bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Colchicine Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, single dose, three-way crossover study will evaluate the bioequivalence of
      two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed
      combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting
      conditions. It will also determine the bioavailability following a standard high-fat meal and
      evaluate the safety and tolerability of the test product.
    

Detailed description: 
      This randomized, single dose, three-way crossover study will evaluate the bioequivalence of
      two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed
      combination product (colchicine 0.5mg with probenecid 500mg), administered under fasting
      conditions. It will also determine the bioavailability of the test product following a
      standard high-fat meal and evaluate the safety and tolerability of the test product.
      Twenty-eight healthy, non-smoking, non-obese (BMI 81-30 kg/m2 and BW ≥110 lbs), 18-45 year
      old, male and female volunteers will be randomly assigned in a crossover fashion to receive
      one of three dosing regimens in sequence with washout periods of at least 14 days between
      dosing periods. After a fast of at least 10 hours, subjects will receive either, one tablet
      of colchicine 0.6 mg, one tablet of colchicine 0.6 mg after a standardized
      high-fat,high-calorie breakfast or 0.5mg/500mg colchicine/probenecid. All doses will be given
      with 240mL of room temperature water. Patients will be confined for at least 15 hours before
      and 24 hours after each dose with daily outpatient visits over the following 3 days. Blood
      will be drawn at times sufficient to adequately define the concentration time curves for each
      dosing regimen, which will be compared to assess the bioequivalence of the reference and test
      products and the effect of food on the test product. Subjects will also be monitored for
      adverse events throughout this same period.
    

Intervention name(s): Colchicine; Colchicine; Colchicine/Probenecid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.6mg tablet administered after a fast of at least 10 hours; 0.6mg tablet administered after a standardized high-fat, high-calorie breakfast; 0.5mg/500mg tablet administered after a fast of at least 10 hours
Other intervention name(s): COLCRYS TM; COLCRYS TM
Intervention MeSH terms: Colchicine; Probenecid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioequivalence; fasting; fed; healthy
Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for C/S
Condition: Cesarean Section Complications; Hypotension; Spinal Anesthesia; Perfusion Index; Pleth Variability Index
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular
      resistance and cardiac output and may cause hypotension in a significant portion of the
      parturients. Hypotension during delivery may cause maternal and fetal complications. If
      parturients who are likely to develop hypotension after spinal anesthesia can be identified
      before surgery, anesthesiologists would have opportunity to take measures such as
      prophylactic vasopressor administration.

      Perfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the
      degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the
      relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile
      versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral
      vasomotor tone.

      Pleth variability index (PVI) is calculated using maximum and minimum values of perfusion
      index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid
      responsiveness.

      The aim of this study is to investigate whether the PI and PVI values at different patient
      positions can predict hypotension during caesarean section.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Parturients scheduled for elective low segment caesarean section under spinal anesthesia
Asian Study on Cilostazol Effectivity in Neuropathies of Diabetes Mellitus Type 2-A Pilot Study in the Philippines
Condition: Polyneuropathy
MeSH terms: Polyneuropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      To describe if there are differences in the subjective, objective and electrophysiologic
      parameters of diabetic polyneuropathies at baseline, four (4) weeks, eight (8) weeks, and
      twelve (12) weeks after Cilostazol therapy.
    


Intervention name(s): Cilostazol
Intervention type(s): Drug
Intervention description(s): 100 mg, 200mg tablet Cilostazol
Other intervention name(s): Cilostazol, Pletaal, Pletal
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Symmetric Diabetic Polyneuropathy
Metabolic Determinants of Cardiac Function
Condition: Heart Failure; Diabetes Mellitus
MeSH terms: Heart Failure; Diabetes Mellitus
Study type: Observational

Summary: 
      Assessment of cardiac energy metabolism in patients with impaired glucose tolerance
    

Detailed description: 
      Insulin resistance, hepatocellular lipids (HCL) and plasma concentrations of free fatty acids
      (FFA) are predictors of heart failure, the leading cause of mortality in patients suffering
      from type 2 diabetes mellitus (T2DM). Epidemiological data suggest that diabetic
      cardiomyopathy (DC) presents as ventricular dysfunction in patients with T2DM independent of
      coronary artery disease. The underlying cellular mechanisms are poorly understood. Reduced
      mitochondrial activity and insulin resistance of skeletal muscle relates to liver steatosis,
      possibly due to higher substrate flux to the liver. High oxidation rates in the liver result
      in oxidative stress, damage of mitochondria and apoptosis. The investigators hypothesize that
      (i) HCL and impaired liver energy metabolism correlate with ventricular dysfunction, (ii)
      impaired glucose uptake and mitochondrial capacity in skeletal muscle relates to enhanced
      oxidative capacity, oxidative stress and lipid deposition in heart tissue (iii) reduced
      myocardial oxidative capacity limits recovery of myocardial function in patients with acute
      heart failure.

      The investigators aim to assess (i) liver energy metabolism and heart function, (ii)
      respiration and lipid metabolites in skeletal muscle and heart tissue in humans with advanced
      heart failure and (iii) the prognostic impact of these factors in humans with acute heart
      failure.

