bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Acute Respiratory Distress Syndrome (ARDS) and Severe Sepsis on sRAGE Levels in ICU Patients
Condition: Acute Lung Injury; Acute Respiratory Distress Syndrome; Severe Sepsis; Septic Shock; Mechanical Ventilation
MeSH terms: Sepsis; Toxemia; Shock, Septic; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury; Syndrome
Study type: Observational

Summary: 
      sRAGE, the soluble form of the receptor for advanced glycation end products, is a novel
      marker of alveolar epithelial type I cell injury, but is also involved in acute systemic
      inflammation. The purpose of this observational prospective study is to determine whether
      sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during
      ALI/ARDS, regardless of associated severe sepsis or septic shock.
    

Detailed description: 
      BACKGROUND:

      The receptor for advanced glycation end products (RAGE was recently identified as a promising
      new marker of alveolar type I cell injury. RAGE is a member of the immunoglobulin superfamily
      that acts as a multiligand receptor and is involved in propagating inflammatory responses.
      While the precise function of RAGE remains unclear, the elevated levels of RAGE, and its
      soluble isoform sRAGE, correlate with severity of ALI/ARDS in human and animal studies, and
      RAGE levels could reflect impaired alveolar fluid clearance. Thus, it is possible that
      elevated levels of RAGE in ALI/ARDS derive in part from RAGE's role in systemic inflammatory
      cascades rather than purely from its release from alveolar type I cells.

      DESIGN NARRATIVE:

      This observational prospective clinical study will describe and compare sRAGE levels in the
      alveolar edema fluid and in the plasma from ICU patients enrolled within the first 24 hours
      after onset of ALI/ARDS and/or severe sepsis/septic shock, and from patients under mechanical
      ventilation (control group). Edema fluid and plasma samples will be collected simultaneously
      on day 1, day 3, day 6, and day 28 (or at ICU discharge), in order to describe kinetics of
      evolution of sRAGE levels. Undiluted pulmonary edema fluid samples will be collected in
      intubated patients only, and blood samples will be gathered from an indwelling arterial
      catheter. The concentrations of sRAGE will be measured in duplicate by ELISA.
    

Intervention name(s): sRAGE
Intervention type(s): Other
Intervention description(s): The purpose of this observational prospective study is to determine wether sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during ALI/ARDS, regardless of associated severe sepsis or septic shock
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Definied population
      
Keywords: Receptor for advanced glycation end products (RAGE); Soluble RAGE (sRAGE); Acute Lung Injury (ALI); Acute respiratory distress syndrome (ARDS); Severe sepsis; Septic shock; Alveolar epithelium; Mechanical ventilation; Intensive Care Unit (ICU)
Fludara (Oral) Phase II Study for Indolent Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.
    

Detailed description: 
      As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was
      originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer
      Schering Pharma AG, Germany.
    

Intervention name(s): Fludarabine Phosphate (Fludara)
Intervention type(s): Drug
Intervention description(s): Patients received Fludarabine Phosphate orally for 5 consecutive days, followed by a 23-day observation period. Setting this as 1 treatment cycle, 6 cycles will be given.
Other intervention name(s): BAY86-4864
Intervention MeSH terms: Fludarabine; Fludarabine phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fludarabine; Purine analog; Indolent lymphoma
Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioavailability of Primidone 50 mg tablets of
      Dr.Reddy's comparing with that of Mysoline@ tablets of Yamanouchi Pharma Technologies Inc, in
      healthy, adult, human subjects under fasting conditions.
    

Detailed description: 
      An open label, balanced. randomized, two-treatment, two-period, two-sequence, single
      dose,crossover, bioequivalence study of Primidone 50 mg tablets of Dr.Reddy's Laboratories
      Limited, Generics, India comparing with that of Mysoline (containing Primidone 50 mg) tablets
      of Yamanouchi Pharma Technologies Inc, Norman, OK in healthy, adult, human subjects under
      fasting conditions with a washout period of 14 days.
    

Intervention name(s): Primidone
Intervention type(s): Drug
Intervention description(s): Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Mysoline
Intervention MeSH terms: Primidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Primidone
Efficacy of Melatonin in Burning Mouth Syndrome (BMS)
Condition: Burning Mouth Syndrome
MeSH terms: Burning Mouth Syndrome; Syndrome; Burns
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether melatonin is effective in the treatment of
      burning mouth syndrome (BMS).
    

Detailed description: 
      This is a crossover trial involving a total of 20 patients with Burning Mouth Syndrome,
      considered a chronic neuropathic pain. In two consecutive treatment periods, both 8 week
      long, each patient receives externally indistinguishable capsules (placebo or melatonin). A 4
      weeks wash-out period is applied, between these two periods.

      The capsules contain either placebo or 3 mg-melatonin (4 time/day for a total of 12 mg/day of
      melatonin). The primary endpoint is the change in pain intensity at the end of each treatment
      period, measured using VAS, verbal intensity score and NRS, as well as number of oral sites
      affected by the burning sensation. Furthermore, data from quality of life, anxiety and sleep
      questionnaires are collected (sf-36, HAM-A, ESS, MOS).

      Adverse effects are carefully recorded as well as blood samples, in order to measure serum
      melatonin levels during the trial.
    

Intervention name(s): melatonin
Intervention type(s): Dietary Supplement
Intervention description(s): Cross-over randomized clinical trials
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: burning mouth syndrome; treatment; oral chronic pain
Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion
Condition: Radial Artery Occlusion
MeSH terms: Arterial Occlusive Diseases
Study type: Interventional

Summary: 
      Coronary artery disease (CAD) is one of the major health concerns among other
      non-communicable diseases globally. Cardiac catheterization is a diagnostic gold standard to
      determine the extent of disease in coronary arteries due to atherosclerosis. Among the two
      approaches for cardiac catheterization, trans-radial approach has gained more popularity than
      conventional trans-femoral approach over the past decade with availability of compression
      devices for radial artery that assures lesser risk of bleeding and hematoma and has
      translated into increased patient comfort and early mobility post procedure. Radial artery
      occlusion is a common complication of trans-radial procedures often ignored by the operator
      after procedure due to dual blood supply by ulnar artery. Although clinically silent usually,
      it necessitate the need of monitoring radial artery for patency because of risk of limited
      trans-radial access later.Reportedly, RAO occurs in about 10% of cardiac catheterizations. ,
      compression devices applied after sheath removal may be a contributing factor to radial
      artery occlusion because of selective pressure for extended time duration (3-4 hours).
      Various protocols have been developed to remove TR band by different institutions across the
      globe and have been tested to assess post procedure complications. To the best of what we
      know, there exists no standard protocol to deflate TR band. Also, the current protocol in
      practice at our institution has not been evaluated against other protocols that are followed
      in other institution across the globe claiming lesser post procedure complications. Hence,
      our aim was to test through a randomized trial whether our hospital standard protocol is
      non-inferior to the existing international protocol of Cohen & Alfonso that promises lesser
      complication rate
    


Intervention name(s): TR BAND removal protocol
Intervention type(s): Procedure
Intervention description(s): To assess radial artery patency after specific protocol used as already described in previous section.
Other intervention name(s): Ultrasound doppler, plethysmography
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The parallel group, non-inferiority trial
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Radial artery occlusion; TR band; Transradial catheterization
Effect of Preoperative Education Based on Roy Adaptation Model
Condition: Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      This research was conducted as a randomized controlled experiment to determine the effect of
      the education given by the Physiological Mode of Roy Adaptation Model in patients with hip or
      knee arthroplasty on physical adaptation and mobility.
    

Detailed description: 
      The research was conducted between 01.11.2017 - 01.04.2018 at the Orthopedics and
      Traumatology Surgery Service of a private University Hospital in Istanbul.

      In the study, the number of samples to be taken; the training, the training group control
      group mobility scale scores between The Observer at least 5% of the study considering that
      would make a difference, and power 80%, α=0.05 and power analysis adopted by participants for
      each group were calculated and it was determined that there should be at least 27.

      The sample was composed of 78 individuals 41 experimental and 37 control. Patients' physical
      adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility
      Scale and Physical Adaptation Assessment Form.

      Randomization of the study was achieved by planning patients who met the inclusion and
      non-inclusion criteria for training and control groups sequentially, without dividing them
      into hip or knee arthroplasty. In the randomization table, those with the number 1 are
      assigned to the training group.
    

