bioihbjkbjnl/mcl2 huggingface dataset:
Mitochondrial Function in Circulating Cells and Muscle Tissue
Condition: Healthy; Obesity; Insulin Sensitivity; Women
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      The main goal of this project is to determine whether mitochondrial function in circulating
      cells is related to that measured in the muscle fibers of the same subjects.
    

Detailed description: 
      Data from human and animal models strongly suggests that reduced tissue mitochondrial
      function can be an early marker for detection of dysfunctional metabolism. It is unclear if
      tissue mitochondrial dysfunction can be detected using less invasive methodology. In this
      project, the investigators plan to study mitochondrial bioenergetics in circulating cells and
      paired muscle biopsies in two metabolic disparate groups of women; healthy lean vs.
      overweight/obese with/without insulin resistant women of similar age. Women of similar age
      that are either healthy lean or overweight/obese with/without insulin resistance will be
      recruited to participate in one study that includes a blood draw and a muscle biopsy.
      Mitochondrial function in circulating blood cells and muscle tissue will be determined. The
      association between circulating blood cells and muscle tissue mitochondria respiration will
      be determined for the two groups combined, and differences between groups will also be
      investigated.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Twenty (20) healthy lean and 20 insulin resistant and obese women, age 25-35 years.
      
Keywords: Mitochondria; women; muscle; PBMC
The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine
Condition: Cocaine Addiction; Cocaine Abuse; Cocaine Dependence; Substance Abuse
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to asses the potential interactions between intravenous cocaine
      and doxazosin in cocaine dependent volunteers who are not seeking treatment. The study will
      evaluate the effects of doxazosin on the cardiovascular and subjective effects of cocaine in
      a human laboratory study.
    

Detailed description: 
      Primary Objective: The primary objective is to determine the safety of treatment with
      doxazosin in cocaine-dependent volunteers by examining hemodynamic and subjective effects of
      administration of ascending doses of cocaine (0, 20mg, and 40mg) and a placebo dose during
      treatment with doxazosin.

      Secondary Objectives: To evaluate the effect of doxazosin on the pharmacokinetics of
      intravenously administered cocaine; To determine effects of treatment with doxazosin, as
      compared to placebo, on subjective effects produced by administration of cocaine or placebo.
    

Intervention name(s): Placebo; Doxazosin
Intervention type(s): Drug; Drug
Intervention description(s): Matching administration of a placebo pill.; The dose of doxazosin needed to alter the effects of cocaine is unknown and preclinical animal studies have not been conducted. Because of this, initially we will study the effects of a low dose of doxazosin (4 mg daily) compared to placebo daily. Because this class of medication needs to be titrated upward due to the potential for hypotension, treatment will begin at 1 mg and increased by 1 mg increments every three days until 4 mg is reached on day 12.
Other intervention name(s): Sugar pill; Cardura
Intervention MeSH terms: Doxazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Cocaine; Doxazosin
Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation
Condition: Living Donor Liver Transplantation
Study type: Interventional

Summary: 
      The aim of this study was to characterize pharmacokinetics of fentanyl during and after
      Living Donor Liver Transplantation (LDLT), using population pharmacokinetic analysis with non
      linear mixed effects modeling.
    

Detailed description: 
      Patients received an initial intravenous bolus of fentanyl 100 μg and infused at variable
      rates ranging from 250 to 400 μg/hr.

      Arterial blood samples (3ml) were taken immediately before the start of infusion (baseline),
      and at scheduled time which were coincident with laboratory tests during surgery as follows.
      In pre-anhepatic phase, blood were taken at 10min, 30min, 1hr, 3hr, 5hr until clamping of the
      hepatic blood supply and venous drainage, after the star of anhepatic phase, blood were taken
      at 5 min, 10 min, 30 min, 60 min, 90 min, 2hr until the vessels were reconnected to new
      liver. In neo-hepatic phase, blood were taken at 5min, 10min, 30min, 60min, 90min, 2hr, 3hr,
      5hr until fentanyl-infusion stop, and at 0hr, 1hr, 3hr, 5hr, 8hr, 12hr, 24hr immediately
      after the stop of infusion. Samples were collected into tubes containing heparin as an
      anticoagulant and immediately placed on ice. After centrifugation for 8 min at 1800 g, the
      plasma was transferred to a cryovial and stored at -70°C until assay.
    

Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention description(s): an initial intravenous bolus of fentanyl 100 μg and infusion of fentanyl at variable rates ranging from 250 to 400 μg/hr
Intervention MeSH terms: Fentanyl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LDLT
Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects
Condition: Healthy Volunteers; Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem
      to treat bacterial infections, including those due to multi-drug resistant bacteria.
    

Detailed description: 
      The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly
      members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of
      hospital acquired infections. In particular, the recent dissemination of a serine
      carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable
      threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.

      Rempex is developing a fixed combination antibiotic of a carbapenem plus a new beta-lactamase
      inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This
      Phase 1 study will assess the safety, tolerability and pharmacokinetics of RPX7009,
      administered alone, in healthy adult subjects.
    

Intervention name(s): RPX7009; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.; Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
Other intervention name(s): (beta-lactamase inhibitor); Normal saline
Intervention MeSH terms: beta-Lactamase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of an mHealth Intervention for Youth With Congenital Heart Disease
Condition: Congenital Heart Disease; Adolescent Behavior
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The aims of this study were to evaluate the long-term effectiveness of the Care & Organize
      Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program, on improving
      disease knowledge and physical activity in youth with congenital heart disease (CHD). The
      COOL program is a 12-month randomized controlled trial that compared two active intervention
      groups to a standard-care control group (n = 47). Participants with simple and moderate CHD
      aged 15-24 years were recruited from pediatric or adult CHD outpatient departments.
      Participants in one active intervention group (n = 49) were provided with COOL Passport, a
      mobile healthcare application. Those in the other group (n = 47) were provided with access to
      the Health Promotion Cloud system and use of game-based interactive platforms along with COOL
      Passport. Outcomes were the Leuven Knowledge Questionnaire for CHD and the International
      Physical Activity Questionnaire-Taiwan Show-Card Version.
    

Detailed description: 
      Background: Mobile health initiatives may provide youth with congenital heart disease (CHD)
      relevant health information and a platform for managing the complex health care needs
      associated with undergoing transitional care.

      Aims: To evaluate the long-term effectiveness of the Care & Organize Our Lifestyle (COOL)
      program, a self-regulation theory-based mHealth program, on improving disease knowledge and
      physical activity in youth with CHD.

      Methods: The COOL program is a 12-month randomized controlled trial that compared two active
      intervention groups to a standard-care control group (n = 47). Participants with simple and
      moderate CHD aged 15-24 years were recruited from pediatric or adult CHD outpatient
      departments. Participants in one active intervention group (n = 49) were provided with COOL
      Passport, a mobile healthcare application. Those in the other group (n = 47) were provided
      with access to the Health Promotion Cloud system and use of game-based interactive platforms
      along with COOL Passport. Outcomes were the Leuven Knowledge Questionnaire for CHD and the
      International Physical Activity Questionnaire-Taiwan Show-Card Version.
    

Intervention name(s): an mHealth intervention
Intervention type(s): Behavioral
Intervention description(s): The Care & Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula
Condition: Pancreatic Fistula
MeSH terms: Pancreatic Fistula; Fistula
Study type: Observational [Patient Registry]

Summary: 
      For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard
      treatment. However, PD is technically demanding and has high morbidity and mortality rates.
      The most significant and life-threatening complication of PD is postoperative pancreatic
      fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically
      relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this
      study.
    

Detailed description: 
      For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard
      treatment. However, PD is technically demanding and has high morbidity and mortality rates.
      The most significant and life-threatening complication of PD is postoperative pancreatic
      fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically
      relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this
      study.
    

Intervention name(s): pancreaticoduodenectomy procedure
Intervention type(s): Procedure
Intervention description(s): Pancreaticoduodenectomy operation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all consecutive patients who were treated with a pancreaticoduodenectomy
      
Keywords: risk factors,; clinically relevant pancreatic fistula,; pancreaticoduodenectomy
Effect of Nitrous Oxide on EEG
Condition: Nitrous Oxide; Electroencephalography; Anesthetic, Inhalation
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      Our recent preclinical observations suggest that monitoring of slow electroencephalogram
      (EEG) oscillations may be used to predict the efficacy of rapid-acting antidepressants such
      as ketamine or nitrous oxide. In this project we will carry out critical clinical research on
      healthy volunteers and study the effects of nitrous oxide on EEG. Results will be used for
      the design of clinical trials on depressed individuals. The project will be done in
      collaboration between neuroscientists at the University of Helsinki and clinicians at the
      Tampere University Hospital.
    


Intervention name(s): Nitrous Oxide
Intervention type(s): Drug
Intervention description(s): 50% nitrous oxide
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: EEG; Slow wave activity; Nitrous oxide; N-methyl-D-aspartate-receptor blockade; Delta wave; Self-reported psychiatric symptoms
Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study
Condition: Cervical Dystonia; Spasmodic Torticollis
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional

Summary: 
      The overall objective of this application is to therapeutically target the dysfunctional
      premotor-motor interaction in dystonia-and to provide a focused treatment of specific
      anatomical networks in order to reduce side effects and to improve symptom control over
      conventional therapies.
    

Detailed description: 
      We propose using repetitive transcranial magnetic stimulation (rTMS) over distinct premotor
      areas in patients with cervical dystonia (CD) with the goal of improving symptoms and
      reducing unwanted side effects. The knowledge gained in this proposed research will identify
      a specific premotor area to be targeted with rTMS that is expected to result in a novel
      intervention that could enhance or replace current treatments for CD. rTMS could be included
      as an adjunct treatment to botulinum toxin that could sustain treatment effect and decrease
      the frequency of re-injection, potentially resulting in cost savings without a decrease in
      symptom control. In addition to medical cost reduction, improved quality of life could be
      expected with the successful development of therapies that extend dystonia symptom control.
      rTMs has been FDA-approved for the treatment of depression and our proposal uses an even
      lower stimulation rate, suggesting continued use within clearly safe parameters. Successful
      completion of this research could lead to rapid adoption of this therapeutic modality.

      We will test the hypothesis that rTMS of a distinct premotor site will provide more effective
      treatment of CD than non-specific activation of the entire premotor region. This will be done
      by performing a randomized, observer-blinded exploratory pilot study to determine the optimal
      site of rTMS over various sites of the premotor and motor cortex to improve the symptoms of
      cervical dystonia. Completion of this aim should lead to development of targeted TMS therapy
      for CD.
    

Intervention name(s): rTMS
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cervical dystonia; torticollis; rTMS
Multi Modal Stimulations in Pre-term Neonates
Condition: Preterm Birth; Infant, Premature, Diseases
MeSH terms: Premature Birth; Infant, Premature, Diseases
Study type: Interventional

Summary: 
      A total of 56 neonates with LBW will recruited by the convenience sampling to participate in
      this two group pre-test post-test, single blinded randomized clinical study. After the
      demographics, recruited NLBW will be randomly divided into two groups, group A and group B
      with block randomization. There will be four blocks, with the matrix design of 4X14 here 14
      being rows. Each block contained 4 chits (2 chits for each group), totalling 56. The subjects
      will be allotted to the group based on the randomly chosen chit by their parents. Once the
      block will be allotted, next row block was opened. Thus, equal number of NLBW will be
      assigned to each group over time.

      Group A will be receiving multimodal sensory and kinesthetic stimulation (MSKS) and Group B
      will be receiving regular lifesaving hospital care. Group A will receive the interventions
      for 2 weeks period, totalling 10 sessions. Each session will last for 30 minutes duration.
    


Intervention name(s): Sensory Stimulation; Movement therapy; Routine hospital care
Intervention type(s): Other; Other; Other
Intervention description(s): Auditory, tactile, visual, vestibular and oro motor stimulation; Passive range of movements, antigravity movements in prone and supine; Maintaining the vitals
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group pre-test post-test design
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Preterm; Neonate; Multi-modal stimulation
Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Positive reactions in Atopy patch test in children with food allergy-related gastrointestinal
      symptoms
    

Detailed description: 
      The prevalence of food allergy seems to be increasing, which might explain the increased
      demand for reliable evaluation of patients with suspected food-related gastrointestinal
      symptoms. Little is known about the diagnostic accuracy of atopy patch tests(APT) in the
      clinical practice. APT seems to have a better specificity than the IgE methods and seems to
      reflect late-phase clinical reactions.The aims of this study were to evaluate:

      (i) The prevalence of positive reaction of APTs for food allergy-related gastrointestinal
      diseases. (ii)Positive reaction of APT compare with skin prick test. (iii)Positive reaction
      of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or
      adverse events of APT
    

