bioihbjkbjnl/mcl2 huggingface dataset:
A Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers
Condition: Acute Herpes Zoster
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the potential for a PK drug-drug interaction between
      FV-100 and ritonavir. The study is a single-center, open-label, randomized, 2-way crossover
      design in healthy volunteers.
    


Intervention name(s): FV-100
Intervention type(s): Drug
Intervention description(s): Subjects will be randomized to one of two treatment sequences: AB or BA.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg +
      Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in
      healthy adult human subjects, under fasting conditions.
    

Detailed description: 
      Open randomized, two treatment, two period, two sequence, single dose, crossover study of 26
      healthy human adult subjects under fasting conditions with a washout period of 14 days.
    

Intervention name(s): Naproxen Sodium & Pseudoephedrine HCl
Intervention type(s): Drug
Intervention description(s): Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets
Other intervention name(s): Aleve Cold and Sinus
Intervention MeSH terms: Naproxen; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Naproxen Sodium and Pseudoephedrine Hydrochloride
MW151-101: First-in-human Study of MW151
Condition: Drug Toxicity
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 1

Summary: 
      MW01-2-151SRM (=MW151), a small molecule, is being developed for the treatment of cognitive
      disorders. The development program is based on nonclinical evidence that MW151 improves
      neurocognitive outcomes in animal models of radiation-induced cognitive impairment,
      Alzheimer's disease, and other central nervous system (CNS) disorders.

      The present study will provide safety and pharmacokinetic (PK) information on single
      ascending doses to support decisions for continued clinical development.
    

Detailed description: 
      The primary objective of this trial is to assess the safety and tolerability of single
      ascending doses of MW151 when administered orally to healthy adults.

      Subjects will be screened prior to inpatient admission. Subjects will be admitted to the
      inpatient clinic on the day prior to dosing (Day -1) and will remain in the unit until
      discharge on Day 3. A follow-up visit will be done on Day 7. A single dose of study drug or
      placebo will be administered on Day 1. Healthy adult female subjects will be randomly
      assigned to one of 5 dose cohorts (8 subjects each). Each subject will receive a single dose
      of MW151 (10-160mg) or placebo under fasted conditions.

      Following a review of safety and tolerability data for the first 24 hours of dosing in each
      cohort (including reported adverse events (AEs), physical examination findings, clinical
      laboratory results, vital signs, and electrocardiograms (ECGs), the remaining 6 subjects will
      be randomized in a 5:1 ratio. Dosing of the remaining subjects in a cohort may proceed after
      review of sentinel subject safety data collected during the first 24 hours of dosing and
      determination that no stopping rules are met. The remaining subjects in each cohort will be
      dosed sequentially, not simultaneously.
    

Intervention name(s): Placebo; MW151, 10mg; MW151, 20mg; MW151, 40mg; MW151, 80mg; MW151, 160mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Matched placebo administered orally; 10 mg MW151, 1 x 10mg capsule administered orally; 20 mg MW151, 1 x 20mg capsule administered orally; 40 mg MW151, 2 x 20mg capsule administered orally; 80 mg MW151, 1 x 80mg capsule administered orally; 160 mg MW151, 2 x 80mg capsule administered orally
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose-escalation study.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: cognitive disorder; pharmacokinetics; MW151; MW01-2-151SRM; PK; dose escalation
Omega-3 Fatty Acid Treatment in Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Based on previous clinical studies indicating beneficial treatment effects of omega-3 fatty
      acids in multiple sclerosis, and the increasing evidence of anti-inflammatory effects of
      omega-3 fatty acids, this study aims to evaluate treatment effects of concentrated omega-3
      fatty acids (Triomar™) in MS, both as monotherapy and in combination with standard
      immunomodulatory therapy defined as interferon-beta 1a (Rebif™).
    

Detailed description: 
      Patients with relapsing-remitting multiple sclerosis with evidence of disease activity
      defined as at least one relapse or at least one new MRI lesion during the year prior to
      inclusion will be included in the study.

      Eligible patients will be randomised for daily treatment with either oral omega-3 fatty acid
      (Triomar™) or placebo. After six months all patients will in addition receive interferon-beta
      1a (Rebif™) 44 mcg subcutaneous three times per week for another 18 months.

      The patients will undergo monthly contrast enhanced MRI for the first nine months and
      thereafter at months 12 and 24. They will also be examined by clinical and laboratory tests
      at six months intervals in addition to month 9 (3 months after start of IFNB treatment).
      Fatigue and QoL registration will be performed at baseline and at months 6, 12 and 24. Tests
      for circulating neutralising antibodies against interferon-beta will be performed during the
      study.
    

Intervention name(s): Triomar™ (omega-3 fatty acids)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: RRMS; Omega-3; Treatment
Study of Autologous Mesenchymal Stem Cells to Treat Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical Trial Phase I, open, multicentric, non randomized, study with escalating doses, to
      evaluate the safety and feasibility of treatment with mesenchymal stem cells in patients with
      diagnosis of idiopathic pulmonary fibrosis.

      Primary endpoint: The aim is to evaluate the safety and feasibility of the endobronchial
      administration of mesenchymal autolog stem cells derived from bone marrow (BM-MSC)in patients
      with mild-to-moderate idiopathic pulmonary fibrosis.

      Secondary endpoint:Assess the possible effect of the infusion of BM-MSC in stopping the fall
      of pulmonary function in patients with mild-to-moderate idiopathic pulmonary fibrosis.
    


Intervention name(s): Endobronchial infusion of adult mesenchymal stem cells; Autologous mesenchymal stem cells derived from bone marrow
Intervention type(s): Biological; Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Idiopathic pulmonary fibrosis; Stem cells; Mesenchymal stem cells
Designing a Bayesian Model of the Plasma Clearance of Calcium Edetate de Sodium for the Calculation of GFR and Validity Compared to the Renal Clearance of Inulin
Condition: Kidney Disease
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Diagnosis of patients with renal insufficiency and recommendations for medical treatment of
      patients who suffer from chronic renal failure are based on the different stages of
      Glomerular Filtration Rate (GFR). Many formulas exist to assess GFR. However these formulas
      are unreliable in many clinical situations (old people, obese patients…). Methods for
      measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference
      tracers. Renal clearance of Inulin is the gold standard. However, using these methods is
      restricted to specialized services because it is long and expensive.

      There is no medical data for the use of Calcium edetate de sodium as a tracer to assess GFR.
      Calcium edetate de sodium is a treatment for lead intoxication. The extension of use as a
      tracer comes from its exclusive elimination by glomerular filtration.

      Plasma and renal clearance of Calcium edetate de sodium and Inulin will be measured for every
      included patient during a hospital day care (First visit V1). For transplanted patients,
      plasma clearance of Calcium edetate de sodium will be repeated within one week (more or less
      48hours) during annual medical check-up of renal transplantation (Second visit V2).
    


Intervention name(s): Dosage of Calcium edetate de sodium
Intervention type(s): Drug
Intervention description(s): There is no medical data for the use of Calcium edetate de sodium as a tracer to assess GFR. Calcium edetate de sodium is a treatment for lead intoxication. The extension of use as a tracer comes from its exclusive elimination by glomerular filtration. Plasma and renal clearance of Calcium edetate de sodium and Inulin will be measured for every included patient during a hospital day care (V1). For transplanted patients, plasma clearance of Calcium edetate de sodium will be repeated within one week (more or less 48hours) during annual medical check-up of renal transplantation.
Intervention MeSH terms: Edetic Acid; Calcium; Pentetic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: GFR; Bayesian model; plasma clearance; Calcium edetate de sodium; Inulin
Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH.
      Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new
      version of ibuprofen is expected to produce fewer stomach/intestine related side effects when
      compared to many existing marketed formulations of Ibuprofen.

      This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way
      crossover and Part C is a maximum of a 4 way crossover. The size of Parts B & Part C and
      allocated interventions will be confirmed after review of data from Parts A and/or B
      respectively.

      A total of 30 subjects will take part in the study; 10 per study part.

      The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and
      without a selection of different excipients. The pharmacokinetic properties will include how
      quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug
      that reaches the bloodstream.
    


Intervention name(s): Ibuprofen; Ibuprofen Lysine; Ibuprofen-LDH
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of LY2963016 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There
      will be at least 6 days between each injection.

      The study will compare LY2963016 to Lantus at two different doses.

      This study is approximately 10 weeks long, not including screening. Screening is required
      within 4 weeks of the start of the study.
    


Intervention name(s): LY2963016; Lantus
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Feasibility Study of a Temporary Peripheral Nerve Stimulator
Condition: Nerve Injury
Study type: Interventional

Summary: 
      A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and
      preliminary efficacy.
    


Intervention name(s): Temporary Peripheral Nerve Stimulator
Intervention type(s): Device
Intervention description(s): Temporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin
Condition: Healthy Young and Older Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to assess whether the application of a selective serotonin reuptake
      inhibitor (SSRI) enhances and prolongs the learning enhancement achieved by anodal
      transcranial direct current stimulation (atDCS). For this, young and older healthy subjects
      will be tested with a well established learning paradigm. Results of this study may help to
      support the application of atDCS also in patients, e.g. with dementia or mild cognitive
      impairment.
    


Intervention name(s): tDCS; Citalopram; sham-tDCS + placebo
Intervention type(s): Procedure; Drug; Other
Other intervention name(s): transcranial direct current stimulation; SSRI
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: transcranial direct current stimulation (tDCS); selective serotonin reuptake inhibitor (SSRI); young; older adults
Effect of Real-fire Training on Vascular Function
Condition: Vascular Function; Atherothrombosis
Study type: Interventional

Summary: 
      Fire-fighters are at increased risk of death from heart attacks when compared to other
      emergency service professionals whose jobs involve similar components such as emergency
      call-outs and shift work. The unique risk to fire-fighters is likely to reflect a combination
      of factors including extreme physical exertion, mental stress, heat and pollutant exposure.

      In the largest analysis of cause of death amongst on-duty fire-fighters, fire-fighter deaths
      were classified according to the duty performed during the onset of symptoms or immediately
      prior to any sudden death. The majority of deaths due to a cardiovascular cause (i.e. heart
      attack) occurred during fire-suppression whilst this activity represented a relatively small
      amount of a fire-fighters professional time. Fire simulation training centers offer a unique
      opportunity to assess the heart, blood and blood vessel response to fire suppression in a
      controlled environment.

      In this study the investigators will assess healthy career fire-fighters on two occasions:
      following a fire-suppression training exercise in a purpose built real-fire training center,
      and following a sedentary period as a control. The investigators will take blood samples to
      measure platelet activity (platelets are the particles in blood that help blood clot) and
      will examine how blood clots outside of the body. The investigators will then perform studies
      placing small needles in the arm to assess blood vessel function following fire suppression.
      By undertaking this comprehensive assessment of blood, blood vessel and heart function we
      hope to understand the mechanisms whereby the risk of a heart attack is influenced by fire
      suppression. The investigators hypothesize that following the fire-suppression exercise
      firefighters blood will clot more readily and their blood vessels will not relax properly
      which are two of the main processes in the development of a heart attack.
    


Intervention name(s): Forearm Vascular Study; Badimon Chamber Study
Intervention type(s): Procedure; Procedure
Intervention description(s): Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 µg/min).; Ex-vivo assessment of thrombus formation using the Badimon Chamber
Other intervention name(s): BK; SNP; ACh; VP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: firefighters; fire-simulation training; myocardial infarction; endothelial function; thrombosis
Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The current study aims to test an online, non-restrictive diet among persons with multiple
      sclerosis (MS). Diet is the number one searched second-line therapy among persons with MS,
      however there are currently no established dietary approaches to improve health and wellbeing
      among persons with MS. Participants will complete the 8-week diet program using an online
      application. The primary research question is whether the diet program is acceptable and can
      improve general health indicators including cholesterol, glucose, body weight, body fat as
      well as MS symptoms (i.e., walking, cognition, fatigue, and quality of life).
    


Intervention name(s): 800g Challenge
Intervention type(s): Behavioral
Intervention description(s): The intervention will involve 8 weeks of an online diet program. Outcomes testing will occur at baseline and post-intervention (following 8 week diet program). During the first 4 weeks, participants will receive educaitonal material and log their daily points in an online application and attend a weekly check-in call with members of the research team. During weeks 5-8, participants will log their daily points in the online application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, Randomised, Placebo-Controlled, Single-Ascending Dose and Multiple-Dose with 3 novel
      RIFAXIMIN Formulations.

      2 phases: Single-Ascending Dose (SAD) Phase and a Multiple-Dose (MD) Phase, Plus optional
      open-label, crossover Food Effect (FE) Evaluation

      Primary objective: evaluate the safety and tolerability of three novel formulations of
      rifaximin in healthy volunteers.

      Secondary objective: evaluate the pharmacokinetics (PK) of the novel formulations and to
      assess for the presence of exploratory biomarkers.
    


Intervention name(s): Rifaximin Novel Formulation; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rifaximin Novel Formulation; Placebo
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Omega-3 Fatty Acid Supplementation to Enhance Performance
Condition: Strength; Body Composition; Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The goal of this intervention study is to determine if omega-3 fatty acid supplementation as
      compared to placebo improves performance in track and field athletes. The main questions it
      aims to answer are:

        1. Can performance be improved

        2. Can strength be enhanced

        3. Will positive body composition changes occur (lean vs fat mass)

        4. Will feelings of muscle soreness be diminished Participants will take either omega-3
           fatty acid supplements or placebo and continue with their sport specific training
           regimen.

      Researchers will compare the supplement group to placebo group to determine if there are any
      significant differences.
    

Detailed description: 
      This is a randomized, placebo-controlled trial to determine the efficacy of fish oil-derived
      omega-3 fatty acid supplementation. Up to sixty participants will be randomized to receive
      one of two conditions: 4.0 grams of FO n-3/day or placebo (coconut oil) for the 10-week
      protocol study period. Nordic Naturals (Ultimate Omega) will be used as the intervention at a
      dose of 6 capsules/day (3840 mg total FO/1950 mg EPA/1350 mg DHA). Although protocols have
      varied among studies with regards to dosage, the proposed regimen was selected based on
      studies on strength in older adults and college-aged athletes utilizing a range of 2-5g FO
      n-3 per day. Blinded randomization will be accomplished with a research associate providing
      every first (of two) participants the placebo, while the second will receive the supplemented
      condition until recruitment is complete. Participants will be provided their supplement in
      2-week increments and instructed to consume with/near their evening meal. Used bottles will
      be returned after two weeks and participants will receive the next 2-week supply of
      supplement and the leftover pill count will determine compliance rate.

      The target population is apparently healthy college athletes (male and female of all
      ethnicities) between the ages of 18-25 years at Baylor University. Participants must be able
      to read and understand English and sign their own consent form. Up to 60 subjects will be
      recruited via direct contact or team briefings with permission of the coaches.
    

Intervention name(s): Omega-3 fatty acid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6 capsules per day of 3840 mg that included 1950 mg EPA and 1350 mg DHA; 4 capsules per day of coconut oil
Other intervention name(s): Nordic Naturals Ultimate Omega
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: omega-3 fatty acid; strength; body composition; muscle soreness