bioihbjkbjnl/mcl2 huggingface dataset:
Sympathetic and Parasympathetic Responses to Specific Chiropractic Adjustments
Condition: Autonomic Nervous System
Study type: Observational

Summary: 
      A study to determine if a chiropractic adjustment in the cervical spine will effect the
      parasympathetics and a chiropractic adjustment in the thoracic spine will effect the
      sympathetics.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Random ages 25-55 asymptomatic
Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Imprime PGG™ Injection
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a Phase Ib, randomized, double-blind, placebo-controlled, multiple-dose (7 day),
      dose-escalation study assessing the safety, pharmacodynamics, and pharmacokinetics of
      intravenous Imprime PGG™ Injection in healthy adult subjects.
    


Intervention name(s): Imprime PGG TM for Injection
Intervention type(s): Biological
Intervention description(s): Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Safety in Healthy Adult Subjects
RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer: RAD001+XELOX
Condition: Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      It is expected that RAD001 works in gastric cancer by inhibiting PI3K/AKT/mTOR pathway and
      Hif1A (hypoxia inducible factor 1, alpha subunit), a key player in angiogenesis and the
      growth of tumors like renal cell carcinoma.However, RAD001 alone looks not enough to control
      gastric cancer. By the mechanisms above, RAD001 can show additive or synergistic effect in
      combination with conventional chemotherapy. In this study, XELOX was selected as a
      conventional combination chemotherapy because it was proven very active and safe in gastric
      cancer. Combination of XELOX and RAD001 has been never tried for the treatment of cancer
      patients yet. So, the optimal dose will be first determined in this phase I study
    

Detailed description: 
      For the first cohort of this phase I study, each drug of capecitabine, oxaliplatin, and
      RAD001 will be started at one or two dose below the ordinary full dose of each drug as a
      single agent.
    

Intervention name(s): RAD001, Capecitabine, Oxaliplatin
Intervention type(s): Drug
Intervention description(s): Dose level -1 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 5mg po qd D1-21
Dose level 1 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 7.5mg po qd D1-21
Dose level 2 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 7.5mg po qd D1-21
Dose level 3 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 7.5mg po qd D1-21
Dose level 3A : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 10mg po qd D1-21
Dose level 3B : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 10mg po qd D1-21
Dose level 4 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 7.5mg po qd D1-21
Dose level 5 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 10mg po qd D1-21
Intervention MeSH terms: Capecitabine; Oxaliplatin; Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: XELOX; RAD001; phase 1
MRE Consumption and Gut Health
Condition: Gastrointestinal Tract
Study type: Interventional

Summary: 
      The objective of this study is to determine the impact of consuming MREs as the sole source
      of subsistence for 21 days on gut bacteria community composition and gut health. Up to 80
      free-living adults will be randomized to consume their usual diet or only MREs for 21
      consecutive days. MREs will be provided by the Military Nutrition Division, US Army Research
      Institute of Environmental Medicine (USARIEM). Fecal, urine and blood samples will be
      collected periodically before, during and after the intervention to measure gut barrier
      integrity, gut bacteria community composition, and markers of gut health, inflammation, and
      nutritional status.
    


Intervention name(s): MRE
Intervention type(s): Other
Intervention description(s): MRE consumption
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Gut microbiota; Intestinal permeability; Gut barrier integrity
Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis
Condition: Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hypertension, Portal; Hepatitis, Alcoholic; Hypertension; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the role of endotoxins and the endotoxin mediated
      immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect
      of Liver assist (liver dialyses) intervention on these parameters in patients with severe
      alcoholic hepatitis.
    


Intervention name(s): Prometheus Liver Dialysis system (Fresenius Medical Care)
Intervention type(s): Device
Intervention description(s): 6 hour dialysis for 3 consecutive days
Other intervention name(s): The prometheus albumin dialysis by Fresenius Medical Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Alcoholic Hepatitis; Alcohol; Endotoxin; LPS; Liver dialysis; Innate immunity; Toll Like receptors
Impact of Trans Fatty Acids From Natural and Industrial Origin in the Induction of Insulin Resistance Development
Condition: Insulin Resistance; Obesity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The investigators' project has as for principal objective to understand the impact of trans
      fatty acids from dairy products and industrial origin on the development of insulin
      resistance in obese woman. Because of the different isomeric position of the double bound
      those trans fatty acids may have different metabolic effects.
    

Detailed description: 
      Women will be included in the study according to their susceptibility to develop a insulin
      resistance (evaluated starting from the body index of mass IMC superior to 28 kg.m-², of the
      waist measurement 88 cm). Once included in the study, the volunteers will receive for 4 weeks
      butter, dairy products and biscuits enriched in stearic, elaidic or vaccenic acid. The
      volunteers will undergo a measurement of the body composition by biphotonic absorptiometry as
      well as a complete metabolic assessment (blood and urinary samples, clamp to insulin and
      biopsies).
    

Intervention name(s): vaccenic acid enriched diet; Elaidic acid enriched diet; control diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The experimental milk fat, entitled "vaccenic acid enriched milk fat" (VAMF), has been obtained by feeding cows with a diet containing sunflower oil.; Mixture of vegetable oils (including partially hydrogenated oils); Mixed of different oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Trans fatty acid; Insulin resistance; Skeletal muscle; Adipose tissue
Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety/tolerability and
      pharmacokinetics/pharmacodynamics of CKD-519.
    


Intervention name(s): CKD-519; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Anesthesia Related Neurocognitive Deficits in Children
Condition: Anesthesia
Study type: Observational

Summary: 
      The infantile brain has to pass essential, mayor steps in the first 36 months of life. During
      that period of development it is particularly vulnerable to toxic, exogenic influences. This
      study wants to review the long-term effects of children who were exposed to anesthesia in the
      first three years of their life. Therefore the investigators will examine children at age of
      4-10 that were exposed to anesthesia and compare their neurocognitive capacity to children
      who did not have any exposure to anesthesia. The investigators plan on measuring the
      intelligence quotient using standardized tests which will be performed by a trained
      psychologist. In addition there will be a questionnaire concerning behavioral characteristics
      and educational development which is filled by the parents. The exposed children will be
      recruited from our preexisting database, the control group will be recruited from
      practitioners and the pediatric walk-in-clinic.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children age 4-10 who underwent general anesthesia below the age of 36 months in context of
        surgical or diagnostic procedures or sedation uring intensive care.
      
Keywords: Anesthesia; Children; General Anesthesia; Neurocognitive Outcome
Treatment of Venous Malformation
Condition: Venous Malformation
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Vascular malformations are birth defects that happen when different stages of angiogenesis
      shut down. 44 - 64% of all vascular malformations are venous malformations (VMs).
      Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular
      endothelial cells in the lesion. One of the most common and well researched sclerosing agents
      for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.
    


Intervention name(s): Direct Puncture Repair / Ethanol; Direct Puncture Repair / Polidocanol
Intervention type(s): Procedure; Procedure
Intervention description(s): Ethanol is an organic compound that will be injected in the venous malformation as a sclerotherapy by Direct Puncture Repair; Polidocanol is a sclerosing agent that will be injected in the venous malformation by Direct Puncture Repair
Intervention MeSH terms: Ethanol; Polidocanol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
Condition: Viral Infection
MeSH terms: Infections; Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective is to evaluate the safety and tolerability of a single-ascending oral dose of
      UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption
      and elimination following a single dose of UV-4B in healthy subjects.
    

Detailed description: 
      The causative agent of dengue fever is Dengue Virus (DENV), a member of the flavivirus genus.
      There are four DENV serotypes. Infection with one serotype results in lifelong immunity
      against that serotype, but only limited short-term cross-protection from infection with the
      other serotypes. Immunity to one serotype has a downside as subsequent infections by other
      serotypes increase the risk of developing more severe forms of dengue, which includes the
      most lethal form of the disease, dengue hemorrhagic fever. Traditional epidemiologic and
      serologic-based estimates suggest a range of 50 to 100 million DENV infections per year
      distributed over 100 countries. Recent cartographic-based modeling studies suggest that up to
      390 million of dengue infections per year, of which 96 million are associated with clinical
      symptoms.
    

Intervention name(s): UV-4B 3 mg; UV-4B 10 mg; UV-4B 30 mg; UV-4B 90 mg; UV-4B 180 mg; UV-4B 360 mg; UV-4B 720 mg; UV-4B 1000 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dengue; Arbovirus Infections; Flaviviridae Infections; Flavivirus Infections; Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Pharmaceutical Solutions; Pharmacologic Actions; Therapeutic Uses
Effect of 35624® Alflorex® in Functional Gastrointestinal Disorders (FGIDs) in Children.
Condition: Functional Gastrointestinal Disorders; Functional Abdominal Pain
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Abdominal Pain
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of supplementation with Bifidobacterium
      longum 35624® Alflorex® on frequency and severity of symptoms of abdominal pain using an
      adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS) to accurately reflect the
      pediatric population using the aid of the validated Numeric Pain Rating Scale (NRS-II) in
      children with Functional Gastrointestinal Disorders (FGIDs).
    

Detailed description: 
      This is an open label study to assess the safety and effectiveness of Bifidobacterium longum
      35624® Alflorex® when consumed once daily by children with Functional Gastrointestinal
      Disorders (FGIDs). The 12-week intervention study will be conducted in 63 non-coeliac
      children aged 8 to 18 years old with an FGID who experience at least two episodes of
      abdominal pain per week. The study will consist of 5 visits over a 14 week period commencing
      with a screening visit. The second visit will be the baseline (start of intervention),
      followed by third (mid-intervention), fourth (end of treatment) and fifth (follow up) visit.
      Questionnaires will be administered from the second to the fifth visit. A blood sample will
      be taken before treatment to rule out coeliac disease.
    

Intervention name(s): Alflorex®
Intervention type(s): Dietary Supplement
Intervention description(s): Each probiotic capsule contains 1 x 10^9 CFU of B. longum 35624® and corn starch, hydroxypropyl methyl cellulose and magnesium stearate.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bifidobacterium longum 35624®; Probiotic; Food supplement; Alflorex®
A Safety and Immunogenicity Study of Heterologous and Homologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and
      Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult
      participants.
    

Detailed description: 
      This study consists of 3 parts: the first and third part with standard doses and the second
      part with higher doses. All parts are randomized, placebo-controlled, observer-blind to
      evaluate the safety, tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV
      administered in different doses, sequences and schedules to healthy adult participants. The
      study consists of a screening period of up to 28 days, a vaccination period in which
      participants will be vaccinated at baseline (Day 1) followed by a boost on Day 15, 29, or 57,
      and third vaccine 1-year post-prime (3rd vaccination is optional for subjects in groups 1-8).
      The total duration of the study will be about 1 year for participants who wiil receive boost
      vaccine and about 3 months for participants who will receive placebo and 2 year for
      participants who will receive a 3rd dose. Safety will be monitored during the study.
    

Intervention name(s): MVA-BN-Filo; Ad26. ZEBOV; MVA-BN-Filo; Ad26. ZEBOV; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Other
Intervention description(s): One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).; One 0.5 mL IM injection of 5*10^10 viral particles (vp).; One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).; One 0.5 mL IM injection of 1*10^11 viral particles (vp).; One 0.5 mL IM injection of 0.9% saline.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Healthy; Ebola viruses; Ebola Viral Disease (EVD); Filoviruses; monovalent vaccine; Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector; Safety; Immunogenicity
Effect of Riocigaut on Cerebral Vasodilation and Headache Induction in Healthy Volunteers
Condition: Headache
MeSH terms: Headache
Study type: Interventional

Summary: 
      This double-blind, randomized, placebo-controlled cross-over clinical trial aims to
      investigate the effects of riocigaut on cerebral arteries and headache inducing properties in
      healthy volunteers.
    

Detailed description: 
      The investigators believe that activation of sGC could play a role in migraine
      pathophysiology and propose that stimulation with riociguat causes cranial arterial dilation
      alongside headache in healthy volunteers.

      Twelve healthy volunteers participate at a screening visit, and if eligible, on two separate
      study days, where participants, in a randomized cross-over fashion, will ingest either
      riociguat (active comparator arm) or placebo (placebo comparator arm), serving as their own
      controls. On the two separate study days the investigators will measure change in diameter of
      superficial temporal artery and middle cerebral artery blood flow velocity and register
      possible headache until 4 hours after intake of riociguat or placebo. At home participants
      are expected to fill out a headache diary until 12 hours from intake of riociguat or placebo.

      Leading up to the main study described above, the investigators will conduct a pilot
      dose-finding study (experimental arm) of increasing doses of riociguat, 2,5mg and 5mg
      respectively, on two separate study days in 5 healthy volunteers, to ensure an appropriate
      dose is applied in the main study.
    

Intervention name(s): Dose Riociguat 2,5 or 5mg; Riociguat; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A selective stimulator of soluble guanylate cyclase (sGC); A selective stimulator of soluble guanylate cyclase (sGC); Placebo
Intervention MeSH terms: Riociguat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
European Exposure Study
Condition: Smoking
Study type: Observational

Summary: 
      The current study was designed to determine the exposure of adult smokers and non-smokers to
      cigarette smoke constituents through evaluation of selected biomarkers of exposure.
    

Detailed description: 
      The purpose of the study was to provide a greater knowledge about human exposure to cigarette
      smoke constituents by evaluating selected biomarkers of exposure in smokers and non-smokers.
      This was an observational, parallel-group study to be conducted at multiple centres in the
      UK, Germany, and Switzerland. It was planned to enrol sufficient subjects such that at least
      1440 subjects complete the study.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male or female 21 years of age or older with a stable health status as determined by the
        Investigator and who were able to understand the subject information and to comply with the
        study procedures and study schedule.
      
Biospecimen description: 
      Urine
Airway Management in Thoracic Anesthesia in Italy
Condition: Mechanical Ventilation Complication
Study type: Observational

Summary: 
      The aim of this study is to compare the success rate of lung isolation and time to accomplish
      a correct placement of the device between anesthetists with experience in thoracic anesthesia
      (defined as at least 4 years clinical practice experience as attending anesthetists in
      thoracic) and residents in training in thoracic anesthesia.
    

Detailed description: 
      The aim of this study is to compare the success rate of lung isolation and time to accomplish
      a correct placement of the device between anesthetists with experience in thoracic anesthesia
      (defined as at least 4 years clinical practice experience as attending anesthetists in
      thoracic) and residents in training in thoracic anesthesia.

      A prospective randomized trial was designed. To check the optimal DLT (Broncho-Cath Covidien,
      Ireland, Dublin, Teleflex Medical, Athlone, Irelanad) and/or BB (Uniblocker, Phycon, Fuji,
      Japan Arndt Cohen Cook, Australia), placement a fiberoptic bronchoscope (FOB) was used. The
      lung collapse was assessed by surgeons.

      Time from laringoscopy to the correct placement of the device, confirmed with FOB, was
      checked.

      Data were analyzed with Student't Test and Chi-square test; p value < 0.05 was considered to
      be significant.
    

Intervention name(s): DLT versus bronchial blockers
Intervention type(s): Device
Intervention description(s): Safety and efficacy of the double-lumen tubes (DLT) and bronchial blockers (BB) for lung isolation in patients undergoing thoracic surgery have been extensively studied and most of the results show similar rates of successful placement and lung collapse. DLT and BB are more frequently inserted by anesthetists who are expert in thoracic anesthesia, with dedicated but different training.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing thoracic surgery