bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children
Condition: Encephalitis, Tick-Borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE
      vaccines administered to children.
    


Intervention name(s): Tick-Borne Encephalitis vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: TBE, children, vaccine
Impact of One Versus Two Amino Acid Chelated Iron Capsules on Prevention of Iron Deficiency Anemia in Non-anemic Women With Twin Gestations
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Anaemia is the most worldwide health problem affecting pregnant women in both developed and
      developing countries. During pregnancy there is an inconsistent increase in plasma volume and
      haemoglobin mass.

      Iron deficiency anemia is the commonest type of anemia during pregnancy. The pregnant woman
      needs about 1000 mg of iron during pregnancy.

      Diet alone cannot give pregnant woman the daily required amount of the iron (about 27 mg/day)
      so the Centers for Disease Control and Prevention recommend that pregnant women take a daily
      supplement of 30 mg of elemental iron as a preventive dose. As most women begin their
      pregnancy with low iron stores, particularly in the second and third trimesters, so
      prevention should start as soon as possible even before pregnancy to prevent depletion of
      iron store and further Iron deficiency anemia.

      Oral iron is a cheap, effective and relatively safe line to prevent Iron deficiency anemia
      during pregnancy. The common available ferrous salts include ferrous fumarate, ferrous
      sulphate and ferrous gluconate. Unfortunately; these iron forms are associated usually with
      constipation, darkened stools, diarrhea, loss of appetite, nausea, stomach cramps, and
      vomiting.

      Iron amino acid chelates have been emerged to be used as agents for prevention and treatment
      of Iron deficiency anemia. These agents provide maximum bioavailability and maximum efficacy
      with minimal unpleasant side effects.

      Twin pregnancies have a significant role in perinatal morbidity due to increased risks of low
      birth weight and preterm birth. The iron requirement for twin pregnancy is probable double
      fold that of a singleton pregnancy and maternal hemoglobin in twin gestations is usually
      lower than in singleton pregnancy resulting in higher rate of Iron deficiency anemia.
    


Intervention name(s): 27 mg elemental iron; 54 mg elemental iron
Intervention type(s): Drug; Drug
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Effect of Lipid Infusion on Toll Like Receptor 4 (TLR4) Signaling
Condition: Diabetes; Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a lipid infusion can up-regulate toll-like
      receptor 4 (TLR4) signaling in human subjects
    

Detailed description: 
      The investigators plan to examine the effect of a lipid infusion on TLR4 expression and
      insulin sensitivity. A group of 30 subjects aged 18-60 years old, lean (BMI < 26 kg/m2)
      normal glucose tolerant subjects without a family history of type 2 diabetes will receive a
      lipid or saline infusion. The subjects will be randomly assigned to first receive either a 48
      hour long lipid or saline infusion. Approximately 4-6 weeks later subjects will return to
      undergo another study (if, in the first study they received lipid, on the second study they
      will receive saline, and vice versa). A near-equal number of women and men will be included
      in each group.
    

Intervention name(s): Intralipid 20%; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 30 ml/h for 48 h; 30 ml/h for 48 h
Other intervention name(s): Liposyn; sodium chloride injection
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: diabetes; obesity; inflammation
Reliability and Diagnostic Accuracy of an Alternate Lachman's Test Performed in a Prone Position
Condition: Anterior Cruciate Ligament Stability
Study type: Observational

Summary: 
      This study is investigating the reliability and diagnostic accuracy of a Lachman's test
      conducted in a prone position to detect the presence of a torn anterior cruciate ligament.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        31 men and 21 women ranging in age from 16-57 years old with complaint of knee pain
      
Keywords: accuracy, anterior cruciate ligament, diagnostic value, examination, knee, Lachman test, sensitivity, specificity
Efficacy of External Nasal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries
Condition: Agitation States as Acute Reaction to Gross Stress
MeSH terms: Psychomotor Agitation
Study type: Interventional

Summary: 
      Emergence agitation following general anaesthesia may lead to serious complications like
      self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia,
      bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence
      agitation. The investigators planned to evaluate the efficacy of external nasal nerve block
      in prevention of postoperative agitation following external nasal surgeries under general
      anesthesia(GA).
    


Intervention name(s): External nasal nerve block; saline adrenaline; Xylocaine, adrenaline
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Nasal surgery; external nasal nerve block; postoperative agitation
Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether mesalazine or budesonide is more active in
      the treatment of active Crohn's disease.
    

Detailed description: 
      Crohn's disease is often treated with glucocorticoids or mesalazine. Both drugs are indicated
      for active Crohn's disease. Treatment with mesalazine is indicated for the treatment of
      mildly to moderately active Crohn's disease. Budesonide 9 mg/day or mesalazine 4.5 g/day are
      better than lower doses.

      So far only one trial compares the efficacy and safety of budesonide and 5-ASA. The result of
      this trial is that budesonide is more effective in inducing remission than mesalazine. The
      primary objective of this trial is to confirm this result for other presentations of
      budesonide and mesalazine; i.e. Budenofalk® capsules (9 mg/day) and Salofalk® tablets
      (Eudragit-L-coated oral mesalazine; 4.5 g/day) in moderately active Crohn's disease.
      Mesalazine is used in this trial as a comparator.
    

Intervention name(s): budesonide; mesalazine
Intervention type(s): Drug; Drug
Intervention description(s): 9 mg; 4.5 g
Intervention MeSH terms: Budesonide; Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Induction of Immunogenicity With Different Doses of TreeMATA in Subjects Allergic to Tree Pollen
Condition: Type I Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 2

Summary: 
      Tree MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide
      pre-seasonal specific immunotherapy for patients with hypersensitivity to tree (birch, alder,
      and hazel) pollen. Different doses of Tree MATA will be administered and immunological
      changes following this treatment will be assessed.
    

Detailed description: 
      Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients
      with proven type I hypersensitivity to tree (birch, alder, and hazel) pollen.

      The tree pollen extract is modified with glutaraldehyde to produce the active ingredient, an
      allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus
      reducing the risk of side effects. However, a simultaneous reduction in other important
      immunological properties, such as IgG and T cell reactivities, is not seen.

      MPL (Monophosphoryl Lipid A), a purified, detoxified glycolipid derived from the cell wall of
      Salmonella minnesota, is included in the product formulation as an adjuvant to increase the
      immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to
      a TH1-like T cell profile.

      The purpose of this study is to assess specific immunological changes (IgG, IgG1, IgG4 and
      IgE) in allergic subjects following 2 subcutaneous injections of different doses of study
      medication (Tree MATA) or placebo administered 3 weeks apart. The immunological changes will
      be used to assess the performance of the R7 IgG reactivity assay over a range of clinically
      efficacious doses.
    

Intervention name(s): TreeMATA MPL
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Allergy; Allergoid; Specific Immunotherapy
SB-659032 Platelet Aggregation Study
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess whether inhibition of plasma Lp-PLA2 activity impacts
      platelet function as assessed by ex vivo platelet aggregation tests and in vivo plasma
      biomarkers.
    

Detailed description: 
      SB-659032 is a selective and orally active inhibitor of lipoprotein-associated phospholipase
      A2 (Lp-PLA2) that is being developed for the treatment of atherosclerosis. This study is
      designed to assess whether inhibition of plasma Lp-PLA2 activity impacts platelet function as
      assessed by ex vivo platelet aggregation tests and in vivo plasma biomarkers. Blood samples
      for PK analysis and measurement of Lp-PLA2 activity will also be collected. Questionnaires
      will be completed to evaluate the frequency of odorrelated AEs with non-enteric coated
      formulation of SB-659032 relative to placebo. This will be a double blind, repeat dose,
      randomized, placebo-controlled, two period, period balanced, crossover study. There will be a
      minimum of a 21 day washout period between dosing in each period.
    

Intervention name(s): SB-659032; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Matched placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Phase I, First in Man Study to Evaluate the Safety and Tolerability of a panRAF Inhibitor (CCT3833/BAL3833)in Patients With Solid Tumours
Condition: Melanoma; Cancer
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a first in man, dose escalation study to evaluate the safety, tolerability and
      how the drug works in the body in patients with all solid tumours. The aim of this study is
      to determine the most effective dose of the study drug that can then be further investigated
      in patients with advanced melanoma.
    

