bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Lateral Positioning on Bronchial Cuff Pressure of Left-sided Double-lumen Endotracheal Tube During Thoracic Surgery
Condition: Lung Cancer; Pneumothorax
MeSH terms: Pneumothorax
Study type: Observational

Summary: 
      The investigators evaluate the effect of postural change on the bronchial cuff pressure (BCP)
      of double-lumen endotracheal tube (DLT) in patients undergoing thoracic surgery, by observing
      the pressure of the bronchial cuff before and after lateral decubitus positioning.
    

Detailed description: 
      It is essential to maintain proper cuff pressure in the endotracheal tube (ETT) when placing
      the ETT in the trachea in patients undergoing general anesthesia. Most of the literature
      recommend maintaining a pressure of 20-30 cmH2O to prevent cuff-related complications such as
      micro-aspiration or airway trauma. Proper pressure is also important for DLTs used in
      thoracic surgery. Furthermore, the cuff pressure of the ETT can change during the patient's
      positional changes. All things considered, we hypothesized that the change from supine to
      lateral decubitus position, which is essential for thoracic surgery would affect the BCP of
      the DLT.
    

Intervention name(s): Lateral decubitus positioning; Cuff-manometer
Intervention type(s): Behavioral; Device
Intervention description(s): After the DLT intubation, the patient is placed in lateral decubitus position; The pressure of the bronchial cuff should be measured with cuff-manometer in supine position, and then measurement should be repeated after lateral positioning.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 18-70 years with an American Society of Anesthesiologists (ASA) physical
        status 1 or 2, who are scheduled to undergo elective lung surgery requiring lateral
        decubitus positioning and one-lung ventilation (OLV) using left-sided DLT
      
Keywords: Double-lumen endotracheal tube; Cuff pressure
A Study to Evaluate the Safety, Tolerability and Plasma PK of a Single Oral Dose of Zoliflodacin in Healthy Male and Female Volunteers
Condition: Gonorrhoea
MeSH terms: Gonorrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is to evaluate the pharmacokinetics and safety profiles of the single-dose of
      zoliflodacin in eight healthy male or female subjects ages 18 to 45 years inclusive. All
      subjects will be dosed in the morning of Day 1 in a staggered fashion with a minimum of
      several minutes apart. Each subject will receive a single 4g dose of zoliflodacin (2 x 2 g
      sachets of zoliflodacin) after at least an 8-h fast, which will continue for at least 4 h
      after dosing. Consumption of water will be permitted during the fasting period. Subjects will
      be monitored as inpatients in the Clinical Trial Unit (CTU) up to Day 4 and at the Final
      Visit (Day 8 ± 2). Study duration is approximately 4 weeks with subject participation
      duration up to 10 days (from dosing to final visit). The primary objective of this study is
      to evaluate the plasma PK of zoliflodacin after administration of a single 4-g oral dose
      under fasting conditions.
    

Detailed description: 
      The trial will be performed as an open-label, non-randomized, single-dose design in eight
      healthy male or female subjects ages 18 to 45 years inclusive to evaluate the
      pharmacokinetics and safety profiles of the zoliflodacin formulation. All subjects will be
      dosed in the morning of Day 1 in a staggered fashion with a minimum of several minutes apart.
      Each subject will receive a single 4g dose of zoliflodacin (2 x 2 g sachets of zoliflodacin)
      after at least an 8-h fast, which will continue for at least 4 h after dosing. Consumption of
      water will be permitted during the fasting period. Subjects will be monitored as inpatients
      in the Clinical Trial Unit (CTU) up to Day 4 and at the Final Visit (Day 8 ± 2). Study
      duration is approximately 4 weeks with subject participation duration up to 10 days (from
      dosing to final visit). The primary objective of this study is to evaluate the plasma PK of
      zoliflodacin after administration of a single 4-g oral dose under fasting conditions. The
      secondary objective is to evaluate the safety and tolerability of a single 4-g oral dose of
      zoliflodacin.
    

Intervention name(s): AZD0914
Intervention type(s): Drug
Intervention description(s): Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent
Intervention MeSH terms: Zoliflodacin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ETX0914; Plasma Pharmacokinetic; Safety; Tolerability; Zoliflodacin
The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
Condition: Breast Reconstruction
Study type: Interventional

Summary: 
      Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to
      breast cancer patients and is considered an integral part of breast cancer treatment. In
      general, breast reconstruction can be accomplished using the patients own tissues or
      implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the
      market and the costs vary widely despite very similar qualities. The two most commonly used
      ADM products in North America by far are Dermacell and Alloderm. The difference between the
      two products include a) level of sterility, with Dermacell being sterilized to 10-9 while
      Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material
      and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has
      shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic
      trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards
      to the postoperative complications, namely infection, seroma formation (as measured by drain
      duration and output), loss of implant, incidence of revisional surgery and capsular
      contracture.
    


Intervention name(s): Alloderm; Dermacell
Intervention type(s): Device; Device
Intervention description(s): Reconstruction material; Reconstruction material
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with
      GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response
      to other drugs.
    

Detailed description: 
      This is a multicenter, open-label study in Japanese patients with compensated chronic
      hepatitis B with poor response to other drugs in order to evaluate the efficacy and safety of
      GSK548470 administered at a dose of 300 mg once daily. The target sample size is set at 32
      subjects. The primary objective is to evaluate the efficacy and safety of once-daily
      treatment with GSK548470 300 mg in subjects with compensated chronic hepatitis B with poor
      response to other drugs. The secondary objective is to evaluate the long-term efficacy and
      safety of once-daily treatment with GSK548470 300 mg.To evaluate the efficacy and safety of
      GSK548470 in the study, subjects receiving a combination of lamivudine (LAM) and adefovir
      pivoxil (ADV) will be switched to a combination of LAM and GSK548470, while subjects on
      entecavir hydrate (ETV) with or without ADV will be switched to a combination of ETV and
      GSK548470.
    

Intervention name(s): GSK548470 300 mg tablet
Intervention type(s): Drug
Intervention description(s): Blue tablets containing 300 mg of tenofovir disoproxil fumarate
Other intervention name(s): GSK548470
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tenofovir disoproxil fumarate, compensated chronic hepatitis B
Role of Ginkgo Biloba Extract in IUGR
Condition: Intrauterine Growth Restriction (IUGR)
MeSH terms: Fetal Growth Retardation
Study type: Interventional
Phase: Phase 2

Summary: 
      The use of herbal medicinal products is increasing enormously in recent years, mainly among
      women, who use them for the most varied purposes, such as in menstrual problems, menopausal
      symptoms, mood disturbances and to strengthen their bones. Most of these benefits are due to
      the flavonoids present in these products. These flavonoids have anticarcinogenic, antiviral,
      antioxidant and antiinflammatory activities, as well as being used in the treatment of
      osteoporosis, menopausal symptoms and cardiovascular diseases . Besides the benefits from the
      consumption of flavonoids, little is known about their safety and potentially harmful toxic
      effects, such as mutagenicity and genotoxicity which might occur if taken in large doses .
      Safety of Ginkgo biloba during pregnancy or lactation was not criticized in literature.
      Roasted and raw ginkgo seed were not reported in the evidence-based medicine literature as
      being either safe or contraindicated in pregnancy or lactation. A higher incidence of
      postpartum hemorrhage was reported in the literature when associated with a 3-month ingestion
      of Ginkgo Biloba extract. Flavonoids are components of Ginkgo biloba L. (Ginkgoaceae), a
      medicinal plant widely used by the population . G. biloba has its origin in China, Korea and
      Japan where its fruits and leaves have been used as food and medicine for a long time.

      The extract of G. biloba (EGb) is composed of different terpene trilactones, i.e.,
      ginkgolides A, B, C, J and bilobalide, many flavonol glycosides, biflavones and alkylphenols
      . The major flavonoids in the extract are kaempferol, quercetin and isorhamnetin] whose
      metabolites were found in the blood of rats and in human urine after oral administration of
      EGb. Due to its actions as an anti-inflammatory and antioxidant, EGb has been largely used in
      the treatment of Alzheimer's disease, pre-menstrual syndrome, cerebrovascular insufficiency
      and peripheral arterial occlusive disease . In folk medicine, EGb is used as a vermifuge, to
      induce labor, for the treatment of bronchitis, chronic rhinitis, chilblains, arthritis and
      edema . The aim of this study was to evaluate the effect of oral supplementation of Ginkgo
      Biloba extract on the fetal weight as well as feto-maternal blood flow in cases of
      intrauterine growth restriction.
    


Intervention name(s): Ginkgo Biloba Extract; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Predictive Value of eGFR for Adverse Cardiovascular Events in Patients With STEMI
Condition: ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Estimated glomerular filtration rate(eGFR) is significantly reduced in patients with
      ST-segment elevation myocardial infarction (STEMI). The aim of this study is to research that
      the incidence of adverse cardiovascular events (MACE) in patients with ST-segment elevation
      myocardial infarction is significantly higher when the glomerular filtration rate below a
      certain value.
    

Detailed description: 
      The investigators retrospectively analyzed the clinical data of 1157 patients with ST-segment
      elevation myocardial infarction. In-hospital adverse cardiovascular events (MACE) was defined
      as: cardiac arrest, cardiac rupture, malignant arrhythmia, and cardiac death. All the
      patients were divided into 3 groups according to the patient's estimated glomerular
      filtration rate(eGFR) (eGFR≥90ml/min/1.73m2; 90ml/min/1.73m2>eGFR≥60ml/min/1.73m2;
      eGFR<60ml/min /1.73m2). COX regression analysis and K-M survival curves are used to calculate
      the correlation between eGFR and in-hospital MACE.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        STEMI Patients
Influence of Virtual Reality on Myocardial Revascularization
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Coronary artery disease is a dysfunction characterized by the narrowing of the coronary
      arteries in due to the accumulation of atheromatous plaques. The surgery of myocardial
      revascularization is a surgical procedure of choice performed in individuals with to improve
      symptoms and survival. Cardiovascular surgeries of this size in an extended time of rest
      after the procedure. Such immobility may have repercussions to the functionality of the
      individual. Thus, the early mobilization with the use of reality in the Intensive Care Units
      (ICU) emerges as a potential means of of complications in the postoperative period of cardiac
      surgery.
    

Detailed description: 
      The study will be performed at the ICU coronary artery of the Hospital de Clínicas Gaspar
      Viana de Belém-Pará. 40 volunteers will participate in the study.

      preoperative period of myocardial revascularization. The oxidative stress (by the method
      called Optical Morphology by Oxidative Stress, using capillary blood drops), the modulation
      autonomic heart rate (with a Polar® model RS800CX) and motor function (through the Medical
      Research Council scale), before and after the application of protocol for cardiac
      rehabilitation with ergometer, virtual reality and ambulation. Volunteers will be randomized
      into a control group who receive the cardiac rehabilitation protocol from the hospital and
      the Early Mobilization Group, which will receive the cardiac rehabilitation protocol plus
      virtual reality training using Wii video game from Nintendo.
    

Intervention name(s): Virtual reality training; Control
Intervention type(s): Other; Other
Intervention description(s): training with Wii games, ergometer exercise, ambulation, standing exercises; chest physical therapy exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: virtual reality; physical therapy; myocardial revascualrization
Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy
Condition: IGA Nephropathy
MeSH terms: Kidney Diseases; Proteinuria; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 4

Summary: 
      TO ASSESS THE EFFICACY OF THE RENIN ANGIOTENSIN SYSTEM PLUS STEROIDS TO DECREASE THE AMOUNT
      OF PROTEINURIA IN IGA NEPHROPATHY
    

Detailed description: 
      Patients whose proteinuria was > 0.5 g/day were to receive enalapril plus valsartan coupled
      with oral 0.5 g/day of methylprednisone for 6 months.
    

Intervention name(s): ENALAPRIL VALSARTAN METHYLPREDNISONE
Intervention type(s): Drug
Intervention MeSH terms: Valsartan; Enalapril
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IGA NEPHROPATHY; STEROIDS; ENALAPRIL; VALSARTAN; PROTEINURIA; IMMUNOGLOBULIN A NEPHROPATHY (IGA NEPHROPATHY)
Development Study Using Vaginal Tactile Imager
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue
      elasticity parameters in the female pelvis.
    

Detailed description: 
      Pelvic organ prolapse affects 40-50% of women in US. This study aims to establish a reliable
      examination procedure, collect data necessary for assessing the performance of Vaginal
      Tactile Imaging sensors, assess clinical suitability of interface software and correlate
      elasticity measurements with clinical examination findings for normal versus prolapse
      conditions of the female pelvis.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult women with normal pelvic anatomy
Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      The study was performed to investigate the effects of a daily consumption of n-3 PUFA
      supplemented products (sausage, bread rolls, wafers, milk beverage) on cardiovascular risk
      factors in hypertriglyceridemic patients.
    

Detailed description: 
      Recent studies suggest that n-3 LC-PUFA intake might be useful to prevent coronary heart
      diseases.

      As a precondition for participating in this study, the patients were provided information in
      writing and verbally about the details of the study. Written informed consent was obtained
      from all volunteers. Before the beginning of the study, all participants were subject to a
      medical examination by their general practitioners. Sixty hypertriglyceridemic patients (with
      triacylglyceride (TAG) values ≥ 150 mg/dl or ≥ 1.7 mmol/L) should entered the study.

      The placebo-controlled, randomized double-blind cross-over study consists of two
      investigation periods of 10 weeks, with a ten-week washout period in between. After the
      washout period the intervention was crossed between the groups and the respective products
      were consumed for another 10 weeks. Patients in the placebo period receive 60g sausage, 2
      bread rolls (2x50g), 2 wafers and one bottle of the milk beverage daily. These products were
      enriched with sunflower oil (20g/d).

      In the intervention period, the products (60g sausage, 2 bread rolls (2x50g), 2 wafers and
      one bottle of the milk beverage) were enriched with a) 20g linseed oil, b) 20g echium oil,
      and c)12g microalgae powder. The daily dose of special n-3 fatty acid amounted to a) 10g
      alpha linolenic acid (ALA), b 2g stearidonic acid (SDA)+6g ALA, or c) 2g docosahexaenoic acid
      (DHA).

      Venous blood is collected at the beginning and at the end of each period.
    

Intervention name(s): n-3 PUFA
Intervention type(s): Dietary Supplement
Intervention description(s): products (sausage, bread rolls, milk beverage, wafers) enriched with Intervention a-c): n-3 rich plant oils/powder
linseed oil (20g/d)(PPM, Magdeburg)
echium oil (20g/d) (HARKE Nutrition)
microalgae powder(12g/d)(HARKE Nutrition)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: n-3 LC-PUFA; hypertriglyceridemic; human; TAG
Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction
Condition: Myocardial Infarction; Inflammation; Endothelial Dysfunction
MeSH terms: Myocardial Infarction; Inflammation; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      During myocardial infarction, inflammatory response may negatively influence ventricle wall
      remodeling as well as endothelium-dependent vasomotor function in the coronary and systemic
      arterial systems. Statins have been consistently proved to attenuate inflammation and improve
      endothelial function. In this study, we tested the effect of different doses of statin on
      inflammatory response and endothelium-dependent vasodilation.
    

Detailed description: 
      During acute coronary syndromes (ACS), the generation of inflammatory mediators negatively
      influences arterial wall remodeling and the endothelium-dependent vasomotor function in the
      coronary and systemic arterial systems. The intensity of this inflammatory upregulation is
      strongly related to the incidence of recurrent coronary events. High dose potent statins can
      rapidly reduce plasma levels of cholesterol-rich lipoproteins and inflammatory activity in
      subjects during ACS. By inference, it is plausible to hypothesize that these effects during
      the acute phase of myocardial infarction may influence the post-discharge endothelial
      dysfunction. So far, data is unavailable to verify this assumption or to define the potency
      required for such statin anti-inflammatory effect in myocardial infarction patients. The
      present study aim to investigate the role of statin dose on the time-course of the
      inflammatory response during the acute phase of myocardial infarction and its late effect on
      endothelium-dependent arterial dilation.
    

Intervention name(s): Simvastatin
Intervention type(s): Drug
Intervention description(s): Simvastatin
Intervention MeSH terms: Simvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: myocardial infarction; inflammation; endothelial dysfunction
Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
Condition: Skin and Soft Tissue Infections; Methicillin-resistant Staphylococcus Aureus
MeSH terms: Soft Tissue Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a randomized, double-blind, placebo-controlled, ascending single dose safety,
      tolerability, and pharmacokinetic study of orally administered EDP-322. This study was
      conducted at a single site. EDP-322 has a benefit to risk profile that supports testing in
      target patient populations.
    


Intervention name(s): EDP-322
Intervention type(s): Drug
Allocation: Randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Macrolides; Antibiotics; Safety; Tolerability; Pharmacokinetics; Phase I; MRSA/SSTI
Management of Spontaneous Ruptured Hepatocellular Carcinoma
Condition: Rupture, Spontaneous; Rupture Liver; Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Rupture, Spontaneous; Rupture
Study type: Observational

Summary: 
      To investigate the best treatment for hepatocellular carcinoma rupture
    

Detailed description: 
      To investigate the best treatment for hepatocellular carcinoma rupture, transcatheter
      arterial embolization or partial hepatectomy. Furthermore, to discuss the choice of emergency
      or staged hepatectomy.
    

Intervention name(s): Partial hepatectomy
Intervention type(s): Procedure
Intervention description(s): Partial hepatectomy was comprised of single or multiple liver resections aiming to excise all macroscopic tumors.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From January 2005 to June 2015, all patients complied with the criteria mentioned above who
        received partial hepatectomy or non-surgical at our center were included in this study.
      
Keywords: Partial hepatectomy; Emergency; Staged; Peritoneal dissemination; Propensity score matching