bioihbjkbjnl/mcl2 huggingface dataset:
Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab
Condition: Arthritis,Rheumatoid
MeSH terms: Arthritis, Rheumatoid
Study type: Observational

Summary: 
      We can speculate that the best responders to tocilizumab should have multiple related
      elements (Treg CD39, adenosine, IL-35) successfully induced and expressed in order to play
      its beneficial role. The study of these elements and its pathways could help identify the
      best responders to tocilizumab treatment.
    


Intervention name(s): Tocilizumab; Adalimumab
Intervention type(s): Drug; Drug
Intervention MeSH terms: Adalimumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        AR patients treated with tocilizumab in monotherapy or treated with adalimumab as control.
      
Biospecimen description: 
      Serum
Evaluate the Pharmacokinetics of Simvastatin When Coadministered With PEX168 in Healthy Adult Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of PEX168 doses on the pharmacokinetics of simvastatin(as determined by
      simvastation acid) in healthy subjects.

      To assess the safety of single doses of simvastation administered with and without PEX168
    

Detailed description: 
      This was an open-label, sequential, single-center study that evaluated the pharmacokinetics
      of simvastatin when coadministered with PEX168 in healthy adult subjects. The total duration
      of each subject's participation in the study was approximately 10 weeks, which included up to
      a 14-day Screening Period, a 34-day Treatment Period, and an approximately 4-week Follow-up
      Period.

      Center: This study was conducted at a single site in Shanghai Mental Health Center (SMHC)of
      China Treatment.All subjects receives a single 40-mg oral dose of simvastatin on Day 1
      followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 3 and a
      second single 40-mg oral dose of simvastatin on Day 33.
    

Intervention name(s): PEX168; Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 200µg,injected subcutaneously,once a week.; 40mg,oral,two times
Other intervention name(s): Polyethylene Glycol Loxenatide; Shujiangzhi
Intervention MeSH terms: Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction
Condition: Acute Myocardial Infarction; Percutaneous Coronary Intervention
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of three different vasodilators
      including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during
      direct percutaneous coronary intervention for acute myocardial infarction.
    

Detailed description: 
      No-reflow/slow-flow is a frequent observation during direct PCI for AMI and associated with a
      poor clinical outcome. The present pharmacological management involves the use of different
      vasodilators including nitrates, verapamil, adenosine and nicorandil. But no randomized trial
      has been conducted to assess any of these agents, or to determine the appropriate dosage.
      This prospective randomized study aimed to confirm favorable effects of diltiazem on
      no-reflow/slow-flow during direct PCI for AMI compared with verapamil and nitroglycerin.
    

Intervention name(s): Diltiazem; Verapamil; Nitroglycerin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intracoronary Infusion 400-2000ug; Intracoronary Infusion 200-1000ug; Intracoronary Infusion 200-1000ug
Intervention MeSH terms: Verapamil; Diltiazem; Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute myocardial infarction; Percutaneous coronary intervention; No-reflow phenomenon; Vasodilator agents
Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO
Condition: Dyslipidemia/Glucose Metabolism Disorder
MeSH terms: Dyslipidemias; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a
      statin and receiving metformin, the superiority of a fixed combination of fenofibrate and
      metformin vs metformin alone on TG and additionally, if the superiority on TG is established,
      to demonstrate the superiority on HDL-C
    


Intervention name(s): fenofibrate (F) + metformin (M) hydrochloride fixed combination; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): F80mg/M500mg - per os - twice a day during 24 weeks / or / F80mg/M850mg - per os - twice a day during 24 weeks /or / F54mg/M850mg - per os - three times a day during 24 weeks; 500mg - per os - twice a day during 24 weeks /or / 850mg - per os - twice a day during 24 weeks /or / 850mg - per os - three times a day during 24 weeks
Intervention MeSH terms: Metformin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
A Study of MVA85A in Healthy Infants
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity
      and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without
      tuberculosis or HIV infection. This study planned to enroll 2784 infants (126 to 182 days of
      age) who received study vaccine or control and were followed for 15 - 36 months. The study
      was conducted at a single site in South Africa.
    

Detailed description: 
      This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity
      and efficacy of MVA85A/AERAS-485 in BCG vaccinated infants without tuberculosis or HIV
      infection. Infants (126 to 182 days) received intradermal (ID) study vaccine
      (MVA85A/AERAS-485 or Candida skin test antigen control). All infants were to be followed for
      at least 15 months after the last infant was enrolled into the study. Given completion of
      enrollment in 21 months, the total duration of follow-up for each infant was scheduled to be
      at least 15 months and up to 36 months. Infants were to be followed for the entire duration
      of the study both for the development of tuberculosis and serious adverse events.

      On enrollment to the study, eligible infants were assigned to a study group starting with
      Study Group 1 and were randomized in a 1:1 ratio within a study group to receive either
      MVA85A/AERAS-485 or Candida skin test antigen control. Infants were assigned to a safety
      cohort (Study Group 1), then into 1 of 3 immunological assay evaluation groups (Study Groups
      2-4), and finally the remainder of infants were assigned into the correlate of protection
      cohort (Study Group 5). At least 330 infants were to be randomized in Study Group 1, up to
      50-60 infants each in Study Groups 2-4, and the remaining infants were randomized in Study
      Group 5.
    

Intervention name(s): MVA85A/AERAS-485; Candida Skin Test Antigen
Intervention type(s): Biological; Biological
Intervention description(s): Attenuated virus MVA vector with insertion. Single dose vaccine, 1 x 10^8 pfu.; 1 test, administered once as a placebo control.
Other intervention name(s): Manufactured by IDT of Germany.; Candin(R); Manufactured by Allermed Laboratories of USA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Telerehabilitation in Patients With Chronic Neck Pain
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Telerehabilitation offers more efficient follow-up of patients during their home exercise
      period as a cost-effective and effective treatment model. This study was planned to examine
      the effectiveness of telerehabilitation in patients with chronic neck pain. The aim of the
      study is to compare the video-based and telerehabilitation based home-exercise program in
      patients with chronic neck pain. It is aimed to evaluate the patients in terms of pain,
      functionality, quality of life, and exercise adherence.
    

Detailed description: 
      With telerehabilitation, patients can easily adapt to home exercise programs and be monitored
      remotely. In this way, it will be ensured that individuals can apply their exercises at an
      optimum level in non-clinical settings and to prevent exercise application errors that occur
      due to the learning effect frequently observed in conventional methods. Exercise is
      considered a central element in physical therapy and rehabilitation management in patients
      with chronic neck pain. However, studies have found that improvements after physical therapy
      and rehabilitation are not preserved in the long term, and recurrence of chronic low back
      pain is common. With a more cost-effective treatment model, "telerehabilitation", it is aimed
      that patients can be followed more efficiently during their home exercise period. The aim of
      the study is to compare the video-based and telerehabilitation based home-exercise program in
      patients with chronic neck pain. It is aimed to evaluate the patients in terms of pain,
      functionality, quality of life, and exercise adherence.
    

Intervention name(s): Telerehabilitation (TR); Conventional Rehabilitation (CR)
Intervention type(s): Other; Other
Intervention description(s): The home exercise program will be educated to the patient on the first day. Exercises for isometric and isotonic strengthening, stretching, and stabilization of the neck muscles will be given. Exercises will be presented to the patients in audio-video format and detailed instructions with explanations. The exercise protocol will also be the same as in the conventional rehabilitation group. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.; The home exercise program will be educated to the patient on the first day. Isometric and isotonic strengthening, stretching and stabilization exercises for the neck muscles will be given. Exercise information form including explanation and picture of the exercises will be given to the patients. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telerehabilitation
Evaluation of the Anti-aging Efficacy of Four Skin Health Products
Condition: Anti-Aging; Skin Aging
Study type: Interventional

Summary: 
      The purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four
      different cosmetic products compared to an untreated control (split-face study design)
    


Intervention name(s): Day Cream cosmetic product compared to untreated side; Night cream cosmetic product compared to untreated side; Eye cream cosmetic product compared to untreated side; Serum cosmetic product compared to untreated side
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Applied once daily in the morning; Applied once daily in the evening; Applied twice daily in the morning and in the evening around the eye area; Applied twice daily in the morning and in the evening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Tolerability Comparison of Immediate and Controlled Release Formulations of Ecopipam
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible
      diseases. To date, all clinical studies have been done using the ecopipam immediate release
      (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been
      produced that may be able to improve its effectiveness and reduce its side effects. The main
      purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules when
      given as single oral dose in healthy volunteers.
    

Detailed description: 
      Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible
      diseases. To date, all clinical studies have been done using the ecopipam immediate release
      (IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been
      produced that may be able to improve its effectiveness and reduce its side effects. The main
      purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules when
      given as single oral dose in healthy volunteers. Another purpose of the study is to measure
      how much CR and IR ecopipam gets into the blood stream, and how long the body takes to get
      rid of them. Information about any side effects that may occur will be collected.
    

Intervention name(s): Ecopipam immediate release form; 90 mg controlled release form; 180 mg controlled release form
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet containing 100 mg of the immediate release form of ecopipam; This is the 90 mg controlled release form; This is the 180 mg controlled release capsule
Other intervention name(s): SCH 39166; PSYRX101; SCH 39166; PSYRX101; SCH 39166; PSYRX101
Intervention MeSH terms: Ecopipam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: safety; pharmacokinetics; controlled release; formulation
An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of ciprofloxacin on the pharmacokinetics (PK) of ivacaftor and on the
      pharmacokinetics of VX-661 when administered in combination with ivacaftor
    


Intervention name(s): ivacaftor; VX-661; ciprofloxacin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ciprofloxacin; Ivacaftor
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional

Summary: 
      Although some surgeons prefer one technique rather than the other, both endoscopic and open
      carpal tunnel release procedures are accepted as standard of care surgeries to relieve carpal
      tunnel syndrome. The investigator's research is designed to evaluate the significant
      difference in patient satisfaction between endoscopically-released wrists and open-released
      wrists. The goal of the study is to compare the two techniques using the following criteria:

        1. Primary outcome: patient satisfaction via surveys used in prior publications

        2. Secondary outcome: length of time to return to work

        3. Secondary outcome: clinical data for recovery from carpal tunnel syndrome including a
           thorough physical exam and EMG's

        4. Secondary outcome: complication rates
    


Intervention name(s): endoscopic carpal tunnel release; open carpal tunnel release
Intervention type(s): Procedure; Procedure
Intervention description(s): endoscopic surgery, which is standard of care for carpal tunnel release; open surgery, which is standard of care for carpal tunnel release
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Study type: Interventional
Phase: Phase 1

Summary: 
      Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using
      of the vaccine targeted the three components, it greatly reduced incidence of the three kinds
      of diseases. The Purpose of this study is to preliminary evaluate the safety of DTcP compared
      to adsorbed diphtheria and tetanus combined vaccine （DT），Diphtheria-tetanus-acellular
      pertussis vaccine（DTaP） or PENTAXIM（DTaP-IPV-Hib） in participants.
    

Detailed description: 
      Study participants will receive a single booster dose of DTcP or a single booster dose of
      local DT in 4 to 6 years old ,a singel booster dose of DTcP or a single booster dose of DTaP
      in 18 to 24 months, three basic doses of DTcP or three doses of DTaP/ DTaP-IPV-Hib in 2 to 6
      months.Safety profile will be assessed in all subjects up to Day 30 post vaccination.
    

Intervention name(s): Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed; Diphtheria and Tetanus Combined Vaccine, Adsorbed; Diphtheria-tetanus-acellular pertussis vaccine; Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular Other Name: DTcP; 2mL, Intramuscular Other Name: DT; 0.5 mL, Intramuscular Other Name: DTaP; 0.5 mL, Intramuscular Other Name: PENTAXIM
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Infection; DTcP; Whooping Cough; Vaccine; Diphtheria; Tetanus; Pertussis
Safety and Effectiveness Study of a Fiber Supplement for Weight Loss
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      Overweight and obesity are serious and growing problems within the United States. The usual
      approaches to weight loss-dieting, exercise, and behavioral interventions-rarely result in
      long-term weight loss. Therefore, we will evaluate the safety and efficacy of glucomannan, a
      fiber supplement that has promising weight loss effects.
    

Detailed description: 
      The primary objective of this exploratory project is to evaluate the safety and efficacy of a
      highly viscous, water-soluble fiber supplement, glucomannan, for achieving weight loss in
      overweight and moderately obese individuals. Overweight and obesity are major public health
      problems in the U.S. that account for substantial morbidity, mortality, and healthcare costs.
      Conventional approaches to weight loss are largely ineffective, particularly for long-term
      weight loss and maintenance. Thus, there is a critical need for safe and effective adjunctive
      treatments. A few, limited studies suggest that glucomannan supplementation is associated
      with weight loss, is well-tolerated, and has a favorable safety profile.

      In this preliminary study, the target population will be overweight and moderately obese
      individuals, a population that accounts for nearly 50% of all U.S. adults. The specific aims
      of the project are to: 1) describe the safety of glucomannan for achieving weight loss in
      overweight and moderately obese individuals, and 2) describe the efficacy of glucomannan for
      achieving weight loss in overweight and moderately obese individuals. Participants will take
      glucomannan supplements daily for eight weeks in a double-blind, placebo-controlled,
      randomized clinical trial. Safety and efficacy outcome measures include: gastrointestinal
      symptoms/tolerance, hepatic panel, serum creatinine, weight, body composition, diet intake,
      hunger/fullness, lipid profile, blood glucose, and C-reactive protein. Examination of the
      safety and efficacy of glucomannan for achieving weight loss will extend our understanding of
      additional treatments that may be effective in combating a significant public health problem.
    

Intervention name(s): Glucomannan; Inert microcrystalline cellulose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two 665 mg capsules of glucomannan three times a day for 8 weeks; Two capsules of inert microcrystalline cellulose three times a day for eight weeks
Intervention MeSH terms: (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety; Efficacy; Glucomannan; Dietary fiber; Weight loss
Function of Regulatory T Cells Improved by Dexamethasone in Graves' Patients
Condition: Graves' Disease
MeSH terms: Graves Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Antithyroid drugs is the first choice treatment of Graves' disease in China and Europe.
      However,the relapse rate is very high (40-60%) after therapy withdrawal, and many patients
      need further treatment. In our previous study, a new treatment strategy for GD has been
      introduced. After methimazole (18 months) combined with intrathyroid injection of
      dexamethasone (DEX) (3 months) treatment, the relapse rate of hyperthyroidism was markedly
      reduced compared with methimazole treatment alone (7.4% versus 51%) during the 2-year
      follow-up period. The results have been published in the 'J Clin Endocrinol Metab,
      2009,94:4984-4991'. However, the mechanism by which the DEX reduces the relapse rate of GD is
      not fully understood. In vitro study, we have proven that DEX could effectively improve the
      function of regulatory T (Treg) cells and set up a new balance of T helper 1(Th1)/Th2 in GD
      patients(this results have been in press in the Eur J Endocrinol). In order to elucidate
      mechanism of this treatment strategy in vivo, we plan to recruit 20-30 patients with GD and
      treat those patients by intrathyroid injection of DEX combined with methimazole, and the
      function of Treg cells and balance of Th1/Th2 will be evaluated.
    


Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): The course of treatment will be last for 3 months. The intrathyroid injection of dexamethasone will be performed using a 25-gauge (0.25-mm) needle under ultrasound guidance. The injection will be performed in both lobes of the thyroid. The dosage of dexamethasone is 5mg (1.0 ml) in each lobe, twice a week during the first month of the treatment. The treatment strategy will be changed to once a week in the second month and twice a month in the third month; the dosage of dexamethasone is the same as in the first month.
Other intervention name(s): Hexadecadrol
Intervention MeSH terms: Dexamethasone
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Graves' disease; Dexamethasone; Function of regulatory T cells; The proportion of Th1 and Th2 cells