bioihbjkbjnl/mcl2 huggingface dataset:
Bone Morphogenetic Protein-2 In Grade II Furcation Defects.
Condition: Periodontitis
MeSH terms: Periodontitis; Furcation Defects
Study type: Interventional

Summary: 
      The present study evaluated clinically and radiographically the regenerative potential of
      rhBMP-2 in absorbable sponge and PRF in Grade II furcation.
    

Detailed description: 
      44 subjects were enrolled in the study. PPD, CAL, plaque index and gingival index were
      recorded and the evaluation of bone fill was performed after 6 months by using ImageJ®
      software. After 6 months, the bone fill obtained with rhBMP-2 was higher when compared to
      PRF. From this trial conducted over a period of 6 months, the unique properties associated
      with rhBMP-2 in absorbable sponge makes it a potential agent to be used as a graft material
      for Grade II furcation defects.
    

Intervention name(s): RhBMP-2 absorbable sponge in grade II furcation; PLATELET RICH FIBRIN in grade II furcation
Intervention type(s): Drug; Procedure
Intervention description(s): The collagen sponge is impregnated with rhBMP-2 at a concentration of 0.5 μg/ml/1cm3 and were stored at 4°C. This rhBMP-2 impregnated collagen sponge was then dispensed at grade II furcation site; For preparation of PRF, patient's venous blood is collected into 10ml glass tube or glass-coated plastic tube and centrifuged at 2700 rpm for 12min which leads to two different layers in the test tube, the upper platelet rich fibrin and the lower RBC portion. The formed PRF clot could then be removed from the glass tube and used in grade II furcation
Other intervention name(s): Experimental group; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A- RhBMP-2 absorbable sponge is placed in grade II furcation and Group B- PRF is placed in the grade II furcation
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is being done to evaluate the safety of BHT-3009 alone and when combined
      with atorvastatin (Lipitor) in patients with multiple sclerosis (MS).
    

Detailed description: 
      This research study is being done to evaluate the safety of BHT-3009 alone and when combined
      with atorvastatin (Lipitor) in patients with multiple sclerosis (MS).

      Patients with MS are thought to have an immune response that attacks certain proteins in the
      brain, including myelin basic protein. (Myelin basic protein is a protein that makes up part
      of the outside layer of nerve cells.) BHT-3009 is an investigational immunotherapy product
      that is designed to alter the immune response to myelin basic protein and make the response
      less harmful. BHT-3009 contains the DNA (gene) for myelin basic protein.

      Three different doses of BHT-3009 will be tested to determine if there are any differences in
      safety or effects on immunity. This is the first clinical research study of BHT-3009.
      Laboratory studies have shown that BHT-3009 and atorvastatin given together alters the immune
      response to myelin basic protein and makes the response less harmful.
    

Intervention name(s): BHT-3009-01
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: multiple sclerosis; relapsing-remitting; secondary progressive
The Lean Meats Mediterranean Diet Study
Condition: Cardiovascular Diseases; Dietary Modification
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of the proposed research study is to assess the effects of including greater
      amounts of minimally processed red meat (lean pork and beef) into a Mediterranean Diet on
      cardiometabolic and emotional well-being.
    

Detailed description: 
      All subjects will complete an 18-wk randomized crossover study. Following a 2-wk baseline
      testing period to assess cardiometabolic and emotional well-being and habitual diet, subjects
      will consume a Mediterranean-style, weight-maintenance diet that is either restricted or rich
      in lean, minimally processed red meat for 5 weeks. Following a 4-wk washout period and second
      2-wk baseline testing, subjects will consume the Mediterranean Diet with the alternate
      predominant animal protein sources for 5 weeks. Cardiometabolic and emotional well-being will
      be assessed during baseline and post periods.
    

Intervention name(s): Red Meat Restricted; Red Meat Rich
Intervention type(s): Other; Other
Intervention description(s): restrict intake of red meat while a Mediterranean diet; Mediterranean diet rich in red meat
Other intervention name(s): S44 Mediterranean Diet; S44 Mediterranean Diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cardiovascular disease risk; Mediterranean diet; red meat
Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I/II study to evaluate the safety, tolerability, efficacy, and
      pharmacokinetic (PK) profile of DS-5141b in patients with Duchenne muscular dystrophy (DMD)
      amenable to exon 45 skipping and to determine the dosage for subsequent studies.
    


Intervention name(s): DS-5141b
Intervention type(s): Drug
Intervention description(s): DS-5141b, Subcutaneous injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Duchenne muscular dystrophy; DMD; Oligonucleotides, Antisense; Exon skipping
The Study Of Fluconazole For Vulvovaginal Candidiasis
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Phase 3

Summary: 
      As for the indication of vulvovaginal candidiasis, a single oral administration of
      fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in
      Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and
      topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose
      of this trial is to confirm the efficacy and safety of single oral administration of
      fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.
    


Intervention name(s): Fluconazole
Intervention type(s): Drug
Intervention description(s): Single oral dose of 150mg Fluconazole
Intervention MeSH terms: Fluconazole
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exploring the Mechanisms of Indoxyl Sulfate Production by Oral Tryptophan Challenge Test
Condition: Healthy; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD) is prevalent in patients with chronic kidney disease (CKD) and
      is associated with extremely poor prognosis. Traditional risk factors for the general
      population, such as diabetes mellitus, high blood pressure, and dyslipidemia, are more common
      in patients with CKD but cannot fully explain the increased risk of this population. New
      evidence suggests that the uremic milieu itself plays a critical role in the development and
      progression of CVD. The gut microbiota is markedly altered in CKD, with overgrowth of
      bacteria that produce uremic toxins. Indoxyl sulfate (IS) is among the most representative
      gut-derived uremic toxins and has been most frequently implicated as a contributor to the
      pathogenesis of CVD in CKD. IS is converted from indole, a gut bacteria metabolite of dietary
      tryptophan, by two hepatic enzymes, CYP2E1 and SULT1A1. The majority of studies have assessed
      IS toxicity in cultured cells and animal models. However, human data have been conflicting
      and the benefit of using orally administered adsorbents to reduce IS levels in unselected CKD
      patients was not supported by results from the recent randomized controlled trials. IS levels
      may fluctuate widely from time to time with dietary intakes. The investigators hypothesize
      that a postprandial IS concentration may more reflect its toxicity than a single time point
      (fasting or predialysis IS) concentration measured in clinical studies. Therefore, the
      investigators plan to establish an oral tryptophan challenge test (OTCT) by using an oral
      loading of 2 gm tryptophan to simulate the postprandial increase of plasma IS. The
      investigators will recruit 60 healthy volunteers to undergo OTCT. A pharmacokinetic study of
      IS after the OTCT will be performed in 20 of them to verify and simplify the design of OTCT
      protocol. The results of OTCT will be integrated with whole metagenome analysis of fecal
      microbiota and genetic polymorphism analysis of CYP2E1 and SULT1A1 to explore the mechanisms
      of IS production. In addition to the known genes in microbe produces indoles, other
      supporting bacteria or genes will be examined by using metagenomic shotgun sequencing data.
    


Intervention name(s): Doctor's Best L-Tryptophan
Intervention type(s): Dietary Supplement
Intervention description(s): 2g tryptophan loading once
Intervention MeSH terms: Tryptophan
Intervention model: Single Group Assignment
Intervention model description: All the participants would be introduced to receive 2g tryptophan loading for exploring serum and urine indoxyl sulfate concentration.
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Tolerability, Effect of Vildagliptin and How the Body Changes the Blood Level of Vildagliptin in Healthy Chinese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, effect of vildagliptin and
      how the body changes the blood level of vildagliptin of single and multiple oral doses of
      vildagliptin in healthy Chinese volunteers.
    


Intervention name(s): Vildagliptin (LAF237)
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Safety, tolerability, pharmacokinetics, pharmacodynamics, LAF237, vildagliptin, Chinese, healthy volunteers
Dose Response and Receptor Selectivity of Beta-blocker Effects on Bone Metabolism
Condition: Osteoporosis, Age-Related
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is designed to answer the question as to whether the sympathetic nervous system is
      an important determinant of bone metabolism in humans.
    

Detailed description: 
      In postmenopausal women, who have increased sympathetic outflow, to test the hypothesis that
      treatment with low doses of a non-selective β-blocker (propranolol) will increase serum
      markers of bone formation and reduce markers of bone resorption (Aim 1a); and using
      increasingly β1-AR (adrenergic receptor) selective blockers (atenolol and nebivolol), to
      better define the β-adrenergic receptor selectivity (β1 versus β2) in the regulation of bone
      turnover by sympathetic outflow in humans.
    

Intervention name(s): Atenolol; Nebivolol; Propranolol; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): beta blocker; beta blocker; beta blocker; placebo
Intervention MeSH terms: Propranolol; Atenolol; Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: bone formation
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
Condition: Nonalcoholic Steatohepatitis (NASH); Primary Sclerosing Cholangitis (PSC); Systemic Sclerosis (SSc)
MeSH terms: Fatty Liver; Cholangitis; Non-alcoholic Fatty Liver Disease; Cholangitis, Sclerosing; Scleroderma, Systemic; Scleroderma, Diffuse
Study type: Interventional
Phase: Phase 1

Summary: 
      CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic
      mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis
      (PSC) and systemic sclerosis (SSc). In this current study, the IP is tested in healthy male
      volunteers.
    

Detailed description: 
      A single-center, randomized double-blind, placebo-controlled, single-dose study Healthy
      volunteers were screened for up to 28 days prior to drug administration. The study included
      one dose group of 8 subjects. A single 5 mg/kg CM-101 dose was subcutaneously administered.
      The study was comprised of a screening period, a treatment day, a follow-up (FU) period of 42
      days and an end of study (EOS) FU visit.
    

Intervention name(s): CM-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Anti-human CCL24 monoclonal antibody (CM-101); Placebo Comparator
Intervention MeSH terms: Streptococcal polysaccharide type III group B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Is Anesthetic Loss of Consciousness a Top Down or Bottom up Phenomenon. What Does the Neurologic Examination Say?.
Condition: Anesthesia; Functional
MeSH terms: Unconsciousness
Study type: Interventional

Summary: 
      Using very slow or fast propofol intravenous injection, monitored using standard American
      Society of Anesthesiology (ASA) standard and SEDLine EEG (Med Tech), the patient was evaluate
      by a neurologist every 30 sec using the FOUR coma scale.
    

Detailed description: 
      Clinical experimental randomized study, approved by the Ethic Committee, with informed
      consent, included ASA I- II adults, without neurological illness and normal physical exam.

      The patient randomized in two groups, rapid induction (GR) with propofol in target controlled
      infusion (TCI) effect site mode using the phamacokinetic (PK) model from Marsh ke0 1,21 min-1
      using a calculated target of 5.4 ug/ml (loss of counsciousness EC95) and slow induction (GL)
      10 mg/kg/h with calculated effect site concentrations (CeCALC) same PK model.

      The same neurologist, blind to the correspondent group, evaluated all the patients every 30
      sec using the coma FOUR scale until loss of counsciousness (LOC), defined as a FOUR (E0 no
      eyes opening response and /or M0 no motor response). At LOC the existance of brainstem reflex
      was evaluated (B no pupil and corneal reflex), respiratory pattern (R apnoea), CeCALC and
      patient state index (PSI) SEDline™ was recorded during all the examination.

      After LOC in both groups we maintain in GR the initial target (5.3 ug/ml) and the LOC CeCALC
      during 10 min without intervention, except respiratory support if it was required.

      Frontal EEG 4 channel and spectrogram from SEDline monitor was extracted for each case and
      posterior analysis.

      Fisher exact test was used to describe primary outcome and difference between B and R for
      each group. The difference in time to reach LOC LOC, Ce and PSI was analysed with T- Student.
    

Intervention name(s): FOUR coma scale and frontal espectrograpy evaluation
Intervention type(s): Diagnostic Test
Intervention description(s): systematic evaluation using the validated FOUR coma scale during propofol administration
Other intervention name(s): 4 channel EEG record with SEDline monitor; Non Invasive Blood presure, Saturation 02, Electrocardiogram; propofol infusion in Target controlled infusion using Primea Orchestra infusion pump Fressenius Kabi
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparison of the neurologic behavior between two group, a fast and a slow anesthesia induction
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: propofol; pharmacology; anesthesic induction; drug titration
Reducing Dietary Energy Density by Incorporating Vegetables in Order to Decrease Energy Intake
Condition: Obesity
Study type: Interventional

Summary: 
      This study will test the hypothesis that incorporating vegetables into meals as a method of
      reducing the energy density will result in increased vegetable intake and decreased energy
      intake.
    


Intervention name(s): Incorporating vegetables into the diet to reduce energy density
Intervention type(s): Other
Intervention description(s): The entree portion of breakfast, lunch, and dinner meals will be manipulated to be a standard energy density, a 15% reduction in energy density, or a 25% reduction in energy density.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
Condition: Pediatric Obesity; Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in
      obese adolescents.
    


Intervention name(s): Placebo; VI-0521 Mid Dose; VI-0521 Top Dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): po once daily; po once daily; po once daily
Other intervention name(s): Sugar Pill; Phentermine/Topiramate; Phentermine/Topiramate
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Adolescent Obesity; Childhood Obesity; Qsymia; Pharmacokinetics; VI-0521; Phentermine; Topiramate
Tracking Biologics Along the Silk Road
Condition: Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Colitis, Ulcerative
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative
Study type: Observational

Summary: 
      The objective of this study is to explore and describe the disease characteristics, treatment
      and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic
      arthritis, Crohn's Disease or ulcerative colitis as the major disease treated with REMICADE,
      SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle
      East, and Western Asia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis,
        psoriatic arthritis, Crohn's Disease, or ulcerative colitis as their major disease for
        which they will be treated with REMICADE, SIMPONI, or STELARA within clinical practice.
Bonipar for Acute and Chronic Musculoskeletal Pain
Condition: Chronic Pain; Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a non-inferiority study comparing efficacy and onset of action between the
      herbal extracts topical solution, Bonipar, and diclofenac sodium topical solution, diclofenac
      topical solution 1.5%.
    

Detailed description: 
      This study is a non-inferiority study comparing efficacy and onset of action between the
      herbal extracts topical solution, Bonipar, and diclofenac sodium topical solution, diclofenac
      topical solution 1.5% (approved by the FDA as a topical analgesic). Approximately 168 Duke
      patients will be recruited from Duke Pain Clinic, and selected Duke primary care practices.
      Individuals who report acute (less than 3 months duration) or chronic musculoskeletal pain of
      any intensity will be considered for enrollment into the study. After obtaining consent,
      eligible subjects will be will be randomized to receive Bonipar or diclofenac topical
      solution 1.5%.
    

Intervention name(s): Bonipar; Diclofenac sodium topical solution 1.5%
Intervention type(s): Drug; Drug
Intervention description(s): Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.; Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to one of two study groups (Bonipar or diclofenac topical solution 1.5%), utilizing a predetermined randomization schedule in a 1:1 ratio.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Crossover Trial of the Effect of a High-Fat Meal on the PK of Oral CHR 2797 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the safety and tolerability; and to determine
      the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects.
    

Detailed description: 
      This will be a single center, open-label, 2-arm, 2-way, crossover trial to assess the effect
      of food on CHR-2797 PK following a single 120 mg dose. Approximately 18 normal, healthy male
      subjects will be enrolled with at least 12 subjects completing the study. Two 60 mg capsules
      will be administered for a 120 mg dose of CHR-2797 on Days 1 and 8 with a high-fat meal or in
      the fasted state according to the randomization schedule. Subjects will be confined at the
      clinical research unit (CRU) from the time of Period 1 Check-in until Clinic Discharge on Day
      3, and will return to the CRU on Day 7 for Period 2 Check-in and remain in the CRU until
      Study Completion (on Day 10 of Period 2). Blood samples for PK analysis will be collected
      through 48 hours post dose.
    

Intervention name(s): CHR-2797; CHR-2797
Intervention type(s): Drug; Drug
Intervention description(s): Two 60 mg capsules (120 mg dose) of CHR-2797 administered orally with 240 mL room temperature tap water after an approximately 10 hour fast.; Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal.
--------------------------------------------------------------------------------
Intervention MeSH terms: Tosedostat; Glycine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Male subjects, healthy
The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population
Condition: Impaired Fasting Glucose
Study type: Interventional

Summary: 
      The primary aim of this study is to evaluate the effect of a fibre rich health food drink on
      the post prandial glucose and triglyceride peak in healthy overweight adults with impaired
      fasting glucose (IFG). The study is randomised, stratified, double blind, two treatments, two
      period cross over study.
    


Intervention name(s): 25% fibre; 0% fibre
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Test is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin); Placebo is an energy matched powdered beverage
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: fibre; overweight; impaired fasting glucose