TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Mechanical and Oral Antibiotic Bowel Preparation Versus Oral Antibiotics Alone for the Reduction of Surgical Site Infection Following Elective Colorectal Resection
Brief Summary: This randomized clinical trial studies how well neomycin and metronidazole hydrochloride with or without polyethylene glycol work in reducing infection in patients undergoing elective colorectal surgery. Polyethylene glycol, may draw water from the body into the colon, flushing out the contents of the colon. Antibiotics, like neomycin and metronidazole hydrochloride, may stop bacteria from growing. It is not yet known whether it's better to give preoperative neomycin and metronidazole hydrochloride with or without polyethylene glycol in reducing surgical site infection after colorectal surgery.


Options:
A: Surgical Site Infection Rate (30 days following date of surgery)
B: Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak (Up to 30 days post operation)
C: The primary endpoint of the study was anastomotic failure.
D: occurrence of any SSI within 30 days after surgery. (30 days after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Allogeneic Mesenchymal Stromal Cells for Angiogenesis and Neovascularization in No-option Ischemic Limbs; A Double-blind, Randomized, Placebo-controlled Trial
Brief Summary: The primary objective of this trial is to investigate whether intramuscular administration of allogeneic mesenchymal stromal cells (MSC) is safe and potentially effective, assessed as a composite outcome of mortality, limb status, clinical status (Rutherford classification) and pain score (visual analogue scale), in patients with no-option severe limb ischemia (SLI).

The investigators will conduct a double-blind, placebo-controlled randomized clinical trial to investigate the effect of allogeneic bone marrow(BM)-derived MSC in patients with SLI, who are not eligible for conventional surgical or endovascular therapies. The investigators intend to include 60 patients, who will be randomized to undergo 30 intramuscular injections with either BM-MSC (30 injection sites with 5\*10\^6 MSCs each) or placebo in the lower leg of the ischemic extremity. Primary outcome i.e. therapy success, a composite outcome considering mortality, limb status, clinical status (Rutherford classification) and changes in pain score, will be assessed at six months.


Options:
A: Major amputation
B: Number of participants with treatment-related adverse events occurring during the enrollment period as assessed by the Investigator using the MeDRA scale. (Primary follow up in a 6 month period)
C: Ankle brachial index (6 months)
D: Therapy Success (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Allogeneic Mesenchymal Stromal Cells for Angiogenesis and Neovascularization in No-option Ischemic Limbs; A Double-blind, Randomized, Placebo-controlled Trial
Brief Summary: The primary objective of this trial is to investigate whether intramuscular administration of allogeneic mesenchymal stromal cells (MSC) is safe and potentially effective, assessed as a composite outcome of mortality, limb status, clinical status (Rutherford classification) and pain score (visual analogue scale), in patients with no-option severe limb ischemia (SLI).

The investigators will conduct a double-blind, placebo-controlled randomized clinical trial to investigate the effect of allogeneic bone marrow(BM)-derived MSC in patients with SLI, who are not eligible for conventional surgical or endovascular therapies. The investigators intend to include 60 patients, who will be randomized to undergo 30 intramuscular injections with either BM-MSC (30 injection sites with 5\*10\^6 MSCs each) or placebo in the lower leg of the ischemic extremity. Primary outcome i.e. therapy success, a composite outcome considering mortality, limb status, clinical status (Rutherford classification) and changes in pain score, will be assessed at six months.


Options:
A: N/A
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: AE and symptomatic relief (6 months)
D: Therapy Success (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Observational, Electronic Database With a Prospective Phase and Retrospective Phase for the Follow up of the ATG_FamilyStudy
Brief Summary: Allogeneic hematopoietic stem cell transplantation (HSCT) is capable of definitive cure of acute leukemias. The most important post-transplant complication is graft vs host disease (GVHD) which can be substantially decreased by the addition of anti-T lymphocyte globulin (ATG-Grafalon) to the standard GVHD prophylaxis (cyclosporin and methotrexate) without any increase in relapses and infections (Kroger et al NEJM 2016, ClinicalTrials.gov number, NCT00678275). In the ATG_familystudy (prospective, randomised, multicenter study) a decrease in the incidence of chronic GVHD (from 67.8% to 32.2%) was observed after the addition of ATG (10 mg/kg for three days ,from day -3 to -1) to the standard GVHD prophylaxis in the setting of acute leukemias in any remission, receiving peripheral blood stem cells from an HLA identical sibling donor after myeloablative preparative regimen. In particular, the GVHD extensive form was reduced from 52.4% to 7.6%. The study has been closed in 2014 with a minimum follow up of 2 years from transplant. The investigators would like to evaluate the longer term follow up of this study.


Options:
A: Incidence of acute GVHD, and chronic GVHD (2 years)
B: cumulative incidence of cGVHD (cumulative incidence of cGVHD through study competition, an average of 24 months)
C: Freedom from Chronic GVHD (12 months post transplant)
D: comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic SCT from HLA-identical siblings with or without anti-T-lymphocyte-globulin at 2 years after transplantation (2 years after transplantation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention in Substance Abuse Treatment Programs
Brief Summary: This study will test the effects of the Leadership and Organizational Change for Implementation (LOCI) intervention in facilitating evidence-based practice (EBP) implementation in substance use disorder (SUD) and HIV services settings. LOCI improves implementation leadership and organizational support to develop strategic climate for EBP implementation. Greater efficiency and effectiveness of EBP implementation will improve the public health impact of evidence-based health and allied healthcare innovations and lead to greater effectiveness of SUD and HIV services.

Project Terms:


Options:
A: Implementation Leadership (12 months); Full Range Leadership (12 months)
B: Supportive leadership behaviour questionnaire for assessing head nurses performance (10 months)
C: Fraction of Pulseless Time With no Chest Compressions (From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes))
D: Change in team cohesion (Change from baseline to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effectiveness and Impact of Community Case Management of Severe Acute Malnutrition Through Lady Health Workers As Compared To a Facility Based Program: A Cluster Randomized Controlled Trial
Brief Summary: HYPOTHESIS:

Investigators hypothesize that by provision of care at household level in a community through lady health workers will as effective (recovery rate, burden of SAM, cost effective, coverage) as through health care providers at facility level. OBJECTIVES

1. To evaluate the effectiveness (rate of recovery, burden \& coverage), of SAM standard management of children 06-59 months delivered at household level by first level health care providers (Lady health workers) compared with the standard CMAM program delivered at health facility by Govt./ACF staff.
2. To evaluate the cost effectiveness of treatment of SAM provided by LHWs at community level versus treatment delivered at health facility by Govt/ACF staff.

STUDY DESIGN:

Cluster randomized controlled trial

SAMPLE SIZE \& RANDOMIZATION:

Investigators took 6% prevalence to calculate the sample size with an expected reduction of 20%. A sample size of 3 clusters per group with 150 individuals per cluster is needed. STUDY METHODOLOGY Intervention (Group A): LHWs will identify and treat all cases of severe acute malnutrition (SAM) as per the study eligibility criteria (MUAC \< 11.5 cm) and manage all cases of SAM without complications at home following the national CMAM guidelines. Control (Group B): LHWs will identify SAM as per the CMAM guidelines (MUAC \< 11.5 cm) and will refer all cases to the health facility (ACF) for further management and counselling by health workers at facility.


Options:
A: To evaluate rate of recovery (18 months)
B: Absolute change pre/post intervention (VHV ICCM training) in proportion of U5s receiving (a) antimalarial for fever (b) ORS/Zn for diarrhea (c) Abx for pneumonia (pre- (Dec 2010) post- (Dec 2012) intervention (2 years))
C: Dietary diversity defined as number of food groups consumed out of 10 (12 and 36 months)
D: The coverage of the therapeutic nutritional program in the control and intervention health districts (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial to Assess the Effectiveness of Intermittent Pneumatic Compression in the Prevention of Postoperative Venous Thromboembolism in Surgical Patients at Extremely High Risk
Brief Summary: The aim of the study is to evaluate efficacy and safety of venous thromboembolism prophylaxis by the combination of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins (LMWH) and sequential compression device (SCD) in the mixed group of surgical patients at high and extremely high risk for venous thromboembolism.


