TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I, Double Blind, Parallel-Group, Multi-center, Gene Expression (Synthesis of FGF-1 mRNA) and Tolerability Study of Increasing Single Dose of NV1FGF Administered by Intra-Muscular Injection in Subjects With Severe Peripheral Artery Occlusive Disease (PAOD) Planned to Undergo Amputation Above the Ankle
Brief Summary: The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV1FGF.

Secondary objectives :

* To evaluate the safety and tolerability of IM administration of increasing single doses of NV1FGF
* To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection site and remote site)
* To evaluate the presence of FGF-1 receptors in injected tissues (injection site and remote site)
* To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote site), in multiple organs/tissues when appropriate, and plasma
* To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at remote site
* To collect data from plasma NV1FGF pharmacokinetics
* To evaluate healing of the amputation site


Options:
A: Detection of FGF-1 mRNA (by real-time RT-PCR) in injected tissues at injection site (3 to 8 days after amputation)
B: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)
C: Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (12 weeks)
D: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I, Double Blind, Parallel-Group, Multi-center, Gene Expression (Synthesis of FGF-1 mRNA) and Tolerability Study of Increasing Single Dose of NV1FGF Administered by Intra-Muscular Injection in Subjects With Severe Peripheral Artery Occlusive Disease (PAOD) Planned to Undergo Amputation Above the Ankle
Brief Summary: The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV1FGF.

Secondary objectives :

* To evaluate the safety and tolerability of IM administration of increasing single doses of NV1FGF
* To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection site and remote site)
* To evaluate the presence of FGF-1 receptors in injected tissues (injection site and remote site)
* To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote site), in multiple organs/tissues when appropriate, and plasma
* To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at remote site
* To collect data from plasma NV1FGF pharmacokinetics
* To evaluate healing of the amputation site


Options:
A: Detection of FGF-1 mRNA (by real-time RT-PCR) in injected tissues at injection site (3 to 8 days after amputation)
B: Primary efficacy parameter: ulcer healing.; Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.
C: Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (12 weeks)
D: Time to major amputation of the treated leg or death from any cause, whichever comes first (From randomization up to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I, Multi-Center, Open Label, Safety and Tolerability Study of Single and Repeated Administrations of Escalating Dose(s) of NV1FGF Administered by Intra-Muscular Injection in Patients With Severe Peripheral Artery Occlusive Disease
Brief Summary: The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or Grade III, category 5 and 6).

Secondary objectives are:

* To determine the biological activity of NV1FGF on collateral artery development.
* To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.


Options:
A: Primary efficacy parameter: ulcer healing.; Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.
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: Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (12 weeks)
D: Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months (Baseline, 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I, Multi-Center, Open Label, Safety and Tolerability Study of Single and Repeated Administrations of Escalating Dose(s) of NV1FGF Administered by Intra-Muscular Injection in Patients With Severe Peripheral Artery Occlusive Disease
Brief Summary: The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or Grade III, category 5 and 6).

Secondary objectives are:

* To determine the biological activity of NV1FGF on collateral artery development.
* To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.


Options:
A: Peak Walking Time (at 6 months)
B: Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (12 weeks)
C: Detection of FGF-1 mRNA (by real-time RT-PCR) in injected tissues at injection site (3 to 8 days after amputation)
D: Change in the measurement of pain-free walking distance (PWD) on treadmill (3 months and 6 months after the first injection of Neovasculgen®.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Fifteen-month, Prospective, Randomized, Active-controlled, Open-label, Flexible Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults With Schizophrenia Who Have Been Incarcerated
Brief Summary: The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated.


Options:
A: Time to First Treatment Failure (From date of randomization up to Month 15); Percentage of Participants in Each Event Category of First Treatment Failure (From date of randomization up to Month 15)
B: Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS) (Change from Baseline at 3 months after intervention)
C: The proportion of residents whose preferences and needs, together with the related actions to meet them, are known, documented and satisfied in their 'life-and-care plans'. (6 months after the SDM interview)
D: Selected Treatment (1 month); Health Care utilization (1 year); Health Care utilization (2 years); coping (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of D-cycloserine on Treatment of PTSD in Youth
Brief Summary: The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of posttraumatic stress disorder (PTSD) in 7-12 year old children.


Options:
A: Liebowitz Social Anxiety Scale (LSAS) (Week 13); CGI - Clinical Global Impression of Improvement (Week 13)
B: significant reduction in panic symptoms after completion of treatment
C: Clinician-Administered PTSD Scale (CAPS) (Baseline); Clinician-Administered PTSD Scale (CAPS) (Posttreatment, 8 weeks); Clinician-Administered PTSD Scale (CAPS) (Month 3); Clinician-Administered PTSD Scale (CAPS) (Month 6); Clinician-Administered PTSD Scale (CAPS) (Month 12)
D: Child PTSD Symptom Scale (CPSS) (After 12 therapy sessions, up to 28 weeks.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: D-cycloserine Adjunctive Treatment for PTSD in Adolescents
Brief Summary: The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of posttraumatic stress disorder (PTSD) in 13-18 year-old children.


Options:
A: Child PTSD Symptom Scale (CPSS) (After 12 therapy sessions, up to 28 weeks.)
B: Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). (Baseline, Mid-Treatment, Post-treatment)
C: CAPS-IV at the End of Treatment (after weekly treatment session 9 (at posttreatment assessment))
D: Child PTSD Symptom Scale (CPSS) (After 12 therapy sessions, up to 28 weeks.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Everolimus Added to Long Acting Octreotide as a Volume Reducing Treatment of Polycystic Livers
Brief Summary: The aim of this study is to reduce polycystic liver volume by treating with octreotide, whether or not combined with everolimus; to assess whether combination therapy of everolimus and octreotide gives a bigger reduction of polycystic liver volume than octreotide monotherapy.


Options:
A: Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death. (Patients followed for 5-8 years with average of 6.5 years follow up)
B: Kidney Volume measured by MRI. (Every year)
C: Total Kidney Volume (Baseline, week 24, 52, 104, and 156); Renal Function Test (eGFR) (Baseline, Week 24, 48, 104, and 156)
D: Liver volume (at baseline and at 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo-controlled, Parallel Group and Dose-finding, Multicentric, Safety and Efficacy Study With Intramuscular Injections of NV1FGF in Subjects With Intermittent Claudication
Brief Summary: The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo.

The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.


Options:
A: Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (12 weeks)
B: Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13 (13 weeks)
C: Time to major amputation of the treated leg or death from any cause, whichever comes first (From randomization up to 12 months)
D: Change in Six-Minute Walk Performance at 12-week Follow-up (change from baseline to week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo-controlled, Parallel Group and Dose-finding, Multicentric, Safety and Efficacy Study With Intramuscular Injections of NV1FGF in Subjects With Intermittent Claudication
Brief Summary: The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo.

The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.


Options:
A: Detection of FGF-1 mRNA (by real-time RT-PCR) in injected tissues at injection site (3 to 8 days after amputation)
B: Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13 (13 weeks)
C: evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD.
D: Time to major amputation of the treated leg or death from any cause, whichever comes first (From randomization up to 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)
Brief Summary: Many studies have shown that women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing diabetes later in life. The purpose of the study is to test whether a web-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention Program (DPP), modified specifically for women with a recent history of GDM, incorporating advice about diet and physical activity, delivered in the first 12 months after delivery will help women lose weight, improve overall health, and decrease their risk factors for type 2 diabetes.


Options:
A: Postpartum weight loss (12 months after delivery)
B: Pain Level Twenty Four Hours After Delivery (Twenty-four hours)
C: Opioid Consumption in MME (within 24 hours of delivery)
D: Reduction in the level of perineal pain (3 days); Reduction in perineal swelling (3 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)
Brief Summary: Many studies have shown that women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing diabetes later in life. The purpose of the study is to test whether a web-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention Program (DPP), modified specifically for women with a recent history of GDM, incorporating advice about diet and physical activity, delivered in the first 12 months after delivery will help women lose weight, improve overall health, and decrease their risk factors for type 2 diabetes.


Options:
A: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
B: Weight for Length Body Mass Index (BMI will be assessed at three years of age for the study participants)
C: Postpartum weight loss (12 months after delivery)
D: Exclusive Breastfeeding Rate (3 months postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Patterned Oral Somatosensory Entrainment
Brief Summary: The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e. the study group will be superior to the control).

The secondary hypothesis is that the infants in the NTrainer System® experimental group will have shorter lengths of stay.


Options:
A: Neurobehavioral Assessment of the Preterm Infant (NAPI) (Birth, Transition to by mouth feeding, hospital discharge, 2 mo corrected age)
B: Salivary gene expression (Quantify gene expression probability from salivary samples beginning at 30 wks post-menstrual age, and repeated sampling every 3 days thereafter during the infant's stay in neonatal intensive care unit (NICU) for an average of 14 samples, up to 60 days.)
C: The length of time to reach 100% full oral feeds (14 days on average)
D: Oral feeding performance (20 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: McFlu2 COLD3 Prevention: A Randomized, Placebo-controlled, Double Blind Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections in McMaster University Students
Brief Summary: The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tract infection (URTI) in students attending McMaster University. Investigators hypothesize that

1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.


Options:
A: Percentage of adherence of opportunities for hand hygiene (march 2008, october 2008, may 2009, november 2009)
B: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
C: Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events (60 weeks)
D: the incidence rates of influenza infection (Until 3 months gargling)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: McFlu2 COLD3 Prevention: A Randomized, Placebo-controlled, Double Blind Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections in McMaster University Students
Brief Summary: The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tract infection (URTI) in students attending McMaster University. Investigators hypothesize that

1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.


Options:
A: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
B: The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: (1 month); The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: (1 month); The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: (1 month)
C: Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events (60 weeks)
D: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: McFlu2 COLD3 Prevention: A Randomized, Placebo-controlled, Double Blind Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections in McMaster University Students
Brief Summary: The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tract infection (URTI) in students attending McMaster University. Investigators hypothesize that

1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.


Options:
A: Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days (7 days)
B: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
C: Intraoral viral load (Five days of using gargles)
D: Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4) (Days 2, 3 and 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: McFlu2 COLD3 Prevention: A Randomized, Placebo-controlled, Double Blind Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections in McMaster University Students
Brief Summary: The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tract infection (URTI) in students attending McMaster University. Investigators hypothesize that

1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.


Options:
A: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
B: Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4) (Days 2, 3 and 4)
C: Percent of Healthcare Workers Testing Positive for COVID-19. (3 weeks); Percent of Patients Testing Positive for COVID-9. (2 weeks); Percent of Community Participants Testing Positive for COVID-9. (3 weeks)
D: Intraoral viral load (Five days of using gargles)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: McFlu2 COLD3 Prevention: A Randomized, Placebo-controlled, Double Blind Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections in McMaster University Students
Brief Summary: The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tract infection (URTI) in students attending McMaster University. Investigators hypothesize that

1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.


Options:
A: Intraoral viral load (Five days of using gargles)
B: Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4) (Days 2, 3 and 4)
C: Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days (7 days)
D: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)

Answer: D