bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Lacidipine and Amlodipine on Blood Pressure in Korean ISH Patients Aged 60 to 80 Years
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective -To investigate the clinical effectiveness of lacidipine and amlodipine on
      systolic blood pressure (SBP) in Korean ISH patients aged 60 to 80 years.

      Secondary Objectives -To investigate the clinical effectiveness of lacidipine and amlodipine
      on diastolic blood pressure (DBP) in Korean ISH patients aged 60 to 80 years

      To demonstrate the effectiveness of lacidipine and amlodipine on endothelial function through
      measurement of markers of inflammation.
    

Detailed description: 
      Patients will receive lacidipine 4mg and amlodipine 5mg for initial 4 weeks. If SBP is less
      than 140mmHg at Week 4, subjects continue to take lacidipine 4mg and amlodipine 5mg.

      If SBP is ≥140mmHg at Week 4, the dose of lacidipine will be increased to 6mg and amlodipine
      will be increased to 10mg.

      If BP is not controlled under 140mmHg at Week 8, diuretics will be added. For 12 weeks of
      treatment period, subjects will be visit to clinic at every 4 weeks
    

Intervention name(s): Lacidipine & Amlodipine
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine; Lacidipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lacidipine; Amlodipine
Right-front Direction in Parabolic Flight
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this study is to objectively determine the perceived direction of the right-front
      by the subjects in weightlessness. The direction of the right-front has not been investigated
      to date with the measurements of the position of the eyes. The investigators will compare the
      intersection of the horizontal and vertical saccadic trajectories (jerky) with the apparent
      direction of the right-front indicated by the subjects when they look right front in the dark
      (LOOK) and that they indicate when they determine whether a visual target through the
      right-front apparent (PERCEPTION). Then, the investigators will compare these measurements
      between normal gravity and microgravity hypergravity during parabolic flight.
    


Intervention name(s): Parabolic flight; Measurements of eye movements and perception
Intervention type(s): Other; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: volunteers
Low Calorie Diet or VLCKD Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity
Condition: Sarcopenic Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional

Summary: 
      The prevalence of sarcopenic obesity (SO) is increasing worldwide, posing important
      challenges to public health and national health care system, especially during the COVID
      pandemic. In subjects with SO, it is essential to reduce body weight preserving lean mass, in
      order to avoid a worsening of muscle function. Lifestyle modification with adequate nutrition
      and proper physical activity is essential to counteract SO progression. In accordance with
      the Position Statement of the Italian Society of Endocrinology, Very Low Calorie Ketogenic
      Diet (VLCKD), a well established nutritional intervention in the context of obesity, has been
      promoted also for the treatment of SO. Moreover, the source of protein, timing of intake, and
      specific amino-acid constitution also represent critical factors in increasing muscle mass
      and strength. Recent studies have shown how protein supplementation, especially with high
      leucine content, can be effective in degenerative and end-stage diseases.

      To date, the effects of physical training during VLCKD have not been studied. The aim is to
      determine the efficacy of VLCKD combined with interval training, compared to a VLCKD or a LCD
      alone, on weight-loss, body composition and physical performance in patient with SO.
    


Intervention name(s): meal replacements or supplementation with leucine
Intervention type(s): Dietary Supplement
Intervention description(s): meal replacements or animal protein or supplementation with leucine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Therapy for Depression With Co-occurring Panic or Anxiety Symptoms
Condition: Depression; Anxiety Disorders; Panic Disorder
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders; Panic Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This 6-month study, with a 3-month follow up period, will compare the effectiveness of new
      and traditional psychotherapies for depression with panic or anxiety symptoms.
    

Detailed description: 
      Many depressed patients also experience significant symptoms of panic or anxiety. This study
      will compare the effectiveness of a new therapy called interpersonal psychotherapy for
      depression with panic or anxiety symptoms (IPT-PS) with that of traditional interpersonal
      psychotherapy for depression (IPT).

      Participants are randomly assigned to receive up to 24 weeks of treatment with either IPT-PS
      or traditional IPT. Improvements in interpersonal functioning, quality of life, and symptoms
      of depression and anxiety will be assessed at the end of therapy and at a 3-month follow-up.
    

Intervention name(s): Interpersonal Psychotherapy (IPT); IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mood Disorders; Psychotherapy; Comorbidity
Comparison of Retinal Oxygenation and Retinal Vessel Diameters in Healthy Subjects and Patients With Diabetic Retinopathy or Retinal Vein Occlusion Between DVA and Oxymap
Condition: Healthy Subjects; Diabetic Retinopathy; Retinal Vein Occlusion
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Vein Occlusion
Study type: Interventional

Summary: 
      To date two different instruments are commercially available to measure retinal oxygen
      saturation and retinal vessel diameters: Dynamic Vessel Analyzer (DVA) and Oxymap. Retinal
      oxygen saturation analysis is based on spectroscopic evaluation of retinal fundus images. Up
      to now no data comparing both instruments for the measurement of retinal oxygen saturation
      and vessel diameter are available in the literature.

      Study objectives: To compare retinal oxygenation and retinal vessel diameters in healthy
      subjects and patients with diabetic retinopathy or retinal vein occlusion between 2
      commercially available systems (DVA, Oxymap T1)

      Study design: Open pilot study

      Study population:

      30 healthy volunteers, age 18-80 years 30 type 2 diabetic patients with mild or moderate
      non-proliferative diabetic retinopathy, age 18-80 years 30 patients with retinal vein
      occlusion, age 18-80 years

      Topically administered medication:

      Tropicamide (Mydriaticum "Agepha"®, Agepha, Vienna, Austria), dose: 1-2 drops per study day
      for dilation of the pupil Oxybuprocainhydrochloride combined with sodium fluorescein
      (Thilorbin®, Alcon Pharma GmbH, Freiburg, Germany), dose: 1 drop in one eye for measurements
      of intraocular pressure Nonylacidvanillylamide combined with
      Nicotinic-acid--ß-butoxyethylester (Finalgon®, Boehringer Ingelheim RCV GmbH & Co KG, Vienna,
      Austria): topical on the earlobe

      Methods:

      Dynamic vessel analyzer Oxymap T1 Blood pressure and pulse rate measurement Applanation
      tonometry Oxygen and carbon dioxide partial pressure measurement in arterialized blood from
      earlobe

      Main outcome variables:

      Difference of oxygen saturation of retinal vessels between DVA and Oxymap T1

      The motive for this investigation is to compare data between 2 commercially available
      instruments for the measurement of retinal oxygen saturation and retinal vessel diameter in
      healthy subjects as well as in patients with ocular disease associated with altered retinal
      oxygenation. Comparative data from both systems are currently not available. Data from this
      study will allow the comparison of studies performed with different systems. All oxygen
      measurement procedures are non-invasive and painless. Hence, the risk/benefit ratio appears
      to be acceptable.
    


Intervention name(s): Dynamic Vessel Analyzer; Oxymap T1
Intervention type(s): Other; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: retinal oxygenation; retinal vessel diameters; Dynamic vessel analyzer (DVA); Oxymap T1
Insulin Resistance and Hypertensive Disorders in Pregnancy
Condition: Hypertension in Pregnancy; Diabetes Mellitus in Pregnancy
MeSH terms: Hypertension, Pregnancy-Induced; Pregnancy in Diabetics; Hypertension; Insulin Resistance
Study type: Observational

Summary: 
      The purpose of this study is to determine whether insulin resistance might affect the
      pathogenesis of hypertensive disorders in pregnancy since midtrimester. Furthermore, markers
      of vascular and placental injuries, of oxidative stress and inflammation will be evaluated.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant outpatients
      
Keywords: Pre-eclampsia; Gestational diabetes; Insulin resistance; hypertension in pregnancy
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Condition: Heavy Uterine Bleeding; Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this proof-of-concept study is to assess the safety and effectiveness of
      elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to
      reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with
      heavy uterine bleeding.
    


Intervention name(s): Elagolix; Placebo; Estradiol/Norethindrone acetate (E2/NETA); Estradiol; Progesterone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Elagolix tablets; Matching placebo tablets; A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg.; 1.0 mg micronized estradiol tablets administered once a day; Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle
Other intervention name(s): ABT-620; Activella®; Estrace®; Prometrium®
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uterine Fibroids; Heavy Uterine Bleeding; Elagolix; Menorrhagia; ABT-620; Leiomyomata; Elagolix sodium
Blood Flow Restriction Training for The Shoulder
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to determine if BFR-LIX promotes greater increases in shoulder lean
      mass, rotator cuff strength, endurance, and acute increases in shoulder muscle activation
      compared to LIX alone.
    

Detailed description: 
      Thirty-two healthy adults were randomized into two groups (BFRm=13,f=3, NoBFRm=10,f=6) that
      performed 8wks of shoulder LIX [2/wk, 4 sets (30/15/15/fatigue), 20%max] using common rotator
      cuff exercises [cable external rotation (ER), cable internal rotation (IR), dumbbell scaption
      (SCAP), and side-lying dumbbell ER (SLER)]. The BFR group also trained with an automated
      tourniquet placed at the proximal arm (50%-occlusion). Regional lean mass
      (dual-energy-xray-absorptiometry), isometric strength, and muscular endurance
      (repetitions-to-fatigue, RTF, 20%max, with and without 50%-occlusion) was measured before and
      after training. Electromyographic amplitude (EMGa) was also recorded from target shoulder
      muscles during endurance testing. A mixed-model ANCOVA (covaried on baseline measures) was
      used to detect within and between-group differences in primary outcome measures (α=0.05).
    

Intervention name(s): Blood flow restriction therapy
Intervention type(s): Device
Intervention description(s): The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to either perform exercises with blood flow restriction therapy or without
Masking: None (Open Label)
Primary purpose: Basic Science
Association of Lumbar MODIC Changes With Chronic Low Back Pain in Southern European Subjects
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      In this case-control study, cases were chronic LBP patients aged 30-50 in whom a lumbar MRI
      had been prescribed. Controls were subjects aged 30-50 in whom a cranial MRI had been
      prescribed for headache, who did not suffer from LBP and had no history of clinically
      relevant LBP. Two hundred and forty cases and 64 controls were recruited consecutively in
      Radiology services across six cities in Spain. Imaging findings and subjects' characteristics
      were gathered through previously validated instruments. Radiologists who interpreted MRIs
      were blinded to subjects' characteristics. A multivariate logistic regression model was
      developed to assess the association of Modic changes with LBP, adjusting for sex, age,
      body-mass index, lifetime exposure to smoking, physical activity, and disk degeneration.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Cases: chronic LBP patients aged 30-50 in whom a lumbar MRI had been prescribed. Controls:
        subjects aged 30-50 in whom a cranial MRI had been prescribed for headache, who did not
        suffer from LBP and had no history of clinically relevant LBP.
      
Keywords: MODIC changes; chronic low back pain; magnetic resonance imaging (MRI); vertebrae; intervertebral disc
A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect
      of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.
    


Intervention name(s): insulin degludec; insulin detemir
Intervention type(s): Drug; Drug
Intervention description(s): NN1250 (insulin degludec) injected s.c. (under the skin) once daily for 6 days; Insulin detemir injected s.c. (under the skin) once daily for 6 days
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Chronic Liver Disease in Urea Cycle Disorders
Condition: Urea Cycle Disorder
MeSH terms: Liver Diseases; Urea Cycle Disorders, Inborn
Study type: Observational

Summary: 
      This is a pilot, cross-sectional study to assess liver stiffness and markers of hepatic
      injury, function, and fibrosis in patients with urea cycle disorders. This study will be
      conducted at 3 UCDC sites: Baylor College of Medicine in Houston, Texas, University of
      California San Francisco (UCSF), San Francisco, California and Seattle Children's Hospital,
      Seattle,Washington
    

Detailed description: 
      Urea cycle disorders (UCDs) are among the most common inborn errors of liver metabolism.With
      early diagnosis and improved treatments, the survival of individuals with UCDs has improved,
      and this improved survival has led to unmasking of some long-term complications such as
      hepatic dysfunction and progressive fibrosis in a subset of patients. Hepatic complications
      in UCDs are quite variable and dependent upon the specific metabolic defect. Currently, there
      are no guidelines for monitoring hepatic complications or extent of liver disease in UCDs.

      The purpose of this study is: 1) To determine whether liver stiffness is higher in
      individuals with ASS1D, ASLD, and ARG1D as compared to females with OTCD, and to assess liver
      stiffness in other UCDs (citrin deficiency, NAGSD, CPS1D, and males with OTCD), 2) To test
      whether markers of hepatocellular injury and function and novel serum biomarker panels for
      hepatic fibrosis provide evidence of chronic liver disease in individuals with ASS1D, ASLD,
      and ARG1D as compared to OTCD and to assess these sample markers of hepatocellular injury and
      function and novel serum biomarker panels for hepatic fibrosis in other UCDs (citrin
      deficiency, NAGSD, CPS1D, and males with OTCD).
    

Intervention name(s): Diagnostic Ultrasound
Intervention type(s): Other
Intervention description(s): All individuals will undergo a blood draw for measurement of biomarkers of liver disease and an ultrasound with shear-wave elastography.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals with urea cycle disorders
      
Biospecimen description: 
      Blood
Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication
Condition: Chronic Hepatitis C, HCV Genotype 1
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Open-label, single centre study evaluating efficacy and viral kinetics of combination
      PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral
      clearance demonstrated between 4 - 12 weeks, then randomised to further continued combination
      treatment for one of three defined durations. Followed-up for 24 weeks after treatment
      cessation.

      Objectives:

        1. To determine the necessary duration of combination treatment with Pegylated-Interferon
           alfa2a (PEGASYS) & Ribavirin in Patients infected with genotype 1, in order to achieve
           viral clearance

        2. To identify host factors, which are associated with different patterns of virological
           response to combination treatment (fast responder, slow responder, non-responder). On
           this basis, to identify possible predictors for the duration of antiviral treatment.
    

Detailed description: 
      Forty treatment-naïve patients with chronic hepatitis C, all infected with genotype 1, will
      be entered into this study. All 40 patients will be started on the same regimen of 180mg
      Pegylated-Interferon alfa2a (PEGASYS) weekly plus Ribavirin 1000-1200mg daily. HCV RNA in the
      serum will be monitored by qualitative PCR at treatment weeks 4, 8 and 12. Patients who
      become HCV RNA negative at any of the above time-points (4,8 or 12), will be randomised into
      one of three groups to continue the same antiviral regimen for an additional 3 month, 6 month
      or 9 month period. All these patients will subsequently be followed-up and monitored for a
      further 6 months after stopping all antiviral treatment.

      Treatment will be discontinued for patients who remain persistently HCV RNA positive at
      treatment week 12 and they will be withdrawn from the study protocol.
    

Intervention name(s): Pegylated interferon-alfa2a (Pegasys); ribavirin
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV, genotype 1, treatment, HCV kinetics, T-cells
The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Many studies showed that soy foods or soy isoflavones can lower the risk of cardiovascular
      disease (CVD), osteoporosis and some cancers, but few human studies assessed effects of
      purified isoflavone components (genistein and daidzein) on glucose metabolism. This
      double-blinded, randomized, placebo-controlled trial will examine the effects of purified
      genistein and daidzein on glucose metabolism in prediabetic or diabetic women. One hundred
      and eighty eligible women age 30-70 years(without any treatment of diabetic drugs) will be
      recruited and randomly allocated into the following three arms: Placebo (10g isolated soy
      protein, ISP); Genistein (10g ISP + 50mg genistein); Daidzein (10g ISP + 50mg daidzein) per
      day for 6 mo. Fasting glucose, lipids, insulin, inflammation marks and post-load for glucose
      and insulin will be determined at 0, 3th, and 6th month. Changes in these indices will be
      compared among the three groups.
    

Detailed description: 
      Subjects were Chinese adult women, age 30-70 year, with an FG concentration ranging from 5.6
      to 7.0 mmol/L or 2-h PG concentration ranging from 7.8-11.0 mmol/L or with newly diagnosed
      diabetes not requiring medication treatment according to a doctor's suggestion or
      participants did not willing to take medication themselves, and managed their diabetes just
      with a stable diet and exercise. Women were excluded if they had a history of coronary heart
      disease, stoke, thyroid disease, severe liver, lung, or gastrointestinal tract diseases; were
      currently or in the past 8 weeks used hypoglycemic or lipid-lowering or weight-reduction
      agents; were occurrence of diabetic complications; use of hormone replacement therapy;
      allergy to soy;were long-term antibiotics users.
    

Intervention name(s): Placebo; Daidzein; Genistein
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 10g soy protein isolated per day; 50mg daidzein +10g soy protein isolated per day; 50mg genistein +10g soy protein isolated per day
Intervention MeSH terms: Genistein; Daidzein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: genistein; daidzein; impaired glucose regulation; glucose metabolism; lipids metabolism; inflammation; women