bioihbjkbjnl/mcl2 huggingface dataset:
In-hospital Versus After-discharge Complete Revascularization
Condition: STEMI - ST Elevation Myocardial Infarction; Multivessel Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Patients with STEMI and multivessel disease in whom the culprit lesion has been successfully
      revascularized during prmimary PCI, will be randomized to in-hospital or after-discharge
      complete revascularization.

      The purpose of this study is to evaluate the impact of these two different strategies in
      terms of hospital stay.
    

Detailed description: 
      STEMI patients with mutivessel disease are, after successful primary angioplasty, randomized
      1:1 ratio to either in-hospital complete revascularization or after-discharge complete
      revascularization strategy.

      Eligible non-culprit coronary arteries must be >2.0 mm in diameter and at the discretion of
      the operator suitable for PCI. Only arteries with angiographically stenoses ≥70% or between
      ≥50% and <70 in proximal segments can be randomized.

      Patients in the in-hospital revascularization group will undergo to non-culprit percutaneous
      coronary intervention (PCI) at least 24 hours after ST-segment elevation myocardial
      infarction. On the other hand, patients in the after-discharge group will undergo to
      non-culprit PCI within 4-6 weeks after STEMI.
    

Intervention name(s): In-hospital nonculprit-lesions percutaneous coronary intervention (PCI); After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)
Intervention type(s): Other; Other
Intervention description(s): To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure during index admission.; To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure after hospital discharge.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: STEMI; Multivessel; PCI
Type 2 Diabetes and Alteration of Immune System of Intestinal Mucosa : Proof of Concept
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Type 2 diabetes is the predominant type of diabetes. Because a quiet evolution, it is
      difficult to have a rapid diagnose. A better knowledge about pathophysiological mechanisms at
      the origin of type 2 diabetes and about its complications could make it possible to improve
      the prevention and the treatment of this disease.

      Research team developped a new research axis : the microbiota of the intestinal mucosa. They
      proved a translocation process of intestinal bacteria from the intestinal mucosa to different
      tissue of the organism implicated in glucose homeostasis. This mechanism is involved in the
      type 2 diabetes development. A clinical study (MICIMAB) of predictive biomarkers of diabetes
      and obesity is ongoing.

      In parallel, the same team explored the role of intestinal immunity modifications in the
      bacteria translocation from the gut to the blood circulation. They already have some results
      on animal model but not yet in human. In animal model, a solid reduction of lymphocytes T CD4
      Th17 in the intestinal wall is responsable of the translocation of intestinal bacteria and in
      the induction of a metabolic inflammation wich promotes insulin resistance, abdominal obesity
      development and type 2 diabetes.

      The aim of this study is to explore this hypothesis in human to have therapeutic solution
      later.
    


Intervention name(s): Biopsy
Intervention type(s): Other
Intervention description(s): Ileon and colon biopsy
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with a diagnoses of type 2 diabetes and patient who do not have a know diabetes
        diagnose.
      
Biospecimen description: 
      Ileon and colon biopsy
    
Keywords: Coloscopy
A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects
Condition: Safety and Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study in
      which the safety, tolerability, and pharmacokinetics of orally administered GB1211 will be
      evaluated in healthy adult subjects and adult subjects with indication of suspected
      Nonalcoholic steatohepatitis (NASH) and liver fibrosis.
    

Detailed description: 
      The study consisted of 2 parts: a SAD phase (Part A) which enrolled a total of 5 cohorts of
      healthy subjects and a MAD phase (Part B) which enrolled 2 cohorts of healthy subjects. Two
      additional cohorts A6 and A7, were added following dose escalation analysis.

      The planned optional Part C was to include a multiple-dose cohort of 25 subjects with
      suspected NASH and liver fibrosis (Cohort C1). However, Part C of the study was not performed
      as per Sponsor's decision.
    

Intervention name(s): GB1211; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hard capsules for oral use; Hard capsules for oral use
Other intervention name(s): GB1211
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part A: 56 subjects will be studied in 7 cohorts (Cohorts A1 to A7) Part B: 22 subjects will be studied in 2 cohorts (Cohorts B1 to B2)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: GB1211; Phase 1; First Time in Human; Safety; Tolerability; Pharmacokinetics; Single Ascending Dose (SAD); Multiple Ascending Dose (MAD); Healthy Volunteers; Nonalcoholic Steatohepatitis (NASH); Liver Fibrosis
Can Genetic Markers Predict Weight Loss After Gastric By-pass Surgery
Condition: Obesity
MeSH terms: Weight Loss
Study type: Observational

Summary: 
      There is a variability in weight loss after gastric bypass surgery for obesity despite a
      standardised surgical procedure. This study aims to investigate if genetic markers can
      predict outcome after gastric by-pass surgery in treatment of obesity. The investigators will
      also study if adenovirus infection can influence the outcome after surgery. In a subgroup of
      patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid and protein
      patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as well as
      liver biopsies and whole blood are stored in a biobank. The same tissues will be collected
      from non-obese controls undergoing gallbladder surgery.
    


Intervention name(s): Gastric bypass or cholecystectomy
Intervention type(s): Procedure
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obesity
      
Biospecimen description: 
      Tissue biopies, liver and subcutaneous and omental fat Whole blood EDTA-plasma Serum
Metabolic Syndrome in Patients With First-episode Schizophrenia
Condition: Metabolic Syndrome X; Schizophrenia
MeSH terms: Metabolic Syndrome; Syndrome; Schizophrenia
Study type: Observational

Summary: 
      The metabolic syndrome (MetS) is highly prevalent in patients with schizophrenia and is a
      major risk factor of type-2 diabetes, cardiovascular disease and early death. Genetic
      factors, antipsychotic medication, sleeping disturbances and unhealthy lifestyle are possible
      causes of developing metabolic syndrome. Several studies have investigated the metabolic
      side-effects of antipsychotic medication. However it is still unanswered how unhealthy
      lifestyle, comprising physical inactivity, smoking, unhealthy dieting, and sleeping
      disturbances adds to the metabolic risk of patients with schizophrenia. The aim of this study
      is to investigate the prevalence and development of MetS in first-episode patients with
      schizophrenia and 1 year after onset of treatment. The study's main hypothesis is that
      physical inactivity, regardless of medication, is an independent risk factor for metabolic
      syndrome in patients with schizophrenia. In comparison inpatients with major depression and
      healthy controls, both matched on gender, age and level of education will be included in the
      study. It is anticipated that the study's results will provide new knowledge about the risk
      of developing metabolic syndrome in first-episode schizophrenia and how different risk
      factors contribute to this.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to The OPUS project, Region of Midtjylland, Denamrk In comparison
        in-patients with major depression, Aarhus University Hospital, Risskov and healthy controls
        matched on gender, age and level of education.
Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy
Condition: Pneumoperitoneum
MeSH terms: Pneumoperitoneum
Study type: Interventional

Summary: 
      The purposes of this study is to investigate the effects of moderate vs. deep neuromuscular
      block on respiratory mechanics and biotrauma in patients with intraoperative protective lung
      ventilation for laparoscopy.
    

Detailed description: 
      Mechanical ventilation results in the disruption of the alveolar-capillary barrier and
      increased permeability, a hallmark of experimental ventilator-induced lung injury. These
      mechanical forces also induce an increase in the concentrations of inflammatory cytokines.

      The benefits of deep neuromuscular blocks for laparoscopic procedures are controversial and
      most of the studies undertaken have only sought to improve surgical conditions.
      Theoretically, deep neuromuscular block permits a lower abdominal insufflation pressure,
      which leads to better respiratory mechanics and gas exchange. The investigators examined the
      effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in
      patients with intraoperative protective lung ventilation for laparoscopy. The investigators
      hypothesized that deep neuromuscular block (PTC 1 or 2) and low pressure pneumoperitoneum (8
      mmHg) would improve respiratory mechanics and reduce inflammatory processes associated with
      biotrama during mechanical ventilation compared with moderate neuromuscular block (TOF count
      1 or 2 ) and standard pressure pneumoperitoneum (12-15 mmHg).
    

Intervention name(s): Deep neuromuscular block; Moderate neuromuscular block
Intervention type(s): Drug; Drug
Intervention description(s): Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum; Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum
Other intervention name(s): Deep neuromuscular block with rocumeron; Moderate neuromuscular block with rocumeron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: biotrauma; laparoscopic surgery; neuromuscular block; sugammadex
Dual-Loop Target Controlled Infusion in Laparoscopic Cholecystectomy (DLTCI)
Condition: Cholecystolithiasis
MeSH terms: Cholecystolithiasis; Cholelithiasis; Gallstones
Study type: Interventional
Phase: Phase 4

Summary: 
      Laparoscopic Cholecystectomy applied to Artificial pneumoperitoneum and the extent of
      Surgical stimulation cause the wave of hemodynamics increase vigorously, which make it
      difficult to judge the depth of anesthesia according to traditional hemodynamics index such
      as heart rate and blood pressure.In case of this, the investigators design this research to
      study the Closed-Loop Target Controlled Infusion to anaesthesia of individualization guided
      by a Narcotrend index monitor in Laparoscopic Cholecystectomy.
    

Detailed description: 
      Anesthetics alter electrocortical activity in a dose-dependent manner,and it is suggested
      that electroencephalographic(EEG)activity can provide a reliable basis for a surrogate
      measurement of hypnosis.An EEG monitor,the Narcotrend Index(NI),has proven useful to titrate
      hypnotic drugs.Because it is a single composite measure monitored continuously,it has been
      used in controlled studies to automatically guide propofol
      administration.Conversely,automated delivery systems for opioids have seldom been described
      using EEG activity There are no specific measures to quantify analgesia
      directly.Nevertheless,in the interaction between opioid-hypnotic synergy and loss of
      consciousness,when the dose of analgesic administered is sufficient to inhibit autonomic
      response to noxious stimuli,then the required hypnotic concentration is only that needed to
      achieve loss of consciousness.Moreover,a noxious stimulus such as laryngoscopy or periosteal
      pressure to the tibia may cause electrocortical activation with an increase in Narcotrend
      index,which indirectly reflects the analgesic state or the level of
      antinociception.Finally,an excitatory EEG arousal reaction resulting from nociceptive
      stimulation can provide a rational basis for analgesia administration.It can then be
      hypothesized that Narcotrend index could also be the controlled variable for opioid
      administration.
    

Intervention name(s): Dual-loop TCI; manual
Intervention type(s): Device; Device
Intervention description(s): the controller in the current study measures and calculates the error(NI error),which is the difference between the set point(NI=36)and the measured NI.If the NI error is different from 0,the controller determines a new propoflo and/or remifentanil concentration.; the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Dual-Loop TCI; NI; Laparoscopic Cholecystectomy
Olanzapine in the Treatment of Hair Pulling (Trichotillomania)
Condition: Trichotillomania
MeSH terms: Trichotillomania
Study type: Interventional
Phase: Phase 4

Summary: 
      Trichotillomania (TTM) or hair-pulling has been considered as part of the obsessive
      compulsive disorder (OCD) spectrum, although treatment with OCD medications has largely been
      unsuccessful. Tics/Tourrettes' Syndrome (TS) is a disorder, which appears to be related to
      TTM, but is treated with a different class of medications than used in OCD, namely
      antipsychotics such as olanzapine. This is a study of the safety and efficacy of olanzapine
      in the treatment of hair pulling.
    


Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Relative Bioavailability Study of Acetaminophen 650 mg Extended Release Gelcaps Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The study was conducted as an open label, balanced, randomised, two-treatment, two-period,
      two-sequence, single dose, crossover bioavailability study comparing acetaminophen extended
      release gelcaps 650 mg (containing acetaminophen 650 mg) of OHM Laboratories Inc. with
      TYLENOLÒ arthritis pain caplets 650 mg (containing acetaminophen 650 mg) of McNeil Consumer &
      specialty Pharmaceuticals in healthy, adult, human, male subjects under fed condition.
    

Detailed description: 
      A single oral dose of acetaminophen 650 mg was administered (except Subject No. 17) with 240
      mL of drinking water during each period under supervision of trained study personnel.

      During the course of the study, safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical,
      serology parameters and urine analysis) at base line. Laboratory parameters of hematology and
      biochemistry were repeated at the end of study (except Glucose and cholesterol).
    

Intervention name(s): Acetaminophen
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Acetaminophen fed study
Using Deep Learning and Radiomics to Diagnose Benign and Malignant Breast Lesions Based on Ultrasound
Condition: Breast Diseases
MeSH terms: Breast Diseases
Study type: Observational

Summary: 
      This retrospective study aimed to create a prediction model using deep learning and radiomics
      features extracted from intratumoral and peritumoral regions of breast lesions in ultrasound
      images, to diagnose benign and malignant breast lesions with BI-RADS 4 classification.

      Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong
      First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their
      general clinical features, information on preoperative ultrasound diagnosis, and
      postoperative pathologic data were reviewed.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with breast lesions attending the First Affiliated Hospital of Shandong First
        Medical University were selected.
Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine in Early Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Primarily, this clinical investigation compares the rates (percentages) of pathological
      complete remissions attained at the time of final surgery following 6 cycles each of
      epirubicin + docetaxel + capecitabine-containing chemotherapy ± trastuzumab (in HER-2
      positive disease) vs. epirubicin + docetaxel-containing chemotherapy ± trastuzumab (in HER-2
      negative disease).
    

Detailed description: 
      This study is a prospective, randomized, multicentre, phase III trial in the neoadjuvant
      treatment of patients with primary breast cancer and no distant metastases. Patients will be
      stratified at inclusion according to the centre, to the clinical tumour stage (T1, T2, T3,
      T4a-c), the axillary lymph node status (positive, negative), the menopausal status
      (pre-menopausal, post-menopausal), histology (invasive ductal, invasive lobular, mixed), the
      hormone-receptor status (positive [ER+/PR+, ER+/PR-, ER-/PR+], negative [ER-/PR-], not
      determinable]), the HER-2 status (positive, negative, not determinable), the grading (G1/G2,
      G3, not determinable) and will be randomly assigned to receive either 6 cycles of neoadjuvant
      epirubicin, docetaxel and capecitabine ± trastuzumab in HER-2 positive disease or 6 cycles of
      neoadjuvant epirubicin and docetaxel ± trastuzumab in HER-2 positive disease.
    

Intervention name(s): Epirubicin; Docetaxel; Capecitabine; Trastuzumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 6 cycles 75mg/m2 i.v. day 1 q3w; 6 cycles 75mg/m2 i.v. day 1 q3w; 6 cycles 1000mg/m2 oral, day 1-14 q2d; cycle 1: 8mg/kg i.v. day 1 cycle 2-6: 6mg/kg i.v. day 1 (=6 cycles q3w)
Other intervention name(s): Taxotere; Xeloda; Herceptin
Intervention MeSH terms: Docetaxel; Capecitabine; Trastuzumab; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epirubicin; Docetaxel; Capecitabine; Herceptin; Breast cancer
Evaluation of Intensive Parent-Child Interaction Therapy"
Condition: Behavior Problem; Parenting
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The purpose to the current study was to examine the comparative efficacy of a more condensed
      intensive version of Parent-Child Interaction Therapy (I-PCIT; 5 days/week over the course of
      2 weeks) versus a more traditional weekly PCIT format (1 day/week over the course of 10
      weeks) in treating early childhood externalizing behavior problems (EBP).
    

Detailed description: 
      The purpose to the current study was to examine the comparative efficacy of a more condensed
      intensive version of Parent-Child Interaction Therapy (I-PCIT; 5 days/week over the course of
      2 weeks) versus a more traditional weekly PCIT format (1 day/week over the course of 10
      weeks) in treating early childhood externalizing behavior problems (EBP). Using a randomized
      trial design, 60 young children (M child age = 4.33 years; range 2-6.92; 65% male; 85%
      Latinx) with elevated levels of EBP and their mothers were assigned to either I-PCIT (n = 30)
      or traditional PCIT (n = 30). Families completed pre-treatment and post-treatment assessments
      as well as a follow-up assessment 6-9 months following treatment completion. Across all
      assessments, mothers completed measures of child behavior, discipline practices, and
      parenting stress. Observational data on child behavior and parenting was also collected
      during three 5-minute standard situations that vary in the degree of parental control
      (child-led play, parent-led play, & clean-up).
    

Intervention name(s): Parent Child Interaction Therapy
Intervention type(s): Behavioral
Intervention description(s): Behavioral parent training program targeting parent-child relationship
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D and the Influenza Epidemic
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects included in ongoing vitamin d intervention trials were asked by questionnaire if
      they were ill with influenza during the winter season 2009/2010 to see if vitamin d
      supplementation prevented flu like disease.
    


Intervention name(s): choleclaciferol
Intervention type(s): Drug
Intervention description(s): 800-6000 IU cholecalciferol per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vitamin D; influenza; prevention