bioihbjkbjnl/mcl2 huggingface dataset:
Endothelial Dysfunction Induced by Postprandial Lipemia
Condition: Healthy Subjects
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      Postprandial lipemia and exercise oppose each other in terms of cardiovascular risk, however
      the mechanism of their interaction is not well understood.

      Therefore we want to study vascular function, as assessed by brachial artery (BA) flow
      mediated dilation (FMD), in healthy men before and after a high fat meal (HFM) preceded
      (16-18 hrs) by rest, a single bout of continuous moderate intensity exercise (CME), and high
      intensity interval exercise (HIIE).
    


Intervention name(s): exercise training
Intervention type(s): Other
Intervention description(s): moderate intensity exercise group, and high intensity exercise group
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: flow mediated dilatation; maximal oxygen uptake; blood lipid
Impact of an Intensive Multimodal Educative Program on Behavioral Disorders of Patients With Profound Multiple Disabilities and on the Quality of Life and Feelings of Caregivers
Condition: Polyhandicap; Behavior Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Profound multiple disabilities also called in French polyhandicap are defined by the
      combination of a deep mental disability and severe motor deficit with extreme restriction of
      autonomy. Life in institution for people with profound multiple disabilities induces
      emotional and educative deficiency and often conducts to behavioral disorders. These
      behavioral disorders also impact on quality of life and feelings of caregivers. An intensive
      multimodal educative program proposed to patients with profound multiple disabilities can
      improve their psychic well-being, reduce chronic pain and improve also quality of life and
      feelings of caregivers. The intensive multimodal educative program will be compared to the
      usual practice of educative program.
    

Detailed description: 
      People with profound multiples disabilities needs particular follow-up with education, care,
      communication and socialization.

      Our hypothesis is that an intensive multimodal educative program of 5 hours a week during 12
      months compared to the usual practice of 1 hour a week conducts to the reduction of
      behavioral disorders and improves the quality of life and feelings of caregivers.

      This study is multicenter, controlled, randomized in two parallel groups and open-labelled
      comparing usual practice of educative program and intensive educative program during 12
      months.

      The evolution of predominant behavioral disorder and quality of life and feelings of
      caregivers is evaluated at inclusion (M0), six months after (M6) and twelve months after
      (M12).
    

Intervention name(s): Intensive educative management
Intervention type(s): Behavioral
Intervention description(s): 5 hours a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Polyhandicap; Behavior disorders; Educative program; Caregivers; Quality of life.
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
Condition: Acquired Bleeding Disorder; Acquired Haemophilia; Congenital Bleeding Disorder; Congenital FVII Deficiency; Glanzmann's Disease; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors; Healthy
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders; Hemorrhagic Disorders; Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence
      between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a
      new formulation stable at 25°C (VII25).
    


Intervention name(s): activated recombinant human factor VII; activated recombinant human factor VII
Intervention type(s): Drug; Drug
Intervention description(s): One single dose administration, injected i.v. (into the vein); One single dose administration, injected i.v. (into the vein)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study To Evaluate the Safety of Bivalent Vaccine
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the safety of a bivalent vaccine of two new influenza virus reassortants in healthy
      adults prior to the release of the trivalent vaccine (FluMist) containing them.
    

Detailed description: 
      This prospective, randomized, double blind, placebo-controlled release study will enroll
      approximately 300 healthy adults 18-49 years of age. Eligible subjects will be randomly
      assigned in a 4:1 fashion to receive a single dose of bivalent vaccine or placebo by
      intranasal spray. This study will be conducted at multiple sites in the United States.
      Randomization will be stratified by site.
    

Intervention name(s): FluMist
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety, tolerability, and immunogenicity of two
      different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The
      primary hypothesis of the study is that the proportion of participants receiving V114 who
      have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A,
      6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for
      recipients of Prevnar 13™.
    


Intervention name(s): V114 Lot 1; V114 Lot 2; Prevnar 13™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose; Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose; Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
Other intervention name(s): V114-1; V114-2
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
ZP4207(Dasiglucagon) Administered to T1D Patients to Assess the PK and PD Compared to Marketed Glucagon
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial is a single-centre, randomised, sequential, cross-over trial assessing
      pharmacokinetic and pharmacodynamic responses after micro-doses of ZP4207 (dasiglucagon*)
      administered subcutaneously to patients with type 1 diabetes mellitus under euglycaemic and
      hypoglycaemic conditions and compared to marketed glucagon.

