bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
Condition: Human Immunodeficiency Virus (HIV); Cardiovascular Disease (CVD)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Cardiovascular Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the use of rosuvastatin in Human
      Immunodeficiency Virus (HIV) infected individuals lowers inflammation in blood vessels,
      improves blood circulation in the small arteries that provide nutrients to the heart muscle
      and improves neurocognitive function.
    

Detailed description: 
      HIV is a chronic inflammatory disease. Patients with HIV are at a high risk of cardiovascular
      disease (CVD) which may be related to this state of chronic inflammation. HIV infected
      individuals are at up to four times higher risk of suffering a heart attack (also know as
      acute coronary syndrome).

      The medicine rosuvastatin, commonly used to treat high cholesterol, has been shown to reduce
      inflammation in arteries in the general population and also in patients with high risk for
      heart problems.

      72 subjects with HIV infection will be enrolled and divided into 2 groups of 36.

      Group 1: Treatment Group: Participants will receive a low dose of rosuvastatin, 10mg, for 6
      months in addition to their current medical therapy.

      Group 2: Control Group: Participants will not receive rosuvastatin for 6 months and will
      continue with their current medical therapy.

      Participants in both groups will undergo blood tests, Myocardial Contrast Echocardiography
      (MCE) scan and a Positron Emission Tomography/Computed Tomography PET/CT scan using a
      radioactive tracer called fluorodeoxyglucose (FDG-PET), monocyte and serum cytokine studies
      at baseline and 6 months.

      10 subjects without HIV will also be enrolled to undergo monocyte and serum cytokine blood
      tests only, for comparison.
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): Comparison of rosuvastatin to no rosuvastatin
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Human immunodeficiency virus (HIV); Statin therapy; Cardiovascular disease (CVD); Coronary Flow Reserve (CFR); Positron Emission Tomography (PET); Myocardial contrast echocardiography (MCE)
Xinju Xiaogao Prescription Study on Overweight
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Xinju Xiaogao prescription and 10% of it in the treatment of adiposity (stagnation of QI
      causing phlegm retention)clinical study
    

Detailed description: 
      Charged by the three research centers in line with traditional Chinese medicine stagnation of
      QI causing phlegm retention 120 cases have diabetes were randomly divided into Chinese herbal
      compound Xinju Xiaogao prescription group and 10% of the prescription group.The treatment
      groups were compared 24-week step-down and regulation of body weight,waistline, blood lipids,
      blood sugar effect.
    

Intervention name(s): Xinju Xiaogao Prescription; placebo
Intervention type(s): Drug; Drug
Intervention description(s): treatment group; Therapeutic dose of 10%
Other intervention name(s): Xinju Xiaogao decoction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adiposity
The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Condition: Cytomegalovirus Retinitis; HIV Infections
MeSH terms: Cytomegalovirus Retinitis; Retinitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can
      extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS
      patients. To evaluate the safety and tolerance of HPMPC therapy when administered by
      intravenous infusion in AIDS patients with CMV retinitis that is not immediately
      sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV
      shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual
      acuity.
    

Detailed description: 
      Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion
      weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral
      probenecid and IV hydration. Group B receives no treatment until the time of retinitis
      progression (deferred treatment), at which time they receive the same regimen as Group A,
      provided retinitis progression is not immediately sight-threatening.
    

Intervention name(s): Cidofovir; Probenecid
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cidofovir; Probenecid
Primary purpose: Treatment
Keywords: Retinitis; Probenecid; Drug Therapy, Combination; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Antiviral Agents; cidofovir
DDI Study of Etravirine and GSK1265744
Condition: Healthy Subjects; Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare steady-state plasma PK, safety and
      tolerability of GSK1265744 with and without etravirine
    


Intervention name(s): GSK1265744
Intervention type(s): Drug
Intervention description(s): GSK drug
Other intervention name(s): etravirine
Intervention MeSH terms: Cabotegravir; Etravirine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug interaction; integrase inhibitor
COPD and Cardiovascular Risk in the Population
Condition: Chronic Obstructive Pulmonary Disease; Cardiovascular Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases
Study type: Observational

Summary: 
      The prevalence of chronic obstructive pulmonary disease (COPD) in patients with
      cardiovascular disease (CVD) is unknown, and whether or not COPD is adequately diagnosed and
      treated in these patients has not been investigated before.

      We hypothesized that the prevalence of COPD would be significantly higher (30%) in patients
      with CVD than in the general population. Besides, we anticipated that COPD, a potentially
      treatable CV risk factor, would be undiagnosed in more than 80% of CVD patients.
    

Detailed description: 
      We aim to compare clinical and spirometric data in three groups of individuals. Two of them
      are participants in an ongoing population-based study (CORSAIB) aimed at investigating the
      distribution of CVD risk factors in the general population of the Balearic Islands, Spain.
      The design and full methodological details of the CORSAIB study have been published elsewhere
      (Rigo F, et al. Rev Clin Espa 2005). A third group will include patients with stable CVD
      regularly visited at the referral hospital of our community.

      Inclusion criteria for the study are male and female individuals, aged 40 to 81 years,
      residents of the Balearic Islands, and who are willing to participate in this research.
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Random population sample, and a sample of hospital cardiovascular patients
      
Biospecimen description: 
      Samples of serum were frozen at -80 ºC
    
Keywords: Cardiovascular; COPD; Population; Prevalence; Underdiagnosis
Phase 1 Study of MGD010 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary goal of this Phase 1 study is to assess the safety and tolerability of one MGD010
      intravenous (IV) infusion in healthy adult volunteers.
    

Detailed description: 
      This is a Phase 1 study to evaluate the safety, tolerability and PK of MGD010, a CD32B x
      CD79B DART bi-specific antibody-based molecule. This study will be conducted as a
      double-blind, randomized, placebo controlled, single ascending dose study among healthy
      subjects.
    

Intervention name(s): MGD010; Placebo; Hepatitis A vaccine
Intervention type(s): Drug; Drug; Biological
Intervention description(s): MGD010 is a CD32B x CD79B bi-specific antibody-based molecular construct referred to as a Dual Affinity Re-Targeting (DART) molecule. MGD010 will be administered as a single agent.; Placebo comparator.; Hepatitis A vaccine, inactivated
Other intervention name(s): Vaqta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Normal healthy volunteer
High Frequency Oscillations in Neurologic Disease
Condition: Parkinson; Epilepsy
MeSH terms: Nervous System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as
      pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson
      disease. Newly developed technology allows for the chronic recording of these brain signals
      at the same time as clinical stimulation is occuring. We will learn both whether these HFO
      correlate with disease activity and whether the HFO change in response to ongoing stimulation
      (potentially giving insight into the underlying mechanism of action of DBS).
    

Detailed description: 
      This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as
      pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson
      disease. Newly developed technology allows for the chronic recording of these brain signals
      at the same time as clinical stimulation is occuring. We will learn both whether these HFO
      correlate with disease activity and whether the HFO change in response to ongoing stimulation
      (potentially giving insight into the underlying mechanism of action of DBS). Study
      participants will undergo DBS in the same way as is usually done but will receive this newer
      battery with ability to record brain signals.
    

Intervention name(s): Activa PC+S
Intervention type(s): Device
Intervention description(s): The model 37604 Activa PC+S system is a multiprogrammable device that both delivers electrical stimulation and records bioelectric data through one or two leads implanted in the brain.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Using Vegetable and Berry Products Can Improve Skin Conditions
Condition: Skin Condition
MeSH terms: Skin Diseases; Disease
Study type: Interventional

Summary: 
      Hypothesis: vegetable and berry products for 8 weeks can improve skin condition
    

Detailed description: 
      Hypothesis: Using vegetable and berry products for 8 weeks can improve skin condition
    

Intervention name(s): placebo; Vegetable and Berry Drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): subjects drank 50 ml , 1 bottle a day for 8 week; subjects drank 50 ml , 1 bottle a day for 8 week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intensive Drug Therapy for Ischemic Stroke Caused by Severe Intracranial Arterial Stenosis
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Observational

Summary: 
      To observe the safety and efficacy of intensive drug therapy for ischemic stroke caused by
      severe intracranial arterial stenosis.Patients with acute stroke caused by intracranial
      arterial stenosis (stenosis rate ≥70%) were enrolled and accept dual antiplatelet therapy
      (DAPT) (aspirin 100 mg/d and clopidogrel 75 mg/d for 90 days, followed by aspirin 100 mg/d
      for long term) under the guidance of platelet function analysis (Verifynow) combined with the
      intensive statin therapy (40 mg/d for 14 days, followed by 20 mg/d for long term).
    

Detailed description: 
      Patients (35 to 80 years ) with acute ischemic stroke, who can be treated within 72 hours of
      symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of
      the exclusion criteria will be randomly selected.Patients were treated with dual antiplatelet
      therapy (DAPT) (aspirin 100 mg per day and clopidogrel 75 mg per day were administered for 90
      days, followed by aspirin 100 mg per day for long term) and atorvastatin (40 mg per day for
      14 days, followed by 20 mg per day long term) after enrollment. Patients with aspirin
      resistance (aspirin reaction units [ARU] ≥550) or clopidogrel resistance (P2Y12 reaction
      units [PRU] ≥208) were excluded on the 7th day of therapy.The primary objective is to observe
      the safety and efficacy of intensive drug therapy for ischemic stroke patients. A Data and
      Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has
      been approved by Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and
      Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine.
    

Intervention name(s): Intensive Drug Therapy
Intervention type(s): Other
Intervention description(s): Observational only and no predesigned interventions in this study
Other intervention name(s): observational only ,no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with acute stroke caused by intracranial arterial stenosis (stenosis rate ≥70%)
A Single Dose Study of SHR0410 in Healthy Male Participants
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single ascending-dose study to
      investigate the effect of a single intravenous (IV) dose of SHR0410 at 6 dose levels (0.5
      μg/kg, 1 μg/kg, 2 μg/kg, 5 μg/kg, 10 μg/kg and 20 μg/kg) in healthy participants.
    

Detailed description: 
      Forty eight eligible participants will be enrolled into the 6 dose cohorts. For each cohort,
      a sentinel group of 2 subjects (1 receiving SHR0410 and 1 receiving placebo) will be dosed
      first (1:1 ratio). If no drug related adverse events occur in the sentinel participants, the
      remaining 6 subjects in a cohort will be dosed on the next day or later in a 5:1 ratio (5
      subjects receiving SHR0410 and 1 subject receiving placebo). SHR0410 will be diluted in
      saline and administered as a 15 min constant dose IV infusion at a rate of 20 ml/hr on Day 1.
    

Intervention name(s): 0.5μg/kg SHR0410; 1μg/kg SHR0410; 2μg/kg SHR0410; 5μg/kg SHR0410; 10μg/kg SHR0410; 20μg/kg SHR0410
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): a single dose of 0.5μg/kg SHR0410; a single dose of 2μg/kg SHR0410; a single dose of 2μg/kg SHR0410; a single dose of 5μg/kg SHR0410; a single dose of 10μg/kg SHR0410; a single dose of 20μg/kg SHR0410
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Production of iPSC Derived RPE Cells for Transplantation in AMD
Condition: Age Related Macular Degeneration (AMD)
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      No treatments exist for Age-related Macular Degeneration (AMD) when there is cell loss such
      as in late wet AMD or dry AMD. The differentiation of RPE cells from patient derived iPSC
      will offer valuable source of tissue for transplantation in these forms of AMD and may form
      basis for a future treatment option in terms of cell transplantation.
    

Detailed description: 
      It has been shown that adult human skin cells or human blood cells can be reprogrammed to
      become stem cells. This type of stem cell is called an induced Pluripotent Stem Cell
      (iPSC).It has been shown specifically that this type of stem cell can be produced from adult
      human skin cells or blood cells can in turn be converted into Retinal Pigment Epithelial
      (RPE) cells. These RPE cells are a very important cell type in the human retina that are
      abnormal and ultimately lost in Age-related Macular Degeneration (AMD). Although it has been
      shown to be possible to make RPE cells from adult human skin, it has not been done to a level
      to fulfil regulatory requirements for human transplantation in AMD.

      This is a feasibility study involving 10 patients. The efficiency of creating an iPSC-Derived
      RPE cells from a patient's own skin or blood will be examined. A sample size of 10 patients
      will allow us to potentially consolidate the safety and efficacy of this method in order to
      create these cells within the context of a future transplantation trial.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients affected by Age Related Macular Degeneration (AMD)
      
Biospecimen description: 
      Peripheral blood sample and a skin sample will be collected from the study participants
Defining the Optimal Hormonal Replacement Therapy in Turner Syndrome
Condition: Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine whether a larger dosage of estrogen than the one used
      today will secure the development of a normal sized uterus and increase the strength of the
      bones in girls and young women with Turner syndrome.

      The purpose is also to evaluate whether aortic dilatation is present in this group of
      patients, and if the estrogen dosage will influence the emotional well-being and self-esteem
      of the patients.
    

Detailed description: 
      Turner syndrome is a common chromosomal disorder with only one X-chromosome or partial
      deletions in one X-chromosome in all or some of the cell-lines in the body. Appr. 18
      girls/year are being born with the syndrome in Denmark. The syndrome is mostly known for
      reduced final height and the lack of pubertal development with infertility, but it is also
      known for diseases influencing other parts of the body like the heart with the risk of
      development of aortic dilatation and subsequently dissection with the risk of rupture,
      profuse bleeding and sudden death. Reduced bone strength and increased risk of bone fracture
      are also features of the syndrome. Treatment with growth hormone and female sex-hormones are
      well-established treatments.

      Girls and young women with Turner syndrome ages 10 to 21 years will participate. The girls
      ages 15 to 21 years will randomly and double blindly receive treatment with either 2 mg or 4
      mg estrogen for 5 years. Yearly examinations with blood tests, physical examinations,
      questionnaires, ultrasound and MR-scan of the internal female genitalia, DEXA-scan of the
      bones and MR-scan of the heart will be performed.
    

Intervention name(s): estradiol
Intervention type(s): Drug
Intervention description(s): tablets, 2 mg day 1 through day 22 of the menstrual cycle for 5 years
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Turner Syndrome; Hormonal replacement therapy; Bone mineralization; Uterine size; aortic root dilatation
Analysis Of Equilibrium And Motor Coordination Of Deaf Children's Pre And Post Intervention Physiotherapeutic
Condition: Motor Skills in Deaf Children; Deafness
MeSH terms: Deafness; Hearing Loss
Study type: Interventional

Summary: 
      This study aimed to assess and reassess the balance and motor skills of deaf children, passed
      six weeks of intervention and to verify whether a program of physical therapy intervention
      can match or improve motor skills. This study was quasi-experimental before and after, with
      10 children from a school in Caxias do Sul / RS. Motor skills were evaluated using pre and
      post test KTK Coordination Body, and the activities were held once a week for six weeks in
      sessions of forty minutes. It was used for statistical analysis the Student t test dependent
      and independent (p ≤ 0.05).
    


Intervention name(s): physiotherapy intervention
Intervention type(s): Other
Intervention description(s): a program of physical therapy intervention can match or improve motor skills in the deaf children
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physiotherapy.; Deafness.; Postural balance.; Motor skills.
Effect of Single Doses of YF476 on Stomach Acidity
Condition: Hypergastrinaemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to assess the effect of a range of single oral doses of YF476
      on pentagastrin-induced gastric acid output in healthy volunteers
    

Detailed description: 
      The rationale for the study was as follows.

      On the basis of the pre-clinical studies, the original target disease for YF476 was
      gastro-oesophageal reflux disease (GORD), not only because of the excellent anti-secretory
      activity of YF476 but also because of its potential for increasing gastric emptying. But loss
      of the anti-secretory effect of YF476 in healthy subjects after repeated dosing excludes its
      use as an anti-secretory agent in patients with GORD. However, there is some evidence from
      within our repeated-dose studies in healthy subjects that gastrin receptors are blocked
      despite loss of the anti-secretory activity of YF476. Further evidence that repeated doses of
      YF476 cause sustained blockade of gastrin receptors comes from several types of study in
      animals. First, in the 13-week toxicology studies, all dose levels of YF476 reduced the ECL
      population, unlike other anti-secretory agents, histamine H2-antagonists and proton-pump
      inhibitors, which increase the ECL population. Second, YF476 at doses of 0.1 and 1.0 mg/kg
      subcutaneously twice daily for 14 days in rats abolished the increase in gastric output
      induced by pentagastrin on Days 1, 7 and 14.

      This protocol describes a study in healthy subjects using inhibition of pentagastrin-induced
      gastric acid output as a surrogate marker of efficacy of YF476. Pentagastrin has been used
      for many years to test gastric function in healthy subjects and patients. Intravenous
      infusion of 0.6 micrograms/kg/hour is a submaximal and well-tolerated dose.
    

Intervention name(s): YF476; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each subject took one capsule of YF476 (1, 5, 25 or 100 mg) or placebo on five separate occasions. Each capsule was taken with water 150 mL.; Each subject took one capsule of YF476 (1, 5, 25 or 100 mg) or placebo on five separate occasions. Each capsule was taken with water 150 mL.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: YF476; gastrin receptor antagonist; pentagastrin; gastric acid; healthy subjects