bioihbjkbjnl/mcl2 huggingface dataset:
HIV Accelerated Liver Disease in Uganda
Condition: Fibrosis
MeSH terms: Liver Diseases; Fibrosis
Study type: Observational

Summary: 
      Background:

      - Liver disease is a leading cause of death in people who have the human immunodeficiency
      virus (HIV). It especially affects those who have both HIV and hepatitis B or C viruses. Most
      research on HIV-related liver disease has been conducted in North America and Europe.
      However, HIV-related liver disease in Uganda and other African nations may involve other
      diseases that are not common in the West, and may not involve hepatitis B or C. Researchers
      want to study HIV-related liver disease in Uganda to learn more about the differences between
      Western and African trends of this disease.

      Objectives:

      - To study HIV-related liver disease in rural Uganda.

      Eligibility:

        -  Individuals at least 18 years of age who were tested for possible liver disease. Some
           participants will have HIV infection; others will be uninfected.

        -  All participants will be from rural areas of Uganda.

      Design:

        -  Participants will have at least two study visits.

        -  Participants will have a physical exam and medical history. They will complete a
           questionnaire about health and quality of life. Blood, urine, and stool samples will be
           collected. Participants will also have a liver scan to check for liver scarring, and an
           ultrasound to take images of the liver.

        -  Participants who may have liver disease will visit a local hospital for more tests. A
           liver biopsy will be performed to collect liver tissue samples.
    

Detailed description: 
      With improved survival following the introduction of highly active antiretroviral therapy
      (HAART), liver disease has become a leading cause of death among HIV-infected persons in
      Western cohorts, primarily affecting those co-infected with hepatitis B or C viruses (HBV,
      HCV). However, data are sparse on liver disease in HIV-infected populations from Uganda and
      other African nations, where the etiologies of liver disease are broader and include
      aflatoxin, schistosomiasis and other infectious and environmental agents. Our previous
      noninvasive study in rural, Rakai, Uganda indicates that the prevalence of significant liver
      fibrosis is high among HIV-infected individuals (17%) and is 50% higher than in
      HIV-uninfected persons, although the prevalence of viral hepatitis B co-infection is low
      (5%). The study presented here is a biopsy-based study that follows up on these results with
      the objectives of defining the etiology of liver disease and describing the mechanisms of
      HIV-accelerated liver fibrosis in this setting.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Keywords: Fibrosis; Cirrhosis; Africa; Schistosomiasis; Aflatoxin; Liver Disease
Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
Condition: Diarrhoea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      Diosmectite in IQP-MM-101 has been used for diarrhoea control. Backed by data from several
      studies demonstrating their efficacy, the investigators are conducting this study to look
      into the efficacy and safety of IQP-MM-101 in diarrhoea control.
    

Detailed description: 
      The clinical study was intended to evaluate the safety and the potential reduction of
      diarrhoea recovery time post 1st intake of IQP-MM-101 in an open label, single arm,
      multicentre study over a 72 hours period. There were 2 clinic visits: the screening visit and
      final visit.

      At baseline visit (visit 1), written informed consents were collected. Each patients were
      given a diary and the following data were collected: demographics, vital signs, physical
      examination results, use of concomitant medication, previous medical history, and case
      history of the acute diarrhoea episode including date of first watery stool, number of stools
      over the past 24 hours, and presence of other associated symptoms over the past 24 hours
      (nausea, vomiting, abdominal pain).

      Subjects recorded the following data in the diary: date and hour of bowel movement, stool
      consistency (Bristol stool scale) presence of symptoms such as nausea, vomiting, abdominal
      pain and study IP consumption (number, date, and time of tablets taken) and time of vomiting
      (if any) each day during the treatment period. Additionally, subjects recorded the time
      absent from work and a subjective evaluation of their "energy for everyday life".

      Visit 2 took place after 72 hours treatment period. Following data was collected:

        -  Vital signs, physical examination

        -  Adverse events

        -  Use of concomitant medication

        -  Compliance (returned IP and diary)

        -  Global evaluation of efficacy and safety by subjects and investigators

      During the 72-hour treatment period, all subjects were instructed to consumed IQP-MM-101
      according to the following dosage: one (1) tablet, three (3) times a day dissolved in at
      least 125mL (half a glass) of water.
    

Intervention name(s): IQP-MM-101
Intervention type(s): Device
Intervention description(s): Dissolve the effervescent tablets in half a glass of water, to be taken orally
1 tablet, 3 times a day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Vitamin D Supplementation on Fasting Glucose and Interleukin-10 (IL-10) in Arab Women With Impaired Fasting Glucose
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Obesity, and its metabolic consequences - impaired fasting glucose (IFG) and diabetes, is
      highly prevalent among Arab women in Israel and the Middle East. Since life style
      modification is difficult to achieve in this population it is important to assess whether
      other modifiable risk factors can be detected. There is evidence that the homeostasis of
      vitamin D has a significant role in the eventual development of diabetes. Previous cross
      sectional studies have shown that low 25 (OH) vitamin D levels are related to glucose
      intolerance, diabetes, insulin resistance and metabolic syndrome. The study hypothesis is
      that 25(OH) vitamin D deficiency is highly prevalent among Arab women with IFG and that
      vitamin D supplementation may improve IFG and by that reduce the risk for future overt
      diabetes. Additionally, obesity is associated with a low-grade inflammation of white adipose
      tissue (WAT) resulting from chronic activation of the innate immune system. In obesity, there
      is an increased production and secretion of a wide range of inflammatory molecules including
      interleukin-10 (IL-10), which may have systemic effects on WAT and other organs. To that end
      the investigators will assess the influence of vitamin D supplementation on IL-10 and hs-CRP.
    

Detailed description: 
      Eligible women will be invited by their primary care physician to participate in the study.
      After signing an informed consent women will be randomized to receive oral vitamin D 100,000
      IU or similar placebo once a month for three consecutive months. Pertinent clinical and
      demographic date will be documented and relevant laboratory test will be performed by the
      primary care team. One month after the third dose the same data and tests will be retrieved
      on each woman. Compliance with the study protocol will be enhanced and confirmed by a
      research assistant.

      Objectives:

      To assess the relationship between IFG and 25(OH) vitamin D levels in overweight Arab women.

      To assess whether vitamin D supplementation significantly improves IFG. To assess whether
      vitamin D supplementation significantly modifies IL-10 and hs-CRP.
    

Intervention name(s): Oral vitamin D 100,000 IU; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral vitamin D 100,000 IU once a month for three consecutive months.; similar placebo once a month for three consecutive months
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fasting glucose; obesity; arab women; interleukin; diabetes; impaired fasting glucose (IFG)
Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase
      and improves second phase insulin response in subjects with diabetes mellitus type 2.
    


Intervention name(s): Lixisenatide (AVE0010); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for subcutaneous injection 100 µg/mL; Subcutaneous injection
Intervention MeSH terms: Lixisenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insulin release; Diabetes mellitus type 2; GLP-1 agonist
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if combination therapy with Pegylated Interferon
      Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or
      BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC)
      compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48
      weeks.
    

Detailed description: 
      Study Classification: Pharmacokinetics/ Pharmacodynamics
    

Intervention name(s): Pegylated Interferon Lambda (pegIFNλ); BMS-790052 (NS5A Inhibitor); Ribavirin (RBV); BMS-650032 (NS3 Protease Inhibitor); Pegylated Interferon Alfa-2a (pegIFNα-2a); Pegylated Interferon Lambda (pegIFNλ); Ribavirin (RBV); Pegylated Interferon Lambda (pegIFNλ); Ribavirin (RBV); BMS-790052 (NS5A Inhibitor); BMS-650032 (NS3 Protease Inhibitor); Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor); Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor); Placebo for Ribavirin (RBV); Placebo for Ribavirin (RBV)
Intervention type(s): Biological; Drug; Drug; Drug; Biological; Biological; Drug; Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response; Tablets, Oral, 60 mg, Once daily, 24 weeks; Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks; Tablets, Oral, 200 mg, Twice daily, 24 weeks; Solution, Subcutaneous, 180 μg/mL, Once weekly, 48 weeks; Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks; Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks; Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks; Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks; Tablets, Oral, 60 mg, Once daily, 16 weeks; Tablets, Oral, 200 mg, Twice daily, 16 weeks; Tablets, Oral, 0 mg, Twice daily, 24 weeks; Tablets, Oral, 0 mg, Once daily, 24 weeks; Tablets, Oral, 0 mg, Twice daily, 24 weeks; Tablets, Oral, 0 mg, Twice daily, 16 weeks
Other intervention name(s): BMS-914143; BMS-790052; Ribasphere; BMS-650032; Pegasys®; BMS-914143; Ribasphere; BMS-914143; Ribasphere; BMS-790052; BMS-650032; Placebo for BMS-650032; Placebo for BMS-790052; Placebo for Ribasphere; Placebo for Ribasphere
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; HIV Protease Inhibitors; Protease Inhibitors; Asunaprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults.
Condition: Shigellosis
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of
      5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB
      vaccine) administered by intramuscular route in healthy adults (18 to 45 years of age at
      enrollment). The safety profile of the 1790GAHB vaccine is evaluated in comparison to that of
      placebo (GAHB-Placebo), constituted by an aluminum hydroxide suspension having the same
      concentration as study vaccine formulations. A total of 50 eligible subjects will be assigned
      to one of five sequential cohorts of 10 subjects each.

      Within each cohort, in an observer-blind fashion, subjects will be randomized to receive
      three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen
      concentrations) or GAHB placebo. A Data Safety Monitoring Board will be in place to receive a
      summary of all safety data obtained during one week follow-up post-first vaccination with the
      lower dose. Based on evaluation of the safety data, the Data Safety Monitoring Board will
      make a recommendation, as to whether the next cohort should be vaccinated with higher antigen
      concentration or not.

      Expected duration of the study for an individual subject is 9 months. Each subject will be
      followed-up for 6 months after the 3rd vaccination.
    


Intervention name(s): S. sonnei 1790GAHB; Placebo
Intervention type(s): Biological; Biological
Other intervention name(s): Shigella sonnei vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; Shigella sonnei
Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical study will evaluate the safety and tolerability of combination treatment of
      nintedanib and pirfenidone in participants with IPF. Eligible participants must have received
      pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the
      study as a combination treatment for IPF for 24 weeks.
    


Intervention name(s): Nintedanib; Pirfenidone
Intervention type(s): Drug; Drug
Intervention description(s): Participants with IPF will receive nintedanib at the 200-300 mg/day dose up to 24 weeks.; Participants with IPF will receive pirfenidone at 1602-2403 mg/day dose up to 24 weeks.
Other intervention name(s): Ofev; Esbriet
Intervention MeSH terms: Pirfenidone; Nintedanib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of Amitriptyline on Learning in a Visual Discrimination Task
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether 75 mg amitriptyline affect the sleep
      dependent consolidation of procedural memory (visual discrimination task,
      Karni-Sagi-paradigm).
    

Detailed description: 
      Rapid eye movement (REM) sleep is considered critical to the consolidation of procedural
      memory - the memory of skills and habits. Many antidepressants strongly suppress REM sleep,
      however, and procedural memory consolidation has been shown to be impaired in depressed
      patients on antidepressant therapy. As a result, it is important to determine whether
      antidepressive therapy can lead to amnestic impairment. We thus investigate the effects of
      the anticholinergic antidepressant amitriptyline on sleep-dependent memory consolidation in
      32 healthy men in a double-blind, placebo-controlled, randomized parallel-group study.
    

Intervention name(s): Amitriptyline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): amitriptyline 25 mg at 9:30 pm, day 10, and 50 mg at 1:30 am, day 11; placebo(white 8 mm Lichtenstein®) at 9:30 pm, day 10, and at 1:30 am, day 11
Other intervention name(s): Saroten
Intervention MeSH terms: Amitriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: amitriptyline; sleep dependent memory consolidation
Electrophysiologic Measures of Treatment Response in Alzheimer Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to determine the electrophysiological effects of
      cholinergic therapy (cholinesterase inhibitors and transdermal nicotine) in Alzheimer
      disease. The attempt will be to locate electrophysiological markers and predictors of
      cognitive and clinical treatment response.
    


Intervention name(s): Aricept; Exelon; Nicoderm Patch
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Donepezil
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis
Condition: Length of Hospital Stay
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      Background: Bronchiolitis is one of the most common and costly respiratory diseases in
      infants and young children. Despite the high prevalence and morbidity of bronchiolitis,
      therapy remains controversial. Supportive care ensuring adequate hydration and oxygenation
      remains the cornerstone of therapy for these infants.

      Over the past 2 decades, research on bronchiolitis management has explored the use of
      nebulized hypertonic saline that rehydrate the airway surface liquid and improve mucociliary
      clearance, as well as reduce airway edema.

      Aim:The aim of this study is to investigate whether the addition of frequently nebulized
      hypertonic saline to standard therapy affects the length of stay (LOS) of moderately ill
      infants hospitalized with bronchiolitis.
    

Detailed description: 
      The investigators will conduct this prospective double blind randomized clinical trial by
      comparing between 2 groups of patients with bronchiolitis, first group will receive 3%
      hypertonic saline and second group will receive 0.9% saline.

      Data collection includes:

      Name, Age, Mode of delivery, Birth weight, Current weight, Number of sibling, Immunization
      record, Duration of breast feeding, past medical history including number of wheezy chest,
      pneumonia, Parents level of education, Presence of Asthma / Allergic rhinitis in family, Pets
      /Smoke at home)

      Using the validated Respiratory Distress Assessment Instrument (RDAI) investigators will
      assign patients a score before and at the end of treatment.

      To prepare 3% sodium chloride, the investigators will dilute 60 ml 20% sodium chloride
      injection with 500 ml normal saline (NSS) 0.9%.

      Length of stay will be measured in both groups, to establish the efficacy of hypertonic
      saline in reducing length of stay.
    

Intervention name(s): Normal saline; Hypertonic saline
Intervention type(s): Other; Other
Intervention description(s): The normal saline will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.; The mixture (500 ml Sodium Chloride 0.9% with 60 ml Sodium chloride 20%) will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Segment IV Hypertrophy After Liver Venous Deprivation
Condition: Major Hepatectomy
MeSH terms: Hypertrophy
Study type: Observational

Summary: 
      before major hepatectomy, in case of insufisant future liver remanent volume or function,
      portal embolization is a routinely used method to enable growth of the future liver remnant.
      Recently liver venous deprivation has been described in some pioneer centre. The results are
      processing with greater and faster hypertrophy allowing probably less drop out from the
      embolization to surgery compared to portal embolization.

      In major hepatectomy, and specially in right or extended right hepatectomy the segment IV
      plays an important role in the proportion of future liver remnant.

      Despite the growing interest in the scientific community for liver venous deprivation many
      aspects concerning the liver hypertrophy remains unexplored. In particular the the degree of
      hypertrophy of segment IV after liver venous deprivation compared to portal embolization.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with liver tumors selected for surgery with insufficient futur liver remnant