bioihbjkbjnl/mcl2 huggingface dataset:
Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03)
Condition: Influenza A Virus, H5N1 Subtype
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent
      Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine
      with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by
      the A/H5N1 "bird flu" virus in Europe but none of the vaccines to be used in the study are
      approved for use in the United States. The results of this study will help researchers learn
      about better ways to vaccinate people against the H5N1 flu.
    

Detailed description: 
      The influenza virus (a germ) causes influenza or "flu." The flu is an infection of the
      breathing tubes and the lungs. In recent years, flu viruses that at first only infected birds
      have begun to infect humans. One of these strains is called avian influenza (A/H5N1 subtype)
      or "bird flu". Although no human cases of bird flu have been diagnosed in the United States,
      this strain has caused severe illness and death in several hundred people since late 2003. .

      Vaccination is the most effective way of controlling flu and preventing its illness and
      complications. Vaccines help prevent illness by causing the body to make antibodies that
      fight infection. One way to improve the effectiveness of a vaccine is to include a substance
      that can stimulate the immune system to make more antibodies. This type of substance is
      called an adjuvant; one type of adjuvant is called AS03 (Adjuvant System 03).
    

Intervention name(s): H5N1 vaccine plus AS03 adjuvant; H5N1 vaccine without adjuvant
Intervention type(s): Biological; Biological
Intervention description(s): Administered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus with AS03 adjuvant, administered 21 (+/- 3) days apart.; Administered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant.
Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus without adjuvant, administered 21 (+/- 3) days apart.
Other intervention name(s): Q-Pan H5N1; adjuvanted Q-Pan H5N1; unadjuvanted H5N1 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: influenza A (H5N1) virus; H5N1 influenza; influenza A/H5/N1; monovalent H5N1 influenza vaccine; systems biology; AS03 adjuvant; unadjuvanted
Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers
Condition: Hypertension, Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective : To investigate pharmacokinetics after concomitant administration of
      valsartan and rosuvastatin compared to single administration of valsartan or rosuvastatin in
      healthy male volunteers

      Secondary objective : To investigate safety profiles after the administration of valsartan or
      rosuvastatin alone and concomitant administration of valsartan and rosuvastatin in healthy
      male volunteers
    


Intervention name(s): Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R); Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R); Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V); Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V); Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R); Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug; Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug; Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug; Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug; Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug; Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
Other intervention name(s): V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor; V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor; V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor; V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor; V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor; V= Valsartan = brand name : Diovan; R= Rosuvastatin = brand name : Crestor
Intervention MeSH terms: Valsartan; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
Condition: Hemiplegic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This research study will see if electrical stimulation increases heel strike (heel hits the
      floor first when walking), decreases limp, helps muscle contraction, and improves balance in
      children with a hemiplegic leg. An experimental electrical stimulation device called the Gait
      MyoElectric Stimulator (GMES) will be used to stimulate the shin and calf muscles.
    

Detailed description: 
      Physical therapists focus on improving gait and balance in children with hemiplegic cerebral
      palsy (HCP). Functional electrical stimulation (FES) has the potential to improve strength
      and functional gait for children with HCP. The investigators hypothesize that a new FES
      system stimulating the dorsiflexor (DF) and plantarflexor (PF) muscles alternately at the
      correct time during gait, would lead to a significant improvement (p<.05) in foot contact,
      gait symmetry and balance, compared to 12 weeks of a healthy lifestyle program called 5210.
    

Intervention name(s): Gait Myoelectric Stimulator; 5210
Intervention type(s): Device; Other
Intervention description(s): Electrical stimulation during gait for children with CP; Children will eat 5 fruits/vegetables each day, watch 2 hours or less of screen time, perform 1 hour or more of physical activity, and drink 0 sugar-sweetened beverages.
Other intervention name(s): GMES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      This study was designed to assess the bioequivalence between the test products (Albuterol
      Sulfate Inhalation Aerosol 108 mcg Per Actuation) and the reference products (Proair HFA
      [Albuterol Sulfate] Inhalation Aerosol 90 mcg Per Actuation) in healthy volunteers under
      fasting conditions. The test product was considered bioequivalent to the reference product if
      the T/R ln-transformed AUC(0-t), AUC(0-inf), and Cmax were within 80.00-125.00% of those of
      the reference.
    

Detailed description: 
      A single-dose, randomized, open-label, two-period, two-sequence, two-treatment,
      single-centre, crossover bioequivalence study was carried out under fasting conditions in
      healthy adults, aged 20-60 years. For each period, each subject received a single dose as
      equivalent to 180 mcg of albuterol of the study drugs according to the pre-determined
      randomization scheme. Each subject was drawn 22 times over the period of 24 hours. Plasma
      samples were collected and analyzed for albuterol concentrations by using LC-MS/MS. For each
      subject, there were 2 dosing periods separated by a 14-day washout period. During the study,
      standardized meals were provided to all subjects while institutionalized.
    

Intervention name(s): Albuterol Sulfate inhalation aerosol 108mcg per actuation; Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation
Intervention type(s): Drug; Drug
Intervention description(s): MDI, 2 puffs, single dose, fasting; MDI, 2 puffs, single dose, fasting
Other intervention name(s): Albuterol 90mcg/puff; Albuterol 90mcg/puff
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a placebo controlled, double blind, randomized phase II dose-response study to
      evaluate the efficacy and safety of BF-200 ALA (containing the active ingredient 5 -
      aminolevulinic acid- ALA) used with photodynamic therapy (PDT) in patients with actinic
      keratosis (AK).
    

Detailed description: 
      The study was performed to define the effective therapeutic dose of the active pharmaceutical
      ingredient (ALA) in a nanoemulsion formulation in the treatment of actinic keratosis (AK)
      with topical PDT and to assess the efficacy of topical PDT with a new nanoemulsion
      formulation of ALA in the treatment of AK. The efficacy of BF-200 ALA was calculated by the
      AK clearance rate, defined as the proportion of AK lesions showing complete remission 12
      weeks after PDT treatment.

      Subjects of two study centres provided plasma and urine samples for the quantification of ALA
      and its metabolite, the active photosensitizer protoporphyrin IX (PpIX).
    

Intervention name(s): BF-200 ALA 1%; BF-200 ALA 3%; BF-200 ALA 10%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .; topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .; topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .
Other intervention name(s): Ameluz
Intervention MeSH terms: Aminolevulinic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preoperative Frailty and Postoperative Prognosis in the Elderly After Major Surgeries
Condition: Frailty; Age Problem; Surgery
MeSH terms: Frailty
Study type: Observational

Summary: 
      Elderly people often have comorbidities. However, there could be a big difference in their
      health status. Frailty is considered to be relevant to adverse outcomes. Some studies have
      found that preoperative frailty assessment and comprehensive geriatric assessment (CGA) of
      the elderly can improve clinical outcomes, but there has been no valid assessment established
      in China. Therefore it is important to design a research and help to solve this problem.
    

Detailed description: 
      With an aging population and the improvement of medical technology, the number of elderly
      patients who need surgery is gradually increasing. Elderly people often have comorbidities,
      malnutrition, and other conditions leading to an increased risk of anesthesia. What's more,
      there could be a big difference in the health status of the elderly with the same age.
      Frailty is considered to be highly prevalent with increasing age and to confer high risk for
      adverse outcomes. A complete evaluation of elderly patients before surgery may help improve
      the prognosis. Some studies have found that preoperative frailty assessment and comprehensive
      geriatric assessment (CGA) of the elderly can improve clinical outcomes, but there has been
      no valid assessment established in China. In this study, we plan to use a comprehensive
      preoperative frailty assessment and follow up for 30 days after surgery to explore the effect
      of preoperative frailty on postoperative complications in the elderly after major surgeries.
      To better evaluate the postoperative complications, we choose comprehensive complication
      index (CCI), which integrates all complication of the Clavien-Dindo classification and offers
      a metric approach to measure morbidity.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): There is no intervention for both groups.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients over 65 years old who are scheduled for elective major surgery under general
        anesthesia in Peking Union Medical College Hospital
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This research study aims to test the safety and effectiveness of repetitive transcranial
      magnetic stimulation (rTMS) on teens with depression. The study also seeks to understand how
      rTMS treatment affects the neurobiology of teens with depression.
    

Detailed description: 
      This study aims to:

        1. Evaluate the antidepressant effect and safety of rTMS in adolescents meeting criteria
           for major depressive disorder, single or recurrent episode.

        2. Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla (3T), the
           regional specificity [anterior cingulate (AC) vs. left dorsolateral prefrontal cortex
           (L-DLPFC)] of cerebral metabolites (glutamate and glutamine) in adolescent depression
           and study whether glutamine resonances are associated with response or remission of
           clinical depressive symptoms when rTMS is used to treat adolescent depression.

        3. Evaluate the accuracy of an efficient method for locating the F3 position (i.e.,
           L-DLPFC) through comparison with magnetic resonance imaging (MRI).
    

Intervention name(s): Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): 30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment
Other intervention name(s): NeuroStar
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent Depression; Transcranial Magnetic Stimulation
Attention Bias Modification for Transdiagnostic Anxiety
Condition: Anxiety; Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This project seeks to identify neural mechanisms underlying the tendency for anxious
      individuals to pay more attention to threatening information than to other types of
      information. A computerized treatment designed to train individuals to reduce their attention
      towards threat will be tested, with a focus on understanding the aspects of brain function
      that predict response to the treatment. This work could ultimately lead to the ability to
      treat anxiety more effectively by directly targeting the aspects of brain function that are
      altered in a given patient.
    


Intervention name(s): Attention Bias Modification; Neutral Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Excessive attention to threat is theorized to be a critical contributor to chronic anxiety symptoms and related negative health consequences. Attention Bias Modification, which directly targets this mechanism, is a highly cost-effective intervention with growing empirical support for its potential efficacy in clinically anxious populations.; A control version of computerized attention training.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Completer analyses focused on prediction of active ABM outcomes using neural measures. Control arm used for effect size comparisons.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anxiety; attention bias modification; computer
A Study of Lispro Formulations in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine:

        -  Part A

             -  How quickly your body absorbs, breaks down and gets rid of the different
                formulations of insulin lispro compared to insulin lispro alone formulation.

             -  The safety of insulin lispro in different formulations and any side effects that
                might be associated with it.

        -  Part B:

             -  How much insulin lispro from different dose ranges is found in the bloodstream
                using a test insulin lispro formulation (selected from Part A).

             -  The safety of insulin lispro in different formulations and any side effects that
                might be associated with it.

      Participants may only enroll in one part. The study is expected to last up to 10 weeks for
      each part.
    


Intervention name(s): Lispro
Intervention type(s): Drug
Intervention description(s): Administered SC
Other intervention name(s): LY275585
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Impact of Galacto-Oligosaccharides on Adult Microbiome
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the bifidogenic effect and other potentially beneficial
      effects on the microbiome of GOS.
    


Intervention name(s): Milk powder
Intervention type(s): Dietary Supplement
Intervention description(s): one sachet per day dissolved in 200 ml of water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Multiple Ascending Dose Study of TD-0714 in Healthy and Elderly Subjects
Condition: Healthy Adults, Elderly Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TD-0714 in healthy adult and elderly subjects
    


Intervention name(s): TD-0714; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Multiple ascending dose
A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibility Gene) Carriers
Condition: BRCA1 Gene Mutation; BRCA2 Gene Mutation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether adding DIM supplement will decrease breast
      density among female BRCA mutation carriers in two years.
    

Detailed description: 
      The Research Question: In female BRCA mutation carriers, will adding DIM (100mg*1/d, a
      nutritional supplement), decrease breast density in two years?

      Study design: A single center single arm prospective interventional study of the use of DIM
      to decrease risk of breast cancer among female BRCA carriers.

      Study population: Subjects will be female carriers of a BRCA mutation and have more than 10%
      mammographic breast density at baseline.

      Intervention: DIM supplement (100mg*1/d).

      Study Time line: This will be a 2 years study. At initiation a breast mammography will be
      performed and eligibility assessed. Follow-up visits will occur every 4 months and quality of
      life questionnaires as well as adherence to DIM supplementation will be assessed. At the
      initiation and every 4 months blood and urine samples will be collected for Estrogen profile.
      At 12 and 24 months a mammography will be performed to verify changes in breast density.

      Primary Endpoint: A decrease of more than 10% in breast density compared to baseline,
      following DIM supplementation intervention among female BRCA carriers.

      Study impact: Decrease in mammographic breast density was shown to be a good marker for lower
      risk of breast cancer. This study has the potential to dramatically impact the management of
      female BRCA carriers. If we prove that by adding a food supplement breast density is
      decreased, we will change standard of care in these woman. In addition, the urine and blood
      samples collected during the study will be used for future translational research on the
      pathogenesis of breast cancer.
    

Intervention name(s): DIM-Avail 100mg
Intervention type(s): Dietary Supplement
Intervention description(s): DIM 100 mg*1 daily for 2 years
Other intervention name(s): 3,3-Diindolylmethane
Intervention MeSH terms: 3,3'-diindolylmethane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: BRCA mutation; Breast cancer; Estrogen metabolism; 3,3-Diindolylmethane; Breast density
Japanese BAY80-6946 Monotherapy Phase I Study
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted as an open label, single centre, Phase I study of PI3K
      (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or
      refractory solid tumours. The eligible subjects will be dosed intravenously at Day 1, Day 8
      and Day 15 with three weeks on and one week off in each treatment cycle.
    


Intervention name(s): BAY80-6946; BAY80-6946
Intervention type(s): Drug; Drug
Intervention description(s): 0.4mg/ kg, iv, day 1,8 and 15, every 28 days; 0.8mg/ kg, iv, day 1,8 and 15, every 28 days
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase I; Japanese