bioihbjkbjnl/mcl2 huggingface dataset:
Exercise Training and Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether 4-months of interval-walking exercise training
      improves glycemic control in individuals with type 2 diabetes mellitus. The effects of
      interval-walking training will be compared to continuous-walking exercise in a randomised,
      controlled trial design. Changes in glycemic control will be examined using oral glucose
      tolerance tests (OGTT) with stable isotope methodology. In addition, insulin sensitivity and
      secretion will be examined using glucose clamps combined with glucagon-like peptide 1 (GLP-1)
      and glucose-dependent insulinotropic polypeptide (GIP).
    


Intervention name(s): Exercise Training - Interval Walking; Exercise - Continuous Walking
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Duration: 4 months. Exercise training sessions will be performed 3-5 days/week. Sessions will consist of walking for 3 minutes at 70% VO2max followed by 3 minutes at 40% VO2max for up to 60 minutes/day.; Duration: 4 months. Exercise training sessions will be performed 3-5 days/week and will consist of walking for up to 60 minutes/day at 55% VO2max.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Diabetes; Obesity; Insulin Sensitivity; Insulin Secretion; Beta-cell Function; Glycemic Control; GIP; GLP-1
Tumor Metabolism of Head and Neck Cancer in Patients Who Underwent Radiation Therapy Measured With F-18-FDG-PET
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      The purpose of the study is to describe the regional and global FDG-kinetics in head and neck
      cancer during percutaneous radiation therapy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study includes consecutive patients from the Department of Radiooncology with head and
        neck cancer (HNC) intended for a curative chemoradiotherapy.
      
Keywords: Radiation therapy; F-18-FDG
Suvorexant and Cocaine
Condition: Cocaine Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The research proposed here will translate findings from preclinical research and provide the
      initial clinical evidence that orexin antagonism reduces motivation for cocaine, as well as
      other cocaine-associated maladaptive behaviors in active cocaine users. This study will also
      provide basic science information about the orexinergic mechanisms underlying the
      pharmacodynamic effects of cocaine in humans. As such the outcomes will contribute to our
      understanding of the clinical neurobiology of cocaine use disorder. Overall, the proposed
      work seeks to expand the scope of current clinical neuroscience research on cocaine addiction
      by focusing on orexin, which has strong preclinical evidence supporting its critical role in
      addiction but remains unstudied in humans.
    


Intervention name(s): Suvorexant; Cocaine; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The pharmacodynamic effects of suvorexant maintenance will be determined.; The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.; The pharmacodynamic effects of placebo will be determined.
Intervention MeSH terms: Cocaine; Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Observational

Summary: 
      There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal
      intensive care units (NICU) use an underwater bubbling system and others use a ventilator to
      generate the pressure. There is no right or wrong way to generate the pressure and both
      methods are approved and accepted.

      The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each
      for a defined time period and reviewing the infant's vital signs. The investigators expect
      that the pressure generated by bubble CPAP will be better and lead to improved vital signs.
    

Detailed description: 
      There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal
      intensive care units (NICU) use an underwater bubbling system and others use a ventilator to
      generate the pressure. There is no right or wrong way to generate the pressure and both
      methods are approved and accepted.

      The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each
      for a defined time period and reviewing the infant's vital signs. The investigators expect
      that the pressure generated by bubble CPAP will be better and lead to improved vital signs.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Premature infants admitted to the Neonatal Intensive Care Unit (NICU) at Maimonides Medical
        Center.
Vaginal Innate Immunity in Normal and HIV-Infected Women
Condition: HIV; Pregnancy
Study type: Observational

Summary: 
      The innate immunity of the vaginal tract provides first-line defense from abnormal
      microorganisms or overgrowth of common organisms, such as Candida species or Gardnerella
      vaginalis. It is unclear from the current available literature whether the rate of vaginal
      infection increases or decreases in frequency during pregnancy when compared to the
      non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. Vaginal
      infections are important players in HIV disease, potentially increasing the risk of viral
      transmission. In addition, these infections may activate inflammatory markers in the
      reproductive tract and increase the risk of premature delivery or other negative pregnancy
      outcomes. The vaginal innate immune system has not been well characterized in pregnant women,
      or in women with HIV infection. The study of how this system changes in pregnancy and HIV
      infection will provide essential knowledge for further study of vaginal mucosal protection.

      The investigators study is an observational study designed to compare levels of vaginal
      innate immunity markers in women based on a) pregnancy status and b) HIV infection status.
      Comparisons will be made between pregnant and non- pregnant women and between HIV positive
      and HIV negative women. The investigators hypothesize that there will be significant
      differences in levels of innate immunity between the groups.
    


Intervention name(s): Vaginal lavage specimen
Intervention type(s): Other
Intervention description(s): Collection of 3cc of saline used in the vagina to collect innate immunity markers
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women, 18 to 40 years old, with spontaneous menstrual cycles or with normal ongoing
        pregnancy with gestational age between weeks 13 - 30 and able to provide informed consent
      
Biospecimen description: 
      Vaginal lavage samples
    
Keywords: innate immunity; HIV; pregnancy; vaginal immunity
Low-frequency Electrical Stimulation of Acupuncture Points
Condition: Stroke Sequelae
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Abstract:

      Objective: To examine the effect of low-frequency acupoint electrical stimulation (LFES) on
      the surface electromyographic (sEMG) signals of the thumb-to-finger movement muscles in
      stroke patients, and to evaluate the clinical efficacy of LFES on hand function recovery
      after stroke.
    

Detailed description: 
      Methods: Sixty patients who met the inclusion criteria were randomly assigned to a LFES group
      or an electroacupuncture (EA) group, with 30 patients in each group. Both groups received
      conventional treatment, and the EA group was treated with acupoints from the book of
      Acupuncture and Moxibustion, while the LFES group was treated with acupoints from a previous
      study. The sEMG characteristic values (MAX and RMS), Chinese Stroke Clinical Neurological
      Deficit Scale (CSS), Brunnstrom Motor Function Evaluation, Modified Ashworth Scale (MAS),
      Lindmark Hand Function Score and Lovett Muscle Strength Classification were measured before
      and after treatment.
    

Intervention name(s): low-frequency acupoint electrical stimulation
Intervention type(s): Drug
Intervention description(s): In order to determine the efficacy of low-frequency acupoint electrical stimulation and electroacupuncture to improve thumb to finger action after stroke
Other intervention name(s): electroacupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: low-frequency acupoint electrical stimulation
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Interactions Between Artemether-lumefantrine and Antiretrovirals in HIV-patients With Uncomplicated Malaria in Tanzania
Condition: Malaria, Falciparum; HIV Infections
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      As HIV/AIDS is spreading in malaria-endemic countries, many patients here will need
      concomitant treatment for both infections. Effective combination treatments are available for
      both malaria (artemisinin-based combination treatments, ACTs) and HIV/AIDS (antiretroviral
      combination treatments, ARTs), and these treatments are presently recommended for concomitant
      use by ministries of health in many endemic countries, including Tanzania. However,
      theoretically some of these drugs may be involved in harmful interactions with each other, as
      they share common cytochrome enzymes involved in their metabolism. Such interactions could
      lead to less effective treatments and/or adverse effects, as a consequence of reduced or
      increased drug levels, respectively. Only little clinical and pharmacological information is
      however yet available to guide clinicians and policy-makers on this issue.

      The main aim of the InterACT study in Tanzania is to conduct a series of detailed
      observational studies of clinical and paraclinical safety, therapeutic efficacy and
      pharmacokinetic interactions between the currently nationally recommended first-line
      treatment for malaria, artemether-lumefantrine, and first-line antiretroviral treatments,
      primarily nevirapine-based combinations, for HIV/AIDS. The studies will be conducted among
      patients with uncomplicated malaria, who attend the HIV/AIDS Care and Treatment Clinic and
      Muheza Designated District Hospital in Muheza, north-eastern Tanzania, which is an area
      characterized by intense transmission of Plasmodium falciparum malaria and with a prevalence
      of HIV around 8-10%. The study is expected to inform guidelines for the treatment of malaria
      in patients with HIV/AIDS in Tanzania, and elsewhere.
    


