bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
Condition: Primary Biliary Cholangitis; Primary Biliary Cirrhosis; Cholangitis; Cholestasis; Biliary Tract Diseases; Bile Duct Stricture
MeSH terms: Cholangitis; Cholestasis; Liver Cirrhosis, Biliary; Biliary Tract Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801
      (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard
      therapy. Inadequate response is defined as persistently elevated serum alkaline phosphatase
      at greater than or equal to1.5 times the upper limits of normal for the testing lab in spite
      of having been on adequate doses of standard therapy with UDCA (ursodeoxycholic acid) at
      13-15 mg/kg for at least 6 months.
    


Intervention name(s): HTD1801 (BUDCA)
Intervention type(s): Drug
Intervention description(s): HTD1801 (BUDCA) 250 mg tablets. Dose 1000 mg twice daily with food for 12 weeks.
Intervention model: Single Group Assignment
Intervention model description: Single group open label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open-label
The Effect of Foot Reflexology Applied on Dialysis Patients
Condition: Nursing Caries
Study type: Interventional

Summary: 
      Reflexology is massage therapy used to maintain and improve health, as well as relieve some
      symptoms. Foot reflexology, which is thought to have an effect on dialysis symptoms, will be
      applied to hemodialysis patients in 9 sessions. In this study, it is aimed to determine the
      effect of foot reflexology applied to dialysis patients on sleep, anxiety and quality of
      life.
    

Detailed description: 
      Reflexology is defined as a holistic treatment based on stimulating the nerves and blood
      circulation in the body by manually stimulating the reflex points in the hands and feet
      corresponding to all parts of the body, organs and systems. In the literature, there are many
      studies conducted in different samples to evaluate the effectiveness of reflexology massage.
      Hemodialysis patients are also included in these samples. Hemodialysis patients are faced
      with many physical and emotional symptoms such as lifestyle changes, psychosocial effects,
      side effects due to treatment, during their treatment process. Nurses play an important role
      in alleviating and eliminating these complaints. Objective: It is aimed to determine the
      effect of foot reflexology applied to dialysis patients on sleep, anxiety and quality of
      life. Design: Randomized, controlled, prospective study. Setting: University Hospital
      Hemodialysis Center in Izmir. Patients: Forty patients receiving hemodialysis treatment.
      Interventions: Nine sessions of reflexology massage will be given to reflex points including
      the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and
      adrenal glands. Main Outcome Measures: sleep, anxiety, and quality of life.
    

Intervention name(s): massage therapy
Intervention type(s): Behavioral
Intervention description(s): Reflexology is massage therapy used to maintain and improve health, as well as relieve some symptoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised Controlled Trial
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: reflexology; dialysis; nursing care
Hämeenlinna Metabolic Syndrome Research Program: Oxidized LDL and Arterial Elasticity in Metabolic Syndrome and Controls (HMS-01)
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a
      part of Hämeenlinna Metabolic Syndrome Research Program (HMS), 40 men with metabolic syndrome
      and their 40 physically active controls (age: 30 to 65 years) are compared in a
      cross-sectional study. Except routine laboratory parameters, arterial elasticity and levels
      of oxidized LDL are determined.

      Study hypothesis: Levels of oxidized LDL and findings in arterial elasticity may differ
      between subjects with metabolic syndrome and controls explaining the elevated risk for
      cardiovascular diseases among patients with metabolic syndrome.
    

Detailed description: 
      Accumulation of oxidized low-density lipoproteins in the intimae of arteries together with
      risk factors known to enhance atherosclerosis, damage the endothelium of the arterial wall.
      Dysfunction of the endothelium leads into loss of elasticity of the artery. Especially a
      reduction in the elasticity of small arteries has been found prominent in atherosclerosis and
      is believed to serve as a marker for early stages of atherosclerosis.

      In this study, we investigate whether the levels of oxidized LDL and arterial elasticity
      differ between patients with metabolic syndrome and their physically active controls.
      Oxidized LDL is assessed by a two-site ELISA immunoassay (Mercodia, Uppsala, Sweden). The
      capacitive elasticity of large arteries (C1) and the reflective elasticity of small arteries
      (C2) are automatically assessed by the CR-2000 as a mean of five most similar pulse waves
      appearing during the measurement. C1 identifies the elastic properties of aorta and other
      large arteries, C2 the endothelial function of the microvascular circulation. Proper
      statistical methods are used to reveal possible differences and their significance between
      the patients and controls.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic.
      
Biospecimen description: 
      serum, EDTA plasma, citrate plasma
    
Keywords: Metabolic Syndrome; Oxidized Low Density Lipoprotein; Arterial Elasticity; Diabetes Mellitus; Cardiovascular Diseases
A Study to Assess the Effects of Itraconazole and Rifampicin on the Single-Dose Pharmacokinetics of JNJ-53718678 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of itraconazole, a strong cytochrome P
      (CYP)3A4 and p-glycoprotein (PgP) inhibitor, and rifampicin, a CYP3A4, uridine
      5'-diphospho-glucuronosyltransferase (UGT), and PgP inducer, and an inhibitor of organic
      anion-transporting polypeptide (OATP), on the single-dose pharmacokinetics (PK) of
      JNJ-53718678 in healthy adult participants.
    

Detailed description: 
      This is a single-center, open-label, fixed sequence, Phase 1 study in healthy adult
      participants to study the effects of itraconazole and rifampicin on the pharmacokinetics,
      safety, and tolerability of a single dose of JNJ-53718678. This study will be conducted in 2
      separate panels, with 14 participants in Panel 1 and 16 participants in Panel 2. The study
      consists of following phases: Screening (28 days), Treatment phase (11 days) and Follow-up
      (10 to 14 days after the last study drug intake). Blood samples will be collected for
      evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Participants
      will be assessed for safety and tolerability throughout the study.
    

Intervention name(s): JNJ-53718678; Itraconazole; Rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JNJ-53718678 will be applied twice at doses of 250 mg (in Panel 1, Day 1 and Day 9) and 3 times at 500 mg (Panel 2, Day 1, 4 and 9).; Participants will receive itraconazole 200 mg (2 capsules of 100 mg) from Day 4-11.; Participants will receive 600 mg rifampicin (2 capsules of 300 mg) from Day 4-11.
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-53718678; Itraconazole; Rifampicin; Pharmacokinetics
Impaired Endothelial Integrity in Patients With Embolic Stroke of Undetermined Source (ESUS)
Condition: Embolic Stroke of Undetermined Source; Endothelial Dysfunction
MeSH terms: Stroke; Embolic Stroke
Study type: Observational

Summary: 
      Cardioembolism is a postulated mechanism of an embolic stroke of undetermined source (ESUS).
      The investigators will measure endothelial glycocalyx, aortic elastic properties, oxidative
      stress, and their association with left ventricular (LV) and left atrial (LA) function in
      ESUS and age- and sex-adjusted healthy individuals.
    

Detailed description: 
      The investigators aim to evaluate consecutive acute ischemic stroke (AIS) patients satisfying
      ESUS diagnostic criteria in a single tertiary care stroke center (University Hospital,
      Athens, Greece). Moreover, baseline characteristics and outcome measures for all AIS patients
      are going to be recorded and further be classified, according to the Trial of Org 10172 in
      Acute Stroke Treatment (TOAST) and ESUS criteria. Healthy volunteers (colleagues, friends,
      relatives and others) will be included in the control group.

      In participants (patients and controls) the investigators plan to measure: a) perfused
      boundary region (PBR) of the sublingual arterial microvessels (range 5-25 micrometers), a
      marker inversely related with glycocalyx thickness, b) pulse wave velocity (PWV), central
      systolic blood pressure (cSBP) and augmentation index (AIx), c) LV Global Longitudinal strain
      (GLS), d) LA volume and strain using speckle-tracking strain imaging, e) Malondialdehyde
      (MDA), as an oxidative stress marker.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of 83 consecutive patients with embolic stroke of
        undetermined source (ESUS) that fulfill inclusion criteria and of 41 healthy volunteers of
        similar age and sex (control group)
      
Biospecimen description: 
      Plasma
    
Keywords: Embolic stroke; Arterial stiffness; Endothelial function; Endothelial glycocalyx; Left ventricular function; Oxidative stress
ERr 731® Formulation Evaluation
Condition: Menopause
Study type: Interventional

Summary: 
      A comparison of an enteric coated and micro-coated formulation of ERr 731®
    

Detailed description: 
      Current clinical and commercialization experiences have been with enteric-coated formulations
      of ERr 731®. With the demonstrated safety of this formulation and the absence of
      anthraquinones in the extract, there is interest in launching a micro-coated, but not
      enteric-coated, formulation to broaden the commercial availability of ERr 731® in new
      markets. It is proposed that a double-blinded, randomized cross-over design in a
      peri-menopausal/menopausal and preferably symptomatic group of women (target population for
      commercialization) is best suited to demonstrate equivalent tolerability.
    

Intervention name(s): ERr 731 - Micro-coated; ERr 731 - Enteric coated
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.; natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.
Other intervention name(s): Estrovera
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double-blinded, randomized cross-over design in a peri-menopausal/menopausal and preferably symptomatic group of women (target population for commercialization) is best suited to demonstrate equivalent tolerability
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Botanical supplement; Formulation; Rhapontic Rhubarb
Evaluation of Cow Milk-Based Formulas - Functional Proteins
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to look at the function of infant formula components to optimize
      the nutritional content and functionality of a marketed routine infant formula.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        formula-fed and breastfed infants
      
Keywords: optimize nutritional content of infant formula; Infant
NeuMoDx PrEDiCTiNG Study Evaluation Plan
Condition: Chlamydia Trachomatis Infection; Neisseria Gonorrheae Infection
MeSH terms: Infections; Communicable Diseases; Chlamydia Infections; Gonorrhea
Study type: Interventional

Summary: 
      This investigational study will be conducted to evaluate the performance of the NeuMoDx™
      CT/NG Assay on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System
      (collectively referred to as NeuMoDx™ CT/NG Assay test system).
    

Detailed description: 
      Clinical performance characteristics of the NeuMoDx CT/NG Assay on NeuMoDx™ 288 Molecular
      System and NeuMoDx™ 96 Molecular System will be evaluated in a multi-center, prospective,
      sampling study by comparing the diagnoses made by the NeuMoDx™ CT/NG Assay to Patient
      Infected Status (PIS) as the reference standard.

      Prospectively collected urine and swab specimens from individual subjects will be tested
      using the NeuMoDx™ CT/NG Assay at one of the three NeuMoDx testing sites. Subjects' PIS for
      CT and PIS for NG will be determined by a central laboratory using FDA-cleared, legally
      marketed CT/NG combo assays on pre-specified sample matrices according to the PIS
      determination algorithms.
    

Intervention name(s): NeuMoDx CT/NG Assay; FDA-cleared NAATs
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System; Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Combined Study - Phase 3b MenB Long Term Persistence in Adolescents
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after
      the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in
      adolescents [who previously participated in parent studies V72_41 (NCT0142384) and V72P10
      (NCT00661713)] and 2) the kinetics of immune response following booster vaccination with
      rMenB+OMV NZ
    

Detailed description: 
      After all subjects (Groups A and B) from Canada and Australia have completed the study, an
      interim analysis for the primary and secondary immunogenicity objectives will be performed.
      Follow on subjects (Group A) from parent study V72_41 (NCT0142384) will be analyzed for i)
      antibody persistence at approximately 4 years following a 2 dose primary series and ii) the
      immune response at 3, 7 and 30 days after a third dose (booster) of rMenB+OMV NZ. Canadian
      and Australian vaccine naïve subjects (Group B) will be analyzed for the immune response at
      30 days after the first dose, and 3, 7 and 30 days after the second dose of rMenB+OMV NZ.

      Subjects in Group B (naïve subjects) will be randomized into two different blood draw
      schedules according to a 1:1 ratio.
    

Intervention name(s): rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)
Intervention type(s): Biological
Intervention description(s): One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nervous System Diseases; Meningitis; Central Nervous System Diseases
First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-121 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, phase 1, "3+3", placebo-controlled dose escalating study of
      tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single
      subcutaneous injection of the novel monoclonal bispecific antibody against human IL-17/TNFa.
      The study will enroll 28 healthy male volunteers.
    

Detailed description: 
      Simultaneous blockade of IL-17 and TNFa is a potential therapeutic way of treatment of
      several autoimmune disorders. BCD-121 is a novel humanized monoclonal bispecific antibody
      against human IL17 and TNFa developed by JCS BIOCAD (Russia) which is now on the first step
      of clinical evaluation. BCD-121-1 study is the first-in-human clinical trial which is
      intended to evaluate tolerability, safety, pharmacokinetics, pharmacodynamics and
      immunogenicity of BCD-121 when used as a single step-by-step escalating subcutaneous dose in
      healthy male volunteers. During this study it is expected to determine diapason of safety
      doses of BCD-121 (incl. MTD) which thereafter can be evaluated in phase 2 studies.
    

Intervention name(s): BCD-121; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): monoclonal bispecific antibody against human IL-17/ TNFa
Intervention MeSH terms: Antibodies, Bispecific
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate relative bioavailability between 80 mg LY03005
      oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over
      2-period design under fasting condition in healthy subjects between 18 and 50 years of age.
    

Detailed description: 
      Twenty (20) eligible subjects will be enrolled and assigned to either Group A or Group B at a
      1:1 ratio.
    

Intervention name(s): LY03005; Pristiq
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg, oral tablets, single dose; 50 mg, oral tablets, single dose
Other intervention name(s): Desvenlafaxine
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive Disorder, Major; Depressive Disorder; Mood Disorders; Mental Disorders; Desvenlafaxine Succinate; Serotonin and Noradrenaline Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Physiological Effects of Drugs; Antidepressive Agents; Psychotropic Drugs
Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A two part, fixed-sequence, open-label crossover study to evaluate potential CYP1A2-mediated
      drug-drug interactions of ABX464 in healthy subjects using caffeine and fluvoxamine as probe
      drugs
    

Detailed description: 
      This is a Phase 1, 2 part, fixed-sequence open-label, crossover study to evaluate the
      potential CYP1A2-mediated drug-drug interactions (DDI), safety, and tolerability of ABX464
      combined with a known CYP1A2 substrate (caffeine) and a known CYP1A2 inhibitor (fluvoxamine).
      Sixty (60) healthy adult male and female subjects 18 to 55 years of age are planned to
      participate in the study. Separate cohorts of subjects will be enrolled for Part A (24
      subjects) and Part B (36 subjects).
    

Intervention name(s): Caffeine; ABX464; Fluvoxamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This is a 2 part, fixed-sequence open-label, crossover study to evaluate the potential CYP1A2-mediated drug-drug interactions (DDI), safety, and tolerability of ABX464 combined with a known CYP1A2 substrate (caffeine); This is a 2 part, fixed-sequence open-label, crossover study to evaluate the potential CYP1A2-mediated drug-drug interactions (DDI), safety, and tolerability of ABX464 combined with a known CYP1A2 inhibitor (fluvoxamine) and a known CYP1A2 substrate (caffeine).; his is a 2 part, fixed-sequence open-label, crossover study to evaluate the potential CYP1A2-mediated drug-drug interactions (DDI), safety, and tolerability of ABX464 combined with a known CYP1A2 inhibitor (fluvoxamine).
Intervention MeSH terms: Fluvoxamine; Caffeine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase 1, 2 part, fixed-sequence open-label, crossover study to evaluate the potential CYP1A2-mediated drug-drug interactions (DDI), safety, and tolerability of ABX464 combined with a known CYP1A2 substrate (caffeine) and a known CYP1A2 inhibitor (fluvoxamine). Sixty (60) healthy adult male and female subjects 18 to 55 years of age are planned to participate in the study. Separate cohorts of subjects will be enrolled for Part A (24 subjects) and Part B (36 subjects).
Masking: None (Open Label)
Primary purpose: Prevention
Clinical Investigation on Zirconia-ceramic Three-unit Bridges With CAD-on Veneering
Condition: Three-unit Posterior Bridges
Study type: Interventional

Summary: 
      60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered
      with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The goal
      is to compare clinical survival , biological or technical behaviour of the restorations.
    

Detailed description: 
      Randomized prospective controlled clinical study with three-unit posterior bridges made of
      zirconia-ceramic to compare veneering with manually layering or CAD/CAM fabricated lithium
      disilicate ceramic veneers. The hypothesis is that there is no difference in clinical
      survival of the restorations and no difference in biological or technical behaviour.
    

Intervention name(s): CAD/CAM Veneering; Manually layered veneering
Intervention type(s): Device; Device
Intervention description(s): CAD/CAM fabricated zirconia bridge framework is veneered with CAD/CAM fabricated lithium disilicate ceramic veneer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CAD/CAM, three-unit posterior bridges, zirconia framework