bioihbjkbjnl/mcl2 huggingface dataset:
Outcome of Patients Undiagnosed Under Medical Thoracoscopy
Condition: Pleural Diseases
MeSH terms: Pleural Diseases
Study type: Observational

Summary: 
      Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in
      the diagnosis of pleural diseases. MT has an overall diagnostic yield above 90% for malignant
      pleural diseases and pleural tuberculosis. However, others who are diagnosed as fibrinous
      pleuritis make confusion in clinicians. Whether these patients are firmly followed or not ?
      The investigators do not know the answer of this question.

      In this study the investigators aimed to investigate the outcome of the patients who are
      diagnosed as fibrinous pleuritis on MT biopsies.
    

Detailed description: 
      Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in
      the diagnosis of pleural diseases with a sensitivity above 90% and specificity of 1000% for
      malignant pleural diseases and pleural tuberculosis. Except these two groups of patients, in
      others pleural histopathological diagnosis is defined as "non-specific pleuritis" or
      "fibrinous pleuritis". Authors say that the natural evolution of these patients is poorly
      understood. Some of these patients was later established false negative cases for malignant
      pleural diseases. Clinical guidelines recommend close observation of patients with
      undiagnosed exudative effusions, although the length and follow-up regime is not defined,
      yet. In this study the investigators examine the outcome of patients who are diagnosed as
      fibrinous pleuritis by MT.
    

Intervention name(s): Medical thoracoscopy
Intervention type(s): Procedure
Intervention description(s): Performing medical thoracoscopy to diagnose pleural diseases after cytological and other investigational tests.
Other intervention name(s): Rigid thoracoscopy for diagnosis of pleural diseases
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients with undiagnosed exudative pelural effusion by clinical, radiological or
        laboratory investigations.
      
Keywords: Medical thoracoscopy; Pleural effusion; Malignant pleural diseases; Tuberculous pleuritis; Fibrinous pleuritis
Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery
Condition: Hypoplastic Left Heart Syndrome; Heart Defects, Congenital; Pediatric Disorder
MeSH terms: Heart Defects, Congenital; Hypoplastic Left Heart Syndrome; Congenital Abnormalities; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the safety and feasibility of coronary infusion of autologous
      placental cord blood mononuclear cells during the Norwood heart operation in newborn
      hypoplastic left heart syndrome (HLHS) patients.
    

Detailed description: 
      This is a Phase I, open label safety study. Autologous cord blood mononuclear cells (stem
      cell containing, cord blood buffy coat fraction) was delivered by coronary infusion during
      the Norwood cardiopulmonary bypass operation in 10 antenatally diagnosed HLHS patients within
      2-3 days of birth. Safety and clinical status monitoring was performed to Stage II surgical
      intervention for HLHS (at approximately 3 months of age). Treated patients will continue to
      be assessed beyond the trial during follow up between Stage II and III (Fontan) surgical
      interventions.
    

Intervention name(s): Autologous Human Placental Cord Blood Mononuclear Cells
Intervention type(s): Biological
Intervention description(s): Autologous human placental cord blood mononuclear cells are infused into the coronary artery during the Norwood heart operation
Other intervention name(s): Cord blood buffycoat mononuclear cells, incl stem cells
Intervention model: Single Group Assignment
Intervention model description: Safety
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cord blood stem cell; Norwood heart surgery; congenital; heart
The Effectiveness of MSAT for Patients With ROM Limitation of the Shoulders
Condition: Shoulder Joint Disorder
MeSH terms: Joint Diseases
Study type: Observational [Patient Registry]

Summary: 
      This study is a prospective, case-control observational trial. The investigators will compare
      the MSAT group to the control group to analyze the effectiveness of shoulder MSAT.
    

Detailed description: 
      Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle
      created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to
      move the part of their body actively during acupuncture treatment under physicians'
      observation. This treatment is known to relieve the pain and increase the range of
      motion(ROM). However, there has been no specific value for the effect of this treatment.

      Therefore, The investigators conducted observational trial to analyze the effectiveness of
      shoulder MSAT. From July 2019, The investigators will collect 80 patients with ROM limitation
      on both or each shoulder and who are suffering from shoulder pain with the numeric rating
      scale(NRS) over 4.

      The investigators will compare pain, dysfunction, quality of life and satisfaction of
      patients who are treated with Korean medical treatment including MSAT and patients who are
      treated with Korean medical treatment not including MSAT.

      For these two groups, The investigators will compare Range Of Motion(ROM), NRS(Numeric Rating
      Scale), Visual Analogue Scale(VAS), Shoulder Pain and Disability Index(SPADI), Patient Global
      Impression of Change (PGIC) and EuroQol 5-Dimension (EQ-5D-5L).
    

Intervention name(s): Motion Style Acupuncture Treatment(MSAT)
Intervention type(s): Procedure
Intervention description(s): Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are treated in Haeundae Jaseng Korean Medicine Hospital
      
Keywords: Shoulder joints; ROM; Shoulder disorder; MSAT; Motion Style Acupuncture Treatment; Shoulder pains
An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      Tuberculosis remains a concerning health problem, with Mycobacterium Tuberculosis (MTB) now
      causing more deaths than acquired immune deficiency syndrome (AIDS). GSK3036656 is a compound
      with a novel mechanism of action under development for the treatment of tuberculosis. It
      suppresses protein synthesis in MTB by selectively inhibiting the enzyme Leucyl t-ribose
      nucleic acid (RNA) synthetase. Thus, this study will investigate the early bactericidal
      activity, safety and tolerability of GSK3036656 in up to four sequential cohorts of subjects
      with rifampicin-susceptible tuberculosis. The primary objective of this dose-escalation study
      is to establish the anti-tuberculosis effect of GSK3036656 on serial colony forming units
      (CFU) counts of MTB in sputum over 14 days of therapy. Subjects in each cohort will be
      randomized in 3:1 ratio to one of two treatments: either GSK3036656 or standard-of-care
      (RIFAFOUR® e-275) regimen. The approximate duration of the study for an individual subject
      will be 5 weeks, including 1 week of screening, 2 weeks of treatment period and another 2
      weeks of final follow-up visit. RIFAFOUR e-275 is a registered trademark of Sanofi-Aventis.
    


Intervention name(s): GSK3036656; Rifafour e-275
Intervention type(s): Drug; Drug
Intervention description(s): GSK3036656 will be administered; Rifafour e-275 will be administered
Intervention MeSH terms: GSK656
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Eligible subjects in each cohort will be randomized to receive sequential doses of either GSK3036656 or standard-of-care (RIFAFOUR) regimen. This study will employ dose escalation, where the decision to proceed to each subsequent dose level will be made based on safety, tolerability and preliminary pharmacokinetic data from the prior cohort.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Early bactericidal activity; Mycobacterium Tuberculosis; GSK3036656; Pulmonary tuberculosis; Colony forming units
Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age
Condition: Neurodevelopmental Disorders
MeSH terms: Neurodevelopmental Disorders
Study type: Observational

Summary: 
      This study is a retrospective cohort study. The PICU children will include all surviving
      children who were admitted to the PICU of Copenhagen University Hospital between 1st of
      January 2002 and 31st of December 2016.

      A link to a questionnaire including the Strengths-and-Difficulties parental questionnaire
      evaluating neurodevelopmental- and behavioral impartment as well as question on current
      impairments and health, will be sent to parents. For the children aged between 11 and 17
      years an additional self-rated questionnaire will be provided.
    

Detailed description: 
      This study is a retrospective cohort study. The PICU children will include all surviving
      children who were admitted to the pediatric intensive care section of the Department of
      Neonatology of Copenhagen University Hospital between 1st of January 2002 and 31st of
      December 2016.

      The Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and
      behavioral impartment is web-based an hosted on a safe hospital server. The link will be sent
      to the universat digital post-box that all Danish citizens use for contact to the public
      authorities. For the children aged between 11 and 17 years an additional self-rated
      questionnaire will be provided. Furthermore, parents will answer questions on chronic
      illness, motor and sensory handicap, and special pedagogical support in day care institutions
      and school.
    

Intervention name(s): admission to pediatric intensive care with mechanical ventilation
Intervention type(s): Other
Intervention description(s): admission to pediatric intensive care with mechanical ventilation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents
The Breakfast Study
Condition: Glycemic Response; Hunger
Study type: Interventional

Summary: 
      The overall objective is to investigate the effects of low and high glycemic index (GI) meals
      varying in protein content on plasma glucose and insulin response, subjective ratings of
      hunger, and subsequent food intake in twenty healthy, sedentary, overweight and obese men and
      women between the ages of 21-65.
    

Detailed description: 
      Each individual will participate separately in four testing sessions. Each testing session
      will last for approximately 5 hours and will be separated by a minimum of one week.
      Participants will arrive at the Temple University GCRC or CORE at either 7:30 a.m. or 8:30
      a.m. after an overnight fast (10-12 hours) to ensure that all participants are in the same
      metabolic state. Upon arrival the experimenter will ask participants to complete a
      pre-session questionnaire and rate their feelings of hunger and satiety on a visual analog
      scale (VAS). An indwelling catheter will be inserted in an antecubital vein by the study
      nurse and a baseline blood sample will be obtained for measurement of glucose and insulin
      concentrations. Glucose will be measured by the glucose oxidase method using a glucose
      analyzer and insulin will be measured by radioimmunoassay.

      One of four isocaloric meals (see example below), varying in macronutrient content and GI
      value of foods, will be administered in random order at either 8:00 a.m. or 9:00 a.m. Energy
      density will be controlled. The meal and 8 ounces of water will be consumed within fifteen
      minutes. A short visual analog questionnaire will be distributed at the conclusion of the
      meal to rate the meal consumed. Blood samples will be taken 15 minutes after food consumption
      and at 30 minute intervals (i.e., 30, 60, 90, 120, 150, 180, 210, and 240 minutes) over four
      hours following administration of the meal. Four milliliters of blood will be collected at
      each time point (via indwelling catheter), resulting in a total of 40 milliliters of blood
      collected at each study session and 160 milliliters (i.e., 40 ml x 4 testing sessions) within
      an 8 week time period. Participants will be asked to rate their feelings of hunger at these
      time points. Following the last blood sample, participants will be given the opportunity to
      consume food ad libitum from a buffet style lunch. Based on known serving sizes and
      measurements of unconsumed food, the amount of food eaten and its associated energy content
      will be determined.
    

Intervention name(s): high GI; Low GI; Low GI Low Carb; High GI Low carb
Intervention type(s): Other; Other; Other; Other
Intervention description(s): high GI and high carb breakfast; low GI, high carb breakfast; low GI low carb breakfast; high GI low carb breakfast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glycemic response; hunger
Safety Study of Ointment for the Treatment of Plaque-type Psoriasis
Condition: Plaque-type Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how much drug is absorbed throughout the body after
      being applied to the skin.
    


Intervention name(s): AN2728 Ointment; AN2728 Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): 5mg/cm2, BID; 5mg/cm2 BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis
Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant
Condition: Orbital Trauma; Orbital Fractures
MeSH terms: Orbital Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining
      appropriate consent, they are entered into either a control arm where reconstruction of the
      orbit is done with a titanium mesh (established practice) or the experimental arm where
      reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are
      followuped at 1 week, 1 month, 3 months, 6 months & 12 months. CT scan of the orbits are
      performed preop, 6 months & 12 months. End point is the 12 month follow-up appointment.
      Visual acuity, range of motion, enophthalmos & diplopia are assessed in follow-up.
    

Detailed description: 
      Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining
      appropriate consent, they are entered into either a control arm where reconstruction of the
      orbit is done with a titanium mesh (established practice) or the experimental arm where
      reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are
      followuped at 1 week, 1 month, 3 months, 6 months & 12 months. CT scan of the orbits are
      performed preop, 6 months & 12 months. End point is the 12 month follow-up appointment.
      Visual acuity, range of motion, enophthalmos & diplopia are assessed in follow-up.
    

Intervention name(s): Osteosheet(r)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: orbit; orbital; trauma; fractures; facial
Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine
Condition: Influenza; Orthomyxoviridae Infections
MeSH terms: Influenza, Human; Influenza in Birds; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza
      vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity
      using adjuvants were initiated. The present study is part of this endeavor. It is primarily a
      formulation/dose-finding study with a secondary aim at generating safety and immunogenicity
      data for the final formulation for the development of a pre-pandemic vaccine.
    

Detailed description: 
      This is a Phase I, observer-blinded, randomized, controlled multicenter, dose-finding study
      in adult subjects. All vaccines will be administered as a two-dose schedule in (H5N1)
      immunologically-naïve adults. Immunogenicity and safety will be evaluated after each
      injection.
    

