bioihbjkbjnl/mcl2 huggingface dataset:
Saracatinib and Alcohol Drinking
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of the study medication,
      saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory
      setting in which participants are given an initial drink of alcohol followed by the choice to
      drink up to 12 more drinks over a three-hour period. The investigators hypothesize that
      saracatinib will reduce craving and number of drinks consumed prior to and after exposure to
      the initial drink of alcohol and during the three hour drinking period.
    


Intervention name(s): Saracatinib; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Saracatinib 125 mg once per day for 8 days; Placebo once per day for 8 days
Other intervention name(s): AZD0530
Intervention MeSH terms: Saracatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation
Condition: Thrombosis
MeSH terms: Heart Diseases; Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the safety and pharmacokinetics of apixaban in children with congenital or
      acquired heart disease who have a need for anticoagulation.
    


Intervention name(s): Apixaban; Vitamin K Antagonist (VKA); Low Molecular Weight Heparin (LMWH)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): Eliquis; Warfarin; Enoxaparin
Intervention MeSH terms: Vitamin K; Heparin; Enoxaparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Warfarin; Apixaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of
      firsocostat in adults with normal hepatic function, and mild, moderate, or severe hepatic
      impairment and to evaluate the single-dose PK of fenofibrate in adults with normal hepatic
      function and mild hepatic impairment.
    


Intervention name(s): Firsocostat; Fenofibrate
Intervention type(s): Drug; Drug
Intervention description(s): Capsule(s) administered orally on Day 1; Tablet administered orally on Day 1
Other intervention name(s): GS-0976
Intervention MeSH terms: Fenofibrate; Firsocostat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Social Groups for Australian Children on the Autism Spectrum
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study evaluates the KONTAKT social skills group training in Australian children on the
      autism spectrum compared to an active control group which is a group Art class
    

Detailed description: 
      KONTAKT is a manualized Social Skills Group Training program designed for children and
      adolescents with ASD which aims to improve communication, social interaction skills, reduce
      the severity of ASD symptoms, improve the ability to empathise and adapt in a group setting.
      A large randomized controlled trial in Sweden found that adolescents who participated in
      KONTAKT demonstrated improvements in social skills, behaviour, reduced stress and improved
      overall functioning as reported by parents immediately following and at three months after
      the program. However, social skills are at least in part influenced by social cultural
      contexts and there is a need to understand the feasibility, acceptability and effectiveness
      of KONTAKT in an Australian context. Moreover, in the previous studies, the social skills
      groups were compared to treatment as usual groups. Therefore, this study evaluates the
      KONTAKT social skills group training in Australian children on the autism spectrum compared
      to an active control group which is a group art class
    

Intervention name(s): KONTAKT(c); Art group
Intervention type(s): Behavioral; Other
Intervention description(s): KONTAKT is a manualized Social skills group training program designed for children and adolescents on the Autism Spectrum aimed at improving communication, social interaction skills, the severity of ASD symptoms, and the ability to empathise and adapt in a group setting. The KONTAKT participants (4-8 participants) meet face to face weekly for 16 weeks for 75 minutes facilitated by two health professionals with experience of running groups for autistic children; Art program, a manualized Art group delivered in a social format, has been designed for children on the Autism Spectrum delivered by health professionals with experience of running social groups for Autistic children. The Art program's participants (4-8 participants) meet face to face weekly for 16 weeks for 75 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants will be randomly allocated into an intervention group (KONTAKT Australia) and an active control group (Social Art group).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social groups; Active contol group; Children; Australian
EFFECTİVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENTS WITH BELL'S PALSY
Condition: Bell Palsy
MeSH terms: Bell Palsy; Facial Paralysis; Paralysis
Study type: Interventional

Summary: 
      Bell's palsy (idiopathic facial palsy) is the most common peripheral lesion of the cranial
      nerves and the most common mono-neuropathy. Therapeutic ultrasound (US) is among the commonly
      used physical modalities for treating musculoskeletal disorders. The effects of US are due to
      alteration of cell membrane activity, vascular wall permeability and facilitation of tissue
      healing. The aim of this study is to investigate the effect of pulsed US treatment in
      patients with Bell's palsy when added to superficial heating, massage and exercise therapies.
    

Detailed description: 
      In this double -blind, randomized placebo-controlled trial, 32 patients (aged 18-65 years)
      diagnosed as idiopathic facial palsy with appropriate criteria were included. All patients
      were evaluated with motor nerve conduction studies and electromyography at 3-4 weeks after
      the onset of paralysis and 3 months after the treatment. Paralytic side frontalis and
      orbicularis oris muscles were used for electrophysiological analysis. Electrophysiological
      examinations were performed by an experienced electromyographer who was blind to the
      patient's treatments. Patients were separated into two groups as Group 1 (pulsed ultrasound
      therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program
      (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week.
      In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2,
      duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2
      received exactly the same procedure as the treatment group, except that the power switch was
      off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US
      device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at
      baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading
      System, House Brackmann Facial Grading System and Facial Disability Index and
      electrophysiologic parameters were used for outcome evaluation.
    

