bioihbjkbjnl/mcl2 huggingface dataset:
Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation
Condition: Sleep Disordered Breathing Central; Heart Failure; Heart Transplantation
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Heart Failure
Study type: Observational [Patient Registry]

Summary: 
      Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart
      failure patients and the presence of sleep-disordered breathing has been associated with
      increased mortality. This study is designed to investigate prevalence and dynamics of
      sleep-disordered breathing in end-stage heart failure patients pre and post heart
      transplantation.
    

Detailed description: 
      Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart
      failure patients and the presence of sleep-disordered breathing has been associated with
      increased mortality. This study is designed to investigate prevalence and dynamics of
      sleep-disordered breathing in end-stage heart failure patients pre and post heart
      transplantation, as this topic is hardly studied yet and previous reports suggest changes in
      the entity of sleep-disordered breathing through heart transplantation. The circumstances and
      the impact of sleep-disordered breathing or residuals in heart transplant patients is not
      well understood yet and will be subject of this study.
    

Intervention name(s): Sleep-disordered breathing
Intervention type(s): Behavioral
Intervention description(s): Prevalence and dynamic of sleep-disordered breathing after heart transplantation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        End-stage heart failure patients assigned and eligible for heart transplantation
      
Biospecimen description: 
      plasma, serum and urine samples
    
Keywords: Sleep-Disordered Breathing; Heart Failure; Heart Transplantation
Trivalent Chromium Treatment for Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Trivalent chromium has shown good results in abolishing inflammation and had a successful
      result in treating animal model of rheumatoid arthritis. In addition to that, trivalent
      chromium lacks many side effects which are related to the already known medications of the
      disease.

      So this study aims to evaluate the efficacy of trivalent chromium supplementation in
      rheumatoid arthritis treatment and measuring the outcomes of that in rheumatoid arthritis
      patients.
    

Detailed description: 
      Rheumatoid arthritis is a debilitating autoimmune disease which is treated by medications
      that have many side effects. Trivalent chromium, a naturally occurring element with
      regulatory effects on blood sugar, has shown anti-inflammatory properties in many studies and
      has shown a good response at alleviation of rheumatoid arthritis in the disease animal model.
      For these reasons trivalent chromium should be tried in rheumatoid arthritis patients.
    

Intervention name(s): Trivalent chromium versus synthetic and/ or biological DMARDs
Intervention type(s): Drug
Intervention description(s): Supplement and immunesuppressants
Other intervention name(s): Pure trivalent chromium (not in the form of a compound) and treatments the patients are already taking in comparison
Intervention MeSH terms: Chromium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan
      sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial
      hypertension (PAH).
    

Detailed description: 
      The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan
      sodium) as compared to placebo in the treatment of patients with PAH. A cohort of patients
      will be randomized to usual treatment with Tracleer® (bosentan) for observational comparisons
      of safety and efficacy.
    

Intervention name(s): sitaxsentan sodium
Intervention type(s): Drug
Intervention MeSH terms: Sitaxsentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Primary or secondary pulmonary arterial hypertension; Scleroderma; Connective tissue disease; Congenital heart defects; Lupus; Pulmonary Arterial Hypertension
Advanced Oxidation Protein Product and Monocyte Chemoattractant Protein-1 in Periodontal Disease
Condition: Inflammation; Periodontal Disease
MeSH terms: Periodontal Diseases; Inflammation
Study type: Observational

Summary: 
      This study investigates the levels of advanced oxidation protein product and monocyte
      chemoattractant protein-1 in gingival crevicular fluid in periodontal disease and health. 25
      participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally
      healthy subjects are included into this study. In each participant, four sites are identified
      for gingival crevicular fluid samples.
    

Detailed description: 
      Oxidative stress is the disequilibrium between the formation of free radicals and antioxidant
      defense mechanisms via damaging cellular macromolecules (DNA, protein, lipid, etc..) which
      are susceptible to oxidative damage.

      Advanced oxidation protein product is identified as a new marker of protein oxidation.

      Monocyte chemoattractant protein-1 is a major chemoattractant for lymphocytes, monocytes and
      macrophages.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        25 participants with chronic periodontitis, 25 participants with gingivitis and 25
        periodontally healthy subjects are included.
      
Keywords: Advanced Oxidation Protein Products; Gingival crevicular fluid; Monocyte chemoattractant protein-1; Periodontal Disease
Selenium in the Treatment of Arsenic Toxicity and Cancers
Condition: Arsenical Melanosis; Arsenical Keratosis; Arsenical Cancers; Arsenicosis; Arsenic Exposure; Arsenic Toxicity; Arsenic Poisoning
MeSH terms: Keratosis, Actinic; Arsenic Poisoning; Keratosis; Melanosis; Poisoning
Study type: Interventional
Phase: Phase 3

Summary: 
      Context: Approximately 100 million people throughout the world consume water contaminated
      with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh
      alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected
      regions. There are no proven therapies for treating chronic arsenic toxicity or for
      preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a
      variety of animal models. The investigators have recently shown in animals and humans that
      this effect is mediated by the formation of [(GS)2AsSe]- , the seleno-bis(S-glutathionyl)
      arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two
      Phase II studies in China and Bangladesh have suggested clinical benefit to selenium
      supplementation in arsenicosis patients.

