bioihbjkbjnl/mcl2 huggingface dataset:
AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects.
Condition: Safety, Tolerability, Pharmacokinetics of AEF0217
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is divided in 3 parts: FIH-SAD (Single Ascending Doses), FIH-MAD (Multiple
      Ascending Doses) and FIH-FE (Food effects). FIH-SAD will start first. The start of FIH-MAD
      will await the results of at least three cohorts from the FIHSAD study before initiated. The
      starting dose of the FIH-MAD will have been shown to be well tolerated and one dose level
      lower than the highest dose for which safety, tolerability and pharmacokinetic (PK) data are
      available. FIH-FE will be the last to start after the completion of FIH-SAD and conducted in
      parallel with parts of FIH-MAD.
    


Intervention name(s): AEF0217; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PART I: A total of 32 healthy male and female subjects will be randomized into four consecutive single ascending dose cohorts of 8 subjects. The study will have 4 different doses of AEF0217 (0.2, 0.6, 2 & 6 mg) and 1 dose of matching placebo. A given subject can be randomized only in one dose level cohort.
PART II: A total of 24 healthy subjects will be randomized in three consecutive multiple ascending dose cohorts of 8 subjects. The study will have 3 different doses of AEF0217 (0.6, 2 & 6 mg) and 1 dose of matching placebo. Doses could be modified following the results of FIH-SAD. A given subject can be randomized only in one dose level cohort.
PART III: A total of 12 healthy male subjects will be randomly assigned to one of two sequences in the crossover study part. All subjects will receive the same dose of AEF0117 which will be determined following the results of the FIH-SAD.; PART I: A total of 32 healthy male and female subjects will be randomized into four consecutive single ascending dose cohorts of 8 subjects. The study will have 4 different doses of AEF0217 (0.2, 0.6, 2 & 6 mg) and 1 dose of matching placebo. A given subject can be randomized only in one dose level cohort.
PART II: A total of 24 healthy subjects will be randomized in three consecutive multiple ascending dose cohorts of 8 subjects. The study will have 3 different doses of AEF0217 (0.6, 2 & 6 mg) and 1 dose of matching placebo. Doses could be modified following the results of FIH-SAD. A given subject can be randomized only in one dose level cohort.
Other intervention name(s): 3ß-benzyloxy-17α-methyl-pregn-5-en-20-one
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Observational Study of the Differences in Characteristics of the Spontaneous Electroencephalogram, Derived From the Left and Right Hemisphere in Patients With Unilateral Intracranial Tumor During Routine Anesthesia: Comparison With a Control Group Without Intracranial Pathology
Condition: Intracranial Tumor
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during
      anaesthesia.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with unilateral intracranial tumor during routine anesthesia at the University
        Hospital Ghent
      
Keywords: Intracranial tumor patients
A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs
Condition: Pre-diabetes
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this research study is to examine if a combination of a cholesterol
      lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective
      in improving vascular inflammation (irritation of the vessels that transport your blood) and
      other cardiovascular risk factors than the taking of simvastatin alone.
    

Detailed description: 
      Age 21-75 years Metabolic syndrome (must have 3 of the 5 components) elevated waist
      circumference >40inches in men, >35 inches in women elevated triglycerides >150mg/dL reduced
      HDL <40mg/dL in men<50 in women elevated blood pressure >130mmHg systolic, or >85mmHg
      diastolic elevated fasting glucose >100mg/dL
    

Intervention name(s): Rosiglitazone; Placebo Rosiglitazone; Simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4 mg daily; 1 tab daily; 40 mg daily
Other intervention name(s): Avandia; Placebo; Zocor
Intervention MeSH terms: Rosiglitazone; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Vitamin D Supplementation in PCOS Patients
Condition: PCOS
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess whether Vitamin D supplementations for patients with polycystic ovary syndrome in
      conjunction with clomiphene citrate are beneficial or not
    

Detailed description: 
      This study is double blinded randomized controlled study conducted at Tanta University
      hospitals in the period from April 2019 to March 2022. Patients and methods: One hundred
      twelve patients were recruited and randomly allocated into 2 groups; study group with Vitamin
      D supplementation and control group without Vitamin D supplementation.
    

Intervention name(s): Vitamin D; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): receive 6000iu daily for 8 weeks; placebo for the same period
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 2 groups will be treated at the same time
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: PCOS; Vitamin D; Supplementation; Ovulation; Pregnancy
Acute Effects of Alcohol Use on Chronic Orofacial Pain
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain
Study type: Interventional

Summary: 
      Self-medication of pain with alcohol is a common, yet risky, behavior among individuals with
      chronic orofacial pain. Chronic pain status may affect the degree to which alcohol use
      relieves pain, but the independent contributions of pain chronification and alcohol-related
      expectations and conditioning have not been previously studied. This project addresses this
      gap in knowledge and will inform further research and clinical/translational efforts for
      reducing risk associated with these behaviors.
    


Intervention name(s): Ethanol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.; A beverage that does not meaningfully increase breath alcohol concentration.
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: People with and without jaw pain, including temporomandibular joint and muscle disorder (TMD) will receive an active oral dose of alcohol or placebo in a counterbalanced manner.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: alcohol effects
Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
Condition: End Stage Renal Disease (ESRD)
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the safety and efficacy of a new formulation of Myfortic in combination with
      tacrolimus and thymoglobulin.
    

Detailed description: 
      Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and
      anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective
      is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid
      withdrawal protocol.
    

Intervention name(s): Mycophenolic Acid (Myfortic)
Intervention type(s): Drug
Intervention description(s): Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).
Other intervention name(s): mycophenolic acid enteric coated
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney; Transplant; Corticosteroid; Myfortic
Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to look at effects of salmeterol/fluticasone propionate compared to
      placebo on airway inflammation in patients with chronic obstructive airways disease
    


Intervention name(s): Salmeterol/fluticasone propionate 50/500mcg Diskus
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Airways; Pulmonary; Obstructive; Chronic; inflammation; salmeterol/fluticasone propionate
Ambivalence Model of Craving: Re-examining the Drinking-craving Relationship
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The current study combines both clinical trial and daily process methodology to examine the
      dynamic longitudinal relationships between daily approach and avoidance inclinations (i.e.,
      craving) and drinking behaviors in those diagnosed with an Alcohol Use Disorder (AUD) prior
      to, during, and after receiving a brief alcohol intervention. It is hypothesized that daily
      avoidance inclinations will significantly moderate the effect of daily approach inclinations
      on drinking behaviors, and that significant increases in avoidance inclinations will be
      observed prior to treatment entry, followed by significant decreases in approach inclinations
      during treatment.
    


Intervention name(s): Motivational Enhancement Therapy
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Serotonin Transporter in Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The aim of the present proposal is to prove that adult attention deficit hyperactivity
      disorder (ADHD) patients show lower serotonin transporter (5-HTT) binding using positron
      emission tomography (PET) and the selective radioligand [11C]DASB. Specifically, the 5-HTT
      binding will be quantified in 20 adult medication-free ADHD patients (50% females) and in 20
      age- and sexmatched healthy controls. Investigating untreated adult ADHD patients without any
      psychiatric comorbidities will provide the opportunity to estimate the change of serotonin
      transporter binding in adult ADHD patients compared to a group of healthy controls. Several
      lines of evidence support the hypothesis that serotonergic neurotransmission may, in addition
      to dopamine, play an important role in the aetiology of ADHD. So far, no PET study
      investigating serotonergic neurotransmission in adult ADHD patients has been conducted,
      although alterations in the serotonin system may be substantially involved in the
      susceptibility and subtype characterization of ADHD.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        40 participants including ten male adult ADHD patients, ten female adult ADHD patients and
        20 age- and sex-matched healthy volunteers, free of any psychotropic treatments at baseline
      
Biospecimen description: 
      whole blood
Safe Implementation of Thrombolysis in Stroke - Monitoring Study
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      Study to evaluate the safety and efficacy of intravenous alteplase within 3 hours of symptom
      onset in acute ischemic stroke patients
    


Intervention name(s): alteplase
Intervention type(s): Drug
Intervention MeSH terms: Tissue Plasminogen Activator
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        acute stroke patients in the European Union
FST-201 in the Treatment of Acute Otitis Externa
Condition: Acute Otitis Externa
MeSH terms: Otitis; Otitis Externa
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in
      the treatment of acute otitis externa. This study will be conducted at one site, the Lyndon
      B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago,
      American Samoa.
    

Detailed description: 
      The proposed clinical trial will evaluate the efficacy of FST-201 (dexamethasone 0.1% with
      povidone-iodine 1% ) Otic Suspension vs. the FDA-approved drug Ciprodex (ciprofloxacin 0.3%,
      dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in the treatment of acute
      otitis externa. Acute otitis externa is a common inflammatory condition of the external
      auditory canal often associated with infection, allergy and dermatitis. The active ingredient
      in our novel dexamethasone suspension is identical in concentration and route of
      administration to the steroid component of the approved drug Ciprodex, which is currently the
      most widely-prescribed dexamethasone-containing agent in the treatment of acute otitis
      externa. We will enroll 60 patients (30 each in two separate treatment groups) in this trial.
      All patients electing to participate in this study will receive either FST-201 or Ciprodex.
      FST-201 and Ciprodex will be masked and provided free of charge to all study participants.
      Patients will be followed for at least 15 days or until their ear inflammation is either
      resolved or determined to need additional interventions. The study will be conducted with
      attention to all relevant Good Clinical Practice (GCP), International Conference on
      Harmonization (ICH), FDA, Health Insurance Portability and Accountability Act (HIPPA) and
      Declaration of Helsinki guidelines.
    

Intervention name(s): FST201 (dexamethasone 0.1% with povidone-iodine 1%); Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )
Intervention type(s): Drug; Drug
Intervention description(s): 4 gtt BID (twice a day); 4 gtt BID (twice a day)
Other intervention name(s): CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension
Intervention MeSH terms: Ciprofloxacin; Povidone-Iodine; Dexamethasone; Dexamethasone acetate; Povidone; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: otitis; acute; externa; ear
EXIT: Prospective Study of the Response to Exercise
Condition: Liver Fat; Type 2 Diabetes
Study type: Observational

Summary: 
      Background :

      Regular exercise is a cornerstone in the prevention and the management of comorbidities.
      Unfortunately, the metabolic benefit of exercise training is not universal and varies among
      individuals. A main factor likely to explain the exercise training variability is the lack of
      empirical evidence on the determinants of exercise training. A series of muscle-derived
      cytokines have recently been discovered that (1) are released during exercise and (2) exert
      positive effects on peripheral tissues. Irisin is one of these novel "myokines" and might
      contributes to the metabolic adaptations to exercise training.

      Methods:

      The investigators will perform a pilot cohort study in which obese adolescents will perform
      resistance exercise training for 6 weeks. The main exposure variable will be the acute
      release of irisin during resistance exercise. The main outcome measures will be the change in
      hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral
      glucose tolerance test.

      Study Hypothesis:

      The primary overall hypothesis is that the change in plasma Irisin with a single bout of
      exercise will be associated with the metabolic adaptations to 6 weeks of resistance training,
      specifically, the reductions in hepatic triglyceride content and post-prandial glucose
      excursions, in obese adolescents.
    


Intervention name(s): Acute release of irisin after a single exercise session.
Intervention type(s): Other
Intervention description(s): We will determine the amount of Irisin secreted after a single bout of resistance exercise. Participants will be stratified into 3 groups based on the degree of Irisin release during this acute bout of resistance exercise. The metabolic adaptations to the 4 weeks of resistance training will be compared between youth stratified according to the amount of Irisin released during the acute bout of resistance exercise.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A community-based convenient sample of overweight adolescents aged 12-18 years with a BMI >
        95th centile for age and sex.
      
Keywords: Irisin; Obesity; Exercise; Myokine; Impaired Glucose Tolerance
Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)
Condition: Alcoholism; Smoking
MeSH terms: Alcoholism; Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will develop a behavioral and drug relapse prevention program for individuals who
      are dependent on both alcohol and tobacco. The study's goal is to show that individuals
      receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have
      higher rates of abstinence from both smoking and drinking than individuals who do not receive
      the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with
      followup assessments 1, 3, and 6 months after treatment.
    


Intervention name(s): naltrexone (Revia); nicotine replacement patch
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naltrexone; Nicotine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects
Condition: Pandemic; Avian Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a
      seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007
      influenza season in the Southern Hemisphere.
    


Intervention name(s): MF59-eH5N1; eTIV_a; MF59-eH5N1 + eTIV_a
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: MF59 oil emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bird flu; influenza vaccine; Seasonal influenza vaccine; Prepandemic vaccine
Prevention and Reduction of Obesity Through Active Living
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      We will perform a randomized, controlled trial, the primary aim of which is to assess the
      effectiveness of a behavioral-based physical activity program in the prevention and treatment
      of obesity and related co-morbid conditions in a primary care setting. We hypothesize that
      the prevention and/or reduction of obesity and related co-morbidities in patients randomized
      to an individualized education and behavior counseling group will be greater by comparison to
      those randomized to a group that receives standard care alone.
    


Intervention name(s): UC (Usual Care Group); BI (Behavioral Intervention Group)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Usual Care Group - Treatment Implementation by Primary Care Physician; Behavioral Intervention Group - Treatment Implementation by Health Educator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Abdominal obesity, exercise, behaviour modification
Efficacy and Safety of Kochujang Pills on Blood Lipids Profiles in Hyperlipidemia Subjects
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids.
      The investigators measured improvement of blood lipids parameters , including Total
      Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.
    


Intervention name(s): Kochujang Pills; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Kochujang Pills (34.5g/day); Placebo (34.5g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and
      catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after
      single oral ascending doses.
    

Detailed description: 
      Single centre, randomised, double-blind, placebo-controlled study of single ascending doses
      in up to 8 sequential groups of 8 healthy young male subjects.
    

Intervention name(s): BIA 9-1067; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single ascending doses in up to 8 sequential groups of 8 healthy young male subjects; single-dose
Other intervention name(s): Entacapone
Intervention MeSH terms: Opicapone; Entacapone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: BIA 9-1067