bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Ethanol on Intestinal Permeability and Integrity
Condition: Healthy
Study type: Interventional

Summary: 
      Alcohol consumption is a major health problem worldwide. It affects all systems of the body
      especially the gastrointestinal tract. Acute or chronic alcohol consumption has deleterious
      effects on the gastrointestinal mucosa vary from increased intestinal permeability,
      structural changes to sever destruction of the epithelial lining cells. Human data are still
      limited and most of the studies were performed in chronic alcohol abusers.

      The investigators hypothesize that moderate alcohol drinking also may increase small
      intestinal permeability and contribute to the subsequent disruption of the tight junction
      complex. This study may provide more insight into the effects of moderate alcohol drinking on
      the small intestinal permeability.
    


Intervention name(s): Gastroduodenoscopy- Intraduodenal intubation
Intervention type(s): Device
Intervention description(s): 20 g ethanol diluted up to 10% in tap water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Keywords: Permeability; tight junctions; cytokines; inflammatory bowel diseases; The effect of alcohol on the intestinal permeability may have major consequences on health.; It's generally accepted that an increased intestinal permeability in alcoholic subjects lead; to translocation of bacterial endotoxins from the gut lumen into the portal vein and then to the liver.; In the liver, endotoxins trigger the immune system and activate the resident macrophages, Kupffer cells.; Activation of Kupffer cells leads to production of chemokines (IL-8) and; proinflammatory cytokines (IL-1, TNFα),resulting in hepatocytes damage, inflammation, fibrosis and finally cirrhosis.
Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To assess the efficacy of Levopront® in comparison with Libexin® based on daytime cough
      resolution rate by Day 8.

      The daytime cough symptoms resolution corresponds to 0 or 1 points on the "Six-point daytime
      and nighttime cough assessment scale".

      Secondary objectives:

      Treatment effect assessment in terms of the following efficacy and safety parameters:

        -  To assess the efficacy of Levopront® in comparison with Libexin® based on nighttime
           cough resolution rate by Day 8.

        -  Daytime and nighttime cough symptoms resolution according to "Six-point daytime and
           nighttime cough assessment scale" by Day 4.

        -  Change in severity and frequency of daytime and nighttime cough according to "Six-point
           daytime and nighttime cough assessment scale" on Day 4 and Day 8 from baseline on Day 1.

        -  Cough intensity change according to the visual-analogue scale on Day 4 and Day 8 from
           baseline on Day 1.

        -  Change of FEV1 on Day 8 from baseline values on Day 1.

        -  Rate of Adverse events (AE) and Serious Adverse Events (SAE) of the various severity
           according to subjective complaints, laboratory test results, physical examination, vital
           signs and spirometry
    

Detailed description: 
      This is a multicenter, open-label, randomized, clinical trial to assess the efficacy and
      safety of Levopront® syrup 30 mg/5 ml in comparison with Libexin® 100 mg tablets in patients
      suffering from dry non-productive cough caused by acute upper respiratory infection
    

Intervention name(s): Levopront® syrup 30 mg/5 ml; Libexin®
Intervention type(s): Drug; Drug
Intervention description(s): The first study drug administration will be performed at the clinical site on the day of randomization; the last study drug administration will be performed in the evening before Day 8 (±1).; The first study drug administration will be performed at the clinical site on the day of randomization; the last study drug administration will be performed in the evening before Day 8 (±1).
Other intervention name(s): levodropropizine; prenoxdiazine
Intervention MeSH terms: Dipropizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Social Participation After Childhood Craniopharyngioma
Condition: Children With a Craniopharyngioma
MeSH terms: Craniopharyngioma; Adamantinoma
Study type: Observational

Summary: 
      Craniopharyngioma is a rare, benign central nervous system tumor, which may be a source of
      multiple complications, from endocrinology to vision, neurology and neurocognitive functions.
      This morbidity can lead to reduced participation in life activities, as described in the
      International Classification of Functioning, Disability, and Health (ICF). The primary
      objective of this study is to measure participation in life activities in a population of
      children affected by childhood craniopharyngioma, using the assessement of life habits
      questionnaire (LIFE-H questionnaire), validated as a social participation measurement tool in
      various pediatric disabilities.
    


Intervention name(s): observational study so no intervention
Intervention type(s): Other
Intervention description(s): observational study, so no intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients hospitalized in the pediatric neurosurgery department of Hospices Civils de Lyon
        between 2007 and 2013
      
Keywords: Craniopharyngioma; Children; Social participation; Life-H questionnaire
A 52 Week Open-label Extension Trial Following the Double-blind Efficacy and Safety Study R076477-SCH-305.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-Label Extension to the double-blind effectiveness and safety study R076477-SCH-305 to
      evaluate long-term safety and tolerability in patients with schizophrenia.
    

Detailed description: 
      The primary objective of the open-label extension trial was the long-term assessment of
      safety and tolerability of flexibly-dosed ER OROS paliperidone (3 to 15 mg/day) in patients
      with a diagnosis of schizophrenia. Other measures assessed in the extension study included:
      change in the total Positive and Negative Syndrome Scale (PANSS) score; change in PANSS
      subscale (positive and negative) scores; overall functioning, as measured by the Clinical
      Global Impression Scale-Severity (CGI-S); personal and social functioning, as measured by the
      Personal and Social Performance Scale (PSP); and quality of life parameters, as measured by
      the Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4). Paliperidone ER OROS® tablet
      formulation (3 to 15 mg/day) to be taken orally for 52 weeks
    

Intervention name(s): Paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paliperidone; schizophrenia
Care of Child's Hygiene From Zero to Two Years Old
Condition: Children Health Under Two Years Old; Health Professionals
Study type: Observational

Summary: 
      This study aimed to identify the perceptions of family caregivers and professionals of the
      Family Health Strategy (FHS) for health care for children from 0 to 2 years, and actions on
      this issue developed by the FHS.
    

Detailed description: 
      This study aimed to identify the perceptions of family caregivers and professionals of the
      Family Health Strategy (FHS) for health care for children from 0 to 2 years, and actions on
      this issue developed by the FHS. Chosen by a descriptive exploratory with a qualitative
      approach, consisting of 19 subjects while they were 9 professionals and 10 family caregivers.
      For data collection was used a semi-tour interview and for the treatment of empirical data,
      the technique of content analysis recommended by Bardin. For presentation and discussion of
      results the categories from the speech made the interviewers grouped as the possibility of
      confrontation between the speaches of the two groups, total of 6 categories: hygienist model:
      focus on personal hygiene, model medicocêntrico x extended care, environmental risk: the care
      with hygiene and socioeconomic conditions, family and life experience influence care with
      hygiene, process work x on caregiver perception of guidance received by the health service,
      link child / caregiver. The perceptions found in the discourse of professionals and
      caregivers showed that the biologically vision and focus on the body prevalent in health
      care, and that such care is still centered in the figure of the doctor because of the
      historical and cultural hegemony curative.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children's caregivers from zero to two years old monitored in a health center health
        professionals of a team of a health center
      
Keywords: Family Health Program; Hygiene; Child Health
HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients
Condition: Infertility, Female; Intrauterine Adhesion
MeSH terms: Infertility; Infertility, Female; Tissue Adhesions
Study type: Interventional

Summary: 
      Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG)
      stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients
      with moderate to severe intrauterine adhesion (IUA).
    


Intervention name(s): human menopausal gonadotrophin; hormone replacement therapy
Intervention type(s): Drug; Drug
Intervention description(s): experimental group:Women will be given HMG 37.5-150IU daily followed by monitoring of the follicular growth (folliculometry) when serum Estradiol (E2)<100pg/ml，progesterone (P)<1ng/ml. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle ≥20mm in diameter followed by luteal phase support (using progesterone supplements) after 24 hours.; Women will be given 17 β-estradiol hemihydrate 2 mg and estrogen gel 5 g daily from day 3 of the cycle then the endometrial thickness will be assessed on day 7 by transvaginal sonography (TVS). If the endometrium is ≥ 9 mm, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 9 mm, estradiol will be continued until reaching appropriate endometrial thickness and then the luteal phase support will be started. The cycle will be cancelled If the estradiol administration >60 days.
Intervention MeSH terms: Menotropins; Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled BVD-523 in Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to characterize the metabolic disposition,
      pharmacokinetics (PK), and routes of elimination of [14C]-labeled BVD-523 after
      administration of a single, oral dose to healthy male subjects.

      The secondary objective of this study is to evaluate the safety and tolerability of a single
      oral dose of [14C]-labeled BVD-523 in healthy male subjects.
    

Detailed description: 
      This study will be an open-label, absorption, metabolism, and excretion study of
      [14C]-BVD-523 administered as a 600-mg (approximately 200 µCi) oral dose to 6 healthy male
      subjects following a 2-hour fast from food (not including water) that follows breakfast.
    

Intervention name(s): [14C]-BVD-523
Intervention type(s): Drug
Intervention description(s): [14C]-BVD-523 administered as a 600-mg (approximately 200 µCi) oral dose to 6 healthy male subjects following a 2-hour fast from food (not including water) that follows breakfast.
Other intervention name(s): Ulixertinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy
Condition: Gynecologic Cancer
Study type: Interventional
Phase: Phase 3

Summary: 
      Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients
      receiving platinum based chemotherapy than oral iron?
    

Detailed description: 
      Anemia is a common condition during chemotherapy administration. Treatment options usually
      include oral iron supplementation and blood transfusion. However, oral iron has
      gastrointestinal side effects, which affects patient compliance, and only a small amount of
      oral iron can be absorbed from the gastrointestinal tract. Intravenous iron may overcome a
      block of iron absorption and iron recycling induced by hepcidin. Therefore, it may increase
      hemoglobin level and reduced blood transfusion in cancer patients receiving chemotherapy.
    

Intervention name(s): Intravenous iron
Intervention type(s): Drug
Intervention description(s): Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy
Other intervention name(s): Venofer
Intervention MeSH terms: Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intravenous iron; gynecologic cancer blood transfusion
Microfinance Institutions as a Platform for Global Health
Condition: Malnutrition; Anemia
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      This study will analyze data from a program run by an microfinance institution (MFI) in Haiti
      from 2011-2012 where the MFI delivered health goods to some of the villages where it
      operates. By comparing health indicators among children who were in villages targeted by the
      program initially to children who were in villages that were not targeted by the program
      until later, the investigators hope to understand if the MFI successfully delivered the
      intervention and offer a practical platform for delivery of basic health goods.
    

Detailed description: 
      Two-thirds of child deaths could be prevented with increased coverage of existing health
      products and services; however, effectively delivering health products and services to rural
      populations in low-income countries remains a practical challenge. This study investigates
      whether microfinance institutions (MFIs), having invested in community-based infrastructure
      to deliver financial services to 200 million rural poor households globally, offer a
      practical platform for delivery of basic health goods.

      The investigators intend to analyze data from a pilot program implemented by an MFI in Haiti
      during 2011-2012 that distributed an evidence-based health good, micronutrient powders
      (MNPs), to 526 children in 34 villages where the MFI operates. Micronutrient deficiency is
      estimated to be responsible for over 1 million deaths of children under five per year. MNPs
      are one form of micronutrient supplementation proven to effectively combat micronutrient
      deficiency.

      Published cost estimates indicate that leveraging existing supply chains could cut the total
      cost of mass MNP delivery by 25%. Given MFIs reach 200 million households globally, MFI-based
      delivery of health goods may be a promising route to improving health outcomes efficiently.
    

Intervention name(s): MNP
Intervention type(s): Dietary Supplement
Intervention description(s): Program that delivered MNP and implemented by an MFI in Haiti during 2011-2012.
One form of micronutrient supplementation proven to effectively combat micronutrient deficiency.
Other intervention name(s): Micronutrient powders; Sprinkles
Intervention MeSH terms: Micronutrients
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 6-54 months who lived in a household where the head of household was an
        microfinance client.
      
Keywords: microfinance institution; MFI
Coffee Roasting and Glucose Tolerance
Condition: Oral Glucose Tolerance
Study type: Interventional

Summary: 
      Chlorogenic acid (CGA) in coffee may lower the postprandial glucose response. CGA is
      destroyed by dark roasting. In a controlled crossover trial, 11 healthy fasted volunteers
      consumed 300 mL of either light (LIR) or dark (DAR) roasted coffee, or water, followed 30 min
      later by a 75-g oral glucose tolerance test (OGTT). Plasma glukose and insulin, appetite, and
      plasma and urine metabolic profiles will be analysed. The primary aim is to investigate
      whether roasting affects the postprandial glucose area under the curve (AUC).
    

Detailed description: 
      Epidemiologic evidence suggests that coffee consumption is associated with a lower risk of
      type 2 diabetes. Coffee contains caffeine and several other components that may modulate
      glucose regulation. The chlorogenic acids (CGA) in coffee have been indicated as constituents
      that may help to normalize the acute glucose response after a carbohydrate challenge. The aim
      of this study was to investigate whether two coffee beverages that differ in CGA content due
      to different roasting degrees will affect glucose regulation differently.

      In a controlled crossover trial, 11 healthy fasted volunteers consumed 300 mL of either light
      roasted (LIR) or dark roasted (DAR) coffee, or water, followed 30 min later by a 75-g oral
      glucose tolerance test (OGTT). Blood samples were drawn at baseline, 30, 60 and 120 min.
      Differences in glucose and insulin responses and insulin sensitivity index (ISI) were
      analyzed. The CGA and caffeine contents in the coffees were analyzed using UPLC-MS/MS.
    

Intervention name(s): DAR; LIR; CTR
Intervention type(s): Other; Other; Other
Intervention description(s): Volunteers ingested 300 mL of coffee with a dark roast containing low levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water; Volunteers ingested 300 mL of coffee with a light roast containing high levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water; Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
Other intervention name(s): 300 mL of coffee with a dark roast + OGTT; 300 mL of coffee with a light roast + OGTT; 300 mL of water + OGTT
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coffee; Chlorogenic acid; Insulin; Appetite; Metabolomics
Paracetamol for Catheter Related Bladder Discomfort
Condition: Catheter Related Bladder Discomfort
Study type: Interventional
Phase: Phase 4

Summary: 
      The insertion of an urinary catheter in a patient undergoing a surgical procedure, especially
      in urinary interventions, may lead to catheter-related bladder discomfort with varying
      degrees of severity during the postoperative period. Catheter-related bladder discomfort
      (CRBD) symptoms associated with indwelling urinary catheter are similar to overactive bladder
      symptoms such as discomfort in the suprapubic region, urinary urgency, frequency, burning
      sensation with or without urge incontinence. Paracetamol is a drug with proven efficiency for
      the management of mild and moderate postoperative pain. In this study, the investigators
      hypothesized to address the effect of single-dose intravenous paracetamol on postoperative
      CRBD following percutaneous nephrolithotomy surgery (PNL).
    


Intervention name(s): intravenous paracetamol; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): 30.11.2005-118/79
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intravenous paracetamol; catheter related bladder discomfort; urologic surgery
A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma
Condition: Allergic Bronchopulmonary Aspergilloses
MeSH terms: Aspergillosis; Pulmonary Aspergillosis; Aspergillosis, Allergic Bronchopulmonary
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Allergic bronchopulmonary aspergillosis (ABPA) is a immunological pulmonary disorder caused
      by hypersensitive reaction to spores of Aspergillus fumigatus. The prevalence of disease is
      about 1-2% in asthmatics and 2-15% in patients with cystic fibrosis. The interest in ABPA
      stems from the fact that the disease is glucocorticoid-sensitive and early treatment can
      prevent progression to end-stage lung disease. Recently anti-Th2 therapies have been
      suggested as treatment for ABPA. Vitamin D has been shown to suppress the Th2 responses and
      decrease the levels of Th2 interleukins. Hence, the investigators propose to assess the role
      of vitamin D in treating ABPA.
    

Detailed description: 
      Allergic bronchopulmonary aspergillosis (ABPA) is a immunological pulmonary disorder caused
      by hypersensitive reaction to spores of Aspergillus fumigatus. The prevalence of disease is
      about 1-2% in asthmatics and 2-15% in patients with cystic fibrosis. The interest in ABPA
      stems from the fact that the disease is glucocorticoid-sensitive and early treatment can
      prevent progression to end-stage lung disease.

      Systemic steroids remain the mainstay of treatment in ABPA. Antifungal agents are also useful
      as they reduce fungal load. Newer therapies like omalizumab (anti immunoglobulin E [IgE]
      antibody), inhalational amphotericin and Anti Th2 therapies are being studied.

      In pathogenesis of ABPA, there is heightened Th2 activity as a result of type 1
      hypersensitive reaction to Aspergillus fumigatus and levels of Th2 cytokines like IL-3, IL-5
      and IL-13 and IgE levels are increased in patients with ABPA compared with asthma patients
      without ABPA.

      Recently anti Th2 therapies have been suggested as treatment for ABPA. Vitamin D has been
      shown to suppress the Th2 immunity and decrease the levels of Th2 interleukins. Hence, the
      investigators propose to assess the role of vitamin D in treatment of ABPA.
    

Intervention name(s): Glucocorticoids; Vitamin D
Intervention type(s): Drug; Drug
Intervention description(s): Oral prednisolone for four months; Oral vitamin D for two months
Intervention MeSH terms: Vitamin D; Glucocorticoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment