bioihbjkbjnl/mcl2 huggingface dataset:
Application of Magnetic Fields as Adjunctive Treatment for Type II Diabetes
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if using a device called the Resonator, that puts out a
      very low electromagnetic field, effects blood glucose and A1c levels in people with Type 2
      Diabetes.
    

Detailed description: 
      The purpose of this pilot study is to determine whether application of magnetic fields
      generated by the Resonator result in statistically significant reductions in finger stick
      blood glucose levels, serum glucose and hemoglobin A1c levels. The study will also
      investigate any induced changes in serum lipids and liver function tests as indirect markers
      of insulin resistance.
    

Intervention name(s): Resonator Device
Intervention type(s): Device
Intervention description(s): comparison of different parameter settings of electromagnetic fields using the Resonator Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome
Condition: Turner Syndrome; Turner Syndrome Mosaicism, 45, X/46, XX or XY; Turner Syndrome Mosaicism 46,X,I(X)(Q10)/45,X; Turner Syndrome Karyotype 46,X With Abnormal Sex Chromosome , Except I(Xq)
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Observational

Summary: 
      This study plans to learn more about how the energy system works in girls with Turner
      syndrome. This is important to know so that the investigators understand how Turner syndrome
      relates to diseases such as diabetes, extra weight gain, heart disease and liver disease, and
      how this impacts day to day life.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Investigators will enroll adolescent and young adult females with Turner syndrome who will
        complete all study procedures. One parent will also be enrolled (either mother or father)
        to complete questionnaires about the daughter.
      
Biospecimen description: 
      Blood (serum and plasma)
    
Keywords: Turner syndrome; 45,XO; body composition; cardiometabolism; quality of life; fitness
Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children
Condition: Children; Muscle Strength; Reproducibility of Results; Muscle Strength Dynamometer; Knee
Study type: Interventional

Summary: 
      Reliability of isokinetic strength measurement of the knee in typically developing children
      has yet been studied and seems to be good. Because in daily life activities strength of the
      hip- and ankle-joint muscles are also important, the investigators aim to study the
      reliability and validity of isokinetic strength measurements of the hip and ankle.
    

Detailed description: 
      Intra-tester reliability of isokinetic strength measurements of the knee, hip and ankle in a
      Biodex System 4 device will be studied. Children will be assessed at different movement
      velocities using the test-positions as proposed by the manufacturer. Maximum peak torque will
      be established.

      Children will also perform functional strength assessments and the relation with the results
      of isokinetic strength measurements will be analysed.
    

Intervention name(s): Biodex System 4
Intervention type(s): Device
Intervention description(s): Reliability and validity of isokinetic strength measurement of the knee, hip and ankle in typically developing children.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: child; dynamometry; knee joint; reproducability of results; strength testing
Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus
Condition: Correction of Nasolabial Folds
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to verify that Dermalax Implant Plus is not inferior to the reference device,
      Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds
    


Intervention name(s): Dermalax Implant Plus; Restylane Sub-Q
Intervention type(s): Device; Device
Intervention description(s): Dermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.; Restylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Using Diffuse Noxious Inhibitory Control (DNIC) to Predict Acupuncture Therapy Outcome: A Pilot Study
Condition: Pain
Study type: Interventional

Summary: 
      The investigators hypothesize that acupuncture modifies the DNIC efficiency and that DNIC can
      serve as a predictor to identify 'good responders' to acupuncture early in therapy.
    


Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): Electroacupuncture
Other intervention name(s): Pantheon Electroacupuncture Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Pain; Acupuncture; DNIC; Electroacupuncture
Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this pilot study is to determine whether a program involving both in-lab and
      at-home training using cranial nerve stimulation (CN-NINM) delivered via the tongue can
      reduce symptoms of multiple sclerosis (MS) and improve movement control and therefore provide
      ground work for a controlled clinical trial. The effects of the stimulation will be measured
      using a variety of standardized tests of movement control and cognitive function, functional
      brain imaging, and MS-specific surveys of your quality of life.
    

Detailed description: 
      Fourteen MS patients, seven each in an active and a sham stimulation group are expected to
      participate.

      Participants will receive intensive physical therapy and working memory training for 14
      weeks.

      Functional magnetic resonance imaging (fMRI) using motor imagery and working-memory tasks
      will be completed prior to and following therapy, as will be sensory organization tests
      (SOT), motor performance measures, and neuropsychological assessment.

      Prior to the start of CN-NINM training, each participant will undergo baseline evaluations
      including structural and fMRI, balance tests (SOT), Dynamic Gait Index (DGI),
      neuropsychological assessment (Handedness; Wechsler Abbreviated Scale of Intelligence (WASI)
      Vocabulary and Matrix Reasoning; California Verbal Learning Test (CVLT)-11; D-Kefs Trails,
      Color/Word and Verbal Fluency; Tower of London Second Edition; Ruff 2 and 7; Wechsler Adult
      Intelligence Scale Fourth Edition (WAIS-IV) Letter-Number sequencing, Coding and Symbol
      Search; Paced Auditory Serial Addition Test (PASAT); Leonard Tapping; and Grooved Pegboard).
      In addition, the MS Impairment Scale, Fatigue Impact Scale, Cognitive Function Inventory for
      MS, and Beck Depression and Anxiety questionnaires will be completed.
    

Intervention name(s): Portable Neuromodulation Stimulator
Intervention type(s): Device
Other intervention name(s): PoNS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fourteen MS patients, seven each in an active and a sham stimulation group, participated.
Participants received intensive physical therapy and working memory training for 14 weeks. Functional magnetic resonance imaging (fMRI) using motor imagery and working-memory tasks were completed prior to and following therapy, as were sensory organization tests (SOT), motor performance measures, and neuropsychological assessment.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Recirculating Memory T Cells in the Pathogenesis of Psoriatic Arthritis and Cutaneous Psoriasis
Condition: Psoriasis; Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study is to investigate the link between pro-inflammatory T cells responses
      arising in the skin in patients with cutaneous psoriasis and those present in the joints of
      patients developing psoriatic arthritis.

      The study is based on the hypothesis that a fraction of T cells with memory phenotype can
      recirculate from the skin and relocalize at extracutaneous sites including enthesis or
      synovial tissue thus propagating the pro-inflammatory cycle. This could represent a
      pathogenic mechanism in the development of PsA.

      The main aim of the study is to define the phenotypic and functional differences of
      circulating T cells in patients cutaneous psoriasis, patients with psoriatic arthritis and in
      control group of healthy subject.

      To this end the investigators analyze the expression of cell surface markers of central
      memory (TCM), effector memory (TEM) and effector (Teff) cells, within this subsets the
      investigators evaluate the expression of chemokine receptors as well as skin and tissue
      homing molecules. There will be also an evaluation of the T cell polarization towards Th1/Tc1
      or Th17/Tc17 phenotype by evaluating the cytokine expression profile.

      In selected patients with PsA the researchers analyze in parallel the phenotype and the
      cytokine profile of T cell subpopulations in peripheral blood and in synovial fluid, The
      results of this study could possibly allow to define distinctive features of circulating T
      cells in patients with PsA and to understand the link between circulating and synovial fluid
      T cells in patients with PsA.
    


Intervention name(s): blood sample collection; Synovial Fluid collection
Intervention type(s): Other; Procedure
Intervention description(s): Blood samples are collected from patients with psoriasis vulgaris and patients with psoriatic arthritis following the routine procedure. Blood samples will also be collected from healthy control subjects.; Synovial fluid is collected when prescribed in patients with psoriatic arthritis
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Cohort
      
Biospecimen description: 
      Peripheral blood mononuclear cells, blood serum, synovial fluid mononuclear cells, synovial
      fluid
    
Keywords: T-cells; circulation; synovial fluid; psoriasis; psoriatic arthritis
Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)
Condition: HIV/AIDS; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Non-randomized, comparative study (1:1 allocation) to study interactions between
      nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.
    


Intervention name(s): ETHINYL ESTRADIOL AND LEVOGESTREL; ETHINYL ESTRADIOL AND LEVOGESTREL
Intervention type(s): Drug; Drug
Intervention description(s): 30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL; 30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: AE; AIDS; ALT; ART; AST; DCF; DMC; FDA; GCP; HB sAg; ICH; IND; IRB; IU; mg; mm3; PCR; SAE; ULN; WB; COC; Combined Oral Contraceptives
Assessment of Cardiopulmonary Function in Duchenne Muscular Dystrophy
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      This study seeks to develop and validate non-invasive assessments of cardiac and respiratory
      muscles with magnetic resonance imaging (MRI) to better predict the natural disease
      progression of Duchenne muscular dystrophy (DMD) in affected individuals over time, as well
      as determine whether peripheral skeletal muscle dysfunction can predict cardiopulmonary
      dysfunction. The central hypothesis is that non-invasive MRI measures of the heart, muscle,
      and peripheral skeletal muscles can sensitively predict future cardiopulmonary decline.
    

Detailed description: 
      Magnetic Resonance Imaging (MRI) of the heart and breathing muscles, special breathing tests
      (called pulmonary function testing), special exercise tests (using a stationary bike), and
      possibly an echocardiogram (ultrasound of the heart, commonly known as an "echo") will be
      completed up to 4 times per year for up to 4 years. Most participants will complete testing
      once or twice each year; however, some participants will be asked to repeat some of the tests
      twice during each visit.
    

Intervention name(s): Magnetic Resonance Imaging (MRI); Pulmonary Function Testing (PFT); Metabolic Exercise Testing using stationary bicycle; Echocardiogram
Intervention type(s): Other; Other; Other; Other
Intervention description(s): It is a non-invasive method to determine ventricular size, volumes, mass, and ejection fraction.; It is non-invasive breathing tests that characterize respiratory muscle function, as well as lung compliance and physiology.; Metabolic exercise testing, including assessment of exercise capacity and MVO2, evaluates global cardiopulmonary functional status. This is performed with the use of a stationary bicycle.; The echocardiogram performed with the multiple-echo Dixon method helps to assess participants cross-sectionally and longitudinally for variations and changes in myocardial structure.
Other intervention name(s): Multiple-echo Dixon
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        As the focus of this study is on validating novel measures of cardiac and respiratory
        function in individuals with DMD, this study will utilize a single-group design with up to
        60 males with DMD between 5 and 15 years old upon entry to the study. The participant
        selection is limited to children since the detrimental effects of DMD begin in early
        childhood, and the life expectancy of these boys is shortened to the early- to mid-20s.
        Only males will be eligible to participate in the study because DMD is an X-linked
        recessive genetic disorder that only leads to the characteristic disease in males. Although
        females may be carriers, they do not exhibit the same phenotype as males.
A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate the safety and tolerability, as well as PK profile of ceftazidime-avibactam (CAZ
      -AVI) administered in single and repeated intravenous (IV) infusions in healthy Chinese
      subjects.This study data will be used to support CAZ-AVI NDA in China.
    


Intervention name(s): CAZ-AVI; 0.9% Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): A single 120 minute IV infusion on Day 1, followed by three times daily (every 8 hours, q8h) as 120 minute IV infusions for 7 days (Day 2 to Day 8), and one single 120 minute IV infusion on Day 9.; A single 120 minute IV infusion on Day 1, followed by three times daily (every 8 hours, q8h) as 120 minute IV infusions for 7 days (Day 2 to Day 8), and one single 120 minute IV infusion on Day 9.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: CAZ-AVI China phase I PK study
MARS - Monitored Atherosclerosis Regression Study
Condition: Atherosclerosis; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Atherosclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether significant alterations in serum
      lipoproteins as provided by the drug lovastatin can substantially reduce atherosclerosis
      progression or even induce regression.
    

Detailed description: 
      Two conceptual advances occurring in the 1980's made it possible to test the hypothesis that
      significant alterations in serum lipoproteins can substantially reduce atherosclerosis
      progression or even induce regression. The first advance was in the development of
      arteriograms used in characterizing atherosclerosis, greatly reducing the number of patients
      required for the evaluation of an intervention designed to prevent coronary atherosclerosis
      progression. The second advance was the development of lovastatin that provides a
      lipid-lowering alternative much easier to tolerate than the niacin/colestipol combination
      previously used, and has been shown to be comparably effective for LDL reduction in patients
      with a family history of high cholesterol.

      A total of 270 high-risk coronary artery disease patients, not eligible for coronary artery
      bypass surgery, were recruited for the study. All patients received angiograms and were
      randomly assigned to either the lovastatin or placebo groups stratified by three baseline
      factors: sex, smoking status, and plasma cholesterol levels.

      Patients initially received lovastatin 40mg twice a day or a matching placebo. Those patients
      receiving lovastatin whose total plasma cholesterol level was less than 110mg/dL at one visit
      or 120 mg/dL on two successive visits had their dosage halved, and were maintained on the
      optimal dosage for the remainder of the study. Coronary angiography was performed prior to
      screening and at month 24 (visit 18). Angiographic assessment of both femoral arteries was
      also performed at baseline and at month 24. Noninvasive ultrasound imaging of the carotid
      arteries (including carotid intima-media thickness) was performed every 6 months. Patients
      reported to the clinic monthly for 12 months, and at two-month intervals thereafter. Plasma
      lipids, routine laboratory safety and physical examinations were also performed.
    

Intervention name(s): lovastatin
Intervention type(s): Drug
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: CAD; familial hypercholesterolemia
Absorption, Metabolism, and Excretion of (-)-[2-14C]Epicatechin in Humans
Condition: ADME
Study type: Interventional

Summary: 
      The purpose of this study is to determine the absorption, metabolism and excretion of
      (-)-epicatechin using the radiolabeled tracer (-)-[2-14C]epicatechin in healthy male
      volunteers observing a flavanol-/procyanidin-controlled background diet.
    

Detailed description: 
      Flavanols and their oligomeric derivatives, the procyanidins, are plant-derived compounds
      commonly present in the human diet. Accumulating data demonstrate a causal role for dietary
      flavanols in mediating the cardiovascular benefits associated with the consumption of
      flavanol-/procyanidin-containing foods. In this context, there exists a great interest in
      understanding the absorption, distribution, metabolism and excretion (ADME) of flavanols in
      humans. While significant advances in understanding the ADME of flavanols were made, the data
      obtained thus far remain fairly preliminary and with significant shortfalls and seeming
      contradictions. Aimed at addressing the challenges and gaps of previous investigations, this
      study will investigate the ADME of (-)-epicatechin, one of the most abundant dietary
      flavanols, following the intake of radiolabeled (-)-[2-14C]epicatechin by healthy humans
      observing a flavanol-/procyanidin-controlled background diet.
    

Intervention name(s): Controlled dietary background; (-)-[2-14C]epicatechin intake
Intervention type(s): Other; Other
Intervention description(s): Controlled dietary flavanol-/procyanidin- background, consisting of daily intake for 14 days (day -17 to -4) of a commercially available flavanol-/procyanidin-containing cocoa-based drink (250 mg cocoa flavanols; 40 mg of (-)-epicatechin) followed by a 4-day period (day -4 to 0) of a low-flavanol diet.; Single oral intake of an aqueous solution of a mixture of non-radiolabeled (-)-epicatechin and a single-carbon-14 radiolabeled (-)-[2-14C]epicatechin. The target amount of EC delivered with test drink will be 60 mg, 58.5 mg of which consist of non-radiolabled EC and 1.54 mg (300 µCi) consist of (-)-[2-14C]epicatechin.
Other intervention name(s): (-)-cis-3,3',4',5,7-Pentahydroxyflavane; (2R,3R) - 2- (3,4- Dihydroxyphenyl) - 3,4- dihydro- 1(2H) - benzopyran- 3,5,7- triol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Epicatechin; Flavanols; Procyanidins; Polyphenols; Phytonutrients; AMDE; Antioxidants
Can Airflow Limitation in Chronic Obstructive Pulmonary Disease (COPD) be Reversible by Drugs?
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Critical combination of various approved drugs in management for patients suffering with
      COPD.
    


Intervention name(s): Macrolid, Theophylline, Inhaler Corticosteroids
Intervention type(s): Drug
Intervention description(s): we have no permission to include them in detail because of privacy policy of mentioned journal for publication
Intervention MeSH terms: Theophylline
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Macrolid; reversibility; Theophylline; Corticosteroids; symptoms PFT
An Exploratory Investigation of Dietary Supplementation and Its Effect
Condition: Quality of Life
Study type: Interventional

Summary: 
      The primary objective of this study is to understand if the test product (HUM supplement)
      improve symptoms experienced.
    

Detailed description: 
      This will be a 2-arm randomized, double-blinded, placebo-controlled study.
    

Intervention name(s): HUM supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): HUM supplement - 1 capsule per day; Placebo supplement - 1 capsule per day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a 2-arm randomized, double-blinded, placebo-controlled study
Masking: Single (Participant)
Primary purpose: Other