TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection
Brief Summary: This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.


Options:
A: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug (Up to 24 weeks)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate (12 weeks after last dose of study drug)
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug (Up to 12 weeks)
D: Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (12 weeks after the last actual dose of study drug)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Engaging Fathers in Home Visitation: Incorporation of a Coparenting Intervention
Brief Summary: The purpose of this study is to determine the efficacy of Family Foundations that is to be delivered concurrently with home visiting. Delivered prenatally and postnatally, Family Foundations is a coparenting prevention program for new mothers and fathers that is designed to optimize child outcomes by teaching parents how to work together in raising their child. Using a randomized clinical trial design, families will be assigned to receive Family Foundations + home visiting or home visiting alone. A comprehensive assessment is administered at baseline and then at post-intervention, and 9 and 18 months later. It is hypothesized that families receiving Family Foundations will improve in their resolving of conflict from pre-intervention through follow-up. Additional anticipated outcomes are that those receiving the intervention will have more involved fathers, mothers and fathers will report less conflict, and children will have better emotional and behavioral outcomes relative to those who receive home visiting alone.


Options:
A: Number of symptoms on the BSI 18 and the PFB-K (Before birth (T1), two months after birth (T2)); Severity rating (0-8) of regulatory problems in infants (six months after birth (T3))
B: Change in PTSI symptoms (Baseline, Immediately Post- intervention, 2 months post-intervention, 6 months post-intervention)
C: mother and father resolving of conflict (pre-intervention, post-intervention (up to 9 months after pre-intervention), up to 18 months after pre-intervention, up to 27 months after pre-intervention)
D: SCL-20 depression (baseline, 3, 6 12, 18 month follow-ups)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Determination of Beta-cell Responsiveness to the Incretin Hormones GLP-1 and GIP in Cystic Fibrosis
Brief Summary: In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when either the body does not make enough insulin or the body does not respond correctly to this insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar) from the food we eat to the cells of the body for energy. While cystic fibrosis related diabetes (CFRD) has many features similar to both T1D and T2D, patients with CF may not have the same symptoms as either T1D or T2D patients. Currently, there is little understanding of CFRD and the best options for treatment remain unclear.

The purpose of this research study is to examine and understand the various mechanisms that contribute to CFRD and gain a better understanding of potential means to treat CFRD. In particular, we plan to study the effects of incretin hormones that can enhance insulin production in CF patients.

Enrollment is complete for the protocol as initially written. In order to further study the role of the incretin hormone on Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) function , we have received approval to extend our investigation to include the following study groups:

* Cystic Fibrosis participants with normal glucose tolerance
* Non-Cystic Fibrosis controls


Options:
A: Second-phase insulin response during GPA test (5 hours)
B: HbA1c (2 years)
C: The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes (12 months)
D: Change in glycemia at 2h of -1.5 mmol/L (baseline and week 13)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Determination of Beta-cell Responsiveness to the Incretin Hormones GLP-1 and GIP in Cystic Fibrosis
Brief Summary: In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when either the body does not make enough insulin or the body does not respond correctly to this insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar) from the food we eat to the cells of the body for energy. While cystic fibrosis related diabetes (CFRD) has many features similar to both T1D and T2D, patients with CF may not have the same symptoms as either T1D or T2D patients. Currently, there is little understanding of CFRD and the best options for treatment remain unclear.

The purpose of this research study is to examine and understand the various mechanisms that contribute to CFRD and gain a better understanding of potential means to treat CFRD. In particular, we plan to study the effects of incretin hormones that can enhance insulin production in CF patients.

Enrollment is complete for the protocol as initially written. In order to further study the role of the incretin hormone on Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) function , we have received approval to extend our investigation to include the following study groups:

* Cystic Fibrosis participants with normal glucose tolerance
* Non-Cystic Fibrosis controls


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF, where the primary variable is coefficient of fat absorption (CFA%) (72 hrs)
C: Percent Coefficient of Fat Absorption (CFA%) (Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods)
D: Second-phase insulin response during GPA test (5 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: POSITIVE: PerfusiOn Imaging Selection of Ischemic STroke PatIents for EndoVascular ThErapy
Brief Summary: Primary Endpoint:

The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT with respect to endpoint defined as:

• 90-day global disability assessed via the modified Rankin score (mRS), analyzed using raw mRS scores. Statistical details can be found in section 7.2.

Secondary Endpoints:

* 90-day global disability in the 6-12 hr cohort assessed via the overall distribution of mRS
* Proportion of patients with good functional recovery for the 6-12 hr cohort as defined by mRS 0-2 at 90 days
* Mortality at 30 and 90 days
* Intracranial hemorrhage with neurological deterioration (NIHSS worsening \>4) within 24 hours of randomization
* Procedure related serious adverse events (SAE's)
* Arterial revascularization measured by TICI 2b or 3 following device use


Options:
A: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)
B: Assessment of modified Rankin Scale shift analysis at 90 days after onset (90 days)
C: Combined death and disability (90 days)
D: Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS) (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: POSITIVE: PerfusiOn Imaging Selection of Ischemic STroke PatIents for EndoVascular ThErapy
Brief Summary: Primary Endpoint:

The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT with respect to endpoint defined as:

• 90-day global disability assessed via the modified Rankin score (mRS), analyzed using raw mRS scores. Statistical details can be found in section 7.2.

Secondary Endpoints:

* 90-day global disability in the 6-12 hr cohort assessed via the overall distribution of mRS
* Proportion of patients with good functional recovery for the 6-12 hr cohort as defined by mRS 0-2 at 90 days
* Mortality at 30 and 90 days
* Intracranial hemorrhage with neurological deterioration (NIHSS worsening \>4) within 24 hours of randomization
* Procedure related serious adverse events (SAE's)
* Arterial revascularization measured by TICI 2b or 3 following device use


Options:
A: Modified Rankin Scale (mRS) 0-1 (3 months)
B: Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS) (90 days)
C: Modified Rankin Scale 0-1 (90 days after stroke onset)
D: Modified Rankin Scale (mRS) 0-1 (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV cps2, Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age
Brief Summary: Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children. This study will evaluate the safety and immune response to an RSV vaccine in healthy RSV-naïve children.


Options:
A: To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh (17 months)
B: Number of Subjects With Abnormal Biochemical Laboratory Values. (At Day 7); Number of Subjects With Abnormal Biochemical Laboratory Values. (At Day 30); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 7); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 30); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 7); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 30); Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Haematology Change From Baseline by Maximum Grade (From Day 7 up to Day 30); Number of Subjects With Solicited Local Symptoms (During a 7-day follow-up period (from Day 0 to Day 6) after vaccination); Number of Subjects With Solicited General Symptoms (During a 7-day follow-up period (from Day 0 to Day 6) after vaccination); Number of Subjects With Unsolicited Adverse Events (AEs) (During a 30-day follow-up period (from Day 0 to Day 29) after vaccination); Number of Subjects With Serious Adverse Events (SAEs) (From vaccination (Day 0) up to study end (Day 30))
C: Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study (Days 0-28) (Measured through Day 28); Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination (Measured through study follow-up period, up to 1 year after study entry)
D: Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) (From Day 2 to Day 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo and Active-controlled Study of Pregabalin for the Treatment of Uremic Pruritus
Brief Summary: Pruritus s a very distressing problem affecting patients with uremia and the prevalence of uremic pruritus (UP) ranges between 22% to 66%. Although some studies suggested pruritus is being decreased recently by use of better dialysis techniques, accumulating studies have shown the still high prevalence of UP. Because of its long duration, frequency and high intensity, UP has been reported to have a negative impact upon the patients' quality of life (QoL). However, the therapies in use, including antihistamines, ultraviolets, opioid antagonists and topical agents, are generally of insufficient efficacy, failing to provide adequate and long-lasting relief. Based on the neuropathic hypothesis and frequent co-occurrence of chronic pruritus and peripheral neuropathy in the patients undergoing hemodialysis, gabapentin, a medication widely used for a spectrum of neuropathic pain syndromes, has recently been suggested to be effective in the treatment of UP.Pregabalin, another gabaergic drug structurally related to gabapentin, have an advantage over gabapentin in terms of its more rapid response to stressful symptoms. Only two very recently small-scaled studies evaluate the effect of pregabalin for UP. However, both these studies were not randomized, placebo-controlled trails.As UP is still one of the most vexing and disabling symptoms in patients with ESRD, we decided to do this multicenter, randomized double-blind placebo-controlled trial (RCT) with a larger sample size and a longer duration.


