bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Omega -3 Supplements on the Serum Levels of ACE/ACE2 Ratio as a Potential Key in Cardiovascular Disease and COVID-19; A Randomized Clinical Trial in the Covid-19 Uninfected Jordanian People
Condition: Cardiovascular Risk Factor; Covid19
MeSH terms: COVID-19; Cardiovascular Diseases
Study type: Interventional

Summary: 
      The Renin-Angiotensin-Aldosterone System (RAAS) is involved in blood pressure regulation and
      electrolyte balance. Angiotensin-converting enzyme (ACE) is a critical regulator of RAAS by
      cleaving angiotensin (Ang1) to Angiotensin2 (Ang2), which is the most powerful biologically
      active product of RAAS [1]. In the same context, angiotensin-converting enzyme 2 (ACE2)
      converts Ang2 to Ang (1-7), which is a vasodilator, antithrombotic, and antihypertrophic
      peptide [2]. ACE2 which is found in many tissues [3] has opposite effects to ACE on the
      heart, kidneys, and lungs [4]. Many pathological conditions, in particular cardiovascular
      disease (CVD), have shown a link between a disturbance in ACE/ACE2 ratio and the
      downregulation of ACE2 levels [5]. Also, ACE/ACE2 has been reported to be higher in moderate
      to severe chronic heart failure [6] as well as systolic blood pressure [7]. Recently, an
      elevated ACE/ACE2 ratio is linked to Coronavirus disease 2019 (COVID-19). SARS-COV2 enters
      target cells by binding of the spike protein to ACE2 and a specific transmembrane serine
      protease 2 (TMPRSS2) for the spike (S) protein priming, which also leads to downregulation of
      ACE2 [8]. Down-regulation of ACE2 caused by Coronavirus may have a potential role in the
      pathogenesis of COVID-19 infection. Accordingly, people with a higher ACE/ACE2 ratio may be
      more at increased risk of worse Covid-19 consequences [9].

      On the other hand, omega-3 fatty acids could decrease CVD risk by their anti-inflammatory
      anti-thrombotic function [10]. A meta-analysis comprising 15,806 patients, showed that
      omega-3 fatty acids associated with a 30% reduction in fatal myocardial infarction and sudden
      death, in addition to a 20% reduction in overall mortality [11]. To the best of our
      knowledge, no clinical trials have evaluated the effect of omega-3 supplementation on serum
      ACE/ACE2 ratio which is recently ascribed as a potential key in 2019 Covid-19 as well as CVD
      [5,9].
    


Intervention name(s): 300 mg of omega3-FA
Intervention type(s): Dietary Supplement
Intervention description(s): The participant will receive 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Cognitive Effects of Bariatric Surgery
Condition: Bariatric Surgery Patients
Study type: Observational

Summary: 
      There is growing evidence that obesity is associated with adverse neurocognitive outcome.
      Recent studies demonstrate that elevated body mass index (BMI) is an independent risk factor
      for Alzheimer's disease, structural brain abnormalities, and cognitive dysfunction in older
      adults. Preliminary work from our lab extends these findings and shows structural brain
      differences and cognitive dysfunction also exist in obese young and middle-aged adults.

      Bariatric surgery is increasingly viewed as an effective intervention for morbid obesity,
      though its effects on cognition are unknown. Post-operative nutritional deficiencies are
      common and can adversely impact cognitive performance. However, substantial weight loss
      resolves or improves many medical conditions with reversible cognitive effects, suggesting
      bariatric surgery may provide cognitive benefits.

      No study to date has examined the cognitive effects of bariatric surgery. To do so, the
      proposed study will prospectively assess cognitive performance in 125 bariatric surgery
      patients enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS) project and 125
      matched controls. Bariatric surgery patients will complete a computerized cognitive test
      battery at four time points: pre-operatively, 12 weeks post-operatively, 12 months
      post-operatively, and 24 months post-operatively. Matched control participants will complete
      the test battery at similar intervals. Demographic, medical, and psychosocial information
      will be collected to elucidate possible mechanisms of change. We hypothesize that the
      substantial weight loss following bariatric surgery will be associated with improved
      cognitive performance.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from the bariatric and weight loss programs of affiliated
        clinical centers.
      
Keywords: Bariatric Surgery; Obesity; Cognitive Function
Effects of Hallux Valgus Deformity on Rear Foot Position, Pain, Function, and Quality of Life in Women
Condition: Hallux Valgus; Pain
MeSH terms: Hallux Valgus; Bunion
Study type: Observational

Summary: 
      To investigate relationship between HV deformity and position of rearfoot joints, and its
      effects on the quality of life, pain, and related functional status in women with bilateral
      hallux valgus (HV).
    

Detailed description: 
      To investigate relationship between HV deformity and position of rearfoot joints, and its
      effects on the quality of life, pain, and related functional status in women with bilateral
      hallux valgus (HV). Study included 27 right-dominant women. Demographic data, HV angle,
      weight-bearing and non-weight-bearing subtalar pronation (SP), and navicular height were
      recorded. Visual Analog Scale, Foot Function Index (FFI), and the American Orthopaedic Foot
      and Ankle Society (AOFAS) MTP-IP along with AOFAS Mid foot (MF) Scales, and SF-36 were used.
      HV angle, weight-bearing SP, and pain intensity of the left foot were higher. HV angle of
      left foot was correlated with all sub-sections of FFI, pain parameter of AOFAS MTP-IP, and
      pain and total score of AOFAS-MF Scale ). HV angle of left foot was correlated with physical
      role, pain, and social function sub-domains of SF-36. Right HV angles were correlated with
      right foot pain and non-weight-bearing SP.Increasing HV angle and pathomechanical changes in
      rear foot were correlated. Besides, although all participants were right-dominant, their left
      foot problems were more highlighted.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Effects of hallux valgus deformity in women
      
Keywords: hallux valgus; pain; functional status; quality of life
AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, single-blind, placebo-controlled, parallel-group, multicentre study in
      patients with CAD. The study will be conducted at approximately 10 centres in 3 countries.
      Approximately 138 CAD patients will be randomized to AZD5718 or placebo (treatment duration
      12 weeks).
    

Detailed description: 
      This is a randomized, single-blind, placebo-controlled, parallel-group, multicentre study in
      patients with CAD. The study will be conducted at approximately 10 centres in 3 countries
      (Denmark, Finland and Sweden).

      Patients suitable for the study will be identified and screened for eligibility after being
      hospitalized for Acute Coronary Syndrome (ACS) (Visit 1) comprising ST Elevation Myocardial
      Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (non-STEMI). At Visit 1, after
      signing informed consent, study measurements will take place at days 1, 2, 3 and 5 post ACS,
      where feasible. It is planned that approximately 138 CAD patients will be randomized to
      ensure at least 66 evaluable patients receiving AZD5718 Dose B or placebo are included with
      12 weeks treatment. For supporting dose selection in future studies, a treatment arm with 28
      randomized patients receiving AZD5718 Dose A is included in the study. The study was
      originally designed to be a 4-week study and was amended to be a 12-week study. Therefore,
      the total number of patients is greater than required for a 12 weeks study (about 100), since
      some patients will only have 4 weeks of treatment.

      An evaluable patient is defined as a patient with a valid Coronary Flow Velocity Reserve
      (CFVR) measurement at Visit 2 and one post baseline visit as judged by the CFVR Core lab.

      On Day 1 (Visit 2), 7 to 28 days after the ACS event, patients willing to participate in the
      study will complete the screening procedure and, if eligible, be randomized. Treatment
      duration will be 12 weeks. During the treatment phase, patients will come in to the clinic
      for study measurements at 2 weeks (visit 3), 4 weeks (visit 4), 8 weeks (visit 4b) and 12
      weeks (visit 4c).

      A follow-up visit (Visit 5) will be performed at 4 weeks (±4 days) after last dose in order
      to ensure safety and well-being of the patients
    

Intervention name(s): AZD5718; AZD5718; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral dose of AZD5718 (tablet); Oral dose of AZD5718 (tablet); Matching placebo (tablet)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy and Safety of 12-weeks Supplementation of Eubacterium Hallii on Insulin Sensitivity and Glycaemic Control
Condition: Pre Diabetes; Impaired Glucose Tolerance; Insulin Sensitivity; Insulin Resistance; Glucose Metabolism Disorders; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance; Prediabetic State; Glucose Intolerance; Metabolic Diseases; Glucose Metabolism Disorders; Hypersensitivity
Study type: Interventional

Summary: 
      This 12 week placebo-controlled study evaluates the efficacy and safety of E. hallii
      supplementation.
    

Detailed description: 
      There is an increased awareness that the bacteria which forms our microbiome, plays a crucial
      role in human health and diseases. Numerous studies have highlighted the therapeutic
      potential of specific bacteria in preventing and treating metabolic, gastrointestinal and
      other diseases.

      The aim of the study is evaluate the effect of administration of a next generation probiotic,
      Eubacterium hallii, versus placebo on insulin sensitivity and glycemic control, in volunteers
      with some markers of metabolic syndrome.

      Participants will receive their randomized study product daily for 12 weeks. The target
      population will be otherwise healthy hyperglycaemic adults.
    

Intervention name(s): Eubacterium hallii; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Eubacterium hallii, ≥ 1x10^9 live bacterial cells (per capsule); Placebo capsules are identical to the active treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, open-label, non-randomized, 2-period, fixed sequence study to
      characterize the metabolic profile and routes of excretion of oral [14C]PF-06882961 and to
      evaluate the absolute oral bioavailability of PF-06882961 and fraction absorbed of
      [14C]PF-06882961 in reference to intravenous [14C]PF-06882961 in healthy male participants.
    


Intervention name(s): [14C]PF-06882961, 50 mg; PF-06882961, 50 mg and [14C]PF-06882961, 100 ug
Intervention type(s): Drug; Drug
Intervention description(s): A single oral dose of [14C]PF-06882961, will be administered as a liquid formulation.; A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961 will be administered via intravenous infusion.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability; excretion; metabolism; absorption
A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
Condition: End-Stage Renal Disease; Secondary Hyperparathyroidism
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages
      10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal
      dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will
      be in the dosing period of the study for 12 weeks in order to evaluate the incidence of
      hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and
      all 12 will receive paricalcitol capsules.
    


Intervention name(s): paricalcitol
Intervention type(s): Drug
Intervention description(s): Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.
Other intervention name(s): ABT-358, Zemplar
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects
Study to Determine the Pharmacokinetics on TPV/r in Subjects With Mild and Moderate Hepatic Insufficiency
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetics of single-dose and steady-state Tipranavir/Ritonavir
      (TPV/r) 500/200 mg in subjects with mild to moderate hepatic insufficiency
    


Intervention name(s): Tipranavir (TPV); Ritonavir (r)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ritonavir; Tipranavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy
Condition: Melanoma
MeSH terms: Melanoma
Study type: Observational

Summary: 
      To evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma
      by combining semiantigen dinitrophenyl (DNP) in situ immunotherapy and laser therapy, and
      carry out monitoring on related immunological parameters of the patients.

      72 patients with stage III (b or c) or stage IV skin (which could not be excised by
      operations) malignant melanoma were treated by combining simple semiantigen DNP in situ
      immunotherapy and laser therapy respectively. The changes in peripheral blood CD4+CD25+Treg
      regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β and other inhibitory
      cytokines of the patients were detected, the changes in anti-DNP IgG antibody titer was
      monitored, the relationship between delayed-type hypersensitivity (DTH) and survival was
      observed, and results of clinical follow-ups were also examined.
    


Intervention name(s): dinitrophenyl(DNP); Radiation
Intervention type(s): Drug; Radiation
Intervention description(s): laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with stage III (b or c) or stage IV skin (which could not be excised by
        operations) malignant melanoma
A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral
      therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms
      and sleep quality in people who have experienced a traumatic event and are reporting trauma
      symptoms.
    

Detailed description: 
      The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral
      therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms
      and sleep quality in people who have experienced a traumatic event and are reporting trauma
      symptoms. The total length of the program will be 8 weeks. The sessions will be held 3 hours
      per week with 1.5 hours of group cognitive behavioral therapy and 1.5 hours of yoga. Changes
      in PTSD symptoms and sleep quality will be measured at baseline, immediately following the
      program, and at 2 month follow-up.
    

Intervention name(s): Cognitive Behavioral Therapy and Yoga
Intervention type(s): Behavioral
Intervention description(s): Group Cognitive Behavioral Therapy Treatment and Yoga Program
Other intervention name(s): T.E.A.M. Cognitive Behavioral Therapy; Kundalini Yoga
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Posttraumatic Stress; Sleep
The Construction of a Chinese Picture Naming Test and Its Preliminary Normative Data
Condition: Normality
Study type: Observational

Summary: 
      We will construct a Chinese Picture Naming test which include 60 items with various word
      frequency and familiarity and is arranged by their familiarity in daily life.

      Then we will collect the normative data for this test using normal subjects of various age
      and educational level.
    

Detailed description: 
      In this study, we will first construct a Chinese Picture Naming Testing following the format
      of Boston Naming test. We will use the original 60 items from BNT and also choose another 100
      items of objects with various frequency using the word frequency data from the Linguistic
      Corpus of the Academia Sinica. Colored pictures will be constructed accordingly. University
      students will be recruited to name the pictures and to judge the familiarity and image
      agreement for these pictures. Then, we will choose 60 pictures of according to the principles
      of 1. high image agreement 2. high naming agreement 3. including items of various familiarity
      and word frequency 4. double or triple phoneme words 5. including the original BNT items as
      possible. The 60 pictures will be arranged by their familiarity to construct the Chinese
      Picture Naming Test.

      Then, we will recruit normal subjects of various age group and educational level to to the
      Naming test and to construct the preliminary norm.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        1. university student

          2. normal subjects
      
Keywords: naming test
Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and
      feasibility of trigeminal nerve stimulation (TNS) as a treatment for
      Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory,
      pilot study will provide a basis for a federal grant application and larger controlled
      trials.
    


Intervention name(s): EMS 7500 Digital Muscle Stimulator
Intervention type(s): Device
Intervention description(s): A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Minocycline in Clinically Isolated Syndromes (CIS)
Condition: Clinically Isolated Syndromes; Early Single Relapse of Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Syndrome; Sclerosis; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the trial is to demonstrate that 100 mg of oral minocycline twice daily reduces
      the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to
      placebo, over a 6 month follow-up period (primary outcome).

      A key secondary outcome is to confirm that this early treatment benefit is maintained at two
      years.
    

Detailed description: 
      -  Minocycline 100 mg bid orally compared to identical placebo

        -  Clinically Isolated Syndrome (CIS): Patients with a first clinical demyelinating event
           suggestive of multiple sclerosis (At baseline participants may meet 2010 McDonald
           diagnostic criteria for MS, but not 2005 criteria)

        -  Men and women, aged 18-60y, first event within the previous 180 days; brain magnetic
           resonance imaging (MRI) with at least two brain T2 lesions which are at least 3 mm in
           diameter, and at least one of which is ovoid or periventricular or infratentorial.

        -  Up to 24 months of study drug (Up to 12 months of study drug for patients recruited
           after December 31, 2012)

        -  Patients will be discontinued from the study when they convert to McDMS based on the
           2005 McDonald definition.

        -  12 Canadian MS Clinics

        -  A total of 154 patients will be randomized. Because 30% of screened patients with CIS
           who are clinically eligible are not expected to meet the MRI criteria for inclusion, up
           to 280 patients will be screened.
    

Intervention name(s): Minocycline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg twice daily to be taken for up to 2 years; placebo twice daily for 2 years
Other intervention name(s): MINOCIN; Minocycline Hydrochloride
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Multiple Sclerosis; Clinically Isolated Syndrome; Minocycline; Placebo