      Objective: To assess whether daily selenium supplementation counters arsenic toxicity in
      patients exposed to drinking water arsenic. If proven effective, selenium supplementation
      might be safely and cost-effectively implemented in the worst-affected localities.
    


Intervention name(s): sodium selenite; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.; dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast
Other intervention name(s): selenium; selenite
Intervention MeSH terms: Selenium; Selenious Acid; Sodium Selenite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: arsenical melanosis; arsenical melanoses; arsenical keratosis; arsenical keratoses; arsenical cancer; arsenic cancers; arsenic; arsenicosis; arsenic exposure; arsenic toxicity; arsenic poisoning; drinking water; selenium; selenite; sodium selenite
Function of Inner Ear Such as Balance and Perception of Verticality in Children With Idiopathic Scoliosis
Condition: Idiopathic Scoliosis; Vestibular Abnormality
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      The purpose of this study was to evaluate vestibular function in children with idiopathic
      scoliosis as a possible cause of etiopathogenesis of its diagnose.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with Idiopathic scoliosis
      
Keywords: idiopathic scoliosis; subjective visual vertical; vestibular evoked myogenic potentials; posturography
Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.
Condition: Anemia; Constipation; Diarrhea; Abdominal Pain; Heartburn; Side Effect
MeSH terms: Constipation; Diarrhea; Abdominal Pain; Heartburn
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Oral iron supplementation is often associated with rapid onset of gastrointestinal
      side-effects. The aim of this study was to develop and trial a short, simple questionnaire to
      capture these early side-effects and to determine which symptoms are more discriminating.

      The study was a double-blind placebo-controlled randomized parallel trial with one week
      treatment followed by one week wash-out. Subjects were randomized into two treatment groups
      (n=10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron) or
      placebo, both to be taken at mealtimes twice daily during the treatment period. Subjects
      completed the questionnaires daily for 14 days. The questionnaire included gastrointestinal
      symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e.
      nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).
    


Intervention name(s): ferrous sulfate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): ferrous sulphate (200 mg capsules containing 65 mg of iron) to be taken at mealtimes twice daily for 7 days during the treatment period.; placebo capsules: methyl cellulose
Other intervention name(s): ferrous sulphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: healthy participants; gastrointestinal side-effects associated with oral iron
Multimedia Based Information to Parents in a Pediatric Acute Ward: A Randomized Controlled Trial
Condition: Health Communication
Study type: Interventional

Summary: 
      The aim of this study is to determine whether multimedia based health information presented
      in a pediatric acute ward to parents of children with breathing difficulties due to lower
      respiratory tract infections, is more effective than verbal information to reduce the
      parent's anxiety and to increase satisfaction with nursing care and health information.
    

Detailed description: 
      The intervention website www.syktbarn.no is an open Norwegian online resource for parents of
      small children, and the site contains videos, audio clips, animations, illustrations,
      pictures and text materials regarding children's illnesses and normal development. In
      addition, the parents can use an interactive symptom checker that will help them to decide
      what to do and when to seek medical advice when their child is sick. The uniqueness of the
      website is the authentic video clips of sick children with common childhood symptoms like
      breathing difficulties, signs of dehydration, rash, cough and fever.
    

Intervention name(s): Multimedia information; verbal information
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Parents; Caregivers; Anxiety; Consumer satisfaction
Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®
Condition: Dietary Modification
Study type: Interventional

Summary: 
      The aim of this study is to evaluate bioavailability and pharmacokinetics of phenolic
      compounds from Oxxynea®, a blend of fruit and vegetable extracts, in healthy volunteers,
      during a randomized, double-blind and cross-over trial. After a single dose supplementation,
      both metabolic profile and urinary excretion will be determined over a 48h-period by means of
      High-Performance Liquid Chromatography coupled with a tandem mass spectrometry (HPLC-MS) to
      identify and quantify phenolic metabolites. In parallel, post-prandial potential
      anti-oxidative and anti-glycemic properties of Oxxynea® will be determined in blood,
      following consumption of a cafeteria-type breakfast.
    


Intervention name(s): Oxxynea®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oxxynea® is a blend of polyphenol-rich extracts from olive, grape, pomegranate, green tea, grapefruit, orange and blueberry. Dosage is 1 x 450 mg-capsule.; Placebo product is 100% maltodextrin. Dosage is 1 x 450 mg-capsule of identical appearance than the verum capsule.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia
Condition: Remimazolam; Desflurane; Cryoablation; Arrhythmia; General Anesthesia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional
Phase: Phase 4

Summary: 
      In anesthesia for ablation for cardiac arrhythmias, abrupt hemodynamic changes or fatal
      arrhythmias can be seen frequently. Remimazolam is a novel ultra-short acting benzodiazepine
      that provides good hemodynamic stability compared to conventional anesthetic agents. This
      study aims to investigate whether remimazolam reduces vasoactive agent use during
      cryo/radiofrequancy ablation under general anesthesia, compared to desflurane(RCT).
    


Intervention name(s): Remimazolam besylate
Intervention type(s): Drug
Intervention description(s): Remimazolam besylate TIVA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Remimazolam; Desflurane; Arrhythmia; Cryoablation,heart; Cardiovascular disease
Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia
Condition: Peripheral Vascular Diseases
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and the immediate effect of the VascuActive
      device on patients with peripheral vascular disease and limb ischemia.
    


Intervention name(s): VascuActive
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Serum Bactericidal Activity Assay Development
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      This is a study to collect blood from volunteers to assist in assay development.
    


Intervention name(s): Blood Collection
Intervention type(s): Procedure
Intervention description(s): Blood Collection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Primary purpose: Diagnostic
Intravitreal Anti-VEGF in Exudative AMD With Epiretinal Membranes
Condition: Epiretinal Membrane; Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Epiretinal Membrane
Study type: Observational

Summary: 
      Study designed to evaluate the effect of significant ERM on the visual and anatomic outcomes
      of intravitreal anti-VEGF therapy for eAMD.
    

Detailed description: 
      Gass in 1987 described three cases of epiretinal membrane (ERM) associated with wet macular
      degeneration. Since then we have seen that is not rare to find the coexistence of these
      entities. An ERM may produce intrinsic disorganization of the outer retina leading to
      persistent increased macular thickness and/or edema. This persistent edema may affect the
      effectiveness in the treatment of exudative age-related macular degeneration (eAMD).
      Therefore, this study was designed to evaluate the effect of significant ERM on the visual
      and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        age-related macular degeneration
      
Keywords: choroidal neovascularization; epiretinal membrane; anti-VEGF
Staccato Apomorphine Single and Multi Dose PK
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in 3 parts. A) compare the pharmacokinetics (PK) of a single
      dose of AZ-009 with that of a therapeutically-relevant dose of a commercially available
      apomorphine injector in healthy volunteers; B) ascending doses of active drug in healthy
      volunteers; and C) examine the tolerability, safety, and PK of AZ-009 in subjects with
      established Parkinson's disease.
    

Detailed description: 
      This study will be conducted in 3 parts. Parts A and B will be conducted in healthy
      volunteers and Part C will be conducted in subjects with established Parkinson's disease. The
      primary objectives for each part are as follows.

      Part A: To compare the pharmacokinetics of a single low dose of AZ-009 with that of a
      therapeutically-relevant dose a commercially available apomorphine injector in healthy
      volunteers.

      Part B: To examine the tolerability and safety of AZ-009 of single ascending doses of active
      drug in healthy volunteers while; and to characterize the pharmacokinetics of single
      ascending doses of AZ-009 in healthy volunteers

      Part C: To examine the tolerability, safety, and pharmacokinetics of AZ-009 in subjects with
      established Parkinson's disease and to identify optimal doses to bring into multiple
      ascending dose safety and efficacy studies; and to assess the usability of AZ-009 in subjects
      with Parkinson's Disease
    

Intervention name(s): 009-1; active comparator; 009-0; 009-2; 009-3; 009-4; 009-5
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Inhaled apomorphine via Staccato aerosol, Dose 1; commercially available apomorphine injector; Inhaled placebo via Staccato device; Inhaled apomorphine via Staccato aerosol, Dose 2; Inhaled apomorphine via Staccato aerosol, Dose 3; Inhaled apomorphine via Staccato aerosol, Dose 4; Inhaled apomorphine via Staccato aerosol, Dose 5
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A 3 part study including: A) Single Dose Crossover in Healthy Volunteers, B) Single Ascending Dose with placebo control in Healthy Volunteers, and C) Single Ascending Dose with placebo control in Subjects with Established Parkinson's Disease
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: apomorphine; aerosol
A Study of Single and Multiple Ascending Doses of JNJ-61393215 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this 3 part study are; Part 1: to investigate the pharmacokinetic (PK), safety
      and tolerability of JNJ-61393215 suspension (ascending dose levels) after single oral dose
      administration under fasted conditions, Part 2: to evaluate the relative bioavailability of a
      solid JNJ-61393215 capsule formulation compared to a suspension of JNJ-61393215 under fasted
      conditions, and the effect of food on the PK of the solid JNJ-61393215 capsule formulation,
      Part 3: to investigate the PK, safety, and tolerability of JNJ-61393215 suspension (ascending
      dose levels) after 7 days of once daily dosing in under fasted conditions.
    


Intervention name(s): JNJ-61393215; Placebo; JNJ-61393215
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.; Participants will be administered JNJ-61393215-matching placebo in Part 1, 2 and 3 of study as oral suspension.; Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other