bioihbjkbjnl/mcl2 huggingface dataset:
An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess the long-term safety of exenatide in patients with type 2
      diabetes who were treated with exenatide in Study H8O-MC-GWAA (6-month study) or Study
      H8O-MC-GWAD (12-month study). Study H8O-MC-GWAN serves as an open-ended extension to Studies
      H8O-MC-GWAA and H8O-MC-GWAD.
    


Intervention name(s): exenatide
Intervention type(s): Drug
Intervention description(s): subcutaneous injection, 5mcg or 10 mcg, twice daily
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; exenatide; Byetta; Amylin; Lilly
Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection
Condition: Strangulated Hernia
MeSH terms: Hernia
Study type: Interventional

Summary: 
      Primary suture repair increases the risk for recurrence, the fact of benefit of mesh repair
      in elective situations is documented, and many studies have reported beneficial outcomes of
      mesh hernioplasty in emergency situations. Still there is controversy of using such grafts in
      presence of intestinal resection.
    

Detailed description: 
      Patients with acutely incarcerated hernias (with small intestine contents) who underwent
      polypropylene mesh hernioplasty were included in this prospective study from June 2005
      through Jan. 2011, patients were categorized into 2 groups who required intestinal resection
      anastomosis (group I)or not (group II).
    

Intervention name(s): SURGERY; mesh repair
Intervention type(s): Other; Other
Intervention description(s): REPAIR OF STRANGULATED HERNIA with intestinal resection; mesh repair of strangulated hernia without resection
Other intervention name(s): mesh hernioplasty; mesh hernioplasty without resection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infection; Prosthesis; Recurrence; Strangulation
Point of Care Testing of Platelet Function in Patients With Acute Upper Gastrointestinal Bleeding
Condition: Hematemesis; Melena; Gastrointestinal Hemorrhage; Platelet Dysfunction
MeSH terms: Gastrointestinal Hemorrhage; Hematemesis; Hemorrhage
Study type: Observational

Summary: 
      Acute upper gastrointestinal bleeding (AUGIB) is a common medical emergency. In an ageing
      population, antiplatelet drugs are increasingly being prescribed for treatment and
      prophylaxis against cardiovascular thrombo-embolic events. In many patients, platelet
      dysfunction mostly acquired is the principal cause of bleeding. To clinicians, the management
      of patients on antiplatelet drugs or anticoagulants is a challenge. One has to carefully
      balance the bleeding against thrombo-embolic risks. Therefore measuring platelet function
      should be integral in the management plan. A quantitative measurement allows titration of
      platelet function in accordance with bleeding or thromboembolic risk. Platelet function has
      not been studied in a large cohort of patients with acute upper gastrointestinal bleeding. As
      a first step, the study will determine if platelet dysfunction is associated with clinical
      outcome. In this prospective, observational single centre cohort study of consecutive
      patients with overt signs of acute upper gastrointestinal bleeding, their platelet function
      by point of care tests (light transmittance aggregometry, verify now p2y12,the platelet
      function analysis system (PFA-100) upon their admissions. Patients will be followed up for 30
      days after trial enrollment. The primary endpoint is defined as significant bleeding that
      requires interventions (endoscopic, radiologic or surgery). Secondary end points include
      cardio- and cerebrovascular thrombo-embolic events and all cause deaths. A receiver operating
      characteristic (ROC) curve analysis is calculated for each point-of-care test to evaluate if
      individual test can distinguish between patients with and without primary end point. This
      study aims to evaluate the capability of platelet function tests to predict clinical outcome
      in patients with AUGIB. Logistic regression models will then be built in search for
      independent correlates to the primary and secondary endpoints and to adjust for confounding
      variables.
    


Intervention name(s): blood taking
Intervention type(s): Other
Intervention description(s): in this cohort study, we will take blood to examine the platelet function
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with overt signs of acute upper gastrointestinal bleeding (melena, coffee ground
        or fresh hematemesis with or without circulatory instability)
Genetics and HIV-1 Protease Inhibitors
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5
      (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people
      with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to
      people with the normal metabolizing genotype.
    


Intervention name(s): Atazanavir
Intervention type(s): Drug
Intervention description(s): Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
Other intervention name(s): Reyataz; Norvir
Intervention MeSH terms: Atazanavir Sulfate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Clinical Pharmacology; Pharmacogenomics; HIV
High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease
Condition: Patients With Persistent Objectified Gastroesophageal Reflux and Reflux-Associated Symptoms Despite PPI-Therapy With 40mg Esomeprazole
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Observational

Summary: 
      It has been reported that Baclofen is an appropriate tool in the therapeutic management of
      Gastroesophageal Reflux Disease. To objectify gastroesophageal reflux combined
      pH-metry/impedance monitoring was applied to patients with persistent reflux-associated
      symptoms despite PPI-therapy (40mg esomeprazole for 2 weeks). After provement of pathological
      findings in the test PPI-dosage was escalated to double standard-dosage for another for
      weeks. In case of persistent symptoms another ph-metry/impedance monitoring was performed. In
      case of pathological findings additional baclofen was administered to the therapeutic regime.
      After 3 months another ph-metry/impedance monitoring was performed. At the time point of the
      tests a questionnaire was completed.

      Aim of the study was to evaluate the influence of high dosage PPI-therapy and additional
      baclofen in patients with persistent symptoms and objectified gastroesophageal reflux.
    


Time perspective: Prospective
Keywords: gastroesophageal reflux disease; baclofen; impedance
A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the effect of treatment with romosozumab for 6 months
      compared with placebo on the percent changes in bone mineral density (BMD) at the lumbar
      spine, at the total hip and femoral neck in postmenopausal Chinese women with osteoporosis.
    


Intervention name(s): Romosozumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive romosozumab in a specified sequence during the treatment Period.; Subjects will receive Placebo in a specified sequence during the treatment Period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis; Phase 3; Chinese Patients; Romosozumab
Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis
Condition: Birch Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic
      rhinoconjunctivitis
    


Intervention name(s): Recombinant birch pollen
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Allergy; Birch pollen; Recombinant
Montelukast - a Treatment Choice for COVID-19
Condition: Covid19; SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The current study aimed to make a therapeutic comparison and effectiveness of
      Hydroxychloroquine (HCQ) and Montelukast (ML) in COVID-19 patients in addition to the
      standard of care. The safety and efficacy of HCQ and ML will be assessed as individual
      therapy and in combination with each other and with the standard of care. Cytokine storm
      (Interleukin levels) also will be monitored throughout the study to assess treatment
      progression.
    

Detailed description: 
      To date, no specific medication is available for COVID-19. Many FDA-approved drugs, including
      antivirals, antibacterials, and anti-inflammatory compositions are being tested with the
      intention of repurposing against COVID-19. In this study, investigators have evaluated the
      effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in an individual and
      combination therapy.

      Investigators have performed an observational study of 100 hospitalized COVID-19 patients
      while assessing the safety and efficacy of HCQ, ML, and IV as individual therapy and in
      combination with each other. ECG, interleukin levels, LFTs, blood profiles were continuously
      monitored throughout the study.

      The aim was to observe participants treated with ML and monitor the inflammatory markers to
      see whether they increase or decrease and whether an increase in survival rate is observed.
      The findings have shown that combinational therapy of ML with continuous observation of
      liver/kidney profiles and QTc prolongation can provide robust recovery with suppression of
      cytokines.
    

Intervention name(s): Montelukast; Hydroxychloroquine; Ivermectin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): An FDA approved medicine to treat asthmatic patients; An FDA approved antiarthritis drug; An FDA approved anti-parasitic medicine
Intervention MeSH terms: Hydroxychloroquine; Ivermectin; Montelukast
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients, who were admitted to the hospitals with SARS-CoV-2 contacts (environmental
        exposure or close contact) or obvious COVID-19 symptoms and were diagnosed with COVID-19
        using the PCR tests. Consent was obtained from all patients with a detailed history of any
        known co-morbidities.
      
Biospecimen description: 
      Nasal Swab samples
    
Keywords: COVID-19; Montelukast
Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI)
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The aim of this study is to evaluate the performance of Analgesia/Nociception Index (ANI)
      measured at the end of surgery for the prediction of immediate postoperative pain in
      postoperative care unit in adult patients undergoing general anesthesia.
    

Detailed description: 
      Assessment of the performance of ANI to predict immediate postoperative pain on a 0-10
      numerical rating scale (NRS) >3 by building a receiver operating characteristic curve.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients underoing surgical procedures performed on general anesthesia
      
Keywords: Analgesia Nociception Index; ANI
Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of iloperidone compared to
      placebo and an active comparator in the treatment of patients with schizophrenia in acute
      exacerbation.
    

Detailed description: 
      Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population.
      Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and
      delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or
      emotions). Other symptoms include a reduced ability to recall and learn new information.

      Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial
      will test the safety and efficacy of iloperidone in patients with an acute exacerbation of
      the disease.
    

Intervention name(s): iloperidone; active comparator; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Iloperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; Atypical antipsychotic; psychosis
Megavec 400 mg (Imatinib Mesylate) in Healthy Adult Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg
      (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.
    


Intervention name(s): Megavec; Glivec
Intervention type(s): Drug; Drug
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Juice Study: Sensitivity of Skin Carotenoid Status to Detect Change in Intake
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study is designed to see if drinking a tomato-based vegetable juice will increase skin
      carotenoids.
    

Detailed description: 
      The US Dietary Guidelines for Americans recommends that individuals consume approximately 2-4
      c of vegetables each day to reduce risk of chronic disease, but current methods for assessing
      intake are either inaccurate (self-report) or invasive (blood carotenoid levels). Recent
      research indicates that skin carotenoid status may be a useful biomarker of vegetable intake,
      but the sensitivity to dose in unknown. In this study, we propose to test the dose-response
      of skin carotenoids to consumption of 3 different levels of vegetable juice (with a control
      group receiving water). We will test skin carotenoids in two ways: using resonance Raman
      spectroscopy (RRS), which we have previously validated, and with a new technique, pressure
      mediated reflection spectroscopy (RS; the "Veggie Meter"). We will compare the two techniques
      during an 8-week provided tomato-based juice intervention. Skin carotenoid readings will be
      compared to blood carotenoid concentrations and single nucleotide polymorphisms (SNPs) of
      genes related to the uptake, transport, and metabolism of carotenoids will be examined in
      blood and saliva.
    

Intervention name(s): High dose vegetable juice; Medium dose vegetable juice; Low dose vegetable juice; Control bottled water
Intervention type(s): Other; Other; Other; Other
Intervention description(s): High dose (13 fl oz) vegetable juice; Medium dose (10 fl oz) vegetable juice; Low dose (5.5 fl oz) vegetable juice; Control (12 fl oz) bottled water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      ascending single IV doses of ERB-257 in healthy subjects
    


Intervention name(s): ERB-257; placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Prognostic Factor Research of Sensory Profiles in Development of Central Sensitization
Condition: Sensory Profiles; Central Sensitisation; Low Back Pain; Nociplastic Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      A longitudinal observational cohort study to investigate the value of prognostic factors,
      here sensory profiles , and others, in the development of central sensitization in the low
      back pain population. A type 2 prognostic factor research following the PROGRESS framework.
      Sensory profiles are identified a prognostic factors which can predict the development of
      central sensitization in the low back pain population.
    

Detailed description: 
      After performing an univariable linear regression analyses the regression model predicts the
      dependent variable, central sensitization, significantly, and the models are significant
      prediction factors of the development of central sensitization. In unadjusted analyses, all
      four sensory profiles were significantly associated with the development of central
      sensitization (P<0.001).

      After adjusting for pain, disability, age, and duration of low back pain, baseline sensory
      profiles remained significant predictors of central sensitization. On the other hand, all
      other predictor variables did not contribute to the prediction of central sensitization.
    

Intervention name(s): In line with the Dutch guideline for non-specific low back pain, Standard usual care for non-specific low back pain was applied.
Intervention type(s): Other
Intervention description(s): In line with the Dutch guideline for non-specific low back pain, Standard usual care or non-specific low back pain was applied.
Other intervention name(s): In line with the Dutch guideline for low back pain, Standard usual care or non-specific low back pain was applied.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants were recruited primary care physiotherapy practices randomly spread throughout
        the Netherlands. Participants with acute low back pain were consecutively included by
        physiotherapists.
      
Biospecimen description: 
      patients with acute low back pain (< 6 weeks) were consecutively included with or without
      radiating pain, aged 18 to 60 years with a pain-free episode for at least 3 months before the
      onset of their current back pain. They were also required to be able to read and understand
      the Dutch language.
    
Keywords: Prognostic factors research; Sensory Profiles; Central Sensitisation; Low back pain; Nociplastic Pain
A 2 Week, Crossover Trial of Dietary Nitrate in Obstructive Sleep Apnoea Syndrome (OSAS).
Condition: Obstructive Sleep Apnoea Syndrome
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic
      blood pressure in multiple populations as well as increase organ perfusion in areas of
      interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is
      associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of
      dietary nitrate in OSAS has not been reported.
    

Detailed description: 
      Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic
      blood pressure in multiple populations as well as increase organ perfusion in areas of
      interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is
      associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of
      dietary nitrate in OSAS has not been reported.

      The investigators hypothesize that chronic nitrate consumption might decrease blood pressure
      and dysglycaemia and improve vigilance compared to a placebo beetroot juice.

      This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline,
      mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with
      demographics, questionnaires, vigilance and blood draw. After baseline measures, each subject
      will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when
      assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the
      converse.
    

Intervention name(s): Dietary nitrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.; 140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
Other intervention name(s): Beetroot juice; Nitrate depleted beetroot juice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
"TransRadial Ultra Support Technique" (TRUST)
Condition: Coronary Arterioscleroses; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Arteriosclerosis
Study type: Interventional

Summary: 
      Adequate support is required for challenging percutaneous coronary interventions (PCI). The
      "TransRadial Ultra Support Technique" (TRUST technique) is a new support technique that
      provides active support by deep pass of the coronary wire into the heart cavities (left
      ventricle-LV, right ventricle-RV) or aorta.
    


Intervention name(s): TRUST technique; Anchoring Technique; Coronary stenting
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): A soft hydrophilic wire easily pass through the invisible small vessels in the distal parts of a coronary artery into a heart cavity. It is necessary to pass a wire softly and forward as deep as possible. Quite often the wire goes through the left ventricle to aorta arch, and sometimes distal soft tip can be visible in a descending aorta. Thus the stiffest part of the wire become staying on all length of artery, straightening bends and giving the maximum support. After that balloons and stents can be delivered more easily; A standard endovascular technique of coronary wire support improvement; A standard endovascular procedure of percutaneous coronary intervention with coronary stenting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Percutaneous Coronary Intervention; Coronary Artery Disease; Wire; Coronary stenting