bioihbjkbjnl/mcl2 huggingface dataset:
The Influence of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers on Renal Function in Patients Undergoing Non-emergent Coronary Angiography
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The aim of the current study is to evaluate prospectively whether concomitant administration
      of RAAS blockers (namely ACE-I and ARBs') influence the change in estimated GFR (eGFR) after
      administration of contrast media in patients undergoing non-emergent coronary angiography.
    


Intervention name(s): stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure; ACE/ARB stopped 24 hours before procedure and start immediately after
Intervention type(s): Drug; Drug
Intervention description(s): ACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure; ACE/ARB stopped 24 hours prior to the procedure and restarted immediately after the procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Change in eGFR from baseline to 72 hours following the exposure to the contrast.; Rate of eGFR decrease>25% from the baseline; Length of hospitalization.; Requirement of unplanned therapy for elevated blood pressure
Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1a, randomized, double-blind, placebo-controlled, safety, tolerability,
      and PK study in healthy adult volunteers.

      Participants were screened for eligibility within 14 days prior to enrollment. Four
      successive cohorts were enrolled, with each cohort receiving a single dose of Virazole or
      placebo using different delivery regimens.
    


Intervention name(s): 50 mg/mL Virazole Inhalant Product; 100 mg/mL Virazole Inhalant Product; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted; 100 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted; Placebo (10 or 20 ml total volume) aerosolized and administered until solution depleted
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Color Doppler to Confirm Epidural Catheter Positioning in Parturient
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The aim of this study is to calculate the sensitivity and specificity of using color Doppler
      with pulsed wave Doppler to accurately detect the position of epidural catheter
    

Detailed description: 
      patients will be divided into two groups Group (C) control these are the patients with BMI
      less than 35 and Group (O) for patients with BMI more than 35.All patients will be sitting to
      receive their epidural analgesia for labor pain.

      A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to
      detect the desired level usually between L3-4 or L4-5. patients will be divided into two
      groups Group (C) control these are the patients with BMI less than 35 and Group (O) for
      patients with BMI more than 35. All patients will be sitting to receive their epidural
      analgesia for labor pain.

      A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to
      detect the desired level usually between L3-4 or L4-5. Initially a parasagittal oblique
      interlaminar view will be obtained and by tilting it medially to visualize the laminae and
      interlaminar spaces. Starting by the sacral image, counting will start detecting the L5-S1,
      L4-L5 and L3-L4 levels. After marking the level another imaging in the transverse view will
      be attempted at the previous levels then the anesthetist will detect the posterior complex
      (ligamentum flavum, epidural space and dura) and anterior epidural complexes and according to
      the anesthetist preference a level will be This is followed by a test dose of 10 ml 0.125%
      bupivacaine and patient controlled epidural analgesia will be started by the following
      protocol (0.0625% bupivacaine) Smith Medical ASD,Inc. in intermittent dose (10 ml will be
      injected by the machine every 30 minutes.
    

Intervention name(s): Color Doppler
Intervention type(s): Device
Intervention description(s): color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter
Other intervention name(s): Epidural catheter
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Acetaminophen and Tramadol Combination BID Versus Placebo for the Treatment of Acute Low Back Pain
Condition: Acute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      A multi-center placebo controlled, double-blind, trial comparing the analgesic efficacy and
      safety of Acetram Contramid® BID versus placebo for the treatment of acute low back pain in
      patients between 18 and 80 yrs of age.
    


Intervention name(s): Combination drug (Acetaminophen + Tramadol); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer
Condition: Epithelial Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of paclitaxel and carboplatin followed
      by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.
    


Intervention name(s): gemcitabine; carboplatin; paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aerobic Exercise in Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      Duchenne Muscular Dystrophy (DMD) is the most common neuromuscular disease in childhood with
      an estimate incidence of 1 in 3500 to 5000 male births. The effect of aerobic training on
      muscle architectural properties and motor functions such as muscle activation is not clear in
      DMD. The aim of this study is to investigate the effects of aerobic training on these
      parameters in children with DMD. Twenty children with DMD included in the study will be
      divided into two groups as home program and home program+aerobic training with block
      randomization method. Home program including stretching, respiratory, range of motion and
      mild resistance exercise with body weight will be asked to apply 3-5 days a week for 12
      weeks, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum
      hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down
      period. Muscle architectural properties, muscle strength, muscle activation and motor
      function will be assessed with ultrasonographic, hand-held myometry, surface EMG and Motor
      Function Measure, consecutively. Assessments will be applied at pre-training and after 12
      weeks of training.
    


