bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to assess the safety and immunogenicity of inactivated
      influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to
      receive a single injection of whole virion, Vero cell derived or egg derived influenza
      vaccine on Day 0. Subjects will return to the study site for safety evaluation at
      predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn
      at predetermined intervals to measure their immunologic response to vaccination.
    


Intervention name(s): Inactivated influenza vaccine (whole virion, Vero cell-derived); Inactivated influenza vaccine (egg derived) [licensed control vaccine]
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators objective is to carry out a placebo-controlled, dose-response, randomized
      clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular
      disease risk in overweight adult subjects upon the consumption of pomegranate extract.

      The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such
      as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory
      markers. The correlation between the effect exerted and the subjects' microbiota (capacity to
      produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of
      urolithins on the effects.
    


Intervention name(s): Pomegranate extract-first dose-Group A; Placebo-first dose-Group B; Pomegranate extract-first dose-Group B; Placebo-first dose-Group A; Pomegranate extract-second dose-Group A; Placebo-second dose-Group B; Pomegranate extract-second dose-Group B; Placebo-second dose-Group A
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Group A will consume 1 daily capsule of pomegranate extract for 3 weeks; Group B will consume 1 daily capsules of placebo for 3 weeks.; After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.; After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.; After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.; After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.; After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.; After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
Other intervention name(s): Group A consumes pomegranate extract (first dose); Group B consumes placebo (first dose); Group B consumes pomegranate extract (first dose); Group A consumes placebo (first dose); Group A consumes pomegranate extract (second dose); Group B consumes placebo (second dose); Group B consumes pomegranate extract (second dose); Group A consumes placebo (second dose)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Pomegranate; Cardiovascular; Urolithins; Microbiota; Polyphenols; Nutraceutical; Dietary supplement
Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families
Condition: Emotional Instability
Study type: Interventional

Summary: 
      Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal
      ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health
      resources, coupled with the suffering of families who feel helpless and difficulties in
      handling.

      this study is composed of three diferents studies:

      . The first study's goal is to determine if there are diferences and, which ones, between
      family functioning and cope strategies between adolescents with IE and their families, and
      families of a control group.

        -  the purpose of the second study is to evaluate the effectivenes of a dialectical
           behavior therapy for adolescents with IE and their families who are in treatment in the
           Child Abd Adolescent Mental Heath Service of the Hospital sant Joan de Déu Terres de
           Lleida. This treatment consist on 2 preliminary sessions with parents and patients and
           12 group sessions which purpose is to teach skilss to manage emotions based on
           dialectical Behavior Therapy.

        -  finally, the third study is designed to evaluate the effectiveness of a dialectical
           behavior therapy (DBT) for parents of adolescents with IE who are in treatment in the
           different network devices of Child and Adolescent Mental Health of the Community of
           Madrid. Treatment goals are the development of communication skills, validation and
           crisis management as well as increase understanding and competence of the pathology. The
           DBT intervention will begin with two individual sessions with parents of patients and 10
           theoretical and practical seminars in group format (6-7 families) following the model
           proposed by Marsha Linehan. The DBT interventions will be added to "standard treatment"
           that a patient with IE receives in the investigative devices.
    

Detailed description: 
      -  In the first study, case group is composed by patients with IE and their families, both
           from Madrid and Lérida. The control group is composed by adolescents without mental
           pathologies, recruited from some high scholls from Madrid and Lérida.

        -  In the second study, the results will be measured a after the end of treatment and 6
           months after the treatment ends.

      In the third study, the results will be measured a after the end of treatment and 6 months
      after the treatment ends.
    

Intervention name(s): Dialectical Behaviour Therapy
Intervention type(s): Behavioral
Intervention description(s): Group of families
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Emotional Instability; Family Therapy; BPD; DBT
Effect of Leg Elevation on Prevention of Intraoperative Hypotension During Beach Chair Position
Condition: Intraoperative Hypotension; Cerebral Ischemia; Shoulder Disease
MeSH terms: Brain Ischemia; Cerebral Infarction; Hypotension; Ischemia
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of leg elevation on the prevention of
      intraoperative hypotension during shoulder surgery in the Beach-chair position. patients
      undergoing shoulder surgery in the Beach-chair position will be randomly assigned to Group L
      (with leg elevation) or Group C (no intervention). The primary outcome is the incidence of
      intraoperative hypotension (mean blood pressure < 60mmHg or systolic blood pressure < 80% of
      baseline). Secondary outcomes are the incidence of intraoperative cerebral desaturation
      (cerebral oxygen saturation < 80% of baseline, longer than 30 seconds), total amounts of
      administered inotropic agents, and systolic blood pressure, heart rate, and cerebral oxygen
      saturation at various time points.
    


Intervention name(s): leg elevation
Intervention type(s): Procedure
Intervention description(s): Patients' leg will be raised by a pillow under both legs and the hip and knee joints will be flexed 45 degrees to position both knees at the heart level.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
An Open Trial to Assess the Tolerability of AVANZ® Cupressus Immunotherapy
Condition: Allergic Rhinoconjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is an open, national, multi-centre trial. The main objective of this trial is to
      assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica by measurement
      of related Adverse Events.
    

Detailed description: 
      The main objective of this trial is to assess the tolerability of the up-dosing phase of
      AVANZ® Cupressus arizonica, the measurement rate is the frequency of patients with
      investigational medicinal product (IMP)-related adverse events (AEs) will be the primary
      endpoint.
    

Intervention name(s): AVANZ Cupressus
Intervention type(s): Biological
Intervention description(s): AVANZ Cupressus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cupressus arizonica
A First-in-human Study of a Novel Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to study the tolerability, safety, pharmacokinetics and
      immunogenicity of investigational drug in healthy subjects. The main questions it aims to
      answer are:

        -  Safety and tolerability of investigational drug.

        -  pharmacokinetics and immunogenicity of investigational drug. Participants will receive a
           single intravenous administration of investigational drug or placebo. Blood samples are
           collected at specified time points.
    


Intervention name(s): VDJ001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): a novel recombinant humanized anti-interleukin-6 receptor monoclonal antibody; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
Condition: Primary Immunodeficiency Disease
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in
      treating patients with Primary Immunodeficiency (PID)
    


Intervention name(s): IgG Next Generation (BT595)
Intervention type(s): Biological
Other intervention name(s): Immune Globulin Intravenous (Human), 10% Liquid
Intervention MeSH terms: Immunoglobulins; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES:

      I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to
      moderately severe ulcerative colitis.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by extent of disease.

      Patients are randomly assigned to oral 4-aminosalicylic acid (4-ASA) or placebo administered
      daily for 6 weeks. Optional 4-ASA is available to all patients for up to 1 year.

      Concurrent therapy with low-dose sulfasalazine, prednisone, or equivalent is allowed.
    

Intervention name(s): -aminosalicylic acid
Intervention type(s): Drug
Intervention MeSH terms: Aminosalicylic Acid
Allocation: Randomized
Primary purpose: Treatment
Keywords: gastrointestinal disorders; rare disease; ulcerative colitis
A Trial Investigating the Safety, Tolerability, and Distribution and Activity in the Body of NNC0148-0000-0287 Injected Under the Skin in Healthy Subjects and in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate safety,
      tolerability, pharmacokinetics (the exposure of the trial drug in the body) and
      pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous
      NNC0148-0000-0287 (insulin 287) in healthy subjects and in subjects with type 1 diabetes
    


Intervention name(s): 148-0287-A-4.2mM-cartridge; placebo; 148-0287-A-4.2mM-cartridge; placebo; insulin glargine; sodium chloride 0.9% w/v
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): In a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously.; In a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously.; In a dose-escalating design, subjects with type 1 diabetes will receive a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.; In a dose-escalating design, subjects with type 1 diabetes will receive 148-0287-A-placebo-cartridge in a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.; In a dose-escalating design, subjects with type 1 diabetes will receive insulin glargine once daily, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.; In a dose-escalating design, subjects with type 1 diabetes will receive sodium chloride 0.9% w/v, injected subcutaneously daily. Subjects will only be randomised to receive either treatment A or B.
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Vitamin D on Glycemic Control and Proinflammatory Markers in Adolescents With T1DM
Condition: Type 1 Diabetes; Vitamin D Deficiency/Insufficiency
MeSH terms: Diabetes Mellitus, Type 1; Vitamin D Deficiency
Study type: Interventional

Summary: 
      The investigators are conducting a prospective cross-over study to evaluate the effects of
      vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in
      microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to
      see a significant improvement in glycemic control and a reduction of serum pro-inflammatory
      markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who
      are treated with vitamin D.
    


Intervention name(s): Vitamin D
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes; Vitamin D; Proinflammatory markers
Evaluating Radiomorphometric Indices and Fractal Dimension of the Pediatric Oncology Patients on Panoramic Images
Condition: Oncology; Bone Loss
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      This study evaluated pediatric oncology patients in terms of quality of bone and determine
      any relation between bone quality and radiotherapy/chemotherapy. The alternative hypothesis
      is that the bone quality of the oncology patients who received radiotherapy/chemotherapy is
      lower than the control group.
    

Detailed description: 
      Cancer is the abnormal and uncontrolled proliferation of certain tissues in the body for a
      reason that cannot be determined yet. Childhood cancers occur between 0-17 years of age, and
      follow-up and treatment of these patients are performed in pediatric oncology services.
      Diagnosis in childhood cancers can be made by clinical examination as well as blood tests and
      examination of tissue samples. There are also some imaging methods used for diagnosis;
      ultrasonography, computed tomography, magnetic resonance imaging, positron emission
      tomography / computed tomography (PET / CT).

      Treatment methods in childhood cancers are as follows; surgery, chemotherapy, radiotherapy
      and stem cell transplantation. Once diagnosed, oncologists and surgeons may choose one of
      these treatment options by mutual consultation or decide on a treatment method. Fractal
      analysis is a numerical as fractal dimension. Trabeculae are thin columns with numerous large
      spaces that give a honeycomb or spongy appearance of cancellous bone, which is also called
      trabecular bone or spongy bone. Previously, fractal analysis has been reported as a useful
      method to detect various diseases that affect the trabecular bone structure. Particularly in
      the field of dentistry, studies have shown that fractal analysis by the box-counting method
      can successfully evaluate trabecular changes in the mandible of patients with osteoporosis
      and periodontal diseases and in lactating women.
    

Intervention name(s): Panoramic Radiography
Intervention type(s): Radiation
Intervention description(s): Diagnostic Panoramic Dental Radiographs were taken.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients received chemotherapy and radiotherapy for a Pediatric oncologic disease
      
Keywords: pediatric oncology; fractal analysis; panoramic mandibular indices; radiotherapy; chemotherapy
Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.
Condition: Metabolic Clearance Rate
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that
      metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of
      these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical
      observations suggest that oxcarbazepine does not induce these enzymes to the same degree.

      This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4
      enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme
      activity.

      It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.
    


Intervention name(s): carbamazepine oxcarbazepine
Intervention type(s): Drug
Intervention MeSH terms: Carbamazepine; Oxcarbazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CYP3A4; Induction; Oxcarbazepine; Carbamazepine; Quinidine; Human; In vivo
Effect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol
Condition: Coronary Artery Disease; Diabetes
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized study. Patients with coronary artery disease equivalent will be randomized to
      receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day.
      Oxidized LDL cholesterol will be measured at baseline and after 8 weeks of treatment.
      Hypothesis is that ezetimibe will lower oxidized LDL
    


Intervention name(s): ezetimibe
Intervention type(s): Drug
Intervention description(s): Patients will receive 10 mg/day of ezetimibe for 8 weeks
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Periodontal Disease Treatment of a Physically Challenged Population
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      Many physically handicapped patients at the dental department, Toronto Rehabilitation
      Institute(TRI) have considerable gingival inflammation and breath odour because of the
      inability to effectively handle a toothbrush. These patients have considerable periodontal
      disease. There is a concern that these pathogens may have a detrimental effect on wound
      healing in other areas of the body.

      Hypothesis: Patients attending the dental department at TRI that are treated with the
      antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial
      decrease in periodontal disease as measured by bleeding points and pocket depth when compared
      to the group that continues to use their regular oral hygiene methods (control group).
    


Intervention name(s): metronidazole-nystatin oral rinse
Intervention type(s): Drug
Intervention MeSH terms: Metronidazole; Nystatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: periodontal disease; bleeding on probing; periodontal pockets; disabled
Psychological Skill Training for Athletes
Condition: No Conditions
Study type: Interventional

Summary: 
      The investigator will determine the effectiveness of psychological skill training on
      quantitative EEG in athletes before the competition.
    

Detailed description: 
      Psychological skills training is the mental training that can apply for increased athletes'
      performance to make athletes more confident. The objective of psychological skill training is
      to develop the potential of athletes to be able to show their abilities (Peak Performance),
      and to create satisfaction, self-esteem, for athletes. Additionally, the ability to
      concentrate and reduce anxiety could affect athletes' emotions and be ready to participate in
      the competition. Therefore, this study will apply psychological skills training for athletes.
      The effectiveness of psychological skill training will be measured by using quantitative EEG
      before and after training. The quantitative EEG assessments could demonstrate an anxiety
      level at different stages of the competition and it could reveal the changes caused by
      training. The intervention will begin 3 months before the competition. The quantitative EEG
      measurements are arranged 4-5 times following the previous study. The sequence of the
      measurement will be including a baseline: one month before the competition, two weeks before
      the competition, a week before the match, three days before the match (depend on the
      situation), three days after the match (post-training).
    

Intervention name(s): Experiment; Control
Intervention type(s): Behavioral; Other
Intervention description(s): breathing control and self-talk with objectives; The participant in the control group will receive consultations by a sport psychologist for goal setting and positive thinking. The duration is similar to the training group (4-5 minutes in each session, 4 sessions per week for 1 month)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Study of the Blood Concentrations of Two Formulations of REGN1033 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective: Determine blood concentrations of two formulations of REGN1033.

      Secondary Objective: Assess safety and tolerability of REGN1033.
    


Intervention name(s): REGN1033
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug concentration; REGN1033; blood