bioihbjkbjnl/mcl2 huggingface dataset:
The Implementation of Novel 'Heavy' Water Techniques for Determining Modulation of Muscle Protein, DNA and Lipid Synthesis Due to Ageing
Condition: Healthy
Study type: Interventional

Summary: 
      Maintenance of body's skeletal muscle is key to a healthy older age. However, as we age we
      lose on average 1-2% of our muscle each year. In order to slow this loss we need to
      understand fully the mechanisms regulating muscle mass with ageing. In this project we aim to
      determine these mechanisms using a new novel technique of 'heavy' water ingestion, which will
      allow us to measure multiple aspects of skeletal muscle mass control during normal everyday
      activities in young and old individuals over a period of 6 weeks. We will also determine the
      influence of resistance exercise training during this period in offsetting declines in muscle
      with ageing using this method
    


Intervention name(s): Resistance Exercise
Intervention type(s): Behavioral
Intervention description(s): 6 Weeks progressive unilateral resistance exercise, 3 times per week, 70% 1-RM, 6 x 8 Repetitions. 2 minutes rest between sets
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Phase 2 Trial of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to evaluate efficacy and safety of therapeutic Hepatitis B Virus（HBV） vaccine
      (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective
      dosage and provide the rational for optimal dosing schedule.
    

Detailed description: 
      First stage(0-76 weeks):

      Eligible subjects are enrolled and assigned to 3 groups randomly in a 1:1:1 ratio：

        1. εPA-44 600μg group：Subcutaneous inject εPA-44 600μg at week 0, 4, 8, 12, 20, 28；Polyene
           Phosphatidylcholine Capsules will be taken orally beginning in week 28.

        2. εPA-44 900μg group：Subcutaneous inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28；Polyene
           Phosphatidylcholine Capsules will be taken orally beginning in week 28.

        3. Placebo control group：Subcutaneous inject empty liposome at week 0, 4, 8, 12, 20,
           28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28.

      The study cycle consists of screening and enrollment period (week -6-0), treatment period
      (week 0-28) and follow-up period (week 28-76).

      Second stage(76-144 weeks):

      In this follow-up stage the trial is open designed, and all the subjects completed the first
      stage study(0-76 weeks):

        1. Subjects with no virological response and no serological response in the first stage ,
           and refuse to continue the this follow-up study, will be provided domestic Adefovir
           Dipivoxil for one year freely;

        2. Subjects with virological response but no serological response/with serological response
           but no virological response/neither virological nor serological response in the first
           stage, and be willing to continue the this follow-up study, will be treated by εPA-44
           900 μg；

        3. Subjects with both virological and serological response, will be followed-up to 144
           weeks with no Adefovir Dipivoxil or εPA-44 900 μg treatment.

      The definition of response is defined as below:

        1. Virological response: HBV DNA<2.93×10∧3IU/ml at 76 weeks;

        2. Serological response: serological conversion of HBeAg at 76 weeks.
    

Intervention name(s): εPA-44; Placebo
Intervention type(s): Biological; Other
Intervention description(s): subcutaneously injection of εPA-44 at week 0, 4, 8, 12, 20, 28.; subcutaneously injection of Placebo at week 0, 4, 8, 12, 20, 28.
Other intervention name(s): Therapeutic HBV vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B; HBeAg positive; Therapeutic HBV Vaccine; HBV-specific Cytotoxic T Lymphocyte
Effects of L-arginine and L-citrulline Supplementation on Muscle Respiration
Condition: Dietary Exposure
Study type: Interventional

Summary: 
      The objective of this trial is to determine the effects of dietary supplementation with the
      amino acids, L-arginine and L-citrulline, on endurance performance and mitochondrial
      respiration in healthy men compared to supplementation with L-arginine alone and a placebo
      supplement.
    

Detailed description: 
      This study is a randomized, double-blind, cross over trial of L-arginine and L-citrulline
      supplementation, L-arginine supplementation alone and placebo supplementation in healthy men.
      The intervention period will be 8-11 weeks for each participant and a minimum of 15
      individuals will be recruited and enrolled to complete the trial. Subjects will complete the
      experimental protocol described below over 3 individual 10 day supplementation periods,
      separated by washout periods of approximately 2 weeks. Subjects will ingest corn-starch as a
      placebo, L-arginine (3g/day) or L-arginine (1.5 g/day) + L-citrulline (1.5g/day). On day 7 of
      the supplementation period, a skeletal muscle biopsy and blood sample will be obtained from
      the subjects to investigate mitochondrial function and blood amino acid and nitric oxide
      levels. On day 10 of the supplementation period, subjects will complete a performance test on
      a cycle ergometer to investigate their endurance performance. These assessments will be
      performed to determine the effects of co-ingesting L-arginine and L-citrulline compared to
      L-arginine alone and placebo administration.
    

Intervention name(s): Dietary Supplement; Endurance exercise on a cycle ergometer
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Dietary Supplement: L-arginine and L-citrulline supplement, L-arginine supplement, or placebo supplement (corn-starch) Subjects will complete 3 individual 10 day supplementation periods, separated by washout periods of approximately 2 weeks.; On day 10 of each supplementation period, subjects will complete a performance test on a cycle ergometer to investigate their endurance performance.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Endurance performance; Mitochondrial function; L-arginine; L-citrulline; Healthy males
Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to confirm the safety and clinical benefit of benralizumab
      administration in asthma patients with mild to moderate persistent asthma in order to gain an
      understanding of the benefit/risk of benralizumab across the spectrum of asthma disease.
    


Intervention name(s): Benralizumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Benralizumab administered subcutaneously every 4 weeks; Placebo administered subcutaneously every 4 weeks
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases,
Examining the Link Between Trace Elements and Cardiovascular Disease Risk Factors in Young Adults
Condition: Cardiovascular Diseases; Metabolic Syndrome X; Hypertension; Inflammation; Atherosclerosis
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Metabolic Syndrome; Inflammation
Study type: Observational

Summary: 
      Cardiovascular disease (CVD) affects millions of people in the United States; each year, more
      people die from CVD than from any other disease. There are many dietary and lifestyle factors
      that may increase the risk of developing CVD. Preliminary research has shown that the
      presence of certain trace elements may be associated with the development of CVD. This study
      will examine toenail clippings and laboratory data to evaluate the link between trace
      elements and CVD risk factors in young adults.
    

Detailed description: 
      CVD is a disorder that affects the heart's ability to function normally. The most common
      cause of heart disease is narrowing or blockage of the coronary arteries, which supply blood
      to the heart. There are many risk factors for CVD, including inflammation, high blood
      pressure, high cholesterol, and obesity. Small quantities of trace elements, also known as
      micronutrients, are essential in maintaining a healthy body. Research has shown that some
      trace elements may be associated with the development of CVD, but more research is needed to
      confirm this connection. This study will examine concentrations of several trace elements in
      toenail samples of young adults participating in the Coronary Artery Risk Development in
      Young Adults (CARDIA) study. The CARDIA study is measuring changes in CVD risk factors in
      individuals as they age and is identifying lifestyle habits that influence those changes. The
      purpose of this study is to determine the link between trace elements and CVD risk factors in
      young adults. The results of this study may help to identify whether dietary, lifestyle, or
      environmental factors can be modified at a young age to prevent the development of CVD.

      This study will examine laboratory and medical history data of participants who are already
      enrolled in the CARDIA study; there are no additional study visits specifically for this
      study. Toenail samples collected from participants during their Year 2 CARDIA study visit in
      the late 1980's will be examined to determine the presence of selenium, chromium, arsenic,
      and mercury. Participants' CARDIA study data will be reviewed and several CVD risk factors
      will be analyzed, including the thickness of heart arteries; calcium buildup within the
      arteries; inflammatory markers, such as high sensitivity C-reactive protein and interleukin
      6; blood pressure levels; body weight; and levels of cholesterol, fat, and sugar.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participating in the CARDIA study.
Safety and Preliminary Evidence of Efficacy of Escalating Doses of Dimiracetam in AIDS Patients With Painful Neuropathy
Condition: Neuropathy; AIDS
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      One hundred consenting AIDS patients suffering from treatment induced painful neuropathy will
      be blindly randomize to Active and Placebo groups (ratio A/P = 3/2 and will receive
      increasing oral doses of dimiracetam starting from 400 mg b.i.d. and doubling the dose every
      two weeks until a maximum of 1600 mg b.i.d. Escalation to the the higher dose is allowed only
      if the previous dose did not cause tolerability problems. The highest reached dose will be
      maintained for a total of 8 week treatment. Patients must have a self evaluated pain of at
      least 4 on a 10 cm visual analog scale (VAS). Primary end point of the study will be the
      number of Adverse Events (AEs) reported in the placebo versus the active group. Preliminary
      evidence of efficacy will be sought by comparing active and placebo group as to the intensity
      of their pain at study onset and at study end. The pain will be evaluated by the VAS the
      Total Symptoms Score and the Clinical Global Impression
    


Intervention name(s): dimiracetam; sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg capsules for oral use to be administered twice a day for a total of 8 weeks; capsules containing 400 mg of inert material will be orally administered twice a day, one pill for 2 weeks, 2 pills for other 2 weeks and 4 pills for the last 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Neuropathic pain; AIDS; Dimiracetam; Treatment related painful neuropathy in AIDS patients
The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making
Condition: Fistula in Ano; Ano Fistula
MeSH terms: Rectal Fistula; Fistula
Study type: Interventional

Summary: 
      An anal fistula is an abnormal communication between the luminal surface of the anorectal
      canal and the perianal skin. Fistulas can vary in their complexity and can be challenging to
      treat, due to the anatomical relation to the anal sphincter complex that controls continence.
      In addition, fistulas can display complex features such as branches, cavities and horseshoes;
      where the tract travels radially around the anal canal. All these features have a role in
      determining the most appropriate surgical treatment option, and are key to understanding the
      surgical decision-making process. This study will determine patient understanding of fistula
      anatomy, their perception of their own understanding, their rating of how good their
      clinician's explanation is and how this impacts the decision-making process using standard
      explanation with 2D images, versus a 3D printed model of a fistula.
    

Detailed description: 
      Previous work has established a method of using traditional two-dimensional MR images to
      construct and print 3D models of perianal fistula, however the clinical utility of these
      models in the outpatient setting and their impact on patient knowledge of disease have not
      yet been assessed. This study is aimed at understanding how the use of 3D printed models can
      influence patient understanding of disease and support them in making decisions regarding
      treatment.

      Participants attending routine outpatient appointments will have their fistula explained to
      them using either a standard explanation, or a 3D printed model of a fistula. They will
      complete a short series of questionnaires and their answers will be analysed to determine if
      there is any benefit of using 3D models in a clinical consultation.
    

Intervention name(s): Explanation with 3D printed fistula model; Standard explanation
Intervention type(s): Other; Other
Intervention description(s): Explanation of fistula and surgery using a 3D printed model of an anal fistula that depicts the anatomy of the anal canal, the path of the anal fistula and its relation to anatomic structures.; Explanation of fistula and treatment using words, diagrams and MRI images as per consultant choice. Standard clinical care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomised pilot study
Masking: None (Open Label)
Primary purpose: Other
The Effects of D-cycloserine on Stimulus Generalization of Conditioned Fear Healthy Controls.
Condition: Post Traumatic Stress Syndrome
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      PROJECT SUMMARY:

      PTSD is a debilitating psychiatric condition precipitated by exposure to extreme, or life
      threatening, trauma with an estimated lifetime prevalence between 8% and 9% in U.S. adults.
      One core symptom of PTSD is intense psychological distress in the presence of stimuli that
      "resemble" one or more aspects of the trauma experience (DSM-IV). This phenomenon referred to
      as stimulus generalization has received surprisingly little empirical testing in the context
      of clinical anxiety in general, and PTSD more specifically. The current proposal represents
      the first effort to study the neurobiology and pharmacology of this PTSD-relevant learning
      phenomenon across those with and without PTSD. The objective of this particular proposal is
      to apply fMRI and pharmacologic methods to: 1) identify brain mechanisms associated with
      generalization of conditioned fear and 2) examine the pharmacologic modifiability of levels
      of generalization using a partial agonist at the NMDA receptor complex (D-cycloserine) shown
      to increase discrimination of CS+ (danger cue) and CS- (safety cue) in animal studies.
    

Detailed description: 
      To fullfill the objectives of this application, a generalization paradigm has been designed
      and psychophysiologically validated in which 6 rings presented on a computer screen gradually
      increase in size. For half of participants the smallest ring is the conditioned stimulus
      paired with electric shock (CS+) and the largest is the unpaired stimulus (CS-), and for the
      other half of participants this is reversed. Activity in fear-related brain structures
      measured via fMRI are predicted to gradually decrease as the presented stimulus gradually
      becomes less similar to the CS+, forming a generalization slope or gradient. One central
      hypothesis of the current application is that DCS (Seromycin) will dose dependently increase
      the steepness of generalization gradients (i.e., reduce fear generalization). This study will
      include 3 groups of healthy adults recieving either 1) 500 mg Seromycin, 2) 250 mg Seromycin,
      or placebo only prior to acquisition of fear conditioning. Twenty four hours later,
      participants will return to complete an fMRI during which brain responses to the danger cue
      and stimuli resembling the danger cue will be assessed.
    

Intervention name(s): Seromycin; Seromycin
Intervention type(s): Drug; Drug
Intervention description(s): 250 mg versus 500 mg versus placebo effects on conditioned fear generalization
Other intervention name(s): D-cycloserine
Intervention MeSH terms: Cycloserine
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy adults between the ages of 18-55.
      
Keywords: PTSD
Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to evaluate the effect on mental state (known as
      "neurocognitive function") with use of Praluent.
    


Intervention name(s): Praluent (Alirocumab); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Alirocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders
Medication-overuse Headache: 4 Years Follow up
Condition: Medication Overuse Headache
MeSH terms: Headache Disorders, Secondary; Headache
Study type: Observational

Summary: 
      From 1 January 2004 to 31 December 2006 64 individuals with probable medication overuse
      headache were included in a randomized, 1-year open-labeled, multicentre study to evaluate
      the effect of early introduction of prophylactic treatment compared to abrupt withdrawal and
      with a control group (ClinicalTrials.gov number NCT00159588). In this follow-up, randomized
      patients still alive 4 years after primary inclusion time will be invited to a follow up
      interview, evaluating the headache complaints and the proportion of recurrent medication
      overuse.
    

Detailed description: 
      The participants will be interviewed by telephone or consult the study doctor completing a
      headache diary for at least 1 month before attending the visit.
    

Intervention name(s): No new specific intervention
Intervention type(s): Other
Intervention description(s): No new specific intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 18-70 years remitted to the out-patient clinics of the neuroloical
        departments of five University Hospitals in Norway with probable medication overuse
        headache included in a 1-year open-labeled trial during 2004-2006.
      
Keywords: Headache; Medication overuse; chronic; relapse
Pilot Study of OXP001(2) and Brufen in Healthy Subjects
Condition: Gastroduodenal Erosions
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will compare the study drug to an already marketed formulation of prescription
      strength ibuprofen (Brufen® the reference product) by looking at how the drug is taken up by
      the body and also by performing a specialist procedure called an endoscopy (or more
      specifically, a gastroscopy). The safety and tolerability of the study drug will also be
      assessed.

      The study will consist of 2 parts involving up to 54 healthy male and female subjects.
      Subjects will be randomly assigned to receive either the study drug or reference product.
      Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of
      800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001
      or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on
      progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or
      Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach
      irritation using endoscopy.
    


Intervention name(s): Ibuprofen
Intervention type(s): Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study
Condition: Peptic Ulcer Bleeding
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Study type: Observational [Patient Registry]

Summary: 
      The purpose of the investigators study is to investigate the factors associated with
      rebleeding in patients with peptic ulcer bleeding.
    

Detailed description: 
      The investigators are performing a nationwide population based cohort study to investigate
      the factors associated with rebleeding in patients with peptic ulcer bleeding. The results of
      the investigators study should give us information about patients who are at high risk of
      rebleeindg and enable us to manage these patients appropriately.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who visit the hospital with symptoms suggestive of peptic ulcer bleeding such as
        melena or hematemesis. These patients recieve endoscopy and when they are diagnosed with
        peptic ulcer bleeding are eligible for enrollment.
      
Keywords: Peptic ulcer bleeding; rebleeding; mortality; nationwide