bioihbjkbjnl/mcl2 huggingface dataset:
ADME Study of [14C]-Ibrexafungerp in Healthy Male Subjects
Condition: Fungal Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the
      absorption, distribution, metabolism, and excretion (ADME) of an oral solution of
      [14C]-ibrexafungerp following administration in healthy male subjects.

      Each subject will receive a single dose of [14C]-ibrexafungerp and will be followed for up to
      20 days. During this period total radioactivity will be measured in blood, urine and faeces.
    

Detailed description: 
      This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the
      absorption, distribution, metabolism, and excretion (ADME) of an oral solution of
      [14C]-ibrexafungerp following administration in healthy male subjects.

      Each subject will receive a single dose of [14C]-ibrexafungerp and will be followed for up to
      20 days. During this period total radioactivity will be measured in blood, urine and faeces.

      All subjects will undergo preliminary screening procedures for the study at the screening
      visit. Subjects will be admitted to the clinical unit on the evening prior to dosing (Day
      -1). A single oral dose containing [14C]-ibrexafungerp oral solution will be administered to
      subjects. Individual subjects will be released from the clinical unit following study-related
      procedures on Days 8 to 20 according to their % of radioactivity collected in relation to the
      dose administered.
    

Intervention name(s): [14C]-Ibrexafungerp
Intervention type(s): Drug
Intervention description(s): Radio-labeled Ibrexafungerp, single dose.
Other intervention name(s): [14C]-SCY-078
Intervention MeSH terms: Ibrexafungerp
Intervention model: Single Group Assignment
Intervention model description: Open Label, single arm
Masking: None (Open Label)
Primary purpose: Other
Keywords: SCY-078; Ibrexafungerp; ADME
Local Measures to Prevent Diabetes in the Værnes Region.
Condition: Diabetes Mellitus Type 2; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This is a development project involving four different municipalities in Central Norway. The
      aim is to identify adults with overweight and with an increased risk of developing diabetes
      mellitus type 2, then to prevent the disease to develop by the means of a behaviour change
      programme. The programme is group based.
    


Intervention name(s): Behavioural change programme
Intervention type(s): Behavioral
Intervention description(s): The programme consists of a introductory course, organised physical activity 2-3 times a week, meetings every 3rd month with lectures and theme nights, and organising self-help groups.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention; public health; community health services; Norway
Case Management Alternatives for African American Women at High Risk for HIV
Condition: HIV
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test two innovative case management approaches designed to
      increase linkages and engagement with drug abuse treatment, HIV-related care, and other
      health services among an underserved population of African American women at risk for HIV.
    

Detailed description: 
      The study is fundamentally concerned with the implementation and evaluation of
      theoretically-based, culturally appropriate case management interventions targeting
      individual, social and environmental factors among highly vulnerable African American women.
      The research is designed to test innovative, comprehensive approaches to HIV
      prevention/intervention through case management driven service linkage and engagement.
      Testing new approaches to intervention with African-American women at high risk for HIV
      addresses a particularly urgent public health need in Miami, as well as other large
      metropolitan areas, where officials continue to document epidemic rates of HIV/AIDS clustered
      in urban, impoverished African-American communities.

      Comparison: Participants will be randomly assigned to: a Strengths-Based / Professional Only
      Condition in which clients participate in a "strengths-based" case management approach; or, a
      Strengths-Based / Professional/Peer Condition in which a team composed of: a) a credentialed,
      professional case manager and b) a recovering addict peer - both trained in "strengths-based"
      case management techniques - develop and facilitate the implementation of a service plan.
    

Intervention name(s): strengths-based case management
Intervention type(s): Behavioral
Intervention description(s): 5 session individual strengths-based case management; peer-involvement v. no peer involvement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HIV/AIDS; African Americans; Women; Case Management
Myths and Misconceptions About HSCT in a Limited Resource Region
Condition: Hematopoietic Stem Cell Transplantation
Study type: Interventional

Summary: 
      This study aimed to assess myths and misconceptions about hematopoietic stem cell
      transplantation, among students of medical colleges and to evaluate the value of an
      educational program in correcting those misconceptions. 218 undergraduate medical and nursing
      students included in this study. An intervention Quasi Experimental study design
      (pre/post-test) was used for this work.
    

Detailed description: 
      This study aimed to assess myths and misconceptions about hematopoietic stem cell
      transplantation, among students of medical colleges and to evaluate the value of an
      educational program in correcting those misconceptions. The last aim was to detect further
      needs for advancement of health education about bone marrow transplantation at Assiut
      University.

      Study subjects: two groups, Group 1: 5th year undergraduate medical students(118 students),
      Group 2: 4th year undergraduate nursing students(100 students). Each group were randomly
      selected . Both groups 1 and 2 assumed to have knowledge about BMT from their study courses,
      also they represent a sector from the general population that could be involved in a BMT team
      in their future career. this work that was conducted at Assiut University Faculties of
      Medicine and Nursing at Assiut Governorate during the period from July 2019 to May 2020. The
      subject's inclusion criteria were:

        -  Willingness to participate in the study

        -  Good ECOG performance status

        -  Intact physical and mental health

      And the Exclusion criteria were:

        -  HSCT team

        -  Drug users
    

Intervention name(s): educational program
Intervention type(s): Other
Intervention description(s): The needed knowledge about hematopoietic stem cell transplantation in a trial to correct their myths and misconceptions about this type of treatment. The educational pamphlet included three theoretical parts: bone marrow transplantation, bone marrow donation, and stem cells banking
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An intervention Quasi Experimental study design (pre/post-test)
Masking: Single (Participant)
Primary purpose: Health Services Research
Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease
Condition: Peripheral Artery Disease; Restenosis of Peripheral Vascular Stent; Restenosis, Vascular Graft; Endothelial Dysfunction
MeSH terms: Peripheral Arterial Disease; Graft Occlusion, Vascular
Study type: Observational

Summary: 
      The study is aimed at evaluating the role of the activity of the key hemostatic parameters of
      endothelial dysfunction (nitric oxide II (NO) metabolites, plasmin activator inhibitor-1
      (PAI-1), von Willebrand factor (vWF), coagulation factor VIII (FVIII), soluble endothelial
      protein C receptors (sEPCR)) in the development of disease progression, thrombotic
      complications and restenosis in subjects with atherosclerotic peripheral artery disease.
    

Detailed description: 
      The study will involve patients with atherosclerotic peripheral artery disease (Rutherford
      category 3-5). The subjects are to be divided into three groups:

      Group A: patients who undergo bypass surgery with a synthetic graft on aorto-iliac or
      femoro-popliteal segment; Group B: patients who undergo endovascular balloon angioplasty and
      stenting on aorto-iliac or femoro-popliteal segment; Group C: patients who undergo standard
      of care conservative treatment.

      Decisions on revascularization or conservative treatment alone is to be made by a team of
      vascular specialists in accordance with the severity of the disease, previous treatment,
      anatomy, possible need for repeat procedures in the future, and patient's preferences.
    

Intervention name(s): an arterial reconstructive procedure
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A prospective study is aimed at enrolling 200 patients with atherosclerotic peripheral
        arterial disease, Rutherford category 3-5. The patients with PAD are scheduled to undergo
        either open or endovascular reconstructive procedures on aorto-iliac and femoro-popliteal
        segment or conservative treatment alone. The subjects of similar age, sex, and ethnicity
        are to be divided into three groups, respectively.
      
Biospecimen description: 
      peripheral blood samples for the assessment of the concentration of NO metabolites, PAI-1,
      sEPCR, and activity of vWF, FVIII.
    
Keywords: hemostasis, endothelial dysfunction, restenosis, thrombosis
Hand Grip Strength in Chilean Adults
Condition: Hand Grasp
Study type: Observational

Summary: 
      Context Hand grip strength (HGS) is an important parameter to assess hand function during the
      rehabilitation of hand injuries. HGS serves as a clinical predictor of complications after
      surgery.

      Purpose Establish HGS reference values in healthy adult Chilean population.

      Study design analytical cross-sectional.

      Method 311 healthy women and men, ages 18 to 65 years participated in the study. HGS was
      measured with a dynamometer, according to the American Society of Hand Therapists protocol.
      Additionally, anthropometric and labour characteristics were registered. Kruskal-Wallis test,
      Wilcoxon-Mann-Whitney test and multiple linear regression were used for data analysis.
      Significance was set at .05.

      Results Median HGS in women was 26 kg and 43 kg for men. Men demonstrated 3% more HGS on the
      dominant versus non-dominant hand. Women's median HGS was no different between dominant
      versus non-dominant hand. In men and women, manual labour activity was associated with a
      higher HGS. The relationships between subject anthropometric measurements and HGS were
      different in women versus men.

      Conclusions This study determined HGS in Chilean healthy adults. Results can be used as a
      reference standard for clinical measures related to illness, injury and rehabilitation.
    


Intervention name(s): Dynamometry
Intervention type(s): Diagnostic Test
Intervention description(s): Hand grip dynamometer measure of strength and anthropometric measurements
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        healthy adult Chilean subjects with age between 18-65yo
      
Keywords: hand grip strength; anthropometry; grip; normative values
Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
Condition: Fertility, Male; Sub-Fertility, Male
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the agreement in measurement of sperm concentration
      in human semen between lay users with TRAK and a recognized reference method. The study will
      also include the measurement of matched samples by TRAK when tested by healthcare
      professionals trained in use of the TRAK device.
    


Intervention name(s): TRAK device
Intervention type(s): Device
Intervention description(s): Use of TRAK to attain sperm concentration measurement
Other intervention name(s): Sperm Concentration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Male Fertility; Male Infertility; Fertility; Sperm; Sperm Concentration
Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The purpose of this study was to identify the prognostic factors of affecting pT4bN0M0
      colorectal cancer patients, so as to better stratify the prognostic differences among
      patients with the same stage.
    

Detailed description: 
      Patients with pT4b stage colorectal cancer (CRC) are a complex and special group due to the
      diversity of infiltrated organs, patients with the same stage often have different prognosis
      after multivisceral resection (MVR), some important prognostic factors have not been deeply
      explored, and additional prognostic factors are needed to improve the survival assessment of
      these patients. In this study, investigators attempted to evaluate the prognostic factors of
      pT4bN0M0 colorectal cancer, and then stratify the prognosis of such patients to distinguish
      the survival differences among different patients.

      This study was a multicenter retrospective cohort study based on a multicenter database which
      contained hospitalization.The prognostic factors of pT4bN0M0 colorectal cancer patients were
      analyzed, and the prognostic grading system was constructed to accurately stratify the
      survival of pT4bN0M0 patients.
    

Intervention name(s): multivisceral resection
Intervention type(s): Procedure
Intervention description(s): The prognostic factors were analyzed for pT4bN0M0 colorectal cancer after multivisceral resection
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patient experienced multivisceral resection for pT4bN0M0 colorectal cancer from January
        2010 to December 2021.
      
Keywords: Colorectal Cancer; Multivisceral resection; Prognosis
Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) and Rosuvastatin Calcium
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and compare the pharmacokinetic
      parameters from the fixed dose combination ABT-143 relative to that from the
      co-administration of the two monotherapies.
    


Intervention name(s): ABT-143; ABT-335; rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): once, see arm description for more information; once, see arm description for more information; once, see arm description for more detail
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adverse Events
Noninvasive Measurement of Sympathetic Nerve Activity in Healthy Volunteers
Condition: Sympathetic Nerve Activity
Study type: Interventional

Summary: 
      Activation of the sympathetic nervous system is associated with increased risk of ventricular
      arrhythmias and sudden cardiac death (SCD). Development of simple, noninvasive, reliable
      tools to measure sympathetic outflow in human subjects is therefore highly desirable.

      Microneurography is the current gold standard measurement technique, whereby multiunit
      postganglionic sympathetic nerve activity is recorded with tungsten ultrafine microelectrodes
      inserted selectively into nerve fascicles of the peroneal nerve. Though this technique is
      considered extremely safe, and has been used successfully for decades in human translational
      physiology experiments, it has not been adopted for routine clinical assessment due to the
      requirement for sophisticated equipment and specific technical training and skills.
      Alternatively, many have adopted heart rate variability as a simple, noninvasive technique
      for assessing sympathetic nerve activity. However, heart rate variability does not directly
      measure sympathetic nerve activity, and there is much debate in the literature as to the
      exact source of sympathetic nerve traffic. For example, many believe it is an accurate
      reflection of cardiac sympathetic nerve activity, but does not accurately reflect changes in
      muscle or skin sympathetic nerve activity.

      To address these limitations, the investigators have developed a simple, noninvasive
      technique to measure sympathetic nerve activity using surface electrodes.

      Despite its great promise, this new approach has not yet been directly validated. The purpose
      of this study is therefore to validate this new technique (refered to as EKG-NA) against the
      current gold standard measurement technique, microneurography.
    


Intervention name(s): Physiologic maneuvers
Intervention type(s): Other
Intervention description(s): Subjects will perform cold pressor test, valsalva maneuver, hand grip and post-exercise occlusion in a controlled research environment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Decision-Making and the Relationship to Food Intake in Kids
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      The purpose of this 18-month project is to investigate how decision-making influences food
      choice and consumption in children ages 7 to 11 years old. Although several studies suggest
      that the ability to make good decisions relates to eating behaviors, no studies have looked
      at how food reward influences the decision-making process to impact actual food intake. This
      proposal will answer these questions and bridge this gap in knowledge, which could lead to
      the development of more effective interventions for childhood obesity. To accomplish this,
      the investigators have assembled a diverse team with expertise in food intake, nutrition, and
      decision sciences. First, the investigators will establish if there are differences in
      decision-making between children varying in weight status. Second, the investigators will
      determine if performance on behavioral decision-making tasks relates to food consumption in
      the laboratory. Third, the investigators will examine response functional magnetic resonance
      imaging (fMRI) blood-oxygen-level-dependent (BOLD) response to various rewards (i.e. food and
      money) and determine if this is influenced by child weight status. Fourth, the investigators
      will examine differences in fMRI BOLD at rest in decision-making regions are correlated with
      food intake and weight status. Eighty-two children will participate in our study. The
      long-term goal of this project is to investigate if there are differences in brain regions
      corresponding to these behaviors in overweight children and if these differences relate to
      eating behaviors in this population. Children will undergo fMRI while playing a reward task
      as well as consume meals in our laboratory. Decision-making will also be assessed by having
      children complete various behavioral measurements of reward and inhibitory control.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children aged 7-11 years old.
A Study of GSK256073 in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this combined, two part study is to evaluate the safety and glucose lowering
      effects of GSK256073 when administered to diabetic subjects for 12 weeks.
    

Detailed description: 
      The study will be conducted at centers in Europe and the United States. The study is being
      conducted in two parts. Part A (n = 90 subjects) will provide a preliminary evaluation of 12
      weeks of treatment. Initiation of part B (n = 210 additional subjects) will be dependent on
      the results observed in part A. The emerging data from part A will be used to guide selection
      of the doses in Part B. Up to 8 dose levels of GSK256073 may be included in part B. The
      emerging exposure response relationships from the part A interim analysis will be used to
      guide dose selection.

      Each subject enrolled in the study will undergo screening procedures, a 2 week placebo run-in
      period, baseline assessments, randomization, a twelve week treatment period, and a 2 week
      follow-up period. Following completion of the baseline visit and randomization into the
      study, subjects will return to the clinic for safety and efficacy assessments at Weeks 3, 6,
      9, and 12. A subject's total participation in the study will last up to approximately 20
      weeks. Subjects will continue their current prescribed regimen of metformin (glucophage)
      monotherapy and will monitor fasting blood glucose levels daily using a glucometer.
    

Intervention name(s): GSK256073 1mg; GSK256073 5mg; GSK256073 10mg; GSK256073 25mg; Placebo; Sitagliptin 100mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): GSK256073 1mg capsule; GSK256073 5mg capsule; GSK256073 10mg capsule; GSK256073 25mg capsule; placebo capsule; Sitagliptin 100mg capsule
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Safety; Dose Ranging; Efficacy
Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders
MeSH terms: Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the safety, tolerability and pharmacokinetics of multiple
      oral 200-mg doses of Pf-05175157 administered twice daily for 14 days in healthy overweight
      and obese subjects.
    


Intervention name(s): Pf-05175157; placebo; midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200-mg administered twice daily for 14 days; placebo administered twice daily for 14 days; midazolam 3-mg admistered as single doses on Day 0 and Day 11.
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science