bioihbjkbjnl/mcl2 huggingface dataset:
Basal Insulins - Pharmacodynamics
Condition: Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      To purpose of this study is to compare the pharmacodynamic properties of insulin detemir,
      insulin glargine and NPH insulin after a single subcutaneous injection.
    

Detailed description: 
      In this randomized, double-blind, euglycemic glucose clamp study, 10 healthy male volunteers
      received a subcutaneous injection of 0.4 U/kg insulin detemir, insulin glargine or NPH
      insulin on three separate study days in a cross-over design. After insulin administration,
      plasma glucose was maintained at 0.3 mmol/l below fasting level for 24 hours by manually
      adjusted glucose infusion. C-peptide, insulin, NEFA and counter regulatory hormones were
      measured throughout the clamp period. Endogenous glucose release (EGR) was assessed by the
      isotope dilution technique (3-3H-glucose).
    

Intervention name(s): Insulin detemir; Insulin glargine; Insulatard
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.4 U/kg bw insulin detemir injected s.c. in the thigh.; 0.4 U/kg bw insulin glargine injected s.c. in the thigh; 0.4 U/kg bw NPH insulin injected s.c. in the thigh
Other intervention name(s): Levemir; Lantus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans
Trial of Subretinal Injection of (rAAV2-VMD2-hMERTK)
Condition: Retinal Disease; Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa; Retinal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was to assess the safety of gene transfer via subretinal administration of
      rAAV2-VMD2-hMERTK in subjects with MERTK-associated retinitis pigmentosa (RP).
    

Detailed description: 
      In this phase I open-label, dose-escalation trial, one eye of each patient (the worse-seeing
      eye in five subjects) will receive a submacular injection of the subretinal
      rAAV2-VMD2-hMERTK. Patients will be followed daily for 10 days and then at 30, 60, 90, 180,
      270, 365, 540, and 730 days post-injection. Data will be collected on (1) full ophthalmologic
      examination including best-corrected VA, intraocular pressure, color fundus photographs,
      macular spectral-domain optical coherence tomography, and full-field stimulus threshold test
      (FST) in both the study and fellow eyes; (2) systemic safety data including CBC, liver, and
      kidney function tests, coagulation profiles, urine analysis, AAV antibody titers, peripheral
      blood PCR and ASR measurement; and (3) listing of ophthalmological or systemic adverse
      effects.
    

Intervention name(s): Subretinal administration of rAAV2-VMD2-hMERTKRecombinant Adeno-Associated Virus
Intervention type(s): Biological
Intervention description(s): The study is an open-label, dose-escalation, phase I clinical trial of subretinal administration of rAAV2-VMD2-hMERTK in patients with retinitis pigmentosa due to MERTK mutation.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Ocular Subretinal administration of rAAV2-VMD2-hMERTK .
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Retinal Disease; subretinal gene therapy; MERTK; retinitis pigmentosa
A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to evaluate the
      variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects
      with type 1 diabetes.
    


Intervention name(s): insulin degludec; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days; The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Development of an Insomnia Treatment for Depressed Adolescents
Condition: Insomnia; Depression
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression
Study type: Interventional

Summary: 
      Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90%
      of those adolescents have insomnia. If left untreated, insomnia increases the risk of relapse
      and recurrence of depressive episodes, unintentional injuries, poor school performance,
      substance use, obesity, and the risk for suicide. This project seeks to develop a
      nonpharmacological treatment for insomnia in adolescents with depression that is feasible and
      effective. The specific methodologies that will help accomplish these results are: 1) use of
      focus groups of adolescents with depression and insomnia to determine how the current
      standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for
      insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2)
      determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in
      adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This
      project will help to improve the quality and scope of delivery of mental health services in
      Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate
      depression in adolescents and b) to provide mental health professionals with a
      nonpharmacological treatment option for insomnia in adolescents with depression.
    


Intervention name(s): Cognitive Behavioral Therapy for Insomnia
Intervention type(s): Behavioral
Intervention description(s): A non-pharmacological therapy for insomnia based on behavior and cognitive therapy approaches
Other intervention name(s): CBTI
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent; Depression; Insomnia
Pharmaceutical Care for Asthma Control Improvement (PHARMACI)-Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity
      of pharmaceutical care for asthma patients.
    

Detailed description: 
      The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity
      of pharmaceutical care for asthma patients. Patients will be randomly allocated to the
      control group (= no input from pharmacist) or intervention group (= with pharmaceutical care
      at baseline and follow-up visits over 6 months).
    

Intervention name(s): Pharmaceutical care for asthma patients
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Geriatric Anorexia Study
Condition: Healthy
MeSH terms: Anorexia
Study type: Observational

Summary: 
      Reduction in appetite and/or food intake among older individuals is referred to as anorexia
      of aging (AOA, also known as Geriatric Anorexia). AOA is linked with myriad comorbidities
      associated with aging, contributes significantly to adverse health consequences in old age,
      and has been used as a predictor of morbidity and mortality. The overall aim of this study is
      to assess the feasibility and burden of the proposed in-laboratory and out-of-laboratory
      assessments to study Geriatric Anorexia. This will be accomplished with the use of
      questionnaires as well as devices that evaluate movement, metabolism, body weight
      composition, glucose levels, and nutritional scale.
    

Detailed description: 
      This is a study to evaluate movement, metabolism, body weight composition, glucose levels,
      and nutritional scale in healthy adults. Subjects, age 65 to 85 years will be recruited.

      The proposed study will consist of an initial (in-clinic) intake visit on Day 1 where the
      subject will be screened and enrolled in the study after signing an informed consent
      document, followed by an at-home phase where the subject will wear a watch like device on one
      wrist. After training, the subject will return for their Day 8 in-clinic visit, where the
      subject will repeat some intake assessments and activities, as well as some additional
      standing and walking activities. The subject will then be asked to perform at-home activities
      and assessments with the use of a smart phone, digital food scale, smart body weight scale,
      and continuous glucose monitor, while continuing to wear the watch-like device and a movement
      measurement device around their waist (Days 8-21). A final in-clinic visit will take place on
      Day 21 for final assessments and device collection. A +/- 4 days will be allocated for the
      scheduling of all visits to accommodate subject's schedules and commitments. All
      in-laboratory activities will take place in the Laboratory for Human Neurobiology while
      in-home activities will be completed in the subject's home. The study procedures will be
      identical for all subjects for the three groups.
    

Intervention name(s): Continuous Glucose Monitor; Wrist Actigraphy Device; Food Weight Scale; Smart Body Weight Scale
Intervention type(s): Device; Device; Device; Device
Intervention description(s): a handheld reader and a wearable sensor placed on the back of the arm used to obtain glucose measurements; a watch like wearable sensor; a scale to measure food weight; a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends
Other intervention name(s): Freestyle Libre; Geneactiv Watch; Renpho; Renpho
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults
      
Keywords: Healthy; Wearable Devices; Geriatric Anorexia
Preoperative Measurement of Heart Rate Variability as a Predictor of Postoperative Outcome
Condition: Major Abdominal Surgery
Study type: Observational

Summary: 
      The purpose of the study is to confirm the hypothesis that a dysfunction of the autonomic
      nervous system could complicate the postoperative course in the patient undergoing surgery.
      Measurement of heart rate variability (HRV) is a non-invasive method for evaluation of the
      autonomic nervous system.
    

Detailed description: 
      The autonomic nervous system (ANS) plays an important role in the maintenance of systemic
      homeostasis. The homeostasis is modified continually by internal and external stimuli to
      which the autonomic nervous system modulates the response of organism by tight control on
      essential functions such as circulation, respiration, hormonal secretion and
      thermoregulation. Dysfunction of the autonomic nervous system could complicate the
      perioperative course in the patient undergoing surgery; therefore it should be considered as
      another risk factor during preoperative evaluation. Nowadays the evaluation of the autonomic
      nervous system function like a tool for prediction postoperative outcome is not considered in
      daily anaesthesiology practice. Measurement of heart rate variability (HRV) is a method for
      evaluation the autonomic nervous system function. It is a non-invasive method that provides
      information about the autonomic regulation of organism and thus it identifies patients with
      the autonomic nervous system dysfunction.
    

Intervention name(s): Pre-operative measurement of heart rate variability
Intervention type(s): Procedure
Intervention description(s): Pre-operative measurement of heart rate variability in patients undergoing elective major abdominal surgery
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective major abdominal surgery.
      
Keywords: heart rate variability; post-operative outcome
Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with
      the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
    


Intervention name(s): Budesonide/formoterol Easyhaler 320/9 microg; Symbicort Turbuhaler forte
Intervention type(s): Drug; Drug
Intervention description(s): 2 inhalations as a single dose; 2 inhalations as a single dose
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Smoking Cessation for Young Adults Who Binge Drink - 1
Condition: Adherence; Tobacco Use Cessation; Alcohol & Drug Use; Nicotine Transdermal System
MeSH terms: Binge Drinking
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is develop and test the success of a new smoking cessation
      intervention that includes a component to eliminate binge drinking.
    

Detailed description: 
      The primary aim of this pilot investigation is to develop and evaluate the acceptability and
      feasibility of a novel tobacco dependence intervention that includes a component to eliminate
      binge drinking. This study will also estimate the magnitude of the effect of the novel
      intervention on the cigarette smoking behavior of young adult college student smokers.
    

Intervention name(s): Lifestyle counseling
Intervention type(s): Behavioral
Intervention description(s): assigned to a 6-week individual behavioral treatment involving: 1) a novel brief office intervention for cigarette smoking that includes a treatment component intended to eliminate binge drinking
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobacco use cessation
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Rationale: Survivors of childhood cancer are at an increased risk of developing
      cardiovascular risk factors as well as early cardiovascular disease, likely due to the
      intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich
      source of flavonoids and a powerful antioxidant. Clinical studies in both diseased and
      healthy adults suggest that daily consumption of PGJ contributes to increased antioxidant
      capacity, reduced low-density lipoprotein (LDL) oxidation, and improved vasodilation.

      Purpose: This randomized clinical trial is evaluating whether purple grape juice can reduce
      oxidative stress and improve the vascular health of survivors of childhood cancer in the
      early stages of cardiovascular disease.
    

Detailed description: 
      Primary Objective:

        -  To evaluate the effect of PGJ on endothelial function, a key measure of vascular health
           and considered a barometer for cardiovascular disease risk.

      Secondary Objective:

        -  To evaluate the effect of PGJ on biomarkers of vascular and systemic oxidative stress.

      Outline:

      Patients undergo a 4-week washout period and refrain from consuming any type of juice, juice
      drink (less than 100% juice), wine or grapes. Patients are then randomized to 1 of 2 arms.

      Arm 1: Beginning in week 4, patients consume 6 ounces of purple grape juice (PGJ) twice daily
      for 4 weeks. Beginning in week 12, after a 4 week washout period, patients crossover to
      consume apple juice (AJ) as in Arm 2.

      Arm 2: Beginning in week 4, patients consume 6 ounces of AJ twice daily for 4 weeks.
      Beginning in week 12, after a 4 week washout period, patients crossover to consume PGJ as in
      Arm 1.
    

Intervention name(s): Purple Grape Juice; Apple Juice
Intervention type(s): Other; Other
Intervention description(s): 6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization; 6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization
Other intervention name(s): clear apple juice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: childhood cancers; cardiovascular disease; childhood cancer survivor
the Accuracy and Safety of Coronary Artery Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, prospective, controlled and diagnostic clinical trial which will
      enroll 30 patients scheduled for coronary angiography in China.Patients will receive
      contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide
      nanoparticle before percutaneous coronary angiography.In order to evaluate the safety of
      polysaccharide superparamagnetic iron oxide nanoparticle, patients will detect iron levels in
      peripheral and tissue before and after the examination.The main indicators of the study are
      the degree of coronary artery stenosis and the stability of coronary atherosclerotic plaque
      assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide
      superparamagnetic iron oxide nanoparticle.
    


Intervention name(s): domestic polysaccharide superparamagnetic iron oxide nanoparticle
Intervention type(s): Drug
Intervention description(s): Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ultrasmall Superparamagnetic Particles of Iron Oxide; Contrast-Enhanced Magnetic Resonance; Plaque Stability
Effect of Cognitive-behavior Therapy on Fear Responses to Body Symptoms in Patients With Panic Disorder
Condition: Panic Disorder With Agoraphobia; Panic Disorder Without Agoraphobia
MeSH terms: Panic Disorder; Agoraphobia
Study type: Interventional

Summary: 
      The present study aims to investigate a potential mechanism of successful CBT for panic
      disorder, i.e., the reduction of excessive anxious apprehension and fear responses to
      panic-related body symptoms in the context of CBT treatment. In the present non-randomized
      interventional study, effects of cognitive behavior therapy on reported symptoms and fear
      responses to panic-related body symptoms are investigated. It is expected that symptom
      improvement during CBT is associated with a decrease in the activation of the brain's fear
      network to panic-related body symptoms.
    

Detailed description: 
      Changes in fear responses to body symptoms in the course of CBT are investigated in patients
      with PD by applying a highly standardized hyperventilation task (provoking panic-related body
      symptoms) prior to and after a manualized CBT or a waiting period. Activation of the brain's
      fear network (defensive activation) is indexed by the potentiation of the startle eyeblink
      response.
    

Intervention name(s): Cognitive-behavior therapy
Intervention type(s): Behavioral
Intervention description(s): The manualized protocol (Gloster et al., 2011) comprise of 12 weekly sessions of CBT focusing on therapist-guided interoceptive and in-situ exposure exercises.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)
Condition: Fatigue Syndrome, Chronic; Myalgic Encephalomyelitis
MeSH terms: Encephalomyelitis; Fatigue Syndrome, Chronic; Myalgia; Syndrome; Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of oral melatonin plus zinc
      supplementation in relieving self-reported fatigue in CFS/ME
    

Detailed description: 
      Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is a complex medical condition,
      characterized by severe disabling fatigue with no known cause, no established diagnostic
      tests, and no universally effective treatment. No studies have evaluated symptomatic
      treatment using oral melatonin plus zinc supplementation in CFS/ME. The primary endpoint was
      to assess the effect of melatonin plus zinc supplementation on self-reported fatigue.
      Secondary measures included self-reported outcomes of sleep problems, anxiety/depression,
      dysautonomia, QoL and side-effects during treatment.
    

Intervention name(s): melatonin plus zinc; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks; Isomaltose o.d. 1 hour before going to bed during 16 weeks
Other intervention name(s): MelatoZinc; Control
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: melatonin; zinc; Myalgic Encephalomyelitis; Chronic Fatigue Syndrome; sleep; pain
Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment
Condition: Gastrointestinal Cancer
MeSH terms: Gastrointestinal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the health-related quality of life following dietary
      supplementation with an immunonutrition formulation vs an isocaloric/isoprotein control diet
      supplement in patients suffering from upper digestive tract neoplasia undergoing oncological
      treatment.
    


Intervention name(s): Nutritional supplements containing arginine, n-3 and nucleotides; Isocaloric control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nutritional intervention with immuno-nutrients; Isocaloric and isonitrogenous control without immuno nutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Quality of life; Cancer; Immunonutrition