bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788
Condition: Safety in Normal Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to determine the safety of single doses of orally
      administered EDP-788.

      Secondary objectives of the study are:

        -  To describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after single
           doses of orally administered drug

        -  To estimate the bioavailability of EDP-788 capsules relative to an oral liquid
           suspension

        -  To estimate the effect of co-administration of food on the absorption of EDP-788
    

Detailed description: 
      Subjects are enrolled in successive cohorts and are randomized to receive either EDP-788 or
      placebo capsules. If the safety profile of the drug is acceptable, based upon review of
      blinded data, the cohort receiving the next higher dose will be treated. Up to 8 cohorts will
      be recruited. All subjects receive a single dose of study drug (EDP-788 or placebo).

      Subjects in Cohort C will receive a second single dose of study drug (EDP-788 or placebo)
      approximately 2 weeks after the first dose. The second dose will be administered as a liquid
      suspension rather than as a capsule formulation. The purpose of the second dose is to
      estimate the bioavailability of the capsule formulation relative to the suspension.

      Subjects in Cohort E will receive a second single dose of study drug (EDP-788 or placebo)
      approximately 2 weeks after the first does. The second dose will be administered with a
      standard test meal. The purpose of the second dose is to estimate the effect of food on
      absorption of EDP-788.
    

Intervention name(s): EDP-788; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses; Matching placebo capsules or matching suspension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Normal Volunteers, Safety, Pharmacokinetics
Safety of the Intramuscular Route of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation Therapy
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      Until now, the best administration route of the anti-flu vaccine for patients receiving long
      term oral anticoagulation therapy has been the subcutaneous one; the intramuscular route has
      not been recommended because it may increase the risk of muscular haematoma. Although this
      practice is widely extended, no significant differences between the safety of both routes
      have been found. Some authors, analysing a small group of patients, affirm that the anti-flu
      vaccine can be administered safely by the intramuscular route on patients receiving long term
      oral anticoagulation therapy, while a previous opinion article recommended the subcutaneous
      route without any scientific evidence. Due to this, the investigators have done a clinical
      trial with the aim of determining the safety and effectiveness of the flu-vaccine
      intramuscular route in patients receiving long term oral anticoagulation therapy and also to
      analyse the possible interactions between the vaccine and the oral anticoagulant treatment.
    

Detailed description: 
      Phase IV, simple blind, 2-parallel groups, multicentric randomized trial where each patient
      will receive a single dose of the recommended by the WHO anti-flu vaccine for the 2003-2004
      period, the control group will receive it subcutaneous and intervention group intramuscular.
      The assignation to each group will be randomized. The study included 4 basic areas of
      Barcelona city. Three visits have been scheduled for each patient: moment 0, 24 hours and 10
      days after the vaccination, and a 7 month follow up period to control the incidence of the
      flu.
    

Intervention name(s): Influenza vaccine intramuscular administration route
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Influenza Vaccines; Acenocoumarol; Drug Administration Routes; Anticoagulants
Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery
Condition: Shock; Cardiovascular Diseases; Critical Illness
MeSH terms: Cardiovascular Diseases; Shock; Critical Illness
Study type: Observational

Summary: 
      This study will examine the differences in microcirculatory function and mitochondrial
      respiration in patients with shock after cardiovascular surgery.
    

Detailed description: 
      Post-cardiotomy shock (PCS) occurs in up to 5% of cardiovascular surgeries and has an
      in-hospital mortality rate as high as 75%. It is unclear if patients with PCS despite
      achieving standard resuscitation goals have impairments in oxygen delivery or oxygen
      utilization. This study will examine the difference in microcirculatory function and
      mitochondrial respiration in patients with shock to better understand the driving mechanism
      of bioenergetic failure in patients with PCS.
    

Intervention name(s): coronary artery bypass grafting, valve repair/replacement
Intervention type(s): Procedure
Intervention description(s): cardiovascular surgery with cardiopulmonary bypass
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with cardiovascular disease
      
Biospecimen description: 
      Peripheral blood mononuclear cells, plasma
    
Keywords: microcirculation; mitochondrial respiration; circulatory shock; cardiovascular surgery; resuscitation
MIS MiLIF Versus Open
Condition: Chronic Low Back Pain; Leg Pain
MeSH terms: Low Back Pain
Study type: Observational

Summary: 
      This study is being undertaken to compare the clinical outcomes of patients that have
      unilateral posterolateral lumbar interbody fusion using a traditional open approach versus
      the MiLIF procedure based on the MiCOR Precision Bone Allograft, specialized Atavi
      instrumentation, and minimally invasive visualization capabilities.
    

Detailed description: 
      This is a prospective, multi-center, non-randomized cohort design clinical study to evaluate
      the clinical outcomes of patients that have a minimally invasive lumbar interbody fusion
      (MiLIF) through the Atavi system compared to traditional unilateral open lumbar interbody
      fusion through a midline incision. the study will involve up to approximately 12
      investigational sites and enroll up to 126 patients.
    

Intervention name(s): The Atavi System
Intervention type(s): Device
Intervention description(s): The primary device in the Atavi system is the Flex Posture retractor and accessories such as dilators and an Expander Instrument.
The Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. Once the retractor is in place, the visualization components of the system may be used.
Other intervention name(s): MIS; Minimally invasive; Atavi; Flex Posure; retractor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic low back and/or leg pain who are candiates for elective lumbar
        interbody fusion through a postierior unilateral approach, that present to either group of
        surgeons, will be screened for inclusion in the study. If the patient meets all of the
        eligibility criteria, they wil be enrolled into the study and have either the MiLIF or open
        procedure depending on the surgoen they present to (i.e., what group their surgeon agreed
        to participate in).
      
Keywords: MIS; Minimally invasive; Atavi; Flex Posure; retractor; Patients with chronic low back and/or leg pain who are candidates for elective lumbar interbody fusion through a posterior unilateral approach,; for inclusion in the study.; If the patient meets all of the eligibility criteria,; they will be enrolled into the study and have either the MiLIF or open procedure depending on the surgeon they present to; (i.e., what group their surgeon agreed to participate in.)
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
Condition: Bacterial Infection
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this protocol is to study if two different tablet formulations of doxycycline
      are bioequivalent to each other.
    


Intervention name(s): doxycycline monohydrate tablet; doxycycline carragenate tablet
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, 100 mg, Single dose; Tablet, 100 mg, Single dose
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence
Optimal Bowel Cleansing Trial
Condition: Bowel Cleansing for Colonoscopy
Study type: Interventional

Summary: 
      Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel
      cleansing, randomizing adult outpatients by invitation letter
    

Detailed description: 
      This randomized quality assurance trial aims to compare cleansing quality of two different
      principles of colonoscopy lavage. Large volume PEG solutions are considered safe, but
      cumbersome and inpalatable, while osmotic solutions are generally more acceptable, however,
      the risk of electrolyte disturbances or renal decompensation may increase.

      The study will focus on patient experience and compliance, as well as cleansing quality,
      endoscopic findings and other technical parameters of the colonoscopy procedure that may be
      adversely affected by poor bowel cleansing. Three centers will participate, ensuring a
      diverse patient population. 800 patients are planned for recruitment, but an interim
      assessment of statistics of the primary aim parameter (bowel cleansing) will be performed to
      adjust the number.
    

Intervention name(s): Laxabon; CitraFleet
Intervention type(s): Other; Other
Intervention description(s): 4 l PEG solution split dose cleansing; Small volume osmotic bowelcleansing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: colonoscopy; bowel cleansing
Cold Therapy and Cross-Education of Muscle Strength
Condition: Cerebrovascular Stroke; Muscle Weakness
MeSH terms: Muscle Weakness; Stroke
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether a cold application to the contralateral
      (affected side) extremity in addition to unilateral neuromuscular electrical stimulation
      (NMES) application has a facilitating effect on muscle strength in post-stroke hemiplegia
      patients.
    

Detailed description: 
      In this prospective randomized controlled single-blind study, a total of 25 patients, 16 men,
      and 9 women were included according to inclusion and exclusion criteria. Patients were
      randomly assigned to the experimental group (n=12) or the control group (n=13). NMES has
      applied to the non-affected side ankle dorsiflexors five sessions for a week in both groups.
      In addition to the experimental group, the cold application was applied on the affected side
      dorsiflexor muscle skin. The cold application was done on a moist towel for five minutes
      using a cold pack. A five-minute break was given and a further 5-minute cold application was
      repeated. The cold application was done simultaneously with NMES. A conventional
      rehabilitation program was applied to all patients by a physiotherapist. Before and after
      treatment, both ankle dorsiflexor strength was measured with a force sensor. For force
      measurements, a force transducer (FC2211-0000-0100-L Compression Load Cell, TE Connectivity
      company, France) was used. Force transducer signals were received with a data acquisition
      device (POWERLAB® data acquisition system ADInstruments, Oxford, UK) and evaluated offline on
      the computer. The measurement values were expressed in kilogram.force (kg.f) and this value
      was normalized according to body weight.
    

Intervention name(s): Cold pack; NMES
Intervention type(s): Other; Device
Intervention description(s): Five minutes cold pack was applied on the affected side dorsiflexor muscle skin, a five-minute break was given and a further 5-minute cold application was repeated; NMES was applied to the nonaffected side ankle dorsiflexors
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cold therapy; Cross-education; Neuromuscular electrical stimulation; Hemiplegia
Nephropathy In Type 2 Diabetes and Cardio-renal Events
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The NID-2 study, a multicentric study (21 centres enrolled), was planned in two phases:

      Phase 1(observational study, completed in September 2005): after the identification of a
      type-2 diabetic population with typical Diabetic Nephropathy (DN), to study of the rate of
      renal and cardiovascular events during a middle term follow-up.

      Phase 2(interventional study, started in October 2005): after randomization in two groups, a
      group (intervention group) is treated with an intensive multifactorial intervention whose aim
      is to reduce morbidity and mortality due to diabetic complications. The other group (control
      group) continues the conventional therapy . To avoid bias in the treatment in each center,
      the randomization was performed for centre.
    

Detailed description: 
      The same patients that completed the first phase of the NID-2 study (observation) were
      enrolled for the phase 2 of the study (intervention).
    

Intervention name(s): SoC therapy; irbesartan; ramipril; hydrochlorothiazide; furosemide; amlodipine; atenolol; doxazosin; clonidine; insulin; simvastatin; fibrate; erythropoietin; aspirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): the patients have to be treated according the standard good medical practice by any center; Therapy for hypertension:
- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die; Therapy for hypertension:
- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die; Therapy for hypertension
- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl); Therapy for hypertension
- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl); Therapy for hypertension
- Step 3: amlodipine up to 10 mg/die; Therapy for hypertension
- Step 4: atenolol up to 100 mg/die; Therapy for hypertension
- Step 5: doxazosin up to 4 mg/die; Therapy for hypertension
- Step 6: clonidine; Therapy for Hyperglycaemia (to achieve HbA1c <7):
- insulin; Therapy for hypercholesterolemia:
- for reducing LDL cholesterol < 100 mg/dl: simvastatin up to 80 mg/die; Therapy for hypertriglyceridemia
- for reducing triglycerides < 150 mg/dl and/or increasing HDL cholesterol > 40-50 mg/dl: a fibrate; Treatment of anaemia:
- erythropoietin; Antiplatelet therapy (in all patients without contraindications):
- aspirin up to 160 mg/die
Intervention MeSH terms: Aspirin; Atenolol; Amlodipine; Hydrochlorothiazide; Clonidine; Ramipril; Irbesartan; Doxazosin; Furosemide; Epoetin Alfa; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: type 2 diabetes; nephropathy; cardiovascular (CV) events
The Effect of Exercises on Physiological Changes and Clinical Symptoms in Allergic Rhinitis Patients
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      1. Moderate exercise training decrease cytokine response and rhinitis symptoms in patients
           with allergic rhinitis

        2. Moderate exercise training combined with vitamin C supplementation decrease cytokine
           response and rhinitis symptoms in patients with allergic rhinitis

        3. Moderate exercise training combined with vitamin C supplementation has more beneficial
           effects than moderate exercise training alone for decreasing cytokine response and
           rhinitis symptoms in patients with allergic rhinitis
    


Intervention name(s): Aerobic exercise with Vit. C; Aerobic exercise; No exercise
Intervention type(s): Other; Other; Other
Intervention description(s): walking - running on a treadmill at intensity of 65-70% HRR for 30 minutes per session three times a week combined with taking vitamin C supplemented daily with an oral dose of 2,000 mg 2 times/day for 8 weeks.
Nasal challenge with house dust mites with the evaluation of cytokines in nasal lavage fluid,
Nasal peak flow measurement,
Nasal blood flow measurement,
Exercise training regimen including VO2max measurment at baseline and at the end of the experiment.; walking - running on a treadmill at intensity of 65-70% HRR for 30 minutes per session three times a week for 8 weeks.
Nasal challenge with house dust mites with the evaluation of cytokines in nasal lavage fluid,
Nasal peak flow measurement,
Nasal blood flow measurement,
Exercise training regimen including VO2max measurment at baseline and at the end of the experiment.; Sedentary control.
Nasal challenge with house dust mites with the evaluation of cytokines in nasal lavage fluid,
Nasal peak flow measurement,
Nasal blood flow measurement,
Exercise training regimen including VO2max measurment at baseline and at the end of the experiment.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Exercise training; Allergic rhinitis; Vitamin C; Cytokine; Rhinitis symptoms
Recto-Anal-Repair in the Treatment of Advanced Haemorrhoidal Disease
Condition: Haemorrhoids
MeSH terms: Hemorrhoids
Study type: Observational

Summary: 
      Prospective observational study to evaluate the impact of Recto-Anal-Repair (a technique of
      ultrasound guided haemorrhoidal ligation) in the treatment of stage III/IV haemorrhoidal
      disease.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with haemorrhoids stage III/IV
Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.
Condition: Liver Neoplasms; Adenoma; Carcinoma; Liver Abscess
MeSH terms: Abscess; Liver Abscess; Adenoma; Liver Neoplasms
Study type: Observational

Summary: 
      Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging
      agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than
      18 years. Data that has been recorded in the child's medical records relating to the
      injection of Primovist/Eovist will be collected. Information will be collected from up to 2
      weeks before the child received Primovist/Eovist until 12 months after the child received
      Primovist/Eovist. Copy of the child's MR images that were taken right before and after the
      child received Primovist/Eovist and all other reports (laboratory reports, other imaging
      reports, etc) that are part of the child's medical records during that time period will be
      collected.
    


Intervention name(s): Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Intervention type(s): Drug
Intervention description(s): Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric subjects who have had a Primovist/Eovist enhanced MRI for known or suspected
        focal liver disease
      
Biospecimen description: 
      Pediatric subjects who have had a Eovist/Primovist enhanced MRI for known or suspected focal
      liver disease
    
Keywords: Liver neoplasms; Adenoma; Liver cell carcinoma; Hepatocellular; Liver abscess
Insitu Repair Versus Uterine Exeriorization During Cesarean Section
Condition: Complications; Cesarean Section
Study type: Interventional
Phase: Phase 3

Summary: 
      Two types of uterine repair described during cesarean section, the investigators will try to
      compare between the two techniques.
    

Detailed description: 
      Insitu repair of the uterus during cesarean section in Comparison to exteriorisation of the
      uterus during uterine closure
    

Intervention name(s): insitu repair; exteriorisation of the uterus
Intervention type(s): Procedure; Procedure
Intervention description(s): closure of the uterine incision while the uterus initu; uterine closure while the uterus is exteriorised
Other intervention name(s): repair insitu; uterine closure with exteriorisation of the uterus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: insitu repair; intestinal motility