bioihbjkbjnl/mcl2 huggingface dataset:
Choline Source, Gut Microbiota and Trimethylamine-N-oxide Response
Condition: Metabolism
Study type: Interventional

Summary: 
      The purpose of this research is to determine the production of trimethylamine-N-oxide (TMAO)
      from different forms of choline and whether this response is modified by the gut microbiota
      composition.
    

Detailed description: 
      The overall goal of this research is to identify dietary and physiological factors
      contributing to elevated levels of trimethylamine-N-oxide (TMAO), a choline-derived
      gut-microbiome-dependent metabolite that has been identified to increase cardiovascular
      disease risk. Our recent findings indicate that the gut microbiome may account for variations
      in TMAO levels, whereby those with a greater enrichment of Firmicutes to Bacteroidetes had
      elevated TMAO response to dietary precursor intake. However, the interaction between choline
      intake and gut microbiota composition as a determinant of interindividual variations in TMAO
      response has not been investigated. This study sought to i) compare plasma and urinary TMAO
      response after acute challenge containing different forms of choline; and ii) to determine
      the association between differences in TMAO response with differences in gut microbiota
      composition. To accomplish these objectives, a randomized, controlled cross-over study was
      conducted in healthy participants (n=41). The study incorporated three arms comprised of
      study meals containing (i) 600 mg choline as choline bitartrate; (ii) 600 mg choline as
      phosphatidylcholine; or (iii) no choline. Each meal was served with a bagel with
      margarine-butter spread and one cup of water, administered in a single day and separated by a
      1-week washout period. Baseline blood sample was obtained by a phlebotomist using a standard
      venipuncture procedure, and participants collected their baseline urine sample. They also
      turned in a one-time self-collected baseline stool sample. Following the consumption of the
      study meal, serial blood samples were collected at 30 min and 1, 2, 4 and 6 h, and urine
      samples collected throughout the 6 h study period. At 4.5 h, participants were provided a
      fixed fruit snack (i.e., 2 single serving prepackaged applesauce) and water.
    

Intervention name(s): Water-soluble choline; Fat-soluble choline; No choline control
Intervention type(s): Other; Other; Other
Intervention description(s): 600 mg choline as choline bitartrate; 600 mg choline as phosphatidylcholine; No choline
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, controlled crossover design where participants consume 3 meals containing (i) free choline; (ii) phosphatidylcholine; or (iii) no choline in a random order separated by a 1-week washout period
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Dietary precursor; Metabolism; Gut microbiota
Tesmilifene in Combination With Docetaxel in the Treatment of Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II study designed to evaluate whether the co-administration of a fixed dose
      of tesmilifene and a standard regimen of docetaxel alters the plasma pharmacokinetics of
      docetaxel. This study will also assess the safety and efficacy of the tesmilifene/docetaxel
      combination in metastatic breast cancer patients.
    

Detailed description: 
      Primary Objective:

      1. To evaluate whether the co-administration of a fixed dose of tesmilifene (5.3 mg/kg) with
      a standard dose of docetaxel (100 mg/m2) alters the plasma pharmacokinetics of docetaxel
      compared to the pharmacokinetics of docetaxel when given alone.

      Secondary Objectives:

        1. To correlate plasma tesmilifene levels during and following the infusion with the acute
           tesmilifene-related adverse events observed during and after the infusion.

        2. To collect safety information for tesmilifene when administered in combination with
           docetaxel.

        3. To evaluate response rate, duration of response and overall survival in metastatic
           breast cancer patients receiving docetaxel plus tesmilifene.
    

Intervention name(s): Tesmilifene (YMB1002)
Intervention type(s): Drug
Intervention MeSH terms: Tesmilifene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic breast cancer; Tesmilifene; DPPE
Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety
Condition: Anxiety Disorder; Panic Disorder
MeSH terms: Anxiety Disorders; Panic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication
      behavior in anxious patients with varying histories of using other drugs.

      II. Establish outpatient methods for the study of self-medication and drug reinforcement in
      patients vulnerable to prescription drug abuse or dependence.

      III. Evaluate the influence of alcohol and other non-prescription drug use as determinants of
      vulnerability in these patients.

      IV. Identify personality, attitudinal, or other variables that might predict different
      patterns of self-medication.

