bioihbjkbjnl/mcl2 huggingface dataset:
the Effect of Universal Salt Iodization on Thyroid Diseases
Condition: Thyroid Nodule
MeSH terms: Thyroid Nodule; Thyroid Diseases
Study type: Observational [Patient Registry]

Summary: 
      1. acquire the environmental iodine status of Hangzhou

        2. acquire the iodine status of population in Hangzhou

        3. acquire the prevalence of thyroid diseases in Hangzhou

        4. explore the association between iodized salt and thyroid disease
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This study was conducted in Hangzhou, Zhejiang Province, China, which locates at east of
        China. This city covers eight districts and five counties. There are 8.7 millions residents
        in Hangzhou city; 73.25% of them living in urban areas, 26.75% in rural areas. This study
        was designed to be representative of the civilian from Hangzhou and collected information
        on demographic characteristics, health status, iodine intake and thyroid disease.
      
Biospecimen description: 
      The participants were invited to local community health center before 8:00 am after 8-hour
      fasting overnight. Firstly, each participant provided 10 ml spot urine samples. Then, 5 ml
      venous blood was collected using vacuum blood collection tube.
Neurotransmitter Measurements Using (WINCS) During Deep Brain Stimulation Neurosurgery
Condition: Essential Tremor; Parkinson's Disease; Dystonia
MeSH terms: Parkinson Disease; Dystonia; Essential Tremor
Study type: Observational

Summary: 
      In this study, the investigators will monitor extracellular neurotransmitter levels using a
      probe that is able to perform real time electrochemical detection during deep brain
      stimulation surgery. The overall question this study is designed to answer is: Are there
      neurotransmitters released during deep brain stimulation?
    

Detailed description: 
      In this study, the investigators will monitor extracellular neurotransmitter levels using a
      probe that is able to perform realtime electrochemical detection during DBS neurosurgery. The
      overall question this study is designed to answer is: Are there neurotransmitters released
      during deep brain stimulation? We propose to enroll 45 patients (15 patients each at the
      three targets for DBS) with Essential Tremor, Parkinson's Disease, and Dystonia who are
      undergoing DBS neurosurgery. This will be an acute study. Patients with medically
      identifiable symptoms of the above diseases who have been approved by Mayo DBS committee for
      implantation of DBS will be selected for this study. These patients will then be consented
      preoperatively to undergo extracellular electrophysiology which is typical in these cases to
      determine the target site for implantation of the DBS electrodes. Following this
      electrophysiologic procedure, the patient will have electrochemical electrode implanted to
      (1) determine whether there is adenosine release at the site of stimulation during ventral
      intermediate nucleus (VIM) thalamic DBS, (2) determine whether there is dopamine and
      adenosine release within the caudate nucleus or putamen during subthalamic nucleus DBS, and
      (3) determine whether there is dopamine and adenosine release at the site of stimulation
      during Globus Pallidus DBS.
    

Intervention name(s): WINCS
Intervention type(s): Device
Intervention description(s): The experimental protocol will involve, after implantation of the DBS electrodes, the patient will have a single electrochemical recording electrode will be implanted along the same trajectory path as the electrophysiology and the DBS electrode
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult Patients with medically intractable Essential Tremor, Parkinson's Disease, and
        Dystonia who have been approved for DBS surgery by the interdisciplinary Mayo DBS
        committee.
Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      The purpose of this study is to determine whether genetic markers unique to liver cancer are
      present and to assess usefulness as a diagnostic tool.
    

Detailed description: 
      Hepatocellular carcinoma (HCC) is the most common form of liver cancer and a growing trend
      worldwide. Decision-making regarding treatment for patients is limited by the lack of
      clinically actionable biomarkers. This is pronounced in the case for determining and
      monitoring liver transplant recipients. In an effort to improve diagnosis, the use of
      circulating serum-based microRNA isoforms (isomiRs) can serve as non-invasive, screening
      biomarkers in HCC patients pre- and post-transplantation of the liver.
    

Intervention name(s): None - Standard of Care
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hepatocellular Carcinoma Clinic Pre-Liver Transplant Clinic
      
Biospecimen description: 
      Hepatocellular carcinoma tumor tissue Background liver tissue
    
Keywords: HCC; Liver Cancer
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Condition: Active Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment
      regimen of anifrolumab versus placebo in adult participants with moderately to severely
      active, autoantibody-positive systemic lupus erythematosus (SLE).
    

Detailed description: 
      This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled
      study to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab
      versus placebo in participants with moderately to severely active, autoantibody-positive
      systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment.
      Participants must be taking either 1 or any combination of the following: oral
      corticosteroids (OCS), antimalarial, and/or immunosuppressants. The study will be performed
      in adult participants aged 18 to 70 years of age.

      Approximately 360 participants receiving SOC treatment will be randomised in a 1:1 ratio to
      receive a fixed intravenous dose of anifrolumab 300 mg or placebo every 4 weeks for a total
      of 13 doses (Week 0 to Week 48), with the primary endpoint evaluated at the Week 52 visit.
      Investigational product will be administered as an intravenous infusion (IV) via an infusion
      pump over a minimum of 30 minutes, every 4 weeks.
    

Intervention name(s): Anifrolumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Intravenous infusion (IV); Intravenous infusion (IV)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Active Systemic Lupus Erythematosus
Efficacy and Safety of MEDITOXIN® in Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the hypothesis that the efficacy and safety of
      Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.
    

Detailed description: 
      The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 200~300U in
      cervical muscles. The efficacy and safety are evaluated for 12weeks through 4 follow up
      visits.
    

Intervention name(s): Medytoxin; Botox
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection up to 300U.; Intramuscular injection up to 300U.
Other intervention name(s): botulinum type A toxin; botulinum type A toxin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CD phase III
Repeat Dose Food Effect Study of GSK256073F in Healthy Adult Subjects
Condition: Dyslipidaemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the effects of fasting and fed conditions with repeat
      doses of GSK256073F in HVT subjects.
    


Intervention name(s): GSK256073
Intervention type(s): Drug
Intervention description(s): GSK256073 100 mg study drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Food Effect; GSK256073F; TRIS Salt
Effect of Exercise on Cardiometabolic Profile in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Polycystic Ovary Syndrome (PCOS) is a complex hormonal and metabolic disorder that has been
      shown to affect women's fertility. It can also share many symptoms with pre-diabetes, and
      women with PCOS often have an increased risk for type 2 diabetes, heart attack and stroke.

      This study aims to assess the feasibility and acceptability of exercise intervention and
      increased lifestyle physical activity to improve cardiovascular disease risk factors in women
      with PCOS.
    

Detailed description: 
      This is a three arm feasibility study in which participants will be allocated to an exercise
      group, an increased lifestyle physical activity group, or a control group. We will determine
      the appropriateness of procedures for recruitment, allocation, measurement and retention for
      the intervention procedures in women with polycystic ovary syndrome.

      The investigators will also determine if we are able to detect changes in blood lipid
      profile, inflammation, and hormonal and metabolic profile as a result of the intervention(s)
      using blood biomarkers.
    

Intervention name(s): Exercise Intervention; Lifestyle Physical Activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 2 sessions of supervised exercise training each week for 8 consecutive weeks and 3 sessions of supervised exercise training each week for the final 4 consecutive weeks, at 57-74% heart-rate max. Each session will last approximately 60 minutes.; Advice and information on how to increase physical activity will be provided. Participants will be asked to monitor and track their daily physical activity using a smart-phone fitness application. The research team will gain permission to access their recorded activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised into either an exercise group, a lifestyle physical activity group, or a control group, for a duration of 12 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: polycystic ovary syndrome; exercise; physical activity; cardiovascular disease; low-density lipoprotein; metabolism
Comparison of Conventional Triple Therapy Versus Sequential Therapy for H. Pylori in Peptic Ulcer Disease: Prospective Randomized Trial
Condition: Helicobacter Infected Patients
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to improve first line Helicobacter pylori eradication rate and
      to compare the sequential versus conventional triple therapy.
    


Intervention name(s): sequential versus triple
Intervention type(s): Drug
Intervention description(s): sequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe lansoprazole 30mg bid+clarithromycin 500mg bid+amoxicillin 1000mg bid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Abdominal Hypopressive Technique on Postpartum Low Back Pain
Condition: Postpartum
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Postpartum Low back pain (PP-LBP) is more common and can lead to limitations to women's daily
      activity. Pregnancy related low back pain has been reported to occur in 55% to 78% women
      worldwide.This study is planned to determine the effects of abdominal hypopressive technique
      on postpartum low back pain, mobility and disability.
    

Detailed description: 
      literature suggests the use of hypopressive abdominal techniques to be effective in
      increasing the thickness of the abdominal muscles and hence add to the stability of the spine
      and alleviation of low back pain in the postpartum period. This will be a randomized
      controlled trial, with two groups.

      Participants in the experimental group will learn how to perform the "hypopressive maneuver",
      which consisted of exhaling to their expiratory reserve volume, then holding their breath
      (apnea), and expanding their rib cage, to draw their abdominal wall inward and cranially
      without inhalation. control group will perform general exercises. Both groups will be
      assessed at pre and post test (after 6weeks)
    

Intervention name(s): Abdominal hypopressive Exercises (AHE); General exercises
Intervention type(s): Other; Other
Intervention description(s): Active and specific Therapeutic exercises will be used to treat postpartum low back pain in this study. AHE consisted of exhaling to their expiratory reserve volume, then holding their breath (apnea), and expanding their rib cage, to draw their abdominal wall inward and cranially without inhalation. Each exercise will have a specific frequency, intensity, and duration.; General exercises are therapeutic exercises for core muscles for the treatment of postpartum low back pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a Pretest-Postest Control group Design with parallel assignment of patients into two groups.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Aprepitant on Cyclophosphamide Pharmacokinetics in Patients With Breast Cancer
Condition: Breast Cancer; Nausea and Vomiting
MeSH terms: Breast Neoplasms; Nausea; Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Antiemetic drugs, such as aprepitant, may help lessen or prevent nausea and
      vomiting in patients undergoing chemotherapy.

      PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works
      compared to placebo in preventing nausea and vomiting in patients undergoing chemotherapy for
      breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate the effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide
           pharmacokinetics as measured by plasma AUC in patients with breast cancer.

      Secondary

        -  To evaluate total control of nausea and vomiting, as defined by no vomiting episodes and
           no use of rescue medication, 72 hours after courses 1 and 2 of chemotherapy.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive aprepitant 125 mg orally once daily on day 1 and 80 mg orally
           once daily on days 2 and 3. Beginning 1 hour after receiving aprepitant, patients
           receive an infusion of cyclophosphamide on day 1. During course 2, patients crossover
           and receive treatment (placebo) as in arm II.

        -  Arm II: Patients receive a placebo 125 mg orally once daily on day 1 and 80 mg orally
           once daily on days 2 and 3. Beginning 1 hour after receiving the placebo, patients will
           receive an infusion of cyclophosphamide infusion on day 1. During course 2, patients
           crossover and receive treatment (aprepitant) as in arm I.

      Patients complete a diary documenting nausea and vomiting on days 1, 2, and 3 of both
      courses. Patients also complete The Functional Living Index-Emesis (FLIE) questionnaire
      documenting compliance, rescue antiemetic therapy, and any adverse effects and record them in
      the diary for each course. Information in the patient's diary is obtained by the coordinator
      via telephone on day 4 of each course.

      Patients undergo blood sample collection periodically for pharmacokinetic studies via high
      performance liquid chromatography.
    

Intervention name(s): aprepitant; cyclophosphamide; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Given orally; Given IV; Given orally
Intervention MeSH terms: Cyclophosphamide; Aprepitant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nausea and vomiting; breast cancer
A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to determine the side effects related to LY3437943 given as a
      single injection under the skin to healthy participants. Blood tests will be performed to
      check how much LY3437943 gets into the bloodstream and how long the body takes to get rid of
      it. Each enrolled participant will receive a single dose of LY3437943 or placebo. The study
      will last up to approximately 71 days for each participant, including screening.
    


Intervention name(s): LY3437943; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (SC); Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols
Condition: Mildly Hypercholesterolemic Subjects
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at
      different moments of the day in lowering blood cholesterol of hypercholesterolemic.
    


Intervention name(s): 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit; 2- Low fat drinkable fermented dairy product without plant sterols (control)
Intervention type(s): Other; Other
Intervention description(s): 1-Intervention with test product (morning, evening or snack); 2 - Intervention with control product (morning and/or evening)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Plant sterol - hypercholesterolemia - dairy - meal
Poor Quality of Life Associated With Traditional Chinese Medicine Constitution in HIV-infected Men Who Have Sex With Men
Condition: HIV Infections; Quality of Life
Study type: Observational

Summary: 
      This study explores the pathological constitution as it relates to low quality of life with
      HIV- infected MSM patients, as a reference for clinical treatment.
    

Detailed description: 
      Introduction :This study explores the pathological constitution as it relates to low quality
      of life with HIV- infected MSM patients, as a reference for clinical treatment.

      Methods :It has a cross-sectional research design using structured questionnaires to collect
      data,including patient's basic case data, CD4+, CD4+/CD8+ ratio, Wang Qi constitution and
      WHOQOL-BREF -Taiwan version questionnaires. We consider the association between the
      constitutions and quality of life for HIV-infected MSM patients.
    

Intervention name(s): World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version)
Intervention type(s): Diagnostic Test
Intervention description(s): WHOQOL-BREF-Taiwan version is used to measure the quality of life in HIV infected.
Wang Qi nine kinds of TCM constitution Questionnaire is used to measure the constitution of HIV infected.
Other intervention name(s): Wang Qi nine kinds of TCM constitution Questionnaire
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We invited all people diagnosed with HIV infected through MSM in the outpatient Department
        of Infection, Taipei City United Hospital, Linsen Chinese Medicine and Kunming Branch, to
        participate in this study.
Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection
Condition: Hiv
MeSH terms: Coinfection
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4 single-arm, post-marketing clinical trial evaluating the efficacy and
      safety of tenofovir disoproxil fumarate, lamivudine and efavirenz in adults with human
      immunodeficiency virus-1 and hepatitis B virus coinfection.
    

Detailed description: 
      HIV/HBV co-infections are frequently observed due to shared routes of transmission. TDF and
      3TC are nucleotide analogues that can inhibit both HIV and HBV DNA polymerases. There is
      higher risk to cause drug resistance in treating HBV or HIV infection with 3TC or TDF
      monotherapy than combination trerapy. Combination tharapy could decreases drug resistance.
      China's HIV epidemic remains one of low prevalence overall, but with pockets of high
      infection among specific sub-populations and in some localities. China has a very high
      endemicity for hepatitis B too. A substantial proportion of HIV-infected individuals are
      co-infected with HBV. TDF + 3TC + EFV will be a common regimen for HIV/HBV co-infected
      Chinese individuals.

      The purpose of this study of this study is to determine whether TDF will be safe for patients
      with HIV and HBV co-infection and the combination of TDF+3TC+EFV will suppress HIV and HBV
      viral load below LDL at week 48 of treatment in patients with HIV and HBV co-infeciton.This
      study will enroll 100 adult subjects and follow these patients for 48 weekes.There will be
      one enrollment visit(baseline) and visits at 2,4,8,12,24,36,48 weeks after initiation of the
      study regimen.
    

Intervention name(s): Regimen:TDF+3TC+EFV
Intervention type(s): Drug
Intervention description(s): TDF+3TC+EFV for HIV/HBV co-infection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HBV co-infection ART TDF