bioihbjkbjnl/mcl2 huggingface dataset:
Renin-Angiotensin Aldosterone System and Fibrinolysis Interaction in Humans-Specific Aim 3
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the study is to determine if giving isosorbide,a drug that is used to treat
      chest pain, affects blood vessel release of an anti-clotting factor.
    

Detailed description: 
      To test the hypothesis that the administration of the NO donor isosorbide dinitrate,but not
      the phosphodiesterase inhibitor sildenafil, will attenuate stimulated vascular t-PA release
      whereas both agents will improve glucose uptake.
    

Intervention name(s): Control (bradykinin); L-NMMA + bradykinin; Isosorbide + L-NMMA + bradykinin; Sildenafil + L-NMMA + bradykinin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Graded doses of bradykinin (Clinalfa AG, Läufelfingen, Switzerland) will be infused at 50, 100, and 200ng/min. Each dose will be infused for 5 minutes and FBF will measured during the last 2 minutes of infusion. Arterial and venous blood samples will be obtained for measurement of net t-PA release after each dose.; Thirty minutes after administration of bradykinin a continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be started started. While continuing the infusion of L-NMMA, baseline measurements and infusion of bradykinin will be repeated.; Following the second bradykinin infusion, 12 subjects will receive 5mg isosorbide dinitrate (an exogenous NO donor; Major Pharmaceuticals Inc, Livonia MI). Sixty minutes after the administration of isosorbide the continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be restarted and baseline measurements and bradykinin infusion will be repeated.; Following the second bradykinin infusion, 12 subjects will receive 50mg sildenafil (phosphodiesterase type 5 (PDE5) inhibitor to increase cGMP without increasing NO; Pfizer, NY). Sixty minutes after the administration of sildenafil the continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be restarted and baseline measurements and bradykinin infusion will be repeated.
Other intervention name(s): N-monomethyl-L-arginine
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Sildenafil Citrate; Bradykinin; omega-N-Methylarginine; Kininogens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Bradykinin; Obesity; Nitric Oxide Donor; tissue type plasminogen activator; isosorbide dinitrate; phosphodiesterase inhibitor; Renin-Angiotensin Aldosterone System; Fibrinolysis; Angiotensin converting enzyme
Spinal Anesthesia - Intraocular Pressure
Condition: Intraocular Pressure
Study type: Interventional

Summary: 
      We aim to investigate the effect of spinal anesthesia on intraocular pressure.
    

Detailed description: 
      Spinal anesthesia provides adequate anesthetic conditions for many operations. These
      operations include orthopedic, urological, gynecological and many general surgery operations.
      Although few, side effects of the procedure and its effects on body are well known. However,
      there is inadequate knowledge about the effects of spinal anesthesia on pressure changes in
      the eyes. These pressure changes in eyes can result in some detriments. Elevated pressures in
      the eyes can result in disease known as glaucoma, that makes hazard to eyes. Decreased eye
      pressures can also result in some eye detriments.

      We aimed to investigate the effects of spinal anesthesia procedure on eye (intraocular)
      pressure changes.
    

Intervention name(s): Spinal anesthesia
Intervention type(s): Other
Intervention description(s): Routine spinal anesthesia procedure will be made to the patients for surgical anesthesia.
Intervention MeSH terms: Anesthetics
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the medium term efficacy and safety profile of
      inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In
      particular, we will assess the impact on: lung function; airway inflammation; sputum
      microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs
      of hospital and community care; and cost-effectiveness.
    


Intervention name(s): mannitol; mannitol + pulmozyme; Dornase alpha
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400mg BD for 12 weeks; combination; 2.5mg daily for 2 weeks
Other intervention name(s): rhDNase, pulmozyme
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cystic fibrosis
Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method
Condition: Pregnancy; Habitual Aborter; Weeks of Gestation 37 or More
MeSH terms: Abortion, Habitual
Study type: Interventional

Summary: 
      Clinical Investigation Protocol for a study designed to determine the equivalence of the
      Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC)
      monitoring during labor. The study will be carried out on subjects in the first and second
      stages of labor.
    

Detailed description: 
      The study is a prospective, randomized, single-center observational study designed to compare
      the Fetal Heart Rate (FHR) and Uterine Activity (UA) output data obtained by the Monica AN24
      monitor during the first and second stages of labor to those generated by existing
      FDA-approved devices.Patients were enrolled at the facility but the patient details were
      removed from the results in order that the data could be randomized for the statistical
      analysis.
    

Intervention name(s): Monica AN24 (K101081); Philips 50XM
Intervention type(s): Device; Device
Intervention description(s): If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM; If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
Other intervention name(s): Philips Series 50XM (K954351)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Fetal Heart Rate (FHR); Uterine Activity (UA); Labor & Delivery
Elemental Formula Hypoallergenicity
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      The primary objective of this clinical trial is to determine whether a new amino acid-based
      formula is hypoallergenic as defined by the American Academy of Pediatrics (2000),
      demonstrating that the test formula does not provoke allergenic activity in 90% of infants or
      children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a
      commercially available hypoallergenic formula.
    


Intervention name(s): Amino Acid formula; Commercially available Amino Acid Formula
Intervention type(s): Other; Other
Intervention description(s): Amino Acid baby formula; Hypoallergenic Baby formula
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cow milk allergy; CMA
Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17
      years diagnosed withADHD
    

Detailed description: 
      To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in the
      symptomatic treatment of adolescents aged 13-17 years diagnosed with
      Attention-Deficit/Hyperactivity Disorder (ADHD) by Diagnostic and Statistical Manual of
      Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The evaluation of
      safety will be based on treatment-emergent adverse events (TEAEs), laboratory tests, vital
      signs, physical examinations, electrocardiograms (ECGs), and skin tolerability to MTS based
      on the dermal response score (DRS).
    

Intervention name(s): Methylphenidate Transdermal System
Intervention type(s): Drug
Intervention description(s): One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months
Other intervention name(s): DAYTRANA
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF
Condition: Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      Retrieval of immature oocytes from women with polycystic ovaries, their in-vitro maturation,
      fertilization and embryo transfer can prevent hormonal treatment that can lead to ovarian
      hyperstimulation. In addition, it can decrease discomfort and side-effects of routine daily
      administration of hormones and it can be cost-effective. Thirty healthy women with Polycystic
      Ovarian Syndrome aged 20-35, with BMI 18-30 kg/msq will be included in the study. Their
      immature oocytes will be retrieved from small follicles without any hormonal treatment. The
      oocytes will be fertilized post in-vitro maturation. The developed embryros will be
      transferred to the patients as in a routine IVF cycle.
    


Intervention name(s): In-vitro maturation oocytes
Intervention type(s): Other
Intervention description(s): Immature oocytes (development stage GV or M1) will be matured in-vitro in IVM culture medium for approximately 28-32 hours. The oocytes will be routinely observed and when they reach maturation (M2) they will be fertilized. The developed embryo will be transferred to the patient 24 hours post-fertilization.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCO/PCOD; IVM; Immature Oocytes
Evaluation of SOST, TWEAK, RANKL, OPG Levels in Smokers and Non-Smokers With Periodontitis
Condition: Periodontitis; Smoking
MeSH terms: Periodontitis
Study type: Observational [Patient Registry]

Summary: 
      Periodontitis is a chronic inflammatory disease with multifactorial etiology. Although
      periodontal disease is initiated by pathogens within the biofilm layer, disease development
      and tissue destruction occur as a result of the interaction of periodontal pathogens and the
      host immune response. It has been determined in the literature that smoking has a significant
      negative effect on periodontal tissues and increases the risk of periodontitis by 2-5 times.
      It has been shown that there is a relationship between smoking and the incidence and
      progression of periodontitis. However, the mechanisms by which this occurs have not been
      explained. In this study, the effect of smoking on the levels of sclerostin (SOST), tumor
      necrosis factor-like weak inducer of apoptosis (TWEAK), receptor activator of nuclear
      factor-kB ligand (RANKL), and osteoprotegerin (OPG), which are effective in bone metabolism,
      in gingival crevicular fluid (GCF) and saliva will be evaluated. Participants in the study
      were in accordance with the 2017 World Workshop on Classification of Periodontal and
      Peri-implant Diseases and Conditions criteria as a result of clinical evaluations
      systemically healthy, non-smokers diagnosed with stage 2, 3 and/or 4 periodontitis (Group 1)
      (n=26); systemically healthy, diagnosed with stage 2, 3 and/or 4 periodontitis and smokers
      (Group 2) (n=26); systemically and periodontally healthy, non-smokers (Group 3-Control Group)
      (n=26). Clinical periodontal indixes will be obtained from participants meeting the inclusion
      criteria; GCF and saliva samples will be collected. The samples will be examined by ELISA
      test at Gazi University Faculty of Medicine, Department of Immunology.
    


Intervention name(s): GCF and saliva analysis
Intervention type(s): Diagnostic Test
Intervention description(s): ELISA
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Periodontitis: Stage 2,3,4 and grade A,B,C periodontitis non-smoker patient included.

        Smoking-periodontitis: Stage 2,3,4 and grade A,B,C periodontitis patients which smoking 10
        or more daily for at least 10 years included.

        Control: Periodontally healthy, non-smoker subjects included.
      
Keywords: periodontitis; smoking; RANKL; OPG; TWEAK; SOST
Comparison Between Three Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia
Condition: Anesthesia; Adverse Effect; Cesarean Section Complications
MeSH terms: Pre-Eclampsia; Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      Maternal hypotension after subarachnoid block is a frequent and deleterious complication
      during lower segment caesarean section (LSCS). Prophylaxis against hypotension using
      vasopressors had become a standard recommendation. In mothers with preeclampsia, post-spinal
      hypotension is less frequent compared to healthy mothers; thus, the latest guidelines do not
      recommend using vasopressors in preeclampsia patients unless there is a hypotensive episode .
      The incidence of post-spinal hypotension in mother with preeclampsia is nearly 25%. The
      commonly used vasopressors during CS are ephedrine, phenylephrine, and recently
      norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and
      foetal acidosis. Phenylephrine (PE) had been the first line for prevention and management of
      maternal hypotension; however, its use in mothers with preeclampsia had not been adequately
      investigated. Thus, the best vasopressor for management of hypotension in mothers with
      preeclampsia is unknown. Norepinephrine (NE) is an alpha adrenergic agonist with weak beta
      adrenergic agonistic activity; thus, it does not cause significant cardiac depression as
      phenylephrine does. NE was introduced for use during CS with promising results when used as
      infusion and as boluses in healthy mothers .

      The use of NE boluses in management of hypotension in preeclamptic mothers was not adequately
      investigated. A dose 4 mcg NE was recently evaluated in preeclamptic mothers. In this study,
      we will compare 3 NE bolus doses (3 mcg, 4 mcg, and 5 mcg) in management of maternal
      hypotension after spinal block during CS in preeclamptic mothers.
    


Intervention name(s): Norepinephrine
Intervention type(s): Drug
Intervention description(s): mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation
Other intervention name(s): levophed
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of PF-04995274 after
      administration of a single dose to healthy volunteers, and to evaluate the plasma drug
      concentrations after single dose in healthy volunteers.
    

Detailed description: 
      The purpose is to evaluate the safety and pharmacokinetics of a single dose of PF-04995274 in
      healthy adult volunteers.
    

Intervention name(s): PF-04995274; PF-04995274; PF-04995274; PF-04995274
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Planned single PO 0.15mg, 1.5mg, 15mg doses of PF-04995274 interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.; Planned single PO 0.5mg, 5mg, 50mg doses of PF-04995274, interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.; Planned single PO 120mg and 210mg doses of PF-04995274; single PO dose of PF-04995274; dosage to be determined by safety and pharmacokinetic data
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: healthy volunteer; safety; pharmacokinetic
Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate
Condition: Cholecystitis
MeSH terms: Cholecystitis
Study type: Interventional
Phase: Phase 1

Summary: 
      529 patients performed elective LCC at Chonbuk National University Hospital between April
      2014 and August 2015. Total 509 patients were enrolled by inclusion criteria.

      They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1
      dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The
      clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body
      temperatures, symptoms and imaging of chest x-ray to evaluate the infections.
    

Detailed description: 
      529 patients performed elective LCC at Chonbuk National University Hospital between April
      2014 and August 2015. Total 509 patients were enrolled by inclusion criteria. They were
      randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1
      dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The
      clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body
      temperatures, symptoms and imaging of chest x-ray to evaluate the infections.
    

Intervention name(s): Cefotetan
Intervention type(s): Drug
Intervention description(s): Cefotetan (as Disodium) 1 GM Injection before surgery
Other intervention name(s): antibiotics group
Intervention MeSH terms: Anti-Bacterial Agents; Cefotetan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: GB stone
A Multimodal Neuroimaging Study of Brain Activation Patterns Under Ketamine
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of the project is to establish a multimodal imaging approach for the investigation of
      the neural mechanisms underlying neuroreceptor regulation, glutamatergic metabolism and brain
      function that are of particular relevance for major depressive disorder (MDD) and that can be
      translated into clinical applications.

      There is growing evidence for imbalance with regard to glutamatergic neurotransmission in
      stress-related affective disorders. Further support for the hypothesis that dysfunctional
      glutamatergic signaling underlies major depressive disorder, and indeed that its reversal
      constitutes a potential efficacious mechanism of action, is provided by the evidence that
      pharmacological compounds active at the N-methyl-D-aspartate (NMDA) ionotropic glutamate
      receptor such as ketamine exert rapid antidepressant effects. As a tool compound ketamine
      enables the safe investigation of the brain region-specific effects of NMDA receptor
      antagonism in terms of glutamatergic neurotransmission, brain function and the association of
      these neural changes with emotional state, thereby allowing for increased understanding of
      the therapeutic mechanism of action.

      The possibility to simultaneously study brain perfusion (arterial spin labeling), functional
      brain activity (fMRI) and connectivity (resting state fMRI), neurometabolism (proton magnetic
      resonance spectroscopy) and metabotropic glutamate receptor densities (positron emission
      tomography) will unravel their functional interplay in the mechanisms underlying the
      regulation of mood and cognition. Combining those imaging modalities with treatment
      interventions in healthy subjects and depressed patients, this project aims at providing
      insight into the neuropharmacological effects of ketamine and its antidepressant properties.
    


Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): i.v. infusion of 0.25 mg/kg S-ketamine over 40 min; i.v. infusion of NaCl over 40 min
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
the Pharmacokinetic Profiles of Linagliptin With DW1029M
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of
      Linagliptin after oral administration in healthy male volunteer.
    

Detailed description: 
      A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M
      influence the pharmacokinetic profiles of Linagliptin after oral administration in healthy
      male volunteer.
    

Intervention name(s): Linagliptin 5mg; DW1029M 1200mg and Linagliptin 5mg
Intervention type(s): Drug; Drug
Intervention description(s): Linagliptin 5mg once daily for 7 days; Linagliptin 5mg 1 tablet once daily and DW1029M 300mg 2 tablets b.i.d for 7 days
Other intervention name(s): Trajenta Tablet; Concomitant of DW1029M 1200mg and Linagliptin 5mg
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Healthy
A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension
Condition: Intracranial Hypertension; Elevated ICP (Intracranial Pressure)
MeSH terms: Intracranial Hypertension; Hypertension
Study type: Observational

Summary: 
      There is statistically significant correlation between invasive measures of intracranial
      pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms
      to predict ICP. Furthermore, characteristics within this physiologic waveform data will allow
      modeling for trend prediction of derived ICP information. Specific aims:

        1. Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic
           brain injury in humans.

        2. Predict and anticipate changes in ICP for preemptive management purposes.

        3. Analyze characteristics of changes in ICP after treatment failure.

        4. Analyze data to predict/anticipate confounding physiologic factors that affect ICP and
           its treatment.

        5. Test the resulting models in real time.
    


Intervention name(s): No Interventions
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Surgical intensive care unit patients
      
Keywords: Intracranial Hypertension; Elevated ICP (Intracranial Pressure)