bioihbjkbjnl/mcl2 huggingface dataset:
A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the levels of study drug called LY3502970 in
      the blood stream when administered alone and in combination with cyclosporine in healthy
      participants. The study will also evaluate the safety and tolerability of LY3502970 in
      healthy participants. This study will last up to approximately 76 days for each participant.
    


Intervention name(s): Midazolam; LY3502970; Cyclosporine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Cyclosporine; Midazolam; Cyclosporins
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
Condition: Chronic Kidney Disease; Bacterial Infection
MeSH terms: Bacterial Infections; Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to:

        1. Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and
           peritoneal dialysis (PD).

        2. Determine urine, HD and PD clearance of daptomycin.
    

Detailed description: 
      Infectious and sepsis events are one of the most common complications in children with
      chronic kidney disease. The incidence is highest in children with an access for dialysis,
      especially in those with catheters. Staphylococcal species account for more than 50% of
      access infections (ranging from 58-77%). Failure to clear the infection results in loss of
      dialysis access.

      Daptomycin is a new antibiotic that provides coverage against most gram positive bacteria
      including methicillin-resistant staphylococci, vancomycin-intermediate Staphylococcus aureus,
      and vancomycin-resistant enterococci. The pharmacokinetics of daptomycin in children on
      dialysis, a group of patients who may need the medication the most, remains unknown.

      Children on HD or PD with suspected or confirmed infections due to gram-positive bacteria and
      who are concurrently treated with standard of care antibiotics will be considered for this
      study. Each patient will be given a onetime dose of Cubicin (daptomycin). After receiving
      daptomycin, serial blood samples along with dialysis effluent and urine (obtained from
      non-anuric patients) will be collected to evaluate the pharmacokinetic profile of the drug.
    

Intervention name(s): Daptomycin
Intervention type(s): Drug
Intervention description(s): Daptomycin IV 5 mg/kg one time dose
Other intervention name(s): Cubicin
Intervention MeSH terms: Daptomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hemodialysis; Peritoneal dialysis; Daptomycin; Pharmacokinetics
Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The study hypothesis is that XOMA 052 improves glycemic control in subjects with Type 2
      Diabetes.

      Study X052078 is designed to establish efficacious dose(s) for future studies based on
      improvement in HbA1c.
    


Intervention name(s): XOMA 052; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sterile solution subcutaneously administered monthly for 6 months; Sterile solution subcutaneously administered monthly for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Type 2; Mellitus
Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key
      role in generating asthma attacks. In patients with allergies, there is an exaggerated
      production of IgE in response to specific substances such as pollens. Omalizumab is a new
      drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against
      asthma attacks in children with allergic asthma.
    

Detailed description: 
      This study was designed to provide one year efficacy and safety data for subcutaneous (SC)
      omalizumab, compared to placebo in children (6 to < 12 years) with moderate to severe
      persistent asthma who have inadequate asthma control despite treatment according to National
      Heart, Lung and Blood Institute (NHLBI) step 3 or 4 (at least medium dose inhaled
      corticosteroids with or without other controller asthma medications).
    

Intervention name(s): Omalizumab; Placebo; Fluticasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The omalizumab dose administered, based on the patient's body weight and total serum IgE level at Screening, and the number of injections and injection volume was determined from the dosing tables in the protocol. Omalizumab 75 to 375 mg was administered subcutaneous (SC) every 2 or 4 weeks depending on the dose.; Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.; Patients entered the study using their current formulation of any inhaled steroid (proprietary drug and device) ≥ 200 μg/day equivalent of fluticasone administered with a dry-powder inhaler.
Intervention MeSH terms: Fluticasone; Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic; asthma; atopic; omalizumab; immunoglobulin E; IgE; anti-IgE
Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder; Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary goal of this pilot project is to demonstrate the safety and feasibility of using
      Cannabidiol (CBD) in combination with standard of care prolonged exposure (PE) psychotherapy
      to reduce PTSD symptoms.
    

Detailed description: 
      This study is an early Phase II double-blind, pilot randomized controlled clinical trial. The
      study team will use a permuted block randomization design stratified by a Posttraumatic
      Stress Disorder (PTSD) severity median score on the PTSD Checklist (PCL-5) derived from a
      recently completed STRONG STAR repository. Participants will be 24 individuals with PTSD to
      investigate the safety, feasibility, and PTSD symptom change associated with CBD 250mg taken
      twice a day for 18 days (n=12) vs. placebo (n=12) in combination with a standard of care,
      10-sessions massed PE psychotherapy administered over 2 weeks. Aims 2 and 3 will evaluate
      biochemical and physiological outcomes associated with the brain endocannabinoid (eCB) and
      PTSD that may be affected by CBD. Permuted block randomization is advantageous in small
      clinical trials to ensure equal allocation of participants in each condition. Participant
      randomization will be subdivided into randomized blocks of four, two patients in each block
      will be assigned to CBD and two will be assigned to placebo.
    

