bioihbjkbjnl/mcl2 huggingface dataset:
Idiopathic Pre-capillary Pulmonary Hypertension in ESKD Patients
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      This study investigates the prevalence and prognosis of idiopathic pre-capillary pulmonary
      hypertension (PH) in patients with end-stage kidney disease (ESKD).
    

Detailed description: 
      Pulmonary hypertension (PH) is a rare cardiovascular disease with progressive and fatal
      features. PH is classified into the 5 groups, and the prevalence of group 1 pulmonary
      arterial hypertension, including idiopathic and heritable, is 5 to 15 cases per one million
      adults and a median survival was reportedly three years. PH found in patients with end-stage
      kidney disease (ESKD) is classified into group 5, because the pathogenesis and clinical
      characteristics have not been clarified. The prevalence of PH in patients with ESKD was
      reportedly around 17~56% based on echocardiographic studies. In this study, we evaluated the
      incidence of idiopathic pre-capillary PH of ESKD patients by right heart catheterization, and
      examined the prognosis by following the occurrence of heart failure death.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ESKD who had received medical treatment at pre-dialysis stage or had
        undergone maintenance hemodialysis in Toujinkai Hospital from January 1, 2001 to December
        31, 2014
      
Keywords: heart failure; survival; end-stage kidney disease
Good Rate of Clinical Response to Cholinesterase Inhibitors in Alzheimer's Disease After Three Months of Treatment
Condition: Late Onset Alzheimer
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      Life expectancy in Brazil has increased markedly over the last 30 years. Hence, age-related
      disorders, such as Alzheimer's disease (AD), warrant special attention due to their high
      prevalence in the elderly. Pharmacologic treatment of AD is based on cholinesterase
      inhibitors (ChEI) and memantine, leading to modest clinical benefits both in the short and
      long-term.

      However, clinical response is heterogeneous and needs further investigation. Objective: To
      investigate the rate of response to ChEI in AD after three months of treatment. Methods:
      Patients with mild or moderate dementia due to probable AD or to AD associated with
      cerebrovascular disease were included in the study.
    

Detailed description: 
      The subjects were assessed at baseline and again after three months of ChEI treatment.
      Subjects were submitted to the Mini-Mental State Examination (MMSE), Mattis Dementia Rating
      Scale, Katz Basic Activities of Daily Living, Pfeffer Functional Activities Questionnaire,
      Neuropsychiatric Inventory and Cornell Scale for Depression in Dementia. Good response was
      defined by a gain of ≥2 points on the MMSE after three months of treatment in relation to
      baseline.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A longitudinal, naturalist study, conducted at the Geriatric Outpatient Clinic of the
        Hospital das Clínicas at the Federal University of Minas Gerais (UFMG), in Belo Horizonte
        (MG), Brazil.

        The sample comprised patients evaluated from June, 2009 until October, 2011.
      
Biospecimen description: 
      A blood sample was drawn from the patients on the first consultation for use in DNA
      extraction and Apolipoprotein E (APOE) genotyping. For the patients who were taking
      donepezil, after three, six and twelve months of treatment another blood sample were also
      drawn, separated in plasma and kept into the freezer at - 70 Celsius degree for further
      analysis of serum level of donepezil.
    
Keywords: Alzheimer, MMSE, response, colinesterase inhibitors (ChEI)
Cannabidiol on Reward- and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the impact of cannabidiol on reward- and
      stress-related neurocognitive processes among individuals with opioid use disorder on
      buprenorphine or methadone treatment.
    

Detailed description: 
      Individuals with opioid use disorder (OUD) demonstrate reward- and stress-related
      neurocognitive changes compared to individuals without OUD, including cravings for opioids in
      response to exposure to triggers, tendency to make impulsive and disadvantageous decisions,
      and a strong attentional bias towards drug-related cues. Together, these deficits are
      significant contributors to relapse and discontinuation of treatment. Cannabidiol (CBD) has
      been shown to impact some of these cognitive deficits but studies of CBD among individuals
      with OUD are mostly lacking. Therefore, this study aims to answer whether CBD has any impact
      on reward-related neurocognitive deficits in individuals with OUD. If successful, this line
      of research will lay the groundwork for future studies to evaluate CBD's impact on OUD
      treatment outcomes.
    

Intervention name(s): Cannabidiol 100 MG/ML [Epidiolex]; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600mg; Matching placebo
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a double-blind, placebo-controlled, cross-over trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Dioxidin Versus Miramistin in Superficial Pyoderma
Condition: Pyoderma
MeSH terms: Pyoderma
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is aimed to:

        -  evaluate the effectiveness of 10-day therapy with Dioxidin® compared with Miramistin® in
           the treatment of superficial pyoderma,

        -  evaluate the safety and tolerability of 10-day therapy with Dioxidin® compared with
           Miramistin® for the treatment of superficial pyoderma.
    


Intervention name(s): Hydroxymethylquinoxalindioxyde; Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium
Intervention type(s): Drug; Drug
Intervention description(s): Dioxidin®, 0.025% solution for local and external use (Valenta Farm, Russia).; Miramistin®, topical solution 0.01% (Infamed K LLC, Russia)
Other intervention name(s): Dioxidin; Miramistin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Efficacy and Safety of Topiramate in the Treatment of Obese Patients With Mild to Moderate Essential Hypertension
Condition: Obesity; Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of daily topiramate (96mg or
      192mg) versus placebo in obese patients with mild to moderate high blood pressure.
    

Detailed description: 
      Topiramate is not approved for the treatment of obesity. The use of topiramate to reduce
      weight in obese patients may have the adjunctive benefit of reducing blood pressure in
      subjects with treated or untreated hypertension, on or off background antihypertensive
      medications. This double-blind, placebo controlled study investigates the long-term efficacy
      of topiramate for reduction of weight and blood pressure in obese patients with mild-moderate
      hypertension, and the safety and tolerability of topiramate in this patient population. The
      study consists of 4 phases: 6 week run-in phase (2 weeks screening and 4 weeks single-blind
      placebo), 8 week titration phase (topiramate group will have their dose increased from
      16mg/day to either 96mg/day or 192mg/day), 52 week maintenance phase (patients will receive
      fixed dose of either topiramate or placebo) and 6 week follow-up phase. Beginning at
      enrollment and throughout the study, all subjects participated in a standardized behavioral
      modification program which provides subjects with lifestyle and self-management strategies
      for diet, nutrition and physical activity. Effectiveness will be evaluated by multiple
      measurements such as change in body weight, sitting diastolic blood pressure, sitting
      systolic blood pressure, Body Mass Index, number and proportion of treatment responders,
      volume of left ventricle of the heart as measured by echocardiography, and fasting lipid
      profile. Safety evaluations (incidence and severity of adverse events, vital signs, 12 lead
      ECG, clinical laboratory results) will be conducted throughout the study. The study
      hypothesis is that topiramate is effective in reducing blood pressure in obese patients with
      mild to moderate hypertension and is well tolerated. During the initial 8 weeks, the dose of
      topiramate or placebo will be gradually increased to the target doses (either 48mg twice
      daily or 96mg twice daily by mouth) and the doses will be maintained for 52 weeks.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Obesity; Essential Hypertension; Mild Hypertension; Moderate Hypertension; High Blood Pressure
Anti-thymocyte Globulins for Graft-versus-host Disease Prophylaxis
Condition: Leukemia, GVHD, ATG, Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      Age is a risk factor for graft-versus-host disease (GVHD) after human leukocyte antigen
      (HLA)-matched sibling allogeneic stem cell transplantation (allo-SCT). The incidence of acute
      GVHD is significantly higher in patients at 40 years of age or more than those at 18 to 39
      years of age after allo-SCT. It was found that Anti-thymocyte globulins can be used for
      prophylaxis of both acute and chronic GVHD after allo-SCT.Prophylaxis of GVHD using ATG in
      patients at 40 years of age or more in matched sibling allo-SCT settings might significantly
      decrease the incidence of acute and chronic GVHD and the incidence of late effect after
      transplantation.
    

Detailed description: 
      Prophylaxis for GVHD included CSA, MTX and MMF±ATG. In the trial group, CSA was started
      intravenously on day -1, at the dosage of 3 mg/kg, and switched to oral formulation as soon
      as the patient was able to take medication after engraftment. The dosage was adjusted to
      maintain a trough blood level of 200-300ng/ml. MMF was administered orally, 0.25g every 12
      hours, from day -1 before transplantation to day 30 after transplantation. The dosage of MTX
      was 15 mg/m2, administered i.v. on day 1, and 10 mg/m2 on days 3, 6, and 11 after
      transplantation. ATG (Thymoglobulin 2.5mg/kg per day i.v.) on days -2 through -1. In the
      control group, CSA was started intravenously on day -1, at the dosage of 3 mg/kg, and
      switched to oral formulation as soon as the patient was able to take medication after
      engraftment. The dosage was adjusted to maintain a trough blood level of 200-300ng/ml. MMF
      was administered orally, 0.25g every 12 hours, from day -1 before transplantation to day 30
      after transplantation. The dosage of MTX was 15 mg/m2, administered i.v. on day 1, and 10
      mg/m2 on days 3, 6, and 11 after transplantation.
    

Intervention name(s): anti thymoglobulin
Intervention type(s): Drug
Intervention MeSH terms: Thymoglobulin; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma
Condition: Esophageal Cancer
MeSH terms: Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the treatment of locally advanced
      esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel,
      cisplatin and radiation improve clinical outcomes.
    

Detailed description: 
      Esophageal cancer is the sixth leading cause of cancer death worldwide.

      Over the past 2 decades, well-designed clinical trials have documented the clinical benefits
      of combination of chemotherapy and radiation for localized esophageal cancer, either as
      primary therapy or in neoadjuvant setting.

      Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer.
      Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy
      Oncology Group (RTOG) trials of nonoperative management of esophageal cancer.

      Accumulating clinical evidence suggests that epidermal growth factor receptor (EGFR)
      represents a viable target in the treatment of esophageal cancer. EGFR expression is
      associated with poor prognosis. Cetuximab, a monoclonal antibody, binds specifically to EGFR
      on both normal and tumor cells and competitively inhibits the binding of EGF and other
      ligands, such as transforming growth factor (TGF)-α.

      Preclinical models have suggested synergy between cetuximab, paclitaxel, cisplatin and
      radiation. For patients with locally advanced head and neck cancer, the combination of
      cetuximab and radiation has demonstrated both response and survival benefit.

      With all these, the investigators hypothesize that treatment of locally advanced esophageal
      squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and
      radiation may further improve clinical outcomes. This trial results will be important as it
      may support further studies for setting the new treatment standard for ESCC.
    

Intervention name(s): cetuximab (Erbitux); Paclitaxel; Cisplatin; Radiation
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): Cetuximab,injection,loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8); Paclitaxel,injection,loading dose 45 mg/m^2,(Day1 in every week for Weeks 2-8); Cisplatin,injection,loading dose 20 mg/m^2,(Day1 in every week for Weeks 2-8); Radiation, External beam therapy, total 59.4 Gy , 33 fractions, 1.8 Gy per fraction.(Day 1-Day 5 in every week 2-week 8).
Other intervention name(s): erbitux; Conformal Radiotherapy; Intensity Modulated Radiotherapy
Intervention MeSH terms: Paclitaxel; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Therapeutic; Drug Therapy, combination; Radiotherapy
The Impact of Lixisenatide on Postprandial Glucose Tolerance in Pancreatectomised Subjects
Condition: Diabetes After Total Pancreatectomy
Study type: Interventional

Summary: 
      Postprandial glucose (PPG) excursions are not only determined by insulin-mediated glucose
      disposal and endogenous glucose production (regulated by insulin and glucagon); also the rate
      of gastric emptying constitutes an important determinant of PPG levels 1. The short-acting
      glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide is used in the treatment of
      type 2 diabetes. It increases glucose-dependent insulin secretion, suppresses glucagon
      secretion and reduces gastric emptying of meals 2. These three mechanisms most likely
      constitute the weightiest mechanisms behind the potent impact of lixisenatide on exaggerated
      PPG excursions in patients with type 2 diabetes - which often are normalised during
      lixisenatide treatment 3. However, the separate impact of lixisenatide-induced reduction of
      gastric emptying (independently of the pancreatic effects) has been difficult to determine.
      Importantly, treatment with lixisenatide also decreases appetite and food intake and may,
      like native GLP-1, increase energy expenditure 4. So far an exact demarcation of the
      pancreatic and extrapancreatic effects of lixisenatide in humans remains to be established.

      The present project serves to determine whether effects of lixisenatide on gastric emptying,
      appetite, food intake and resting energy expenditure are dependent on the endocrine pancreas.

      The study is a randomised, placebo-controlled, double-blinded, cross-over study.

      12 healthy persons and 12 pancreatectomized patients (i.e. patients who have had their
      pancreata removed due to pancreatic cancer or severe chronic pancreatitis) will be subjected
      to two experimental days on which they will undergo a liquid meal test followed by a fasting
      period and finished off with an ad libitum meal with lixisenatide and placebo, respectively.
    


Intervention name(s): Lixisenatide; Lixisenatide-Placebo; Standardized liquid meal
Intervention type(s): Drug; Drug; Other
Intervention description(s): single injection of 20 µg lixisenatide subcutaneously; standardized liquid meal (200 ml containing 1,650 kJ (394 kcal): carbohydrate 50%, protein 15%, fat 35%, consisting of glucose (48.4 g + 1.6 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol).
Other intervention name(s): Lyxumia
Intervention MeSH terms: Lixisenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication?
Condition: NAFLD; Alcoholic Hepatitis
MeSH terms: Hepatitis, Alcoholic
Study type: Interventional

Summary: 
      Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle.
    

Detailed description: 
      In this study, we aim to evaluate the tissue adequacy of EUS guided liver biopsy for
      parenchymal liver disease and to evaluate if diagnostic yield of left lobe is non-inferior to
      right lobe biopsies and to assess if combination biopsies have better yield than single lobe
      biopsies. Safety of the procedure and technical success would be noted.

      The data would be analysed using SPSS software and needful variables and tests would be used
      as per statistical requirement.
    

Intervention name(s): Endoscopic USG guided Liver biopsy; Percutaneous Liver Biopsy
Intervention type(s): Device; Device
Intervention description(s): Diagnostic yield with EUS guided liver biopsy - Left lobe Bx vs combined right and left lobe or vs right lobe would be assessed.; All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield .
Intervention MeSH terms: Liver Extracts
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield.
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Effects of Mindfulness-based Cognitive Therapy on Brain Mechanisms in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of Mindfulness-Based Cognitive
      Therapy (MBCT) on brain mechanisms associated with interoceptive awareness and rumination in
      individuals suffering from major depressive disorder (MDD).
    


Intervention name(s): MBCT; PRT-PsyEd
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain
Condition: Non-specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      evaluation of core muscles endurance and strength following backward walking training
      programe
    

Detailed description: 
      A randomized controlled trial will be conducted at the Isokinetic laboratory, Faculty of
      Physical Therapy, Cairo University, to investigate the effect of backward walking training on
      core muscles strength and endurance, pain severity, and disability level in subjects with
      NSLBP. Sixty females clinically diagnosed with nonspecific low back pain with age range from
      18-45 years will participate in the study. They will be randomly assigned into 3 groups
      according to the received intervention; backward walking group (BWG), core stability group
      (CSG), and control group (CG). The isokinetic strength of trunk muscles, and hip extensors
      and abductors will be evaluated in a concentric mode of muscle contraction. McGill's core
      endurance tests will be used to examine participants' core endurance. The visual analog scale
      will be used for measuring the pain intensity. The oswestry disability index will be used to
      assess pain related disability and quality of life in subjects with LBP.
    

Intervention name(s): backward walking program; core training
Intervention type(s): Other; Other
Intervention description(s): six weeks of backward walking program at self selected speed for 30 minutes 3 times per week; six weeks of core training program including curl up, lateral plank on both sides, bird dog exercises done 3 times per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: NSLBP