bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Given by Mouth and Into a Vein as an Injection
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The sponsor wants to investigate how well the test medicine is taken up by the body when
      given orally (by mouth) as a tablet or capsule and as a solution for infusion (into a vein).
      The capsule and the solution will be radiolabelled. 'Radiolabelled' means that the test
      medicine has a radioactive component which helps us to track where the test medicine is in
      the body.
    


Intervention name(s): GLPG1690 film-coated tablets; [14C]-GLPG1690 solution for infusion; [14C]-GLPG1690 capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): a single oral dose of GLPG1690; a 15-minute IV infusion [14C]-GLPG1690; single oral dose of [14C]-GLPG1690
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Racial Differences in Vagal Control of Glucose Homeostasis
Condition: Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators will test the hypothesis that acute central acetylcholinesterase inhibition
      will restore PNS activity and reduce oxidation in AAW compared to whites.
    

Detailed description: 
      Obesity has a greater detrimental impact on the health of African American women (AAW) than
      on any other racial or gender group. Nearly 80% of AAW are overweight or obese. Reduced
      insulin sensitivity is more prevalent among AAW as compared to white women and men of both
      races. This condition puts AAW at increased risk for the development of type 2 diabetes
      mellitus. The exact mechanism underlying these pathophysiological differences remains
      unknown. The investigators have found that obese AAW have decreased parasympathetic nerve
      (PNS) activity compared to whites and recent studies in animal models showed that the PNS
      confers protection against oxidative stress. In our AA cohort, PNS activity was directly
      correlated with insulin sensitivity in obese AAW even after controlling for differences in
      age, blood pressure and visceral adiposity. Equally important, the investigators also showed
      that the decrease in insulin sensitivity was associated with increased oxidative stress as
      measured by plasma levels of F2-isoprostanes. Taken together these findings lead us to
      hypothesize that the decreased PNS activity in obese AAW compared to white women has
      deleterious effects on oxidative stress and insulin sensitivity.The investigators will test
      the hypothesis that acute central acetylcholinesterase inhibition will restore PNS activity
      and reduce oxidation in AAW compared to whites.
    

Intervention name(s): Galantamine; Placebo Oral Capsule; Intralipid; Heparin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 16 mg po prior to the infusion of intralipid; Placebo oral capsule prior to the infusion of intralipid/heparin; Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine; heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
Other intervention name(s): Razadyne; I.V. Fat Emulsion
Intervention MeSH terms: Heparin; Galantamine; Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of MK0359 in Patients With Chronic Asthma (0359-013)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to test the effect of MK0359 in lessening the symptoms of asthma as compared to
      placebo.
    


Intervention name(s): MK0359
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase 2 Study of the Safety of Diannexin in Kidney Transplant Recipients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is evaluate the safety and tolerability of Diannexin in kidney
      transplant recipients.
    

Detailed description: 
      Ischemia-reperfusion injury, which occurs when the blood supply to an organ, or part of an
      organ, is cut off and subsequently restored, is an important clinical problem in the organ
      transplant setting. Diannexin, a recombinant form of the endogenous human Annexin V protein,
      is in development as a therapeutic agent designed to prevent ischemia-reperfusion injury
      following organ transplantation. Pharmacology studies indicate that Diannexin has protective
      effect in various ischemia-reperfusion injury and organ transplantation models. Diannexin
      binds to phosphatidylserine on cell surfaces, which is believed to underlie its ability to
      attenuate ischemia-reperfusion injury. In a completed Phase 1 trial, Diannexin was judged
      safe and well tolerated in healthy adult subjects. The present study is designed to determine
      the safety and tolerability of single escalating doses of Diannexin in kidney transplant
      recipients.
    

Intervention name(s): Diannexin; Placebo; Diannexin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose, 200 µg/kg IV; Single dose, IV; Single dose, 400 µg/kg IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: kidney transplantation; ischemia-reperfusion injury; phosphatidylserine binding
Acute Graft-Versus-Host Disease (aGvHD) Prophylaxis With ATG-Fresenius in Matched Unrelated Donor-Stem Cell Transplantation (MUD-SCT)
Condition: Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The study aim is to evaluate the influence of the anti-T-lymphocyte globulin ATG-Fresenius S
      given pre-transplant in addition to standard GvHD prophylaxis with cyclosporine A and a short
      course of methotrexate with respect to efficacy and safety.
    

Detailed description: 
      To assess the efficacy of ATG-FRESENIUS S in addition to standard therapy (cyclosporine A /
      methotrexate) with respect to early treatment failure defined by the occurrence of severe
      acute GvHD grade III-IV or early mortality within 100 days post transplantation compared to
      standard therapy alone.

      All patients receive myeloablative therapy. Recommended regimens: For patients with ALL:
      fractionated TBI (8-12 Gy) plus cyclophosphamide (1-2 x 60 mg/kg) [etoposide/melfalan are
      also allowed]. For all other indications: either TBI (8-12 Gy) or busulfan (per os 14-16
      mg/kg b.w. or equivalent for IV administration) plus cyclophosphamide (1-2 x 60 mg/kg) or
      thiotepa ≥ 15 mg/kg or BCNU ≥ 300 mg/m2.

      Conditioning regimens may differ from centre to centre; each centre decides for constant
      (disease specific) regimen(s) throughout the whole study period.

      Standard GvHD prophylaxis consists of cyclosporine A (target trough level ≥ 200 ng/ml
      starting from day -1 until day +100) and short course methotrexate (15 mg/m2 at day +1, 10
      mg/m2 at days +3, +6 and +11).
    

Intervention name(s): ATG-Fresenius S
Intervention type(s): Drug
Intervention description(s): 20 mg rabbit immunoglobulin (IgG) in 1 ml of sterile solution
20 mg/kg body weight per day diluted in 500 ml physiological saline, slow intravenous infusion at days -3, -2, -1 prior to transplantation
Other intervention name(s): ATG-Fresenius; Anti-T-Lymphocyte globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: GvHD; aGvHD prophylaxis; Matched unrelated donor; ATG; SCT; BMT; polyclonal antibody; GvHD prophylaxis for patients with ALL, AML, CML, MDS, OMF; Patients with allogeneic BM or PBSC transplantation; Patients with a matched unrelated donor
Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
Condition: Infection, Human Immunodeficiency Virus; HIV-1 Infection
MeSH terms: Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected
      adults
    


Intervention name(s): GSK364735
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GSK364735; HIV-1; integrase inhibitor
Effects of Acupuncture in the Treatment of Infant Colic
Condition: Infant Colic
MeSH terms: Colic
Study type: Interventional
Phase: Phase 2

Summary: 
      Standardized acupuncture treatment for infant colic is a common treatment in general practice
      for doctors educated in medical acupuncture.

      The investigators plan to study whether the perceived opinion on positive results can be
      verified in a multi-center clinical trial. The investigators aim to measure the effect of
      standardized acupuncture treatment, three repeated sessions, on infant colic in a randomized
      singe blinded prospective multi-center study, starting September 2009. The study will be done
      in thirteen locations in Norway by specialists in General Practice trained in acupuncture.

      The investigators intend to include a total of 130 patients, 65 in the intervention group and
      65 in the control group.
    


Intervention name(s): Acupuncture with Seirin 020x15 mm sterile acupuncture needle
Intervention type(s): Procedure
Intervention description(s): Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.
Other intervention name(s): Seirin 020x15mm sterile acupuncture needle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Infant Colic; Acupuncture; General Practice
In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators propose to study oral commercial silver nanoparticle products on human
      enzyme activity.
    


Intervention name(s): 32ppm Silver Particle; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral silver dose of 32ppm; Sterile Water No Silver
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Baclofen Effects in Cigarette Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI), a
      functional candidate gene association approach (of dopaminergic addictions-targeted
      polymorphisms), and the dopamine-modulating and gamma-aminobutyric acid (GABA) B receptor
      agonist, baclofen, to examine the brain and behavioral responses in smokers to appetitive
      smoking reminders (cues that motivate continued smoking and relapse). These studies will
      provide a means to identify an appetitive cue-sensitive pharmacologic-responsive
      endophenotype. Once brain/behavioral/genetic endophenotypes can be determined prior to
      treatment, smoking cessation treatments can be structured to meet individual needs, which
      will significantly improve treatment outcome.
    


Intervention name(s): Baclofen; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Kemstro; Lioresal; Liofen; Gablofen; Beklo
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nicotine Addiction; fMRI; Baclofen
The Effect of Lipmatte K
Condition: Aesthetic; Cosmetic; Healthy
Study type: Interventional

Summary: 
      This study is conducted to evaluate the safety and the effectiveness of Lipmatte K on lip
      hydration and brightening. The study duration is 4 weeks and the lip assessment will be
      carried out at baseline, week 2 and week 4.The main questions this study aims to answer are:

        1. The hydration effect of the product on lip.

        2. The brightening effect of the product on lip.

        3. To observe any adverse effect occurrence with the usage of the product.
    


Intervention name(s): Lipmatte K
Intervention type(s): Other
Intervention description(s): Lipmatte K contain ingredients that may hydrate and brighten the lip
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
Condition: Migraine, Without Aura
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to determine the efficacy and tolerability of TREXIMET (formerly
      known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a
      sub-type of migraine.
    


Intervention name(s): sumatriptan succinate / naproxen sodium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): sumatriptan 85mg / naproxen sodium 500mg; Placebo to match Treximet tablets
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sumatriptan succinate,; naproxen sodium,; parallel group,; double-blind,; placebo-controlled,; Combination product,; migrainous headache; Probable migraine, a sub-type of Migraine; probable migraine,
Effects of Combined Physical-cognitive Training on Cognitive Function in MCI
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The present study aims to investigate the effects of combined physical-cognitive training on
      cognitive function as well as peripheral BDNF level and mitochondrial function of individuals
      with MCI. It is hypothesized that: 1) the combined physical-cognitive training program will
      be superior to the physical and cognitive training program alone; and 2) the degree of
      cognitive improvement will be positively correlated with the improvement of plasma BDNF and
      mitochondrial function.
    

Detailed description: 
      Recent research suggests that the benefits of combined physical-cognitive training may be
      greater than either physical or cognitive training alone. Nevertheless, this synergistic
      effect has been demonstrated mainly in cognitively intact older adults. Studies examining the
      effects of combined physical-cognitive training in older adults with MCI are scarce and show
      mixed results. Moreover, few studies have determined the effects of the combined training on
      peripheral brain-derived neurotrophic factor (BDNF) and mitochondrial function. Thus, the
      present study aims to investigate the effects of combined physical-cognitive training on
      cognitive function as well as peripheral BDNF level and mitochondrial function of individuals
      with MCI. The present study will provide insight into the interplay among the training
      program, peripheral BDNF concentration, mitochondrial function, and cognitive function.
      Importantly, the findings will have clinical implication regarding the training program that
      is feasible and effective in improving cognitive function of older adults with MCI which
      ultimately will have great impact on public health as this population is at high risk of
      progression to AD.
    

Intervention name(s): Combined physical-cognitive training; Physical training; Cognitive training
Intervention type(s): Other; Other; Other
Intervention description(s): combined physical-cognitive training; Multi-component physical exercise; cognitive training
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: mild cognitive impairment; combined physical-cognitive training; BDNF; mitochondrial function; cognitive function
The Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac
Condition: Influenza A Virus Infection; Influenza A; Influenza Epidemic; Influenza H5N1
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The present clinical phase I study designed to examine the safety, reactogenicity and
      immunogenicity of the medicinal product - Vaccine vector against influenza A - in healthy
      volunteers after a single dose in the three groups with dose escalation.
    

Detailed description: 
      According to the results of the screening of volunteers who signed the informed consent Form,
      a sequential set of three groups of volunteers with different doses of the drug, the total
      number of volunteers who received the drug will be at least 36 people.

      Given the fact that the drug is investigated for the first time with the participation of the
      people, will initially be admitted to hospital on 5 volunteers who will receive the
      investigational drug in the 1 dose The total number of recombinant pseudo-adenoviral
      particles (2.5 ± 1.25) x 10*10 VP/dose). If the safety of the drug is confirmed by the
      results of observation on the 7th day of the study, the study will continue with the
      participation of 7 more volunteers in this dosing group.

      Further, according to a similar scheme (each time after an interim safety assessment on day
      7), the study will include volunteers receiving the drug at a dose of 0.5 ml (Total amount of
      recombinant pseudo-adenoviral particles (1.0 ± 0.5) x 1011 VP/dose), particles/dose and 0.5
      ml, -The total number of recombinant pseudo-adenoviral particles (2.5 ± 1.25) × 1011 VP/dose
      .
    

Intervention name(s): GamFluVac
Intervention type(s): Biological
Intervention description(s): 1 dose (0,5 ml)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Taking into account the fact that the drug is being studied for the first time with the participation of people, initially 5 volunteers will be hospitalized, who will receive the study drug at a dose of 1. If the safety of the drug is confirmed by the results of observation on the 7th day of the study, the study will continue with the participation of 7 more volunteers in this dosing group.
Further, according to a similar scheme (each time after an interim safety assessment on day 7), volunteers receiving the drug at a dose 2 and dose 3 will be included in the study.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza; vaccine; vector vaccine
Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with
      non-alcoholic fatty liver disease.
    

Detailed description: 
      76 children or adolescents aged 6-19 with NAFLD will be included in the study. Diagnosis of
      NAFLD is set by increased alanine transaminase and features of liver steatosis on ultrasound.
      Patients will be randomized to receive either fish oil (EPA/DHA, 400-1200mg) or placebo
      (sunflower oil) for 6 months. All children will be advised to reduce weight (dietetic
      intervention + increased physical activity). Laboratory tests, liver ultrasound,
      anthropometric analysis will be performed at the start, after 3 months and 6 months.
    

Intervention name(s): Fish Oil
Intervention type(s): Dietary Supplement
Intervention description(s): Fish oil given in supplementary dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fatty liver; hepatitis; insulin resistance; unsaturated fatty acids; NAFLD, children
Multi-level Supermarket Discount Study
Condition: Obesity
Study type: Interventional

Summary: 
      The study team's objective is to test the effect of supermarket discount levels on fruit and
      vegetable (F&V) and non-caloric beverage purchasing and consumption, as well as health
      outcomes. The study team will implement this economic intervention in a local supermarket
      chain to assess the effects of a 32-week intervention of fruit and vegetable (F&V) and
      non-caloric beverage discounts of 30%, 15%, and 0% (control group) on purchasing, dietary
      intake, and health outcomes, including body weight and composition, blood pressure, and
      biochemical markers of cardiovascular disease risk. The 32-week intervention will be preceded
      by an 8-week baseline and will have a follow-up period of 16 weeks. There will be no
      discounts in effect during the baseline and follow-up periods.
    

Detailed description: 
      The objective is to test the effect of supermarket discount levels on fruit and vegetable
      (F&V) and non-caloric beverage purchasing and consumption, as well as health outcomes. The
      study team will implement this economic intervention in a local supermarket chain to assess
      the effects of a 32-week intervention of fruit and vegetable (F&V) and non-caloric beverage
      discounts of 30%, 15%, and 0% (control group) on purchasing, dietary intake, and health
      outcomes, including body weight and composition, blood pressure, and biochemical markers of
      cardiovascular disease risk. The prediction is that the impact will increase with the level
      of discount. The 32-week intervention will be preceded by an 8-week baseline and will have a
      follow-up period of 16 weeks. There will be no discounts in effect during the baseline and
      follow-up periods. The prediction is that some of the interventional effects will carry over
      to the follow-up period.
    

Intervention name(s): Discount Intervention
Intervention type(s): Behavioral
Intervention description(s): 15% or 30% discount on fruits and vegetables
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nutrition