Intervention name(s): Aerobic Training; Home exercise program
Intervention type(s): Other; Other
Intervention description(s): Aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down period to children in treatment group.; Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Duchenne Muscular Dystrophy; Aerobic Training; Ultrasonography; Motor Function
Validation of the SIGAM/VF Mobility Grade
Condition: Amputation
Study type: Observational

Summary: 
      The objective of this study is to demonstrate the validity, the reproducibility and the
      coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM)
      mobility scale questionnaire in adults with lower-limb amputations.
    


Intervention name(s): SIGAM Questionnaire
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with temporary or permanent prosthesis
Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs
      delivered via the intracoronary route in the treatment of patients with ST-elevation acute
      myocardial infarction (STEMI).
    

Detailed description: 
      This is a prospective, randomized, two arm, placebo-controlled, double blind, study that will
      enroll approximately 216 patients at no more than thirty-five (35) international clinical
      sites. Additional blinding measures will be taken in the assessment of study outcomes. The
      dose of the test material (ADRCs)is described in the protocol. The study will include two
      arms.
    

Intervention name(s): Dose A; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): ADRC Dose A; Placebo Comparator
Other intervention name(s): Adipose-Derived Regenerative Cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Attack; Regenerative Cells; Stem Cells
Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection
Condition: Large Polyps in the Gastrointestinal Tract
Study type: Interventional
Phase: Phase 2

Summary: 
      For removal of large flat lesions of the gastro-intestinal tract injection of a solution
      under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal
      tract wall. Various solutions are currently used, but some of them are easy to inject but
      quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl
      methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive
      and not always available. The investigators performed previously animal experiments which
      demonstrated that blood is easy to inject and creates a protective cushion which lasts longer
      than other fluids which are currently used for protective cushion creation.
    

Detailed description: 
      For removal of large flat lesions of the gastro-intestinal tract injection of a solution
      under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal
      tract wall. Various solutions are currently used, but some of them are easy to inject but
      quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl
      methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive
      and not always available. The investigators decided to use blood drawn from the patient for
      injection under the lesion. The investigators performed previously animal experiments which
      demonstrated that blood is easy to inject and creates a protective cushion which lasts longer
      than other fluids which are currently used for protective cushion creation. Blood can also
      have local hemostatic action preventing from bleeding during polypectomy.
    

Intervention name(s): Autologous blood injection; Normal saline; HPMC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion; Normal saline will be injected under the lesion to create submucosal cushion; Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: submucosal cushion; polypectomy; endoscopic mucosal resection
Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC
Condition: Advanced Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      "Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Nexavar
      to advanced Hepatocellular carcinoma patients when compared with the control group who did
      not receive administration of the drug.
    

Detailed description: 
      -  primary outcome Compare clinical efficacy of group treated with cell therapeutic
           Immuncell-LC evaluated by progression free survival with that of untreated group

        -  secondary outcome compare clinical efficacy of group treated with Immuncell-LC, a drug
           for treating advanced hepatocellular carcinoma evaluated by overall survival, disease
           control rate, changes of Alpha Feto Protein(AFP) figures from baseline to the last
           observation date and that of untreated group and evaluate adverse reactions, clinical
           pathological tests and its safety.
    

Intervention name(s): Immuncell-LC
Intervention type(s): Drug
Intervention description(s): intravenous dripping of 200ml(10^9~2x10^10 lymphocytes/60kg adult) for 1 hour
Other intervention name(s): Activated T lymphocyte
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immuncell-LC, advanced hepatocellular carcinoma
DDI Strong CYP3A4 Inducer
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the relative bioavailability of a
      single dose of BI 425809 when given alone (Reference, B) compared with co-administration
      (Test, A) on the 7th day of a 10-day treatment with rifampicin following oral administration
      in healthy male volunteers.
    


Intervention name(s): Rifampicin; BI 425809
Intervention type(s): Drug; Drug
Intervention description(s): once daily; once daily
Intervention MeSH terms: Rifampin; BI 425809
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
How Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma?
Condition: Glaucoma Diagnosis
MeSH terms: Glaucoma; Disease
Study type: Interventional

Summary: 
      Evaluate sensitivity and specificity of NOVA-DN visually evoked potentials (VEP) protocol and
      new software method (Corda) for glaucoma detection using optical coherence tomography (OCT)
      images to differentiate between normal subjects and glaucoma suspects.
    

Detailed description: 
      The aim of this study was to evaluate the ability of NOVA-DN VEP protocol and Corda
      parameters to discriminate between healthy eyes and eyes with early to moderate glaucomatous
      visual field loss. We will evaluate measurements of the NOVA-DN VEP protocol, Corda software
      and Cirrus spectral domain (SD) OCT software in order to compare and correlate.

      Hypotheses is that NOVA-DN VEP protocol and Corda analysis results in a high sensitivity,
      specificity and area under the Receiver Operating Characteristic (ROC) curves (ROC area) for
      glaucoma detection. Second hypothesis is NOVA-DN VEP protocol and Corda parameters can
      differentiate between normal and glaucoma suspects.
    

Intervention name(s): Optical Coherence Tomography; Visual evoked potential
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.; Visual evoked potential is a means of objectively testing visual field by viewing a computer monitor at 1 meter with a square black/white checkerboard pattern reversal stimulus. Electrodes are placed on the head and face to monitor Electroencephalogram (EEG) activity during testing. Output parameters from VEP system include amplitude and latency measures for each stimuli.
Other intervention name(s): OCT; VEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Improving Embryogenesis by Adding Growth Factors to In Vitro Human Culture Media
Condition: In Vitro Human Embryo Development
Study type: Interventional

Summary: 
      The investigators suppose that adding growth factors that had been found in the female tubal
      fluid and uterus to In Vitro single step culture media for human embryos might improve the
      the embryogenesis In Vitro and the clinical outcome of the resulting off spring.
    

Detailed description: 
      The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we
      suppose that adding growth factors ( Insulin-like growth factor I, Insulin-like growth factor
      II, transforming growth factor-beta and epidermal growth factor ) as a promoting growth
      factors to Lifeglobal culture media might improve embryo development in vitro so we decide to
      design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to
      arm of the same culture media and the same culture condition but with one arm with growth
      factors and the other is traditional one and closely monitor the outcome within the 2 arms
      and record the results.
    

Intervention name(s): Growth Factors and Cytokine adding to embryo culture media; No Intervention
Intervention type(s): Other; Other
Intervention description(s): Nothing to Add
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the
      anal verge.
    


Intervention name(s): LifeSeal™ Kit
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      This was a randomized, double blinded, controlled trial. The aim of the study was to compare
      xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis.

      The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine
      inhalation for treatment of bronchiolitis.

      Signed informed consent was obtained from a parent of each child. And the human ethics
      committee of our hospital approved the study according to the principles of the Declaration
      of Helsinki.(Approved - 2002)

      Patients:

      65 infants who were admitted to Pediatric A- a general pediatric ward, in Schneider
      Children's Medical Center because of bronchiolitis during winter in two consecutive years
      2004-2005.

      The inclusion criteria were: Full term previously healthy Infants, ages 1-12 months, after
      informed consent was signed with clinical presentation of mild to moderate bronchiolitis
      according to a clinical score .Exclusion criteria were as follows: prematurity, congenital
      lung or cardiac disease, infants who had past hospitalization due to respiratory illness and
      severe bronchiolitis (score>7 with a range scale 0-10).
    

Detailed description: 
      All eligible patients were randomly assigned to one of two groups: Group 1 (control) received
      inhalation of epinephrine 1mg, in 2cc of 0.9% saline solution four times a day, and nasal
      drops of 0.9% saline for each nostril every twelve hours. Group 2 - the study group received
      four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL to
      each nostril twice a day. This treatment continued until the patient was ready for discharge.

      Patients were examined and evaluated at the study entry and were re-evaluated every 10-12
      hours. Length of hospital stay,time to improve Oxygen saturation, time to the need of IV
      fluid and clinical score between the two groups of treatment were compared.
    

Intervention name(s): xylometazoline HCL 0.05%; Epinephrine 1mg
Intervention type(s): Drug; Drug
Intervention description(s): Receive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day.; Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
Other intervention name(s): xylometazoline HCL = Otrivin nasal drops
Intervention MeSH terms: Epinephrine; Xylometazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Epinephrine; Nasal decongestant; RSV; xylometazoline; Bronchiolitis
OPS-2071 Single and Multiple Dose Study to Investigate PK and PD Profile in Healthy Korean Male Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial is to evaluate the safety and tolerability of single and multiple
      ascending oral doses of OPS-2071 in healthy male Korean
    


Intervention name(s): Part1 : OPS-2071; Part1 : Placebo of OPS-2071; Part2 : OPS-2071; Part2 : Placebo of OPS-2071
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single oral dose under fasted condition; single oral dose under fasted condition; multiple twice-daily oral dosing for 5-7days; multiple twice-daily oral dosing for 5-7days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Intestinal Infection