Intervention name(s): Education booklet
Intervention type(s): Other
Intervention description(s): Hip/Knee Replacement Adaptation Booklet explains preoperative preparation, post-operative care practices, how to walk with walker, what needs to be done at home after discharge
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The sample was composed of 78 individuals 41 experimental and 37 control. The intervention group was given practical training in accordance with the adaptation booklet prepared by the researcher. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assesment Form. Data of the control and intervention groups were collected two times: preoperative and within 12 hours before the discharge.
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Roy Adaptation Model; hip arthroplasty; knee arthroplasty; physical adaptation; preoperative education
Safety and Efficiency of γδ T Cell Against Hepatocellular Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, effects of γδT cells on human hepatocellular liver cancer in combination with
      tumor reducing surgery, for example cryosurgery going to be investigated.
    

Detailed description: 
      Liver tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the
      patient will be separated from peripheral blood. After making them potential cancer killer γδ
      T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.
    

Intervention name(s): DC-CIK cells; γδ T cells; γδ T/DC-CIK cells
Intervention type(s): Biological; Biological; Biological
Intervention description(s): DC-CIK cells will be used against tumor cells.; γδ T cells will be used against breast tumor.; γδ T/DC-CIK cells will be used against breast tumor.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Immunotherapy, γδ T Cell, heptocellular liver cancer
Myocardial Protection in Minimally Invasive Mitral Valve Surgery
Condition: Myocardial Protection; Minimally Invasive Surgery; Mitral Valve Prolapse
MeSH terms: Mitral Valve Prolapse; Prolapse
Study type: Observational

Summary: 
      Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve
      (MV) surgery have evolved over time and remarkable short- and long-term results have been
      re-ported. However, some concerns have emerged about the adequacy of myocardial protection
      dur-ing the minimally invasive approach and about the role of aortic clamping strategies in
      this contest.

      Aim of this study was to compare the efficacy, in terms of myocardial protection, of the
      en-do-aortic clamp (EAC) versus the trans-thoracic aortic clamp (TTC) in patients undergoing
      right mini-thoracotomy MV repair.

      A single center, prospective observational study was performed between June 2014 to June 2018
      on patients undergoing right mini-thoracotomy MV repair with retrograde arterial perfusion
      and EAC or TTC. The selection of one setting in respect to the other was patient orientated.
      Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) and
      cardiac Troponin T (cTn-T) blood levels immediately after the surgical procedure and at 6,
      12, and 24 hours and compared between the two groups.
    


Intervention name(s): Aortic clamp
Intervention type(s): Device
Intervention description(s): In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All comers at our Deparment with diagnosis of mitral valve disease with surgical indication
        for mitral valve repair through the right mini-thoracotomy approach and retrograde arterial
        perfusion.
First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients
Condition: Kidney Transplant
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This first in human study aims at evaluating LIS1, a stabilized solution of purified anti-T
      lymphocytes polyclonal glyco-humanized swine IgG with immunosuppressive activity, in regards
      of safety, T cell depletion, and pharmacokinetics / pharmacodynamics in 10 kidney transplant
      recipients.
    


Intervention name(s): LIS1
Intervention type(s): Biological
Intervention description(s): LIS1 is an induction treatment on top of maintenance immunosuppressive regimen. All patients from AD and TD cohort will receive the conventional immunosuppressive regimen: tacrolimus (0.2 mg/kg) / mycophenolic acid (MMF, 2x1000 mg) / prednisone (20 mg from day 2). This conventional treatment should be started and monitored for all patients independently of their participation in the clinical trial. Methylprednisolone 500 mg / 100 mL saline / 30 minutes will be administered before reperfusion during the surgery and on post operation day 1 just before LIS1 administration.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a phase I/II interventional, uncontrolled, single center, open-label study with an adaptive design conducted in two cohorts: Ascending Dose (AD) cohort and Therapeutic Dose (TD) cohort.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immunosuppression; polyclonal IgG; allograft transplantation; induction treatment; acute graft rejection
Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing
Condition: Skin Diseases; Surgical Site Infection
MeSH terms: Surgical Wound Infection; Skin Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study evaluates the effects of to compare bactericidal efficacy using the
      reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub
      method in order to test if pass the standard european norm 12791.
    

Detailed description: 
      The investigators conducted a crossover clinical trial to evaluate the antiseptic
      effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by rub and scrub.
      Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.
    

Intervention name(s): Hand antisepsis by scrub; Hand antisepsis by scrub
Intervention type(s): Drug; Drug
Intervention description(s): Surgical Hand scrubbing using P-1 of both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side.; Surgical Hand rubbing using P-1 of both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side.
Other intervention name(s): Propanolol; Propanolol
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover design is used
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hand antisepsis
A Study of Single Doses of ABT-072 in Japanese Healthy Male Adults
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of
      blinded, single ascending oral doses of ABT 072 under non-fasting conditions in healthy adult
      Japanese male subjects.
    


Intervention name(s): ABT-072; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See arm description for more information; See arm description for more information
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers; HCV Infections
Evaluation of the Stinging Potential in Human Eyes
Condition: Sunscreen Agents
Study type: Interventional

Summary: 
      The objective of this study was to compare the human eye stinging potential of experimental
      formulas and an industry standard shampoo mixture. The study was conducted under the
      supervision of a Board Certified Ophthalmologist.
    


Intervention name(s): BAY 987516 (Y65-122); BAY 987516 (Y65-118); Control
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 µL in one eye; 5 µL in one eye; 5 uL in other eye
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Investigation of Scapular Dyskinesia, Shoulder Mobilization and Serve Speed Variables in Asymptomatic Adolescent Tennis Players
Condition: Healthy
MeSH terms: Dyskinesias
Study type: Observational

Summary: 
      Tennis is a sport where high performance, strokes and wide ranges of motion around the court
      must be created and high-strength movements are repeated repeatedly. Speed and control are
      important in terms of sportive performance during the serve throw in tennis. While these
      actions are taking place, a dynamic load that exceeds the physiological limits of the joint
      is placed on the shoulder. Disruption in the kinetic chain can cause injury to the shoulder.
      In this regard, the incidence of tennis injuries is approximately 21.5 injuries per 1000
      training hours. The glenohumeral joint creates a wide range of motion for the shoulder and is
      also biomechanically related to the scapula. Scapular dyskinesia, the pathological position
      of the scapula, has been associated with common pathologies such as rotator cuff tears,
      labral tears, and shoulder impingement. Although there are studies with different opinions
      about the causality of scapular dyskinesia, the current literature has reported that scapular
      dyskinesia is indirectly associated with shoulder pain in overhead athletes. Achieving
      maximum shoulder performance in sports that require overhead activities such as tennis
      largely depends on the delicate balance between the scapula and the clavicle, humerus and rib
      cage joints. Tennis, which is an increasingly widespread sport in our country, exposes the
      shoulder joints to high stresses. If changes are not detected and necessary precautions are
      not taken, the shoulder structure may be at risk of injury. In the current literature review,
      no study was found that evaluated the relationship between scapular dyskinesia, shoulder
      mobility and serving speed in tennis players. The aim of our study is to evaluate the effects
      of scapular dyskinesia, glenohumeral joint mobility and posterior capsule tension on serving
      speed in tennis players. It is thought that the results to be obtained from our study will
      guide the creation of appropriate exercise programs in athlete training by determining the
      effects on sportive performance by determining the changes seen or to be seen in the shoulder
      complexes of tennis athletes.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Asymtomatic dolescent tennis players aged 7-17 years who have been actively attending a
        tennis club for at least 1 year will be form tennis players group.
      
Keywords: Tennis; Adolescent; Scapular Dyskinesia; Shoulder Mobilization; Serve Speed
Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries
Condition: Athletic Injuries
MeSH terms: Wounds and Injuries; Soft Tissue Injuries; Athletic Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to determine whether Flector Patch is safe for use in
      children. The secondary purpose is to assess blood levels of diclofenac, the active
      ingredient in Flector Patch.
    


Intervention name(s): Diclofenac hydroxyethylpyrrolidine
Intervention type(s): Drug
Other intervention name(s): Flector Patch
Intervention MeSH terms: Diclofenac; Diclofenac hydroxyethylpyrrolidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Minor athletic injuries; Pain; Diclofenac; Topical