bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
Condition: Non-alcoholic Fatty-liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Primary Objectives:

        1. To determine whether a 4 week reduction in dietary fructose intake improves hepatic
           steatosis in overweight children who have a baseline high fructose consumption and
           hepatic steatosis.

        2. To determine if a 4 week reduction of dietary fructose improves fasting plasma
           triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as
           well as post-prandial levels in response to a high fructose meal.

        3. To determine if a 4 week reduction of dietary fructose improves markers of oxidative
           stress.

      Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose
      beverages administered over 4 weeks.
    

Detailed description: 
      Planned Sample Size: Phase 1) 96 subjects Phase 2) 40 subjects

      Patient Population: Overweight Hispanic children with non-alcoholic fatty-liver disease age
      11 to 18 years who are stable and not taking any chronic medication with no recent acute
      illnesses.

      Definitions:

        -  BMI >95th %tile for age and gender

        -  Self-identified as Hispanic/Latino

        -  Baseline hepatic fat fraction > 10% (Have nonalcoholic fatty liver disease)

        -  Sweetened beverage intake of at least 24 ounces/day
    

Intervention name(s): Fructose Drink; Glucose Drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fructose Based beverage 8 oz; Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: NASH; non-alcoholic fatty-liver disease; Hispanic; overweight
Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
Condition: Covid19; Acute Respiratory Failure; Acute Respiratory Distress Syndrome
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury
Study type: Observational

Summary: 
      The investigators aim to achieve experts consensus on respiratory interventions in management
      of COVID-19 related acute respiratory failure (C-ARF).
    

Detailed description: 
      The investigators aim to achieve experts consensus on respiratory interventions in management
      of COVID-19 related acute respiratory failure (C-ARF). The pandemic of COVID-19 is unique in
      terms of a multitude of patients suffering from ARF and requiring invasive mechanical
      ventilation with single underlying inciting etiology.The experts have given divergent
      opinions on respiratory support of C-ARF which may have confused physicians globally.

      The investigators are going to use a modified Delphi based methodology involving global
      participating experts. The objective is to achieve consensus statement on the management of
      C-ARF using "collective intelligence".

      The whole process of this study will be done in the form of two-three rounds of Google
      Forms-based Delphi surveys. In this survey questionnaire, the investigators have prepared
      statements on the concern areas in the respiratory support of C-ARF. The survey has been
      divided into five sections related to C-ARF management. The majority of these statements are
      to be rated on Likert scale and others have multiple choices. There is an option for
      collecting participating experts comments in provided open space in round one which will be
      considered during round two questionnaire.
    

Intervention name(s): Experts consensus
Intervention type(s): Other
Intervention description(s): Consensus opinion using Delphi Methodology
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Global Experts in Respiratory or Critical Care Medicine
Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Condition: Recurrent Epithelial Ovarian Cancer; Recurrent Fallopian Tube Cancer; Recurrent Primary Peritoneal Cancer
MeSH terms: Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Ovarian Epithelial; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well tivozanib works in treating patients with recurrent
      ovarian, fallopian tube, or primary peritoneal cancer. Tivozanib may stop the growth of tumor
      cells by blocking some of the enzymes needed for cell growth.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the clinical activity of tivozanib in patients with platinum-resistant,
      recurrent ovarian, fallopian tube or primary peritoneal cancer.

      SECONDARY OBJECTIVES:

      I. Determining the potential survival advantage and characterizing the safety of single agent
      tivozanib in patients with platinum-resistant ovarian cancer.

      OUTLINE:

      Patients receive tivozanib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses
      repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for 2 years and
      then every 6 months for 3 years.
    

Intervention name(s): Tivozanib
Intervention type(s): Drug
Intervention description(s): 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
Other intervention name(s): AV-951; Oral VEGF receptor tyrosine kinase inhibitor AV-951
Intervention MeSH terms: Tyrosine Protein Kinase Inhibitors; Tivozanib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Recurrent; Ovary; Fallopian Tube; Primary Peritioneal; Phase II; Platinum Resistant
Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children
Condition: Verifying the Correct Position of Intravenous Catheters
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Sodium bicarbonate injected into a blood vessel transforms to carbon dioxide and water. The
      increase in carbon dioxide production can be detected by measuring the exhaled carbon dioxide
      in the lungs.

      This study is conducted to access the clinical application of measuring exhaled carbon
      dioxide to verify the correct position of intravenous catheters.Once the catheter is in the
      correct position the injected bicarbonate will be detected as a distinct elevation of exhaled
      carbon dioxide. A similar study was already performed in adults and was found useful. The
      investigators now extend the clinical application to children.
    

Detailed description: 
      Extravasation is the unintentional injection or leakage of fluids into the perivascular or
      subcutaneous space resulting in potential tissue injury. This prospective controlled study,
      will assesse the diagnostic utility of using intravenous diluted sodium bicarbonate to
      confirm placement of intravenous (IV) catheters in ventilated children. Diluted sodium
      bicarbonate will be created using undiluted standard 8.4% (1 meq/mL) sodium bicarbonate mixed
      in a 1:3 ratio with sterile water to achieve a final diluted concentration of 2.1% (0.25
      mEq/mL). In 20 ASA I-II mechanically ventilated children age 2-8 years, the effects of 1
      ml/kg of diluted 2.1% sodium bicarbonate or 0.9% normal saline,injected in a randomized
      order, will be analyzed. All children will have venous blood samples taken prior to injection
      and 10 minutes after injection for analysis of venous blood pH and electrolytes.
    

Intervention name(s): intravenous sodium bicarbonate
Intervention type(s): Device
Intervention description(s): Dilted sodium bicarbonate 2.1%
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: infiltration; extravasation; end-tidal carbon dioxide; sodium bicarbonate
Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the percentage of clinical objective responses (cOR) in patients with HER2 negative
      early breast cancer treated with pre operative (neoadjuvant)lapatinib and letrozole
    


Intervention name(s): lapatinib; letrozole; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 1500 mg administered orally daily; 2.5 mg administered orally daily; 1500 mg administered orally daily
Intervention MeSH terms: Letrozole; Lapatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neo-adjuvant; letrozole; lapatinib; primary breast cancer
A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous
      administered golimumab in patients with rheumatoid arthritis.
    

Detailed description: 
      A Phase 1, randomized (study drug route of administration assigned by chance), open label
      (both physician and patient know that golimumab has been assigned), study of golimumab in
      patients with rheumatoid arthritis (RA). The purpose of this study is to compare the
      pharmacokinetic (how the body effects the drug) and pharmacodynamic (how the drug effects the
      body) effects of golimumab administered through a vein in the arm or by injection under the
      skin. Safety assessments will be performed throughout the study and include obtaining and
      evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and
      severity of adverse events. The study will also assess the clinical effects of golimumab on
      RA. The study is planned for approximately 45 patients, which are randomized at a 2:1 ratio
      to receive golimumab SC or IV. Male or female patients who have been diagnosed with RA for at
      least 3 months and who are 18 years of age or older may be able to participate. Subcutaneous
      (SC) injections of 100 mg golimumab every 4 weeks through Week 20 or intravenous (IV)
      administrations of 2 mg/kg golimumab on Days 1 and 85.
    

Intervention name(s): Golimumab; Golimumab
Intervention type(s): Drug; Drug
Intervention description(s): SC injection of 100 mg every 4 weeks through Week 20; IV infusions of 2 mg/kg golimumab on Days 1 and 85.
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Golimumab; Simponi; Rheumatoid Arthritis; PK; PD
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithkline (GSK) Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients With Persistent Airflow Obstruction.
Condition: Respiratory Disorders
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase II study is to assess the safety, reactogenicity and immunogenicity
      of the investigational Non-typeable Haemophilus influenzae (NTHi) vaccine in patients with
      moderate and severe persistent airflow obstruction.
    


Intervention name(s): NTHi-10-AS01E; NaCl Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immunogenicity; Observer-blind; Reactogenicity; Chronic Obstructive Pulmonary Disease; Safety
Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication
Condition: Helicobacter Pylori Infection; Chronic Gastritis
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy and safety of berberine, amoxicillin and
      vonoprazan containing triple therapy in Helicobacter Pylori first-line eradication. It is
      hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is
      non-inferior to bismuth-containing quadruple therapy or vonoprazan -containing quadruple
      therapy. Patients diagnosed with H. pylori infection will be randomly divided into one of the
      above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or
      helicobacter pylori stool antigen test will be performed to confirm eradication.
    

Detailed description: 
      The study will include three phases: screening, treatment and follow-up. Screening: this
      phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing
      informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool
      antigen test will be performed in addition to the baseline routine evaluations.

      Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A
      randomization visit will take place on Day 0 and an end-of-treatment visit will take place
      between day 13 and 17.

      Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication
      of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter
      pylori stool antigen test.
    

Intervention name(s): Berberine; Vonoprazan; Amoxicillin; Rabeprazole; Bismuth; Clarithromycin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): berberine 500 mg, twice daily for 14 days; Vonoprazan 20 mg, twice daily for 14 days; amoxicillin 1000mg, twice daily for 14 days.; Rabeprazole 10mg, twice daily for 14 days.; Bismuth 220mg, twice daily for 14 days.; clarithromy 500mg, twice daily for 14 days.
Intervention MeSH terms: Amoxicillin; Clarithromycin; Rabeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Berberine; Bismuth; vonoprazan; Helicobacter Pylori
Characterization of Laryngeal Contact Granulomas: Retrospective Analysis of Symptoms, Promotive Factors and Therapy
Condition: Laryngeal Contact Granuloma
MeSH terms: Granuloma
Study type: Observational

Summary: 
      Retrospective analysis of data from patients with laryngeal contact granulomas in order to
      identify possible differences and/or similarities between the cases and in order to determine
      whether and which conclusions can be drawn on disease and therapy.
    

Detailed description: 
      This is a retrospective analysis of data from patients with laryngeal contact granulomas in
      order to identify possible differences and/or similarities between the cases and in order to
      determine whether and which conclusions can be drawn on disease and therapy.
    

Intervention name(s): Retrospective analysis of data
Intervention type(s): Procedure
Intervention description(s): Retrospective data analysis
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Former patients with laryngeal contact granuloma who were treated in this hospital.
      
Keywords: Laryngeal contact granuloma; Treatment type; Outcome
Cough Reflex Sensitivity and Bronchial Hyper-responsiveness
Condition: Gastroesophageal Reflux Disease; Chronic Cough; Broncho-hyperreactivity
MeSH terms: Gastroesophageal Reflux; Cough; Bronchial Hyperreactivity
Study type: Observational

Summary: 
      The aim of this study is to provide pilot data on the possible gastrointestinal predictors of
      respiratory hyper-responsiveness and how these relate to the clinical sub-types of
      gastroesophageal reflux disease (GERD) and visceral acid hypersensitivity.
    

Detailed description: 
      This study recruited participants into three groups: reflux patients with non-erosive disease
      (NERD) with abnormal levels of acid reflux, NERD patients with normal levels of reflux and
      healthy volunteers. Participants were assessed for cough reflex sensitivity (CRS) to citric
      acid and bronchial-hyperresponsiveness (BHR) to methacholine challenge, both before
      (baseline) and after esophageal acid infusion (HCl, 0.15M) or normal saline control
      (8ml/min). The order of CRS and BHR was randomized, as was the order of the acid/saline
      infusions.
    

Intervention name(s): Cough Reflex Sensitivity; Methacholine Challenge
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects inhaled increasing concentrations of citric acid, which induces coughing in a dose-dependent, reproducible matter. Following each inhalation, the number of coughs in the subsequent 15 seconds was counted and recorded. The challenge was terminated once the citric acid induced 5 or more coughs and the logarithmic (base 10) concentration provoking 5 coughs was recorded.; A baseline spirometry was used to assess how well the participant's lungs work by measuring how much air was inhale, how much was exhale and how quickly the participant exhaled. If this was normal, the subject inhaled slowly and deeply the methacholine test solution from a nebulizer and was told to hold their breath for 5 seconds. This was repeated until 5 inhalations were performed in no more than two minutes.
Intervention MeSH terms: Methacholine Chloride
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study will recruit participants into three groups ages 18-60 years: 12 reflux patients
        with non-erosive disease (NERD) with abnormal levels of acid reflux, 12 NERD patients with
        normal levels of reflux and 12 healthy volunteers.
Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy
Condition: Pain Management; Nerve Block; Laparoscopic Adrenalectomy
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This prospective, randomized control study aims to compare the analgesic effect, satisfaction
      with anesthesia and analgesia between single-injection QLB (quadratus lumborum block)+general
      anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic
      adrenalectomy.
    


Intervention name(s): single-injection QLB(quadratus lumborum block); Placebo Control
Intervention type(s): Procedure; Procedure
Intervention description(s): Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major muscle
Device: The curved (C1-5) probe of Ultrasound Scanner Philips CX50 is used for scan
Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine is given immediately after the correct position of needle tip is verified.; Inject 0.4ml/kg saline between quadratus lumborum and psoas major muscle
Device: The curved (C1-5) probe of Ultrasound Scanner Philips CX50 is used for scan
Drug: single dose 0.4ml/kg 0.9% NS is given immediately after the correct position of the needle tip is verified
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transmuscular quadratus lumborum block; adrenalectomy
Oral CXA-10 Study in Healthy Volunteers
Condition: Chronic Kidney Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be the first-in-human (FIH) study with the oral formulation of CXA-10. The main
      purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of
      CXA-10 and its metabolite(s) administered as single ascending oral doses to healthy
      volunteers (Part A). The effects of food on the PK of CXA-10 will also be investigated (Part
      B).
    

Detailed description: 
      This will be the first-in-human (FIH) study with oral formulation of CXA-10. The main purpose
      of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10
      and its metabolite(s) administered as single ascending oral doses to healthy volunteers (Part
      A). The effects of food on the PK of CXA-10 will also be investigated (Part B). Part A of the
      study will be a single-center, randomized, double-blind, third party open (sponsor)
      placebo-controlled study. Sequential single ascending doses will be administered in up to 5
      cohorts of subjects. Each cohort of subjects will be randomized to receive a single dose of
      CXA-10 or placebo in, a fasted state, as illustrated in the table below. Part B of the study
      will be a single-center, open-label, two-period study conducted in two cohorts of subjects as
      follows. The selected dose and the interval between Period 1 and Period 2 will be determined
      based on emerging PK data from Part A. The selected dose will be an intermediate dose level
      to avoid a food effect interaction that markedly enhances exposure. Subjects who participate
      in Part B of the study will receive two doses of CXA-10.
    

Intervention name(s): CXA-10; CXA-10 placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part A has sequential single ascending doses will be administered in up to 5 cohorts of subjects. Each cohort of subjects will be randomized to receive a single dose of CXA-10 or placebo in, a fasted state. Part B has 2 periods and subjects will receive two doses of the selected dose of CXA-10.
Intervention MeSH terms: CXA-10
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment