bioihbjkbjnl/mcl2 huggingface dataset:
The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient.
Condition: HIV Infection; Yellow Fever
MeSH terms: Yellow Fever; Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      Main objective :

      To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever
      Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative
      individuals who had not been given YFV before.

      Secondary objectives :

        -  To develop and assess ELISPOT technology for yellow fever and to measure the response
           within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects
           and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy
           (HAART) for at least one year, with a viral load < 50 copies/mL since at least 6 months)
           in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3)
           neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference
           method) and a new pseudotype based method, (4) post-vaccination viremia and (5)
           diversity of viral quasi-species.

        -  To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and
           viral load.
    

Detailed description: 
      Method :

      Clinical Trial Phase III, Multicentre protocol at Saint-Louis hospital, Bichat hospital and
      Cochin-Pasteur hospital, with CERVI, INSERM U 941 and SC10 collaboration.

      Trial treatment : Yellow fever vaccination (STAMARIL)

      Criterion :

      Immuno-virologic: At J-7, J7, J28, M3 and M12 will be determined the levels of antibodies by
      fluorescence, at J0, J7, J28, M3 and M12 titles and neutralization with Prnt pseudotypes, the
      ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide
      sequences on phylogenetic strains of viremia. Titles and Amariles kinetics of viremia,
      neutralizing antibodies and ELISPOT will be considered as surrogate markers of response in
      terms of groups.

      Clinical and biological tolerance: At all follows up will be measured the incidence of CDC
      classification events (for HIV+) and general and local reactions of degree ≥ 2 in the setting
      of the injection of STAMARIL®.

      Schedule :

      Date of first enrolment : third quarter 2011. Inclusion period : 18 months. For each subject,
      participation in this trial will be for 12 months.
    

Intervention name(s): Yellow fever vaccination (STAMARIL); Yellow fever vaccination (STAMARIL)
Intervention type(s): Biological; Biological
Intervention description(s): Yellow fever vaccination (STAMARIL); Yellow fever vaccination (STAMARIL)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Levetiracetam in Early Psychosis
Condition: Psychosis; Schizophrenia; Schizo Affective Disorder; Schizophreniform
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      In order to establish target engagement and identify an effective dose the investigators will
      conduct a placebo-controlled single-dose parallel group trial of levetiracetam 185 mg and 500
      mg in 24 medication-naïve early psychosis (EP) patients, measuring hippocampal activity by
      pulsed arterial spin labelling (ASL) pre-dose and 2 hours post-dose. The lower dose is
      calculated to achieve blood levels within the range that were associated with reduced
      hippocampal activity and improved cognition in patients with mild cognitive impairment; the
      higher dose is a typical antiepileptic dose. Successful demonstration of target engagement
      will be defined by an effect size of 0.5 or greater compared to placebo in reduction by
      levetiracetam of hippocampal blood flow measured by ASL. The optimal dose will be defined by
      maximal reduction of hippocampal perfusion in the absence of clinically-significant adverse
      effects. The investigators will also study 8 healthy control subjects to verify that baseline
      hippocampal blood flow is elevated in the sample of EP subjects.
    


Intervention name(s): Levetiracetam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.; Prepared in capsules to appear identical to levetiracetam.
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Early Psychosis; Levetiracetam
Skin Cancer Prevention in a Pediatric Population
Condition: Skin Cancer
MeSH terms: Skin Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Skin cancer risk is largely determined by sun exposure during childhood. This study
      determines the effectiveness of a mailed intervention designed to increase sun protection for
      children age 6-9 years old. The intervention includes newsletters for parents that include
      risk information tailored to each child. Also included are sun protection resources such as a
      swim shirt, a sun hat, and sunscreen. Participants receive the intervention over 3
      consecutive years, and data collection includes telephone interviews and skin exams. The
      study hypothesis is that receipt of the intervention will result in improved sun protection
      of the child.
    

Detailed description: 
      About 1 in 90 American children born in the late 1990's will develop malignant melanoma in
      their lifetimes. Sun exposure in childhood appears to be the most important preventable risk
      factor for this disease. This project will develop a tailored, risk-based, written
      intervention, which will be mailed to parents of children age 6-9 years in the spring of each
      year. The tailored intervention will utilize the Precaution Adoption Process Model, which has
      a primary focus on risk perception and suggests that there are seven stages leading to
      sustained health behavior change. The effectiveness of the intervention will be tested using
      a randomized controlled trail involving 1000 children recruited from health care facilities
      and community locations at age 5-6 years and followed for 3 years using telephone interviews
      to assess sun protection behaviors and skin exams to observe changes in melanocytic nevi,
      freckling, and tanning.
    

Intervention name(s): Semi-tailored newsletter
Intervention type(s): Behavioral
Intervention description(s): Delivered over 3 consecutive years, in the spring
Other intervention name(s): Semi-tailored newsletter intervention; for parents and children
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: skin cancer prevention; precaution adoption process model; semi-tailored newsletter; pediatric; behavioral intervention
Prevalence and Characteristics of Nonpolypoid Colorectal Neoplasms - A Chinese Cohort Study
Condition: Nonpolypoid Colorectal Neoplasms(NP-CRN)
MeSH terms: Neoplasms; Colorectal Neoplasms
Study type: Observational

Summary: 
      The nonpolypoid colorectal neoplasms (NP-CRNs) are relatively common in patients with
      gastrointestinal alarm systoms. The depressed lesions have a greater risk of having cancer
      than flat and polypoid lesions.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        consecutive adult patients undergo colonoscopy by one endoscopist from Jan 2009 to Dec 2010
      
Biospecimen description: 
      All the lesions will be removed endoscopically or surgically and examined histologically by
      an independent gastrointestinal pathologist.

      Histological diagnosis is determined according to the World Health Organization (WHO)
      criteria.Pedunculated lesions are categorized according to Haggitt's classification.
    
Keywords: nonpolypoid colorectal neoplasms(NP-CRN); prevalence; histology
Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a Buteyko-based breathing
      technique on physiological and psychological parameters in adults with asthma
    

Detailed description: 
      The investigators explore the effects of a Buteyko-based breathing technique training using a
      treatment group vs. control group design and a repeated measures design with follow-up
      measurements 3 and 6 months after the intervention. The sample size calculation was made for
      an effect of d = .20 with repeated measures, a power of 1- β = .80 and α = .05. Additionally
      the investigators plan to take measurements (only once) from healthy volunteers matching them
      (age and gender) with the asthma patients.
    

Intervention name(s): Buteyko Breathing Technique
Intervention type(s): Other
Intervention description(s): Patients are trained in various exercises aiming at breath reduction and breath control as introduced by Dr. K. Buteyko
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Buteyko-based breathing technique training
A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.
    


Intervention name(s): Itraconazole; ALKS 5461
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally in a crossover design; Administered sublingually in a crossover design
Other intervention name(s): Itraconazole or placebo; ALKS 5461 or placebo
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of a Silicone Hydrogel Daily Disposable Multifocal Contact Lens to a Marketed Product
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single-masked, 2×3 crossover, randomized-controlled, dispensing clinical trial to
      evaluate overall quality of vision.
    


Intervention name(s): JJVC Investigational Multifocal Contact Lenses; Dailies Total 1® Multifocal Contact Lenses
Intervention type(s): Device; Device
Intervention description(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in Twin Pregnancy Management.
Condition: Twin to Twin Transfusion Syndrome; Pregnancy Complications; Multiple Gestation; Maternal Care
MeSH terms: Pregnancy Complications; Fetofetal Transfusion
Study type: Observational

Summary: 
      The ZTWINS registry study is an observational, prospective, multi-center study observing
      women carrying a twin pregnancy who receive snp-based non-invasive prenatal screening and
      zygosity assessment as part of their medical care.
    

Detailed description: 
      This observational data collection study will include subjects with ultrasound-confirmed twin
      pregnancy and planned NIPS zygosity assessment as a part of their clinical care. Initial
      chorionicity assessment and, when available, planned twin pregnancy management (e.g.,
      frequency of prenatal ultrasounds, maternal fetal medicine (MFM) referral etc) will be
      recorded in the study database. Following zygosity results being returned through clinical
      care NIPS, updated chorionicity & amnionicity will again be recorded in the study database.
      Other clinical data in the medical record as part of clinical care, including monochorionic
      twin pregnancy complications (TTTS, FTC referral, etc), placenta pathology findings, and
      delivery and neonatal outcomes will also be recorded in the study database. There will be no
      study blood sample collection or other study procedures performed as part of this study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women carrying a twin pregnancy
Insulin by Jet-injection for Hyperglycemia in Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the pharmacokinetic and pharmacodynamic profile of
      the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by
      jet-injection to that of the same insulin injected with a conventional pen in the management
      of hyperglycemia in subjects with diabetes
    

Detailed description: 
      Recently, we showed in both healthy, non-diabetic volunteers and in patients with type 1
      (T1DM) and insulin-treated type 2 diabetes (T2DM) a 40-50% faster absorption of rapid-acting
      insulin analogues when administered by jet injection technology rather than by conventional
      insulin pen. The faster insulin action of insulin administration by jet injection may be
      especially advantageous for correction of hyperglycemia.

      To investigate this, a open-label randomised controlled cross-over study will be performed in
      20 adult patients (18-75 years) with T1DM or T2DM on basal-bolus insulin treatment.

      The pharmacokinetic and pharmacodynamic profile of insulin aspart will be derived from the
      time-action profiles of insulin and glucose, respectively, in response to insulin (in a dose
      of 1.5 times the amount of insulin needed to reduce blood glucose to 6 mmol/l calculated by
      the insulin-sensitivity factor) after reaching hyperglycemia (18-23 mmol/l). All patients
      will be investigated twice, where on one occasion the jet-injector device will be used to
      inject insulin, and on the other occasion insulin will be injected with a conventional
      insulin pen. The order of these occasions will be randomised. Both devices will be operated
      by the patient after sufficient training. Ease of use will be evaluated.
    

Intervention name(s): insulin aspart
Intervention type(s): Drug
Intervention description(s): After hyperglycaemia (18-23 mmol/l) has been reached (by decreasing or interrupting exogenous insulin administration 12-24 hours before the experiment), aspart insulin (in a dose of 1.5 times the amount of insulin needed to reduce blood glucose to 6 mmol/l calculated by the insulin-sensitivity factor) will be administered subcutaneously by Insujet pen or conventional insulin pen, on two separate occasions, or vice versa. The injection will be given by the subject under supervision of the research staff.
Other intervention name(s): Novorapid
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; insulin administration; hyperglycaemia; insulin aspart
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin
      versus combination metformin and a secretagogue
    


Intervention name(s): Technosphere Insulin; Metformin & Secretagogues; Technosphere Insulin & Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhalation, 15U/30U, prandial; Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.; Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Secretagogues
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal
      insulin glargine and once-daily prandial insulin lispro, in participants with Type 2
      Diabetes.
    


Intervention name(s): Insulin Lispro Low Mixture (LM); Insulin Glargine; Prandial Insulin Lispro
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participant-dependent dose, administered subcutaneously for 24 weeks; Participant-dependent dose, administered subcutaneously for 24 weeks; Participant-dependent dose, administered subcutaneously for 24 weeks
Other intervention name(s): Humalog Mix75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection); Humalog; LY275585
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Protamines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic Diseases; Diabetes Mellitus, Type 2; Glargine; Diabetes Mellitus; Insulin LISPRO; Insulin
Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional

Summary: 
      Aim of this study is to investigate whether and to what extent a cautious respiratory and
      exercise therapy can complement medical treatment and change the condition, oxygen uptake,
      quality of life, the pulmonary vascular pressures, the size of the right heart and the
      6-minute walk distance in patients with pulmonary hypertension.
    


Intervention name(s): respiratory and exercise therapy
Intervention type(s): Other
Intervention description(s): Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: respiratory therapy; exercise therapy; oxygen uptake; quality of life; right ventricular function; severe pulmonary hypertension
The Potential Effect of Avena Sativa L. on Wellness/Wellbeing During Smoking Reduction/Cessation Experience
Condition: Smoking Reduction
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the potential effect of Avena Sativa L. on wellbeing
      during smoking reduction/cessation
    

Detailed description: 
      The duration of the study will be 90 days (12 weeks). The consumption time will be set at 60
      days (8 weeks), the remaining 30 days will be for follow up, the product will not be
      consumed. Each day of the study will be recorded in a diary by each subject.

      Subjects are randomized based on the number of cigarettes and the Richmond test. In addition,
      subjects with a high score on the DASS-21 test items could not participate in the study.
    

Intervention name(s): Experimental product consumption; Control product consumption
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Consumption of the experimental product 2 capsules daily, morning and evening (450 mg each capsule) for 60 days; Consumption of control product of identical appearance 2 capsules daily for 60 days, morning and evening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Wellbeing; Wellness
The Visuo-attentional Mediator of Social Facilitation
Condition: Social Facilitation
Study type: Interventional

Summary: 
      Social psychology has long established that the mere presence of others influences the
      investigator's individual behavior and performance. "Social facilitation" refers to any
      improvement or deterioration of performance due to the presence of others. For more than a
      century, social psychology has acquired a solid knowledge of the principles governing this
      fundamental form of social influence.

      But the underlying mechanism of social facilitation remains debated, as behavior alone cannot
      identify it with certainty. This major unresolved problem makes it particularly difficult to
      translate laboratory results on social facilitation into real applications in areas such as
      school or work, where others are ubiquitous. The purpose of this study will therefore be to
      identify the mediator of social facilitation.
    


Intervention name(s): Social Facilitation
Intervention type(s): Behavioral
Intervention description(s): During the functional Magnetic Resonance Imaging (fMRI) scans, the subject will perform cognitive tasks measuring eye movements and attention alternatively observed by a familiar peer (in an adjacent room) or not.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Functional Magnetic Resonance Imaging (fMRI); Healthy Subjects
A Study of BMS-582949 in Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical research study is to learn if BMS-582949 alone is an effective
      treatment for moderate to severe psoriasis. The safety of the drug and the effectiveness of
      each dose will also be studied.
    


Intervention name(s): BMS-582949; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, Once daily, 12 weeks; Tablets, Oral, Once daily, 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and Forxiga®
      after a single oral dose in healthy volunteers.

      The study will also compare the pharmacokinetics and safety profiles of DA-2811 under fasting
      and fed states in healthy subjects.
    


Intervention name(s): Forxiga; DA-2811; DA-2811; DA-2811
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single dose administration after 10hr fasting; single dose administration after 10hr fasting; single dose administration after 10hr fasting; single dose administration after high fat and calorie fed diet
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment