bioihbjkbjnl/mcl2 huggingface dataset:
Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Olokizumab (OKZ) has been shown to reverse the inhibitory effect of IL-6 on the activity of
      Cytochrome P450 (CYP450) isozymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4/5 in vitro.

      The goal of the study is to assess the effect of OKZ on the pharmacokinetics (PK) of the
      CYP450 probe substrates, caffeine (CYP1A2), S-warfarin (CYP2C9), omeprazole (CYP2C19), and
      midazolam (CYP3A4) in subjects with rheumatoid arthritis (RA).
    

Detailed description: 
      This is a Phase 1, open-label, 3-period, single-sequence, crossover study in subjects with RA
      with increased C-reactive protein (CRP).

      Approximately 15 eligible subjects will be enrolled at approximately 3 study centers to have
      at least 12 evaluable subjects completing the study. However, if necessary, additional
      subjects may be dosed to obtain the 12 evaluable subjects required.

      There will be a 35-day Screening Period, followed by a 29-day study duration: eligible
      patients will be administered a cocktail of 4 substrates alone during 7-day PK-sampling
      (Period 1); a single subcutaneous dose of 128 mg OKZ will be administered (Period 2)
      approximately 2 weeks prior to the second administration of the cocktail in 7-day PK-sampling
      (Period 3). After completion of the Period 3 patients will be followed-up for 19 weeks (133
      days) for safety evaluations.

      Overall duration of the study will be approximately 200 days (6 and a half months).
    

Intervention name(s): Olokizumab; Omeprazole; Caffeine; Warfarin+ Vitamin K; Midazolam
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Sterile solution for subcutaneous (SC) injection, 128 mg (0.8 mL injection); Tablets, 20 mg, oral; Tablets, 100 mg, oral; Warfarin -Tablets 10 mg, oral. Vitamin K - solution for intravenous injection, 10 mg/mL ampoule; Syrup, 2 mg/mL, oral
Intervention MeSH terms: Vitamin K; Midazolam; Caffeine; Omeprazole; Warfarin
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: moderate Rheumatoid Arthritis; severe Rheumatoid Arthritis; subcutaneous; Olokizumab; drug interaction; CYP450
Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease
Condition: Coronary Arteriosclerosis; Endothelial Function
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Arteriosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of orally given paracetamol on the
      vascular function and on 24-hour blood pressure in patients with coronary artery disease
    

Detailed description: 
      Patients with chronic pain diseases (e.g. osteoarthritis) are dependent on effective
      medication. NSAIDs are very effective in lowering pain in these patients. Recently there has
      aroused major concern with regard to cardiovascular side effects and safety, especially in
      selective cyclooxygenase-2 inhibitors (coxibs) but also in "regular" NSAIDs.

      At the moment, there is a big confusion, whether these drugs still should be used, especially
      in patients with known coronary artery disease. Physicians now try to switch to high dose
      paracetamol, despite the weaker efficacy in pain relieve, because this drug is considered
      generally as not harmful.

      As there is very few information on the cardiovascular effect of this drug, we plan to
      perform this study and investigate the impact of paracetamol on endothelial function, an
      important cardiovascular surrogate marker, on inflammatory markers and on oxidative stress in
      patients with coronary artery disease on top of standard medication, including aspirin
    

Intervention name(s): Paracetamol
Intervention type(s): Drug
Intervention description(s): Paracetamol 3x1000mg daily or Placebo for two weeks in a crossover design with a two-week washout-phase in between.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
BABA Robotic Thyroidectomy Without Gas is Safe Enough as That Use a Gas
Condition: Thyroidectomy; Thyroid Diseases
MeSH terms: Thyroid Diseases
Study type: Interventional

Summary: 
      In this study, a randomized controlled study was conducted between two groups of 14 classic
      recipients of Carbon dioxide insufflation during BABA robotic-thyroidectomy and 14 recipients
      of Gasless method during BABA robotic-thyroidectomy. This is a study to see if there is any
      difference in hemodynamic and metabolic changes and pain .
    


Intervention name(s): Gasless BABA; Classic BABA
Intervention type(s): Procedure; Procedure
Intervention description(s): BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.; BABA robotic-thyroidectomy that is using carbon dioxide.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gasless; Bilateral axillo-breast approach; Da Vinci; Robot-assisted thyroid surgery
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled,
      parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab
      (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or
      severely active Crohn's disease.
    

Detailed description: 
      This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled,
      parallel-group study to examine the efficacy, safety, and pharmacokinetics of intravenous
      vedolizumab (300 mg) infusion in induction and maintenance therapy in Japanese participants
      with moderately or severely active Crohn's disease.
    

Intervention name(s): Vedolizumab; Vedolizumab placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vedolizumab IV injection; Vedolizumab placebo-matching IV infusion
Other intervention name(s): MLN0002
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy
Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty
Condition: Osteoarthritis, Hip; Ambulation Difficulty
MeSH terms: Osteoarthritis; Osteoarthritis, Hip; Mobility Limitation
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to study the effect of Denosumab on Bone Mineral Density,
      Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The
      primary hypothesis is to demonstrate that Denosumab is superior to placebo.
    

Detailed description: 
      A clinical study with 64 patients, age 35-65 years, with unilateral osteoarthritis of the
      hip, randomised to two groups of patients, either receiving Denosumab or placebo

      The patients will operated with an uncemented total hip arthroplasty with a Continuum
      acetabular cup with trabecular surface (Tantalum) and longevity Highly Cross-linked
      Polyethylene liner, Zimmer, Warsaw, IN, USA, and a CFP femoral stem with Titanium surface and
      a chrome cobalt 28 mm head, Waldemar Link, Hamburg, Germany.

      Clinical outcome evaluated by Harris Hip Score and EQ-5D, Bone Mineral Density by DXA,
      Standardised Uptake Value of Fluoride tracer, by PET/CT and biochemical markers for bone
      formation and bone resorption will be analyzed together with conventional radiology for
      implant position and fixation.
    

Intervention name(s): denosumab
Intervention type(s): Drug
Intervention description(s): Two doses of 60 mg in a solution of 1 ml, given as an subcutaneous injection with a 6 month interval
Other intervention name(s): Prolia
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Osteoarthritis of the hip; Uncemented Total Hip Arthroplasty; DXA; BMD; PET; CT; Biochemical bone markers
Performance Study to Test the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Over the last years, a number of systems for continuous subcutaneous glucose monitoring have
      been marketed and are routinely used in patients with diabetes to obtain more detailed
      information about 24-hour glucose profiles.

      In the hospital, numerous factors influencing glycemic control and possibly leading to
      glucose excursions out of the desired range exist, e.g. interventions for which the patient
      has to remain fasting or medications such as corticosteroids or vasopressors. A reliable
      continuous glucose signal could help to observe levels of glycaemia not only at defined
      time-points but continuously, making it possible for physicians and nursing staff to better
      adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo-
      or hyperglycaemia.

      In the hospital setting, vascular access is granted in the majority of patients and could as
      well be used as an alternative site for continuous glucose monitoring.

      The aim of the present study is to assess accuracy of the glucose data obtained by means of
      an intravascular microdialysis-based CGM system against venous blood glucose reference
      measurements.
    


Intervention name(s): Vascular microdialysis using the GMD-system; Vascular and subcutaneous microdialysis using the GMD-system
Intervention type(s): Device; Device
Intervention description(s): Glucose levels will be monitored by means of vascular microdialysis using the GlucoMen(R)Day system; Glucose levels will be monitored by means of vascular and subcutaneous microdialysis using the GlucoMen(R)Day system
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with type 1 diabetes
      
Keywords: Type 1 diabetes; Intravascular continuous glucose monitoring; Subcutaneous continuous glucose monitoring
Subjective Sleep and Fatigue During and After Acute Diverticulitis
Condition: Acute Diverticulitis
MeSH terms: Diverticulitis
Study type: Observational

Summary: 
      The purpose of this study is to investigate subjective sleep quality and fatigue during and
      after Acute uncomplicated diverticulitis assessed by questionnaires and a sleep-diary. The
      investigators hypothesis is that subjective sleep and fatigue are correlated with the
      inflammatory activities.
    

Detailed description: 
      An increasing number of experimental studies have showed that inflammation can induce
      disturbances in sleep architecture, mediated by cytokines. some studies showed that cytokines
      also induce daytime fatigue. In this study the investigators aim to describe the patient
      experiences of sleep and fatigue during the acute inflammation and the recovery, and the
      investigators seek to exam the correlation of fatigue with Polysomnography-measured night
      sleep and cytokine levels in plasma.

      Following methods will be applied

        -  Other: Karolinska Sleepiness Scale

        -  Other: Physical Fatigue Scale

        -  Other: Visual Analog Scale and 10 point-scales to measure fatigue, general well-being,
           subjective sleep and pain

        -  Other: Sleep-diary

        -  Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)

        -  Procedure: Plasma cytokines (IL-2, IL-6 and TNF-alfa(tumor necrosis factor))

        -  Procedure: Plasma CRP(C reactive protein) and leukocytes

        -  Device: Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New
           York, USA
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        16 x Acute uncomplicated diverticulitis (Hansen and stock stage 1) patients aged 18-75
        years managed by antibiotic treatment at Herlev Hospital.
      
Biospecimen description: 
      plasma
Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension
Condition: Ocular Hypertension
MeSH terms: Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Aim: Evaluation of a single subconjunctival injection of liposomal EggPC formulation of
      latanoprost in treating glaucoma.

      Hypothesis: The investigators have already evaluated carrier stability, drug partitioning, in
      vitro drug release, tolerance, and efficacy of latanoprost-incorporated EggPC liposomes upon
      subconjunctival administration in both rabbit and monkey eyes. Therefore, the investigators
      hypothesize that this would be safe and efficacious in humans as well.

      Methodology: A pilot study to assess a liposome formulation containing latanoprost. The
      investigators will recruit 6 study subjects with eyes that have raised IOP, for
      subconjunctival injection of this liposome formulation. The recruited eye will be injected
      and monitored for inflammation, toxicity and pain as primary end-points. Monitoring of the
      eye will be for the first 24 hours post-injection, week 2, months 1, 2 and 3 thereafter.

      Importance: If proven safe, this method of drug delivery could potentially be used for
      treatment of raised intraocular pressures in blinding conditions such as glaucoma.
    

Detailed description: 
      The number of recorded adverse events and intolerance to the subconjunctival injection
      procedure by the participants during the study period was used as a measure of safety.
    

Intervention name(s): Subconjunctival injection of liposomal latanoprost
Intervention type(s): Drug
Intervention MeSH terms: Latanoprost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glaucoma; raised intraocular pressure
Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects
Condition: Overweight; Hyperlipidemia
MeSH terms: Overweight; Hyperlipidemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Barley, like oats, is a rich source of the soluble fibre β-glucan, which has been shown to
      significantly lower LDL-cholesterol (LDL-C). However, barley foods have been less widely
      studied.
    

Detailed description: 
      This study investigated whether the supplementation of barley β-glucan is reduce the visceral
      fat as well as the serum low-density lipoprotein cholesterol (LDL-C) and total cholesterol
      (TC) in mildly hypercholesterolemic subjects. In a 12 week double-blind, controlled study,
      subjects were randomized to one of treatment group(3.0g/day as β-glucan) or placebo group.
    

Intervention name(s): Barley beta-glucan(3.0g); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Barley beta-glucan(3.0g/day) for 12 weeks; Placebo for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Soluble fiber; Polycan; Overweight; LDL-C(Low Density Lipoprotein-cholesterol)
Opposing Step-by-step Insulin Reinforcement to Intensified Strategy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objectives :

        -  To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus
           metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm
           2) compared with insulin glargine plus metformin combined with 3 bolus of insulin
           glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal
           insulin therapy with oral antidiabetic drugs.

        -  To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus
           metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm
           2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea
           or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively
           (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy
           with oral antidiabetic drugs.

      Secondary objectives :

        -  To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of
           subjects with HbA1c <= 7% at the end of the study, evolution of blood glucose profiles,
           incidence of hypoglycemia, insulin doses, evolution of body weight and treatment
           satisfaction.
    


Intervention name(s): Insulin Glargine; Insulin Glulisine; Metformin; insulin secretagogue
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One daily injection in the evening. 100 U/ml; Given immediately before each of the three main meals. 100 U/ml; At same dosages as the previous treatment; sulfonylurea or glinide
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin glulisine; Secretagogues
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Typing Proficiency Following Carpal Tunnel Release
Condition: Carpal Tunnel Release
MeSH terms: Carpal Tunnel Syndrome
Study type: Observational

Summary: 
      This study will investigate how soon a patient's typing proficiency returns to their
      pre-operative levels following carpal tunnel release surgery. In order to determine this,
      patients will undergo typing tests at different time points that will record their typing
      accuracy and speed. The results will then be compared to determine on average how soon a
      person returns to their pre-operative baseline results.
    

Detailed description: 
      Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist.
      It causes such symptoms as numbness, tingling, weakness, muscle damage, and pain. If
      non-operative treatments do not work generally patients go on to carpal tunnel release
      surgery in which the transverse carpal ligament is released. After surgery patients usually
      return to work with no restrictions within six weeks. Patients often ask how soon they are
      able to return to typing after surgery, and what their typing ability will be like after
      surgery. Currently there are no studies that evaluate how long it takes for patient's typing
      skills to return to that of the pre-operative skill level. We would like to answer that
      question by comparing typing results from different time points including a baseline prior to
      surgery. We additionally seek to identify which patient characteristics are predictive of a
      faster return of typing proficiency.

      An additional innovative aspect of this project is the use of a web-based typing test that
      will be used in the assessment of patient typing proficiency. We will additionally use a
      web-based model for the collection of our survey data.
    

Intervention name(s): Typing assessment
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Vanderbilt Hand & Upper Extremity Center Outpatient Clinic
Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency
Condition: Weight Loss; Muscle Loss; Bone Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Military personnel face many physiological challenges, including sustained physical activity
      and prolonged periods of negative energy balance. Chronic energy deficiency often results in
      a loss of skeletal muscle mass and can reduce overall bone health. Recent evidence suggests
      that dietary interventions that provide protein in excess of the current national dietary
      recommendation may confer protection against the negative effects of energy deficiency on the
      musculoskeletal system. The primary objective of this randomized, controlled study is to
      assess the effects dietary protein intake spanning the current acceptable macronutrient
      distribution range on musculoskeletal health following prolonged energy deficiency. Findings
      from this investigation will improve current understanding of dietary conditions necessary to
      reduce the damaging effects of caloric deficiency on musculoskeletal health in warfighters.
      Furthermore, given the rise in obesity in military populations, findings may aid in the
      development of nutritional weight management strategies that promote healthy weight loss
      without compromising musculoskeletal health.
    


Intervention name(s): Dietary Protein Intake
Intervention type(s): Other
Intervention description(s): Protein intakes within the current recommendation
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dietary supplement; protein metabolism; bone turnover
Oral Versus Vaginal Misoprostol for Induction of Labor
Condition: Termed Pregnancy With Indications for Labor Induction.
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare the efficacy between a single dose of oral
      misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor.
    

Detailed description: 
      Induction of labor is widely carried out all over the world in cases where continuation of
      pregnancy is hazardous to both the mother and/or fetus. The induction in a ripe cervix is not
      difficult but complications are significantly increased when the cervix is unripe. The only
      agent approved for cervical ripening and induction of labor in patients with an unripe cervix
      is dinoprostone(PGE2). Misoprostol is a synthetic PGE1 analogue marketed for the prevention
      and treatment of gastro-duodenal ulcers. Misoprostol costs much less than dinoprostone and
      does not require refrigeration and has few systemic side effects.In addition, it is rapidly
      absorbed orally and vaginally. Although misoprostol is not registered for such use, it has
      been widely used for obstetric indications such as induction of abortion and of labor.
      Misoprostol for induction of labor in preceding literatures mainly prescribed in multiple
      dosing regimen. The adverse effects on uterus potentially occur owing to the frequent
      administration of misoprostol. The objective of this study was to compare a single dose oral
      misoprostol with vaginal misoprostol.
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cervical ripening.; Induction of labor.; Misoprostol.