bioihbjkbjnl/mcl2 huggingface dataset:
TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects
Condition: Intestinal Disorders; Bowel Diseases, Inflammatory
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption,
      distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in
      cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of
      [14C]-TD-1473. Subjects in cohort 2 will receive a single oral dose of [14C]-TD-1473 only.
    


Intervention name(s): TD-1473 oral capsule; [14C]-TD-1473 IV bolus; [14C]-TD-1473 Oral Capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): (Intervention description included in arm description); (Intervention description included in arm description); (Intervention description included in arm description)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Absolute Bioavailability; ADME; Healthy Normal Males
Modifying the Workplace to Decrease Sedentary Behavior and Improve Health
Condition: Workplace Inactivity; Total Worker Health
Study type: Interventional

Summary: 
      The primary objective of this project is to determine the effects of decreasing sedentary
      behavior at work by at least 3hrs/day using treadmill (walking and standing) and sit-to-stand
      (standing only) workstations on the health of overweight office workers.
    


Intervention name(s): Active workplace
Intervention type(s): Behavioral
Intervention description(s): This is a 12-month, cluster-randomized trial with an intent-to-treat design to determine the effects of using treadmill and sit-to-stand workstations at the workplace on health variables in overweight office workers (N=66) with seated desk jobs and (2) to compare the efficacies of treadmill and sit-to-stand workstations in decreasing workplace sedentary behavior. The intervention will examine the effects of using these workstations on weight, cardiovascular and metabolic health variables , musculoskeletal discomfort, psychological affect and job stress. The study will also measure change in time spent sitting, standing and walking will be measured using wearable non-invasive acceleration sensors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Programmed intermittent epidural bolus (PIEB) for labour analgesia allows an epidural pump to
      be programmed to deliver small amounts of the local anesthetic and opioid solution at
      regularly timed intervals. However, little evidence is available to guide optimal settings
      for PIEB. The gaps in evidence include: (1) programmed timing for the first PIEB bolus
      (referred to as the "NEXT bolus") (2) determination of PIEB bolus volume (3) the interval for
      subsequent doses (PIEB interval). Response Surface Methodology will be utilized to best
      estimate the optimal PIEB settings (NEXT bolus interval, PIEB interval time, PIEB volume) by
      using the following clinical primary outcome measures: maternal satisfaction score, need for
      a clinician administered rescue bolus, and the ratio of PCEA boluses requested/delivered.
    


Intervention name(s): Coordinate A; Coordinate B; Coordinate C; Coordinate D; Coordinate E; Coordinate F; Coordinate G; Coordinate H; Coordinate I; Coordinate J; Coordinate K; Coordinate L; Coordinate M; Coordinate N
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL; PIEB "Next Bolus": 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL; PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL; PIEB "Next Bolus": 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL; PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL; PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL; PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL; PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL; PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL; PIEB "Next Bolus": 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL; PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL; PIEB "Next Bolus": 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL; PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL; PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind randomized trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia; Epidural; Labor; Obstetric Analgesia; Obstetrical
The Analysis for Termination of Treatment and Satisfaction in Traffic Accident Patient
Condition: Accidents, Traffic; Whiplash Injuries
MeSH terms: Whiplash Injuries
Study type: Observational

Summary: 
      Data of one hospital will be used to find out the patient's satisfaction with the treatment,
      analyze the factors effecting on the treatment termination.

      Also, plan to see if there is a correlation between prognosis according to the seriousness of
      the accident. In addition, investigators want to find out the participants' perception of car
      insurance and their satisfaction with traditional Korean medicine treatment.
    

Detailed description: 
      Retrospective data will be extracted using electronic medical records and computerized data
      of hospitalized patients. Based on this, investigators will conduct research in the form of
      prospective survey and analyze the causal relationship and factors using the two data.

      The hospital's medical records will be used to analyze the patient's condition during the
      hospitalization period and to determine the situation after the end of treatment through
      questionnaire. The questionnaire will be developed after consultation with experts from
      musculoskeletal system and related societies, and will be used for the questionnaire.
    

Intervention name(s): electronic medical record(EMR) Data and patient survey
Intervention type(s): Other
Intervention description(s): Retrospective Data Collection (1) Neck Disability Index (NDI), Oswestry Low Back Disability Index(ODI), euroqol-5 dimension(EQ-5D) scores during hospitalization (2) symptom onset date, symptom onset motive, past history, accident occurrence date, accident treatmen termination agreement date, etc.
Question items (consistent with the case record) according to the purpose of the investigation (1) General: Demographic sociological characteristics (gender, age, occupation, income, etc.) (2) Matters concerning the correlation between traffic accident agreements and symptoms
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients who ended up the hospitalization and treatment through car insurance in Haeundae
        Jaseng Korean Medicine Hospital
      
Keywords: traffic accident; traditional Korean medicine; car insurance; whiplash injury
Percutaneous Electrolysis and Vacuum Myofascial Therapy deviceTrial.
Condition: Epicondylitis
Study type: Interventional

Summary: 
      The concept of epicondylitis refers to the manifestation of pain in the area of insertion of
      the epicondile muscles, and that it is accompanied by limitation functional. A tendinopathy
      is characterized as a process of degeneration, with fibroblast proliferation and
      disorganization of the fibers of collagen. This tendon pathology especially affects the
      epicondyle extensors and especially the first and second radial and short extensor carpal.
    

Detailed description: 
      Experimental group will be treated Therapeutic Percutaneous Electrolysis and Vacuum
      Myofascial Therapy device once week for four weeks associated with eccentric exercises
      devices at home and the control group will be included 10 sessions of ultrasound pulsatil
      therapy (US) and massage associated with eccentric exercises devices at home.
    

Intervention name(s): Vacuum Myofascial Therapy device; physical therapy program; Therapeutic Percutaneous Electrolysis; ultrasound pulsatil therapy (US) and massage
Intervention type(s): Device; Other; Procedure; Procedure
Intervention description(s): Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home.; The multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.; Therapeutic Percutaneous Electrolysis; ultrasound pulsatil therapy (US) and massage
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A specialist physician will be diagnosed the epicondylitis
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tendinopathy; Electrolysis; Exercise; Dry needing; massage; cupping; vacuum; negative pressure
A Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose escalation study that will assess the safety and efficacy of LCL161 in
      combination with weekly paclitaxel in adult patients with advanced solid tumors.
    


Intervention name(s): LCL161; Paclitaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LCL161; solid tumors; paclitaxel
Hypothyroidism Treated With Calcitonin
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Interventional
Phase: Phase 4

Summary: 
      Some people with hypothyroidism have persistent symptoms despite adequate treatment with
      thyroid hormones. We are testing whether giving calcitonin to such people will improve their
      quality of life.
    

Detailed description: 
      It is known that a proportion of patients with hypothyroidism despite serum TSH levels being
      within the normal reference range, may continue to express symptoms of hypothyroidism. Common
      symptoms include fatigue, muscle pain, weight gain, and mood changes. Saravanan et al.
      reported in a large community-based survey that patients on levothyroxine even with a normal
      TSH showed significant impairment in psychological well-being compared with age- and
      sex-matched controls. These patients are challenging to manage and are often unhappy with
      they care.

      Established treatment of hypothyroidism is levothyroxine. Thyroid follicular cells synthesize
      and secrete thyroxine and triiodothyronine. However, even when people are receiving adequate
      levothyroxine replacement therapy, their quality of life may not improve. Calcitonin (CT) is
      also produced by the thyroid gland, parafollicular cells. Their levels are not tested in
      hypothyroidism because the exact role of calcitonin in human health and disease is not fully
      known. CT has long been thought to play an important role in bone and mineral homeostasis,
      particularly with respect to its ability to regulate calcium metabolism. CT has been found in
      fish, reptiles, birds, and mammals. Salmon-derived CT is 50-100 times more potent than human
      CT. Hence, salmon CT (sCT) has been used for medicinal purposes.

      There is a need for further research in order to understand the nature of persisting symptoms
      in patients on T4 monotherapy despite a serum TSH within the reference range. Calcitonin has
      been shown to alleviate pain in patients with bone or mineral disorders. To date, the use of
      calcitonin for relief of hypothyroid symptoms has not been studied.
    

Intervention name(s): Calcitonin
Intervention type(s): Drug
Intervention description(s): calcitonin nasal spray
Other intervention name(s): Miacalcin
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Motivational Enhancement System for Adherence
Condition: HIV
Study type: Interventional

Summary: 
      This is a two-phase study, consisting of the following plan:

      Phase I - This is a pre-test of the feasibility and acceptability of the beta version of a
      computer-delivered intervention, Motivational Enhancement System for Adherence (MESA), as
      well as the control intervention Motivational Enhancement System for Health (MESH) at three
      selected AMTUs. Following analysis of the responses in Phase I and further modification of
      the intervention, Phase II will be initiated.

      Phase II - This is a pilot, randomized, controlled trial (RCT) testing a two-session
      computer-delivered intervention, MESA, designed to increase motivation for adherence to
      Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin
      medications, as well as an attention control, MESH, matched for dose and delivery format.
      Phase II is open to all 15 AMTUs.
    


Intervention name(s): Motivational Enhancement System for Adherence (MESA); Motivational Enhancement System for Health (MESH)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MESA is designed to increase motivation for adherence to Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin medications.; Motivational Enhancement System for Health (MESH) is an attentional control providing information on nutrition and exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: HAART; HIV; Adherence
Comparison of Ocular Surface Features in Patients With Diabetes and Dry Eye Syndrome
Condition: Dry Eye Syndrome; Diabetes Mellitus Type 2
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Diabetes Mellitus; Diabetes Mellitus, Type 2; Syndrome
Study type: Observational

Summary: 
      The study aims to compare the differences of ocular surface features in controls and patients
      with diabetes and dry eye syndrome, to thoroughly evaluate the ocular surface health of
      diabetics, and to find out the relationship between dry eye syndrome and diabetes
    

Detailed description: 
      In this study, we perform a completely comparison of ocular surface characteristic including
      the Ocular Surface Disease Index (OSDI) questionnaire,tearfilm break up time(BUT),corneal
      fluorescein scores(CFS),Shirmer test,corneal sensitivity)among diabetic patients with DE,
      diabetic patients without DE, non-diabetic patients with DE and normal subjects and analysis
      of EGF, IL-17A, IL-1β, IL-8 and TNF-α in tears and their clinical correlations are also
      performed to investigate potential biomarkers for diagnosis of diabetic with DE.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Asian
      
Biospecimen description: 
      tears from the subjects
    
Keywords: ocular surface
Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease
Condition: Meniere Disease
MeSH terms: Meniere Disease
Study type: Interventional

Summary: 
      Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the
      patients Meniere disease. Methods: We enrolled 88 patients at Beijing TongRen Hospital. All
      treatments were self-administered by the patients at home after training at the hospital.
      Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks. Tinnitus
      Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, visual
      scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects. A
      difference of P < 0.05 was considered statistically significant.
    


Intervention name(s): Transcutaneous Auricular Vagus Nerve Stimulation with Betahistine
Intervention type(s): Other
Intervention description(s): Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on the left ear was selected and stimulated with electronic acupuncture apparatus (Hwato, SDZ-IIB), with continuous wave, 25 Hz in frequency, 4 to 8 mA in intensity depending on patient's tolerance. The first 3 treatments were conducted in hospital, during which, the patients were trained to use the apparatus under the instruction of research staff. Afterwards, the rest treatments were exerted at home, twice a day, after every breakfast and dinner respectively, 30 min each time. The treatment was given from Monday to Friday a week, totally for 12 weeks.
Participants received betahistine mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.
Intervention MeSH terms: Betahistine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Meniere Disease; taVNS; RCT
Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT
Condition: Insulin Resistance; Atherosclerosis; Cardiovascular Disease; HIV/AIDS; HIV Infections
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Insulin Resistance; Inflammation; Plaque, Atherosclerotic
Study type: Observational

Summary: 
      People with diabetes are at increased risk for atherosclerosis and have high CVD morbidity
      and mortality rates. Tools for detecting and quantifying atherosclerotic pro/regression in
      people with diabetes and other CVD risk factors lack sensitivity and specificity for
      molecular level events that occur during the early stages of atherogenesis. Inflammatory
      macrophage infiltration in the vessel endothelium is an early, molecular level proatherogenic
      event. Activated macrophages consume glucose at a high rate. Novel in vivo radiotracer PET/CT
      techniques have been developed to detect, image and quantify molecular level events like
      macrophage inflammation and glucose utilization (18FDG) in human vessels. We propose to
      develop and test this novel technique in the Center for Clinical Imaging Research (CCIR) at
      WUMS. We propose that HIV-infected people with significant CVD risk profiles are a suitable,
      unique human model for testing these novel imaging techniques. HIV-infected people taking
      anti-HIV medications develop insulin resistance, T2DM, dyslipidemia, central adiposity, and
      hypertension. HIV replicates in macrophages and represents a chronic proinflammatory
      condition. Recent data indicate that HIV+ CVD risk have greater risk for atherosclerosis and
      MI than HIV-negative people. To test feasibility, we hypothesize that: a.18FDG-PET/CT imaging
      will detect more macrophage glucose uptake and inflammation in the carotid and aorta arteries
      of HIV-infected people with CVD risk than in HIV-negative controls; b. radiotracer PET/CT
      measures of proatherogenic processes will correlate with carotid intima media thickness; a
      standard measure of carotid atherosclerotic burden. We propose to obtain pilot data that
      shows feasibility for a novel analytical approach that will expand capabilities for
      researchers interested in studying the links between diabetes, inflammation, and CVD in
      humans.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited through the AIDS Clinical Trials Unit (ACTU), Washington
        University Infectious Diseases Clinics, primary care physicians in the community who refer
        patients to these clinics and Volunteers for Health (VFH).
      
Keywords: vascular imaging; diabetes; rupture prone plaques; HIV; treatment experienced
Microbiome Changes in Severe Burns
Condition: Burns Greater Than 20% BSAB; Burns
MeSH terms: Burns
Study type: Observational

Summary: 
      The purpose of the study is characterizing changes in the microbiome of severely-injured
      adult patients as they progress through stages of injury, reconstruction, and recovery from
      burns.
    

Detailed description: 
      There exists a vast collection of bacteria that live on, and within, each human body. All
      surfaces exposed to the external environment, such as the nares, mouth, airway, skin, and
      intestines, are colonized, and it is estimated that over 100 trillion microbes live within
      the gastrointestinal tract alone. The interactions between these colonizers and their host
      have been demonstrated to affect myriad aspects of human health from autism and inflammatory
      bowel disease to cancer therapy response. Investigations into the role of the intestinal
      microbiome in sepsis have been ongoing for decades. Data has shown that critically ill
      patients can not only experience increased intestinal permeability - a factor that allows for
      the translocation of bacteria and non-microbial tissue injurious factors into the, primarily
      lymphatic, circulation, but also a disruption of the symbiotic relationship to one of
      dysbiosis, resulting in what is known as a "pathobiome."

      That the microbiome is affected by thermal injury should be no surprise; burn injury has been
      shown to drive significant intestinal ischemia and inflammation with subsequently increased
      intestinal permeability. , Burn-induced lung injury has been linked to these changes, and
      alterations in the microbiome between critically-burned patients (when compared with healthy
      controls) have been demonstrated, with resultant overgrowth of gram-negative anaerobes. Thus,
      the microbiome has a clear role in affecting the clinical course of thermally-injured
      patients.

      This is a descriptive case series study examining microbiome changes in two adult patients
      admitted with severe burn injuries. This will be done by obtaining regular stool samples and
      analyzing the microbial content, as well as obtaining clinical data on patients including
      those factors likely to influence the microbial content.
    

Intervention name(s): Characterizing changes in the microbiome
Intervention type(s): Other
Intervention description(s): Analyzing the microbial content from stool samples
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible patients will be admitted patients at the Regions Hospital Burn Center
      
Biospecimen description: 
      fecal samples from patients will be non-invasively collected