Intervention name(s): Monovalent subvirion H5N1 influenza vaccine; Monovalent subvirion H5N1 influenza vaccine; Monovalent subvirion H5N1 influenza vaccine; Monovalent subvirion H5N1 influenza vaccine; Monovalent subvirion H5N1 influenza vaccine; Monovalent subvirion H5N1 influenza vaccine; Monovalent subvirion H5N1 influenza vaccine; Monovalent subvirion H5N1 influenza vaccine; Physiological saline
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, IM, 2 injections, Formulation 1; 0.5 mL, IM, 2 injections, Formulation 2; 0.5 mL, IM, 2 injections, Formulation 3; 0.5 mL, IM, 2 injections, Formulation 4; 0.5 mL, IM, 2 injections, Formulation 5; 0.5 mL, IM, 2 injections, Formulation 6; 0.5 mL, IM, 2 injections, Comparator 1; 0.5 mL, IM, 2 injections, Comparator 2; 0.5 mL, IM, 2 injections
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; A/H5N1; Orthomyxoviridae Infections; Influenza Pandemics
Romiplostim in Thoracic Transplantation
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Observational

Summary: 
      The investigators developed a platelet transfusion saving strategy based on thrombopoietin
      administration in heart or lung transplantation (HLT) patients or assist device implantation
      in bridge-to-transplantation (BTT) or bridge to-decision (BTD). This strategy was applied
      from May 2014 to October 2015 in patients whose platelet counts were below 100 Giga per liter
      (G/L). As part of a health care quality improvement project, the investigators evaluated this
      strategy in a before/after design. January 2010 to December 2013 constituted the before
      period.
    

Detailed description: 
      In may 2014, after Heart or Lung transplantation or assist device implantation, the
      investigators decided to off-label administered Romiplostim in patients with thrombocytopenia
      below 100 Giga per liter. The purpose was to reduce platelets transfusion side effects.
      Romiplostim was used off treatment algorithm was based on previously published data in
      idiopathic, thrombocytopenia, cirrhotic and hematological patients. The first subcutaneous
      injection of 1.5 to 2 μg/kg of romiplostim was administered in the postoperative periods. An
      algorithm based on patient weight and platelet count evolution was established to determine
      romiplostim doses to administered weekly. Romiplostim posology was adjusted between 2 and
      5μg/kg according to platelet count with a maximum of 4 administrations in the ICU. If
      platelets remained below 50 Giga per liter after 2 injections, bone marrow analysis after
      hematologist referral was discussed. Platelet count until day 15 after the last injection was
      monitored to detect thrombocytosis.

      In January 2016, the investigators decided to retrospectively assess Romiplostim
      implementation in the standard of care in the ICU through a Healthcare quality improvement
      project in a before/after design.
    

Intervention name(s): Non interventional study
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Heart or lung transplantation (HLT) patients or assist device implantation in
        bridge-to-transplantation or to-decision; with platelet counts below 100G/L at least once
        in the post-operative period
      
Keywords: transfusion saving strategy; heart or lung transplantation; assist device; Extra Corporal Life Support (ECLS); Left Ventricular Assist Device (LVAD ); Total artificial Heart
Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients
Condition: Pruritis
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in
      the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled
      comparative trial.
    

Detailed description: 
      This was a 4-week, randomized, double-blind, controlled study. Fourteen subjects received
      treatment lotion (1% pramoxine HCl) and the remaining 14 received a bland emollient (Cetaphil
      lotion). A target lesion limited to one anatomic site, excluding face and genitals, was
      selected at baseline. Each subject was instructed to apply lotion twice daily to all affected
      areas of pruritus for four weeks. The use of any other topical or systemic medication to
      treat uremic pruritus was not permitted while participating in the study. Subjects were
      clinically evaluated for erythema, xerosis, lichenification and overall severity at baseline,
      week 1, and week 4 (end of study)
    

Intervention name(s): Sarna; Cetaphil
Intervention type(s): Drug; Drug
Intervention description(s): Active Ingredient: Pramoxine Hydrochloride Inactive ingredients:Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate (&) PEG-100 Stearate, Isopropyl Myristate, Petrolatum, PEG 8 Stearate, Purified Water, Stearic Acid, Sodium Hydroxide; Purified Water, Glycerin, Hydrogenated Polyisobutene, Cetearyl Alcohol, Ceteareth 20, Macadamia Nut Oil, Dimethicone, Tocopheryl Acetate, Stearoxytrimethylsilane, Stearyl Alcohol, Panthenol, Farnesol, Benzyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Citric Acid
Other intervention name(s): Cetaphil Lotion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Uremic Pruritis