bioihbjkbjnl/mcl2 huggingface dataset:
Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)
Condition: Confirmed Genetic Diagnosis of Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.
    

Detailed description: 
      Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.
      Study medication will be administered for 91 days. The study will be conducted in two steps:

        -  Step 1 - 10-15 adult subjects with PWS will be treated.

        -  DSMB review and SUKL review - following the completion of the treatment of the adult
           subjects, unblinded efficacy, safety, PK data as well as all data from the study in
           subjects with type 2 diabetes (TM001) will be reviewed by an independent Data Safety
           Monitoring Board (DSMB) and State Institute for Drug Control (SUKL). Following the
           SUKL's approval the study will proceed to:

        -  Step 2 - 10-15 children with PWS.
    

Intervention name(s): Tesofensine/Metoprolol; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Study medication will be administered for 91 days.; Study medication will be administered for 91 days.
Other intervention name(s): Tesofensine; Metoprolol; Placebo
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Biomechanical and Electrophysiological Effects of Duloxetine in the Treatment of Women With Urinary Stress Incontinence
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 3

Summary: 
      Biomechanical and electrophysiological effects of duloxetine in the treatment of women with
      urinary stress incontinence
    


Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat
      throughout the world and development of medicines with new mechanism of action have an
      important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in
      HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will
      collect information on safety, tolerability and drug levels in the body of in healthy
      subjects for GSK3640254. The information collected in this study will help in further
      clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in
      HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single
      oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be
      randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be
      given immediately after a moderate fat meal. Maximum duration of study participation will be
      approximately 12 weeks.
    


Intervention name(s): GSK3640254; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK3640254 is a capsule available in 1 milligram (mg), 10 mg and 100 mg dosing strength. GSK3640254 capsule will be given via oral route during each dosing day with approximately 240 mL of water.; Placebo capsule matching to the study treatment will be given via oral route during each dosing day with approximately 240 mL of water.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a dose-escalation study and dose will be escalated based on the safety data of the initial dose.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: FTIH; Healthy; Tolerability; Dose-escalation; HIV-1; Safety; PK; GSK3640254; Maturation inhibitor
CARDIOSPACE Evaluation in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this porject is to test the Cardiospace system that integrates several medical
      devices to monitor the cardiovascular system:

        -  ECG

        -  Brachial blood pressure

        -  Continuous finger blood pressure

        -  Ultrasound

        -  Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the
           cardiovascular system of astronauts for research purpuse.
    


Intervention name(s): CARDIOSPACE System
Intervention type(s): Device
Intervention description(s): autonomic nervous system test
tilt test
ultrasound exploration at rest (heart / vessels)
laser doppler + iontophoresis test
sub-maximal exercise test
Other intervention name(s): Physiological tests
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo
      during an 8-hour laboratory classroom day.
    


Intervention name(s): Dex-methylphenidate hydrochloride extended-release (Focalin XR); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg capsule orally once a day for 7 days; orally once a day for 7 days
Other intervention name(s): Focalin XR
Intervention MeSH terms: Methylphenidate; Dexmethylphenidate Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD; children; laboratory classroom; Attention Deficit Hyperactivity Disorder
A Study of Eribulin in Combination With Oral Irinotecan for Adolescent and Young Adult Patients With Relapsed or Refractory Solid Tumors
Condition: Relapsed Solid Tumors; Refractory Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This IND-exempt Phase I trial will establish the recommended Phase II (RP2D) dose of eribulin
      in combination with fixed doses of oral irinotecan in adolescents and young adults with
      relapsed or refractory solid tumors. Eribulin will be administered intravenously on days 1
      and 8 of a 21-day cycle, while irinotecan will be administered orally on days 1-5.

      Patients will be assigned an eribulin dose level at the time of enrollment using a 3+3 Phase
      I design, and there will be no intrapatient dose escalation. Once the RP2D has been
      established, there will be up to 10 patients enrolled in a dose expansion cohort. In absence
      of disease progression or toxicity, subjects may receive up to 17 cycles of therapy.
    


Intervention name(s): Eribulin; Irinotecan; Cefixime
Intervention type(s): Drug; Drug; Other
Intervention description(s): Intravenous eribulin administered on days 1 and 8 of a 21-day cycle.; Irinotecan will be administered orally at a fixed dose of 90 mg/m2/day on days 1 -5 of a 21-day cycle.; Cefixime will be given to all patients to reduce irinotecan-associated diarrhea. It will be administered Day -1 through Day 8 of each cycle.
Other intervention name(s): Suprax
Intervention MeSH terms: Cefixime; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: young adults; adolescents
Adjuvant Vinorelbine Plus Cisplatin(NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer(NSCLC)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar
      prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with
      completely resected IB-IIIA non-small-cell lung cancer.
    

Detailed description: 
      It is an open labelled, randomized, mono-center phase III clinical trail.A total of 250
      patients with resected stage IB to stage IIIA non-small cell lung cancer will either the
      group of vinorelbine plus cisplatin plus endostar or the group of vinorelbine plus cisplatin
      randomly. The primary end point was overall survival; principal secondary end points were
      recurrence-free survival and the toxicity and safety of the regimens.The major inclusive
      criteria are pathological confirmed non-small cell lung cancer after complete resection and
      can tolerate chemotherapy safely.The tissue and blood samples will be banked for further
      investigation. All of the enrolled patients will be followed up until death or over 5 years.
    

Intervention name(s): recombinant human endostatin
Intervention type(s): Drug
Intervention description(s): recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed
Other intervention name(s): endostar
Intervention MeSH terms: Endostatins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adjuvant therapy; non-small cell lung cancer; vinorelbine; cisplatin; recombinant human endostatin; endostar
Tolerability and Safety of An Infant Formula
Condition: Milk Hypersensitivity
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with
      cow's milk allergy.
    


Intervention name(s): Nutramigen Lipil (Infant formula)
Intervention type(s): Other
Other intervention name(s): Extensively hydrolyed infant formula (Nutramigen Lipil)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Keywords: infant formula; cow's milk allergy
Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Idiopathic pulmonary fibrosis (IPF) is a disease of unknown cause in which areas of normal
      lung tissue are replaced by scars. As a result it becomes harder for the lungs to extract
      oxygen from the air. IPF is commonly progressive, and around 50% of patients diagnosed with
      the disease die after approximately 3 years. The most common, troublesome symptoms of IPF are
      breathlessness on exertion, and cough. No drug treatments have been unequivocally shown to
      improve the death rate, or to significantly impact upon symptoms, in IPF.

      In recent years it has been recognised that cough can be caused by small amounts of liquid
      coming up from the stomach and "going down the wrong way" into the lungs, a process commonly
      known as "reflux". As liquid in the stomach is usually acidic, patients' lungs may repeatedly
      be exposed to small amounts of acid. Reflux is unusually common in IPF and could potentially
      contribute to the debilitating cough found with the disease. However there are many potential
      causes for cough in IPF.

      Stomach acid can be efficiently "switched off" by drugs called "proton pump inhibitors", one
      of which is called omeprazole. If reflux of stomach acid does contribute to cough in IPF,
      omeprazole might be expected to reduce cough. The purpose of this study is therefore to test
      whether omeprazole does reduce cough in patients with IPF. Sixty patients with IPF will be
      randomly allocated to have 3 months of omeprazole or a placebo. Neither the patient nor the
      doctor will be aware which treatment has been given, ie this is a randomised "double-blind",
      placebo--controlled trial. Patients' cough frequency will be measured before and after
      treatment and the change in cough frequency compared in those receiving omeprazole and those
      receiving placebo. Change in cough frequency is the main thing we aim to compare, but a range
      of other measurements will be assessed such as the numbers of patients eligible to take part,
      agreeing to randomisation and providing outcome data, patients' lung function, symptom
      scores, the amount of reflux, and the amount of inflammation in the lungs.
    


Intervention name(s): Omeprazole; Matched placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug; Matched placebo
Other intervention name(s): Losec
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: omeprazole, idiopathic pulmonary fibrosis
Cystatin C as an Early Marker of Contrast-Medium Nephropathy in Cardiac Catheterization Patients
Condition: Contrast Induced Nephropathy; Acute Renal Failure
MeSH terms: Kidney Diseases; Acute Kidney Injury
Study type: Observational

Summary: 
      Hypothesis:

      Cystatin C compared with creatinine is a better and earlier marker of contrast-induced
      nephropathy in high and intermedium risk cardiac catheterization patients.

      Primary Objective:

      Establish if Cystatin C is superior detecting contrast-induced nephropathy than creatinine in
      high and intermedium risk cardiac catheterization patients.
    

Detailed description: 
      Contrast induced-nephropathy is a complication that is underestimated in clinical practice
      after cardiac catheterization. During the last 30 years, because of the increasing use of
      contrast medium for diagnostic and therapeutic procedures, this has become the third
      in-hospital cause of acute renal failure (12%). That's why, it is necessary to establish an
      earlier marker of renal dysfunction that can help us in the diagnosis and allow us to
      initiate the appropriate therapeutics, because depending on the severity of the renal damage,
      it can increase the cardiovascular risk and morbidity.

      The risk of contrast medium nephropathy is still present even with the use of low osmolarity
      contrast media, and many patients increase their in-hospital days, costs and hemodialysis
      requirement.

      Cystatin C is a non glucosylated protein produced in nucleated cells in a constant rate, and
      because of its low molecular weight it's filtered through the glomerular membrane without
      restriction and it's fully reabsorbed in the proximal tubule, that's why it's considered an
      excellent marker evaluating the glomerular filtration rate in patients with acute renal
      failure during the first 24-48 hours.

      We propose that Cystatin C can be useful as an earlier and superior marker of
      contrast-induced nephropathy in high and intermedium cardiac catheterization patients.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients over 20 years old with an indication for coronariography and/or percutaneous
        coronary intervention, and with a MEHRAN contrast-induced nephropathy score from six to
        fifteen.
      
Keywords: Contrast-induced nephropathy; Cystatin C; Contrast media; Creatinine; Cardiac Catheterization
Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses
Condition: Cancer
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of a nature-centred integrative oncology
      day care unit programme ("outdoor concept") compared with an already established integrative
      oncology day care unit programme ("indoor concept").
    


Intervention name(s): Nature-near integrative day care unit programme; Conventional integrative day care unit programme
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme; Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Nature; Mind-Body Therapies; Mindfulness; Yoga; Meditation
Early Diagnosis in Glaucoma With GDxVcc
Condition: Exfoliation Syndrome
MeSH terms: Exfoliation Syndrome; Syndrome
Study type: Observational

Summary: 
      To compare the Retina Nerve Fiber Layer thickness, measured with Scanning Laser Polarimetry
      in subjects with exfoliation syndrome and normal controls and to evaluate the value of
      scanning laser polarimetry in the early diagnosis and management of exfoliative glaucoma
    

Detailed description: 
      To compare the Scanning Laser Polarimetry findings in subjects with exfoliation syndrome and
      normal controls and to evaluate the value of scanning laser polarimetry in the early
      diagnosis and management of exfoliative glaucoma. Prospective study in progress. The
      investigators compare and analyze the scanning laser polarimetry parameters in consecutive
      subjects with exfoliation syndrome and normal intraocular pressure and compared them with
      consecutive normal controls. Randomly selected patients with exfoliation syndrome and normal
      controls undergo a comprehensive ophthalmic exam which includes 3 IOP measurements, corneal
      pachymetry, automated perimetry and assessment of the retina nerve fiber layer with scanning
      laser polarimetry. The investigators hypothesize that patients with exfoliation syndrome may
      show worse scanning laser polarimetry parameters than normal controls and this may prove to
      be an early sign of exfoliative glaucoma development. Evaluation of retina nerve fiber layer
      thickness may help us in identifying earlier those individuals with exfoliation syndrome that
      will develop exfoliative glaucoma.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals with and without exfoliation
      
Keywords: Exfoliation; Scanning Laser Polarimetry; Corneal Thickness
Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS)
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      This overall goal of this trial will be to demonstrate that DYV700 is safe and effective as a
      treatment for acute gout flares.
    

Detailed description: 
      Gout presents as intermittent acute painful and debilitating gout flares. High serum uric
      acid levels lead to the deposition of urate crystals in and around the joints, most commonly
      the big toe (also called podagra) and other peripheral joints. An acute gout flare causes
      extreme pain and inflammation of the afflicted joints. It initially presents as a
      monoarticular condition but can affect several joints as the disease progresses. Gout flares
      typically take 7-10 days to resolve.

      Currently, the inflammation and pain associated with acute gout flares are treated
      anti-inflammatories, including non steroidal anti-inflammatory drugs (NSAIDs), colchicine,
      corticosteroids, and adrenocorticotropic hormone. However these drugs are limited in
      efficacy, contraindicated for some patients and may take more than 24 hours to relieve gout
      symptoms (e.g. colchicine).

      DYV700 will be developed to reduce the pain associated with acute gout flares. DYV700 is
      applied topically and utilizes a proprietary drug delivery system to deliver it's active
      ingredients.
    

Intervention name(s): DYV700; Placebo; Colchicine 0.6 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Proprietary transdermal delivery platform; Vehicle transdermal delivery platform; Standard of care, 2 tablets (1.2 mg) loading dose followed by 1 tablet (0.6 mg) 1 hour later at onset of gout flare.
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement
Condition: Gingivitis
MeSH terms: Gingivitis; Dental Caries
Study type: Interventional

Summary: 
      This study will test if applying calcium silicate cements (Biodentine) to restore cervical
      carious lesions might adversely affect the gingival health in comparison with conventionally
      used tooth colored material (GIC)
    

Detailed description: 
      The study will compare two different dental materials on dental lesions near the gum line. .
      The study will determine if one material is more effective in gingival health, after the
      placement of the two different dental materials.The oral hygiene and the gingival health of
      the restored teeth will be evaluated clinically at 1, 3 and 6-month intervals.
    

Intervention name(s): GIC; Biodentine
Intervention type(s): Device; Device
Intervention description(s): tooth colored filling; White filling -Biodentine
Other intervention name(s): Calcium Cilicate
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group will be treated with a tooth colored filling that will be placed near the gum line (Glass Ionomer). The second group will be treated with Biodentine that will be placed near the gum line.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: gingiva; plaque; pocket depth