      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
    

Detailed description: 
      Seventeen (17) adult patients with T1DM treated with continuous subcutaneous insulin infusion
      (insulin pumps, CSII) will be randomized and take part at four dosing visits. The dosing
      visits are separated by 3-7 days. For the three lowest dose levels (0.03 mg, 0.08 mg, and 0.2
      mg) the patients will receive two doses of ZP4207(dasiglucagon) (the first at euglycaemic and
      the second at hypoglycaemic conditions) and one dose of glucagon at euglycaemic conditions at
      visit 2-4. The first two dose administrations (Day 1, visit 2-4) will be separated by at
      least five hours. The third dose, which is ZP4207(dasiglucagon) during hypoglycemia, will for
      all dosing visits be administered the next morning after a standardized carbohydrate-rich
      meal in the evening before. The patients will stay at the clinical site over night between
      Day 1 and Day 2. The dose of 0.6 mg will only be administered for ZP4207(dasiglucagon). The
      order of the micro-dose levels as well as the order of the treatment, ZP4207(dasiglucagon)
      vs. glucagon, will be randomized. For all patients the 0.6 mg dose of ZP4207(dasiglucagon)
      will be administered at visit 5.

      For each dose level there will be 2 sets of PK/PD profiles for ZP4207(dasiglucagon), one
      initiated during euglycaemia and another during hypoglycaemia. Each patient enrolled will
      therefore provide a total of 11 PK/PD profiles covering four different dose levels; 8
      profiles from ZP4207(dasiglucagon) and 3 profiles from glucagon
    

Intervention name(s): ZP4207(dasiglucagon) glucagon analogue; Glucagon (Native glucagon)
Intervention type(s): Drug; Drug
Intervention description(s): Cross-over design with single s.c. administration in euglycemic and hypoglycemic T1D; Cross-over design with single s.c. administration in euglycemic T1D
Other intervention name(s): dasiglucagon; Lilly Glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of KW-6356 in Subjects With Early Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's
      disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score
      between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.
    


Intervention name(s): KW-6356; KW-6356; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration; Oral administration; Oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present study is to assess the reactogenicity and immunogenicity of a
      thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the
      standard formulation of Influsplit SSW® 2003/2004.
    


Intervention name(s): Thiomersal free trivalent influenza split vaccine 2003/2004; GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses, intramuscular injection; 2 doses, intramuscular injection
Other intervention name(s): Thiomersal free trivalent influenza split vaccine 2003/2004
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Thiomersal-free influenza split vaccine 2003/2004; Influsplit SSW®/Fluarix™ 2003/2004; Influenza
Broccoli Supplement Dose Response
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Do daily high (4 tablets) or intermediate (2 tablets) administration of the broccoli-based
      dietary supplement Avmacol® have improved bioavailability over a broccoli sprout beverage
      rich in sulforaphane and its biogenic precursor, glucoraphanin? The beverage formulation has
      been used successfully in the investigators' previous intervention studies in regions of
      China with high levels of air pollution to reduce the body burden of carcinogenic and toxic
      pollutants. The investigators seek to evaluate a more stable, less expensive formulation of a
      broccoli sprout preparation that can be used for disease prevention in future studies.
    

Detailed description: 
      The investigators will conduct a 3-armed placebo-controlled 16-day intervention with the
      dietary supplement Avmacol® to determine the bioavailability with repeated dosing of a simple
      tablet-based intervention in the study participants. As shown in Scheme 1, the 3 arms are: 1)
      4 tablets of Avmacol® daily for 14 days; 2) 2 tablets of Avmacol® daily for 14 days together
      with 2 placebo tablets to maintain parity in consumption; and 3) 4 placebo tablets daily for
      14 days. In addition, all participants will receive 4 placebo tablets for 2 consecutive
      run-in days prior to commencing intervention in the 3 distinct arms. Consecutive overnight
      (12-hour) urine samples will be collected during the 2-day run-in, the 14-day intervention
      and during a 5-day run-out period (total = 21 days). Additional day-time urine collections
      will be made at 2 timepoints: the day after administration of Avmacol® tablets begins and the
      day after the last administration of Avmacol® tablets. A blood sample will be collected at
      the beginning of the run-in and after the last Avmacol® dose (Day 17 for intervention groups,
      and for the placebo group) from each participant. The tablets will be taken before dinner
      each day.
    

Intervention name(s): Avmacol tablets; Placebo tablets
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The active components of Avmacol® are ground broccoli seeds that provide glucoraphanin and freeze-dried broccoli sprouts that provide a stabilized form of the enzyme myrosinase, which converts glucoraphanin to sulforaphane.; MCC 90M Emcocel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Polyneuropathy
MeSH terms: Diabetic Neuropathies; Polyneuropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to study the clinical effects of the investigational drug, SB-509
      versus placebo in patients with diabetic neuropathy.
    

Detailed description: 
      SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a
      researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around
      the injection site and causes these cells to make a protein. This protein causes your cells
      to increase production of another protein called vascular endothelial growth factor (VEGF),
      which may improve the structure and function of nerves. In addition, there are changes in the
      levels of 28 additional proteins in your cells. These proteins function to promote the growth
      of cells, are structures in cells, help synthesize products, and affect immune cells, and
      some have unknown functions. This increase in your own VEGF proteins may protect and repair
      the damaged nerves caused by diabetic neuropathy.

      The study doctor will test SB-509 (60 mg) and placebo. Everyone in this study will receive
      intramuscular (IM-directly into the muscle) injections into both legs. This will happen 3
      times over about 4 months. Two out of every 3 participants will receive SB-509 and 1 out of
      every 3 will receive placebo. You will not know, and the study doctor will not know, whether
      you will receive SB-509 or whether you will receive placebo.
    

Intervention name(s): SB-509; Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): 60 mg dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic neuropathy; Diabetes Type I or II; Mild to moderate sensorimotor diabetic polyneuropathy
Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms in Adolescents With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus; Depressive Symptoms
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Depression
Study type: Interventional

Summary: 
      This study evaluates the use of an established internet-based cognitive behavioral therapy
      intervention in a group of adolescents with type 1 diabetes and mild to moderate depressive
      symptoms. Half of the participants will receive the internet-based intervention while the
      other half will receive usual care.
    

Detailed description: 
      Adolescents with diabetes have a higher incidence of subclinical and clinical depression
      compared to healthy adolescents. Patients with diabetes who are clinically or subclinically
      depressed are at high risk for poor glycemic control.

      Studies evaluating prevention and treatment strategies for depression in patients with type 1
      diabetes have shown that group cognitive-behavioral therapy (CBT) and individual
      interpersonal psychotherapy (IPT) can reduce the risk of depressive illness in adolescents
      with diabetes. Computerized interventions show evidence of being efficacious, and have been
      recommended as the "first line" intervention.

      The Competent Adulthood Transition with Cognitive Humanistic and Interpersonal Teaching
      (CATCH-IT) internet program has shown positive results with adolescents at risk for
      depression, but has not been used in patients with a chronic illness like diabetes. CATCH-IT
      is based on established CBT and IPT treatment models. It includes a) an innovative and
      effective brief practitioner-provided motivation enhancement component (in person at
      enrollment and through phone calls) and b) self-directed modules for the adolescent that can
      be accessed on the internet.
    

Intervention name(s): CATCH-IT
Intervention type(s): Behavioral
Intervention description(s): The CATCH-IT internet program consists of 14 modules and exercises and activities based on best practices components of depression prevention. They will be instructed to complete at least 2 modules a week, over a period of 6 weeks. This would require at least 40 minutes per week (approximately 20 minutes minimum per module).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized at the baseline visit to the CATCH-IT Intervention or Control group
Masking: None (Open Label)
Primary purpose: Treatment
Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole
Condition: Schizophrenia; Mental Disorder; Nervous System Diseases
MeSH terms: Nervous System Diseases; Schizophrenia; Mental Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the usability of the Medical Information Device #1
      (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.
    

Detailed description: 
      Poor adherence to medication is a well-recognized problem in psychiatric patients. Although a
      variety of treatment models have been developed to improve management of patients in general
      and medication adherence in particular, poor medication adherence remains a major barrier to
      achieving optimal health.

      The MIND1 System includes a drug-device combination, a patch, and application software to
      convey level of activity and rest and to mark events through the act of ingestion.

      The purpose of this open-label study is to determine the usability of the Medical Information
      Device #1 (MIND1) System in adults with schizophrenia. Approximately 32 subjects with
      schizophrenia, between 18 and 65 years of age (inclusive) who are currently prescribed and
      stabilized on oral aripiprazole, will be enrolled.
    

Intervention name(s): MIND1 System
Intervention type(s): Device
Intervention description(s): Subjects will receive aripiprazole tablets embedded with an IEM. They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole + IEM tablets (eg, at the previously prescribed dose) during the 8-week treatment period for this study. Aripiprazole + IEM tablets must be taken on a once-daily dosing schedule.
Other intervention name(s): OPC-14597 Digital
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OPC-14597 Digital; Aripiprazole; Medical Information Device #1 System (MIND1); Treatment Adherence; Ingestible Event Marker
Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.
Condition: Prophylactic Pneumococcal Diseases
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK
      Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .
    

Detailed description: 
      The study is open and subjects will receive two vaccine doses of GSK Biologicals' 11 PCV
      vaccine. Five blood samples will be taken: prior to and one month after each vaccine dose,
      and 2 weeks after dose 2.
    

Intervention name(s): pneumococcal vaccine
Intervention type(s): Biological
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention