bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I clinical trial to compare the pharmacokinetics and safety of
      fimasartan/Atorvastatin combination tablet and coadministration of fimasartan and
      Atorvastatin in healthy male volunteers.
    

Detailed description: 
      After subjects have signed informed consent voluntarily, they go through screening period for
      within 21 days.

      Group 1 period 2 period 3 period A F A F+A B F F+A A C A F+A F D A F F+A E F+A F A F F+A A F

      At each period taking Fimasartan, subjects of this Group have blood sampling 0, 0.25, 0.5,
      0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each
      period).

      At each period taking Atorvastatin, subjects of this Group have blood sampling 0, 0.5, 1,
      1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hour after medication(12 times in each period).

      At each period taking Fimasartan and Atorvastatin, subjects of this Group have blood sampling
      0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times
      in each period).
    

Intervention name(s): Fimasartan; Atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Fimasartan
Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea
Condition: Campylobacter Infection
MeSH terms: Campylobacter Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of increasing doses of a potential vaccine
      against Campylobacter with and without Alhydrogel®, an aluminum hydroxide adjuvant. This
      study will also assess immune responses induced by the vaccine.
    

Detailed description: 
      This is an open-label, dose-escalating study in which a total of 48 healthy volunteers will
      receive 2 vaccinations (one on Day 0 and one on Day 28 ± 2 days).

      There are 3 cohorts (dose levels) with 2 groups of 8 volunteers in each cohort. A cohort will
      be administered one of 3 intramuscular (IM) doses at 2 μg, 5 μg, or 10 μg of
      Capsule-Conjugate Campylobacter Vaccine (CJCV1) with or without Alhydrogel®, aluminum
      hydroxide adjuvant (alum) at 125 μg.

      An interval no less than 1 week will separate the last dose of a volunteer group from the
      first dose of the next volunteer group (receiving different CJCV1 doses). Blood specimens
      will be collected at intervals to examine systemic and mucosal antigen-specific immune
      responses. Vaccine safety will be actively monitored during vaccination and for 28 days (± 2
      days) following the second vaccination and complete the study with a telephone follow-up
      approximately 6 months (± 1 month) after the first vaccination. The total duration of
      participation in this study is up to 270 days (including screening).
    

Intervention name(s): Capsule-Conjugate Campylobacter Vaccine (CJCV1); Alhydrogel®, aluminum hydroxide adjuvant (alum)
Intervention type(s): Biological; Drug
Intervention description(s): The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Campylobacter jejuni
Complete Removal of Neoplastic Large Colorectal Polyps: a Prospective Randomized Comparison of Endoscopic Mucosal Resection or Conventional Polypectomy
Condition: Colorectal Polyps
MeSH terms: Polyps
Study type: Interventional

Summary: 
      Recently, it was reported that the incomplete resection rate of neoplastic large polyps after
      conventional polypectomy was markedly high in clinical practice. The incomplete resection
      rate of neoplastic large polyps after endoscopic mucosal resection (EMR) is not known.

      The aim of this study is to compare the incomplete resection rate of neoplastic large polyps
      after EMR or conventional polypectomy. The EMR technique is preferable to conventional
      polypectomy for the complete resection of the large polyps (>15 mm in diameter)
    


Intervention name(s): Endoscopic mucosal resection; Conventional polypectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter were resected after submucosal injection of saline solution before removal.; Nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter were resected using conventional polypectomy. Submucosal injection of saline solution before removal was not performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: nonpedunculated; neoplastic; colorectal; polyps
Effects Of Moderate Physical Activity On Hb, Physical Fitness And Psychological Well Being In Females
Condition: Anemia; Quality of Life
Study type: Interventional

Summary: 
      The study is design To determine the effectiveness of moderate physical activity on Hb,
      Physical fitness and psychological well-being in females.
    

Detailed description: 
      The majority of literature showed that level of physical activity is associated with Hb
      level. But there is paucity in the literature regarding the cause and effect relationship of
      PA and Hb. Literature shows lacking that there is any defined physical activity, which can
      affect the Hb concentration. According to literature, different studies conduct at Hb level
      in individuals with different diseases i.e. rheumatic arthritis, Diabetes mellitus etc. The
      aim of my study is to determining the cause and effect relationship of moderate physical
      activity on Hb level in healthy female population, one of the easiest moderate physical
      activity is brisk walk. Brisk walk is an aerobic exercise. People do get best physiological
      results of aerobic exercise with intensity of exercise 60-70% of the maximum pulse with
      longer time duration as well as increase frequency of exercise, which increase no of
      hemoglobin level due to this need more oxygen to performing physical activity in return basal
      metabolic rate increases and achieve physical fitness and gain relieve from the psychological
      problems.
    

Intervention name(s): Brisk walking (moderate physical activity)
Intervention type(s): Other
Intervention description(s): Warm up and cool down
Brisk walk (30 mintues each session per week 5 days)
Week 1 to 6
Other intervention name(s): Moderate physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Single (Participant)
Primary purpose: Other
Comparison of Two Counseling Induction Strategies
Condition: Methadone; Drug Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      New admissions (n = 120) to the Addiction Treatment Services (ATS) will be stabilized on
      methadone and randomly assigned to one of two induction conditions: 1) routine stepped care,
      or 2) low threshold stepped care. All participants will continue with routine stepped care in
      month 4. Treatment retention is the primary outcome measure, while drug use (measured via
      weekly urinalysis testing) is the major secondary outcome.
    

Detailed description: 
      This randomized clinical trial will evaluate two induction strategies for helping
      out-of-treatment opioid abusers transition to methadone maintenance treatment. All study
      participants (n = 120) will be new admissions to the Addiction Treatment Services at Hopkins
      Bayview (ATS), stabilized on 80 mg of methadone, and randomly assigned to one of two study
      conditions. The experimental induction condition will receive low threshold stepped care
      (LTSC) for the first 3-month of treatment that reduces the counseling demands of maintenance
      treatment (i.e., one counseling session / month). This condition will be compared to routine
      stepped care (RSC) for the first 3-months, which provides escalating intensity of counseling
      schedules contingent on drug use or poor adherence. RSC is routine treatment at ATS. All
      participants will receive routine stepped care following the 3-month induction phase, and
      will have the opportunity to remain in treatment at ATS following study participation.
      Participation is for 4-months. Retention is the primary outcome. Participants will also
      submit urine samples weekly on a random schedule each month. We hypothesize that LTSC
      participants will exhibit better retention than RSC participants, and that both conditions
      will exhibit reductions in drug use compared to baseline.
    

Intervention name(s): low threshold care; stepped-based care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Low threshold care refers to a service delivery method that reduces the treatment demands for new admissions to substance abuse treatment. In the present study, participants will be scheduled to attend less counseling sessions, and will have greater access to methadone.; Stepped-based care is routine treatment at ATS. Participants begin a low intensity care, and are advanced to more intensive levels of care (i.e., more intensive schedules of counseling) based on urine samples and counseling adherence.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment retention; methadone maintenance; treatment induction; Retention in methadone maintenance treatment
Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to investigate the safety and the antiviral activity of two doses
      of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection
      compared to entecavir 0.5 mg.
    

Detailed description: 
      LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral
      activity against wild-type HBV. LB80380 is undergoing clinical development by LG Life
      Sciences for use in the treatment of chronic HBV infection.

      In this study, the treatment period is 48-week with 24-week of follow-up period.
    

Intervention name(s): LB80380 90 mg; LB80380 150 mg; entecavir 0.5 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LB80380 90 mg + placebo tablets, once daily, for 48 weeks; LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks; entecavir 0.5 mg tablet, once daily, for 48 weeks
Other intervention name(s): LB80380; LB80380; Baraclude
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis B; LB80380; treatment-naive; entecavir
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical Applications of AP611074 5% Gel for up to 16 Weeks in Condyloma Patients
Condition: Condyloma
MeSH terms: Condylomata Acuminata
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind placebo controlled, randomized, phase 2 study to assess the safety,
      tolerability, pharmacokinetics and efficacy of twice daily topical applications of AP611074
      5% Gel for up to 16 weeks in condyloma patients
    


Intervention name(s): AP611074 5% gel; AP611074 matching placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Genital warts; HPV types; Sexually Transmitted Disease; Papillomavirus Infections; Viral Disease; Anogenital warts; AGW; HPV6; HPV11; Human papillomavirus infection; HPV; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen
Investigation of the Effect of Nomophobia on Musculoskeletal System and Sleep
Condition: Dependence
Study type: Observational

Summary: 
      The aim of this study; Investigation of the effects on the musculoskeletal system and sleep
      by determining the nomophobia levels of individuals between the ages of 18-25.
    

Detailed description: 
      The research was planned as a quantitative research. Data collection was done online.

      The scales and forms used are as follows:

        1. Demographic Information Form

        2. Nomophobia Scale

        3. Cornell Musculoskeletal Disorder Questionnaire

        4. Smart phone Addiction Scale

        5. Pittsburgh Sleep Quality Index

        6. International Physical Activity Survey

        7. McGill Melzack Pain Questionnaire

      Questionnaires will be sent to the participants online by invitation. Participants will be
      asked to participate in the study by reaching them through social media, mail or mobile phone
      applications. The data obtained will be analyzed statistically.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): The scales and forms used are respectively:
Demographic Information Form
Nomophobia Scale
Cornell Musculoskeletal Disorder Questionnaire
Smart phone Addiction Scale
Pittsburgh Sleep Quality Index
International Physical Activity Survey
McGill Melzack Pain Questionnaire
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        people with whom we were able to create the survey and who met the inclusion criteria
      
Keywords: nomophobia; sleep
Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty
Condition: Shoulder Disease
Study type: Interventional

Summary: 
      The combination of a modified lateral sagittal infraclavicular block and a suprascapular
      nerve block has not been studied in a cohort of total arthroplasty patients. Such
      diaphragm-sparing nerve blocks for shoulder arthroplasty may provide a very good anesthetic
      alternative in lung diseased patients who are in need for total arthroplasty of the shoulder.
    

Detailed description: 
      The investigators hypothesized that a combination of suprascapular nerve block and lateral
      sagittal infraclavicular block of the posterior and lateral cords would provide good
      postoperative analgesia for patients undergoing shoulder arthroplasty.

      The primary aims of this study were to document numeric rating scale (NRS, 0-10) and use of
      morphine equivalents during the first 24 hours after surgery. Secondary aims were to
      determine the incidence of diaphragm paresis 30 minutes after the block and to quantify
      postoperative hand grip force at 1 hr.
    

Intervention name(s): Peripheral nerve blocks
Intervention type(s): Procedure
Intervention description(s): LSIB + SSNB
Intervention model: Single Group Assignment
Intervention model description: Single intervention
Masking: None (Open Label)
Primary purpose: Treatment
Beta Blockers for the Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Current asthma medicines include inhalers. A common inhaler used in asthma is called a
      beta-agonist (for example salbutamol). They improve asthma symptoms by stimulating areas in
      the human airway resulting in widening of the human airway. Although these drugs are useful
      after the first dose, longterm use can cause worsening asthma symptoms.

      Beta-blockers are the complete opposite type of medication. Just now they are avoided in
      patients with asthma as after the first dose they can cause airway narrowing and cause an
      asthma attack.

      New research has suggested that long term use of beta-blockers can reduce airway inflammation
      which can improve asthma control and improve symptoms.

      This research was done in asthmatic patients who didn't need inhaled steroids to control
      their asthma. What the investigators want to do is see if the same benefit of beta-blocker
      use is asthma can be seen in people who take inhaled steroids.
    


Intervention name(s): propranolol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg twice daily escalated to 80mg once daily; Matched placebo
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients
Condition: Diabetes Complications
MeSH terms: Diabetes Complications
Study type: Interventional

Summary: 
      The purpose of the study is to determine if pyridostigmine bromide improves heart rate
      variability of type 2 diabetes mellitus subjects with cardiovascular autonomic neuropathy.
    

Detailed description: 
      The reduced heart rate variability is associated with increased risk of death in patients
      with diabetes mellitus. Cholinesterase inhibition with pyridostigmine bromide increases heart
      rate variability in normal individuals and congestive heart failure subjects but its effects
      on patients with diabetes mellitus is unknown. Based on those evidences, we will test if the
      short-term administration of pyridostigmine bromide increases heart rate variability in
      patients with diabetes mellitus.
    

Intervention name(s): Pyridostigmine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.; If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days
Intervention MeSH terms: Pyridostigmine Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pyridostigmine; autonomic modulation; diabetes mellitus; heart rate variability
Newborn Screening for Congenital Heart Disease
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      The purpose of this study is to test the accuracy of 7 indicators in screening congenital
      heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these
      indicators could be applied in the nationwide newborn CHD screening. The investigator's
      hypothesis is that 7 indicators are effective in neonate CHD screening with the acceptable
      accuracy.
    

Detailed description: 
      Congenital heart defects (CHD) are among the most common major congenital anomalies, and they
      occur worldwide with an incidence of about 8-12/1,000 live births , Most of these defects are
      mild or moderate. They either do not need treatment or treatment is needed only after
      infancy. Other defects are severe and require early treatment in infancy, which are the
      primary objectives of screening, because they are at risk of adverse or irreversible outcomes
      as a consequence of congenital heart defects. However, about half the neonates in the nursery
      have no distinctive clinical signs (symptoms, abnormal murmurs or cyanosis).So it's necessary
      to develop a screening strategy for neonatologist and pediatrician, especially physicians in
      community. Screening strategy in our study consists of 7 indicators: Family history of CHD,
      tachypnea, heart murmurs(≥ 2 grade), cyanosis, other non-cardiac malformations,special face
      feature（relating to chromosomal or non-chromosomal syndromes）, subnormal Pulse Oximetry
      reading (Oxygen saturation of less than 95% in either limb or more than 3% difference）。The
      newborn babies with any of these 7 indicators positive will be considered positive-screened
      and echocardiography will performed.

      The whole study (screening for CHDs with 7 indicators and performing the echocardiography for
      diagnosis) will be conducted by one single investigator (Quming Zhao from Children's Hospital
      of Fudan University). The new generation Pulse Oximetry has been proved to have low
      intraobserver and interobserver variability, but the interobserver variability in clinical
      evaluation (especially murmurs and cyanosis) remain unknown, the investigator will also
      assess the interobserver variability by comparing Quming Zhao and other two pediatricians
      (from the participating Hospital)(blind to each other).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All consecutive neonates including pre-mature neonates and symptomatic neonates) will be
        recruited prospectively from two collaboration hospitals of the ongoing projects- "Key
        Clinical Research Project Sponsored by Ministry of Health Screening, evaluation and
        intervention of congenital heart disease in newborn infants(2010-239)"
      
Keywords: Congenital heart disease; Newborn; Pulse oximetry; Screening
Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Ketamine infusions resulted in an acute reduction in global depression scores and in severity
      of suicidal ideation. The investigators therefore plan to investigate the feasibility and
      efficacy of repeated intravenous administration of ketamine in severely depressed, treatment
      resistant patients. The results of the study could lead to development of new strategies for
      treating depression.
    


Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug-drug Interaction Study With GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim of this study is to investigate the possible effect of GLPG4716 on the
      pharmacokinetics (PK) of pirfenidone and nintedanib. Further aims are to investigate safety
      and tolerability of GLPG4716 alone or administered simultaneously with pirfenidone or
      nintedanib.
    


Intervention name(s): Pirfenidone; GLPG4716; Nintedanib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): On Days 1 and 13, participants will receive an oral dose of pirfenidone.; From Day 3 to Day 14, participants will receive GLPG4716 daily.; On Days 1 and 13, participants will receive an oral dose of nintedanib.
Intervention MeSH terms: Pirfenidone; Nintedanib
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science