TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Non-absorbable (Silk) Sutures Verses Absorbable (Vicryl) Sutures During the Surgical Treatment of Trachomatous Trichiasis
Brief Summary: Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by Chlamydia trachomatis causes in-turning of the eyelids / lashes (trichiasis), leading to corneal damage and blindness. The WHO recommends corrective eyelid surgery for trichiasis. Unfortunately, trichiasis frequently returns following surgery. The purpose of this study is to compare the outcome of surgery (at one and two years) for trichiasis using two currently used alternative suture types: non-absorbable (silk) and absorbable (vicryl). We, the researchers, hypothesise that the supportive presence of the absorbable suture for a longer period produces more stable wound healing, leading to a better outcome.


Options:
A: Recurrent trichiasis (One and two years)
B: Number of Eyelids With Presence of Recurrent Trichiasis (2 years); Number of Eyelids With Pyogenic Granuloma (2 years); Number of Eyelids Experiencing an Unfavorable Outcome (2 years); Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities (2 years)
C: Recurrent Trichiasis in Tetracycline and Azithromycin Groups (Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery); Recurrent Trichiasis Between Two Azithromycin Arms (Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery)
D: Trichiasis (One and two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Mental Activity and Exercise on Cognitive Function in Older Adults Who Self-Report a Recent Decline in Memory or Thinking
Brief Summary: The primary objective of this study is to conduct a randomized, controlled trial to determine whether engaging in mental activity or exercise, either alone or in combination, improves cognitive function in non-demented, inactive older adults who self-report a recent decline in memory or thinking. In addition, we, the researchers at the University of California, San Francisco, plan to seek funding to follow subjects over time to determine whether these interventions are associated with changes in rate of cognitive decline or risk of dementia after the intervention period has ended.


Options:
A: the change in cortical thickness between the baseline and the post-intervention assessment. (between the baseline and the post-intervention assessment (12 week training))
B: Changes in Cognitive Abilities of Memory From Baseline to Year 10 (Up to 10 years); Changes in Cognitive Abilities of Reasoning From Baseline to Year 10 (Up to 10 years); Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10 (Up to 10 years); Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10 (Up to 10 years); Changes in Everyday Problem Solving From Baseline to Year 10 (Up to 10 years); Changes in Everyday Speed of Processing From Baseline to Year 10 (Up to 10 years)
C: sleep measures (3-6 months)
D: Change in cognitive function summary score (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Mental Activity and Exercise on Cognitive Function in Older Adults Who Self-Report a Recent Decline in Memory or Thinking
Brief Summary: The primary objective of this study is to conduct a randomized, controlled trial to determine whether engaging in mental activity or exercise, either alone or in combination, improves cognitive function in non-demented, inactive older adults who self-report a recent decline in memory or thinking. In addition, we, the researchers at the University of California, San Francisco, plan to seek funding to follow subjects over time to determine whether these interventions are associated with changes in rate of cognitive decline or risk of dementia after the intervention period has ended.


Options:
A: Activity Compliance (Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks)
B: the change in cortical thickness between the baseline and the post-intervention assessment. (between the baseline and the post-intervention assessment (12 week training))
C: Change in cognitive function summary score (12 weeks)
D: sleep measures (3-6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Mental Activity and Exercise on Cognitive Function in Older Adults Who Self-Report a Recent Decline in Memory or Thinking
Brief Summary: The primary objective of this study is to conduct a randomized, controlled trial to determine whether engaging in mental activity or exercise, either alone or in combination, improves cognitive function in non-demented, inactive older adults who self-report a recent decline in memory or thinking. In addition, we, the researchers at the University of California, San Francisco, plan to seek funding to follow subjects over time to determine whether these interventions are associated with changes in rate of cognitive decline or risk of dementia after the intervention period has ended.


Options:
A: Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests. (Changes from baseline at 4 months in z-scores.)
B: Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group)
C: Change in cognitive function summary score (12 weeks)
D: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Mental Activity and Exercise on Cognitive Function in Older Adults Who Self-Report a Recent Decline in Memory or Thinking
Brief Summary: The primary objective of this study is to conduct a randomized, controlled trial to determine whether engaging in mental activity or exercise, either alone or in combination, improves cognitive function in non-demented, inactive older adults who self-report a recent decline in memory or thinking. In addition, we, the researchers at the University of California, San Francisco, plan to seek funding to follow subjects over time to determine whether these interventions are associated with changes in rate of cognitive decline or risk of dementia after the intervention period has ended.


Options:
A: Changes in Cognitive Abilities of Memory From Baseline to Year 10 (Up to 10 years); Changes in Cognitive Abilities of Reasoning From Baseline to Year 10 (Up to 10 years); Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10 (Up to 10 years); Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10 (Up to 10 years); Changes in Everyday Problem Solving From Baseline to Year 10 (Up to 10 years); Changes in Everyday Speed of Processing From Baseline to Year 10 (Up to 10 years)
B: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)
C: Change in cognitive function summary score (12 weeks)
D: Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis
Brief Summary: Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by Chlamydia trachomatis causes a gradual scarring process of the inner surface of the eyelid (conjunctiva) leading to in-turning of the eyelids (entropion) and lashes touching the eye (trichiasis). The rate of progression and the severity of disease are variable. Some people develop severe disease with extensive entropion and trichiasis, whilst others have a mild problem with only a few lashes touching the eye, which does not progress.

In more advanced cases there is a broad consensus that the entropion / trichiasis should be corrected by surgery. In mild cases (minor trichiasis: 1-5 lashes touching the eye) the optimal treatment is uncertain. Some advocate early surgery to turn the eyelid out for any individual with one or more lashes touching any part of the eye. Others consider this to be too early for surgical intervention, as surgery can have a high recurrence rate and complications can arise. Instead, they recommend that minor trichiasis can be managed by epilation (pulling out lashes with forceps). In many endemic regions the uptake of surgery is low, with many patients preferring to epilate for mild disease.

The primary purpose of this study is to compare the outcome of immediate surgery to regular epilation for the management of minor trichiasis. The epilation would be done by a person with good eyesight using proper epilation forceps.


Options:
A: Recurrent trichiasis (One and two years)
B: Recurrent Trichiasis in Tetracycline and Azithromycin Groups (Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery); Recurrent Trichiasis Between Two Azithromycin Arms (Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery)
C: Number of Eyelids With Presence of Recurrent Trichiasis (2 years); Number of Eyelids With Pyogenic Granuloma (2 years); Number of Eyelids Experiencing an Unfavorable Outcome (2 years); Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities (2 years)
D: Trichiasis (One and two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Transcranial Magnetic Stimulation (TMS) Effects on Pain and Depression in Patients With Fibromyalgia
Brief Summary: In this pilot study, the PI proposes to include 20 African American participants with Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms.


Options:
A: Average Pain (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE HAMILTON DEPRESSION RATING SCALE (HRDS) (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up)
B: Numeric Rating Scale (NRS) for Pain (baseline); Numeric Rating Scale (NRS) for Pain (day 5); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (baseline); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (day 5); Six-minute Walk Test (baseline); Six-minute Walk Test (day 5); Short Physical Performance Battery (SPPB) (baseline); Short Physical Performance Battery (SPPB) (day 5); Heat Pain Threshold (baseline); Heat Pain Threshold (day 5); Heat Pain Tolerance (baseline); Heat Pain Tolerance (day 5); Pressure Pain Threshold (baseline); Pressure Pain Threshold (day 5); Punctate Mechanical Pain Sensitivity (baseline); Punctate Mechanical Pain Sensitivity (day 5); Conditioned Pain Modulation (CPM) (baseline); Conditioned Pain Modulation (CPM) (day 5)
C: Analgesic efficiency (36 months)
D: Change in pain Scores as measured by the Visual Analog Scale (2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Transcranial Magnetic Stimulation (TMS) Effects on Pain and Depression in Patients With Fibromyalgia
Brief Summary: In this pilot study, the PI proposes to include 20 African American participants with Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms.


Options:
A: Pain severity (up to three months after the end of treatment)
B: Numeric Rating Scale (NRS) for Pain (baseline); Numeric Rating Scale (NRS) for Pain (day 5); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (baseline); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (day 5); Six-minute Walk Test (baseline); Six-minute Walk Test (day 5); Short Physical Performance Battery (SPPB) (baseline); Short Physical Performance Battery (SPPB) (day 5); Heat Pain Threshold (baseline); Heat Pain Threshold (day 5); Heat Pain Tolerance (baseline); Heat Pain Tolerance (day 5); Pressure Pain Threshold (baseline); Pressure Pain Threshold (day 5); Punctate Mechanical Pain Sensitivity (baseline); Punctate Mechanical Pain Sensitivity (day 5); Conditioned Pain Modulation (CPM) (baseline); Conditioned Pain Modulation (CPM) (day 5)
C: Change in pain Scores as measured by the Visual Analog Scale (2 months)
D: Average Pain (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE HAMILTON DEPRESSION RATING SCALE (HRDS) (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
Brief Summary: The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who previously received denosumab or placebo, respectively.


Options:
A: To compare % change in Lumbar Spine BMD from Baseline to Month 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
B: Number of Participants With Adverse Events (AEs) (84 months); Number of Participants With Laboratory Toxicities of Grade ≥ 3 (84 months); Number of Participants With Antibodies to Denosumab (Every 12 months through Month 84)
C: Number of Participants With New Vertebral Fractures (36 months)
D: Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
Brief Summary: The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who previously received denosumab or placebo, respectively.


Options:
A: Incidence of hip fxs; Incidence of new vertebral fxs
B: Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum (Baseline, Month 24)
C: Number of Participants With Adverse Events (AEs) (84 months); Number of Participants With Laboratory Toxicities of Grade ≥ 3 (84 months); Number of Participants With Antibodies to Denosumab (Every 12 months through Month 84)
D: Significant reduction in rate of clinical fractures after surgical repair of hip fracture

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies
Brief Summary: The aim of the trial is to determine the recommended phase II dose of weekly intravenous topotecan in combination with a fixed dose (25 mg or 15 mg) of weekly intravenous temsirolimus in patients with and without prior pelvic radiation.


Options:
A: Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines (Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.)
B: Tolerability of regimen (4 weeks)
C: Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST) (Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.)
D: 6 Month Progression-free Survival (PFS) (6 months); Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Up to 5 years); Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) (Up to 5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies
Brief Summary: The aim of the trial is to determine the recommended phase II dose of weekly intravenous topotecan in combination with a fixed dose (25 mg or 15 mg) of weekly intravenous temsirolimus in patients with and without prior pelvic radiation.


Options:
A: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))
B: Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) (Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred))
C: Tolerability of regimen (4 weeks)
D: 6 Month Progression-free Survival (PFS) (6 months); Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Up to 5 years); Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) (Up to 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline, an Alpha 4 Beta 2 Nicotinic Acetylcholine Receptor Partial Agonist, on Cognitive Dysfunction in 120 Patients With Schizophrenia: a Randomized, Double Blind, 8 Weeks Trial
Brief Summary: The primary objective of this project is to examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. The secondary objective is to evaluate the effect of this combination therapy on smoking in people with schizophrenia. This study will be a randomized, double blind, parallel group, placebo controlled 8 weeks trial.


Options:
A: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)
B: N/A
C: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)
D: 52-Week Point-Prevalence Abstinence (Assessed 52 weeks after quit date)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline, an Alpha 4 Beta 2 Nicotinic Acetylcholine Receptor Partial Agonist, on Cognitive Dysfunction in 120 Patients With Schizophrenia: a Randomized, Double Blind, 8 Weeks Trial
Brief Summary: The primary objective of this project is to examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. The secondary objective is to evaluate the effect of this combination therapy on smoking in people with schizophrenia. This study will be a randomized, double blind, parallel group, placebo controlled 8 weeks trial.


Options:
A: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
B: Continuous abstinence Weeks 13 -24.
C: Electronic cigarette use (weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks); electronic cigarette acceptability (Baseline, week 2, week6, week 10 and week 24); Respiratory symptoms (weekly measures from baseline to 10 weeks and at 24 weeks); Cotinine (Baseline, week 2, 6, 10 and 24); Nitrosamines (Baseline and at 6 week); Side effects of antipsychotics (weekly the first 10 weeks and at 24 weeks); Withdrawal symptoms (weekly the first 10 weeks and at 24 weeks); Respiratory symptoms (weekly the first 10 weeks and at 24 weeks)
D: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline, an Alpha 4 Beta 2 Nicotinic Acetylcholine Receptor Partial Agonist, on Cognitive Dysfunction in 120 Patients With Schizophrenia: a Randomized, Double Blind, 8 Weeks Trial
Brief Summary: The primary objective of this project is to examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. The secondary objective is to evaluate the effect of this combination therapy on smoking in people with schizophrenia. This study will be a randomized, double blind, parallel group, placebo controlled 8 weeks trial.


Options:
A: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
B: Continuous abstinence Weeks 13 -24.
C: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)
D: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)

Answer: C