bioihbjkbjnl/mcl2 huggingface dataset:
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration
Condition: Bone Cysts; Bone Atrophy; Bone Deformity; Bone Fracture; Bone Loss; Tooth Loss
MeSH terms: Bone Cysts; Tooth Loss; Fractures, Bone
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the gene-activated bone
      substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial
      growth factor (VEGF) for maxillofacial bone regeneration. The patients with congenital and
      acquired maxillofacial bone defects and alveolar ridge atrophy will be enrolled.
    

Detailed description: 
      All participants of the study will receive standard treatment according to the medical care
      standards for diseases and pathological conditions characterized by maxillofacial bone
      defects and/or alveolar ridge atrophy. Bone grafting procedures as part of the surgical
      treatment will be performed with the use of investigated medical device. The safety and
      efficacy of the implanted gene-activated bone substitute will be evaluated by clinical
      examination, comprehensive laboratory tests, and computer tomography within 6 months after
      surgery.
    

Intervention name(s): Gene-activated matrix (OCP + plasmid DNA with VEGF gene)
Intervention type(s): Device
Intervention description(s): Bone grafting procedure with investigated medical device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gene-activated matrix; Bone substitute; Bone grafting; Dental implantation; gene therapy; plasmid DNA; VEGF gene; octacalcium phosphate
A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and
      digestive system, significantly impairing the quality of life, with those affected having a
      median age of death at 40. The objectives of this study are to assess the effect of food on
      the safety and pharmacokinetics of navocaftor and galicaftor.
    


Intervention name(s): Galicaftor; Navocaftor
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): ABBV-2222; ABBV-3067
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Galicaftor; Navicaftor; ABBV-3067; ABBV-2222
A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults
Condition: Nausea and Vomiting, Chemotherapy-Induced
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to
      test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy
      human subjects.
    


Intervention name(s): Casopitant 150 mg; Ketoconazole; Casopitant 150 mg matching placebo; Casopitant 50 mg; Casopitant 50 mg matching placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Casopitant 150 mg will be available as white, film-coated tablets. Casopitant tablets will be taken with 240 milliliters (mL) of water at room temperature on an empty stomach.; Ketoconazole will be available as 200 mg tablets which will be taken with 240 mL of water on an empty stomach (after a 2 hour fast on Day 4 of Treatment Period 2 and after a 1 hour fast on all other dosing days).; Casopitant 150 mg matching placebo will be available as white, film-coated tablets.; Casopitant 50 mg will be available as pale orange, film-coated tablets. Casopitant tablets will be taken with 240 mL of water at room temperature on an empty stomach.; Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets.
Other intervention name(s): Casopitant
Intervention MeSH terms: Ketoconazole; Casopitant
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: GW679769; healthy adult subjects; casopitant; ketoconazole
Developing a Self-Management Program for People With Depression and Chronic Medical Illness
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study seeks to adapt an existing chronic disease self-management program for people with
      both chronic medical illness and depression.
    

Detailed description: 
      Depression is a common but serious disorder that affects millions of people every year.
      Depression can severely impact people's lives, causing them to often feel sad and hopeless as
      well as affecting their sleep patterns, concentration, and energy levels. Treatment typically
      includes a combination of antidepressant medication and talk therapy. This study will
      evaluate the effectiveness of an adapted group education program typically used for chronic
      medical illness in improving the health status, health behaviors, and use of health care
      services among people with depression and a chronic illness.

      Participants in this open-label study will attend a group education program used to manage
      chronic medical illness. Group sessions will be held for 2.5 hours, once a week, for 6 weeks.
      Group leaders, also suffering from a chronic medical condition, will lead discussions based
      on the following topics: nutrition; exercise; appropriate use of medications; ways to
      communicate effectively with family, friends, and health care professionals; and how to make
      informed treatment decisions. Participants will also complete two surveys: one at the
      beginning of the study and one at the end. The first survey will ask basic questions related
      to participants' health status and any feelings of stress, anxiety, or sadness. The second
      survey will include a brief interview that will require participants to describe their
      experience in the group sessions and to suggest ways of improving the program to better
      accommodate people with depression and chronic illness. Responses to questions will be used
      to enhance the effectiveness of the group education program for treating people with both
      depression and a chronic medical condition.
    

Intervention name(s): Chronic Disease Self-Management Program
Intervention type(s): Behavioral
Intervention description(s): Chronic disease self-management is a 6-week group program that teaches participants how to manage their chronic medical illness. Group leaders, also suffering from a chronic medical condition, will lead discussions based on the following topics: nutrition; exercise; appropriate use of medications; ways to communicate effectively with family, friends, and health care professionals; and how to make informed treatment decisions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Self-management programs; Chronic medical illness
Effect of Muscle Strength on Hamstring Flexibility in Children With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy; Muscle Strength; Lower Extremity; Hamstring Contractures
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Contracture
Study type: Observational

Summary: 
      Investigator researched that the effect of trunk and lower extremity muscle strength on
      hamstring flexibility in children with Duchenne Muscular Dystrophy.
    

Detailed description: 
      Thirty children were asessed by physical therapist. Nineteen children was Level 1 and eleven
      children was Level 2 according to Brooke Lower Extremity Functional Classification Scale.
    

Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Thirty children whose functional levels were in 1 or 2 according to the Brooke Lower
        Extremity Functional Classification Scale were included in the study. Flexibilities of
        hamstrings was evaluated by Popliteal Angle Test. Muscle strenght was assessed with manuel
        muscle strength test and myometer. correlation between the flexibility of hamstrings and
        muscle strength tests were examined.
      
Keywords: Duchenne Muscular Dystrophy; muscle strength; hamstring flexibility; back muscle; lower extremity
Carbohydrate Rinsing and Caffeine Gum on Performance of Romanian Deadlifts Performance
Condition: Carbohydrate; Caffeine
Study type: Interventional

Summary: 
      Two experiments were completed to investigate the effects of carbohydrate mouth rinsing and
      caffeine gum chewing on inertial resistance exercise performance. It was found that both
      carbohydrate gargling and caffeine gum chewing could improve inertial resistance exercise
      performance.
    

Detailed description: 
      This study compared the effects of mouth rinsing with carbohydrates trial (CMR) or a placebo
      trial (PL) on inertial weight training performance with an inertial weight resistance device.
      The participants were recruited in this study. Participants were randomly allocated to the
      CMR and PL groups and subjected to a crossover experiment in which they performed maximum
      inertial resistance training comprising five sets of six reps, with 3-min rests between sets.
      After deducting the first repetition of each sets, the mean values from the five sets were
      analyzed.
    

Intervention name(s): Carbohydrate mouth rinsing; 200 mg caffeine gum
Intervention type(s): Other; Other
Intervention description(s): the carbohydrate solution was prepared by dissolving 6.4 g of colorless and odorless maltodextrin in 93.6 mL of water; the mixtures were then adjusted to a 6.4% maltodextrin solution for the participants to rinse their mouths for 20 seconds; Chewing caffeinated gum for 20 minutes
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Eccentric exercise
Open Label Arimidex in Gynecomastia
Condition: Gynecomastia
MeSH terms: Gynecomastia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, effectiveness, pharmacokinetics and
      pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.
    


Intervention name(s): Anastrozole (ARIMIDEX™)
Intervention type(s): Drug
Intervention MeSH terms: Anastrozole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Function, Locomotion, Measurement and Inflammation
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      FoLoMI is a pilot study in which the investigators will seek to determine if gait
      spatio-temporal and kinematic parameters can explain the evolution of a functional score, the
      Bath Ankylosing Spondylitis Functional Index (BASFI), at 18 months.

      The secondary objectives are: (1) to study the relationship between gait parameters measured
      at T0 and the BASFI at T0, (2) to study the relationship between gait parameters at T0 and
      the BASDAI at T0, (3) to assess general state of health of the patients and its evolution by
      appreciating: level of physical activity, state of fatigue, diurnal sleepiness and quality of
      life, and (4) to compare spatio-temporal gait parameters between patients and healthy
      controls.
    

Detailed description: 
      This longitudinal cohort study is aiming to follow 60 persons with ankylosing spondylitis
      during 18 months. Assessments will be conducted at baseline and every 6 months.

      An healthy control group of 30 persons will be included and age and sex matched to the first
      30 patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with Ankylosing Spondylitis or Axial Spondyloarthritis at any stage of disease
        evolution followed at the Rhumatology unit of Grenoble Hospital
      
Keywords: Ankylosing spondylitis; Gait; BASFI; BASDAI; 6MWT
Diindolylmethane in Healthy Volunteers
Condition: Healthy, no Evidence of Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized phase I trial is studying the side effects and best dose of diindolylmethane
      in healthy volunteers. Chemoprevention is the use of certain drugs or substances to keep
      cancer from forming, growing, or coming back. The use of diindolylmethane may keep cancer
      from forming. Collecting and storing samples of blood and urine from healthy volunteers to
      study in the laboratory may help doctors learn more about the way a person's body handles the
      drug.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the effect of multiple daily dosing with nutritional-grade, absorption-enhanced
      diindolylmethane (BR-DIM) on the disposition of probe drugs metabolized by cytochrome P4501A2
      (CYP1A2) and CYP3A4 in healthy volunteers.

      SECONDARY OBJECTIVES:

      I. Determine the effect of multiple daily doses of BR-DIM on estrogen metabolites in urine
      and on activities of CYP2C9, CYP2D6, and P-glycoprotein/OATP.

      II. Determine the effect of a single dose of BR-DIM on the disposition of probe drugs that
      are metabolized or transported by CYP1A2, CYP2C9, CYP2D6, CYP3A4, and P-glycoprotein (P-go).

      III. Determine the safety and tolerability of single and multiple daily doses of BR-DIM.

      IV. Determine the pharmacokinetics of a single dose of BR-DIM and of the same dose after
      chronic daily dosing.

      V. Determine the pharmacokinetics of a single dose of BR-DIM and of the same dose after
      chronic daily dosing.

      TERTIARY OBJECTIVES:

      I. To determine effects of BR-DIM on activities of glutathione-S-transferase (GST), a phase 2
      enzyme, in lymphocytes.

      OUTLINE: This is a randomized, double-blind study. Participants are stratified according to
      gender. Participants are randomized to 1 of 2 intervention arms.

      Arm I: Participants receive low-dose oral diindolylmethane (BR-DIM) twice daily for 4 weeks.

      Arm II: Participants receive high-dose oral BR-DIM twice daily for 4 weeks.

      In both arms, participants receive an oral probe-drug cocktail comprising caffeine (CYP1A2),
      dextromethorphan (CYP2D6), buspirone (CYP3A4), losartan (CYP2C9), and fexofenadine
      (P-glycoprotein) before randomization and after the first and last dose of BR-DIM.

      Blood and urine are collected periodically for pharmacokinetic profiles of BR-DIM and probe
      drugs.

      After completion of study intervention, participants are followed at 1 week.
    

Intervention name(s): oral microencapsulated diindolylmethane
Intervention type(s): Drug
Intervention description(s): Given PO
Other intervention name(s): BioResponse DIM; BR-DIM
Intervention MeSH terms: 3,3'-diindolylmethane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Repeated EUS-guided Fine Needle Biopsy of Pancreatic Masses After Non-diagnostic or Inconclusive Results
Condition: Pancreatic Adenocarcinoma; Pancreas Cancer; Pancreas Metastases
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      The primary aim of REuBio study is to evaluate the diagnostic accuracy of repeated endoscopic
      ultrasound-guided fine needle biopsy after a previous non-diagnostic or inconclusive
      EUS-guided sampling of solid pancreatic lesions.
    

Detailed description: 
      Endoscopic ultrasound-guided fine needles biopsy (EUS-FNB) represents the gold standard
      method for the diagnosis of solid pancreatic lesions (SPLs), even if a non-negligible risk of
      false-negative or inconclusive results still exists.

      In such cases, major guidelines recommend repeating EUS-guided tissue sampling. Nevertheless,
      this recommendation is not based on high-quality evidence and little is known about the
      performance of repeated EUS-FNB (rEUS-FNB).

      The primary aim of this study is to evaluate the diagnostic accuracy of rEUS-FNB after a
      previous non-diagnostic or inconclusive EUS-guided sampling of SPLs.

      The secondary aims of this study are to evaluate rEUS-FNB sensitivity, specificity, positive
      predictive value, negative predictive value, specimen adequacy, Bethesda classification,
      adverse events incidence and factors that influenced rEUS-FNB performance.
    

Intervention name(s): endoscopic ultrasound-guided fine needle biopsy
Intervention type(s): Diagnostic Test
Intervention description(s): repeated endoscopic ultrasound-guided fine needle-biopsy after a previous non diagnostic or incoclusive endoscopic ultrasound-guided tissue aquisition for pancreatic solid lesions.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A multicenter retrospective observational study enrolling all the consecutive patients who
        underwent a repeated EUS-guided tissue sampling for solid pancreatic masses with an EUS-FNB
        needle, after previous non-diagnostic or inconclusive result.
      
Keywords: Endoscopic Ultrasound; EUS-FNB; Solid Pancreatic lesion
Efficacy of Wharton Jelly in Erectile Dysfunction
Condition: Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
MeSH terms: Erectile Dysfunction; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Efficacy of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the
      treatment of erectile dysfunction in diabetic patients.
    

Detailed description: 
      This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which 22 male
      patients ranging from 25-70 years diagnosed with erectile dysfunction will be selected. This
      diagnosis is based on medical history, validated questionnaires, physical examinations,
      laboratory tests and specific diagnostic tests.

      The patients are followed by clinical assessment, laboratory investigations as well as
      Doppler ultrasound.

      The investigators hypothesize that the intracavernous injection of stem cells will facilitate
      the recovery of erectile function resulting in satisfying clinical outcomes in patients.
    

Intervention name(s): Wharton Jelly Mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Intracavernous injection of Wharton Jelly Mesenchymal stem cells.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Wharton jelly mesenchymal stem cells; efficacy
TIFACT Study - Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects.
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Tissue factor is the main activator of coagulation cascades. Excessive tissue factor
      expression is made responsible of thrombosis in a number of clinical situations including
      thrombosis in contact with atherosclerotic plaques. Recent work showed that tissue factor
      gene expression in adipose tissue was significantly increased in obese versus lean mice.

      The main objective of this study is to show that tissue factor expression is increased in
      human adipose tissue obtained from obese subjects and to identify its main tissular origin by
      comparing abdominal and subcutaneous adipose tissue.

      The secondary objectives are to identify the cell origin of tissue factor (adipocytes versus
      stromal cells) and to analyze the relation ship between blood tissue factor and (i) tissue
      factor expressed by adipose tissue, (ii) the amount of subcutaneous and profound adipose
      tissue, and (iii) coagulation activation markers.
    

Detailed description: 
      Tissue factor is the main activator of coagulation cascades. Excessive tissue factor
      expression is made responsible of thrombosis in a number of clinical situations including
      thrombosis in contact with atherosclerotic plaques. Recent work showed that tissue factor
      gene expression in adipose tissue was significantly increased in obese versus lean mice.

      The main objective of this study is to show that tissue factor expression is increased in
      human adipose tissue obtained from obese subjects and to identify its main tissular origin by
      comparing abdominal and subcutaneous adipose tissue.

      The secondary objectives are to identify the cell origin of tissue factor (adipocytes versus
      stromal cells) and to analyze the relation ship between blood tissue factor and (i) tissue
      factor expressed by adipose tissue,
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Inclusion Criteria:

          -  BMI > 35

          -  Stable obesity

          -  Abdominal or pelvic surgery

          -  Agree to participate to the study

        Exclusion Criteria:

          -  malignancy,

          -  infectious or inflammatory disease, notably HIV infection

          -  pregnancy

          -  history of ischemic cardio or neurovascular event, lower limb arteritis
      
Biospecimen description: 
      samples of plasma and serum and greasy fragments
    
Keywords: Tissue factor; Obesity; Adipose tissue; Microparticles