bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Evaluation of Tirofiban Using a Single High-Dose Bolus In Subjects With Varying Degrees of Renal Function
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate tirofiban concentration in the blood over a period
      of 24 hours after tirofiban administration. Subjects with varying degrees of renal
      insufficiency (i.e. kidney function) will be included in the study. Tirofiban is known to be
      cleared from the blood by the kidneys and so people with kidney problems clear tirofiban to a
      slower extent compared to people without kidney problems. By comparing the tirofiban
      concentration profile between subjects with healthy kidney function versus with impaired
      kidney function, a tirofiban dosing recommendation for subjects with impaired kidney function
      can be made.

      This is a non-randomized, single-center, open-label study. A single dose of tirofiban (25
      µg/kg administered intravenously over a 3 min period) will be administered to subjects with
      normal renal function (>90 mL/min CrCl), moderate (30-59 mL/min CrCl), and severe (<30 mL/min
      CrCl) renal impairment with non-dialysis-dependent renal insufficiency
    

Detailed description: 
      Tirofiban is cleared from the plasma largely by renal excretion. As a consequence, a dosage
      adjustment of 50% of the tirofiban label dosing regimen (0.4 μg/kg/min for a period of 30
      minutes, followed by an infusion of 0.10 μg/kg/min) is recommended in patients with severe
      renal impairment (<30 mL/min CrCl), including those who require hemodialysis. The dosage
      adjustment for the tirofiban high-dose bolus regimen (25 μg/kg bolus followed by a 0.15
      μg/kg/min maintenance) for patients with varying degrees of renal insufficiency is however
      unknown. The purpose of this study is to determine the extent of dosage adjustment for the
      high-dose bolus regimen for patients with moderate (30-59 mL/min CrCl), and severe (<30
      mL/min CrCl) renal insufficiency.

      This non-randomized, single-center, open-label study evaluating the pharmacokinetic (PK),
      pharmacodynamic (PD), and safety profile of a single high-dose IV bolus injection of
      tirofiban (25 µg/kg). A single dose of tirofiban will be administered to the subjects with
      normal renal function (>90 mL/min CrCl), moderate (30-59 mL/min CrCl), and severe (<30 mL/min
      CrCl) renal impairment with non-dialysis-dependent renal insufficiency (NDDRI).
    

Intervention name(s): Tirofiban
Intervention type(s): Drug
Intervention description(s): A single high-dose bolus (3 min IV infusion) of tirofiban (25 µg/kg)
Other intervention name(s): Aggrastat
Intervention MeSH terms: Tirofiban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tirofiban; pharmacokinetic; renal insufficiency; Phase 1; pharmacodynamic
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with
      ADHD are dosed to optimal effect.
    

Detailed description: 
      Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse
      (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD
    

Intervention name(s): Vyvanse (lisdexamfetamine dimesylate)
Intervention type(s): Drug
Intervention description(s): Vyvanse™ 20mg once daily at 7 a.m.; dose increased weekly by 10mg until an acceptable response is achieved. Titration may proceed to a maximum daily dose 70mg/day.
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fructose Supplementation in Carriers for Hereditary Fructose Intolerance
Condition: Hereditary Fructose Intolerance
MeSH terms: Fructose Intolerance
Study type: Interventional

Summary: 
      This study aimed to examine metabolic response to a short-term fructose enriched diet in
      carriers for hereditary fructose intolerance compared to controls. Effects of fructose
      coffees will be assessed in 7 healthy volunteers and 7 subjects with heterozygous mutation
      for ALDOB gene in a randomized, controlled, crossover trial.
    

Detailed description: 
      A high fructose intake also increases blood lactate and uric acid concentrations. It has been
      proposed that uric acid may contribute to insulin resistance by impairing
      endothelium-dependent vasodilation, promoting pro-inflammatory effects and dyslipidemia by
      activating de novo lipogenesis.

