bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D Supplementation on Cardiovascular Risk Factors
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the present pilot study is to determine the effect of vitamin D
      supplementation (4000 IU or 6000 IU once daily for 6 months) on reducing heart disease risk
      and in improving blood glucose control in type 2 Diabetes subjects . The investigators are
      working with Hispanics and African Americans living in Miami, Florida.
    

Detailed description: 
      Insufficient vitamin D levels have been found in subjects with type 2 diabetes (T2D).
      Similarly, a negative association between serum vitamin D levels and insulin resistance has
      been reported in a large sample representative of the adult US population and in subjects at
      risk for T2D. In addition, a strong association between hypovitaminosis D and
      hypertriglyceridemia has been demonstrated in studies done in US adult population.

      Literature has indicated that subjects with T2D and insulin resistance (IR) are more likely
      to develop arteriosclerosis and all of the complications related to this condition, such as
      myocardial infarction and stroke.

      These findings have increased the interest about the effect of vitamin D on metabolic
      abnormalities grouped under the term "cardiovascular disease (CVD) risk factors", which
      includes hypertension, dyslipidemia, obesity, glucose intolerance, inflammation and T2D which
      is in itself a risk factor for CVD.

      Therefore, the purpose of the present pilot study will be to determine the effect of
      supplemental vitamin D intake (4000 IU or 6000 IU of Cholecalciferol daily for 6 months) on
      CVD risk markers and glycemic control; primarily lipid panel, insulin resistance, and
      glycosylated hemoglobin (A1C), in a sample of Hispanics and African-Americans with T2D and
      vitamin D insufficiency. If repletion of vitamin D level improves insulin resistance,
      glycemic control, inflammation, hypertension, dyslipidaemia or kidney functions, it may
      prevent the development of CVD events and decrease T2D complications.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): 4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.
Other intervention name(s): Vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Cholecalciferol; Vitamin D; Insulin resistance; Cardiovascular disease risk; Minorities
Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics, the absolute
      bioavailability and the lung bioavailability of inhaled Glyco pMDI.
    


Intervention name(s): Glycopyrrolate; Glycopyrrolate; Glycopyrrolate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single administration of Glyco pMDI 100 µg; Single administration of Glyco pMDI 100 µg after charcoal ingestion; Single intravenous injection of glycopyrrolate 100 µg
Other intervention name(s): CHF 5259; CHF 5259; Robinul Injection
Intervention MeSH terms: Glycopyrrolate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: None (study in healthy volunteers)
A Pilot Study of Psychodynamic Psychotherapy for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of this study was to compare a group psychotherapy intervention, the Integrative
      Outpatient Model, to a convenience control, in adults with bipolar disorder.
    

Detailed description: 
      The psychotherapy literature suggests that psychological treatments can have a significant
      impact on the clinical course and outcome for bipolar disorder (Swartz & Frank, 2001). Very
      few outcome studies have been conducted in group psychotherapy for bipolar disorder, and
      there are no preliminary studies conducted using the Integrative Outpatient Model, developed
      specifically for bipolar disorder. Given the lack of preliminary data, a pilot study with a
      matched-control design is indicated to obtain preliminary data regarding this treatment
      modality and approach. The IOM is a weekly, long term psychotherapy.

      Comparison: Individuals who participate in group psychotherapy will be compared to a control
      group on mood and symptom ratings, up to 1 year post intervention.
    

Intervention name(s): Group Psychotherapy
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psychotherapy; bipolar disorder; psychodynamic; psychoeducation; illness management; controlled trial; pilot study
A Phase 1 Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 in Healthy Participants and Otherwise Healthy Participants With Obesity
Condition: Healthy
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to assess the safety, tolerability and blood levels
      following a single dose or after multiple doses of CK-0045 given subcutaneously to healthy
      participants or otherwise healthy participants with obesity. 76 participants will receive
      CK-0045 or matching placebo at different escalating doses in 2 study parts: 40 healthy
      participants will receive a single dose and 36 otherwise healthy participants with obesity
      will receive 6 doses one week apart.
    


Intervention name(s): CK-0045; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Interleukin-22 agonist; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Interleukin-22; Safety; Tolerability; Pharmacokinetics
Selenoprotein P and Non-alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease; Insulin Resistance
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Insulin Resistance
Study type: Observational

Summary: 
      The pathogenesis of nonalcoholic fatty liver disease has not been fully elucidated. The most
      widely supported theory implicates insulin resistance as the key mechanism leading to hepatic
      steatosis, and perhaps also to steatohepatitis.

      Selenoprotein P(SeP) is a secretory protein primarily produced by the liver. Previous studies
      demonstrated that SeP, a liver-derived secretory protein, causes insulin resistance.

      Therefore, the purpose of this study is to determine the different Sep levels between healthy
      normal group and NAFLD group.
    

Detailed description: 
      Nonalcoholic fatty liver disease (NAFLD), a disease spectrum that includes simple steatosis,
      nonalcoholic steatohepatitis (NASH) and cirrhosis, has been increasingly recognized as the
      hepatic manifestation of metabolic syndrome. Both inflammation and insulin resistance are
      considered to be pivotal pathogenic mechanisms of NAFLD, as well as metabolic syndrome, type
      2 diabetes, and atherosclerosis. There is mounting evidence implicating adipokines secreted
      from adipose tissue in the pathogenesis and progression of NAFLD, in addition to the
      development of insulin resistance and inflammation. Selenoprotein P (SeP) has recently been
      reported as a novel hepatokine that regulates insulin resistance and systemic energy
      metabolism in rodents and humans. Although previous studies have shown a close relationship
      among insulin resistance, inflammation, and NAFLD, as far as we know, there is no previous
      report evaluating the association between SeP and NAFLD. In the present study, we examined
      serum SeP levels in subjects with increased visceral fat area (VFA) or liver fat accumulation
      measured with computed tomography (CT). We evaluated the relationship between SeP levels and
      cardiometabolic risk factors.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers for visiting routine medical check in our clinic
      
Biospecimen description: 
      blood samples. Abdominal VFA and total abdominal fat area were measured via CT scan without
      an intravenous contrast agent
HAIC Combined Sintilimab for Liver Metastasis From Esophageal Squamous Cell Carcinoma
Condition: Hepatic Arterial Infusion Chemotherapy; Liver Metastases; Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Neoplasm Metastasis; Liver Neoplasms; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with liver metastasis from esophagus squamous (ESC) are usually offered systemic
      therapy. However, for those with predominant liver disease or failure of system therapy,
      local liver management becomes an option. This prospective single center study aimed to
      evaluate the efficacy and adverse events of hepatic arterial infusion chemotherapy (HAIC)
      using percutaneous catheter placement techniques for liver metastases from esophagus squamous
      (ESC).
    


Intervention name(s): HAIC combined with intravenous PD-1
Intervention type(s): Drug
Intervention description(s): Hepatic arterial chemoinfusion (HAIC) was used for interventional therapy with at least 2 cycles of hepatic arterial infusion. The intervention was started with sintilimab at the same time, 200mg each time, and the drug was repeated every 3 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatic arterial infusion chemotherapy; liver metastasis; esophagus carcinoma
Osteopathic Sympathetic Harmonization and Depression
Condition: Osteopathic Manipulative Treatment
MeSH terms: Depression
Study type: Interventional

Summary: 
      Depression appears to be resistant to the available pharmacological treatments. Autonomic
      responses accompanied by any psychological stress are sympathetic nervous system (SNS) and
      neuroendocrine responses are formed by hypothalamus-pituitary-adrenal (HPA) axis. The purpose
      of this study is; assessment of effectiveness of osteopathic approach on sympathetic nervous
      system and HPA axis in adolescents with depression.
    

Detailed description: 
      Depression diagnosed and volunteer to participate 39 cases who between the ages of 15-21
      included. All participants were recruited and randomly assigned into two groups, the
      osteopathy group (OG) and the placebo group (PG). Stimulation on the sympathetic truncus and
      prevertebral ganglia were performed in the OG group. The stimulation of the PG group was
      performed with a lighter touch and a shorter duration in similar areas. Each participant was
      filled in the demographic data form, Beck Depression Scale and State and Trait Anxiety
      Inventory (STAI Form - 1 and Form - 2) before the application. Emotional state visual analog
      scale and STAI Form - 1 was filled and blood pressure and pulse measurement were made and
      saliva sample was taken before application, immediately after application and 20 minutes
      after application.
    

Intervention name(s): Osteopathic sympathic harmonization; Sham intervention
Intervention type(s): Other; Other
Intervention description(s): Treatments that harmonize at the sympathetic nerves or plexus, e.g., sympathetic trunk stimulation by means of the rib-raise technique or stimulation of the prevertebral ganglia.; Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind, placebo-controlled, randomized study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Sympathetic nervous system; Cortisol
Cognitive Behavioral Treatment for Improving Sleep in Overweight and Obese Youth
Condition: Sleep
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a randomized controlled trial (RCT) to evaluate the
      efficacy of brief cognitive behavioral treatment for child sleep (CBTcs) to improve sleep in
      an important high-risk population, overweight/obese (OV/OB) youth with behavioral sleep
      disorders. OV/OB youth with behavioral sleep disorders and their parent(s) will be randomly
      assigned to 8 sessions of either CBTcs or an Educational Control (EC). CBTcs will address
      behavioral sleep issues in children; EC will address sleep and dietary education and general
      coping strategies. Child sleep (total wake time, total sleep time, bed/wake times), height,
      weight, physical activity, dietary intake, quality of life (QOL), fatigue, and daytime
      sleepiness will be assessed at baseline, post-treatment, and 3-month follow-up. It is
      hypothesized the children in the CBTcs will experience greater improvement in sleep than
      children in the EC.
    

Detailed description: 
      Assessment Procedures: Subjects will participate in 8 treatment sessions and 3 full
      assessment meetings over the course of 7 months. All meetings will be held at the Magnolia
      Park Sleep Disorders Center. The following procedures will be performed:

      Stage 1 - Phone Screening, Stage 2 - Screening and Baseline Measures, Stage 3 - Overnight
      Sleep Monitoring, Stage 4 - Two weeks Wrist Actigraphy, Sleep Diaries, Dietary Recalls Stage
      5 - Intervention, Stage 6 - Post-Treatment Measures, Stage 7 - 3-Month Follow-Up
    

Intervention name(s): Cognitive Behavior Therapy Sleep; Education Control
Intervention type(s): Behavioral; Other
Intervention description(s): Children in this arm will receive instructions on the use of 'coping thoughts.' Common elements across the CBTcs sessions include reviewing progress, setting goals for change, problem solving to address challenges/barriers, and reinforcing progress; Children in this arm will receive sleep and dietary education, as well as general coping strategies and controls for staff attention and seasonal effects that could influence changes in sleep and health outcomes.
Other intervention name(s): CBTcs; EC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Children; Sleep; Obesity
Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes
      but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose
      regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT),
      will be performed at baseline and again ~4 weeks after treatment with study drug. We will
      also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before
      each time the MMTT/OGTT are performed. Several hormones that may affect the way the body
      regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will
      assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine
      has on the hormones measured during the OGTT and MMTT.
    


Intervention name(s): Sitagliptin
Intervention type(s): Drug
Intervention MeSH terms: Sitagliptin Phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cystic fibrosis; CF; CFRD; sitagliptin; incretins; GLP1; GIP; beta cell function; adolescents
The Articulated Oral Airway as an Aid to Mask Ventilation
Condition: Mask Ventilation; Airway Obstruction Upper; Airway Management
MeSH terms: Airway Obstruction
Study type: Interventional

Summary: 
      The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the
      tongue, allowing for a greater cross-sectional area for mask ventilation. The investigators
      hypothesize that, in patients with predictors for difficult mask ventilation, the AOA will be
      non-inferior to the Geudel oral airway in terms of expired tidal volumes.
    

Detailed description: 
      Difficult mask ventilation (MV) is common in the obese population and can result in patient
      morbidity and mortality. The Articulating Oral Airway (AOA) is a novel oral airway which
      actively displaces the tongue, allowing for a greater cross-sectional area for MV. The
      investigators hypothesize that, while using the same ventilatory pressure in neuromuscularly
      blocked patients with predictors for difficult mask ventilation, MV with an AOA will not
      result in smaller expired tidal volumes than MV with a similarly sized Guedel oral airway
      (GDA). In other words, the AOA will be non-inferior to the GDA in terms of expired tidal
      volumes.
    

Intervention name(s): Articulated Oral Airway; Guedel oral airway (active comparator)
Intervention type(s): Device; Device
Intervention description(s): The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.; The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation.
Other intervention name(s): AOA; Abrons AOA; Abrons Articulated Oral Airway
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Prospective, randomized, crossover design. All patients will receive both interventions during a single anesthetic, with the order of intervention being randomized.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Morbid obesity; Obstructive sleep apnea; Mask ventilation; Upper airway obstruction
A Study to Investigate Delayed-release Tablets
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, non-randomised, two-arm study in 12 healthy male
      volunteers. This study is designed to correlate the gastrointestinal transit behaviour of
      delayed-release diclofenac potassium tablets with their pharmacokinetic (PK) absorption
      profiles.

      We will be looking at:

        1. The behaviour of the tablets (when, where and how quickly they break up)

        2. The gastric emptying time of the tablets (when they leave the stomach)

        3. The gastrointestinal transit of the tablets (how long they take to travel through the
           gut)

        4. Blood levels of the drug (diclofenac)
    

Detailed description: 
      The tablets being tested will contain the drug, diclofenac potassium. Diclofenac potassium is
      a non-steroidal anti-inflammatory drug (NSAID) taken to reduce inflammation and as an
      analgesic, reducing pain in certain conditions such as rheumatoid arthritis, gout and
      post-operative pain.

      The 2 treatments are as follows:

      Tablet T4: Radiolabelled delayed release diclofenac potassium tablet with time delay of 4 h

      Tablet T6: Radiolabelled delayed release diclofenac potassium tablet with time delay of 6 h

      In this study we will be using a type of radioactive material (known as technetium-99m) which
      is routinely used in investigations of this type. A small amount of technetium-99m will be
      put into each tablet.

      Primary Objective A)To assess the site and time of onset and complete release of radiolabel
      from two delayed-release diclofenac potassium formulations

      Secondary Objectives B)To determine gastrointestinal transit parameters of two
      delayed-release diclofenac potassium formulations C)To determine the plasma concentrations of
      diclofenac at each PK sampling point post-administration of two delayed-release diclofenac
      potassium formulations D)To assess and compare between the two delayed-release diclofenac
      potassium formulations, as a minimum, the following PK parameters: tlag, tmax, Cmax and
      AUC0-15h
    

Intervention name(s): Radiolabelled T4 Tablet; Radiolabelled T6 Tablet
Intervention type(s): Drug; Drug
Other intervention name(s): Delayed release diclofenac potassium tablet; Delayed release diclofenac potassium tablet
Intervention MeSH terms: Diclofenac
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Formulation behaviour; Drug absorption profile
Plasma Rich in Growth Factors (PRGF) Treatment for Muscle Tear
Condition: Muscle Tear
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      the improvement of symptoms and disease progress by the treatment of OA of the knee with PRGF
    


Intervention name(s): PRGF; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 3-6mg IM (to area of muscle tear); 3cc IM of physiological saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment