bioihbjkbjnl/mcl2 huggingface dataset:
Corticospinal Excitability and Rehab in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To determine differences in thigh muscle function in individuals with and without knee
      arthritis, and also determine the effectiveness of common physical therapy interventions on
      clinical and patient oriented outcomes.
    

Detailed description: 
      The primary objective of the proposed research evaluates the concurrent changes in
      corticospinal excitability and central sensitization of pain pathways for their influence on
      quadriceps voluntary activation. A secondary objective is to establish the feasibility of an
      intervention study to determine if changes in the excitability of these supraspinal motor and
      sensory processes can be modified by physical therapy interventions targeting pain and muscle
      strengthening. We hypothesize that patients with knee osteoarthritis will show measurable
      deficits in quadriceps voluntary activation that can be explained by lower levels of
      corticospinal excitability and increased pain sensitization. A 1 week physical therapy
      intervention will improve voluntary activation and reduce pain with concurrent changes in
      underlying motor and sensory processes. We further hypothesize that part of this improvement
      will be attributed to positive treatment expectation.
    

Intervention name(s): Transcutaneous Electrical Nerve Stimulation; Physical Therapy Exercises; No Intervention
Intervention type(s): Other; Other; Other
Intervention description(s): The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 8 hours per day for 1 week.; Patients will be given detailed verbal and hands-on instruction in a home exercise program. This program will consist of 6 exercises modeled from established protocols focuses on improving lower extremity strength. Patients will be instructed to do the exercises daily and to progress the exercises over the week for a maximum of 30 repetitions per day for 1 week.; Patients will be instructed to maintain their usual activity level.
Other intervention name(s): TENS; Sensory TENS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: knee osteoarthritis; grade I and II knee osteoarthritis; arthritis
Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to demonstrate that there is a benefit in switching chronic
      schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy,
      neurological safety and patient's outcome.
    


Intervention name(s): olanzapine; haloperidol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Haloperidol; Olanzapine; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Epidemiology of Long QTand Asian Sudden Death in Sleep
Condition: Cardiovascular Diseases; Heart Diseases; Arrhythmia; Death, Sudden, Cardiac; Long QT Syndrome
MeSH terms: Cardiovascular Diseases; Heart Diseases; Long QT Syndrome; Death, Sudden, Cardiac; Death; Death, Sudden
Study type: Observational

Summary: 
      To conduct a cross-sectional epidemiologic study of the determinants of prolonged heart rate
      corrected QT interval (QTc) among 300 men and 300 woman in the population with the highest
      known risk of SUDS: Southeast Asian refugees in Thailand. .
    

Detailed description: 
      BACKGROUND:

      Sudden and unexplained death in sleep (SUDS) is a leading cause of death of young men in
      several Asian populations. The immediate cause is ventricular fibrillation in the absence of
      known disease. A strong environmental component may be inferred from the regional nature of
      SUDS in groups that are culturally and genetically distinct and the rapid decline in rates of
      SUDS after migration of Southeast (SE) Asian refugees to the United States. Risk of SUDS
      rises sharply to a peak among men aged 35 years of age, then declines with increasing age. In
      a pilot studies of SE Asian refugee men in Thailand with the highest known risk of SUDS, the
      investigators documented high-prevalences of prolonged heart rate corrected QT interval
      (QTc), thiamine deficiency, hypokalemia, and a positive association between poor thiamine
      status, measured by erythrocyte transketolase activity (ETK), and QTc. These limited studies
      were unable to precisely quantify the relationship between QTc and thiamine status, lacked
      sufficient power to examine the relationship between QTc and hypokalemia, did not include
      other electrolytes, and did not address the striking differences in risk of SUDS by sex and
      age.

      DESIGN NARRATIVE:

      The study was cross-sectional in design. During a 14-month period, informed consent was
      obtained from subjects selected in an age-stratified random sample of refugees scheduled for
      routine medical screening. Blood samples, 12-lead and 24-hour ECGs, and interview data were
      collected to test the following hypotheses: (1) mean QTc was greater in men than women, (2)
      mean QTc was greater in men aged 30-39 years than in men younger or older; no similar
      relationship was expected among women, (3) QTc was positively correlated with poor thiamine
      status, measured by erythrocyte transketolase activity, (4-6) QTc was negatively correlated
      with serum levels of potassium, magnesium, and total calcium, and (7) QTc was associated with
      abnormalities of autonomic control of the heart, as indicated by power spectral analysis of
      heart rate variability. Secondary aims included studying interactions of thiamine status and
      electrolytes in the prolongation of QTc, dynamic analysis of QT variation by heart rate level
      in 24-hr ECGs, and collection of blood specimens for later genetic studies
Biomarkers in Bone Marrow Samples From Patients With Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may
      help doctors learn more about changes that occur in DNA and identify biomarkers related to
      cancer.

      PURPOSE: This laboratory study is studying bone marrow samples from patients with acute
      myeloid leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  To rigorously examine fractionated hematopoietic stem and progenitor cells from patients
           with acute myeloid leukemia (AML).

        -  To define somatic mutations occurring in de novo AML, including the FLT3-ITD, CEBPA,
           NPM1, TET2, ASXL1, IDH1, and IDH2 mutations.

        -  To examine what cellular compartments (LT-HSC, ST-HSC, CMP, GMP, and MEP) contain the
           selected mutations and in what order those mutations occur.

      OUTLINE: Archived bone marrow specimens are analyzed for sequencing and detection of
      mutations by Sanger-based resequencing of PCR amplicons. Results are then compared with the
      results of age-matched healthy controls.
    

Intervention name(s): mutation analysis; polymerase chain reaction; immunologic technique; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E1900 from whom samples were submitted for research
      
Keywords: adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with del(5q); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); untreated adult acute myeloid leukemia; adult acute minimally differentiated myeloid leukemia (M0); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute megakaryoblastic leukemia (M7)
Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in
      reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice
      daily applications. The study will also evaluate the safety of the study products using
      tolerance and adverse event data.
    


Intervention name(s): Epiduo vehicle gel; CD07223; CD07223; Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks; 500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks; 500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks; 500 microliters Epiduo Gel on one of the half-face for the morning dose
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first in human study of 162, and the primary objective is to evaluate the safety
      and tolerability of 162 with a single ascending dose in healthy adult subjects.

      The dose-escalation stage will be conducted sequentially at 5 dose levels, which are 100 mg
      in the pre-test, and 200 mg, 400 mg, 800 mg and 1200 mg in the formal test.

      Two healthy adult subjects will be enrolled at 100 mg dose level and all given 162. Eight
      healthy adult subjects will be enrolled at each remaining dose levels (200 mg, 400 mg, 800 mg
      and 1200 mg), respectively.
    


Intervention name(s): 162; Placebo
Intervention type(s): Biological; Other
Intervention description(s): The investigational product 162 is a novel neutralizing antibody targeting HBsAg, for the treatment of patients with chronic hepatitis B; an intervention that appearance is the same as 162, but contains no active ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.
Condition: Uterine Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      To evaluate the therapeutic response to uterine artery embolization in 30 patients with
      leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).
    


Intervention name(s): Uterine Embolization
Intervention type(s): Device
Intervention description(s): Uterine Embolization with PVA Microspheres
Intervention model: Single Group Assignment
Intervention model description: Prospective, single-arm, open label study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Embolization; Uterine Leiomyoma; Embospheres; Microspheres
Pharmacodynamic Properties of CJ-12420 on Evening Dosing
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare and evaluate impact on pharmacodynamic
      characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male
      volunteers
    

Detailed description: 
      Evaluation Criteria:

        1. Pharmacokinetic Endpoints Cmax, tmax, AUClast of CJ-12420

        2. Pharmacodynamics Endpoints Time pH > 4 Time pH > 6 Integrated acidity Percent inhibition
           of integrated acidity Percent inhibition time gastric pH ≤ 4 Median pH

        3. Safety Assessments Physical examination, ECGs, vital signs (blood pressure, heart rate,
           body temperature), laboratory test (CBC, Chemistry, UA), and adverse events (AEs)
    

Intervention name(s): Dexlansoprazole 60 MG; CJ-12420 50mg; CJ-12420 100mg; CJ-12420 200mg
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): R; T1; T2; T3
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fractional Exhaled Nitric Oxide (FeNO) Result Prediction Factors in Children With Allergic Diseases
Condition: Asthma; Allergic Rhinitis; Atopic Dermatitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      In about 800 children with allergic diseases (asthma, allergic rhinitis, atopic dermatitis)
      the investigators will retrospectively and cross-sectionally analyze the
      influence/correlation of diagnosis, treatment methods, allergy status (skin prick test
      results), lung function tests results on/with the concentration of nitric oxide in exhaled
      breath.
    

Detailed description: 
      In about 800 children with allergic diseases from our Outpatient Clinic (asthma, allergic
      rhinitis, atopic dermatitis) we will retrospectively and cross-sectionally analyse the
      influence/correlation of diagnosis, treatment methods, allergy status (skin prick test
      results), lung function tests results on/with the concentration of nitric oxide in exhaled
      breath.
    

Intervention name(s): measurements of lung function tests
Intervention type(s): Procedure
Intervention description(s): Measurement of the concentration of FeNO , measurement of spirometry, plethysmography, exercise challenge test (ECT -spirometric), bronchial obstruction reversibility pharmacological test
Other intervention name(s): NO analyzer- Sievers 280i analyzer; Spirometry and Plethysmography - Jaeger; Exercise provocation test treadmill- Kettler
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children with asthma (allergic), and/or allergic rhinitis and/or atopic dermatitis
      
Keywords: Asthma; Allergic Rhinitis; Atopic Dermatitis; Children; lung function; skin prick tests; FeNO
Safety and Immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP Vaccines in Malaria Endemic Areas
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and
      MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The
      regime proposed in this trial has protected non-immune volunteers against sporozoite
      challenge in clinical trials performed by Oxford, and so may be protective against naturally
      acquired infection in Kenya.The study population will comprise 30 healthy adult males aged
      18-50.

      The investigators do not propose to include a placebo group. At this stage the investigators
      objective is to describe the safety profile in a small number of individuals, and the
      confidence intervals for the proportion of individuals with a particular event would be too
      wide for meaningful comparison with a placebo group. Immunogenicity will be judged by
      comparison with baseline.
    


Intervention name(s): AdCh63 ME-TRAP followed by MVA ME-TRAP; AdCh63 ME-TRAP followed by MVA ME-TRAP
Intervention type(s): Biological; Biological
Intervention description(s): AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly; AdCh63 ME-TRAP 5x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intradermal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Immune response
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single Ascending Doses of CC-92480 in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part study to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of CC-92480 and explore the effect of food on the bioavailability of
      CC-92480 in healthy subjects.

      Part 1:

      Part 1 is a single-center, randomized, double-blind, placebo-controlled study to evaluate the
      safety, tolerability, PK, and pharmacodynamics (PD) of CC-92480 following administration of
      single oral doses in healthy adult subjects. Part 1 will consist of escalating single doses
      in sequential groups. Approximately 40 subjects will be enrolled into 5 planned dose level
      cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive CC-92480
      and 2 subjects will receive placebo according to the randomization schedule.

      Part 2 Part 2 is a single-center, open-label, randomized, 2-period, 2-way crossover study to
      explore the effect of food (Food and Drug Administration [FDA] standard high-fat breakfast)
      on the single-dose PK of CC-92480 in healthy adult subjects.
    


Intervention name(s): CC-92480; CC-92480
Intervention type(s): Drug; Drug
Intervention description(s): Part 1 dose escalation; CC-92480
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Subjects; CC-92480; Food Effect
Study to Evaluate HL-TOF Tab. 5 mg Compared With XelJanz Tab. in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of
      XelJanz tab. in healthy volunteers
    

Detailed description: 
      The purpose of this study is to evaluate the safety and pharmacokinetics of tofacitinib after
      single oral administration of Xeljanz tab. 5mg as reference drug and HL-TOF tab. 5mg as test
      drug in healthy voluteers. AUC and Cmax would be evaluated for the pharmacokinetics. Adverse
      event, Laboratory examination and other examination result would be evaluated for the safety.
    

Intervention name(s): HL-TOF tab. 5mg; Xeljanz tab. 5mg
Intervention type(s): Drug; Drug
Intervention description(s): HL-TOF; Xeljanz
Other intervention name(s): Tofacitinib freebase; Tofacitinib citrate
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2X2
Masking: None (Open Label)
Primary purpose: Basic Science
Fasted Bioavailability Study of Cilostazol Tablets, 50mg
Condition: Therapeutic Equivalency, Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate and compare the relative bioavailability of a test
      formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after
      a single oral dose administered under fasting conditions.
    

Detailed description: 
      The purpose of this study is to evaluate and compare the relative bioavailability of a test
      formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after
      a single oral dose administered under fasting conditions. Thirty-two non-smoking, non-obese,
      healthy male and female volunteers between the ages of 18 and 55 will be randomly assigned in
      a crossover fashion to receive each of two cilostazol dosing regimens in sequence with a 7
      day washout period between dosing periods. On the morning of Day 1, after an overnight fast
      of at least 10 hours, subjects will receive either a single oral dose of the test
      formulation, cilostazol (2 x 50 mg tablets), or a single oral dose of the reference
      formulation, Pletal® (2 x 50 mg tablets). After a 7 day washout period on the morning of Day
      8, following an overnight fast of at least 10 hours, subjects will receive the alternate
      regimen. Blood samples will be drawn from all participants before dosing and for 24 hours
      post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics
      of cilostazol. Blood sampling will then continue on a non-confined basis at 36 and 48 hours
      post-dose. A further goal of this study is to evaluate the safety and tolerability of this
      regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion
      of the study for adverse reactions to the study drug and/or procedures. Blood pressure and
      pulse will be measured before dosing and at 3 and 24 hours post-dose. All adverse events
      whether elicited by query, spontaneously reported, or observed by clinic staff will be
      evaluated by the investigator and reported in the subject's case report form.
    

Intervention name(s): Cilostazol 50 mg Tablets; Cilostazol (Pletal®) 50 mg Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Cilostazol (2 x 50 mg tablets) administered after an overnight fast of at least 10 hours; Cilostazol (Pletal® Tablets, 2 x 50mg) administered after an overnight fast of at least 10 hours.
Other intervention name(s): Pletal®
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)