Intervention name(s): Therapeutic Pulsed Ultrasound; Sham Ultrasound
Intervention type(s): Device; Device
Intervention description(s): Patients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2). Pulsed ultrasound treatment were applied with 5-cm2 head Enraf-Nonius Sonopuls 434 ultrasound device.; Control group received sham ultrasound treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bell's palsy; facial paralysis; pulsed ultrasound
Utilizing Free DNA in Embryo Culture for PGT
Condition: Chromosome Abnormalities; Genetic Diseases, Inborn; Mutation
MeSH terms: Genetic Diseases, Inborn; Chromosome Disorders; Chromosome Aberrations
Study type: Observational

Summary: 
      In the way for developing and optimizing protocol to be used as non- invasive methodology
      used as routine testing for PGS.

      This protocol is to be adapted to replace the using of life embryo cells for genetic testing
      and aneuploidy study as well as for any type of genetic testing including single gene
      disorder or HLA typing or study.
    

Detailed description: 
      Compare 100 embryos studied using NGS for chromosomal aneuploidies, and compare the results
      came from free media DNA with this results.
    

Intervention name(s): NGS reading for Media Free DNA
Intervention type(s): Procedure
Intervention description(s): NGS reading for Media Free DNA instead of blstomer biopsy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Embryos arranged for PGS study
      
Biospecimen description: 
      Blastomer for growing IVF embryos culture media with its free DNA
    
Keywords: PGS; PGD; free embryo DNA; NGS; PGT; PGT-a; PGT-m; PGT-HLA
GB004 in Adult Subjects With Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, randomized, double-blind-, placebo-controlled, multi-center study to
      evaluate the safety, tolerability, and PK of GB004 in adult subjects with active ulcerative
      colitis. Target engagement and effect of GB004 on pharmacodynamic biomarkers will be
      assessed.
    

Detailed description: 
      The safety, tolerability, pharmacokinetics, and pharmacodynamics of GB004 will be explored in
      a Phase 1b randomized controlled trial in adults subjects with active ulcerative colitis
      (UC). Subjects will be evaluated based on incidence of AEs, laboratory parameters, GB004
      serum and colonic tissue concentrations, and changes in the signs and symptoms of UC.
    

Intervention name(s): GB004; Placebo; GB004
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GB0004 high dose; Placebo; GB004 low dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Disease; Ulcerative Colitis
SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding
Condition: Allergic Rhinitis; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based
      on reduction of upper airways reactivity after 5 months of treatment with different dosages
      of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be
      assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch
      compared to placebo.
    


Intervention name(s): SUBLIVAC FIX Birch
Intervention type(s): Drug
Intervention description(s): Comparison of different dosages to placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sublingual immunotherapy; Dose range finding; Dose tolerability; Birch pollen; Allergic rhinitis/rhinoconjunctivitis; Safety; Immunogenicity
Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of
      an omega-3 fatty acid concentrate in a group of people who normally are not treated for high
      lipids.
    


Intervention name(s): 4/day of 4g P-OM3 capsules; 4/day of 1g P-OM3 capsules; Corn Oil Placebo, 4 capsules/day for 8 weeks
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4/day of 4g P-OM3 capsules for 8 weeks; 4/day of 1g P-OM3 capsules for 8 weeks; 4 capsules per day of corn oil placebo for 8 weeks
Other intervention name(s): OM3AEE; Lovaza; Fish oil; OM3AEE; Lovaza; Fish oil; Corn oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: triglycerides; hypertriglyceridemia; omega-3; n-3; eicosapentaenoic acid; EPA; docosahexaenoic acid; DHA; flow mediated dilation; fish; Moderate hypertriglyceridemia
A Phase 2 Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease
Condition: Intermittent Claudication
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether sapropterin dihydrochloride is safe and
      effective in the treatment of intermittent claudication (IC) caused by peripheral arterial
      disease (PAD).
    

Detailed description: 
      This was a Phase 2, multicenter, multinational, prospective, randomized, double-blind,
      placebo-controlled, parallel study designed to assess the efficacy and safety of sapropterin
      dihydrochloride in subjects with intermittent claudication (IC) caused by peripheral arterial
      disease (PAD). Subjects who met initial screening criteria were monitored criteria and that
      dosages of permitted concomitant medications were stable.
    

Intervention name(s): Placebo; Sapropterin Dihydrochloride
Intervention type(s): Other; Drug
Intervention description(s): Subjects receive matching oral Placebo twice daily for 24 weeks.; Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks.
Intervention MeSH terms: Verapamil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Intermittent Claudication; IC; Symptomatic Peripheral Arterial Disease; Peripheral Arterial Disease; PAD; 6R-BH4; BH4; sapropterin dihydrochloride; endothelial dysfunction; Nitric Oxide; NO
Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in Patients With Schizophrenia
Condition: Schizophrenic Disorders
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind study to determine how well intramuscular (IM) olanzapine
      depot works compared to oral olanzapine; evaluate the safety and tolerability of IM
      olanzapine depot compared to oral olanzapine; evaluate different doses of IM olanzapine
      depot; and determine the blood levels of IM olanzapine depot in patients at different points
      in time after an injection.
    


Intervention name(s): Intramuscular Olanzapine Depot; Oral Olanzapine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines
Condition: Infections, Respiratory Syncytial Virus
MeSH terms: Respiratory Tract Infections; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first time in human (FTiH) study is to evaluate the safety,
      reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus
      (RSV) investigational vaccines in healthy men.
    

Detailed description: 
      This protocol posting has been updated following protocol amendment 3 to amend the respective
      exclusion criterion as to only exclude subjects with clinically significant hematological/
      biochemical abnormalities as per opinion of the investigator.
    

Intervention name(s): RSV vaccine GSK3003892A (formulation 1); RSV vaccine GSK3003893A (formulation 2); RSV vaccine GSK3003895A (formulation 3); RSV vaccine GSK3003896A (formulation 4); RSV vaccine GSK3003898A (formulation 5); RSV vaccine GSK3003899A (formulation 6); Placebo comparator
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Drug
Intervention description(s): Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule; Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule; Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule; Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule; Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule; Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule; Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immunogenicity; Respiratory Syncytial Virus; Reactogenicity; Vaccination; Safety
A Study of Single-dose MY008211A in Healthy Adults
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is the first human trial. The safety, tolerability, PK and PD of MY008211A Tablets
      will be evaluated in healthy subjects.
    

Detailed description: 
      This is a single ascending dose, randomized, double-blind study，with 5 dose groups preset.
    

Intervention name(s): MY008211A tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral; Single oral
Other intervention name(s): no name; no name
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The effects of n-3 LC-PUFA-supplemented dairy products on inflammation and immunological
      parameters, biomarkers of oxidative stress, serum lipids, and disease activity were
      determined in patients with rheumatoid arthritis (RA).
    

Detailed description: 
      Recent studies suggest that n-3 LC-PUFA may improve cardiovascular and inflammatory diseases.

      As a precondition for participating in this study, the subjects were provided information in
      writing and verbally about the details of the study. Informed consent was obtained from all
      volunteers. Before the beginning of the study, all participants were subject to a medical
      examination in the Clinic for Rheumatology (Internal Medicine III, Friedrich Schiller
      University, Jena). The RA was diagnosed according to the 1987 revised criteria of the
      American Rheumatism Association (ARA). Severity of disease activity was evaluated by using
      the disease activity score DAS 28.

      Forty five subjects (43 f, 2 m) were randomly divided into two groups to carry out a
      double-blind, placebo-controlled cross-over study.

      The study consisted of two investigation periods of 12 weeks, with an eight-week washout
      period in between. Patients received about 40 g fat daily (200 g yoghurt with 3.8% fat, 30 g
      cheese with about 50% fat in the dry matter, and 20-30 g butter). The milk fat was partially
      exchanged by special oils with high amounts of eicosapentaenoic acid (EPA), docosahexaenoic
      acid (DHA), and alpha linoleic acid (ALA). The daily dose of n-3 FA amounted to 2.4 g,
      consisting of 1.1 g ALA, 0.7 g EPA, 0.1 g DPA, and 0.4 g DHA. The placebo products were
      commercial dairy products with comparable fat contents.

      Venous blood and 24h urine were collected at the beginning and at the end of each period. The
      DAS 28 score was assessed at the beginning and the end of each period, respectively.
    

Intervention name(s): n-3 LC-PUFA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients received about 40 g fat daily (200 g yoghurt with 3.8% fat, 30 g cheese with about 50% fat in the dry matter, and 20-30 g butter). The milk fat was partially exchanged by special oils. The daily dose of n-3 FA amounted to 2.4 g, consisting of 1.1 g ALA, 0.7 g EPA, 0.1 g DPA, and 0.4 g DHA.; The placebo products were commercial dairy products with comparable fat contents.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: n-3 LC-PUFA; Rheumatoid arthritis; disease activity; inflammation; oxidative stress; immune system
Efficacy of Peripheral Magnetic Stimulation Compare to Dry Needling in Myofascial Pain Syndrome
Condition: Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      Compare efficiency between repetitive peripheral magnetic stimulation and dry needling in
      patient with upper trapezius myofascial pain syndrome.
    


Intervention name(s): Repetitive Peripheral Magnetic Stimulation; Dry needling
Intervention type(s): Device; Procedure
Intervention description(s): Repetitive Peripheral Magnetic Stimulation at trigger point of upper trapezius muscle; Dry needling at trigger point of upper trapezius muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment