bioihbjkbjnl/mcl2 huggingface dataset:
Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction
Condition: Acute Myocardial Infarction; Acute Myocardial Ischemia; STEMI - ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Myocardial Ischemia; ST Elevation Myocardial Infarction; Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of
      Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction
    

Detailed description: 
      Dutogliptin 60 mg administered by twice daily subcutaneous (SC) injection for 14 days in
      combination with a fixed standard dose of filgrastim (10 µg/kg) administered SC daily for 5
      days. This study will be conducted in adults with ST-elevation myocardial infarction (STEMI)
      with successful revascularization following percutaneous coronary intervention (PCI) and
      stent implantation.

      Primary Objective

      • To evaluate the safety and tolerability of dutogliptin in combination with filgrastim in
      subjects with STEMI compared with placebo

      Secondary Objectives

        -  To assess preliminary efficacy of dutogliptin in combination with filgrastim in subjects
           with STEMI compared with placebo as determined by cardiac magnetic resonance imaging
           (cMRI)

        -  To determine the pharmacokinetics (PK) of dutogliptin in a subset of the study
           population

        -  To establish the pharmacodynamics (PD) of dutogliptin (plasma DPP4 activity) in a subset
           of the study population

      Exploratory Objectives

        -  To examine the effects of dutogliptin in combination with filgrastim on:

        -  Change from baseline in plasma stromal cell-derived factor (SDF)-1a levels

        -  Change from baseline in plasma biomarkers, including N-terminal pro-b-type natriuretic
           peptide (NT-proBNP) and high sensitivity troponin
    

Intervention name(s): Dutogliptin Tartrate; Filgrastim Injectable Product; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active treatment; Active treatment; placebo control
Other intervention name(s): dutogliptin; filgrastim; placebo
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      Heart failure with normal ejection fraction is often under diagnosed and certainly under
      treated in hemodialyzed patients. Because of the benefit of reducing heart rate, ivabradine,
      a pure heart-rate lowering agent without effects on blood pressure, is of potential
      therapeutic utility.
    


Intervention name(s): Ivabradine
Intervention type(s): Drug
Intervention description(s): ivabradine titrated to 7.5 mg BID
Other intervention name(s): Procoralan; Corlentor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart failure with normal ejection fraction; hemodialysis patients; ivabradine; Echocardiography; NYHA class; 6-minutes walking test
Comparison of Efficacy of Two Supraglottic Airway Devices: I-gel and the Self-pressurized Air-q in Elderly Patients
Condition: Supraglottic Airway Devices
Study type: Observational

Summary: 
      Supraglottic airway devices with noninflatable cuff have advantages in omitting the cuff
      pressure monitoring and reducing potential pharyngolaryngeal complications. Typical devices
      without cuff inflation available are the i-gel™ and the self-pressurized air-Q™ intubating
      laryngeal airway (air-Q SP).

      The i-gel airway is a supraglottic airway management device made of thermoplastic elastomer,
      which is soft, gel-like, and transparent. It was designed to create a noninflating anatomical
      seal of the pharyngeal, laryngeal, and perilaryngeal structures while avoiding the
      compression trauma that can occur with inflatable SADs.

      The i-gel has evolved as a device that accurately positions itself over the laryngeal
      framework, providing a reliable perilaryngeal seal, and therefore no cuff inflation is
      necessary. Its advantages include easier insertion, minimal risk for tissue compression, and
      stability after insertion.

      The air-Q is a new SAD intended for use as a primary airway and an aid for tracheal
      intubation in situations of anticipated or unanticipated difficult airways. The intracuff
      pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the
      patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and
      seal.

      The anatomical and physiological changes that accompany ageing may have a significant
      influence on the efficacy and safety of SADs. The distinctive features of the air-Q SP and
      i-gel may lead to a substantial difference in performance in the elderly, and it is planned a
      head-to-head comparison of these two devices in patients aged between 65 and 85 years.
    


Intervention name(s): I-gel; Self-pressurized air-Q
Intervention type(s): Device; Device
Intervention description(s): The i-gel airway is a supraglottic airway management device made of thermoplastic elastomer, which is soft, gel-like, and transparent.
The i-gel has evolved as a device that accurately positions itself over the laryngeal framework, providing a reliable perilaryngeal seal, and therefore no cuff inflation is necessary.; The self-pressured air-Q is a supraglottic airway management device The intracuff pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and seal.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        65-85 years old patients who undergo urologic surgery
Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is the evaluation of a bioimpedance method for determination of dry
      weight in dialysis patients. Additionally normal tissue hydration in non-Dialysis patients is
      investigated in healthy subjects and patients with chronic kidney disease in stages K/DIGO
      I-IV
    


Intervention name(s): Bioimpedance Analysis
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Post-COVID-19 Pneumo-hematocele
Condition: COVID-19 Respiratory Infection
MeSH terms: COVID-19; Respiratory Tract Infections; Hematocele
Study type: Observational

Summary: 
      Introduction. As the COVID-19 pandemic has continued, an increasing number of long-term
      complications are emerging. Recently, the appearance of characteristic pulmonary lesions has
      been noted, being described as post COVID-19 pneumatocele. The aim of this study is to
      describe the clinical, histopathologic and imaging features of post COVID-19
      pneumo-hematoceles (PHC) and secondarily to suggest a treatment algorithm in these patients.

      Methods. A retrospective study was performed in patients admitted with diagnosis of SARS-CoV2
      infection from March 2020 to September 2021 who presented PHC on imaging studies. Clinical
      and demographic variables were recorded and CT scans were analyzed. A logistic regression
      analysis was performed to determine the risk for rupture according to PHC characteristics.

      It appears that PHC occurs secondary to encapsulation of blood accumulation, the result of
      micro capillary bleeding, with partial reabsorption of blood and subsequent air filling. The
      recommendation is to operate on patients with PHC of 5cm and those with persistent lesions of
      3cm.
    


Intervention name(s): Pulmonary resection
Intervention type(s): Procedure
Intervention description(s): Resection of pneumohematocele
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a positive chain reaction for SARS CoV-2 who had PHC on imaging studies in
        two hospitals of Mexico City
      
Keywords: COVID-19; Pneumohematocele; Giant bullae; Pneumatocele
Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy
Condition: Male Partner; HIV Counseling and Testing; Home Based; Pregnancy
Study type: Interventional

Summary: 
      The investigators hypothesize that home based HIV counseling and testing can increase male
      partner uptake of HIV testing during pregnancy.

      The investigators study aims through a randomized clinical trial to determine whether a
      home-based model (HBM) versus a partner-friendly clinic model (PFM) can increase male uptake
      of HIV counseling and testing during pregnancy.
    


Intervention name(s): HIV counseling and testing
Intervention type(s): Other
Intervention description(s): Male partner HIV counseling and testing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Male partner; HIV counseling and testing; Home based; Pregnancy
GSK372475 Bioequivalence Study
Condition: Healthy Subjects; Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is to show the new salt formulation of GSK372475 is equivalent to the old salt
      formulation of GSK372475.
    


Intervention name(s): GSK372475
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Bioequivalence
Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults
Condition: Healthy Adult Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      The prescription of intravenous maintenance solutions - although widespread - lacks important
      data on the optimal sodium and potassium content, which has given rise to an important debate
      in the scientific literature. Our study compares two different infusion fluids in 12 healthy
      adult volunteers without renal failure in a single-blind randomized crossover design over two
      48 hour periods during which subjects are not allowed to eat or drink. Fluid 1 is a premixed
      solution containing 54 mmol/L of sodium and 26 mmol/L of potassium; fluid 2 is sodium
      chloride 0.9% in glucose 5% with 40 mmol/L of potassium. Both solutions are administered at
      25 mL/kg of ideal body weight, as recommended by current guidelines (NICE 174) and both
      solutions are widely used in daily clinical practice. The primary hypothesis is that isotonic
      maintenance solutions lead to more fluid retention than hypotonic fluids. Metabolism of both
      solutions is assessed by sequential analysis of urine and serum, clinical parameters and
      bioelectrical impedance analysis.
    


Intervention name(s): NaCl 0.9% in Glucose 5% with 40mEq Potassium; Glucion 5%
Intervention type(s): Drug; Drug
Intervention description(s): NaCl 0.9% in Glucose 5% with 40mEq Potassium, administered at 25 mL/kg IBW/h for 48h; Glucion 5% (premixed solution containing 54 mmol/L sodium and 26 mmol/L potassium amongst others), administered at 25 mL/kg IBW/h for 48h
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Maintenance; Intravenous solutions; Intravenous fluids; Tonicity; Potassium; Sodium; Fluid retention
Bioavailability of BIBR 963 ZW After 50 mg of BIBR 1048 MS With and Without of Pantoprazole in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the amount of BIBR 953 ZW in urine of 50 mg of BIBR 1048 bid over three days each
      administered as four experimental capsule formulations relative to drinking solution with and
      without coadministration of 40 mg pantoprazole.
    


Intervention name(s): BIBR 1048 MS Capsule A; BIBR 1048 MS Capsule B; BIBR 1048 MS Capsule C; BIBR 1048 MS Capsule D; BIBR 1048 MS tartaric acid solution; Pantoprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Pantoprazole; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery
Condition: Tympanomastoid Surgery; Cochlear Implant; Mastoidectomy; Cholesteatoma
MeSH terms: Cholesteatoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators goal is to determine the efficacy and duration of analgesia with the
      addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of
      the great auricular nerve in children undergoing tympanomastoid surgery.
    

Detailed description: 
      The surgical anesthesia during the operative procedure will be maintained using volatile
      anesthetics. No prophylactic dexamethasone or ondansetron would be provided to any patients
      in either group. Anesthesia will be discontinued at the end of the procedure and the patient
      will be extubated once standard extubation criteria have been met. Patients will be then
      taken to the postoperative recovery room where they will be evaluated for pain and discomfort
      by a blinded observer using the CHIPPS (Children and Infants Postoperative Pain Scale). If
      two consecutive pain scores at 5 minute intervals is >6, they will be rescued with
      incremental doses of 0.05 mg/kg of intravenous morphine required to reach a score of <6. The
      number of rescue doses as well as the pain scores will be documented. These patients will be
      also observed for the presence of nausea/vomiting. Any patient who vomits more than two times
      will be rescued with ondansetron 0.1 mg/kg intravenously. All patients will be continued to
      be evaluated in the 23 hour unit. Pain and side effects will be assessed for the next 6 hours
      or until discharge from the 23 hour observation facility. Standard doses of acetaminophen
      with codeine will be provided for pain relief in the 23 hour observational unit, as well as
      on discharge. The number of doses of acetaminophen with codeine will be recorded. Time to
      discharge from the hospital will also be noted. A questionnaire designed to address
      parent/patient satisfaction will be utilized and will allude to the need for rescue analgesia
      and the need for any other additional analgesics provided. The use of any additional rescue
      pain medication will be provided to the families at the time of discharge. A follow-up phone
      call will be made in 24 hours to note the information provided on the questionnaire.
    

Intervention name(s): 0.25% Bupivacaine + Clonidine
Intervention type(s): Drug
Intervention description(s): Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
Other intervention name(s): Marcaine
Intervention MeSH terms: Clonidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Tympanomastoid Surgery; Cochlear Implant; Mastoidectomy; Cholesteatoma; Pediatrics; Clonidine; Bupivacaine; Greater Auricular Nerve Block; Regional Anesthesia
How is Physical Activity Level and Educational Expectations of Patient With Knee Osteoarthritis : Epidemiological Study in Spa Therapy
Condition: Knee Osteoarthritis; Physical Activity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      The primary purpose is to evaluate the level of physical activity in patients with knee
      osteoarthritis in a spa treatment and doing epidemiological study about this patient.
    

Detailed description: 
      Explain the physical activity level of knee osteoarthritis by socio-demographic, clinical
      variables, barriers and facilitators of regular physical activity practice, fears and beliefs
      about their condition, functional limitations and physical inactivity.
    

Intervention name(s): Epidemiological study Survey
Intervention type(s): Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients with knee pain reported to osteoarthritis
      
Keywords: Physical activity level; Knee osteoarthritis; Non pharmacological treatment; Survey; Socio-demographic, clinical variables; Barriers, facilitators Fears and beliefs; Function
Correlation Between Various Inflammatory Markers and Vascular Inflammation Measured by 18FDG-PET
Condition: Atherosclerosis
MeSH terms: Atherosclerosis; Inflammation
Study type: Observational

Summary: 
      Vascular inflammation is a key factor in both the pathogenesis and outcome of
      atherosclerosis. Various inflammatory markers such as LpPLA2,MCP-2 and hsCRP are well-known
      prognostic factors for the cardiovascular event.

      18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for
      identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore,
      the purpose of the study is to demonstrate the correlation between various inflammatory
      markers and vascular inflammation detected by 18FDG-PET.
    


Intervention name(s): Cross section study
Intervention type(s): Other
Intervention description(s): This is not intervention study. The purpose of the study is to examine the relationship between various inflammatory markers and PET imaging at the cross section setting
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy participatin who underwent a medical health check in the health promotion center in
        Korea Guro University
      
Biospecimen description: 
      Whole blood, serum
    
Keywords: atherosclerosis; vascular inflammation; LpPLA2; hsCRP; MCP-1; 18FDG-PET
Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10
      mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical
      status, adverse events and laboratory investigations and assess relative safety and tolerance
      under fed conditions.
    

Detailed description: 
      An open-label randomized, single dose, two way crossover oral bioequivalence study to compare
      Amlodipine Besylate/Benazepril Hydrochloride 10 mg/40 mg capsules (Dr. Reddy's Laboratories
      Ltd.,) with Lotrel® capsules Novartis Pharmaceuticals Corporation in healthy human subjects
      under fed conditions.
    

Intervention name(s): Amlodipine Besylate/Benazepril HCl
Intervention type(s): Drug
Intervention description(s): Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules
Other intervention name(s): Lotrel
Intervention MeSH terms: Amlodipine; Benazepril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound for Comparison of Gastric Antral Volume in Pregnants and Non-pregnants
Condition: Pregnancy
Study type: Observational

Summary: 
      This study evaluates the effectiveness of ultrasound in term pregnant patients posted for
      elective lower segment cesarean sections and compared them with non pregnant females posted
      for elective surgeries.
    

Detailed description: 
      There is increased risk of aspiration in pregnancy due to various reasons i.e. increased
      progesterone levels, decreased motilin levels and distortion of gastric antrum due to gravid
      uterus.Ultrasound was proposed to be point of care tool, to assess risk stomach. A comparison
      with respect to the effectiveness of ultrasound was made in this study. The visibility of
      gastric antrum by ultrasound in term pregnant females posted for elective lower segment
      cesarean sections was compared with non-pregnant females posted for elective surgeries.

      The secondary aim of the study was to compare the gastric antrum in either groups
      qualitatively and quantitatively.
    

Intervention name(s): ultrasound
Intervention type(s): Other
Intervention description(s): Sonosite ultrasound (Sonosite, FUJIFILM M-Turbo, made in USA)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population are term pregnants posted for elective lower segment cesarean section
        and non-pregnant patients posted for elective surgeries in PGIMER.
Carbon Dioxide Insufflation (CO2) and Warm Water Infusion (WWI) Versus Standard Air Insufflation (AI) for Unsedated Colonoscopy
Condition: Warm Water; CO2 Colonoscopy; Unsedated Colonoscopy
Study type: Interventional

Summary: 
      Due to the increasing demand for colonoscopy in clinical practice, great interest has
      recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm
      Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as
      compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance
      of the above techniques versus AI in unsedated patients.
    


Intervention name(s): CO2; Warm water
Intervention type(s): Procedure; Procedure
Intervention description(s): CO2 insufflation; warm water irrigation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)