bioihbjkbjnl/mcl2 huggingface dataset:
BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction
Condition: Circumferential Reduction; Waist Circumferential Reduction
Study type: Interventional

Summary: 
      Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 HFT in achieving
      3 cm or greater average waist circumferential reduction in HFT group of subjects relative to
      the base line and 1 cm or greater reduction relative to the average waist circumferential
      reduction of the Placebo group.
    

Detailed description: 
      Prospective, randomized, blinded, two-arms study of waist circumferential reduction following
      5 once-a-week treatments. One arm is the HFT group of 64 subjects who are treated with the
      BTL-9000 HFT and the other arm is the Placebo group of 38 subjects treated with the sham
      device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 HFT
      treatment in achieving average post-treatment waist circumference reduction of 3 cm or
      greater across the waistline relative to the baseline assessment and of 1 cm or greater than
      the average waist circumferential reduction of the Placebo group.
    

Intervention name(s): BTL-9000 HFT; sham BTL-9000 HFT
Intervention type(s): Device; Device
Intervention description(s): Deep tissue heating with the BTL-9000 HFT for HFT group; sham deep tissue heating with BTL-9000 HFT in Placebo group
Other intervention name(s): BTL-9000 High Frequency Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High Frequency; Waist circumferential reduction
Endocytoscopy for in Vivo Determination of Mucosal Inflammatory Cells and Intestinal Disease Activity in Inflammatory Bowel Disease (IBD)
Condition: Crohn´s Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Precise activity assessment of inflammatory bowel disease (IBD) is essential to determine the
      extent and severity of the disease for further specific therapy. Nevertheless, despite
      ongoing developments in the field of gastrointestinal endoscopy, the final diagnosis still
      relies on the interpretation of histopathological features of intestinal biopsies taken
      during the endoscopic examination. Recently, endocytoscopy (EC) was introduced as a new
      endoscopic imaging modality, enabling microscopic imaging within the mucosal layer of the gut
      at a magnification level of up to 1400-fold.
    


Intervention name(s): Endocytoscopy
Intervention type(s): Device
Intervention description(s): Patients with Crohn's disease and ulcerative colitis who underwent colonoscopy are prospectively included in this study. Methylene blue or toluidine blue is topically applied to enable EC (XEC-120-U, Olympus, Tokyo, Japan). Data are digitally saved and analyzed independently from each other by two gastroenterologists and one pathologist who are blinded to clinical and endoscopic data.
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Crohn's disease and ulcerative colitis who underwent colonoscopy.
The Effect of Salmeterol on Eosinophil (EOS) Function
Condition: Allergic Asthma
Study type: Interventional

Summary: 
      This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or
      the combination treatment with fluticasone and salmeterol, is associated with a greater
      number of sputum eosinophils following antigen challenge and, under these circumstances, the
      migrating peripheral blood eosinophils are less adherent.
    

Detailed description: 
      An antigen challenge is when a participant inhales either cat, ragweed, or dust dander in
      increasing concentrations until their lung function drops 15 or 20 percent.
    

Intervention name(s): salmeterol; Fluticasone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): salmeterol diskus 50 mcg twice per day; placebo diskus, fluticasone MDI 88 mcg twice per day; placebo diskus
Other intervention name(s): Seravent; Advair; flovent; advair; no drug; comparator treatment
Intervention MeSH terms: Fluticasone; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility (≥ 50% completion rate) of a 6-week
      nutrition, movement, and mindfulness program for youth with recent diagnosis of psychosis.
    

Detailed description: 
      The purpose of this study is to determine the feasibility of a 6-week nutrition, movement,
      and mindfulness program (M³ Program) for youth with a recent diagnosis of psychosis. Program
      effects on metabolic and mental health outcomes compared to wait-list control will also be
      assessed. Participants will be 15-25 years of age, and have a recent diagnosis of psychosis.
      Twenty participants and their study partners (20 study partners) will be equally divided into
      two cohorts. Participants will sign up for one of the two series on a rolling enrollment
      basis until both of the program date frames are filled. Participants that signed up for the
      second series will serve as a wait-list control; outcomes from the participants in the first
      series will be compared to this group. M³ will be a combination of didactic and experiential
      training. The course will meet once-a-week for six weeks. Participants will learn how to
      prepare healthy snacks and meals, make healthy choices when eating out, and interpret food
      packaging and labels. They will also learn about different forms of mindfulness exercises and
      movement, such as yoga, martial arts, and a Japanese style of drumming. Feasibility will be
      assessed throughout the program.
    

Intervention name(s): M3 Program; Control
Intervention type(s): Other; Other
Intervention description(s): Participants and their study partners will learn about food, movement, and mindfulness through hands-on curriculum.; Participants will not participate in M3 program but will have same outcomes measured at same time points (baseline, 6 weeks, 12 weeks).
Other intervention name(s): Meals, Mindfulness and Moving Foward Program
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Respiratory Function and Functional Capacity in Pediatric Patients With Chronic Kidney Disease (CKD)
Condition: Chronic Kidney Diseases; Chronic Renal Disease; Chronic Renal Failure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Observational

Summary: 
      Chronic kidney disease (CKD) is defined as a permanent abnormality in kidney structure or
      function that persists for more than 3 months (for example, glomerular filtration rate [GFR]
      <60 mL/min/1.73 m2 or albuminuria ≥30 mg/24 hours) and, it effects the 8% to 16% of the
      population worldwide.In pediatric patients with CKD, exercise capacity begins to decline in
      stage 3 of the disease and progressively decreases in stage 5, in dialysis and transplant
      patients (4, 5). Reduction in respiratory muscle strength and six minute walk test (6MWT) is
      observed in patients with CKD treated with hemodialysis (HD).The aim in present study is to
      evaluate the relationship between functional capacity and respiratory functions in stage 1-5
      pediatric chronic kidney disease patients.
    

Detailed description: 
      The aim of this study is to evaluate functional capacity with six minutes walk test (6MWT),
      respiratory functions with spirometer and the correlation between functional capacity and
      respiratory functions in pediatric CKD patients.
    

Intervention name(s): 6 minute walk test,
Intervention type(s): Other
Intervention description(s): submaximal exercise test used to evaluate the functional capacity of patients
Other intervention name(s): pulmonary function tests
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients aged 5-18 years with stage 1-5 chronic kidney disease
      
Keywords: pediatric chronic kidney disease; pulmonary function; functional capacity
Multi-modality MRI Study on Effect to Collateral Circulation and Blood Perfusion of Acute Cerebral Infarction by Human Urinary Kallidinogenase
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Human urinary kallidinogenase can promote the establishment of collateral circulation in the
      ischemic penumbra due to the stenosis or occlusion of middle cerebral artery and then
      increase the perfusion.
    

Detailed description: 
      Patients with acute ischemic stroke will be given human urinary kallidinogenase .Then we will
      estimate the cerebral collateral circulation in ischemic regions and final infarct volume,
      comparing with traditional therapy such as Shuxuening injection, which will provide new
      evidence for the treatment of ischemic stroke. Perfusion Weighted Imaging(PWI) could be a
      method to reflect the infarction center and low perfusion of tissue.
    

Intervention name(s): Human Urinary Kallidinogenase; Shuxuening injection
Intervention type(s): Drug; Drug
Other intervention name(s): youruikelin
Intervention MeSH terms: Kallikreins
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Assessment of Lung Inflammation With FDG PET/CT in COVID-19
Condition: COVID-19; FDG PET/CT; Inflammation
MeSH terms: COVID-19; Pneumonia; Inflammation
Study type: Observational

Summary: 
      The aim of the study was to assess the inflammatory status at the presumed peak of the
      inflammatory phase in non-critically ill patients requiring admission for COVID-19. Patients
      admitted with COVID-19 from March 27th to May 3rd, 2020 were prospectively enrolled. All
      patients had an initial chest CT-scan for diagnosis on admission and a second chest CT-scan
      for follow-up concomitant with a FDG PET/CT between day 6 and day 14 after the onset of
      symptoms.
    

Detailed description: 
      [18F]-2-fluoro-2-deoxy-D-glucose PET/CT (FDG PET/CT) is a sensitive and quantitative technic
      for detecting inflammatory process. Glucose uptake is correlated with increased anaerobic
      glycolysis seen in activated inflammatory cells such as monocytes, lymphocytes and
      granulocytes.

      The aim of the study was to assess the inflammatory status at the presumed peak of the
      inflammatory phase in non-critically ill patients requiring admission for COVID-19.

      Patients were included if COVID-19 was confirmed according to the WHO guidance (11) by a
      positive result of RT-PCR assay of nasal and pharyngeal swabs, if they were hospitalized
      during the time period from day 6 to day 14 of the onset of symptoms, and if their initial
      (on admission) chest CT-scan presented ground-glass opacities (GGO) or consolidation.

      Group of 13 consecutive patients prospectively enrolled. All patients had an initial chest
      CT-scan for diagnosis on admission and a second chest CT-scan for follow-up concomitant with
      a FDG PET/CT between day 6 and day 14 after the onset of symptoms.

      Based on the changes between the two chest CT, patients were classified as follows:

        -  CT worsening: increase of CT abnormalities extent > 20% or additional GGO or
           consolidation. Conversion of GGO into consolidation was not considered as additional
           finding.

        -  CT stability: changes of CT abnormalities extent ≤ 20% without additional GGO or
           consolidation.

        -  CT improvement: decrease of CT abnormalities extent > 20% without additional GGO or
           consolidation.

      Based on FDG PET/CT imaging, patients' profiles were classified as follows:

        -  Inflammatory: lungs hypermetabolic volume ≥ 50 ml and / or SUVmax ≥ 7

        -  Low inflammatory: lungs hypermetabolic volume < 50 ml and / or SUVmax< 7 Patients'
           short-term clinical outcome was classified as follows: worsening, stability,
           improvement.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted with COVID-19 from March 27th to May 3rd, 2020 were prospectively
        enrolled.
Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients
Condition: Polycystic Ovary Syndrome; Anovulation
MeSH terms: Polycystic Ovary Syndrome; Anovulation; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves
      hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and
      intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin
      B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus
      patients treated with metformin.

      Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if
      folate supplementation may improve endothelial structure and function in PCOS patients.
    

Detailed description: 
      Fifty patients affected by PCOS without additional metabolic or cardiovascular diseases
      grouped in two age- and body mass index-matched treatment arms.

      Interventions: A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram
      daily) (experimental group, n=25) or placebo (control group, n=25) supplementation.

      In each patient were evaluated: Complete hormonal and metabolic patterns, serum Hcy, folate,
      vitamin B12, and endothelin-1 (ET-1) concentrations, brachial artery diameter at baseline
      (BAD-B) and after reactive hyperemia (BAD-RH), flow-mediated dilation (FMD), and intima-media
      thickness (IMT) on both common carotid arteries.
    

Intervention name(s): Folate plus metformin; Placebo plus metformin
Intervention type(s): Drug; Drug
Intervention description(s): A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily).; A six-month course of metformin (1700 mg daily) plus placebo
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study assessed the therapeutic effect of exenatide and metformin as the initial
      therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).
    

Detailed description: 
      The present study was a prospective, nonrandomized, interventional study.The drug-naïve,
      overweight or obese patients with newly diagnosed T2D were consecutively enrolled. The
      inclusion criteria: 1) age 20 - <65 years, 2) body mass index (BMI) ≥ 24 kg/m2 [7], and 3)
      HbA1c ≥ 7% (53mmol/mol). An oral glucose tolerance test was performed during the screenings.
      All of the patients have no diabetes antibodies and were diagnosed with T2D within the
      previous 3 months, according to the ADA diagnostic criteria. None of the patients had
      administered anti-diabetic drugs or diet therapy before participation. Neither of the
      patients presented any history of pancreatitis, coronary artery disease, liver function
      impairment, renal function impairment, intestinal surgery, chronic hypoxic diseases
      (emphysema and cor pulmonale), infectious disease, hematological disease, systemic
      inflammatory disease, or cancer. Patients who were pregnant, possibly pregnant, or ingesting
      agents known to influence glucose or lipid metabolism were also excluded.
    

Intervention name(s): Exenatide or metformin hydrochloride
Intervention type(s): Drug
Intervention description(s): Exenatide was administrated with 5 μg bid for 4 weeks and 10 μg bid for 8 weeks. Metformin hydrochloride was initiated at a dose of 500 mg bid for 2 weeks, and added to 2.0 g/day for 8 weeks.
Intervention MeSH terms: Metformin; Exenatide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets
Condition: Hyperlipidemias; Atherosclerosis; Coronary Heart Disease; Carotid Stenosis; Peripheral Vascular Diseases; Diabetes Mellitus
MeSH terms: Carotid Stenosis; Heart Diseases; Atherosclerosis; Vascular Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Peripheral Vascular Diseases; Peripheral Arterial Disease; Hyperlipidemias; Hyperlipoproteinemias
Study type: Observational

Summary: 
      A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia
      (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and
      rate of patients who are treated to target (which is <100mg/dl for patients with high risk
      and <70mg/dl for patients at very high risk) are screened (office-based specialists). The
      doctors therapy decisions after the screening and possible reasons for these decisions will
      be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are
      treated to their LDL-C target and to underline the importance of treating patients to their
      cholesterol targets.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female type II diabetics with: coronary disease with event: acute coronary
        syndrome, status post MI, PTCT, CABG, angiographically verified), or proven atherosclerotic
        progression (PAVK min. IIb or S.p. revascularization, stroke/TIA, carotis-plaque:
        asymptomatic min. 70% or S.p. revascularization)
      
Keywords: Hyperlipidemia; Need-to-treat; NIS; Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes
Nerve Morphology in Diabetic Patients
Condition: Peripheral Neuropathy; Carpal Tunnel Syndrome; Entrapment Neuropathies; Diabetes Complications
MeSH terms: Peripheral Nervous System Diseases; Carpal Tunnel Syndrome; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy; Diabetes Complications
Study type: Observational

Summary: 
      The underlying basis of carpal tunnel syndrome and the basis of its increased incidence in
      diabetes are unknown. The aim of this study was to quantified pathology in an uncompressed
      nerve (posterior interosseous nerve in the forearm between diabetic and non-diabetic patients
      with CTS.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients referred to a specialized hand clinic
      
Biospecimen description: 
      Biopsies of the posterior interosseous nerve
The Short-Term MBT Project
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the benefitial and harmful effects of short-term (20 weeks) compared
      to long-term (14 months) mentalization-based therapy for outpatients with subthreshold or
      diagnosed borderline personality disorder.
    

Detailed description: 
      Psychotherapy for borderline personality disorder is often lengthy and resource-intensive.
      Mentalization-based therapy is an example of an evidence-based treatment that currently has
      empirical support as an 18-months outpatient program for borderline personality disorder.
      However, this duration is rarely available, and the long and costly treatment combined with a
      highly prevalent disorder result in insufficient access to evidence-based care.

      The trial is an investigator-initiated, single-centre, assessor-blinded, randomized clinical
      superiority trial of short-term (20 weeks) compared to long-term (14 months) outpatient
      mentalization-based therapy for borderline personality disorder or subthreshold borderline
      personality disorder. Participants will be recruited from the Outpatient Clinic for
      Personality Disorders at Stolpegaard Psychotherapy Centre, Mental Health Services, Capital
      Region of Denmark. Participants will be assessed at trial intake using the Mini International
      Neuropsychiatric Interview and the Structured Clinical Interview for DSM-5 Personality
      Disorders. Participants will be included if they meet a minimum of four DSM-5 criteria for
      borderline personality disorder. Participants will be assessed blind to treatment allocation
      at baseline, and at 8, 16, and 24 months after randomization.

      The primary outcome is severity of borderline symptomatology assessed using the Zanarini
      Rating Scale for Borderline Personality Disorder interview. Secondary outcomes include
      self-harm incidents, functional impairment (Work and Social Adjustment Scale), quality of
      life (Short-Form Health Survey), and global functioning (Global Assessment of Functioning
      scale). Psychiatric symptoms (Symptom Checklist 90) will be included as an exploratory
      outcome. Measures of personality functioning, attachment, group alliance, borderline symptoms
      and mentalization skills will be included as predictor and mediator variables.
    

Intervention name(s): Short-term MBT; Long-term MBT
Intervention type(s): Other; Other
Intervention description(s): Short-term mentalization-based therapy; Long-term mentalization-based therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mentalization-based therapy; borderline personality disorder; randomized clinical trial; psychotherapy research; treatment intensity