      These consequences of fructose overconsumption may be even more marked in individuals with
      hereditary alterations in fructose metabolism. Indeed, individuals with hereditary fructose
      intolerance (HFI), due to biallelic mutations in the gene coding for aldolase B (ALDOB), may
      develop acute, life-threatening manifestations when exposed to fructose. Heterozygous
      carriers of ALDOB mutation are quite common in the general population, with a predicted
      frequency ranging between 1:55 and 1:120. Few studies have examined the effect of fructose
      ingestion in heterozygotes subject for HFI. Heterozygous carriers are generally considered to
      have normal fructose metabolism since a ~ 50% level of aldolase B activity is presumed to be
      sufficient for adequate function. However, heterozygous carriers were reported to have
      enhanced uric acid responses to large intravenous and/or oral fructose loads.

      Investigators hypothesized that heterozygous carriers may also have mild defects of fructose
      metabolism and/or a larger increase in cardiometabolic risk factors than the normal
      population after ingestion of moderate amounts of fructose.
    

Intervention name(s): Experimental diet Fru rich diet; Experimental low Fru diet
Intervention type(s): Other; Other
Intervention description(s): 7 days (day 1 to day 7) with fructose enriched drinks 3x/d. Test meal at day 7 with fructose (0.7 g/body weight) and glucose (0.7 g/body weight); 7 days (day 1 to day 7) with low-fructose diet (<10g/d). Test meal at day 7 with fructose (0.7 g/body weight) and glucose (0.7 g/body weight)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fructose; Uric acid; Glucose homeostasis
Autologous Platelet Lysate in Corneal Epithelial Defects
Condition: Persistent Corneal Epithelial Defect
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous
      platelet lysate.
    

Detailed description: 
      Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal
      epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing
      of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored
      ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be
      taken in multiple doses.
    

Intervention name(s): Platelet Lysate
Intervention type(s): Biological
Intervention description(s): Eye drops of Platelet Lysate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Persistent corneal epithelial defect; Platelet Lysate
Protopic Ointment in Children Atopic Eczema
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Children with atopic eczema and a poor response to topical corticosteroid applied either
      Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more
      weeks once a day if needed.
    

Detailed description: 
      Treatments were to be applied twice daily until clearance, for a maximum of 3 weeks and then,
      in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of
      a flare-up the treatment was to be resumed twice a day until the end of the study.

      Statistical methods: An interim analysis was performed on 30% of the planned total sample
      size, i.e. 140 included patients who had completed the study, to reassess the assumptions
      made during the planning phase.
    

Intervention name(s): Tacrolimus 0.03%; Fluticasone 0.005%
Intervention type(s): Drug; Drug
Intervention description(s): ointment; ointment
Other intervention name(s): Protopic® 0.03%; Flixovate® 0.005%
Intervention MeSH terms: Fluticasone; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dermatitis, Atopic; Dermatologic Agents; Topical Drug Administration; Tacrolimus; Calcineurin; Corticosteroid; Fluticasone propionate; Child
Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This study has three objectives about persons with Parkinson's Disease during bicycling:

        1. Determine the effect of visual feedback and competition during virtual bicycling on
           neuromuscular and cardiovascular intensity

        2. Determine the effect of visual-feedback and competition during virtual bicycling on the
           user experience of motivation, enjoyment & perception of exercise intensity

        3. Determine if attention differs during visual feedback compared to competition virtual
           bicycling
    

Detailed description: 
      Participants will attend one sessions lasting about 2-3 hours. They will complete movement
      assessments and questionnaires about physical activity. They will then exercise exercise in
      three different virtual reality augmented bicycling conditions while wearing a head mounted
      display (goggles). Each of the three conditions will last approximately 8 minutes and will be
      followed by questionnaires about the participant's experience.
    

Intervention name(s): Virtual reality bicycling
Intervention type(s): Other
Intervention description(s): This is a single arm study in which all participants will execute the same three bicycling tasks over one session. Exercise intensity and enjoyment are measured while participants bicycle in a virtual reality environment (wearing virtual reality goggles) in three different conditions lasting approximately 8 minutes each.
Intervention model: Single Group Assignment
Intervention model description: Repeated measures design
Masking: None (Open Label)
Primary purpose: Other
Keywords: parkinson disease; parkinsonian disorders; Basal ganglia disease; Brain diseases; central nervous system diseases; nervous system diseases; movement disorders; synucleinopathies; neurodegenerative diseases
Evaluation of the Lung Capillary Blood Volume in Children With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Sickle cell disease (SCD) is the most common inherited disease of the world affecting African
      and Caribbean populations. SCD is caused by the homozygous inheritance of the gene for sickle
      hemoglobin (HbS). Most patients with SCD develop abnormal pulmonary function characterized by
      airway obstruction, restrictive lung disease, abnormal diffusing capacity, hypoxemia and
      pulmonary hypertension In healthy subjects, lung capillary blood volume (Qc) and membrane
      diffusing capacity (Dm) can be accurately measured by the nitric oxide-carbon monoxide
      (NO-CO) method. We propose to study, for the first time, lung capillary blood volume and
      alveolar membrane diffusing capacity, using the NO-CO method, in children with SCD aged of at
      least 6 years Early determination of lung function and pulmonary circulation in children with
      SCD is very important, not only for the understanding of physiopathologic mechanisms of the
      disease but also for a better therapeutic management of these children.
    

Detailed description: 
      We propose to study, for the first time, lung capillary blood volume and alveolar membrane
      diffusing capacity, using the NO-CO method, in children with SCD aged of at least 6 years. We
      will compare lung function and measurement of Qc and Dm in 2 groups of 120 subjects, one
      group of SCD children, and the other of normal children matched on age and ethnic origin.
      Measurement of lung capillary blood will be measured twice, to assess short term
      reproducibility. The measurement will be done in sitting position and lying down for one part
      of subjects, and at rest and during a moderate rectangular exercise for the other part of
      subjects. These different tests are designed to assess the physiological adaptation of
      pulmonary circulation in these two populations of children. Combined with complete lung
      function measurements, echocardiographic assessment of pulmonary hemodynamics, and
      measurement of exhaled nitric oxide, these evaluations will lead to a better understanding of
      pathophysiology of lung injury in SCD. The study will be completes at Robert Debré Hospital,
      in close collaboration with Sickle Cell Disease Center and Physiology Department. Children
      will be included after informed consent signed, as legally prescribed.
    

Intervention name(s): NO-CO inhalation and expiration; NO-CO inhalation and expiration
Intervention type(s): Other; Other
Intervention description(s): NO-CO inhalation and expiration; NO-CO inhalation and expiration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Sickle cell disease;; Lung capillary blood volume;; Children
Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer
Condition: Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC)
      followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant
      treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to
      determine whether lapatinib combined with chemotherapy was safe and resulted in an increase
      in pathologic complete response rates.
    

Detailed description: 
      Lapatinib acts as a dual inhibitor of both epidermal growth factor receptor (EGFR) and ErbB-2
      (Her2/neu) tyrosine kinase activity. EGFR and ErbB2 receptors are frequently over-expressed
      or altered in human cancers including breast cancer. This study plans to determine the
      antitumor activity of this regimen and its effectiveness preventing tumor growth and spread.

      Neoadjuvant chemotherapy which achieves pathologic complete responses (pCR) has been shown to
      predict improved long-term survival and serves as a surrogate for clinical outcome. By using
      this primary endpoint we can obtain statistical data with smaller patient numbers and at a
      lower overall cost. Additionally, we hope to correlate clinical and radiologic outcomes with
      gene expression data.
    

Intervention name(s): Lapatinib; Doxorubicin; Cyclophosphamide; Docetaxel; Pegfilgrastim; Filgrastim; Dexamethasone; Trastuzumab
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles); 60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide.; 600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin.; 100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide; 6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments.; 300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies.; 8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel; Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year
Other intervention name(s): GW572016; Adriamycin; Adriablastin; Cytoxan; ASTA; Taxotere; Neulasta; Neupogen; Granulocyte Colony-Stimulating Factor (G-CSF); Adexone; Herceptin
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Docetaxel; Doxorubicin; Trastuzumab; Lapatinib; Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation
Condition: Atrial Fibrillation; Stress; Quality of Life; Anxiety; Depression; Hostility
MeSH terms: Atrial Fibrillation; Depression
Study type: Interventional

Summary: 
      The purpose of this study is to determine if an eight week multimodal Relaxation Response
      Resiliency Program (3RP) intervention can effectively improve symptom severity, frequency and
      quality of life (Q.O.L) in atrial fibrillation (AF) patients. This will be measured by a
      reduction in AF symptom score, perceived stress, anxiety, hostility and depression.
    

Detailed description: 
      Atrial fibrillation (AF) is a very common cardiovascular disease. Symptoms include dizziness,
      palpitations, lightheadedness, shortness of breath, fatigue and exercise intolerance. AF is
      also associated with a high risk of complications like thrombo-embolism and stroke, heart
      failure, dementia. The presence and severity of these symptoms and complications adversely
      affect a patient's health related quality of life. Improvement in quality of life (QOL) is an
      important measure for evaluating response to treatment in AF patients. Depression and anxiety
      are significant part of the psychosocial burden faced by approximately one-third of AF
      patients, and are important components that effect QOL in these patients. In this study the
      investigators will apply the 3RP (Relaxation Response Resiliency Program - developed at the
      Benson Henry Institute at Massachusetts General Hospital) intervention among AF patients to
      assess the reduction in their stress, anxiety and depression levels and the reduction in AF
      symptom burden and severity.
    

Intervention name(s): Relaxation Response Resiliency Program
Intervention type(s): Behavioral
Intervention description(s): 8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga
Other intervention name(s): 3RP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Atrial Fibrillation; Relaxation Response Resiliency Program Intervention; AF Symptom Severity and Burden; Stress, Anxiety, Depression and Hostility; Quality of Life; AF; QOL; 3RP
Study of the Safety of Intravenous Artesunate
Condition: Malaria; Malaria, Cerebral
MeSH terms: Malaria; Malaria, Cerebral
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish the safety, tolerability, and pharmacokinetics of a
      multiple dose of the antimalarial drug artesunate.
    

Detailed description: 
      This study was a Phase 1b, randomized, double-blind, placebo-controlled trial using multiple
      ascending doses of intravenous artensunate (AS) to determine it's safety, tolerability, and
      PK in healthy subjects. Subjects were screened within 21 days of dosing. At the screening
      visit, subject underwent baseline assessments: vital signs were recorded; a physical
      examination, urinalysis, urine drug screen, and urine pregnancy test were performed; a
      complete blood cell count (CBC) with differential and indices, reticulocyte count,
      coagulation markers, and blood chemistry assessments were performed and medical and
      medication history was collected. Eligible subjects were scheduled for a 6-hour pre-dose
      electrocardiogram (ECG) and vital sign assessment with measurements taken at approx. the same
      times as Day 1 (dosing day). On Day 0, subjects were admitted to the clinical pharmacology
      unit to begin the inpatient phase of the study. Subjects had a brief physical examination and
      all procedures for the inpatient stay were reviewed. On Day 1, pre-dose vital signs and ECG
      were performed. Subjects then received study drug or placebo by IV bolus infusion. Subjects
      were closely monitored by evaluating hemodynamic measurements, periodic ECGs, and assessment
      of spontaneously reported AEs. Blood was drawn for blood count and chemistry analysis 6h and
      24h after each dose. PK blood samples were drawn pre-dose and approx. 5min, 20min, 40min, 1h,
      2h, 4h, 6h, and 24h after each dose. On Days 2 and 3 subjects received their second and third
      doses, respectively, of study drug or placebo with the same monitoring and laboratory
      measurements as for the first dose. Subjects were discharged 24 hours after the 3rd dose of
      drug or placebo and were followed as outpatients on Days 7, 10, and 15.
    

Intervention name(s): Intravenous Artesunate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1); Mannitol (200 mg/vial) diluted in Phosphate Buffer and given IV in equivalent volume by subject's weight.
Other intervention name(s): IV AS; Mannitol
Intervention MeSH terms: Artesunate; Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: artesunate; artemisinin; falciparum
Effect of Acupuncture on Postoperative Nausea and Vomiting
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to investigate if P6 acupuncture made after induction of general
      anaesthesia might be effective for the prevention of PONV as ondansetron and if the
      acupuncture-ondansetron combination could enhance single therapy efficacy in patients
      undergoing laparoscopic cholecystectomy.
    


Intervention name(s): Acupuncture; Ondansetron; Physiological saline solution; Sham acupuncture; Ondansetron; Acupuncture at P6 point; Physiological saline solution; Sham acupuncture
Intervention type(s): Other; Drug; Drug; Other; Drug; Other; Drug; Other
Intervention MeSH terms: Ondansetron; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Patients undergoing laparoscopic cholecystectomy for cholelithiasis