Intervention name(s): Artemether-lumefantrine (AL)
Intervention type(s): Drug
Intervention description(s): Standard treatment-dose of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria according to national treatment guidelines
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: uncomplicated malaria; HIV/AIDS; drug interactions; antimalarial drug efficacy; antiretrovirals; pharmacovigilance; Tanzania
Impact of Meal Fatty Acids on Postprandial Vascular Reactivity
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD) is the leading cause of death in women. Premenopausal women have
      a lower risk of CVD compared with men of a similar age. However, the incidence of CVD
      increases greatly after the menopause. The risk of heart disease is strongly associated with
      the health of an individual's blood vessels. It is thought that changes to the type of fat
      the investigators eat in their diet may affect the normal functioning and elasticity of the
      blood vessels, as well as affect cholesterol levels in the blood. Types of fat in the diet
      include monounsaturated fats (found mainly in olive oil), n-6 polyunsaturated fats (found
      mainly in sunflower oil) and saturated fats (found mainly in dairy products, such as butter
      and cheese). Since the investigators are in the fed (or postprandial) state for up to 18
      hours of the day, it is important to see how these different fats affect the investigators
      blood vessels and blood fats over the course of the day after eating a meal. The aim of this
      study is to determine how consuming meals rich in saturated fats, n-6 polyunsaturated fats or
      monounsaturated fats influence the normal functioning and elasticity of the blood vessels
      throughout the day in postmenopausal women. A secondary aim is to determine the effects of
      these different dietary fats on a range of accepted heart disease risk markers including
      circulating levels of fats (lipids) and glucose in the blood.
    


Intervention name(s): Saturated fat; Monounsaturated fat; n-6 polyunsaturated fat
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Other intervention name(s): SFA; MUFA; n-6 PUFA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiovascular disease; Fatty acids; Vascular function; Blood pressure; Plasma lipids; Insulin resistance; Endothelial activation
Overcoming Barriers and Obstacles to Adopting Diabetes Devices
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study will create a comprehensive, multicomponent behavioral intervention package
      (ONBOARD; OvercomiNg Barriers & Obstacles to Adopting Diabetes Devices). ONBOARD will provide
      adults with type 1 diabetes (T1D) the skills to maximize benefit and minimize daily
      interference from barriers associated with continuous glucose monitoring (CGM) and increase
      readiness for closed loop.
    

Detailed description: 
      The proposed research will create and refine the ONBOARD intervention for CGM use.
      Participants will be tracked using metrics of A1c, time in glucose target range, number of
      days using CGM, blood glucose (BG) downloads, diabetes problem solving, diabetes distress,
      and technology attitudes. The investigators will examine whether ONBOARD leads to improved
      diabetes and psychosocial outcomes and sustained CGM use. At the end of this study, the
      investigators will have created and refined a comprehensive, multicomponent intervention
      package to promote increased and sustained uptake of CGM and increase readiness for closed
      loop adoption.
    

Intervention name(s): ONBOARD
Intervention type(s): Behavioral
Intervention description(s): Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Cavosonstat (N91115) in Healthy Subjects (SNO-9)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is designed to assess the safety and tolerability of escalating, multiple
      ascending doses of Cavosonstat (N91115) in healthy subjects.
    

Detailed description: 
      This study will assess the safety and tolerability of escalating, multiple ascending doses of
      Cavosonstat (N91115) in healthy subjects.

      Approximately 5 ascending cohorts are planned with approximately 8 subjects per cohort (6
      active, 2 placebo). Each subject will undergo screening (Day -28 to Day -2) and, if eligible,
      return to the unit on Day -1 when eligibility will be reconfirmed.

      Eligible subjects will be randomized in a 3:1 ratio to receive investigational medicinal
      product (IMP) N91115 (daily [QD] or every 12 hours [Q12H]) or matching placebo (QD or Q12H)
      for 7 days and will be followed for safety while housed in the clinical research unit (CRU)
      until discharge on Day 8. Pharmacokinetics will be followed from Study Day 1 through the
      morning of Study Day 8. The subjects will be discharged from the CRU and complete the post
      treatment withdrawal phase, including a follow-up phone call on Day 15.
    

Intervention name(s): Cavosonstat; Placebo
Intervention type(s): Drug; Other
Intervention description(s): CFTR modulator that stabilizes CFTR; Matched placebo
Other intervention name(s): N91115
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: N91115; Cavosonstat; Healthy Volunteer
D-Ribose for Fatigue in Subjects With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and to determine the efficacy of D-ribose for the amelioration of
      fatigue in subjects with fibromyalgia. This is a phase IIa, randomized, double-blind,
      placebo-controlled, multi-center, multiple dose study of D-ribose versus placebo administered
      at doses of 5 g three times a day (TID) over a 12-week period to subjects who are
      experiencing fatigue associated with a diagnosis of fibromyalgia.
    


Intervention name(s): D-Ribose Powder; Placebo Powder
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 5 g TID for 12 Weeks; 5 g TID for 12 Weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Fatigue; D-Ribose
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      • To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK
      5107 alone and in combination with cefepime in healthy adult human subjects.
    


Intervention name(s): WCK 5107 250 mg to 2000 mg; Cefepime 2000 mg; WCK 5107 1000/2000 mg with Cefepime 2000 mg combination; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Cefepime
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Non-invasive Measurement of Hemoglobin in Infants and Neonates
Condition: Hemoglobins
Study type: Observational

Summary: 
      Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective
      congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared
      to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM
      3500 premiere).
    

Detailed description: 
      Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective
      congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared
      to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM
      3500 premiere). Data collection whenever an arterial blood gas analysis is indicated by the
      experienced attending anesthetist - before and after cardiopulmonary bypass.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants and neonates undergoing congenital heart surgery weighing between 3kg and 20kg
      
Keywords: blood gas monitoring; non-invasive; hemoglobin
Effect of Gastric Bypass Surgery on Diabetes Status and Microvascular Complications in Obese Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus; Obesity; Diabetic Retinopathy; Diabetic Nephropathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study evaluates the long-term benefits of Roux-en-Y gastric bypass (RYGB) on type 2
      diabetes mellitus, focussing on the prevalence and predictors of T2DM improvement and
      remission after RYGB, and subsequently relapse of type 2 diabetes mellitus after RYGB.
      Moreover, the study evaluates the possible effect of RYGB on diabetic microvascular
      complications such as nephropathy and retinopathy. Finally, the study provides insight into
      the factors influencing glucose-insulin homeostasis after RYGB, including altered microbiota
      diversity and bile acid levels.
    

Detailed description: 
      One hundred Danish type 2 diabetes mellitus (T2DM) patients who underwent Roux-en-Y gastric
      bypass surgery (RYGB) between 2006-2011 will be evaluated clinically together with 50 T2DM
      patients, matched on gender, age, presurgical body mass index, and diabetes duration.

      The clinical follow-up consists of a physiological check-up, a thorough paraclinical work-up,
      and a whole body dual-energy x-ray absorptiometry (body composition and bone mineral density)
      a peripheral quantitative compute tomography (HR-pQCT), stool samples (microbiota),
      ophthalmological examination including retina photo, and a questionaire.

      More over, a liquid meal test with sampling of total bile acids, fibroblast growth factor 19
      and 21 (FGF 19 and FGF 21), plasma glucose, and insulin will be performed on a smaller part
      of the patients.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Cases: Type 2 diabetes mellitus patients living in Central Denmark region that have
        undergone Roux-en-Y gastric bapass between 2006-2011.

        Controls: Type 2 diabetes mellitus patients living in Central Denmark region,
        non-RYGB-operated
      
Biospecimen description: 
      blood samples urine samples stool samples
    
Keywords: Roux-en-Y gastric bypass; obesity; type 2 diabetes mellitus; diabetic nephropathy; diabetic retinopathy
Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without
      coadministration of 150 mg ranitidine.
    


Intervention name(s): BIBR 1048 MS; Ranitidine
Intervention type(s): Drug; Drug
Intervention description(s): Low, medium or high dose; 150mg
Other intervention name(s): Zantic ®
Intervention MeSH terms: Ranitidine; Ranitidine bismuth citrate; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment