bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      Insulin treatment often causes the blood glucose levels to fall too low. The body usually
      responds to low blood glucose levels by releasing hormones which act against the insulin to
      help correct the low blood glucose levels. However, this hormone response can be altered in
      people with diabetes. Currently there are no therapeutic agents that can be used to improve
      the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people
      who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it
      can also affect the levels of the hormones which are released during hypoglycemia. The aim of
      this study is to determine whether naltrexone can be used to improve and accelerate the
      recovery from hypoglycemia in patients with type 1 diabetes.
    


Intervention name(s): Naltrexone High Dose; Naltrexone Low Dose
Intervention type(s): Drug; Drug
Intervention description(s): Naltrexone 100mg for two administrations.; Naltrexone 50mg for two administrations.
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypoglycemia; Type 1 diabetes
Is Dexmedetomidine Associated With a Lower Incidence of Postoperative Delirium When Compared to Propofol or Midazolam in Cardiac Surgery Patients
Condition: Delirium
MeSH terms: Delirium
Study type: Observational

Summary: 
      The purpose of this chart review study is to determine whether the use of dexmedetomidine, a
      selective α2-adrenergic receptor agonist with sedative, analgesic, and antinociceptive
      properties, would be associated with a lower incidence of delirium when compared to propofol
      and midazolam. We hypothesize that sedation with dexmedetomidine following cardiac surgery
      with CPB will be associated with a lower incidence of postoperative delirium.
    

Detailed description: 
      Delirium is the most common psychiatric syndrome found in the general hospital setting.
      Between 32 - 80% of cardiac surgery patients may experience post-operative delirium. Because
      failure to recognize delirium leads to increased morbidity and mortality and prolonged
      hospital stays, there are compelling clinical and financial reasons to improve the
      identification and treatment of delirium. Dexmedetomidine, a selective alpha2-adrenergic
      receptor agonist, may be an alternative to current postoperative sedation when it comes to
      lowering the incidence of delirium.

      Comparisons: The use of postoperative (at sternal closure) dexmedetomidine will be compared
      to current standards of care propofol and midazolam for postoperative sedation.
    

Intervention name(s): Dexmedetomidine; Propofol; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dexmedetomidine administered as part of anesthesia in cardiac surgery patients; Propofol administered as part of anesthesia in cardiac surgery patients; Midazolam administered as part of anesthesia in cardiac surgery patients
Other intervention name(s): Precedex
Intervention MeSH terms: Midazolam; Dexmedetomidine; Propofol
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Cardiac surgery patients
      
Keywords: cardiac surgery; valvular surgery; delirium; postoperative delirium; cognitive dysfunction; altered mental status
QL Block With Exparel in Colectomy
Condition: Laparotomy; Colectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if using a different type of injection of local
      anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a
      quadratus lumborum block) will improve pain control and be easier to manage after surgery
      than the current standard of care epidural (spinal injection) pain relief for patients
      undergoing laparoscopy colectomy.
    

Detailed description: 
      Participants in this study will receive exparel via an abdominal muscle nerve block procedure
      immediately prior to their operation. Participants will be in this study for 96 hours
      following surgery, which is typically 3 days. During participation, the study staff will
      review participant's electronic health records for pain scores and pain medication needs.

      Participants that receive the quadratus lumborum block, may experience improved pain control
      and/or reduced side effects compared to the epidural pain relief option, but it is not known
      yet whether this will be the case.

      The most common risk is being sore in the flank where the block was placed. Other risks of
      the block rarely occur (less than .5-1%), these can include infection, allergy to the local
      anesthetic, bleeding, damage to the nerve, seizures, abnormal heart rhythms, and cardiac
      arrest.
    

Intervention name(s): Exparel; Thoracic epidural analgesia
Intervention type(s): Drug; Other
Intervention description(s): Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.; Historical cohort that received thoracic epidural analgesia
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Compare efficacy of a quadratus lumborum block performed with liposomal bupivacaine for pain relief after laparoscopic colectomy compared to a historical cohort who received thoracic epidural analgesia.
Masking: None (Open Label)
Primary purpose: Treatment
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Asia, Europe and North and South America. The aim of the trial is
      to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus
      insulin aspart for the remaining meals in children and adolescents with type 1 diabetes
      mellitus.
    


Intervention name(s): insulin degludec/insulin aspart; insulin aspart; insulin detemir; insulin aspart
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.; Administered s.c. with the remaining meals. Dose individually adjusted.; Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing.; Administered s.c. at meal-times. Dose individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass
Condition: Bariatric Surgery
Study type: Interventional

Summary: 
      Using intravenous and oral administration of stable isotope tracers, we will investigate the
      importance of altered fat absorption and altered whole body fat metabolism for the reduced
      postprandial systemic TAG concentrations in non-diabetic patients in weight stable phase
      after RYGB.
    


Intervention name(s): Metabolic test; DXA-scan; MRS; Feces collection
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Iv and oral administration of stable isotope tracers during fasting and a high-fat liquid mixed meal; Dual energy X-ray Absorptiometry scan of whole-body fat; Magnetic resonance spectroscopy of liver fat content; 4-day feces collection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fat; triglyceride; triacylglycerol; Roux-en-Y gastric bypass; malabsorption
Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective was to investigate the effect of different doses of BI 10773 on the
      bioavailability of pioglitazone after multiple oral doses of both drugs
    


Intervention name(s): Pioglitazone; Pioglitazone - low dose; BI 10773 - low dose; BI 10773 - medium dose; BI 10773 - high dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Pioglitazone; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Objective Examination and Rehabilitation Treatment of Patients With BPPV
Condition: Postural Vertigo; Vertigo, Paroxysmal; Vertigo, Positional; Coordination Disorder, Developmental; Coordination and Balance Disturbances
MeSH terms: Vertigo; Dizziness; Motor Skills Disorders
Study type: Interventional

Summary: 
      Dizziness (BPPV) causes severe deterioration in quality of life, incoordination, and
      instability.

      In the study, we selected a minimum of 100 patients with BPPV who were examined after
      specialist care. After the acute phase, a physical survey is performed where movement and
      coordination are examined.

      After the results, the patients undergo a rehabilitation training. The workout is submaximal
      and high intensity that is done for 3 weeks.

      Hypothesis: As a result of training, it is possible that the remaining feeling of dizziness
      and insecurity, impaired coordination will decrease or disappear.
    


Intervention name(s): Neurorehabilitation
Intervention type(s): Behavioral
Intervention description(s): After examination of the patients, the patients undergo neurorehabilitation. We use virtual reality therapy. Patients perform a submaximal load that is monitored by a polar clock. We develop endurance, coordination, sensory integration, visual and acoustic input, vestibular training, proprioception training.
Other intervention name(s): BPPV group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: vertigo; balance; instability; rehabilitation
Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2
Condition: Pharmacokinetics; Drug Interactions; Pharmacodynamics; Intestinal Transporter Expression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of a chronic co-medication of efavirenz
      on pharmacokinetics and sterol-lowering effects of ezetimibe at steady-state in healthy
      subjects genotyped for ABCB1, ABCC2, CYP2B6 and UGT1A1.
    


Intervention name(s): Ezetrol (ezetimibe) multiple dose; Ezetrol (ezetimibe) multiple dose and Sustiva (efavirenz) single dose; Ezetrol (ezetimibe) and Sustiva (efavirenz) multiple dose; Sustiva (efavirenz) single dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): administration of 1 tablet/day Ezetrol (10 mg ezetimibe) on study day 6-15 and a pharmakokinetic on study day 15 (0-24 h blood sampling, 0-24 h urine sampling and 5 d feces sampling (study day 11-15)); administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) on study day 16-20 and 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 16 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 16-20); administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) and 2 capsules/day Sustiva(R) (2x200 mg efavirenz) on study day 21-30 and with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) on study day 30 and feces sampling on study day 26-30); administration of 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 1 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 1-5)
Other intervention name(s): Ezetrol; Ezetrol+Sustiva single dose; Ezetrol+Sustiva steady state; Sustiva
Intervention MeSH terms: Efavirenz; Ezetimibe
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Which Nostril Should be Used for Nasotracheal Intubation With Airtraq NT®: the Right or Left? A Randomized Clinical Trial
Condition: Nasotracheal Intubation
Study type: Interventional

Summary: 
      After Ethics committee approval investigators decided to enroll 40 patients ASA I-II, 18-60
      years of age undergoing maxillofascial, oral and double chin surgery to determine which
      nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. We primay
      aimed to compare the glottis visualization time, intubation time and total intubation times.
    