Intervention name(s): Cannabidiol (CBD) oral solution; Placebo; Massed Prolonged Exposure (mPE)
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day; An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day; mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.
Other intervention name(s): Epidiolex; Placebo oral solution; Behavioral Therapy
Intervention MeSH terms: Cannabidiol; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind randomized controlled clinical trial. Permuted block randomization will ensure equal allocation of participants to either study drug or placebo. Randomization will be performed by a designated study team member.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Kidney Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to evaluate pharmacokinetics of Fluzoparib and its main metabolite
      in subjects with impaired kidney function in comparison with healthy subjects, to develop
      dose recommendations for patients with renal impairment.

      The secondary objective is to evaluate the safety of Fluzoparib in subjects with mild and
      moderate renal impairment and in healthy subjects.
    


Intervention name(s): Fluzoparib; Fluzoparib; Fluzoparib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Normal Renal Function:A single oral dose of Fluzoparib will be administered.; Mild Renal Impairment:A single oral dose of Fluzoparib will be administered.; Moderate Renal Impairment:A single oral dose of Fluzoparib will be administered.
Intervention MeSH terms: Fluzoparib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single dose of oral administration of Fluzoparib
Masking: None (Open Label)
Primary purpose: Basic Science
Assessment of Residual Allergenicity of Grass/Rye Pollen Allergoid Using Skin Prick Testing
Condition: Type I Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the residual allergenicity of Grass MATA (modified
      pollen allergen tyrosine adsorbate) by skin prick testing. This is done by a comparison of
      the wheal response after skin prick testing with aqueous native and modified allergen,
      modified tyrosine adsorbed allergen and Grass MATA MPL (modified tyrosine adsorbed + MPL).
    

Detailed description: 
      Grass MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients
      with proven type I hypersensitivity to cross reacting grass pollens.

      MPL (Monophosphoryl Lipid A), a purified, detoxified glycolipid derived from the cell wall of
      Salmonella minnesota, is included in the product formulation as an adjuvant to increase the
      immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to
      a TH1-like T cell profile.

      The grass pollen extract is modified with glutaraldehyde to produce the active ingredient, an
      allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus
      reducing the risk of side effects. However, a simultaneous reduction in other important
      immunological properties, such as IgG and T cell reactivities, is not seen.

      The modification is greater than 75 %, so that only a small amount of unmodified allergen is
      remaining in the product. The purpose of this study is to assess residual allergenicity of
      the modified grass/rye pollen in Grass MATA MPL using skin prick testing.

      In this skin prick test, the following test products will be compared:

        -  7 concentrations of aqueous native allergen

        -  aqueous modified allergen

        -  modified tyrosine adsorbed allergen

        -  Grass MATA MPL (modified tyrosine adsorbed + MPL)
    

Intervention name(s): Grass MATA MPL
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: allergy; skin prick test; allergoid; allergenicity; specific immunotherapy
Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the study drug is effective and safe in the
      treatment of Multiple Sclerosis (MS) in patients of Chinese origin.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer HealthCare AG, Germany.

      Bayer HealthCare AG, Germany is the sponsor of the trial.
    

Intervention name(s): Interferon beta-1b (Betaseron, BAY86-5046)
Intervention type(s): Drug
Intervention description(s): Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MS
Study of the Safety and Immunogenicity of an Influenza Vaccine Administered to Healthy Adults
Condition: Influenza Disease; Flu
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of cell
      culture-derived, inactivated, subunit influenza vaccine in comparison to licensed Fluvirin
      vaccine administered to healthy adults ages 18 < 50 years.
    


Intervention name(s): Influenza Virus Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: influenza; flu
Effects of Restaurant Menu Design on Food Ordering Outcomes
Condition: Food Preferences
Study type: Interventional

Summary: 
      High cognitive load activities can influence energy intake from food. It is unknown how
      restaurant menu designs may affect patrons in terms of cognitive demand and subsequent
      ordering of food.Objective: Our objective was to develop and experimentally test menu designs
      that differ in cognitive load to test the subjective and objective stress measures on food
      ordering.
    

Detailed description: 
      For the first experiment, a parallel randomized trial of healthy young adults (n= 30) was
      conducted to compare ordering from one of two menu designs (easy - E, hard - H) developed in
      a prior pilot study. In the second experiment, restrained eaters were specifically recruited
      and asked to fast before the experiment to determine the influence of cognitive load of menus
      on energy ordered (n=31). Galvanic skin response was used as an objective proxy for relative
      cognitive load, and questionnaires were used to assess perceptions of the menus. The main
      outcomes were the number of items ordered and total energy of the items ordered (in
      kilocalories).
    

Intervention name(s): Menu design
Intervention type(s): Behavioral
Intervention description(s): Participants were given 5 minutes to order a hypothetical meal from the assigned test menu by circling all items they wanted to order.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel arm randomized controlled trial
Masking: Single (Participant)
Primary purpose: Other
Keywords: cognitive load; galvanic skin response; meal size; kilocalories; menu design
Fractal Analysis Method in Periodontal Disease
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      In this study, the effects of periodontal disease on alveolar bone were investigated using
      fractal analysis method.
    

Detailed description: 
      Background: It is very difficult to objectively evaluate the negative changes in bone
      structure due to periodontitis. The present study was aimed to evaluate the trabecular bone
      changes between healthy individuals and periodontitis patients by fractal dimension analysis
      on digital panoramic radiographs.

      Method: The study included 50 periodontally healthy individuals (control group), 50
      individuals with Stage 1 periodontitis (S1-P group), 50 individuals with Stage 2
      periodontitis (S2-P), and 50 individuals with Stage 3 periodontitis (S3-P), a total of 200
      individuals were included. The fractal dimension (FD) value of the trabecular bone in the
      interproximal space between mandibular first molar and second premolar tooth roots was
      evaluated using Image J program. The mean fractal dimension values of the two regions were
      calculated by box counting method.
    

Intervention name(s): fractal analysis
Intervention type(s): Other
Intervention description(s): fractal analysis is a method that numerically expresses bone changes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Digital Radiography; Fractal Analysis; Periodontitis
Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus; Autoimmune Diseases; Metabolic Disease; Glucose Metabolism Disorders; Immune System Diseases; Endocrine System Diseases; Juvenile Diabetes; Insulin Dependent Diabetes; Autoimmune Diabetes; Vitamin D; Physiological Effects of Drugs
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon
      administration directly into a lymph node in combination with an oral vitamin D/Placebo
      regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.
    

Detailed description: 
      The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical
      trial. Eligible patients will receive injections of Diamyd/placebo into an inguinal lymph
      gland at three occasions, with one month intervals in combination with an oral vitamin
      D/placebo regimen (starting 1 month ahead of injections) during 4 months. All patients will
      continue to receive intensive insulin treatment from their personal physicians during the
      whole study period. The patients will be followed in a blinded manner for a total of 15
      months. All patients that have not performed the 15 months visit when the updated protocol is
      implemented, will be asked to participate in the Extension Study Period which includes an
      additional visit at month 24.
    

Intervention name(s): Diamyd; Vitamin D; Placebo for Diamyd; Placebo for Vitamin D
Intervention type(s): Biological; Dietary Supplement; Biological; Dietary Supplement
Intervention description(s): Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD65); Oil suspension of Vitamin D; Alhydrogel® only; Placebo oil suspension for Vitamin D
Other intervention name(s): GAD-alum
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diamyd; Diabetes; Juvenile Diabetes; Diabetes Type 1; Type 1 Diabetes; Autoimmune Diabetes; Insulin Dependent Diabetes; Type 1 Diabetes Mellitus; rhGAD65; GAD65; Diabetes Mellitus; Diabetes Mellitus Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Vitamin D; Vitamins; Micronutrients; Cholecalciferol; Ergocalciferols
International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension
Condition: Hypertension; Renal Denervation
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this First-in-Human Clinical investigation is to evaluate the safety and
      performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the
      treatment of patients with drug-resistant uncontrolled hypertension.
    


Intervention name(s): EnligHTN™ Renal Artery Ablation Catheter
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Behavioral vs. Interpersonal Therapy (IPT) Prevention of Depression in Adolescents
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a cognitive-behavioral vs. an
      interpersonal therapy program for preventing depressive symptoms in adolescents.
    

Detailed description: 
      Hypothesis -- The cognitive-behavioral and interpersonal therapy prevention programs will be
      significantly better than the no-intervention control group in preventing depressive symptoms
      measured at post-intervention and at the 6-month follow-up. Gender differences also will be
      explored.
    

Intervention name(s): Cognitive-behavioral; Interpersonal Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive-behavioral approach; Interpersonal therapy approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: depression; adolescents; prevention; schools