      V. Assess the effects of cognitive-behavioral therapy on alprazolam self-medication.
    

Detailed description: 
      PROTOCOL OUTLINE: This protocol involves different experiments examining self-medication with
      anxiolytic medications in selected patients, and cognitive-behavioral therapy for anxiety.
      Capsules are color coded and taken under double-blind conditions. Compliance is monitored
      with the Medication Event Monitoring System, which automatically registers the date and time
      each bottle is opened.

      The physician directs therapy administration, using some combination of the following: blind
      choice test, antianxiety agent(s), placebo, and cognitive-behavioral therapy.
    

Intervention name(s): alprazolam
Intervention type(s): Drug
Intervention MeSH terms: Alprazolam
Primary purpose: Treatment
Keywords: anxiety disorder; disease-related problem/condition; neurologic and psychiatric disorders; panic disorder; rare disease
LC-MS / MS Adrenal Steroids Assayed on Dried Blot Spot for the Congenital Adrenal Hyperplasia Neonatal Screening (SPECTROSPOT)
Condition: Adrenal Hyperplasia, Congenital
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Study type: Observational

Summary: 
      This research uses the Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS / MS)
      technique on dried blot spot samples for the neonatal screening of congenital adrenal
      hyperplasia.

      The main objective of this study is to demonstrate that this technique allow dosage of
      adrenal steroids on dried blot spot samples as efficiently and with the same sensitivity than
      the current technic on a cohort of 132 newborns aged 2 to 5 days, with a gestational age
      greater than or equal to 30 weeks of amenorrhea.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        National neonatal screening covers all newborns aged between 48 and 120 hours, regardless
        of birth term. Premature babies born before 30 weeks of amenorrhoea are cared for in
        specialized neonatal or intensive care units and are intensively monitored to rule out any
        risk of not diagnosing HCS in a child with it. This is why our study will be conducted on a
        newborn population with a birth term greater than 30 weeks of amenorrhoea.
Modification of Alternative Reward Cue Reactivity and Cognitive Control Through Physical Activity in Human Tobacco Use Disorder
Condition: Healthy; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This study investigates the mechanisms, through which physical exercise impacts positively on
      abstinence in tobacco use disorder, with fMRI and behavioral tests.
    

Detailed description: 
      This study will test the hypothesis that physical exercise training modifies alternative
      reward cue reactivity and cognitive control in tobacco use disorder and that these
      modifications mediate the effect of exercise on abstinence. Continued physical exercise
      training was shown to reduce tobacco consumption and prevent relapse in tobacco use disorder
      (TUD). However, the psychological and neural mechanisms through which exercise training
      exerts its effects on tobacco consumption are not clear. The aim of this project is to
      identify the effects of a 12-week aerobic exercise training in TUD and to test how these
      exercise-related changes may mediate the effect of exercise training on abstinence.
      Investigations will focus on two potential mechanisms of regaining control: (1) modifications
      of tobacco and alternative reward cue reactivity and (2) improvement of cognitive control.
      Two aspects of cognitive control will be addressed: inhibitory control and cognitive
      down-regulation of craving. It is expected, first, that exercise training (compared to
      standard treatment) leads to desensitization towards tobacco cues and sensitization towards
      alternative reward cues, reflected in altered craving and neural (fMRI) cue reactivity.
      Second, it is expected that exercise training will lead to increased cognitive control (i.e.,
      inhibitory control and cognitive down-regulation of craving), reflected in increased
      activation of prefrontal control regions (fMRI). Third, it is expected that effects of
      exercise on abstinence will be mediated by sensitization towards alternative reward cues and
      enhanced cognitive control. In an exploratory manner, gender differences in the effects of
      exercise training will be studied. Understanding the psychological and neural underpinnings
      will help to optimize and individualize exercise trainings in TUD.
    

Intervention name(s): Exercise training; Smoking cessation group program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The moderate-intense aerobic exercise training will involve supervised aerobicycle ergometer training for 30 min with 60-80% HRmax three times per week for 12 weeks.; Participants of both groups will receive a 6-week standard cognitive behavioral therapy-oriented smoking cessation group program (SCP, one 60 min session per week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tobacco use disorder; fMRI; physical exercise; reward system; cognitive control
Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was designed as a single-site, randomized, open-label, four-period complete and
      replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and
      Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a
      fasting state and 36 receiving a high-fat diet.
    

Detailed description: 
      Subjects were randomized into two treatment sequence groups: Sequence 1 = TRTR and Sequence 2
      = RTRT, and each study period was separated by a 7 days washout period. After an overnight
      fast for at least 10 h, the subjects received a single oral dose of the R or T formulation of
      rivaroxaban tablets (20 mg) with 240 mL of water in a seated position. A total of 19 blood
      samples were collected at 0 (within 60 min prior to dosing) and 0.25,0.5, 1.0, 1.5, 2.0,
      2.5,3.0,3.5, 4.0, 4.5,5.0, 5.5,6.0, 8.0, 12.0, 24.0, 36.0 ,and 48.0 hours after dosing.Blood
      samples were collected in a vacuum blood tube containing sodium heparin, gently mixed, and
      stored on ice-water mixture until sample processing and then centrifuged at 2000g at 2-8°C
      for 10 min.
    

Intervention name(s): Rivaroxaban 20 MG Oral Tablet [Xarelto]; Rivaroxaban 20 MG Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet [Xarelto].; The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study was designed as a four-period complete and replicate crossover
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rivaroxaban; pharmacokinetics; bioequivalence
Surgical Removal of Visceral Fat Tissue (Omentectomy) Associated to Bariatric Surgery: Effects on Insulin Sensitivity
Condition: Insulin Resistance; Obesity; Metabolic Syndrome X
MeSH terms: Microvascular Angina; Metabolic Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The intraabdominal fat is associated with insulin resistance, a condition that is in the
      basis of diabetes, metabolic syndrome and some cardiovascular diseases. It is not clear
      whether it is the origin of it or a surrogate marker only. We intend to compare the effects
      of bariatric surgery with versus without omentectomy in morbidly obese people intended to go
      through bariatric surgery, accessing insulin sensitivity by metabolic tests.

      If the visceral fat is causative of insulin resistance, its surgical removal (omentectomy)
      might lead to improvement of insulin action, as seen in animal studies and in one study with
      morbidly obese human volunteers.
    

Detailed description: 
      In order to verify a potential additional benefit of omentectomy combined to Roux-en-Y
      silastic ring gastric bypass, insulin sensitivity will be studied by the gold-standard test,
      euglycemic-hyperinsulinemic clamp, since early postoperative follow-up (before significant
      weight variation), compared to a control group of bariatric surgery (same technique) alone.
      The variables will be analyzed in the post surgical evolution for correlation to metabolic
      changes: adiposity-related hormones and cytokines; lipid profile and other cardiovascular
      risk factors; molecular expression of biopsied subcutaneous adipocytes in vitro;
      anthropometrics; ultrasonography of abdominal subcutaneous and intra-abdominal fat depots and
      carotid intima-media thickness (preclinical atherosclerosis evaluation).
    

Intervention name(s): Roux-en-Y Gastric Bypass plus total omentectomy; Roux-en-Y Gastric Bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): Roux-en-Y Gastric Bypass plus total omentectomy; Roux-en-Y Gastric Bypass without omentectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin resistance; Metabolic syndrome X; Obesity; Intra-Abdominal Fat; Omentum; Bariatric surgery; Glucose Clamp Technique; Intravenous Glucose Tolerance Test; Adiponectin; Cytokines
Staccato Alprazolam and Photoparoxysmal Response
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether people who usually have photosensitive
      epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato
      Alprazolam as compared to placebo.
    

Detailed description: 
      The purpose of this study is to determine whether people who usually have photosensitive
      epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato
      Alprazolam as compared to placebo. People with photosensitive epilepsy have changes on their
      electroencephalogram (EEG) when shown flashing lights. Three dose levels of Staccato
      Alprazolam will be compared to placebo.

      This study will also assess the level of sedation of Staccato Alprazolam compared to placebo.
    

Intervention name(s): A=Placebo; B=Inhaled Alprazolam 0.5 mg; C=Inhaled Alprazolam 1 m; D= Inhaled Alprazolam 2 mg; E=Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Does Cannabidiol Attenuate the Acute Effects of ∆9-tetrahydrocannabinol Intoxication in Individuals Diagnosed With Schizophrenia? A Double-blind, Randomised, Placebo-controlled Experimental Study
Condition: Schizophrenia; Cannabis Use
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study will recruit schizophrenia patients who use cannabis recreationally. Each
      participant will attend the laboratory on three occasions: an initial visit to check that
      they are safe to join the study and two days of testing.

      Participants will be administered, in a randomized order, a pre-treatment with either CBD
      (1000mg) orally or a matching placebo. On both experiments, participants will then inhale
      cannabis containing THC. The THC administration will follow a standardised inhalation
      procedure using a medical-grade vaporizer device.

      Participants will complete a series of tasks measuring cognition, psychosis, anxiety and
      other subjective experiences.

      The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's
      College Hospital.
    


Intervention name(s): Cannabidiol; Placebo; Delta-9-THC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CBD; Placebo; THC
Intervention MeSH terms: Dronabinol; Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)
Condition: Horton's Disease; Infectious Disease; Neoplasia; Solid Tumor; Hemopathy
MeSH terms: Communicable Diseases; Infections; Polymyalgia Rheumatica; Giant Cell Arteritis
Study type: Observational

Summary: 
      The aim of this open, controlled, multicentre biomedical research study is to identify new
      markers specifically associated with Horton's disease. This would make it possible to improve
      the diagnosis and management of this disease.

      Participation consists in taking one or several blood samples depending on the group
      patients/controls.
    


Intervention name(s): 1 blood sample; 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)
Intervention type(s): Other; Other
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Horton' s disease Patients with an infectious disease Patients with neoplasia
        ( solid tumor or hemopathy ) Healthy controls
Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to investigate the safety and efficacy for long term treatment
      of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical
      usage.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated with Pulmicort respules for the first time due to bronchial asthma and
        children of >=6months and <5 years old age at the start of study treatment
      
Keywords: bronchial asthma; Pulmicort Respules; long term use; pediatrics
Genetic Variation and Variability in Posaconazole Pharmacokinetics in Children
Condition: Fungal Infections
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      The main goal of this study is to see how the body breaks down an antifungal drug named
      posaconazole in children with certain cancers, blood disorders, or transplantation of bone
      marrow or similar blood cells. This study will also help us learn whether a child's age,
      genetics, or disease affect how well the body breaks down posaconazole.
    

Detailed description: 
      The purpose of this research study is to see how the body breaks down posaconazole, which has
      limited data in children. Posaconazole injection has been approved by the FDA for prevention
      or treatment of certain fungal infections in adult patients. In children, however, we don't
      have data on how best to give posaconazole or whether the dosing should be personalized to
      individual children. This study aims to determine pharmacokinetics of posaconazole aqueous
      solution for injection in children aged 2 through 17 years and explores differences in drug
      exposure by age, genetics, and disease state. Children will receive a single dose of
      posaconazole injection and have their blood levels of posaconazole checked. The study will
      also check for safety after giving the posaconazole.
    

Intervention name(s): Posaconazole
Intervention type(s): Drug
Intervention description(s): Posaconazole will be given as a one time intravenous (IV) dose. The dose will take ninety (90) minutes to be infused and will be based on weight at the time of the visit.
Other intervention name(s): Noxafil
Intervention MeSH terms: Posaconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: triazoles; fungi; transplantation, hematopoietic stem cell; leukemia; pediatrics; pharmacokinetics; bone marrow failure syndrome
A Study Evaluate Aqueduct's Smart External Drain
Condition: Hydrocephalus; Hydrocephalus in Children; Tumor, Brain
MeSH terms: Brain Neoplasms; Hydrocephalus
Study type: Interventional

Summary: 
      To evaluate the performance characteristics of the Smart External Drain (SED) compared with
      standard EVD drains in the hospital setting, specifically:

        -  Number, type and duration of staff interactions.

        -  Regulating and controlling ICP and CSF drainage.

        -  Maintaining system control with patient movement.
    

Detailed description: 
      In this two day clinical trial, subjects will be observed on Day 1 of study during their
      routine treatment and using their already existing EVD. On Day 2 of study; subjects will be
      switched to the Smart External Drain for monitoring and management of ICP and CSF
    

Intervention name(s): Smart External Drain - SED
Intervention type(s): Device
Intervention description(s): Subject will be treated on Day 2 with the SED. ICP and CSF volumes will be recorded at prespecified intervals while subject is stationary and while subject is engaged in protocol-driven directed movements.
Intervention model: Single Group Assignment
Intervention model description: In this study the subject will act as their own control and will be treated on day one with the standard of care EVD and then on Day 2 treated with the SED.
Masking: None (Open Label)
Primary purpose: Treatment