TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week, Phase III, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Currently ESA Users
Brief Summary: Daprodustat is a drug that is currently being developed as a treatment for renal anemia . This study is to evaluate the efficacy and safety of daprodustat following a switch from erythropoiesis-stimulating agent (ESA) in Japanese HD subjects with renal anemia who are currently treated with ESA. The primary objective is to demonstrate non-inferiority of daprodustat to darbepoetin alfa. This study is a 52-week, Phase III, double-blind, active-controlled, parallel-group, multi-center study. The total duration of the study will be approximately 58 weeks including screening and follow-up.


Options:
A: Percentage of Participants Achieving a Successful Hemoglobin Response (Weeks 19 and 20)
B: Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment (Baseline (pre-dose on Day 1) and up to week 4)
C: Hemoglobin level (24 weeks)
D: Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) (Weeks 40 to 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Full-mouth Periodontal Debridement Associated With Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial
Brief Summary: The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP).


Options:
A: Change in Mean Clinical Attachment Level. (Baseline, 3, 6 and 12 months)
B: Change in Clinical Attachment Level (CAL) (Baseline, 3 and 6 months)
C: probing depth (six months)
D: Probing Depth (six months period (two measurements))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Full-mouth Periodontal Debridement Associated With Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial
Brief Summary: The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP).


Options:
A: Change in Clinical Attachment Level (CAL) (Baseline, 3 and 6 months)
B: Probing Depth (six months period (two measurements))
C: Clinical Attachment Level (6 months)
D: Change in probing pocket depth (PD) (baseline, 4weeks, 8weeks and 12weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults
Brief Summary: The purpose of this study is to assess the safety and efficacy of time-restricted feeding (eating within an 8-hour window) for improving physiological function (vascular, motor, cognitive and metabolic function) in healthy middle-aged and older adults.


Options:
A: Change from baseline shear wave elastography (SWE) at 8 weeks (Change from baseline at 8-week); Change from baseline liver steatosis at 8 weeks (Change from baseline at 8-week); Concentration of high-density lipoprotein (HDL) (Change from baseline at 8-week); Concentration of low-density lipoprotein (LDL) (Change from baseline at 8-week); Concentration of triglycerides (TG) (Change from baseline at 8-week); Concentration of total cholesterol (TC) (Change from baseline at 8-week); Concentration of fasting blood sugar (FBS) (Change from baseline at 8-week); Concentration of alanine aminotransferase (ALT) (Change from baseline at 8-week); Concentration of aspartate aminotransferase (AST) (Change from baseline at 8-week)
B: Progression-free-survival (6 months)
C: Changes in body weight (Kilograms) (Baseline and 16 weeks); Change in insulin resistance (Baseline and 16 weeks)
D: Endothelium Dependent Dilation (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia
Brief Summary: This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).


Options:
A: Overall Response Rate (ORR) (At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort)
B: Overall Response Rate (ORR) (From 3 cycles (90 days) up to 6 cycles (approximately 180 days))
C: Percentage of Participants With Overall Response At the End of Induction Period (Randomization to clinical cutoff: 01 September 2011 (Up to 70 days))
D: Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment (IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Granulocyte Colony Stimulating Factor Plus N-Acetyl Cysteine In Severe Alcoholic Hepatitis
Brief Summary: Alcoholic hepatitis is related to very high mortality rate. About 40% of the patients are died within first 6 months after the detection of the clinical syndrome. Therefore, it is very essential for proper diagnosis and early treatment. In response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate liver and differentiate into hepatic cells. Animal and human studies suggested that injured hepatocyte may be replaced by pluripotent bone marrow cells. However, this hepatocyte repopulation is highly dependent on varieties of liver injury and therapeutic conditions6. The studies has suggested Granulocyte-colony stimulating factors (G-CSF) can regenerate hepatocyte by fusing with hematopoietic cells, thereby enhancing the liver histology and survival rate.

G-CSF is a cytokine capable to regulate a number of functions in neutrophils. In three recent studies mobilization of bone marrow stem cells induced by G-CSF was observed in patients with alcoholic hepatitis. In two of this studies there was a survival benefit with the use of G-CSF.

Alcoholism leads to decrease in endogenous antioxidant potential. Alcoholic liver disease (ALD) patients show low endogenous antioxidants. Chronic ethanol consumption cause selective deficiency in the availability of reduced glutathione (GSH) in mitochondria has been reported. This is due to impaired functioning of GSH transporter from cytosol to mitochondrial matrix. The effect on glutathione replenishing potential by N-acetyl cysteine (NAC) can be used to reduce oxidative stress, which also has excellent safety profile. Therefore, NAC can be used for severe alcoholic hepatitis treatment due to its therapeutic potential factor. NAC also inhibit apoptosis and pro-inflammatory cytokine production. In a study high doses of intravenous N-acetyl cysteine therapy for 14 days conferred neither survival benefits nor early biological improvement in severe alcoholic hepatitis patients with adequate nutritional support.However, these results must be viewed with caution, since the study suffered from a lack of power. In a recent study, NAC and corticosteroids combination therapy benefits among patients with severe acute alcoholic hepatitis in 1 month survival, although the final outcome at 6 month survival was not improved. There are no studies on the use of combination therapy of NAC plus G-CSF in patient with severe alcoholic hepatitis.

Therefore we plan to study the safety and efficacy of combination therapy of G-CSF and NAC in the patients with alcoholic hepatitis.


Options:
A: The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis. (1 Year)
B: Primary end point- Survival at the end of 90 days (90 days)
C: Number of participants alive at 6 months (6 months)
D: Transplant-free survival up to 90 days (death or transplant count as events) (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of a Social Media Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence
Brief Summary: While cardiac rehabilitation (CR) has been shown to be effective at improving cardiovascular disease (CVD), participation is generally poor. The current feasibility study, will evaluate the impact of a social media intervention on motivation for exercise and adherence to CR sessions. Participants will be randomly assigned to a Facebook™ group or an enhanced education comparison group. The intervention will include access to a private Facebook™ group in which participants will receive weekly educational posts, weekly provider support and have the opportunity to communicate with other cardiac rehabilitation patients. Patients in the comparison group will be given the same educational materials, but these will be supplied in email. Participants will be asked to fill out a pre-post motivational questionnaire and the total number of sessions attended at the end of 3 months will be tallied. This study is grounded in Self-Determination Theory (SDT) and utilizes the Behavioral Regulation in Exercise Questionnaire (BREQ-2), which is based on the SDT.


Options:
A: Motivation (12 weeks); Needs Satisfaction (12 weeks)
B: Changes from baseline in patient self-management (Health Education Impact Questionnaire v3.0) every 6 months until study end. (At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject)
C: Cardiac Rehabilitation Enrollment (12 weeks after patient is discharged from hospital)
D: Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52. (baseline and after 12 months); Changes from baseline in self-rated Health related quality of Life (36 item); The SF 36 - item short-form health status survey at week 52 (baseline and after 12 mounth); Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52 (baseline and after 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial
Brief Summary: Women in their 3rd trimester, represent a unique segment of the tokophobic population. In these cases help is needed within a very short and limited period of time. To date, no specific treatment targets this population in order to ameliorate the anxiety and to provide these women and their newborns with better obstetric and psychiatric outcomes. The present study investigates an accessible individual two session intervention conducted by midwives skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable stronger emotional regulation and increase of their capacity to accept unexpected changes during labor and feelings of control. The investigators expect this psychological adjustment to lead to a better course of delivery, less interventions including caesarian sections, and subjective birth experience.


Options:
A: number of spontaneous vaginal deliveries (after delivery within a month)
B: spontaneous vaginal delivery (day of delivery)
C: Pregnancy-Related Anxiety Questionnaire (In the end of second session of intervention- up to 4 weeks from screening)
D: Scores for the Wijma Delivery Expectancy Questionnaire (W-DEQ) (Change in W-DEQ scores measured at entry to the study (approximately gestational weeks 20 to 31) and again at gestational week 36.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: HiFIT Study: Interest of Intravenous Iron and Tranexamic Acid to Reduce Transfusion in Hip Fracture Patients
Brief Summary: Fractures of the upper end of the femur, called commonly "Hip fractures" are very common, with an incidence of approximately 1.6 million cases per year worldwide. This high incidence is anticipated to grow rapidly in the next decades, driven by population aging. Anemia is very frequent on admission for hip fracture, concerning up to 45% of the patients, with a mean hemoglobin level of 12.5±0.2 g/dl. This high prevalence of anemia together with blood losses, secondary to the fracture itself and surgery are responsible for a high rate of blood transfusion (approximately 40-50% of the patients). However, both anemia and blood transfusion are associated with poor outcome, including increased mortality, length of stay, infection rate etc. In addition, blood is a scarce and expensive resource and its use should be limited as much as possible. There is therefore a need to treat this anemia and/or to prevent the decrease in hemoglobin. For this purpose, intravenous iron has been proposed. Some non-randomized, mainly retrospective, studies have shown that perioperative intravenous iron was able to reduce blood transfusion (i.e. the number of patients transfused and the number of units per patient). Another way to reduce blood transfusion would be to reduce perioperative bleeding. Tranexamic acid has proven to be efficient for this purpose both in trauma patients and in elective surgery patients.The interest for perioperative blood management has recently increased thanks to better recognition of the adverse effects of blood transfusion, better understanding of iron metabolism, new intravenous iron drugs and a renewed interest in former medications (i.e. tranexamic acid). HiFIT study therefore propose a 2X2 factorial design for this study in order to answer questions vis-à-vis the interest of iron and tranexamic acid to reduce blood transfusion in hip fracture patients.


Options:
A: Proportion of Subjects Achieving Hemostatic Success (Intra-operative)
B: Proportion of patients who received a blood transfusion during their hospital stay following surgery (From the day of surgery until hospital discharge (or until day 30 if patient is still hospitalized).)
C: Change in hemoglobin (1 day and 3 days post-surgery)
D: Intraoperative blood loss (End of surgery (last suture))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study and Open-Label Extension of SC411 in Children With Sickle Cell Disease
Brief Summary: This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study of SC411 in children with sickle cell disease (SCD). The primary objective of the study is to evaluate the safety and tolerability of three different doses of SC411 compared to a placebo. All patients will undergo eight weeks of oral study treatment and a four-week safety follow-up period. Patients will be randomized to one of three dose levels of SC411 or placebo.


Options:
A: The Number of Occurrences of Sickle Cell Crises (48 weeks)
B: Gardos Channel Activity (12 weeks after randomization); Nitric Oxide (12 weeks after randomization); Mean Corpuscular Hemoglobin Concentration (12 weeks after randomization)
C: Evaluate safety & tolerability of SC411 & determine change from Baseline in the blood cells omega-3 fatty acids index in subjects, treated with active SC411 doses or placebo in Part A and safety and tolerability in Part B. (Week 0 (baseline) through Month 52 (end of treatment))
D: To determine whether supplementation with LOVAZA will exert an anti-inflammatory effect by decreasing levels of the inflammatory biomarker high sensitivity C Reactive Protein (hsCRP) in children and adolescents with Sickle Cell Disease (SCD). (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: New Ulm at HOME (Healthy Offerings Via the Mealtime Environment), NU-HOME
Brief Summary: The goal of the proposed project is to see if an innovative family-based intervention can reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors in the home. In addition, the project will also examine how the NU-HOME family intervention influences children's dietary intake, availability of healthy and unhealthy foods in the home and served at meals and snacks, physical activity as a family, and child screen time (TV, game systems). The study will build upon a similar project conducted in an urban area and translate the lessons learned and adapt the program for a rural community.


Options:
A: Change in Child Body Mass Index (BMI) Z-score (Post intervention (9 months after baseline))
B: PROMIS Asthma Impact Scale (v1.0, SF8a) (Baseline and 6 months after index ED discharge); PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a) (Baseline and 6 months after index ED discharge)
C: Access to specialty services- Referral time (6 month post-enrollment); Access to specialty services- Travel (6 month post-enrollment); Access to specialty services- Missed school/work (6 month post enrollment); Access to specialty services- Out of pocket cost (6 month post-enrollment); Access to specialty services- Visits (6 month post-enrollment)
D: Frequency of Evidence Based Strategies (Discharge or 7 days after admission); Composite Adherence Score (Discharge or 7 days after admission)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.
Brief Summary: The aim of this protocol is to find out about the safety and effectiveness of M2951 in participants with relapsing multiple sclerosis. Participants were placed into 1 of 3 groups to receive M2951, placebo or tecfidera for 24 weeks. After 24 weeks, the participants on placebo were given M2951.


Options:
A: At least 1 point-reduction on Kurtzke functional scale (28 days after beginning of corticotherapy)
B: Total Number of Gadolinium-Enhancing T1 Lesions (Week 12 to Week 24)
C: Efficacy parameters
D: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) (From Baseline until the end of the study (up to a maximum duration of 5.6 years)); Number of Participants With Infusion-Associated Reactions (IAR) (Within 24 hours of any alemtuzumab infusion); Number of Participants With Adverse Events of Special Interest (AESI) (From Baseline until the end of the study (up to a maximum duration of 5.6 years)); Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (From Baseline until the end of the study (up to a maximum duration of 5.6 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients
Brief Summary: Study to investigate whether a smart technology intervention can improve clinical and cost-effectiveness of one-year follow-up in patients who suffered from acute myocardial infarction.


Options:
A: exercise capacity as reported in total time on the exercise test using the BRUCE protocol (16 months)
B: coronary collateral blod flow (4 weeks)
C: Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period (0, 12 and 52 weeks)
D: Controlled Blood pressure (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Phase 2 Study to Identify of the Optimal Neo-Adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo)
Brief Summary: This is an open-label three-arm phase 2 trial (including a Simon stage 2 design) consisting of 90 stage III melanoma patients randomized 1:1:1 to receive either 2 courses 3 mg/kg ipilimumab + 1 mg/kg nivolumab every 3 weeks (Arm A), 2 courses 1 mg/kg ipilimumab + 3 mg/kg nivolumab every 3 weeks (Arm B), or 2 courses ipilimumab 3 mg/kg, directly followed by 2 courses nivolumab 3 mg/kg every 2 weeks (Arm C). All three treatment arms are applied prior to surgery at week 6, 30 patients per arm. Patients will be stratified according to treatment center. An interim analysis will be performed after 13 patients have been included in each arm, thus in total 39 patients have been included.

PRADO extension cohort The trial will enroll in total about 100-110 melanoma patients with macroscopic stage III disease (RECIST measurable disease); inclusion will stop when 50 patients have achieved a pCR or pnCR. All patients will be treated (after marker placement into the largest lymph node metastasis) with the winner combination identified in the first part of the OpACIN-neo study which is 2 courses ipilimumab 1mg/kg + nivolumab 3mg/kg, q3wks. After 6 weeks of treatment, the patients will undergo only surgical resection of the marked index lymph node. Thereafter subsequent surgery and adjuvant therapy will be performed according to the achieved pathologic response.


Options:
A: Pathological response rate (From baseline to 6 weeks)
B: Progression-free Survival (PFS) as Assessed by the Investigator (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)); Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months))
C: Safety as measured by the frequency of grade 3/4 immune-related adverse events, using CTCAE 4.03 (During the first 12 weeks.); Response rate according to RECIST 1.1 (At 6 weeks); Pathological response according to central pathological revision, according to pathological response criteria (At 6 weeks); Pathologic response rate according to central revision of the marked index lymph node (At 6 weeks, prior surgery); RFS at 24 months in patients achieving pCR or pnCR in their marked index lymph node and did not undergo CLND. RFS will be calculated from date of resection of the marked lymph node. (24 months); RFS at 24 months in patients with pNR and being subsequently treated with adjuvant nivolumab+optional radiotherapy (or dabrafenib/trametinib if BRAFV600E pos. and treatment is approved). RFS will be calculated from day of resection of marked lymph node. (24 months)
D: Recurrence-Free Survival (RFS) (24 months after last participant was randomized (data cutoff date of 30 April 2019))

Answer: C