      This study will improve the understanding of mechanisms underlying the development of DC and
      the identification of patients at risk for poor outcome in heart failure.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        patients undergoing myocardial biopsy, left ventricular assist device implantation or heart
        transplantation for medical reasons
      
Biospecimen description: 
      Myocardial biopsies blood samples
    
Keywords: Heart Failure, Diabetes Mellitus, Mitochondrial Respiration
Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users
Condition: Healthy Recreational Drug Users
Study type: Interventional
Phase: Phase 1

Summary: 
      This placebo- and active controlled study will investigate the abuse potential of ACT-541468
      in healthy recreational drug users
    


Intervention name(s): ACT-541468; Suvorexant; Zolpidem; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ACT-541468 will be administered as 50 mg tablets for oral use.; Suvorexant will be administered as 15 mg over-encapsulated tablets for oral use.; Zolpidem will be administered as 10 mg over-encapsulated tablets for oral use.; Matching-placebo will be used.
Intervention MeSH terms: Zolpidem; Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 6-way cross-over study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS
Condition: Systemic-Onset Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      1. Main objective: To test the efficacy of anakinra treatment in children or young adults
           with corticosteroid-resistant or -dependent Systemic-Onset Juvenile Idiopathic Arthritis
           (SO-JIA)

        2. Design: Double blind, randomized trial testing the efficacy of one month Anakinra
           treatment versus placebo (2 groups of 12 patients each). All the patients will be
           treated with anakinra during the following 11 months and the dose of corticosteroids
           will be gradually tapered (= descriptive part of the trial to assess the tolerance and
           efficacy over 12 months).

        3. Hypothesis: 70% significant improvement after 1 month in Anakinra-treated patients
           versus no more than 10% in the placebo group.

        4. Main inclusion criteria : diagnosis of SO-JIA (Durban consensus conference criteria),
           age: 2 to 20 years at inclusion, active, corticosteroid-resistant or -dependent disease,
           no previous IL-1ra treatment.
    


Intervention name(s): Anakinra; Pneumo23
Intervention type(s): Drug; Biological
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: IDIOPATHIC JUVENILE ARTHRITIS; PEDIATRICS; ORPHAN DISEASE; INTERLEUKIN - 1; RECEPTORS , INTERLEUKINS; ANTAGONISTS
Neutrophil Imaging in Healthy Subjects Following Lipopolysaccharide or Saline Challenge and in Subjects With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an exploratory study to further develop an imaging platform for the assessment of
      whole lung neutrophil retention. The primary objective of the study is to quantify and
      compare neutrophil retention in the lungs of lipopolysaccharide-challenged healthy subjects,
      saline-challenged healthy subjects and subjects with stable COPD. There will be two treatment
      groups, one with healthy subjects and the other with subjects with stable COPD. The total
      duration of this study for healthy subjects will be approximately 1 week, in addition to the
      screening window of 28 days. The total duration of this study for subjects with COPD will be
      approximately 1 week for those that complete Visit 1 only, and approximately 2 weeks for
      those subjects with COPD that return to the unit for Visit 2 7-10 days later, in addition to
      the screening window of 28 days.
    


Intervention name(s): Lipopolysaccharide challenge; Saline challenge; Labelled neutrophils and Imaging assessment
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Lipopolysaccharide solution inhaled using a dosimeter.; 0.9% sodium chloride solution inhaled using dosimeter.; Injection of labelled neutrophils and imaging assessments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: lipopolysaccharide; COPD; neutrophil
Bioequivalence Study of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water
      to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
    


Intervention name(s): Doxazosin 4 mg Japanese marketed IR tablet; Doxazosin 4 mg ODT with water; Doxazosin 4 mg ODT without water
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Immediate release tablet, 4 mg, single dose; Orally-disintegrating Tablet , 4 mg, single dose with water; Orally-disintegrating Tablet , 4 mg, single dose without water
Intervention MeSH terms: Doxazosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Orally-disintegrating Tablet
Safety, Tolerability and Effects of L-Arginine in Boys With Dystrophinopathy on Corticosteroids
Condition: Dystrophinopathy; Duchenne Muscular Dystrophy; Becker's Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety, tolerability, and effects of L-Arginine on
      muscles in boys with dystrophinopathy on corticosteroids. Specifically, to see if L-arginine
      reduces muscle signal abnormalities on MRI done pre and post 30 days of L-arginine
      administration.
    

Detailed description: 
      Dystrophinopathy is a muscular dystrophy (includes Duchenne or Becker's Muscular Dystrophy)
      that can be a lethal muscle disorder resulting from defects in the gene for dystrophin, a
      structural protein required to maintain muscle integrity. Absence of functional dystrophin
      leaves the muscle membrane vulnerable to damage during contraction. This damage can be
      exacerbated by an inflammatory response leading to myofiber necrosis.

      L-arginine is a widely available dietary supplement amino acid postulated to affect
      dystrophinopathy in several favorable ways: upregulation of utrophin, vasodilation in muscle
      via nitric oxide, enhanced synthesis of creatine, increase levels of growth hormone.

      We hypothesize that administration of L-arginine may increase levels of creatine and growth
      hormone and in turn reduce the extent of myofiber damage in our patients with
      dystrophinopathy
    

Intervention name(s): L-arginine
Intervention type(s): Drug
Intervention description(s): Subjects will receive oral L-Arginine (0.3 grams/kg/day, divided 2 times per day, not to exceed 14 grams/day)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: L-arginine supplement study
Genotropin Study Assessing Use of Injection Pen
Condition: Growth Hormone Deficiency; Idiopathic Short Stature
MeSH terms: Dwarfism
Study type: Interventional
Phase: Phase 3

Summary: 
      Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and
      preference of Genotropin injection pen. Patients already on genotropin will be asked to use a
      genotropin pen for 2 months. Patient and caregiver will be asked to complete a questionnaire
      at baseline and 2 months.
    


Intervention name(s): New Genotropin Pen
Intervention type(s): Device
Intervention description(s): Subjects will use the genotropin pen for 2 months. After 2 months patients and caregiver will be asked to fill out a questionnaire to assess perception of the genotropin pen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genotropin Medical device Patient reported outcome
A Study of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of a single subcutaneous
      (SC) dose of JNJ-26366821.
    


Intervention name(s): JNJ-26366821; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).; Participants will receive sodium chloride injection as placebo on Day 1.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of America (US) Sourced Stelara in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, three-arm, parallel group, single-dose study to evaluate
      the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 compared to EU sourced
      Stelara® and US sourced Stelara® in healthy subjects
    

Detailed description: 
      This study is a randomised, double-blind, three-arm, parallel group, single-dose study. A
      total of 201 healthy subjects aged 18-55 years will be randomised 1:1:1 to receive a single
      dose of either SB17, EU sourced Stelara®, or US sourced Stelara®. All investigational
      products (IPs) will be administered subcutaneously in the abdomen.
    

Intervention name(s): Ustekinumab
Intervention type(s): Drug
Intervention description(s): 45 mg, single-dose
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
New Food Solutions for Cancer Patients
Condition: Cancer Patients; Taste Disorders; Food Selection
MeSH terms: Taste Disorders
Study type: Interventional

Summary: 
      The ONCOFOOD project aims to design and develop new innovative food solutions for cancer
      patients, taking into account not only their nutritional requirements but also their sensory
      changes, promoting eating pleasure and preventing malnutrition. Research involving cancer
      patients but also their families and health care professionals is a key element of this
      approach to ensure the success of the developed products for the target group.
    

Detailed description: 
      The study will be divided into three stages: in Stage 1, individual interviews will be
      conducted with present and past cancer patients, focus groups with families/care givers of
      cancer patients and health care professionals (cancer specialist nurses, clinical and medical
      oncologists, speech and language therapists, dietitians, oncology social workers and
      counselors). The interviews will help collect data and gain understanding on the needs of
      cancer patients, barriers to current food proposals and expectations from new solutions. In
      subsequent stages, semi-quantitative studies will be conducted with cancer patients that
      require texture-modified foods (Stage 2) and patients with taste & smell alterations (Stage
      3). Patients will be required to evaluate texture-modified products (developed using 3D food
      printing technology) and taste-optimised products (i.e. soups, mousses, fruit and vegetable
      beverages, dairy desserts and seasonings) developed based on the results obtained from Stage
      1 above.
    

Intervention name(s): Texture-modified foods for cancer patients (Stage 2); Taste-optimised foods for cancer patients (Stage 3)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants (cancer patients that require texture-modified foods) will be expected to evaluate a maximum of three meals over a 2-weeks period.; Participants (cancer patients with taste & smell alterations) will be expected to evaluate three foods at home over a period of one month.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 3 stage study design. The first stage will be a qualitative part with interviews and focus group sessions. In the second and third stages participants will evaluate food products. The second and third stages of the study will be conducted single blind as it is not feasible to blind the researcher.
Masking: Single (Participant)
Primary purpose: Other
Keywords: taste & smell alterations; texture-modified foods; taste-optimised foods; cancer patients
Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at
      three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4
      weeks in patients that are treatment-naive or taking a single anti-diabetic medication
      (non-TZD, non-injectable).
    

Detailed description: 
      Approximately 100 patients will be randomized in this study, 20 to each of of the three
      MBX-2982 treatment groups, 20 to placebo, and 20 to the sitagliptin group. Patients will be
      taking 3 tablets and 1 capsule daily. This sample size provides the minimum number expected
      to ensure a power of at least 80% to detect a 20% decrease in the weighted mean glucose level
      associated with an extended mixed meal tolerance test (with 2 standardized meals) relative to
      placebo after 4 weeks of daily treatment with MBX-2982, assuming a drop-out rate of 20% and a
      common SD of 25%.
    

Intervention name(s): MBX-2982; MBX-2982; MBX-2982; Sitagliptin; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablets and capsule once daily; tablets and capsule once daily; tablets and capsule once daily; tablets and capsule once daily; tablets and capsule once daily
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment