TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Open Label, Dose-escalating Clinical Study to Evaluate the Safety, Tolerability and Therapeutic Effects of Transplantation of Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS).
Brief Summary: The study will evaluate the safety, tolerability and therapeutic effects of transplantation of escalating doses of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF), in patients with amyotrophic lateral sclerosis (ALS).


Options:
A: Forced vital capacity (Every 3 months)
B: Safety evaluation and tolerability of a single treatment administration in an escalating-dose of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (At baseline and up to 6 month following treatment administration)
C: Safety evaluation and tolerability of a single treatment administration of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months); Safety evaluation and tolerability of single intrathecal injection (IT) into the cerebrospinal fluid (CSF) of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months)
D: Safety of one or multiple intrathecaland intravenous injections of autologous MSC in Multiple sclerosis (One year for the first phase; 4 years for the extension phase)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Open Label, Dose-escalating Clinical Study to Evaluate the Safety, Tolerability and Therapeutic Effects of Transplantation of Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS).
Brief Summary: The study will evaluate the safety, tolerability and therapeutic effects of transplantation of escalating doses of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF), in patients with amyotrophic lateral sclerosis (ALS).


Options:
A: Safety evaluation and tolerability of a single treatment administration in an escalating-dose of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (At baseline and up to 6 month following treatment administration)
B: Safety evaluation and tolerability of a single treatment administration of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months); Safety evaluation and tolerability of single intrathecal injection (IT) into the cerebrospinal fluid (CSF) of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months)
C: Fever (48hours); Unconsciousness (48hours); vomiting (48hours)
D: Forced vital capacity (Every 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) Trial
Brief Summary: The purpose of the study is to understand whether a new treatment of stroke - endovascular clot removal - can be added to the current standard of care to improve patient outcomes.

All patients will receive the best standard stroke treatment. This includes treating patients with the clot dissolving drug tPA (tissue plasminogen activator). However, t-PA does not work in some patients and others are not eligible to receive t-PA because they present too late for treatment (they woke up with their stroke symptoms or their stroke was not witnessed).

During endovascular revascularization the blockage in the artery is removed with the use of devices called stentreivers and or by giving clot dissolving drug at the site of the blockage in the artery to restore blood flow. Stentrievers are devices that have been designed by different companies to remove blood clots from arteries.

Up to a maximum of 500 people at 20-25 hospitals across Canada and other countries will participate in this study.


Options:
A: Number of Participants With Angiographic Revascularization of the Occluded Target Vessel (At immediate post-procedure); Number of Device-related Serious Adverse Events (Within 24 hours post-procedure); Number of Procedure-related Serious Adverse Event (Within 24 hours post-procedure)
B: Reperfusion at 24 hours (CT or MR perfusion imaging) (24 hours post stroke onset); Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS) (3 days post stroke onset)
C: mRS (the modified Rankin Scale) (3 months after procedure)
D: Shift in the mRS score, defined by a proportional odds model. (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) Trial
Brief Summary: The purpose of the study is to understand whether a new treatment of stroke - endovascular clot removal - can be added to the current standard of care to improve patient outcomes.

All patients will receive the best standard stroke treatment. This includes treating patients with the clot dissolving drug tPA (tissue plasminogen activator). However, t-PA does not work in some patients and others are not eligible to receive t-PA because they present too late for treatment (they woke up with their stroke symptoms or their stroke was not witnessed).

During endovascular revascularization the blockage in the artery is removed with the use of devices called stentreivers and or by giving clot dissolving drug at the site of the blockage in the artery to restore blood flow. Stentrievers are devices that have been designed by different companies to remove blood clots from arteries.

Up to a maximum of 500 people at 20-25 hospitals across Canada and other countries will participate in this study.


Options:
A: clinical (efficacy): favorable modified Rankin Score (less than or equal to 2) (3 months); Rate of symptomatic intracranial hemorrhage (24 hours)
B: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
C: Shift in the mRS score, defined by a proportional odds model. (90 days)
D: Feasibility of enrolling 12 subjects with major vessel occlusion within 1 year and random 1:1 assignment to treatment with IV (N=6) and IA (N=6) IA Activase using the following criteria: Time to clinical and radiological assessments (3 years); Time to IA Activase treatment (3 years); Preliminary safety assessment: 24 hour symptomatic ICH (3 years); Resources utilized and risk-benefit of IA Activase treatment. (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) Trial
Brief Summary: The purpose of the study is to understand whether a new treatment of stroke - endovascular clot removal - can be added to the current standard of care to improve patient outcomes.

All patients will receive the best standard stroke treatment. This includes treating patients with the clot dissolving drug tPA (tissue plasminogen activator). However, t-PA does not work in some patients and others are not eligible to receive t-PA because they present too late for treatment (they woke up with their stroke symptoms or their stroke was not witnessed).

During endovascular revascularization the blockage in the artery is removed with the use of devices called stentreivers and or by giving clot dissolving drug at the site of the blockage in the artery to restore blood flow. Stentrievers are devices that have been designed by different companies to remove blood clots from arteries.

Up to a maximum of 500 people at 20-25 hospitals across Canada and other countries will participate in this study.


Options:
A: Shift in the mRS score, defined by a proportional odds model. (90 days)
B: Score on the modified Rankin scale (3 months)
C: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)
D: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) Trial
Brief Summary: The purpose of the study is to understand whether a new treatment of stroke - endovascular clot removal - can be added to the current standard of care to improve patient outcomes.

All patients will receive the best standard stroke treatment. This includes treating patients with the clot dissolving drug tPA (tissue plasminogen activator). However, t-PA does not work in some patients and others are not eligible to receive t-PA because they present too late for treatment (they woke up with their stroke symptoms or their stroke was not witnessed).

During endovascular revascularization the blockage in the artery is removed with the use of devices called stentreivers and or by giving clot dissolving drug at the site of the blockage in the artery to restore blood flow. Stentrievers are devices that have been designed by different companies to remove blood clots from arteries.

Up to a maximum of 500 people at 20-25 hospitals across Canada and other countries will participate in this study.


Options:
A: Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage (Immediately post treatment); Study Device-related Serious Adverse Events (SAEs) (90 Day); Procedure-related Serious Adverse Events (SAEs) (90 Day)
B: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
C: Shift in the mRS score, defined by a proportional odds model. (90 days)
D: Reperfusion at 24 hours (CT or MR perfusion imaging) (24 hours post stroke onset); Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS) (3 days post stroke onset)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes
Brief Summary: This study will determine whether Home Telehealth-based implementation of an evidence-based intervention targeting Veterans with persistent poorly-controlled diabetes can improve hemoglobin A1c, patient self-management, and comorbid depressive symptoms in this high-risk, high-cost population. If effective, this intervention (Advanced Comprehensive Diabetes Care) offers a feasible, sustainable, and generalizable approach to managing Veterans with persistent poorly-controlled diabetes, which can be implemented using only existing Home Telehealth services.


Options:
A: Rate of LDL cholesterol control (< 100 mg/dL) (12 months); Rate of blood pressure control (< 130/80 mmHg) (12 months); Rate of HbA1c control (<7%) (12 months)
B: N/A
C: Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 (Baseline, Month 12)
D: Diabetes Control (Baseline, 3months, 6months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasal Intermittent Mandatory Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants of the NEOCOSUR Network.
Brief Summary: The purpose of this study is to determine whether Nasal intermittent positive pressure ventilation (NIPPV) non synchronized is better than continuous positive airway pressure (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth weight infants at the NEOCOSUR Network.


Options:
A: The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS. (1 year)
B: Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants (3 months)
C: Extubation failure (apnea rate and respiratory failure.)
D: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasal Intermittent Mandatory Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants of the NEOCOSUR Network.
Brief Summary: The purpose of this study is to determine whether Nasal intermittent positive pressure ventilation (NIPPV) non synchronized is better than continuous positive airway pressure (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth weight infants at the NEOCOSUR Network.


Options:
A: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))
B: Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. (At 7 days after non-invasive respiratorynsupport.)
C: Trigger Delay (last 5-min of each 15-min trial)
D: Extubation failure (apnea rate and respiratory failure.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor
Brief Summary: This is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. At time of surgery, full thickness biopsies will be obtained from a standardized location at the top of vagina. The investigators will measure the thickness of the vaginal muscularis, elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is affected by estrogen therapy. The results will provide important data to support a larger clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term success rates of pelvic reconstructive surgery for pelvic organ prolapse.


Options:
A: Vaginal Wall Composition: Epithelium (Intention to Treat) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Epithelium (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Muscularis (Intention to Treat) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Muscularis (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); hCOL1A1, Per-Protocol (Time of surgery, i.e. after 6-8 weeks of intervention); Total Collagen Content in Vaginal Muscularis, (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Degradative Activity, Muscularis, MMP-9 (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Lamina Propria (Intention to Treat) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Lamina Propria (Per-Protocol) (Time of surgery, i.e. 6-8 weeks of intervention); hCOL3, (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Lysyl Oxidase (LOX) (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); LOXL1 (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Tropoelastin (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); TGFB1 (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Degradative Activity, Mucosa, MMP-9 (Time of surgery, i.e. after 6-8 weeks of intervention)
B: Vaginal Dryness (6 months)
C: Vaginal Health Indexes (vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks)
D: Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains. (baseline and 2-12 weeks after treatment (at time of surgery))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III Trial Investigating if Concomitant Injections of the Diagnostic Agents C-Tb and 2 T.U Tuberculin PPD RT 23 SSI Affect the Induration Responses in Combination With a Safety Assessment of C-Tb
Brief Summary: A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result will show as redness and/or induration at the injection site, while a negative test will leave no reactions.

The aim of this study is to address if the size of induration and the sensitivity of C-Tb is influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is to evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.


Options:
A: All-cause mortality 12 weeks after inclusion (12 weeks)
B: Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics (18 months); Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms (36 months)
C: To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives) (Onset from the injection(s) to 28 days after the injections); To assess if concomitant injections of C-Tb and PPD RT 23 influence the tests abilities to identify positive results of Tuberculosis in Tuberculosis infected patients (Onset from the injection(s) to 28 days after the injections)
D: To demonstrate an increasing trend in C-Tb test positivity across the four study groups, with 'positivity' defined as an induration ≥ 5 mm (Onset between the injections and 28 days after the injections)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer
Brief Summary: Trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.


Options:
A: Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11 (3 Years)
B: Rate of Pathologic Complete Response (pCR) (3 years)
C: response by pCR =ypT0/is ypN0 (24 weeks)
D: Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11 (8 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Restoring Insulin Secretion Adult Medication Study
Brief Summary: The RISE Adult Medication Study is a 4-arm, 3-center, clinical trial of adults with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Adult participants (ages 20-65) will be randomized to one of the following treatment regimens: (1) blinded placebo, (2) blinded metformin alone, (3) early intensive insulin treatment with basal insulin glargine followed by open-label metformin, (4) the glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide plus open-label metformin.

The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention.


Options:
A: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); Insulin Sensitivity, M/I (3-months after a medication washout)
B: Change from baseline in HbA1c at 12 weeks
C: Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 52 weeks)
D: Changes in Insulin secretion rate (Baseline and 96 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Restoring Insulin Secretion Adult Medication Study
Brief Summary: The RISE Adult Medication Study is a 4-arm, 3-center, clinical trial of adults with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Adult participants (ages 20-65) will be randomized to one of the following treatment regimens: (1) blinded placebo, (2) blinded metformin alone, (3) early intensive insulin treatment with basal insulin glargine followed by open-label metformin, (4) the glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide plus open-label metformin.

The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention.


Options:
A: Steady State Beta Cell Compensation (24 months)
B: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)
C: Change in area under the 0-2 hour prandial glucose curve at 12 weeks
D: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); Insulin Sensitivity, M/I (3-months after a medication washout)

Answer: D