Options:
A: Change From Baseline in the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score During Week 8 (Baseline, Week 8)
B: Subjective measurement of reduction in pruritus (3 months)
C: Reduction of UP by more than 50% after Pregabalin administration (2012)
D: The changes in pruritus symptoms assessed by VAS (Week0, week1-12, Week 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay
Brief Summary: Argentina and Uruguay are among the countries with the highest proportion of pregnant women who smoke. The implementation of an effective smoking cessation intervention would have a significant impact on the health of mothers and children. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide. However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the intervention will decrease the frequency of women who smoke by the end of their pregnancies. Prenatal clinics will be randomly allocated to either an intervention or a control group after a baseline data collection period. Midwife facilitators in the ten intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The ten clinics in the control group will continue with their standard in-service activities. A follow-up data collection will be conducted immediately after delivery. The intervention will be tailored by formative research to be readily applicable to local prenatal care services at busy maternity hospitals, as well as to be acceptable to local pregnant women and health providers. The study will be conducted in 48 months.


Options:
A: Frequency of women receiving the cessation smoking advice (Interviews during the first 12 hours after delivery)
B: Biochemically-validated smoking cessation (middle and late pregnancy)
C: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
D: Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. (6 months from participant's quit date)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay
Brief Summary: Argentina and Uruguay are among the countries with the highest proportion of pregnant women who smoke. The implementation of an effective smoking cessation intervention would have a significant impact on the health of mothers and children. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide. However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the intervention will decrease the frequency of women who smoke by the end of their pregnancies. Prenatal clinics will be randomly allocated to either an intervention or a control group after a baseline data collection period. Midwife facilitators in the ten intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The ten clinics in the control group will continue with their standard in-service activities. A follow-up data collection will be conducted immediately after delivery. The intervention will be tailored by formative research to be readily applicable to local prenatal care services at busy maternity hospitals, as well as to be acceptable to local pregnant women and health providers. The study will be conducted in 48 months.


Options:
A: To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post). (prior to and approximately 12 months following each site's enrollment in the study); Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation (June 2013-June 2017)
B: Frequency of women receiving the cessation smoking advice (Interviews during the first 12 hours after delivery)
C: Patient report (Within 3 days of the dental encounter)
D: Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization (between 6 and 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Family Integrated Care Model For The Neonatal Intensive Care Unit: A Cluster Randomised Controlled Trial
Brief Summary: In the highly technological environment of the modern neonatal intensive care unit (NICU), the infant is physically, psychologically and emotionally separated from its parents. Recognition that this impedes parent- infant interaction and is detrimental to the infant, led to the development of programs such as family centered care, kangaroo care and skin-to-skin care1-3. However, they are based on the common premise that only NICU professionals with special skills can provide care for the infant. Parents are relegated to a supportive role, and some have described themselves as voyeurs who are "allowed" to visit and hold their infants4. Many feel anxious and unprepared to care for their infants after discharge5.

In 1979, a shortage of NICU nurses in Estonia prompted Levin1,6 to implement a "humane" care model in which parents provided nursing care for the infant (except for administration of IV fluid and medication), while nurses provided teaching and guidance to parents. This resulted in 30% improvement in weight gain1,30% reduction in infections, 20% reduction in NICU length of stay, 50% reduction in nurse utilization and overall improved satisfaction among parents and staff \[personal communication, Levin,A.\]. Building on the Estonian experience, we have developed a new Family Integrated Care (FIC) model that is adapted for the NICU environment in North America. In a pilot study at Mount Sinai Hospital, Toronto 46 infants and their families were enrolled in the study. Preliminary results and feedback from parents and healthcare providers (HCP) show that the FIC model is both feasible and safe, and may lead to improved outcomes including improved weight gain(paper submitted for publication). This study is a cluster randomized controlled trial in 16 tertiary level NICUs, to evaluate the efficacy of the FIC model in Canada.


Options:
A: Weight Gain (Day 0-21)
B: Occurence of complication(s) of pregnancy, wether maternal, fetal or neonatal (Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.)
C: Proportion of fully immunized children (When the participants reach 2 years of age)
D: Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months (index visit and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis: Randomized Controlled Trial
Brief Summary: The objective of this study is to determine for previously healthy children who present to a Canadian Emergency Department (ED) with acute gastroenteritis (infection or irritation of the digestive tract); if compared with placebo, the administration of a probiotic agent (Lacidofil) will result in a significantly lower proportion of children developing moderate to severe disease over the subsequent 2 weeks and will not be associated with a significantly greater occurrence of side effects.


Options:
A: Clinical symptom 2 days after medication; Microbiology study 3 days and one week after medication
B: Development of moderate to severe disease in the 2 weeks after the index visit (Measured daily for 14 days)
C: Duration of diarrhea (within the first 72 hours during hospitalization)
D: Number of Participants With Modified Vesikari Scale Score >=9 (14 days)

Answer: B