Options:
A: incidence of VTE (up to 30 days after operation)
B: Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound (28 days from randomization)
C: Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound (time of discharge from the hospital or death, up to 45 days)
D: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes (Treatment period : up to day 36+/-6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer - An Open Label, Non-comparative, Randomized, Multicenter Phase II Trial
Brief Summary: AIO-YMO/HEP-0315 (NIFE) is an open label, non-comparative, randomized, multicenter phase II trial


Options:
A: Progression free survival (six months)
B: Progression-free survival [PFS] (approx. 25 months)
C: Progression-free survival rate at 6 months (6 months)
D: Overall Survival (From date of randomisation till date of death or last date of follow-up (up to 5 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study
Brief Summary: Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study


Options:
A: incidence of VTE (up to 30 days after operation)
B: Recurrent venous thromboembolism (6 months)
C: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)
D: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment (Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study
Brief Summary: Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study


Options:
A: Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month)); Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)); Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period (During extended treatment period: up to month 12.); Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication) (More than 2 and up to 30 days after stop of study medication); Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)); Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period (During extended treatment period: up to month 12.)
B: Recurrent venous thromboembolism (6 months)
C: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
D: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study
Brief Summary: Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study


Options:
A: Recurrent venous thromboembolism (6 months)
B: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
C: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
D: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis Harbouring One F508del CFTR Mutation and a Second Gating (Class III) Mutation
Brief Summary: This clinical study is a phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR mutation and a second gating (class III) mutation and on stable treatment with ivacaftor.

Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days. Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from screening until the follow-up visit.


Options:
A: Cohort 1: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)); Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs (Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21 (Cohort 1: Day 14, Day 21); Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56 (Cohort 2 and 3: Day 28, Day 56); Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56 (Cohort 4: Baseline, Day 56)
B: The sum of responses in nasal potential difference (NPD) after perfusion with isoproterenol and chloride-free buffer (TCS: Total Chloride Secretion), in the presence of amiloride. (Change from baseline (pre-dose on Day 1) to end-of-treatment (Day 8))
C: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
D: Part A: Observed Plasma Concentrations From 3-4 Hours (C3-4hr) of LUM and IVA (Day 1 and Day 15); Part A: Observed Pre-dose Plasma Concentration (Ctrough) of LUM and IVA (Pre-dose at Day 8 and Day 15); Part B : Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis Harbouring One F508del CFTR Mutation and a Second Gating (Class III) Mutation
Brief Summary: This clinical study is a phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR mutation and a second gating (class III) mutation and on stable treatment with ivacaftor.

Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days. Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from screening until the follow-up visit.


Options:
A: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
B: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
C: Safety as Determined by Adverse Events (AEs) (Start of study drug through the Follow-up Visit (Up to Day 56)); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 1-5b (Baseline through Day 28); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 6 (Baseline through Day 28); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 7 (Baseline through Day 28)
D: Safety and Tolerability Based on Adverse Events (AEs) (Up to 14 days after last dose (last dose = Day 28))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis Harbouring One F508del CFTR Mutation and a Second Gating (Class III) Mutation
Brief Summary: This clinical study is a phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR mutation and a second gating (class III) mutation and on stable treatment with ivacaftor.

Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days. Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from screening until the follow-up visit.


Options:
A: Cohort 1: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)); Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs (Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21 (Cohort 1: Day 14, Day 21); Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56 (Cohort 2 and 3: Day 28, Day 56); Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56 (Cohort 4: Baseline, Day 56)
B: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
C: Part A: Observed Plasma Concentrations From 3-4 Hours (C3-4hr) of LUM and IVA (Day 1 and Day 15); Part A: Observed Pre-dose Plasma Concentration (Ctrough) of LUM and IVA (Pre-dose at Day 8 and Day 15); Part B : Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 26)
D: Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score (From Baseline Through Week 24)

Answer: B