bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of
      DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched
      control subjects with normal hepatic function.
    

Detailed description: 
      DBPR108 is a potent dipeptidylpeptidase-4 inhibitor. The aim of this study is to evaluate the
      pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment
      (HI) compared to the matched control subjects with normal hepatic function. This study
      consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment
      period (Day 1 to Day 3), and a follow-up call on Day 6.

      Subjects will be enrolled in the following groups:

      (A) mild hepatic impairment (Child-Pugh class A, 5-6 points); (B) moderate hepatic impairment
      (Child-Pugh class B, 7-9 points); (C) control subjects with normal hepatic function will be
      matched with subjects with HI by weight, age, and sex.

      Approximately 8 subjects will be enrolled in each group.
    

Intervention name(s): DBPR108 tablets
Intervention type(s): Drug
Intervention description(s): Drug: DBPR108, tablet, oral
Other intervention name(s): DBPR108
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control as a Means of Reducing Excess Body Weight
Condition: Overweight; Obesity; Overweight and Obesity; Overweight or Obesity; Metabolic Syndrome
MeSH terms: Obesity; Overweight; Metabolic Syndrome; Body Weight
Study type: Interventional

Summary: 
      A randomized, double blind sham controlled clinical trial to evaluate the efficacy of
      vestibular nerve stimulation (VeNS), together with a lifestyle modification program, compared
      to a sham control with a lifestyle modification programme, as a means of reducing excess body
      weight and body fat.
    


Intervention name(s): Vestal Device; Control Device; Hypocaloric Diet
Intervention type(s): Device; Device; Behavioral
Intervention description(s): Vestibular nerve stimulator; Control Device; Hypocaloric diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of a Component of Fish Oil on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional

Summary: 
      Docosahexaenoic acid (DHA) is a component of fish oil that is known to support a healthy
      cardiovascular system, maintain brain function, reduce depression, and improve inflammatory
      diseases. The study hypothesis is that DHA supplementation will diminish exercise-induced
      bronchoconstriction and airway inflammation as compared to placebo.
    

Detailed description: 
      To date, fish oil supplementation studies in patients with asthma have used a combination of
      omega-3 polyunsaturated fatty acids. A study on the specific formula that is most effective
      in preventing exercise-induced bronchoconstriction (EIB) has yet to be conducted in humans.
      Nevertheless, it has been shown that a docosahexaenoic acid (DHA) metabolite, protectin D1,
      is involved in the active resolution of airway inflammation and that its concentration is
      greater in healthy control subjects' exhaled breath condensates as compared to patients with
      asthma during a clinical exacerbation. Supplementing asthmatics with DHA could enable an
      increased availability of protectin D1 to help resolve airway inflammation during an asthma
      attack. Furthermore, DHA is known to support a healthy cardiovascular system, maintain brain
      function, and reduce depression in addition to alleviating inflammatory diseases. Thus, pure
      DHA supplementation could help patients manage their asthma while providing for their overall
      health.

      The main aim of this study is to determine whether pure DHA can attenuate EIB and airway
      inflammation in adults with asthma. It is hypothesized that DHA supplementation will diminish
      EIB and airway inflammation compared to placebo.
    

Intervention name(s): Docosahexaenoic Acid; Placebo Docosahexaenoic Acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 8 docosahexaenoic acid (4.0 grams) capsules per day for 3 weeks.; 8 placebo docosahexaenoic acid (corn and soy oil blend) capsules per day for 3 weeks.
Other intervention name(s): DHA; Corn Oil; Soy Oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Exercise-Induced Bronchoconstriction; Inflammation; Airway; Fish Oil; Docosahexaenoic Acid; DHA
Pharmacokinetic Study of Levocetirizine Oral Solution
Condition: Rhinitis, Allergic, Perennial and Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a single center, open-label, randomized, single dose, in the fasted
      condition and 2-way crossover study to evaluate the pharmacokinetics, the safety and
      tolerability of levocetirizine oral solution 5 mg and cetirizine dry syrup 10 mg in Japanese
      healthy male subjects.

      Approximately 20 subjects will receive both treatments of levocetirizine oral solution 5 mg
      and cetirizine dry syrup 10 mg in the design. Serial pharmacokinetic samples will be
      collected and safety assessments will be performed following each dose.

      The primary objective of the study is to demonstrate the bioequivalence of levocetirizine in
      plasma, when given as levocetirizine oral solution 5 mg relative to cetirizine DS 10 mg in
      Japanese healthy male subjects.
    


Intervention name(s): Levocetirizine; Cetirizine
Intervention type(s): Drug; Drug
Intervention description(s): Levocetirizine; Cetirizine
Intervention MeSH terms: Cetirizine; Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis
Condition: Psoriasis; Immunomodulation
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was conducted in subjects with psoriasis to evaluate drug activity in this patient
      population by analysis of changes in psoriatic lesion biopsy characteristics. This subject
      population was selected to evaluate potentially relevant biological activity of CP-690,550 as
      well as assessing safety and pharmacokinetics.
    


Intervention name(s): tofacitinib; tofacitinib; tofacitinib; tofacitinib; tofacitinib; tofacitinib
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg BID For 13 days and once on Day 14; 10 mg BID for 13 days and once on Day 14*; 20 mg BID for 13 days and once on Day 14; 30 mg BID for 13 days and once on Day 14; 60 mg tablet once a day (QD) for 14 days; 50 mg tablets two times a day (BID) for 13 days and once on day 14
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Psoriasis; PASI; plaques; skin biopsy; immunomodulation
The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research protocol is to determine if the same effects are observed in
      vivo in humans using a similar approach. Demonstrating that mineralocorticoid acts on zona
      glomerulosa cells to regulate aldosterone production in a short feedback loop would provide
      important insight into hormone regulation, and explain variability in pathophysiologic states
      such as hypertension and cardiovascular diseases.
    

Detailed description: 
      In order to provide additional evidence indicating the presence of functional and in order to
      provide additional evidence indicating the presence of functional mineralocorticoid receptors
      (MR) on zona glomerulosa (ZG) cells, the investigators propose the following protocol in
      healthy volunteers. The investigators will evaluate aldosterone and cortisol production in
      response to an angiotensin II infusion after three separate test conditions: 1) placebo, 2)
      following a single dose of fludrocortisone, and 3) following a single dose of eplerenone (a
      MR antagonist).
    

Intervention name(s): Placebo; Fludrocortisone; Eplerenone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo prepared by Investigation Drug Services at Brigham and Women's Hospital; Fludrocortisone 0.1 mg; Epleronone 100 mg
Other intervention name(s): Florinef; Inspra
Intervention MeSH terms: Fludrocortisone; Eplerenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Healthy
Study of a Randomized Intervention Designed to Increase Exercise in Pregnancy
Condition: Gestational Weight Gain
MeSH terms: Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      This project aims to determine whether a mobile-health (m-health) tool, accessible via
      smartphone or website, intervention for overweight and obese pregnant women improves physical
      activity, gestational weight gain, quality of life, stress and depression during pregnancy.
      This study will examine factors associated with using the m-health tool and the most highly
      utilized features of the tool, with a goal of understanding how it can be used and improved
      in future behavior change interventions. The hypothesis is that compared with usual care, an
      m-health intervention will result in increased minutes of moderate-to-vigorous physical
      activity and increased knowledge of the IOM GWG guidelines. The study design is a small pilot
      randomized trial to assess feasibility. This study will recruit and follow 70 overweight and
      obese pregnant women during the first trimester of pregnancy from Kaiser San Francisco and
      other facilities. The m-health intervention has the advantage of enabling overweight and
      obese women to monitor and improve their health behaviors without impacting the work flow of
      clinical care. Depending on the results of this initial evaluation, the clinical implications
      may include its implementation at the health system level and/or being evaluated and improved
      in the future by a larger investigation in a randomized controlled trial. The study team will
      assess adherence and acceptability of the intervention to inform future studies.
    


Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): The goal of the intervention is to help women increase their minutes of moderate-to-vigorous physical activity and to increase their knowledge of the IOM gestational weight gain guidelines. The lifestyle intervention will be delivered through telephone counseling sessions with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and core lifestyle intervention sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: lifestyle; intervention; body weight; pregnancy; Overweight; Obesity; Signs and Symptoms; Body weight changes
Study of Chemotherapy With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients
Condition: Breast Neoplasms; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis; Triple Negative Breast Neoplasms; Breast Neoplasms
Study type: Observational

Summary: 
      To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin
      chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced
      killer cells in triple negative metastatic breast cancer patients
    

Detailed description: 
      1. Metastatic breast cancer patients should be definitively diagnosis based on
           histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative

        2. All the patients enrolled will be given standard cyclophosphamide combined thiotepa and
           carboplatin chemotherapy and cellular therapy.Cellular therapy consisting of one cycle
           of chemotherapy followed by an apheresis and ex vivo cultures to generate DC and CIK,
           followed by low-dose Oral Cyclophosphamide .

        3. The response is assessed using Response Evaluation Criteria in Solid Tumor Group
           (RECIST) guidelines.

        4. Estimate time to progression, survival rates and clinical benefit response on patients.

        5. Find biomarkers associated with drug response.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        female patients with metastatic breast cancer
      
Biospecimen description: 
      about 4ml peripheral vein blood，paraffin section on metastatic tissue，
    
Keywords: breast neoplasm; Neoplasm Metastasis; Drug Therapy
Objective Measures in Implantable Hearing Devices
Condition: Mixed Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Mixed Conductive-Sensorineural
Study type: Observational

Summary: 
      The purpose of this study is to measure objectively the coupling from direct acoustic
      cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked
      potentials.
    

Detailed description: 
      A new technique, called Direct Acoustic Cochlear Stimulation, has very recently been
      introduced to restore hearing in patients with severe hearing loss due to the immobility of a
      small ossicle in the middle ear, the stapes. A piston-like prosthesis, which is placed up
      into the inner ear, is connected to an implantable mechanical stimulator, named DACS.
      Unfortunately, as with other active middle ear implants, until now the correct function of
      this technique cannot be checked during the surgery, leading to a possibly variable outcome
      of hearing. In this project, the objective auditory evoked potentials, like Auditory
      Steady-State Response (ASSR), will be used to measure the efficacy of this method of inner
      ear stimulation. This highly innovative, non-invasive research will provide valuable insight
      in a new promising way of inner ear stimulation and may give a unique possibility to measure
      the correct connection from an implantable hearing device to the inner ear.
    

Intervention name(s): Auditory evoked potentials and audiometry; Auditory evoked potentials
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Different protocols for audiometry and auditory evoked potentials
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Mixed hearing loss
      
Keywords: Hearing; Thresholds; Coupling to the inner ear
Bioequivalence of Two Different Drug Product Batches of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence of two drug product batches of dabigatran etexilate, one
      batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate
      polymorph II in addition to polymorph I
    


Intervention name(s): Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%); Dabigatran polymorph I
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Board Game Intervention to Improve Cognitive and Daily Functioning
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Background:

      With the rapid rise of the aging population, the number of seniors with mild cognitive
      impairment (MCI) has increased, and without timely interventions, participants are at high
      risk of developing dementia. Board games have become a popular tool for cognitive training,
      but many board games may not be appropriate for seniors and lack the support of empirical
      research.

      Objectives:

      To examine the effectiveness of a 12-week board game intervention for MCI seniors in
      improving cognitive functioning and scores on the instrumental activities of daily living
      (IADL) scale.

      Methods:

      A single-blind randomized controlled trial was conducted to collect data from a long-term
      care facility in central Taiwan. Sixty-eight MCI seniors were recruited and randomized into a
      board game group (trial group) and a health promotion group (control group). Participants in
      both groups received a 2-hour intervention once a week for 12 weeks, with the trial group
      receiving 12 weeks of board games and the control group receiving 12 weeks of health
      promotion activities. Before and after the intervention, the primary assessment was conducted
      using the Saint Louis University Mental Status Exam, Contextual Memory Test, and Trail Making
      Test part-A; the secondary assessment was conducted using the IADL scale.
    


Intervention name(s): Board game intervention
Intervention type(s): Other
Intervention description(s): In this study, the two groups, the Board game group (12-week board game intervention) and Health promotion group (12-week general health promotion intervention).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting,
      subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c
      >7.0% and <11.5%.
    


Intervention name(s): Technosphere Insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Group Training for Social Skills in Psychosis
Condition: Psychotic Disorders
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to assess the feasibility of a social skills training group for
      people with psychosis.
    

Detailed description: 
      This study is assessing the feasibility of a psychological intervention targeting social
      cognition problems in people with psychosis. The intervention is a group psychological
      treatment facilitated by a clinical psychologist. The group therapy takes advantage of
      audiovisual material and practical exercises to illustrate strategies and thinking styles
      that may help participants overcome difficulties in social settings.

      A second objective of this study is to test a new method to measure social cognition by using
      portable devices. These devices will be carried by participants in their everyday life and
      will ask about their social activity levels at random times and record activity levels.
    

Intervention name(s): GRASP; Standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): GRoup trAining for Social skills in Psychosis; Treatment as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychosis; Schizophrenia; Social Skills; Therapy
The Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking on the Signs and Symptoms of Bullous Keratopathy
Condition: Bullous Keratopathy
MeSH terms: Corneal Edema
Study type: Interventional

Summary: 
      Recently, riboflavin (0.1%) and ultraviolet-A (UVA) collagen cross-linking (C3R) has shown
      potential to improve the signs and symptoms of bullous keratopathy .The objective of this
      study is to demonstrate the effects of C3R to treat bullous keratopathy.
    


Intervention name(s): ultraviolet-A
Intervention type(s): Radiation
Intervention description(s): Corneal cross linking (C3R) with riboflavin and ultraviolet-A (UVA, 370 nm, 3mW/cm2) for 30 min
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The overall objective of this study is to collect data relevant to the tolerability of
      Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring
      recommendations specified in the package insert.
    

Detailed description: 
      This phase IV, multicenter, prospective, open-label tolerability and safety monitoring study
      will enroll a select cohort of 500 multiple sclerosis patients receiving commercially
      available Novantrone®. The patients will be assessed every 3 months during treatment followed
      by annual assessment for a total of five (5) years.

      The select cohort of MS patients enrolled will have secondary (chronic) progressive,
      progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose
      neurological status is significantly abnormal between relapses).

      The overall objective of this study is to collect data relevant to the tolerability of
      Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring
      recommendations specified in the package insert.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients with a clinically definite or laboratory supported diagnosis of MS
        and having secondary (chronic) progressive, progressive relapsing, or worsening
        relapsing-remitting disease (i.e., patients whose neurologic status is significantly
        abnormal between relapses). Patients with primary progressive disease will not be included
        in this study.