bioihbjkbjnl/mcl2 huggingface dataset:
Oral Bio-equivalence Study
Condition: Bioequivalence; Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      Title of Study: An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period,
      Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules
      (3 x 0.5 mg) in Healthy Adult Human Subjects Under Fasting Conditions.

      Objective: The objective of this study is to compare the oral bioavailability and
      characterize the pharmacokinetic profile of the test formulation relative to that of
      reference formulation in healthy, adult, human subjects under fasting conditions and to
      assess the bioequivalence.
    


Intervention name(s): Fingolimod 0.5 mg capsules- Test drug
Intervention type(s): Drug
Intervention description(s): An oral dose of the assigned formulation (3 capsules) will be administered in the morning to subjects with about 240 mL of water at ambient temperature according to the randomization scheme.
Other intervention name(s): Fingolimod 0.5 mg capsules- Reference drug
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two way crossover
Masking: None (Open Label)
Primary purpose: Other
Treatment Protocols for Patients With Symptomatic Oral Lichen Planus
Condition: Lichen Planus, Oral; Preneoplastic Condition
MeSH terms: Precancerous Conditions; Lichen Planus, Oral; Lichen Planus
Study type: Interventional

Summary: 
      The primary objective of this study was to compare the therapeutic efficacy of clobetasol
      propionate 0.05% oral gel versus an anti-inflammatory mouthwash in an oral solution for the
      management of patients suffering from symptomatic OLP. The secondary objective was to analyze
      which one of the two treatments induced a greater risk of developing side effects.
    

Detailed description: 
      Forty patients were assigned (20 patients per group), through a randomized design, to receive
      clobetasol (clobetasol gel 0.05%), or an anti-inflammatory mouthwash (mouthwash which
      contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins)
      for 3-months. At baseline (T0) and after 3 months (T1), patients were subjected to clinical
      and oral assessments and were evaluated for the symptoms (Numerical Pain Scale, NRS score)
      and signs (Thongprasom's score) of OLP. Data were calculated using T-test for the dependent
      variable, Wilcoxon test and Mann-Witney u test.
    

Intervention name(s): Healing evaluation
Intervention type(s): Drug
Intervention description(s): Treatments were topically applied for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups of patients
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Voluntary Neck Extension on Cerebral Blood Flow, in Breath-hold Divers Ending an Apnoea of Two Minutes or More.
Condition: Healthy Amateur Divers
MeSH terms: Apnea
Study type: Interventional

Summary: 
      The aim of this study is to demonstrate the effect of the voluntary neck extension in the
      occurrence of an increase in the pulsatility index of the right internal carotid artery in
      the amateur diver, realizing an apnea of two minutes or more.
    

Detailed description: 
      In literature concerning apnoea, accidents have been described during neck extension.

      Accidental drowning are frequent on the French coast every year and many of them concern
      apneists victims of apnoeic blackout.

      Neck extension is thus suspected to possibly produce an apnoeic blackout at the end of the
      dive since 1965, when Sir Sciarli (diving medicine pioneer) suspected this hypothesis.

      Physiologically, during a dive in apnea, the human cardiovascular system is subjected to a
      parasympathetic dominance, via the apnea reflex and the diving reflex. This parasympathetic
      dominant could be reinforced during a neck extension at the end of snorkeling during the
      ascent.

      Hypothesis: the neck extension at the end of apnea contributes to increase the pulsatility
      index of the right internal carotid artery by vagal component and thus causes a decrease in
      cerebral blood flow and may lead to the initiation of syncope in the healthy amateur free
      diver or underwater fisherman.
    

Intervention name(s): apnea performing
Intervention type(s): Other
Intervention description(s): The included subjects will make an apnea of two minutes or more, sitting on a chair with cold strips on the face, initially with the head in neutral position. Then, when they feel the end of their apnea, they will have to raise their left hand to signal it to the Doppler manipulator, who will then realize the apnea reference measurement.
As soon as this is done, the subjects will be asked to perform an extension of the neck, so as to look at the ceiling. A final measurement will then be made in apnea, the head always in extension. Subjects then resume their breathing in this same position. A final measurement will then be made.
Intervention model: Single Group Assignment
Intervention model description: Subject will realize an apnea of 2 minutes or more, depending on his abilities, and some parameters will be measured.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: apnea; neck extension; syncope; diving blackout; right internal carotid arteria; pulsatility index; healthy trained apnoea divers; doppler ultrasonography
Role of the Catechol-O-methyltransferase (COMT) in the Physiological Regulation of Vigilance
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, pharmacologic effects of COMT inhibition during sleep deprivation in healthy
      subjects in dependence of their Val158Met genotype of COMT are studied. Potential effects are
      identified by measurement of vigilance and cognitive performance as well as EEG measurements
      during wake and sleep.

        -  Trial with medicinal product
    


Intervention name(s): Tolcapone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 x 100mg Tolcapone compared to placebo (randomized, double-blind, cross-over)
Other intervention name(s): Tasmar
Intervention MeSH terms: Tolcapone
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sleep-wake; regulation; volunteers
Leucine Supplementation and Skeletal Muscle Disuse
Condition: Disuse Atrophy
MeSH terms: Muscular Disorders, Atrophic; Atrophy
Study type: Interventional

Summary: 
      Leucine supplementation is widely known for promoting strong influence on skeletal muscle
      remodeling. This study aims to evaluate the effect of leucine supplementation on
      disuse-induced skeletal muscle atrophy.
    


Intervention name(s): Leucine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 7.2 g of leucine during 2 weeks; 7.2 g of alanine during 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Leucine; Skeletal Muscle Disuse; Atrophy; Proteolysis
Study Evaluating Bapineuzumab In Alzheimer Disease Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of
      mild to moderate Alzheimer disease. Subjects will be in the study for six months and will
      receive subcutaneous injections once per week.
    


Intervention name(s): bapineuzumab; bapineuzumab; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mg bapineuzumab subcutaneous injection once per week for 6 months; 10 mg bapineuzumab subcutaneous injection once per week for 6 months; Placebo subcutaneous injection once per week for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: antibody; immunotherapy
Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      An open-label, single-dose, three-treatment, three-period study to investigate the effect of
      SLCO2B1 genotype and apple juice on pharmacokinetics of atenolol after oral administration in
      healthy male Korean.
    


Intervention name(s): Atenolol; Atenolol with apple juice 1200 mL; Atenolol with apple juice 600 mL
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Atenolol oral administration; Atenolol oral administration with apple juice 1200 mL; Atenolol oral administration with apple juice 600 mL
Intervention MeSH terms: Atenolol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SLCO2B1 genotype; effect of apple juice
Efficacy and Feasibility of Ectoin® Inhalation Solution in Inflammatory Obstruction and Ageing of the Lung
Condition: COPD; Particulate Matter Induced Inflammation of the Lung
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      To investigate the physical inflammation inhibition effects of EIL (Ectoin-Hydro-Complex) in
      subjects of the established SALIA-cohort and the preventive effects on lung function decline.
    


Intervention name(s): Ectoin Inhalation Solution; Placebo
Intervention type(s): Device; Device
Intervention description(s): Once daily inhalation of Ectoin Inhalation Solution; Once daily inhalation of Placebo Inhalation Solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Particulate Matter induced inflammation of the lung
Dental Pain 3rd Molar Tooth Extraction GW842166
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase IIa (proof of concept) study will be conducted as a multi-centre study within the
      European Union (EU). It will be conducted to a randomised, single blind, placebo- controlled,
      parallel group design with a positive control arm to evaluate the analgesic efficacy of
      pre-emptive doses of GW842166 following dental surgery (3rd molar tooth extraction). GW842166
      will be administered as a single pre-operative oral dose in male and female subjects who will
      be randomised to take part in one of four possible treatment regimens. Pain assessments will
      be undertaken over a 10 hr period. Pharmacokinetic blood samples will be collected over a 48
      hr period. Safety and tolerability will be evaluated by adverse event monitoring,
      cardiovascular assessments (ECG and vital signs) and clinical laboratory tests (haematology,
      clinical chemistry and urinalysis).
    


Intervention name(s): GW842166
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: analgesia; post-operative pain; GW842166; non-cannabinoid agonist; third molar tooth extraction
Pilot, Prospective, Comparative Multicentric Study Evaluating the Effects on the Arthrosis Biomarkers, the Clinical Effectiveness, the Tolerance of an Intra-articular Injection of Hyaluronic Acid KARTILAGE CROSS Versus Placebo in Patients Suffering From Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Intra-articular hyaluronic acid injections, also known as viscosupplementation, are a
      treatment option for knee osteoarthritis that serves to restore the decreasing rheological
      properties of synovial fluid. KARTILAGE® CROSS is a visco-elastic gel of highly purified
      reticulated hyaluronic acid. It contains mannitol to provide an anti-oxidative action and to
      avoid hyaluronic acid depolymerization. Reticulation and mannitol increase the residency time
      of the product in the joint cavity then allowing a single injection in painful knee
      osteoarthritis patients.

      The US food and drugs administration (FDA) and European medicine agency (EMA), have recently
      published guidelines recommending a higher level of integration of biomarkers in the
      development and testing of new drugs to advance decision-making on dosing, time and treatment
      effect, trial design, and risk/benefit analysis. Biomarkers can be used not only in the
      process of drug development, but also in the future in assessment of individual patient's
      response to treatment.

      Several soluble biomarkers have been identified as potential candidates to predict or monitor
      the efficacy of intervention. Coll2-1, a degradation product of type II collagen, and
      Coll2-1NO2, a nitrated form of the Coll2-1 peptide have been studied in human osteoarthritis
      and entered the qualification process. Evidences demonstrated them to be pertinent and to be
      foresee as markers used for the diagnosis, the prognosis, the burden of disease and the
      monitoring of a treatment efficacy.

      The aim of this study was to provide with the first kinetic data regarding biomarkers in
      painful knee osteoarthritis patients treated with a new reticulated hyaluronic acid. The
      effects of the treatment were compared to those of saline solution. The primary endpoint was
      a specific osteoarthritis biomarker, Coll2-1. The secondary endpoints were the effects of the
      treatment or placebo on other biomarkers of osteoarthritis, its clinical efficacy and
      tolerance
    


Intervention name(s): KARTILAGE CROSS; PLACEBO
Intervention type(s): Device; Device
Intervention description(s): Intra-articular injection of Kartilage Cross; Intra-articular injection of physiological serum (saline solution)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Nerve Entrapment in Diabetic Patients
Condition: Carpal Tunnel Syndrome; Entrapment Neuropathies; Nerve Compression Syndromes; Diabetes Complications
MeSH terms: Carpal Tunnel Syndrome; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy; Diabetes Complications; Syndrome
Study type: Observational

Summary: 
      The aim of this study is in a prospective, consecutive series of diabetic patients with
      carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having
      idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel
      release.
    


Intervention name(s): Outcome after carpal tunnel release
Intervention type(s): Procedure
Intervention description(s): Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to a specialized hand clinic
      
Keywords: Carpal Tunnel Syndrome; Diabetes; APB strength; Sensory Function; Pillar Pain; Cold Intolerance; Patient Satisfaction
A Study of a Seasonal Trivalent Split, Inactivated Influenza Vaccine
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of
      participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1;
      A/H3N2 and B) or placebo (phosphate buffered saline). A total of 60 healthy male and female
      adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).
    

Detailed description: 
      This is a phase 1, double blinded, randomized, placebo-controlled study. The study will be
      conducted at 1 site in Serbia. Sixty (60) healthy male and female adults, 18 to 45 years of
      age, will be enrolled into the trial. Subjects will be randomized 1:1 to one of two treatment
      allocations: 30 to vaccine, 30 to placebo. The study will utilize a "randomized block design"
      to assure a balance of 1:1 vaccine and placebo when all subjects are enrolled. The study will
      be double blinded, meaning the study subjects, investigators, and the sponsor will be unaware
      of the treatment allocated to each subject until the clinical trial database is declared
      final and locked. The study should take about 5 months to complete, with each subject
      involved for 3 months from the day of injection. The justification for the 3 month follow up,
      rather than 6 month follow up is that this is an inactivated vaccine that follows very
      standard manufacturing practices with standard antigens. The safety of inactivated influenza
      vaccines is well-established. Adding length to the follow up results in delays in future
      testing of the vaccine for licensure.
    

Intervention name(s): Influenza vaccine, split inactivated; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Seasonal trivalent inactivated influenza vaccine (TIV), inactivated split virion, purified by sucrose gradient ultracentrifugation. The vaccine is produced in hen's eggs, and inactivated with beta-propiolactone.; 0.5 mL of phosphate buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Grippe; Human Flu; Human influenza
Residual Gastric Volume in Morbidly Obesa Diabetics. A Comparison of 3 Hour Versus Hour Fasting.
Condition: Obesity; Diabetes; Fasting
MeSH terms: Obesity
Study type: Interventional

Summary: 
      To reduce the risk of aspiration for elective procedures, residual gastric volumes (RGV) have
      traditionally been minimized with overnight fasting. However, prolonged fasting can also have
      some adverse consequences and has been abandoned for some procedures in several patient
      populations with the exception of obese and/or diabetic patients. The aim of this study was
      to assess RGV in morbidly obese diabetic patients after traditional or abbreviated fasting.
    

Detailed description: 
      Patients underwent two endoscopic examinations within two weeks. RGV was measured by
      aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least
      8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water
      containing 25g of 12.5% maltodextrin). All patients received both oral and written
      information about the protocol at the outpatient clinic.

      All the endoscopic procedures began at 9 AM, and were performed by the same board-certified
      endoscopist, JMS, who was blinded as to the duration of the fast. The endoscopies were
      conducted at Gastroclinica, Cuiaba, MT, in the period from April to June, 2013. Sedation was
      performed by a board-certified anesthesiologist, who was also blinded as to the duration of
      the fast. The anesthetic regimem included a intravenous bolus of 2 ml of lidocaine
      hydrochloride (Astra Zeneca, São Paulo, Brazil) followed by 100 to 150mg of propofol before
      endoscopy. Digital oximetry was monitored throughout the procedure. Patients were positioned
      in the lateral recumbent position. A flexible electronic videoendoscope (EG2770K; Pentax
      Corporation, Tokyo, Japan) of 9 mm in outer diameter was used. The main outcome variable was
      the RGV measured by the endoscopist after aspiration of gastric residue.
    

Intervention name(s): Endoscopic examinations
Intervention type(s): Other
Intervention description(s): Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). All patients received both oral and written information about the protocol at the outpatient clinic.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Gastric emptying.; Residual gastric volume.; Preoperative fasting.; Morbid Obesity.; Diabetes.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
Condition: Healthy Participants; Narcolepsy
MeSH terms: Narcolepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy
      participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-925. TAK-925 is being tested in healthy
      participants and participants with narcolepsy. This study will look at the safety,
      tolerability, pharmacokinetics, and efficacy of TAK-925.

      This study will consist of three parts. Part A will be a randomized, double-blind,
      placebo-controlled, multiple rising dose (MRD) study in healthy participants. Part B is a
      randomized, double-blind, placebo-controlled MRD study in participants with narcolepsy. Part
      C is a randomized, double-blind, placebo-controlled, parallel group, multiple repeat dose
      study in participants with narcolepsy. Part A' is a single dose study in healthy
      participants.

      The study will enroll approximately 96 participants planned as total. All participants except
      Part A' will be randomly assigned (by chance, like flipping a coin) to one of the two
      treatment groups-which will remain undisclosed to the participants and study doctor during
      the study (unless there is an urgent medical need):

      Part A:

        -  TAK-925 (Dose Levels A1-A6)

        -  Placebo

      Part B:

        -  TAK-925 (Dose Levels B1-B4)

        -  Placebo

      Part C:

        -  TAK-925 (Dose Levels C1-C2)

        -  Placebo

      Part A':

      • TAK-925 (Dose Levels A'1-A'2)

      All participants will be asked to take TAK-925 or Placebo at the same time each day from Day
      1 to Day 7 in Parts A, B and C, and take TAK-925 on Day 1 in Part A'.

      This multi-center trial will be conducted in Japan. The overall study period is approximately
      15 days in Parts A, B and C, and approximately 7 days for Part A'. Participants will be
      partly admitted to a hospital during the study.
    

Intervention name(s): TAK-925; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-925; TAK-925 Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment