bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.

      The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm
      the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric
      participants with chronic hepatitis C virus (HCV) infection.

      The primary objective of the Treatment Phase is to evaluate the safety and tolerability of
      SOF/VEL for 12 weeks in pediatric participants with chronic HCV.
    


Intervention name(s): SOF/VEL; SOF/VEL
Intervention type(s): Drug; Drug
Intervention description(s): SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment); SOF/VEL FDC 200/50 mg oral granules
Other intervention name(s): Epclusa®; GS-7977/GS-5816; Epclusa®; GS-7977/GS-5816
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of the Laryngeal Mask Airway (LMA) - Unique and LMA-Supreme in Children
Condition: Laryngeal Mask Airway in Children
Study type: Interventional

Summary: 
      The aim of this randomized prospective study is to compare two single-use laryngeal mask
      airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators
      hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA
      Unique.
    

Detailed description: 
      The goal of this study is to compare the LMA Unique and LMA-Supreme in children undergoing
      anesthesia. The investigators hypothesize that airway leak pressures with the LMA Supreme
      will be superior when compared with the LMA Unique at two different standardized intracuff
      pressures (40 and 60 cm H20). Airway leak pressures will be measured by recording the circuit
      pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of
      laryngeal view, feasibility of use, and complications will also be assessed.
    

Intervention name(s): LMA Unique: control device; LMA Supreme: comparison device
Intervention type(s): Device; Device
Intervention description(s): LMA Unique will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.; LMA Supreme will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5, The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
Other intervention name(s): Laryngeal Mask Airway; Laryngeal Mask Airway
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Critical Care Observation of Motor Activity (COMA) and SICU Outcomes
Condition: Motor Activity; Muscle Strength; Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Observational

Summary: 
      In the surgical intensive care unit (SICU), goals of critical care are often discussed in
      long-term ventilated patients around the time of extubation. Muscle weakness predicts
      extubation failure but formal muscle strength assessment by the Medical Research Council
      scale is time-consuming and not part of the daily clinical exam. In this observational study,
      we hypothesize that COMA measurement, routinely used by the SICU nurses, is a reliable and
      valid predictor for patients' SICU outcomes. This prospective observational study is carried
      out within a consecutively enrolled cohort of adult patients who are extubated in two SICUs
      at Massachusetts General Hospital, Boston.
    


Intervention name(s): COMA Score Assessment
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study cohort of adult patients who are extubated in two SICUs at Massachusetts General
        Hospital, Boston.
      
Keywords: critical care; patient discharge; costs and cost analysis; length of stay; hospital mortality
Efficacy Study of New Therapeutic Schedules in Naive Hepatitis C Virus (HCV) Patients Infected With Genotype 3 (HCV-3)
Condition: Chronic Hepatitis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study aimed at evaluating whether current 24 weeks length of combination treatment is
      appropriate or not for patients with HCV genotype 3 infection.
    

Detailed description: 
      Patients are randomized to standard length of treatment or to a variable duration: 12 weeks
      for patients with undetectable HCVRNA at week 4 or 24 or 36 weeks for those with detectable
      HCV RNA at week 4.
    

Intervention name(s): Peg Interferon alpha2b + Ribavirin
Intervention type(s): Drug
Intervention description(s): B 1 I or II: Experimental
variable duration of treatment group according with RVR. In case of RVR present patients will be treated for 12 weeks. Patients without RVR will be treated for 24 (B1I) or 36 (B1II)weeks: different duration of treatment for patients without RVR
Other intervention name(s): variable
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: genotype 3; Combination treatment; Short treatment
Intrathecal Stem Cells in Brain Injury
Condition: Hypoxia-Ischemia, Cerebral; Cerebral Palsy
MeSH terms: Brain Injuries; Cerebral Palsy; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the plasticity of autologous intrathecal
      hematopoietic cells would improve the neurologic evolution of the pediatric patients with
      hypoxic/ischemic brain injury.
    

Detailed description: 
      There is accumulating evidence that shows that the placement of hematopoietic cells in the
      brain may increase growth-enhancing factors of axons and generate active neurons in the
      receptor. It has been found that after introducing hematopoietic cells in the subarachnoid
      space of the spinal cord, these cells may be transported through the cerebrospinal fluid and
      can be deliver more efficiently to the injured area, when compared to the intravenous route.
      Patients will be stimulated 4 times and then harvest the bone marrow. Bone marrow will be
      processed in order to obtain hematopoietic cells (CD34+) and minimize the erythrocytes
      amount. A inoculum of 5 to 10mL of stem cells will be infused intrathecally. Patients will be
      evaluated with the "Battelle Developmental Inventory" before the procedure and one and six
      months after that. An MRI will be performed before the procedure and six months after that.
    

Intervention name(s): Intrathecal Autologous Stem Cells
Intervention type(s): Procedure
Intervention description(s): Patients will be stimulated with Granulocyte Colony Stimulating Factor (G-CSF) 5 times, harvest bone marrow and infused 8 to 10 mL of stem cells (CD34+) by intrathecal via.
Other intervention name(s): Autologous Stem Cells Transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoxia; Ischemia; Brain; Children; Cerebral Palsy
Triamcinolone Levels in Cochlear Perilymph
Condition: Cochlear Hearing Loss
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study Triamcinolone acetonide will be applied intratympanically before cochlear
      implant surgery. After round window exposure, a perilymph sample and simultaneously a blood
      sample will be drawn. Triamcinolone levels will then be analyzed in the samples.
    

Detailed description: 
      At the ENT department of the university hospital Vienna (AKH Wien) patients are treated with
      intratympanic triamcinolone acetonide before cochlea implantation to reduce inflammation and
      in some cases to protect residual hearing. Triamcinolone acetonide levels in cochlear
      perilymph will be evaluated in an open prospective clinical study. Patients scheduled for
      cochlear implant surgery between 18 and 90 years will be included. Patients who are treated
      with steroids preoperatively will be excluded from the study. Patients will be randomized
      after inclusion to one of four groups. The randomization is carried out to generate
      hypothesis for the needed dose and best time of application in the future. Triamcinolone
      acetonide will then be applied 20-24h before surgery or at the beginning of the surgery,
      depending on randomization (see below). About 20 µl of perilymph will be sampled
      simultaneously to a blood sample during cochlear implant surgery.

      The probes will be stored at -80°C. Triamcinolone acetonide levels of the blood and perilymph
      will be determined by the pharmaceutical laboratory (Department of Pharmaceutical Technology
      and Biopharmaceutics, University of Vienna).

      The patients will be randomized to 4 groups. Group 1 - Volon A 10mg administration 20 - 24
      hours before sampling. Group 2 - Volon A 40mg administration 20 - 24 hours before sampling.
      Group 3 Volon A 10mg - administration 1 to 2 hours before sampling. Group 4 - Volon A 40mg
      administration 1 to 2 hours before sampling.

      The time interval of application (1 to 2 hours and 20 to 24 hours before sampling) are a
      result of varying time of surgery depending on surgeons and patient anatomy as well as day to
      day clinical organization. Patients can withdraw consent at any time of the study.

      The active phase of each patient will be between 6 and 9 days depending on time of follow-up
      visit.
    

Intervention name(s): Triamcinolone Acetonide
Intervention type(s): Drug
Intervention description(s): Intratympanic administration
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy Volunteers
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center, open label, randomized, two-period, two-sequence cross-over study is
      designed to evaluate the relative bioavailability of a treprostinil diethanolamine 1 mg
      tablet in reference to treprostinil diethanolamine 1 mg oral solution (administered as four
      0.25 mg doses every 2 hours for a 1 mg total dose) in twenty-four healthy volunteers. Other
      secondary outcomes of interest include assessment of pharmacokinetic parameters of
      treprostinil diethanolamine 1 mg tablets and a treprostinil diethanolamine 1 mg oral solution
      administered as four doses (0.25 mg every 2 hours for a 1 mg total dose) and evaluation of
      the safety and tolerability of each treatment regimen.
    


Intervention name(s): treprostinil diethanolamine
Intervention type(s): Drug
Intervention description(s): Subjects will be administered a 1 mg dose of treprostinil diethanolamine as a single tablet, and treprostinil diethanolamine oral solution 0.25 mg dose every 2 hours for four doses (1 mg total).
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity
Condition: Genital Herpes Simplex Type 2
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Observational

Summary: 
      This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and
      immunogenicity of GEN-003 in subjects with genital HSV-2 infection.
    


Intervention name(s): Observational
Intervention type(s): Biological
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who received at least 1 dose of active GEN-003 and completed the GEN-003-002
        study.
      
Keywords: HSV; Herpes; Genital Herpes
Maternal and Infant Cord Blood Monosaccharide Content
Condition: Pregnancy
Study type: Observational

Summary: 
      Mother's breast milk provides many benefits to babies with regard to development and improved
      health. We believe the simple sugars which make up these complex sugars in breast milk and
      are also found in the brain may be critical to normal brain development in term and preterm
      infants.

      Babies are exposed to these sugars by placental transport during pregnancy and through
      mother's breast milk after they are born. For the preterm infant, we do not know if breast
      milk gives enough of these sugars compared to what the baby gets during pregnancy.

      A maternal blood sample and blood samples from the baby's umbilical cord will provide us with
      background information for developing a supplement of special sugars that can be added to
      infant formulas to provide the amount that the baby usually gets during pregnancy and from
      breast milk.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Twenty-four generally healthy mother-infant pairs.
      
Biospecimen description: 
      plasma will be stored
    
Keywords: Breastfeeding; Infant; Preterm; Nutrition
A Drug-Drug Interaction Study to Study the Effect of AZD1981 on Warfarin
Condition: Pharmakokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine whether the treatment with AZD1981 affect
      the exposure of Warfarin.
    


Intervention name(s): AZD1981; Warfarin; AZD1981
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg per oral, twice daily for 14 days; 10 x 2.5 mg per oral, once daily at day 1 and day 15; 4 x 100 mg per oral, twice daily for 14 days
Other intervention name(s): Waran
Intervention MeSH terms: Warfarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Drug-Drug interaction; warfarin; AZD1981
Role of Mechanical Load on Metabolic Exercise Adaptations in Response to Weight Loss in Obese Adolescents: The POWELL Study
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity; Weight Loss
Study type: Interventional

Summary: 
      While interdisciplinary weight loss intervention have been shown successful among adolescents
      with obesity, a weight regain is most of the time observed within the following weeks or
      months. The aim of the present project will be to better identify the independent role played
      by both the metabolic and mechanical load and their modification during weight loss, on the
      energy expenditure and energy metabolism of adolescents with obesity.
    

Detailed description: 
      A total of 28 adolescents with obesity will be recruited from our local inpatient pediatric
      obesity centers. Before their weight loss intervention the adolescents will complete two
      experimental visits. During the first visit, anthropometric and body composition measurements
      will be performed. Then the participants will be asked to complete a walking exercise on a
      treadmill during the second visit. Their energy expenditure and substrate oxidation will be
      assessed by indirect calorimetry. They will have to walk at 5 different walking speeds. Then,
      they will follow a 12-week weight loss intervention. By the end of this intervention, their
      body composition will be assessed and they will be asked to perform the same walking
      exercise. On a separate occasion (randomly assigned) they will have to repeat this walking
      exercise while carrying a load corresponding of their weight loss.
    

Intervention name(s): Multidisciplinary weight loss
Intervention type(s): Behavioral
Intervention description(s): The adolescents will follow a 12-week intervention combining nutritional education, physical activity 3 times per week and psychological supports.
Intervention model: Single Group Assignment
Intervention model description: One group of adolescents with obesity
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: energy expenditure; weight loss; obesity; adolescents
Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998.
      Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol
      will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions
      discussed above.
    

Detailed description: 
      The primary objectives of this phase II multicenter trial are to:

      Determine the 1 and 2-year survival of patients treated according to protocol. Assess the
      safety and toxicity of this regimen in this patient population.

      The secondary objectives are to:

      Determine the freedom from progression (FFP). Measure the response rate (RR). Obtain
      immunological data from the use of this regimen in vivo (as separate project: Moffitt?).

      The proposed study is a multicenter phase II trial of HD-IL-2 in combination with GM-CSF.
      GM-CSF will be started 7 days before day 1 of HD-IL-2 and will be continued for 4 weeks to
      day 28, encompassing two cycles of HD-IL2. The first 9 patients will be closely monitored for
      unexpected toxicity.
    

Intervention name(s): GM-CSF
Intervention type(s): Drug
Intervention description(s): Concomitant Priming with GM-CSF
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GM-CSF; Interleukin; IL-2; Sargrostim
Study of Inhaled Iloprost in Pediatric Pulmonary Hypertension (PH) After Surgery
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to determine whether inhaled iloprost can be used to prevent and
      treat PH and PHC while in children after operation of CHD
    

Detailed description: 
      Pulmonary hypertension (PH) is a significant contributor to the postoperative morbidity and
      mortality of congenital heart disease. Inhaled iloprost has been approved for the treatment
      of adults with PH, but little is known about the effects in children with PH.

      Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates
      pulmonary vessels without side affecting the systemic circulation. There is no RCTs of
      iloprost have previously been performed in this indication.
    

Intervention name(s): iloprost nebuliser solusion; distilled water
Intervention type(s): Drug; Drug
Intervention description(s): 50 ng/kg/min inhalation for 10 minutes, q2h for 2 days; 2 ml per session
Other intervention name(s): Venatvis; placebo
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioavailability of BIBR 1048 MS Single Doses With or Without Pantoprazole in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule
      formulation using melt extrusion technology was assessed in two separate, single dose, 3-way
      crossover, open design, randomised studies. The 3-way crossover treatments included
      administration of the tartaric acid solution of 50 mg BIBR 1048, the capsule formulation A or
      B and administration of the capsules with coadministration of pantoprazole.
    


Intervention name(s): BIBR 1048 MS capsule formulation A; BIBR 1048 MS capsule formulation B; BIBR 1048 MS powder plus solution; Pantoprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BIBR 1048 MS, formulation A 50 mg; BIBR 1048 MS, formulation B 50 mg; BIBR 1048 MS, powder plus solution 50 mg; Pantoprazole 40 mg
Other intervention name(s): Pantozol®
Intervention MeSH terms: Pantoprazole; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Chlorogenic Acids on the Human Vasculature
Condition: Endothelial Dysfunction
Study type: Interventional

Summary: 
      This study evaluates effects of different doses of chlorogenic acids on vascular health.
    

Detailed description: 
      It has been suggested that consumption of food rich in chlorogenic acids can help to improve
      vascular health, measured by flow mediated dilation.
    

Intervention name(s): Green coffee extract; Placebo
Intervention type(s): Other; Other
Intervention description(s): Reconstituted in water and given to subjects; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Extended Use of Sodium Bicarbonate in Patients With Cancer
Condition: Malignant Neoplasm
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot phase I trial studies the safety of long-term use of sodium bicarbonate in
      patients with cancer. Sodium bicarbonate may neutralize tumor acidity and as a result may
      inhibit the spread of the tumor to other parts of the body (metastases) and improve survival.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine if the dose concentration of 0.5 g/kg/day sodium bicarbonate is feasible and
      well tolerated as measured by the proportion of subjects with first evidence of adherence
      failure.

      SECONDARY OBJECTIVES:

      I. Determine if the dose concentration of 0.5 g/kg/day sodium bicarbonate is safe for long
      term consumption (90 days) as measured by blood pressure, resting pulse rate, and basic
      metabolic panels to assess metabolic alkalosis.

      OUTLINE:

      PHASE I (RUN-IN/ADJUSTMENT): Patients receive sodium bicarbonate orally (PO) dissolved in
      water thrice daily (TID) or twice daily (BID) on days 1-10. The dose may be adjusted as
      necessary.

      PHASE II (LONG TERM): Patients continue to receive sodium bicarbonate PO TID or BID for a
      total of 90 days in the absence of disease progression or unacceptable toxicity.
    

Intervention name(s): Sodium Bicarbonate
Intervention type(s): Drug
Intervention description(s): Given PO
Other intervention name(s): Baking Soda; Bicarbonate of Soda; NaHCO3; Sodium Hydrogen Carbonate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tumor acidity