Detailed description: 
      Metastatic malignant melanoma is the 5th most common cancer in the UK, with a notable
      proportion of young patients. The development of immunotherapies (such as Ipilimumab), and
      targeted therapies (such as Vemurafenib, a BRAF inhibitor) have resulted in improved survival
      outcomes for patients but is still only measured in months and not years. These targeted
      therapies are also only useful for patients with the relevant genetic mutation, leaving a
      significant proportion of patients without targeted therapy options. The need for more
      effective (and ideally curative) melanoma treatments remains. The Institute of Cancer
      Research, with funding from the Wellcome Trust, have created and developed a new panel of
      inhibitors that aim to more effectively terminate the growth, spread and survival signals
      that sustain the cancer. The broader targets allow patients possessing a range of genetic
      mutations to potentially benefit from this targeted therapy. It is hoped that these drugs
      could be used as both primary therapy for treatmentnaive patients as well as rescue therapy
      for those who have progressed on other targeted therapies.

      This is a phase 1 study to evaluate the safety and effectiveness of one of these new
      compounds, CCT 3833, and to define the maximum tolerated dose in patients with advanced
      melanoma. The study also aims to examine the way that CCT3833 works within the body. Once the
      maximum tolerated dose has been established a small number of melanoma patients, with
      specific mutations and at different treatment option stages, will be treated to gain
      additional safety information and an initial indication of the possible efficacy of CCT3833
      on melanoma tumours.
    

Intervention name(s): CCT3833
Intervention type(s): Drug
Intervention description(s): CCT3833 is a poorly soluble crystalline compound. It is multi-polymorphic and one form, designated Form D, has been purified and typically has a particle size of about 15-20 μm. Form D readily absorbs and desorbs water, but is not a hydrate and has been selected as the form to take forward into clinical development.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents (smokeScreen)
Condition: Smoking
MeSH terms: Marijuana Use
Study type: Interventional

Summary: 
      The goal of this sub-study is to learn more about how an educational videogame can feasibly
      be implemented and disseminated in youth programs.
    

Detailed description: 
      The specific aims of this sub-study are:

      Specific Aim #1: Work with game development team to develop a web-based version of
      smokeSCREEN.

      Specific Aim # 2: Build a pre-post survey into the smokeSCREEN game to anonymously collect
      survey information on players' perspectives, beliefs, behaviors around smoking.

      Specific Aim # 3: Collaborate with youth programs to pilot test the implementation of the new
      web-based version of smokeSCREEN into youth programs.
    

Intervention name(s): smokeSCREEN video game
Intervention type(s): Device
Intervention description(s): smokeSCREEN video game is web-based videogame intervention focused on tobacco use prevention in teens. The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products.smokeSCREEN. Guided by the social cognitive theory and the theory of planned behavior, smokeSCREEN addresses a range of challenges that teens often face involving peer pressure and the use of tobacco products. Participants are provided access to the smokeSCREEN game through a private, password-protected website link and instructed to complete the game.
Intervention model: Single Group Assignment
Intervention model description: single group study with pre-post design
Masking: None (Open Label)
Primary purpose: Prevention
Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Study KCC-SMT-002, is a Phase 1, single-site, open-label, non-randomized, crossover, flexible
      dose design study to investigate the pharmacokinetic (PK) and safety comparing the Sofusa™
      system with sumatriptan (KC5010) to Imitrex® oral tablets in 17 healthy volunteers.
    


Intervention name(s): Sumatriptan Succinate Oral Tablet; Transdermal delivery of sumatriptan succinate
Intervention type(s): Drug; Combination Product
Intervention description(s): Sumatriptan succinate commercial Imitrex 100 mg tablet; Sumatriptan succinate transdermal drug delivery system
Other intervention name(s): Sofusa DoseDisc; Sofusa DoseConnect; KC5010
Intervention MeSH terms: Sumatriptan
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine whether at least one formulation of an experimental dengue vaccine
      (V180) is safe and causes an immune response.
    


Intervention name(s): Low-dose V180 with low-dose ISCOMATRIX™ adjuvant; Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant; Medium-dose V180 (non-adjuvanted); Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant; Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant; Medium-dose V180 with Alhydrogel™ adjuvant; High-dose V180 (non-adjuvanted); High-dose V180 with low-dose ISCOMATRIX™ adjuvant; High-dose V180 with medium-dose ISCOMATRIX™ adjuvant; Low-dose V180 with high-dose ISCOMATRIX™ adjuvant; Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant; High-dose V180 with high-dose ISCOMATRIX™ adjuvant; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Three 0.5-mL intramuscular doses of low-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of low-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of medium-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of medium-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of medium-dose V180 containing Alhydrogel™ adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of high-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of high-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of low-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of medium-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of high-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2; Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study to Evaluate the Effects of Tedizolid Phosphate on the Pharmacokinetics and Safety of Midazolam and Rosuvastatin (MK-1986-004)
Condition: Skin Diseases, Bacterial
MeSH terms: Skin Diseases, Bacterial; Skin Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of steady-state tedizolid phosphate on the
      single-dose pharmacokinetics of midazolam and rosuvastatin in healthy, adult participants.
    


Intervention name(s): midazolam; rosuvastatin; tedizolid phosphate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 mg (1 mL of 2 mg/mL oral syrup) administered as a single dose on Days 1 and 14; 10 mg tablet administered as a single oral dose on Days 3 and 16; 200 mg oral tablet administered once daily on Days 5-17
Intervention MeSH terms: Tedizolid; Tedizolid phosphate; Midazolam; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Active Heating on Maternal and Neonatal Well-being
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      This study was conducted to determine the effects of actively warming the patient and using
      warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being
    

Detailed description: 
      This study was conducted to determine the effects of actively warming the patient and using
      warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being.

      The study was conducted in a university hospital with a total of 105 women who gave birth by
      cesarean section randomly selected from 35 intervention 1 (only underbody heater group), 35
      intervention 2 (both underbody heater and heated IV fluid group) and 35 control group. The
      research data were collected with the Individual Information Form, Patient Follow-up Form and
      Visual Analog Scale. APGAR score, body temperature, cortisol and glucose levels were
      evaluated in the infant and body temperature, intraoperative bleeding, shivering,
      postoperative pain, gas and urination were evaluated in the mother between the three groups.

      Descriptive statistics, Chi-square, Shapiro Wilks, Friedman, Wilxocon, Kuruskal Wallis and
      Mann Whitney U test were used in the evaluation of the data and significance level p<0.05 was
      accepted.
    

Intervention name(s): İntervention 1 group (underbody heater group only); İntervention 2 group (group using both underbody heater and heated iv liquid); Control Group
Intervention type(s): Other; Other; Other
Intervention description(s): Resistive heaters can be set to 38-40°C and are used together with the control unit to which they are connected. In the study, an underbody heater (MEDWARM W 300 IM 190MS branded) system measuring 1900x500x40mm was used. In this study, the underbody heater was set to 38°C for patients. Before use, a surgical drape was placed over it to prevent direct patient contact.; IV fluids should be warmed to protect patients from unwanted hypothermia during surgery. One liter of saline solution given at room temperature decreases body temperature by 0.25˚C in adults. Therefore, the fluids given to the patient should be heated to 33 40˚C. In the guideline published by the Turkish Anesthesia Society, it is stated that if more than 1000 2000 mL of fluid is to be given to patients, it should be heated at 37°C (TARD, 2013). In this study, both IV fluids were heated between 37 and 39°C and given to the patient and heated with carbon fiber underbody heaters.; no active heating treatment was applied in this group
Other intervention name(s): MEDWARM W-300 IM-190MS; MEDWARM W-300 IM-190MS, QW3 Blood and Serum Warmer; group without active heating
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized controlled trial
Masking: Single (Participant)
Primary purpose: Supportive Care