bioihbjkbjnl/mcl2 huggingface dataset:
Relative Oral Bioavailability of GABA From Tomatoes
Condition: GABA Plasmakinetics
Study type: Interventional

Summary: 
      In this four-way crossover study, a plasmakinetic profile of GABA from tomatoes as compared
      to a gamma-aminobutyric acid (GABA) supplement in healthy young men will be established. In
      addition, a plasmakinetic profiles of glutamate from a supplement and from tomatoes as well
      as the effects of glutamate from tomatoes and a supplement on the GABA plasma levels will be
      determined. This study will therefore provide information about the effect of a food matrix
      on GABA plasmakinetics.
    


Intervention name(s): Tomato; GABA supplement; Glutamate supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A maximum of 1 kilo pureed tomatoes, containing 1 gram of GABA.; 1 gram of GABA dissolved in water.; A maximum of 8 grams glutamate, adjusted to amount of glutamate given in the tomato arm. Dissolved in water.
Other intervention name(s): Gamma-aminobutyric acid
Intervention MeSH terms: gamma-Aminobutyric Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: For the study, research subjects will visit the university on four test days separated by a wash out period of one week.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: GABA; Glutamate; Tomato; Plasmakinetics; Bioavailability
Cognitive-functional Evaluation of Anosognosia
Condition: Anosognosia; Brain Damage
MeSH terms: Brain Injuries; Agnosia
Study type: Observational

Summary: 
      Acquired brain damage patients usually show severe cognitive deficit that alter their
      performance on every day life activities. Some of them suffer anosognosia and they are not
      aware of their own limitations. This situation increases disability by producing a large
      number of unsafe behaviours, caregivers burn-out and impede rehabilitation by affecting
      patients desire to follow treatment instructions. From disciplines like Neuropsychology,
      Cognitive Neuroscience or Occupational Therapy, it is considered a crucial issue to
      investigate the cognitive and neural mechanisms responsible of anosognosia, as well as to
      increase our knowledge about the most efficient treatments to deal with this phenomenon. The
      main general objective of this project is to generate and validate a detailed cognitive
      assessment protocol within the context of ADL to evaluate the different cognitive components
      of consciousness proposed on the Toglia and Kirk´s model: 1) Offline componente:
      metacognitive knowledge and 2) Online component: emergent awareness, self-regulation,
      anticipatory awareness, self-evaluation and updating processes).
    

Detailed description: 
      The proposed protocol is composed by two ecological tools: The Cog-Awareness ADL Scale (ADL
      scale of metacognitive knowledge) and the Basic and Instrumental ADL performance based test
      (Awareness ADL), to identify the presence of cognitive deficits and anosognosia in patients
      with ABI always within the context of everyday life activities. One first specific aim is to
      test the convergent validity of the two proposed ecological tools with other traditional and
      validated measures usually used to assess similar cognitive processes and components of
      self-awareness. The second specific objective is to investigate the external validity of the
      ecological tools, by testing whether they are able to discriminate between acquired brain
      damage patients with and without anosognosia and a group of neurologically healthy
      participants on every component.

      After conducting a literature review of the subject we found that this would be the first
      protocol developed to identify all these components in the same study.
    

Intervention name(s): Cognitive-functional evaluation
Intervention type(s): Other
Intervention description(s): The participants will be evaluated with a set of tools within the context of meaningful ADL.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Acquired brain damage patients will be recruited on the collaborating hospitals and on
        different acquired brain damage organisations. Both, patients and control subjects, will be
        recruited from Málaga and Granada.
      
Keywords: Activities of Daily Living (ADL); Executive Deficit; Monitoring; Self Awareness
Effect of Low-dose Versus Standard-dose Iron Supplementation on the Gut Microbiome
Condition: Iron Deficiency (Without Anemia)
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Iron deficiency is a common problem that is often treated with the administration of oral
      iron.

      Most of the iron is not absorbed and remains in the intestine, where it influences the
      balance of gut bacteria.

      This influence is usually undesirable and should be kept as small as possible. With lower
      iron doses, the amount of unabsorbed iron is smaller and therefore a smaller change in the
      intestinal bacteria composition is to be expected.
    

Detailed description: 
      Iron deficiency affects about one in five premenopausal women. The first line treatment for
      patients with iron deficiency is an oral therapy with iron-supplements, another option is the
      intravenous iron supplementation.

      The oral supplementation causes side-effects such as nausea, vomiting, abdominal pain and
      many more in a lot of patients. There is a positive correlation between the appearance of
      gastrointestinal side-effects and the applicated iron dose.

      Only a low fraction of orally taken iron is actually absorbed, even in patients with
      iron-deficiency. Since only a fraction of the orally administered iron is actually absorbed,
      the toxicity of high concentrations of iron in the gastrointestinal tract and the altered
      selection advantages of the bacteria presumably leads to microbiome changes.

      The unabsorbed iron is potentially changing the microbiome, which leads to undesirable side
      effects.

      With low-dose iron-supplementation the amount of unabsorbed iron is smaller, therefore a
      dosage dependent microbiome change would be expected.

      The aim of the study is to determine the magnitude of the microbiome response to daily iron
      substitution with 12mg and 100mg.
    

Intervention name(s): Iron
Intervention type(s): Dietary Supplement
Intervention description(s): 4 weeks of daily oral iron therapy. The subjects administer the therapy themselves.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iron; Microbiome; Gut Bacteria
Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This study will evaluate the effects of Aubagio on changes in the brain using MRI.
    

Detailed description: 
      Patients who take Aubagio will have an MRI, eye test, have blood taken, and complete a
      questionnaire on environmental risk factors to evaluate changes in the brain and on disease
      progression. A healthy control group will also complete the same testing regimen.
    

Intervention name(s): MRI
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of
        Neurology, State University at Buffalo, NY, USA who are also taking Aubagio as their
        disease modifying therapy.

        Healthy controls from the general population.
      
Biospecimen description: 
      Serum to be retained.
    
Keywords: multiple sclerosis; relapsing remitting; MRI; teriflunomide; aubagio; gray matter atrophy; gray matter pathology
Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B
Condition: Pain; Analgesia
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 3

Summary: 
      Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This
      study objective is to test the efficacy regarding pain attenuation of 3 interventions
      (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus
      control in healthy newborn infants submitted to intra-muscular vaccination for Hepatitis B at
      48-72 hours of life.
    


Intervention name(s): Water 2mL PO 2 minutes prior to intra-muscular injection; skin-to-skin contact; Glucose 25% 2 mL PO 2 minutes prior to injection; neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Sterile Water 2mL PO - single dose; neonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.; Glucose 25% 2mL PO - single dose; neonates will receive 2 mL of glucose 25% PO (single dose) 2 minutes prior to the acute painful procedure. Skin-to-skin contact will start 2 minutes after the intra-muscular injection and will stop 2 minutes afterwards.
Intervention MeSH terms: Tin Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Newborn Infant; Analgesia
Study to Evaluate the Food Effect of TP-05 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food
      Effect on the Pharmacokinetics of TP-05 under Fed and Fasted Conditions in Healthy
      Participants.
    

Detailed description: 
      This is a Phase 1, open-label, randomized, single-dose, parallel-group study to evaluate the
      food effect on the pharmacokinetics of TP-05 under fed and fasted conditions in healthy
      participants.

      The study will consist of a screening period of up to 28 days. Participants who are eligible
      for the study will check into the clinical research site on Day -1. All participants will
      undergo an overnight fast of at least 10.5 hours prior to dosing. On Day -1 participants will
      be randomized to receive one of three treatment regimens on Day 1: single dose of TP-05,
      fasted; single dose of TP-05 following a high-fat breakfast; or single dose of TP-05
      following a low-fat breakfast.

      Participants will be resident at the clinical research site from Day -1 until completion of
      assessments at 96 hours post-dose (Day 5) and return on Day 60 for a follow-up visit.
      Participants will complete a telephone safety follow-up visit at Day 120.

      Safety will be assessed by adverse events, vital signs, performing physical examinations,
      electrocardiograms, and evaluating clinical laboratory results.
    

Intervention name(s): TP-05 (lotilaner oral), fasted group; TP-05 (lotilaner oral), high-fat group; TP-05 (lotilaner oral), low-fat group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TP-05 (lotilaner oral), fasted group; TP-05 (lotilaner oral), high-fat group; TP-05 (lotilaner oral), low-fat group
Other intervention name(s): TP-05, fasted; TP-05, high-fat meal; TP-05, low-fat meal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuromusuclar Adaptations in the Rheumatoid Arthritis Disease
Condition: Arthritis, Rheumatoid; Muscular Weakness
MeSH terms: Arthritis; Arthritis, Rheumatoid; Muscle Weakness
Study type: Observational

Summary: 
      Rheumatoid arthritis (RA) is a chronic autoimmune disease that causes joint inflammation and
      progressive joint destruction. Rheumatoid cachexia is one of the structural manifestations of
      RA, and consists of a reduction in muscle mass, due to an increased muscle protein catabolism
      induced by inflammatory cytokines. This muscle mass loss generates an impairment in physical
      function and functional capacity in RA patients. The aim of study was to verify neuromuscular
      and functional responses in middle-aged women with RA compared to paired healthy women.
    


Intervention name(s): Neuromuscular and functional capacity tests
Intervention type(s): Diagnostic Test
Intervention description(s): The Timed Up and Go test; Maximal knee-extensor muscle strength (isometric and concentric tests) was measured with a Biodex System 3 dynamometer; A B-mode ultrasonography system with a linear-array probe (60 mm, 7.5 MHz) was used to determine VL and RF muscle thickness, pennation angle, fascicle length and tendon CSA. Measurements were obtained with the volunteer seated in the dynamometer, during isometric contraction at 90° of knee flexion.
An 8-channel EMG system was synchronized with the dynamometer through a Windaq data acquisition system and used to evaluate the vastus lateralis and rectus femoris electrical activity during isometric knee-extensor tests.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        35 RA patients (class I and II according American Rheumatism Association) and 35 healthy
        women, age- and body size-matched to the RA patients, were recruited as controls (CG).
Pharmacokinetics of Acetaminophen in Morbidly Obese Patients
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients
      versus normal weight patients. Specifically the different metabolic pathways of acetaminophen
      in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1
      (cytochrome P450 2E1) oxidation
    


Intervention name(s): acetaminophen 2 g
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the impact of the BMS-986419 new immediate release
      (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to
      assess the effect of food on the drug levels of the IR tablet formulation in healthy adult
      participants.
    


Intervention name(s): BMS-986419 DR Capsule; BMS-986419 IR Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BMS-986419; Healthy male of non-child bearing potential; Healthy women of non-child bearing potential
A Study to Evaluate the Safety and Immunogenicity of H7N9 Influenza Vaccine (AT-501) in Healthy Adult Subjects
Condition: H7N9 Influenza Vaccine
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims to evaluate the safety and immunogenicity of an inactivated cell culture
      derived H7N9 vaccine in healthy adult subjects.
    


Intervention name(s): AT-501 High Dose vaccine; AT-501 High Dose vaccine with Adjuvant; AT-501 Low Dose vaccine; AT-501 Low Dose vaccine with Adjuvant
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Comparison of each dose of vaccine; Comparison of each dose of vaccine; Comparison of each dose of vaccine; Comparison of each dose of vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H7N9 Influenza; Avian influenza A; cell culture derived
VR-Based Physical Therapy Pilot Study
Condition: Extremity Fracture Lower
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility and acceptability of using the
      virtual reality-based physical therapy platform in patients with extremity fracture.
    


Intervention name(s): Virtual Reality Physical Therapy
Intervention type(s): Other
Intervention description(s): Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)
Condition: Hypercholesterolemia; Diabetes Mellitus, Type 2; Coronary Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicenter, randomized, double-blind, placebo-controlled study will assess, after 6
      weeks of dosing, whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be
      more effective than treatment with doubling the dose of simvastatin to 40 mg alone in
      reducing low-density lipoprotein-cholesterol (LDL-C) concentrations and in achieving the
      National Cholesterol Expert Panel (NCEP) III LDL-C target goal of <2.6 mmol/L (<100 mg/dL)
      for subjects with diabetes mellitus and coronary heart disease.
    


Intervention name(s): Ezetimibe 10 mg; Simvastatin 20 mg; Ezetimibe Placebo; Simvastatin 20 mg; Simvastatin Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 x 10-mg tablet, provided as blinded study treatment; 1 x 20-mg tablet, provided as open-label study treatment; 1 tablet matching ezetimibe 10-mg tablet, provided as blinded study treatment; 1 x 20-mg tablet, provided as blinded study treatment; 1 tablet matching 20-mg simvastatin tablet, provided as blinded study treatment
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Rehabilitation After Covid19-Clinical Results and Predictive Factors
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study is to gain insight into the rehabilitation process and predictive
      factors for the outcome after rehabilitation in three patient groups:

        1. SARS-CoV-2-positive patients in the isolation ward

        2. Post-Covid-19 patients

        3. Control group; matched for gender, age and co-morbidity
    


Intervention name(s): Rehabilitation
Intervention type(s): Other
Intervention description(s): Rehabilitative procedures in isolation ward
Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        All patients referred to rehabilitation between March and June 2020 either with active
        Covid19, post-Covid-State oor other indications for inpatient rehab (eg. muskuloskelettal,
        cancer, pulmonary diseases not related to Covid19)
      
Keywords: Covid19; Sars-CoV-2; Rehabilitation; Outcome; Predictive factors
Effect of Renal Impairment on the Pharmacokinetics of NN9535
Condition: Diabetes; Diabetes Mellitus, Type 2; Renal Impairment
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this clinical trial
      is to investigate how different degrees of renal impairment (mild, moderate, severe and
      end-stage renal disease) affect the pharmacokinetics of NN9535.
    


Intervention name(s): semaglutide
Intervention type(s): Drug
Intervention description(s): 10 mg/mL of semaglutide solution for s.c. injection, single dose
Other intervention name(s): NN9535
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Electrogastrography in Small for Gestational Age Preterm Infants
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose of this study is to determine whether small for gestational preterm infants, have
      delayed or decrease gastric motility compared to appropriate for gestational age preterm
      infants.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Preterm infants >31 weeks, - 37 weeks , healthy, on enteralfeeds
      
Keywords: Preterm infants; small for gestational age; electrogastrography
An Extension Study of ABT-806 in Subjects With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an extension study of ABT-806 for subjects with advanced solid tumors.
    


Intervention name(s): ABT-806
Intervention type(s): Drug
Intervention description(s): ABT-806 will be administered by intravenous infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff
Condition: Enterocolitis Clostridium Difficile Recurrent
MeSH terms: Enterocolitis; Recurrence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and
      lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized
      successfully. Endoscopic delivery requires significant health care utilization and associated
      cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality,
      which would significantly reduce patient discomfort, procedure related risks and health care
      costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.
    

Detailed description: 
      Patients with minimum 3 episodes of Clostridium difficile within 6 months are randomized 1:1
      to received FMT by either colonoscopy or capsules. Pts are assessed at 1 week, 2 weeks, 1
      mon, 3 mon, 6 mon and 1 year post FMT. Stool, urine and blood samples are collected. Medical
      cost for previous treatment is collected as well at pt perspective and QoL.
    

Intervention name(s): Fecal Microbiota Transplant
Intervention type(s): Biological
Intervention description(s): transfer of healthy human gut bacteria to restore the microbiome
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment