bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a second generation
      EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes.

      This is a randomized, controlled study which will enroll approximately 70 Subjects with Type
      2 Diabetes. Randomization will be one to one with approximately 35 EndoBarrier device
      Subjects and approximately 35 study diet Subjects. Subjects randomized as diet Subjects will
      be offered the EndoBarrier device after 12 months on study at the investigator's discretion
      if treatment of the device subjects indicates adequate efficacy. This study will be conducted
      at three (3) investigational sites.

      The primary efficacy endpoint is:

        -  Assessment of the percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24
           weeks or last visit from baseline between the two groups.

      Secondary endpoints are:

        -  Percent (%) of Subjects who achieve a HbA1C of 7.0% or lower at week 24 or last visit
           from baseline.

        -  Percent (%) of Subjects who have their diabetic medication(s) dosage decreased or
           discontinued at week 24 or last visit from baseline.

        -  Percent (%) of Subjects who achieve a decrease in post-prandial excursions as evidenced
           by challenge to a standardized meal tolerance test (MTT) at week 24 or last visit from
           baseline.

        -  Assessment of absolute weight loss (Kg) at week 24 or last visit from baseline.

        -  Percent (%) of Subjects who maintain a HbA1c lower than their baseline assessment at 12
           months.

        -  Compare physical component summary (PCS), mental component summary (MCS) and quality
           adjusted life years (QALYs)via analysis of the SF-36v2 QOL.
    

Detailed description: 
      Utilization of the EndoBarrier Gastrointestinal Liner in obese subjects with T2DM
      demonstrated an acceptable safety profile with clinically significant improvements in
      glycemic control and body weight when compared to a similar diet controlled group of
      subjects.
    

Intervention name(s): EndoBarrier; Diet + Lifestyle Counseling
Intervention type(s): Device; Behavioral
Intervention description(s): EndoBarrier implant; Multidisciplinary lifestyle and nutritional counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type II Diabetes; Obesity
Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori
Condition: H Pylori Eradication
Study type: Interventional
Phase: Phase 4

Summary: 
      New drug regimen for Helicobacter pylori eradication, the investigators compare once daily
      dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose
      dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.
    

Detailed description: 
      Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication
      of Helicobacter pylori infection.
    

Intervention name(s): Dexlansoprazole 60 mg once daily
Intervention type(s): Drug
Intervention description(s): Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm
Other intervention name(s): dexilant
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Home-based Leg Heat Therapy
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the benefits of participating for 8 weeks in a
      home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as
      assessed by vascular function, walking tolerance and quality of life.
    

Detailed description: 
      Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance
      vascular function of the leg in old individuals. The objective of this randomized, controlled
      study is to evaluate the benefits of participating for 8 weeks in a home-based daily
      treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by
      vascular function, walking tolerance and quality of life. The central hypothesis of this
      study, based on preliminary data, is that exposure to HT will enhance the oxygenation of calf
      muscles during exercise and as a result, the onset of pain will be delayed and walking
      performance will be enhanced. The duration (8 weeks) was chosen based on the recent report of
      Brunt and co-workers that the improvement in endothelial function promoted by repeat HT in
      sedentary individuals peaks at 8 weeks following the onset of treatment. Heat Therapy will be
      applied daily for 90 minutes using water-circulating 'pants' connected to a water pump.
      Outcomes will be assessed at the halfway point (end of week 4), at the completion of the
      intervention (end of week 8) and 4 weeks after the end of the intervention (week 12).
    

Intervention name(s): Control/Sham Treatment; Heat Therapy
Intervention type(s): Device; Device
Intervention description(s): Thermoneutral water will be circulated through water-circulating trousers to maintain skin temperature at baselines levels daily for 90 minutes for 8 weeks.; Water at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomized (blocked and stratified by sex) using assignments generated from PROC PLAN in SAS Version 9.4 by the study statistician into one of two groups: those receiving leg heat therapy or those receiving the sham treatment.
Masking: Single (Participant)
Primary purpose: Treatment
Isoflurane at Subanesthetic Concentrations - 6
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to conduct experiments to examine subjective and reinforcing
      effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug
      abusers and preference procedures will be used to assess reinforcing effects. To test the
      hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water
      immersion pain in healthy volunteers.
    


Intervention name(s): 40% Nitrous oxide; Sham comparator; 0.2% isoflurane; 0.4% isoflurane; 0.6% isoflurane
Intervention type(s): Drug; Other; Drug; Drug; Drug
Intervention description(s): Used as pain assay positive control; 0% isoflurane in oxygen
Intervention MeSH terms: Nitrous Oxide; Isoflurane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: isoflurane; general anesthetic; inhalant; subjective effects; healthy volunteer
Schistosoma Haematobium Infections and Praziquantel
Condition: Schistosomiasis
MeSH terms: Schistosomiasis; Schistosomiasis haematobia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the impact of praziquantel for the treatment of
      Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan.
    

Detailed description: 
      A longitudinal study will be conducted to evaluate the impact of praziquantel for the
      treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in
      Central Sudan. A cohort of schoolchildren (6-15 years of age) was investigated before and 1
      year after treatment with a single dose of praziquantel 40mg/kg.
    

Intervention name(s): praziquantel
Intervention type(s): Drug
Intervention description(s): praziquantel 40 mg/kg oral tablets
Intervention MeSH terms: Praziquantel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schistosoma haematobium; schoolchildren; Central Sudan; Praziquantel
Myeloid Suppressors in Inflammation
Condition: Asthma
MeSH terms: Inflammation
Study type: Observational

Summary: 
      Myeloid-derived suppressor cells (MDSC) have been studied for their ability to suppress T
      cell responses in vivo and in vitro. As a result, MDSC can regulate cellular responses to
      chronic inflammatory conditions such as cancer, leading to the induction of tolerance and,
      ultimately, tumor escape from immune surveillance.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Ages eligible for study: 18 to 60 years Genders eligible for study: male and female Signed
        and dated written informed consent is obtained prior to study blood draw.

        Subjects being actively treated for chronic moderate to severe asthma based on National
        Heart Lung and Blood Institute guidelines (figure 1). Subjects must carry the diagnosis of
        asthma (made by a physician) for a minimum of six months.

        Subjects within the first seven days of an acute asthma exacerbation, as determined by the
        referring physician.Able to give informed consent.
      
Keywords: asthma
Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA)
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Interventional
Phase: Phase 2

Summary: 
      This proof-of-concept study is designed as a randomized, double-blind, placebo-controlled
      study comparing ubenimex at 150 mg, 3 times daily (total daily dose of 450 mg) with placebo
      for 6 months treatment period in patients with leg lymphedema.
    

Detailed description: 
      Leukotriene B4 (LTB4) inhibits lymphangiogenesis in the mouse tail model of lymphedema and is
      elevated in tissue in patients with lymphedema. Ubenimex is an inhibitor of leukotriene A4
      hydrolase (LTA4H), the biosynthetic enzyme for LTB4. This proof-of-concept study is designed
      as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150 mg, 3 times
      daily (total daily dose of 450 mg) with placebo for 6 months treatment period in patients
      with leg lymphedema. The primary objectives for the study are:

        -  To evaluate the efficacy of ubenimex in patients with leg lymphedema

        -  To evaluate the safety and tolerability of ubenimex in patients with leg lymphedema
    

Intervention name(s): ubenimex; placebo
Intervention type(s): Drug; Other
Other intervention name(s): UBX
Intervention MeSH terms: Ubenimex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Parental Behavior on Child Anxiety Regulation
Condition: Separation Anxiety Disorder; Social Phobia; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social; Anxiety, Separation
Study type: Interventional
Phase: Phase 2

Summary: 
      Does parenting style affect emotion regulation among children who initially demonstrate high
      levels of fear and anxiety? Although recent correlational research has demonstrated a linkage
      between parental behaviors, such as excessive intrusiveness, and children's manifestations of
      fear and anxiety, it is not clear if parenting behaviors directly influence children's
      ability to regulate these emotions. Alternatively, these parental behaviors may be elicited
      by children who express fears and anxieties more frequently than other children do.
      Experimental research designs would offer a more definitive test of these competing
      explanations of the extant correlational findings. Intervention studies, in particular, can
      test whether experimentally manipulating current family interaction patterns affects
      children's ability to regulate emotion. This study provides a preliminary experimental test
      of the relationship between parental behavior and children's regulation of fear and anxiety.
      Some 40 clinically anxious youth, aged 6-13, were randomly assigned to a family intervention
      program for childhood anxiety problems, which includes extensive parent communication
      training, or a child intervention program without parent-training. By comparing these two
      interventions, we tested if it was possible to improve parenting behaviors-such as
      intrusiveness-through intensive parent-training, above and beyond the effects of involving
      children in a child intervention program. We then tested the impact of this change in
      parental behaviors on children's ability to regulate fear and anxiety. We hypothesized that
      parent-training would reduce intrusiveness, which would in turn improve children's anxiety
      outcomes.
    


Intervention name(s): Family cognitive behavioral therapy; Child-focused cognitive behavioral therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-16 weekly sessions of family cognitive behavioral therapy, 60-80 minutes each; 12-16 weekly sessions of child-focused cognitive behavioral therapy, 60-80 minutes each
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children
Condition: Meningococcal Disease; Meningitis
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is part of the post-licensure commitment to evaluate the safety and immunogenicity
      of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age.

      Primary Objective:

      To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30
      days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide
      Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C)
      Polysaccharide Vaccine.

      Secondary Objective:

        -  To describe the immunogenicity for serogroups A and C, 30 days after administration of
           the study vaccines given as a single dose.

        -  To describe the full reactogenicity profile after administration of the study vaccines
           given as a single dose.
    

Detailed description: 
      Eligible participants will receive one injection of either Sanofi Pasteur Meningococcal
      (Groups A and C) Polysaccharide Vaccine or Lanzhou Institute for Biological Products
      Meningococcal (Groups A and C) Polysaccharide Vaccine and will be monitored for safety and
      immunogenicity for up to 30 days post-vaccination.
    

Intervention name(s): Meningococcal (Groups A and C) Polysaccharide Vaccine; Meningococcal (Groups A and C) Polysaccharide Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Other intervention name(s): Meningo A+C®; Meng Ling Kang®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningitis; Neisseria meningitidis; Meningo A+C®; Meng Ling Kang®
Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      Utilization of nitric oxide (NO) therapy has been related to a trend towards short term
      improvement in very premature infants. A two year follow-up of children treated soon after
      birth with NO in the neonatal period, suggests that a significant improvement in
      neurodevelopmental outcome might occur. This study aims to evaluate follow-up at 6 years, in
      respiratory and neurodevelopmental outcome, of children born very prematurely, some of them
      having been treated with nitric oxide in the neonatal period.
    

Detailed description: 
      Utilization of nitric oxide therapy in the neonatal period has been related to a trend
      towards short term improvements in respiratory and neurological outcome at 28 days postnatal
      age or 36 weeks postconceptional age. A two year follow-up in children treated soon after
      birth with NO in the neonatal period, suggests that a significant improvement in
      neurodevelopmental outcome might occur. No long term evaluation on respiratory outcome has
      yet been done. This study aims to evaluate respiratory and neurodevelopmental outcome at 6
      years of age in children born very prematurely, some of them having had Nitric Oxide as a
      rescue treatment for respiratory distress syndrome.
    

Intervention name(s): Nitric Oxide
Intervention type(s): Drug
Intervention description(s): Early low dose (5ppm) NO inhalation Placebo
Other intervention name(s): Reference group (non hypoxemic infants)
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a follow-up study, at 6 years of age, of infants randomized in the neonatal period with one other group studied as a reference group (ie 3 groups)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Follow-up; Premature infants; Nitric Oxide; Respiratory function testing; Neurodevelopmental outcomes
A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions
Condition: Acquired Cold Urticaria
MeSH terms: Urticaria
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare cold urticaria lesions by thermography, volumetry and
      digital time lapse photography in ACU patients treated with placebo, 5 mg and 20 mg
      desloratadine. Hypothesis: The updosing of desloratadine (20 mg)is more effective in the
      treatment of ACU symptoms as compared to standard doses (5 mg desloratadine) and placebo.
    


Intervention name(s): desloratadine; desloratadine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose for 7 days, oral, 20mg; single dose for 7 days, oral, 5 mg; single dose for 7 days, oral
Intervention MeSH terms: Loratadine; Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: urticaria; cold urticaria; acquired cold urticaria
Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining chemotherapy with radiation therapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in
      treating patients who have stomach cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the feasibility of preoperative chemoradiotherapy in patients with potentially
           resectable adenocarcinoma of the stomach.

        -  Determine the pathologic response rate, curative resection rate, and survival in
           patients treated with this regimen.

        -  Determine the tolerability of this regimen in these patients.

      OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1-21, cisplatin IV over 1
      hour on days 1-5, and leucovorin calcium IV over 15 minutes on days 1, 8, 15, and 22. A
      second course is administered beginning on day 29.

      Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest
      (day 57). Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with
      radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on
      days 1, 8, 15, 22, and 29.

      Approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic
      disease undergo surgical resection.

      Patients are followed every 3 months for 1 year, every 6 months for 5 years, then annually
      thereafter.

      PROJECTED ACCRUAL: A total of 21-49 patients will be accrued for this study within 2.5 years.
    

Intervention name(s): cisplatin; fluorouracil; leucovorin calcium; paclitaxel; conventional surgery; neoadjuvant therapy; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Leucovorin; Paclitaxel; Fluorouracil; Calcium; Levoleucovorin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I gastric cancer; stage II gastric cancer; stage III gastric cancer; stage IV gastric cancer; adenocarcinoma of the stomach
Body Compartment Pharmacokinetics of Anti- Retroviral Agents That May be Used for Future HIV Post- Exposure Prophylaxis.
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to determine if the uptake of anti-HIV medications called
      Genvoya® and darunavir is different at several body sites, including mucosal tissues.
    

Detailed description: 
      Men who have sex with men (MSM) continue to be disproportionately affected by HIV. The
      majority of MSM acquire HIV after exposure to the rectal mucosa through unprotected receptive
      anal intercourse. Post-exposure-prophylaxis (PEP) is an intervention that is used to prevent
      HIV infection soon (72 hours) after a potential exposure. HIV-negative people with a possible
      exposure to HIV are instructed to take 28 days of a combination anti-HIV medication regimen,
      Truvada® + Raltegravir. This study is being conducted to determine if the uptake of other
      anti-HIV medications called Genvoya® and darunavir is different at several body sites,
      including mucosal tissues. These other medications might be considered for PEP regimens in
      the future.
    

Intervention name(s): Single dose of Genvoya® and a single 800 mg dose of Darunavir®
Intervention type(s): Drug
Intervention description(s): Men will be instructed to take Single dose of Genvoya® and a single 800 mg dose of Darunavir® per oral
Intervention MeSH terms: Darunavir; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Post-Exposure Prophylaxis; Anti-Retroviral; Pharmacokinetics