonates at birth in combination with NVP and of NVP alone (Throughout study)
D: Number of Participants With Virologic Suppression (Throughout study, including breastfeeding, assessed up to 24 months); Number of HIV+ Infants (Throughout study, including breastfeeding, assessed up to 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms. A Randomised Controlled Trial Against Standard Therapy
Brief Summary: Objective To test the hypothesis that a nurse-led self-management programme is effective for men with uncomplicated lower urinary tract symptoms. This will be achieved by comparing symptom seveirty and the amount of drug therapy used to manage these symptoms in men who attend a self-management programme, compared to those who do not.

Study design This study will use the format of a randomised controlled trial. 200 new patients with uncomplicated LUTS will be randomised to either attend or not attend (standard therapy) a self-management programme. The programme provides education, reassurance, prostate cancer risk, advice on lifestyle modifications (e.g. fluids - type and amount), concurrent medication re-scheduling and behavioural changes (double-voiding, strategies for dribbling, and bladder re-training). These strategies are learnt through group discussion, problem solving and goal setting.

All men start the study with a period of watchful waiting (monitoring symptoms only) and are followed up for a total of 1 year. At each assessment (baseline, 3, 6, and 12 months) symptom severity and the use of drug therapy to control symptoms will be compared between the two groups. The only difference between them is that one group has attended a self-management programme and the other has not.

Potential application of results Self-management focuses on patient involvement in health care by involving them in the day-to-day control of their symptoms. If effective, self-management may provide a long-term method of managing LUTS without using drug therapy, thereby offering considerable health gain and financial savings.

The NHS Modernisation Agency wishes to develop the role of the nurse specialist to manage some patients independently of doctors. Nurse-led LUTS assessment clinics are now well established, perhaps nurses managing these patients with self-management interventions may become part of standard therapy.


Options:
A: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). (Two years); 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) (Two years)
B: treatment failure (use of drug therapy for symptom control, surgical intervention, symptom deterioration of 3 points or more measured with the I-PSS, acute urinary retention, or death)
C: Change from baseline in average number of urinations per patient per day at Week 12
D: Percent Change in Urgency Urinary Incontinence Episodes (Baseline and 2 month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms. A Randomised Controlled Trial Against Standard Therapy
Brief Summary: Objective To test the hypothesis that a nurse-led self-management programme is effective for men with uncomplicated lower urinary tract symptoms. This will be achieved by comparing symptom seveirty and the amount of drug therapy used to manage these symptoms in men who attend a self-management programme, compared to those who do not.

Study design This study will use the format of a randomised controlled trial. 200 new patients with uncomplicated LUTS will be randomised to either attend or not attend (standard therapy) a self-management programme. The programme provides education, reassurance, prostate cancer risk, advice on lifestyle modifications (e.g. fluids - type and amount), concurrent medication re-scheduling and behavioural changes (double-voiding, strategies for dribbling, and bladder re-training). These strategies are learnt through group discussion, problem solving and goal setting.

All men start the study with a period of watchful waiting (monitoring symptoms only) and are followed up for a total of 1 year. At each assessment (baseline, 3, 6, and 12 months) symptom severity and the use of drug therapy to control symptoms will be compared between the two groups. The only difference between them is that one group has attended a self-management programme and the other has not.

Potential application of results Self-management focuses on patient involvement in health care by involving them in the day-to-day control of their symptoms. If effective, self-management may provide a long-term method of managing LUTS without using drug therapy, thereby offering considerable health gain and financial savings.

The NHS Modernisation Agency wishes to develop the role of the nurse specialist to manage some patients independently of doctors. Nurse-led LUTS assessment clinics are now well established, perhaps nurses managing these patients with self-management interventions may become part of standard therapy.


Options:
A: Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach (Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24)
B: treatment failure (use of drug therapy for symptom control, surgical intervention, symptom deterioration of 3 points or more measured with the I-PSS, acute urinary retention, or death)
C: Nocturia episodes (voiding diary) (12 weeks)
D: 24-hour Voiding Frequency (post-treatment (week 8))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms. A Randomised Controlled Trial Against Standard Therapy
Brief Summary: Objective To test the hypothesis that a nurse-led self-management programme is effective for men with uncomplicated lower urinary tract symptoms. This will be achieved by comparing symptom seveirty and the amount of drug therapy used to manage these symptoms in men who attend a self-management programme, compared to those who do not.

Study design This study will use the format of a randomised controlled trial. 200 new patients with uncomplicated LUTS will be randomised to either attend or not attend (standard therapy) a self-management programme. The programme provides education, reassurance, prostate cancer risk, advice on lifestyle modifications (e.g. fluids - type and amount), concurrent medication re-scheduling and behavioural changes (double-voiding, strategies for dribbling, and bladder re-training). These strategies are learnt through group discussion, problem solving and goal setting.

All men start the study with a period of watchful waiting (monitoring symptoms only) and are followed up for a total of 1 year. At each assessment (baseline, 3, 6, and 12 months) symptom severity and the use of drug therapy to control symptoms will be compared between the two groups. The only difference between them is that one group has attended a self-management programme and the other has not.

Potential application of results Self-management focuses on patient involvement in health care by involving them in the day-to-day control of their symptoms. If effective, self-management may provide a long-term method of managing LUTS without using drug therapy, thereby offering considerable health gain and financial savings.

The NHS Modernisation Agency wishes to develop the role of the nurse specialist to manage some patients independently of doctors. Nurse-led LUTS assessment clinics are now well established, perhaps nurses managing these patients with self-management interventions may become part of standard therapy.


Options:
A: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
B: Change in the number of incontinent episodes (6 months)
C: treatment failure (use of drug therapy for symptom control, surgical intervention, symptom deterioration of 3 points or more measured with the I-PSS, acute urinary retention, or death)
D: Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks (6 weeks)

Answer: C