bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge
Condition: Nicotine Pharmacokinetic Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the pharmacokinetics of an investigational 2 mg
      sublingual nicotine tablet (Pharmaceutical Productions Inc.) to a 2 mg Commit® nicotine
      lozenge (GlaxoSmith Kline) in a randomized crossover design in 6 male and female otherwise
      healthy smokers.
    

Detailed description: 
      A single oral dose of each medication will be administered to each participant with a 48 hour
      washout period between administrations. Serial blood samples will be obtained at the
      following times after the administration of the nicotine dosage forms: 0, 4, 8, 10, 12, 16,
      30, 45, 60, 90, 120, and 180 minutes. Vital signs will be obtained prior to dosing and at 30,
      60, 180, and 240 minutes after dosage administration. A craving questionnaire will be
      administered prior to dosing and at 5, 11, 17, 25, 35, 50, and 65 minutes. Craving
      questionnaires will then be administered at 30 minute intervals thereafter up to 180 minutes
      after medication administration. A Product Preference Questionnaire will be completed at the
      end of the second study period. A 30 day follow-up visit will be scheduled with each
      participant at the conclusion of the study
    

Intervention name(s): Nicotine (Pharmaceutical Productions Inc.); Nicotine (Pharmaceutical Productions Inc.)
Intervention type(s): Drug; Drug
Intervention description(s): An investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) will be administered in a randomized crossover design in 6 male and female otherwise healthy smokers.; A Commit® 2 mg nicotine lozenge (GlaxoSmith Kline)will be administered in a randomized crossover design in 6 male and female otherwise healthy smokers.
Other intervention name(s): Investigational 2 mg sublingual nicotine tablet; Commit® 2mg nicotine lozenge (GlaxoSmith Kline)
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nicotine; pharmacokinetics
Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research
Condition: Hydrocephalus
MeSH terms: Hydrocephalus
Study type: Observational

Summary: 
      In normal patients, blood and cerebrospinal fluid (CSF) contain circulating cells and other
      molecules such as proteins and nucleic acids. In patients with central nervous system (CNS)
      and other conditions, the levels of these molecules may be altered. In several other studies
      at our institution, the investigators are investigating such molecules in tumor specimens as
      well as the blood and cerebrospinal fluid of pediatric patients with CNS tumors. However,
      these levels are difficult to interpret without comparing them to levels in patients without
      CNS tumors. The investigators propose a study to collect small amounts of blood and
      cerebrospinal fluid from pediatric patients without CNS tumors who are undergoing a
      diagnostic or therapeutic neurosurgical procedure aimed at addressing altered CSF dynamics.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All children without central nervous system tumors between the ages of 1 year and 21 years
        who are undergoing a neurosurgical procedure to address hydrocephalus during which CSF will
        be obtained will be considered
      
Biospecimen description: 
      whole blood and cerebrospinal fluid
    
Keywords: Hydrocephalus; Survivin; miRNA
A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted in two parts. The first (Part A) will be an open label single
      dose escalation part beginning with the proposed starting dose level of GSK2398852 as 5
      milligram (mg) [approximately equivalent to 0.1 mg/kilogram (kg)]. The next escalation dose
      levels are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg. GSK2315698 will be
      administered at variable doses until the concentration of the serum amyloid P component
      monoclonal antibody (SAP mAb) has fallen below 100 nanogram/millilitre (ng/mL). Decisions
      about these next dose levels will be made following safety review of the prior subjects'
      data; dose levels may be changed (increased and lowered) and dose levels may be repeated
      depending on the observed safety such that Part A extension study may be performed. In
      addition, pharmacokinetics of GSK2315698 (SAP depleter) and GSK2398852 (anti-SAP mAb), and
      circulating SAP concentrations will be assessed. Dose escalation in Part A will continue to
      the highest well tolerated dose or the highest allowable dose. Subjects will be closely
      monitored and will undergo Equilibrium contrast Magnetic Resonance Imaging (EqMRI) including
      organ volume, Elastography and Liver Biopsy if required.

      Part B will be a randomized partially blinded part with the principal objective of assessing
      the dose response of the GSK2398852 in more detail. Subjects will be assigned to one of
      approximately 5 dose groups from Part A. The precise selection of numbers of subjects and
      dose levels will be informed by the results from Part A.
    


Intervention name(s): GSK2398852; GSK2315698
Intervention type(s): Drug; Drug
Intervention description(s): Unit dose strength: 100 mg/mL provided as 1 mL solution per vial. GSK2398852 dosage levels variable with the proposed starting dose level of GSK2398852 as 5 mg [approximately equivalent to 0.1 mg/ kg]. The next escalation dose levels are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg.; Unit dose strength: 200 mg/mL stock to be diluted. GSK2315698 will be administered at variable dosed until the concentration of the serum amyloid P component monoclonal antibody (SAP mAb) has fallen below 100 ng/mL.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetic; systemic amyloidosis; safety; dose escalation; Carboxy Pyrrolidine Hexanoyl Pyrrolidine Carboxylate (CPHPC); biomarker; GSK2315698; GSK2398852; SAP; pharmacodynamic; co-administration; intravenous
Early LA Venting During Venoaterial ECMO Support
Condition: Cardiogenic Shock; Extracorporeal Membrane Oxygenation Support; Refractory Pulmonary Edema
MeSH terms: Pulmonary Edema; Shock, Cardiogenic
Study type: Interventional

Summary: 
      The EVOLVE-ECMO(Early Left Atrial Venting Versus Conventional Treatment For Left VEntricular
      Decompression During Venoarterial ExtraCorporeal Membrane Oxygenation Support) study is a
      randomized controlled trial to evaluate the prognostic effect of early LA venting(when detect
      B-line on serial lung ultrasound) on weaning VA-ECMO support in refractory CS who receive
      VA-ECMO support. The aim of EVOLVE-ECMO trial is to test the hypothesis that early LA venting
      would result in a significant reduction in failure of weaning ECMO support in refractory CS.
    


Intervention name(s): Left atrial venting
Intervention type(s): Procedure
Intervention description(s): The contralateral femoral vein is assessed with an 7-French(Fr) sheath() and femoral artery is assessed with 5-Fr sheath( ) for fluoroscopic guidance using 5-Fr pig-tail catheter. In some cases trans-esophageal echo is used. The inter-atrial septum in punctured with a standard BRK™tran-septal needle(St. Jude Medical Inc., St. Paul, MN) under direct visualization via an 8-Fr Mullin sheath(St. Jude Medical Inc.). A SAFARI™(Boston Scientific, Galway, Ireland) guidewire is advanced into the LA. An 8-Fr Mullin-sheath is removed and atrial septostomy is performed using 21-Fr dilator. A 17-Fr or 21-Fr Biomedicus Percutaneous Femoral cannula(Medtronic Inc., Minneapolis, MN) is then placed in the LA and was attached to the ECMO circuit using a Y connector.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled test
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiogenic shock; Extracorporeal Membrane Oxygenation Support; Left atrial venting
Importance of Dosing Regimen for the Effect of Vitamin D Supplementation
Condition: Hypovitaminosis D
MeSH terms: Rickets; Avitaminosis; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the
      body. Lack of vitamin D is associated with cardio-vascular disease (CVD), type 2 diabetes,
      cancer, infectious and immunological diseases, as well as risk factors for these diseases.
      However, intervention studies with vitamin D have been inconclusive regarding diseases and
      risk factors. This could be due to inclusion of subjects already vitamin D sufficient, and
      short and underpowered studies. In addition, there are indications that the dosing regimens
      may be important, so that daily doses with vitamin D are more efficient than intermittent
      doses, which so far have been generally used. This could be related to the concentration of
      circulating and thereby intracellular vitamin D concentrations, which probably is dependent
      on daily vitamin D doses. This will be tested in the present study where 60 subjects will be
      randomized to vitamin D 160 000 once, vitamin D 4000 IU/day, or placebo for four weeks. The
      primary endpoints will be effects on serum hepcidin and plasma cathelicidin after 4 weeks,
      with effects on serum PTH, RNA expression and microRNA in peripheral blood, telomerase
      activity in peripheral blood mononuclear cells and the ration between serum 1,25(OH)2D and
      24,25(OH)2D as secondary endpoints.
    


Intervention name(s): Vitamin D; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): vitamin D given as bolus versus daily dosing; identical looking as vitamin D
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vitamin D
Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy
Condition: Diabetes
Study type: Interventional

Summary: 
      The investigators anticipate that the use of Detemir will decrease the duration of an insulin
      drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit)
      length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin
      drip is discontinued.
    


Intervention name(s): Detemir
Intervention type(s): Drug
Intervention description(s): Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Other intervention name(s): Levimir
Intervention MeSH terms: Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes
An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a new type of soft contact lens with a
      unique optical design (dual focus) is effective at slowing the progression of myopia
      (near-sightedness) in children.
    

Detailed description: 
      Subjects were randomized to wear test or control soft contact lens to determine whether a new
      type of soft contact lens with a unique optical design (dual focus) is effective at slowing
      the progression of myopia (near-sightedness) in children.
    

Intervention name(s): Dual Focus Soft Contact Lens; Single Vision Soft Contact Lens
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: myopia progression; myopia control
Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome
Condition: Clinically Isolated Syndrome; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Syndrome; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this study is to assess the immune response to vitamin D
      supplementation at two doses (5,000 IU and 10,000 IU daily) in both healthy controls and
      patients with clinically isolated syndrome compared to placebo. Secondary endpoints include
      (1) disease outcome in the clinically isolated syndrome in terms of clinical relapses and
      evidence of new lesions on MRI (McDonald's MS), 2) Safety of doses used
    

Detailed description: 
      Primary endpoint: To determine the effects of vitamin D supplementation at two doses a) 5,000
      IU daily b) 10,000 IU daily compared to c) placebo a 24 weeks period on the change from
      baseline in frequency of CD4 T cell subsets and cytokine responses by peripheral blood
      mononuclear cells in 1) patients with the clinically isolated syndrome. 2) healthy control
      participants.

      Secondary endpoints:

        1. To determine whether there is a dose response effect of supplementation using 5,000 IU
           and 10,000 IU of vitamin D versus placebo over 24 weeks on the change from baseline in
           the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with
           the clinically isolated syndrome (CIS) 2) healthy control participants

        2. To establish whether there is a clinical response to vitamin D measured by a) change in
           the number of T2 lesions and Gadolinium enhancing lesions on MRI scanning at 24 weeks
           compared to baseline b) reduction in relapses over 24 weeks in treated (both 5,000 IU
           and 10,000 IU) CIS patients versus CIS patients receiving placebo.
    

Intervention name(s): 5000IU vitamin D; 10000IU vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Vigantol Oil; Vigantol Oil; Placebo Oil
Other intervention name(s): Vigantol Oil; Vigantol Oil; Placebo Oil
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, dose ranging, two doses of vitamin D, randomised parallel groups with placebo arms in clinically isolated syndrome and heathy control participants
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clinically isolated syndrome; Multiple sclerosis; Vitamin D; Immune response; CD4 T cell subsets; Cytokine
Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts
Condition: Breast Reconstruction; Contour Irregularities; Volume Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate if there is a relationship between the take of
      fat grafts with and without ADSCs and the presence of specific surface markers on the cells
      of the stromal vascular fraction.
    

Detailed description: 
      Two groups of patients will be studied. The control will receive centrifuged fat grafts while
      the other group will receive centrifuged enriched fat grafts with ADSCs. The performance of
      both grafts will be assessed through volume measurement employing MRI before and after 6
      months post-op.
    

Intervention name(s): centrifuged fat graft; ADSCs enriched fat graft
Intervention type(s): Genetic; Genetic
Intervention description(s): fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group.; fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adipocytes; cell transplantations; mesenchymal stem cell; immunophenotyping; adipose tissue; breast reconstruction; mammaplasty; magnetic resonance imaging; fat necrosis
Breath Test for Chemicals (Volatile Organic Compounds)
Condition: Breath Tests; Human Volunteers; Pilot Study
Study type: Observational

Summary: 
      Background:

      - Some types of cancer, like cancer of the esophagus, are difficult to detect at an early
      stage. A possible detection method involves collecting breath samples to look for chemicals
      that may be signs of cancer. However, more research is needed to determine how different
      chemicals appear in different breath samples. This study will involve healthy volunteers.

      Objectives:

      - To study chemicals appearing in breath samples of healthy volunteers.

      Eligibility:

      - Healthy volunteers between 30 and 60 years of age.

      Design:

        -  Participants will fast overnight (midnight to morning) and then provide two breath
           samples taken 5 minutes apart.

        -  Breath samples will be collected on days 1, 49, and 98 of the study
    

Detailed description: 
      Background:

      Although breath tests are common for specific uses where the biomarker is highly concentrated
      (e .g. alcohol, urea for Helicobacter prylori infection), lower concentration compounds in
      the breath can also provide information on exogenous exposures and endogenous metabolic
      processes.

      Employing standardized collection techniques and high sensitivity measurement technologies
      have shown that breath profiles can accurately identify people with diseases such as breast
      cancer and lung cancer.

      Breath profiling technologies have great potential as non-invasive tools for diagnosis and
      risk stratification of precancerous disease as well as elucidation of the causes of cancer.

      Prior to using breath profiles for these purposes it is essential to assess how much of the
      breath profile and which parts of the breath profile are relatively stable over a period of
      time.

      Objectives:

      The primary objective of this pilot study is to assess the intra-individual variability of
      breath profiles sampled over a period of 98 days.

      Eligibility:

      DCEG volunteers aged 30-60 years, inclusive.

      Design:

      Pilot study.

      Five DCEG volunteers will be enrolled for this study.

      We will assess breath profiles sampled in duplicate at three time periods (days 1, 49 and
      98).

      We will calculate a coefficients of variation (CV) to determine the proportion and parts of
      the breath profile which have values less than 10% when collected on the same day,49 days
      apart, and 98 days apart.
    

Observational model: Other
Time perspective: Prospective
Keywords: Breath Tests; Human Volunteers; Pilot Study; Breath Test
The Effect of Oily Fish and Poultry on Children's Cardiometabolic Health and Cognitive Function
Condition: Cardiometabolic Health; Cognitive Function
Study type: Interventional

Summary: 
      The purpose of FiSK Junior is to investigate whether intake of oily fish compared to poultry
      affects cardiovascular risk markers, cognitive function, and behaviour in healthy children.
    

Detailed description: 
      The FiSK Junior study compares the effects of consuming oily fish versus poultry (control) in
      healthy 8-9 year-old Danish children. The children will be randomized to consume
      approximately 300 g/week of either oily fish or poultry for 12 weeks. Measurements and
      biological sampling will be performed at baseline and at the end of the intervention.

      The main objective of the study is to investigate the effect on cardiovascular risk markers,
      primarily blood pressure and plasma triacylglycerol. Moreover, the effects on cognitive
      function, behaviour, emotions and physiological stress response will be assessed. In
      addition, change in n-3 long chain polyunsaturated fatty acid status (compliance),
      anthropometry, body composition, vitamin D status, inflammatory markers, growth markers,
      physical activity and diet will be measured. Outcomes will be analysed with focus on
      potential gender- and genotype-specific effects.
    

Intervention name(s): Oily fish; Poultry
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A selection of oily fish, including salmon, herring and mackerel, provided for dinner and lunch; A selection of poultry, mainly chicken, provided for dinner and lunch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Omega-3; Child nutrition; Dietary recommendations; Cardiovascular risk markers; Cognitive function; Mental health
Circulating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms; Neoplastic Cells, Circulating
Study type: Interventional
Phase: Phase 2

Summary: 
      The majority patients diagnosed with pancreatic cancer have metastatic disease at the time of
      diagnosis. The prognosis is extremely poor with a 5-year survival rate of less than 5%.
      Treatment with chemotherapy can improve efficacy, but still the median progression-free
      survival in patients receiving nab-paclitaxel and gemcitabine is only 5,5 months and median
      overall survival is less than one year. There is a urgent need for tools for predicting the
      efficacy of the treatment. The current trial aims at investigating the biomarker potential of
      circulating tumor cells (CTCs) in metastatic pancreatic cancer patients treated by
      gemcitabine and nab-paclitaxel.
    


Intervention name(s): Nab paclitaxel / gemcitabine
Intervention type(s): Drug
Intervention description(s): Patients will receive gemcitabine/nab-paclitaxel combination chemotherapy
Other intervention name(s): Nab-paclitaxel and Gemcitabine
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Circulating tumor cells; Nab-paclitaxel; Metastatic pancreatic cancer; Gemcitabine