TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients: A Randomized Placebo-Controlled, Double-Blind Clinical Trial
Brief Summary: Cancer patients have an increased risk of developing blood clots in the veins compared to non-cancer patients. Cancer patients who develop blood clots can lead to reduced life expectancy, delayed cancer treatment, and decreased quality of life. Prevention is the most effective way to decrease the complications associated with blood clots in the veins. Although previous clinical trials have shown some benefit on the use of medication to prevent blood clots in the veins in ambulatory cancer patients, these studies have been inconclusive in demonstrating that existing blood thinners significantly reduce the rate of blood clots in cancer patients. One possible explanation relates to the fact that these studies have included a large proportion of cancer patients who are a low risk of developing blood clots in the veins. We are proposing to identify cancer patients who are at a high risk of developing blood clots by using a validated tool at the time of their cancer diagnosis. The identified high risk cancer patients will be asked to participate in a trial to test the safety and efficacy of a new oral medication that has been used to prevent blood clots in patients undergoing surgery. We are enrolling 574 patients in 7 Canadian centers (Ottawa, Halifax, Montreal, Vancouver, Sault Ste. Marie, Toronto and Hamilton). 287 patients will receive the study drug and 287 will receive an inactive substance. Analysis will be performed to assess the safety and the superiority of the study drug.


Options:
A: first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (7 months)
B: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)
C: Progression free survival (5 years)
D: Significant increase of overall survival (At follow up 1 year after treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients: A Randomized Placebo-Controlled, Double-Blind Clinical Trial
Brief Summary: Cancer patients have an increased risk of developing blood clots in the veins compared to non-cancer patients. Cancer patients who develop blood clots can lead to reduced life expectancy, delayed cancer treatment, and decreased quality of life. Prevention is the most effective way to decrease the complications associated with blood clots in the veins. Although previous clinical trials have shown some benefit on the use of medication to prevent blood clots in the veins in ambulatory cancer patients, these studies have been inconclusive in demonstrating that existing blood thinners significantly reduce the rate of blood clots in cancer patients. One possible explanation relates to the fact that these studies have included a large proportion of cancer patients who are a low risk of developing blood clots in the veins. We are proposing to identify cancer patients who are at a high risk of developing blood clots by using a validated tool at the time of their cancer diagnosis. The identified high risk cancer patients will be asked to participate in a trial to test the safety and efficacy of a new oral medication that has been used to prevent blood clots in patients undergoing surgery. We are enrolling 574 patients in 7 Canadian centers (Ottawa, Halifax, Montreal, Vancouver, Sault Ste. Marie, Toronto and Hamilton). 287 patients will receive the study drug and 287 will receive an inactive substance. Analysis will be performed to assess the safety and the superiority of the study drug.


Options:
A: Significant increase of overall survival (At follow up 1 year after treatment)
B: DVT/TVE event rate (After 12 events and after 24 events or after 540 pts recruited)
C: first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (7 months)
D: Progression Free Survival (during chemotherapy and follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
Brief Summary: The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.


Options:
A: Cigarette use (8 weeks)
B: Tobacco use (Six-month follow-up)
C: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)
D: Primary efficacy and Safety endpoint: (within 12 month from enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
Brief Summary: The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.


Options:
A: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
C: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)
D: Cigarette use (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
Brief Summary: The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.


Options:
A: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
B: Cigarette use (8 weeks)
C: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
D: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
Brief Summary: The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.


Options:
A: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
B: Tobacco use abstinence (26 week)
C: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
D: Cigarette use (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
Brief Summary: The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.


Options:
A: Cigarette use (8 weeks)
B: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
C: Smoking Behavior (Nine weeks)
D: Tobacco use (Six-month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
Brief Summary: The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.


Options:
A: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)
D: Cigarette use (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
Brief Summary: The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.


Options:
A: The primary outcome is self-reported consecutive quit at 3 and 12 months following intervention. (3 and 12 month); Secondary outcomes are reduction in use, number of quit attempts at 3 and 12 months, and increases in readiness to quit. (3 and 12 months)
B: Will bupropion reduce relapse to smoking compared to placebo (52 weeks and 76 weeks)
C: Cigarette use (8 weeks)
D: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
Brief Summary: The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.


Options:
A: Continuous abstinence Weeks 13 -24.
B: Quit Rate (4 months)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: Cigarette use (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Is There a Difference in Pain and Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Compared to Robotic Colpopexy? A Prospective Cohort Study
Brief Summary: The purpose of this study is to to determine if there is a difference in patient related outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse repair compared to robotic-assisted repair.

We hypothesize that pain and quality of life following robotic-assisted repair will be similar to that following vaginal reconstruction, when performed in conjunction with vaginal hysterectomy.


Options:
A: Operative Time (Intra operative)
B: Primary outcome: operative time from incision to closure. (Primary outcome: will be obtained immediately at the end of each procedure.)
C: Insulin resistance (3 weeks)
D: Subjective assessment of pain on the morning of post-operative day 1 (One day (the day after surgery))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of "as Required" Sildenafil for Patients With Moderate to Severe Raynaud's Phenomenon (RP)
Brief Summary: The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.


Options:
A: Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo. (7 days)
B: RP Attacks Per Day (baselin and 4 weeks)
C: The primary outcome variables will be frequency and duration of Raynaud's attacks, evolution of trophic digital lesions (6 weeeks and 12 weeks)
D: Change in the Raynaud's Condition Score (daily for 18 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomized Trial of the Impact of an Intimate Partner Violence and HIV Prevention Intervention on Emotional, Physical and Sexual Abuse, Sexual Risk Behaviors and HIV Incidence in Rakai, Uganda
Brief Summary: Intimate partner violence (IPV) is a precursor to and consequence of HIV infection. Few interventions combining HIV and IPV prevention have been evaluated and none has significantly decreased both outcomes.

A cluster-randomized trial was conducted in Rakai, Uganda. Four intervention arm clusters (N=5,339) received an IPV prevention intervention (the Safe Homes and Respect for Everyone (SHARE) Project), enhanced HIV testing and treatment and routine HIV services provided by Rakai Health Sciences Program (RHSP). Seven control arm clusters (N=6,112) received standard of care HIV services alone.

Baseline and two follow-up visits were conducted via the Rakai Community Cohort Study between 2005 and 2009. Primary outcomes were past year emotional, physical and sexual IPV and HIV incidence. Secondary outcomes included past year intimate partner rape/forced sex, number of total and extra-marital sex partners, alcohol use surrounding sex, condom use, discussion about condom use, partner's disclosure of HIV status and respondent's disclosure of HIV status. Analysis was by intention-to-treat. Modified Poisson regression was used to estimate prevalence risk ratios (PRR) to detect the impact of the intervention on IPV and secondary outcomes. Poisson regression was used to estimate incidence rate ratios (IRR) of HIV acquisition per 100 person years (py).

Our study had three research aims and related hypotheses.

Aim 1 was to assess the impact of SHARE + RHSP community services on report of victimization from and perpetration of physical and/or sexual IPV in the past 12 months, compared to the impact of RHSP community services alone.

Hypothesis 1(a): SHARE intervention will reduce women's reports of IPV victimization in intervention vs. control arms.

Hypothesis 1(b): SHARE intervention will reduce men's reports of IPV perpetration in intervention vs. control arms.

Aim 2 was to assess the impact of SHARE + RHSP services on report of sexual risk behaviors among men and women compared to the impact of RHSP community services alone.

Hypothesis 2(a): SHARE intervention will reduce selected sexual risk behaviors in the intervention vs. control arms.

Aim 3 was to assess the impact of SHARE + RHSP services on HIV incidence compared to the impact of RHSP community services alone.

Hypothesis 3(a): Incidence of HIV will be lower in the intervention vs. control arms.


Options:
A: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
B: Intimate partner violence (One year)
C: Change in telomerase activity (pre-intervention (baseline) and post-intervention (5.5 months later))
D: The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components. (6 weeks post randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomized Trial of the Impact of an Intimate Partner Violence and HIV Prevention Intervention on Emotional, Physical and Sexual Abuse, Sexual Risk Behaviors and HIV Incidence in Rakai, Uganda
Brief Summary: Intimate partner violence (IPV) is a precursor to and consequence of HIV infection. Few interventions combining HIV and IPV prevention have been evaluated and none has significantly decreased both outcomes.

A cluster-randomized trial was conducted in Rakai, Uganda. Four intervention arm clusters (N=5,339) received an IPV prevention intervention (the Safe Homes and Respect for Everyone (SHARE) Project), enhanced HIV testing and treatment and routine HIV services provided by Rakai Health Sciences Program (RHSP). Seven control arm clusters (N=6,112) received standard of care HIV services alone.

Baseline and two follow-up visits were conducted via the Rakai Community Cohort Study between 2005 and 2009. Primary outcomes were past year emotional, physical and sexual IPV and HIV incidence. Secondary outcomes included past year intimate partner rape/forced sex, number of total and extra-marital sex partners, alcohol use surrounding sex, condom use, discussion about condom use, partner's disclosure of HIV status and respondent's disclosure of HIV status. Analysis was by intention-to-treat. Modified Poisson regression was used to estimate prevalence risk ratios (PRR) to detect the impact of the intervention on IPV and secondary outcomes. Poisson regression was used to estimate incidence rate ratios (IRR) of HIV acquisition per 100 person years (py).

Our study had three research aims and related hypotheses.

Aim 1 was to assess the impact of SHARE + RHSP community services on report of victimization from and perpetration of physical and/or sexual IPV in the past 12 months, compared to the impact of RHSP community services alone.

Hypothesis 1(a): SHARE intervention will reduce women's reports of IPV victimization in intervention vs. control arms.

Hypothesis 1(b): SHARE intervention will reduce men's reports of IPV perpetration in intervention vs. control arms.

Aim 2 was to assess the impact of SHARE + RHSP services on report of sexual risk behaviors among men and women compared to the impact of RHSP community services alone.

Hypothesis 2(a): SHARE intervention will reduce selected sexual risk behaviors in the intervention vs. control arms.

Aim 3 was to assess the impact of SHARE + RHSP services on HIV incidence compared to the impact of RHSP community services alone.

Hypothesis 3(a): Incidence of HIV will be lower in the intervention vs. control arms.


Options:
A: HIV sero-incidence (24 months post-baseline)
B: Intimate partner violence (One year)
C: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
D: depression (On completion of intervention and six months post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of BiPhasic Nasal Continuous Positive Airway Pressure (BP-NCPAP) vs. Non-invasive High Frequency Ventilation (NIHFV) Following NCPAP Failure: A Pilot Study
Brief Summary: In preterm infants, endotracheal mechanical ventilation is well known to cause various forms of lung injury including volutrauma, barotrauma and oxytrauma - collectively known as ventilator-induced lung injury (VILI). As such, there is a move towards non-invasive ventilation (NIV) in recent decades. However, many infants placed on NIV modes fail and require intubation. A relatively recent mode of NIV is non-invasive high frequency ventilation (NIHFV). Studies on this modality are scarce, but do suggest that neonates can be ventilated effectively. However, its efficacy in comparison with other existing modes of NIV remains unknown due to lack of appropriate studies. The investigators hypothesize that NIHFV is a superior NIV mode than Biphasic Nasal Continuous Positive Airway Pressure (BP-NCPAP) in preterm infants in preventing intubation following NCPAP failure.


Options:
A: paCO2 at 72 h After Extubation (64 h to 80 h)
B: Failure of assignmed non-invasive mode post randomization to NIHFV or BP-CPAP (72 hours)
C: Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes (Within the first 6 hours after birth)
D: intubation rate (3 days); total time of hospitalization (100 days); bronchopulmonary dysplasia(BPD) (at 28 days after birth or 36 weeks'gestational age or at discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of BiPhasic Nasal Continuous Positive Airway Pressure (BP-NCPAP) vs. Non-invasive High Frequency Ventilation (NIHFV) Following NCPAP Failure: A Pilot Study
Brief Summary: In preterm infants, endotracheal mechanical ventilation is well known to cause various forms of lung injury including volutrauma, barotrauma and oxytrauma - collectively known as ventilator-induced lung injury (VILI). As such, there is a move towards non-invasive ventilation (NIV) in recent decades. However, many infants placed on NIV modes fail and require intubation. A relatively recent mode of NIV is non-invasive high frequency ventilation (NIHFV). Studies on this modality are scarce, but do suggest that neonates can be ventilated effectively. However, its efficacy in comparison with other existing modes of NIV remains unknown due to lack of appropriate studies. The investigators hypothesize that NIHFV is a superior NIV mode than Biphasic Nasal Continuous Positive Airway Pressure (BP-NCPAP) in preterm infants in preventing intubation following NCPAP failure.


Options:
A: Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants (3 months)
B: Failure of assignmed non-invasive mode post randomization to NIHFV or BP-CPAP (72 hours)
C: Trigger Delay (last 5-min of each 15-min trial)
D: Duration of Invasive Mechanical Ventilation (up to 8 weeks); Ventilator-free Days (up to 8 weeks); Number of Babies With Reintubation (up to 8 weeks)

Answer: B