Intervention name(s): Atopy patch test with food allergen
Intervention type(s): Device
Intervention description(s): Atopy patches used with food lyophilized allergen and commercial allergen were placed on back of subjects for 48 hrs then atopy patches were taken off. Subjects should return to evaluate the reaction one day later (72 hr after applying atopy patch test)
Other intervention name(s): Fin chamber
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Atopy patch test
Evaluation of Nasal Inflammatory Biomarkers
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      This research aims to establish a panel of inflammatory biomarkers of the early (Histamine,
      Tryptase, ProstaglandineD2) and late (Interleukin-4, Interleukin-5, Interleukin-6,
      Interleukin-13, Eotaxin, Tumor necrosis factor-a (TNF), (Macrophage Inflammatory
      Protein-1beta (MIP1ß)) phase response to nasal bolus allergen challenge (NAC) in subjects
      with out-of-season seasonal allergic rhinitis, suitable for future application in drug
      intervention studies of novel anti-allergy therapeutics.
    

Detailed description: 
      Biomarkers will be sampled by nasal filter paper (NFP) adsorption and lavage (NLF) prior to
      and following NAC. Samples from initial subjects (Cohort A; n~6) will be used primarily for
      validation of biomarker assays in nasal filter paper eluates. Validated biomarker assays will
      be applied to analyze biomarker changes in a further cohort of subjects (Cohort B; n~12) with
      the aim of fully defining the optimum panel and sampling time points for future studies.
    

Intervention name(s): NAC (no drug/no device)
Intervention type(s): Other
Intervention description(s): Nasal allergen challenge (NAC) with mixed grass pollen: a bolus NAC with mixed grass pollen will be conducted
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Misoprostol for Small Bowel Ulcers and Obscure Bleeding Due to Aspirin or Nonsteroidal Antiinflammatory Drugs
Condition: Chronic Arthritis; Ischemic Heart Disease; Atrial Fibrillation; Anemia; Bleeding
MeSH terms: Atrial Fibrillation; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Anti-inflammatory tablets (non-steroidal anti-inflammatory drugs) continue to be used
      commonly worldwide to relieve pain caused by arthritis. Likewise, aspirin is used by many
      patients in order to prevent blood clots. Despite their desired benefits, these medicines can
      cause internal bleeding from the digestive system. The source of this bleeding can be obvious
      (overt), or obscure and thought to come from the small intestine. Obscure bleeding can show
      as anemia due to lack of iron in the blood. Small intestine ulcers are now easily diagnosed
      using an endoscope the size of a big pill (video capsule endoscopy). Small bowel ulcers are
      not related to stomach acid and therefore do not heal using remedies usually taken to stop
      acid formation. A different drug, misoprostol, consists of a chemical (prostaglandin) that is
      usually lacking in patients using aspirin or anti-inflammatory drugs. Misoprostol is licenced
      to heal stomach and duodenal ulcers in patients using these drugs. Our hypothesis is that
      misoprostol might be effective in healing small bowel ulcers as suggested by pilot studies;
      however, such works only included small numbers of patients, did not include control groups
      and both patients and investigators knew the nature of the tablets used. To test this
      hypothesis, we propose to compare misoprostol to a dummy tablet. The numbers of subjects to
      be studied have been calculated using established statistical methods
    

Detailed description: 
      METHODOLOGY:

        -  Upper gastrointestinal endoscopy and colonoscopy on patients with obscure bleeding and/
           or iron deficiency anemia.

        -  Video capsule endoscopy on those fulfilling the inclusion criteria

        -  Randomization to Misoprostol 200 micrograms or placebo, 4 times each day given for 8
           weeks to aspirin/ NSAID users with erosive small bowel lesions.

        -  Video capsule endoscopy at 8 weeks to check healing of small bowel lesions.

        -  Full blood count at baseline and monthly intervals (0, 4, and 8 weeks)
    

Intervention name(s): Misoprostol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Misoprostol oral tablets/ capsules contain 200 mcg of Misoprostol, a synthetic prostaglandin E1 analog; Placebo contains lactose granules
Other intervention name(s): Cytotec (R); Dummy drug
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aspirin; Intestinal bleeding; Misoprostol; NSAIDs; Small intestine; Video capsule endoscopy