Detailed description: 
      After Ethics committee approval, investigators decided to enroll 40 pateints ASA I-II, 18-60
      years of age undergoing maxillofascial, oral and double chin surgery to determine which
      nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. In addition
      is the 90° anti-clockwise rotation of the tip of the tube helpful to insert the tube into the
      trachea. Patients were randomized into right and the left nostril groups. After standard
      anesthesia induction with propofol and fentanyl, rocuronium was used for muscle relaxation.
      Primary aim of this prospective study was to compare the glottis visualization time,
      intubation time and total intubation times. The Cormack-Lehane grades, the need for
      optimization, tube adjustment maneuvers, hemodynamic data, occurrence of epistaxis of the
      patients were recorded during the process.
    

Intervention name(s): Airtraq NT
Intervention type(s): Device
Intervention description(s): channeled video laryngoscope for nasotracheal intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Airtraq NT; nasotracheal intubation; right; left
A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the
      safety of the study drug in healthy Japanese adult male subjects
    


Intervention name(s): DMB-3113; Adalimumab
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneously injected in a single dose of 40 mg.; subcutaneously injected in a single dose of 40 mg.
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bioequivalence, Biosimilarity, Pharmacokinetics, adalimumab
Pilot Study of the Vermont Family Based Approach in Primary Care Pediatrics
Condition: Psychiatric Disorder
MeSH terms: Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      This pilot randomized controlled trial of the Vermont Family Based Approach (VFBA) tested the
      feasibility of the VFBA in primary care pediatrics and its effects on children's and parents'
      emotional and behavioral problems and health-related quality of life. The VFBA is a public
      health framework for evidence-based health promotion, prevention, and treatment that is
      delivered from the family perspective and emphasizes emotional and behavioral health. The
      VFBA group received the VFBA intervention, while the Control group received pediatric primary
      care as usual.
    

Detailed description: 
      To enhance the health of our communities, we need approaches to healthcare delivery that
      focus on the entire family, recognize the central role of emotional and behavioral health in
      relation to all health, use evidence-based health promotion in addition to evidence based
      treatment of existing problems, and intervene early in children's life.

      The VFBA is a public health framework for evidence-based health promotion, prevention, and
      treatment that is delivered from the family perspective and emphasizes emotional and
      behavioral health.

      The study was a pilot RCT of the VFBA in a primary care pediatrics clinic. The goals of the
      study were to test whether the VFBA would (1) be feasible in primary care pediatrics and (2)
      would lead to improved emotional and behavioral health and health-related quality of life or
      children and parents. Families were recruited at the pediatric clinic and randomized to the
      VFBA or Control conditions.

      The VFBA group received family-based assessment of emotional and behavioral health and family
      functioning, family wellness coaching, and a menu of cost-free wellness activities, such as
      parent and child violin instruction, yoga and mindfulness training, and nutrition counseling.
      Where indicated by results of family-based assessment, families in the VFBA group also
      received family-based, evidence-based psychotherapy and psychiatric care. Families in the
      Control group received pediatric primary care, as usual.
    

Intervention name(s): Vermont Family Based Approach; Treatment as Usual
Intervention type(s): Other; Other
Intervention description(s): Comprehensive and individualized program to promote emotional health and wellbeing in families using evidence-based health promotion, prevention and intervention.; Pediatric care as usual.
Other intervention name(s): VFBA; TAU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Health Promotion; Prevention; Mental health; Quality of life; Pediatrics; Wellness; Preventive Medicine; Preventive Psychiatry; Patient Participation; Health Literacy; Patient Activation; Patient Engagement; Emotional Health; Behavioral Health
Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether low-dose pentavalent antimony is equally
      effective when compared to the standard-dose regimen in patients with cutaneous
      leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.
    

Detailed description: 
      The first-choice drug for the treatment of cutaneous leishmaniasis in Brazil is the
      pentavalent antimonial meglumine antimoniate. The treatment with meglumine antimoniate is
      toxic and at least some of the more relevant adverse events associated with that drug are
      dose-dependent. Recently, some research developed in Brazil has shown evidence that lower
      doses of pentavalent antimony are equally efficacious as compared to the standard-dose
      regimen. That evidence has been obtained in patients from the State of Rio de Janeiro who
      were infected by Leishmania (Viannia) braziliensis. The purpose of the study is to evaluate
      the safety and efficacy of the low-dose pentavalent antimony regimen in patients with
      cutaneous leishmaniasis infected by Leishmania (Viannia) braziliensis living in a rural area
      of the State of Bahia, Brazil, where cutaneous leishmaniasis is highly endemic. The
      usefulness of the study is based on the possibility to reduce the toxicity observed during
      treatment and the treatment costs.

      The main comparison of the therapeutic response is going to be made between two groups
      composed of an equal number of properly randomized patients with localized cutaneous
      leishmaniasis treated with any of the following drug schemes:

        -  Meglumine antimoniate (calculated dose based on the concentration of pentavalent
           antimony) 5 mg/kg/d intravenous for 20 days

        -  Meglumine antimoniate (calculated dose based on the concentration of pentavalent
           antimony) 15 mg/kg/d intravenous for 20 days

      The clinical outcomes of cure or failure will be evaluated until the third month of
      follow-up.
    

Intervention name(s): Meglumine antimoniate; Meglumine antimoniate
Intervention type(s): Drug; Drug
Intervention description(s): Meglumine antimoniate 5mg/kg/d for 20 days; Meglumine antimoniate 15 mg/kg/d for 20 days
Other intervention name(s): Glucantime; Glucantime
Intervention MeSH terms: Meglumine Antimoniate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cutaneous leishmaniasis; Leishmania braziliensis; Pentavalent antimony; Meglumine antimoniate
PEDIATRIC SONICS: Pediatric Study of Neuropsychology and Imaging in CNS Demyelinating Syndromes.
Condition: Multiple Sclerosis, Relapsing-Remitting; Neuromyelitis Optica; Acute Disseminated Encephalomyelitis; Transverse Myelitis
MeSH terms: Encephalomyelitis; Myelitis; Myelitis, Transverse; Multiple Sclerosis; Neuromyelitis Optica; Multiple Sclerosis, Relapsing-Remitting; Encephalomyelitis, Acute Disseminated; Sclerosis
Study type: Observational

Summary: 
      Central Nervous System (CNS) demyelinating conditions include multiple sclerosis (MS), Acute
      Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica Spectrum Disorder (NMOSD), Optic
      Neuritis (ON) and Transverse Myelitis (TM). The symptoms of these conditions are quite
      variable from patient to patient, but can include motor, sensory, visual, gait and cognitive
      changes. Conventional MRI can be used to look for new anatomic changes, but fails to measure
      underlying biochemical changes in brain tissue. The purposes of this study are to identify
      the biologic and anatomic correlations between cognitive profiles and disease activity using
      MRI imaging techniques.
    

Detailed description: 
      Pediatric patients (age 12 to 21 inclusive) with a diagnosis of multiple sclerosis, ADEM,
      anti-MOG mediated demyelinating disease as well as healthy controls will be recruited to
      undergo clinical testing. The study visits will include neuropsychological testing, optical
      coherence tomography (OCT) and MRI on both the 3T and 7T magnet. Subjects will be asked to
      undergo two study visits separated by 12 months to 18 months. Each study visit will have the
      same neuropsychological, OCT, and research MRI examinations.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Teenagers before 22 at the time of consent diagnosis with a Central Nervous System
        demyelinating disorder.
      
Keywords: Multiple Sclerosis; NMO; anti-MOG; Acute Disseminated Encephalolmyelitis