bioihbjkbjnl/mcl2 huggingface dataset:
Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on GH-IGF-IGFBP Axis
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to describe the interaction of equal doses of NPH insulin (Neutral Protamine
      Hagedorn), insulin Detemir and insulin glargine on IGFBP-1 (Insulin-like Growth Factor
      Binding Protein-1) production as well as immunoreactive and bioactive IGF-I (Insulin-like
      Growth Factor-I) after once-daily injection on three separate visits in type 1 diabetic
      subjects.
    

Detailed description: 
      Because of the importance of receptors activation and potential effects on the IGF system, a
      head-to-head comparison of the eventual differential impact of intermediate-acting human
      insulin (NPH), insulin detemir and insulin glargine on the growth hormone-insulin-like growth
      factor-insulin-like growth factor binding protein (GH-IGF-IGFBP) axis is relevant to be
      conducted for the safety assurance of insulin analogues. Therefore, this study aims to
      investigate whether the serum insulin profile obtained by once-daily injection of long-acting
      insulin analog, insulin detemir or insulin glargine, has a different impact on IGFBPs
      production and IGF-I concentrations (total IGF-I) bioactivity and tissue-availability as
      compared to that seen during treatment with intermediate-acting human insulin, NPH insulin.
    

Intervention name(s): NPH; Detemir; Glargine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): equal doses of NPH insulin, insulin Detemir and insulin glargine injection; equal doses of NPH insulin, insulin Detemir and insulin glargine injection; equal doses of NPH insulin, insulin Detemir and insulin glargine injection
Other intervention name(s): NPH insulin: Insulatard; insulin Detemir: Levemir; insulin glargine: Lamtus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1
Gut Feeling: Understanding the Mechanisms Underlying the Antidepressant Properties of Probiotics
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Previous research has suggested that probiotics can improve depressive symptoms in patients
      with Major Depressive Disorder (MDD), particularly when used in addition to antidepressants.
      The aim of this exploratory pilot study is to improve the investigator's understanding of the
      mechanisms underlying these effects. This study will assess the effects of an 8-week
      double-blind placebo-controlled probiotic intervention on the gut microbiome, inflammatory
      marker levels, brain activity and neurotransmitter levels in patients with MDD and their
      relationship to changes in mood. This study will also recruit a group of
      demographically-matched healthy controls for gut microbiome comparison with the MDD group
      (non-interventional).
    


Intervention name(s): Multi-strain probiotic; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The intervention in this study is a multi-strain probiotic which contains:
Bacillus subtilis, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus delbrueckii ssp. bulgaricus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Lactobacillus salivarius, Lactococcus lactis ssp. lactis, Streptococcus thermophilus.
Each capsule contains minimum 2 billion live microorganisms per capsule, equivalent to 10 billion live microorganisms per gram.; Visually identical capsules in identical packaging containing no active bacteria.
Other intervention name(s): "BioKult"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: probiotic; depression; microbiome; bacteria
Effect of Acute Arterial Hypertension on Morphine's Requirements and Postsurgical Pain.
Condition: Hypertensive Disease; Pain, Postoperative
MeSH terms: Hypertension; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized clinical trial is to evaluate the effect of acute arterial
      hypertension maintained during surgery on morphine's requirements in patients undergoing
      laparoscopic cholecystectomy
    

Detailed description: 
      The high arterial blood pressure has been correlated with an increase in pain threshold in
      animal and humans. One of the explanations to this phenomenon is a baroreceptor activity and
      vasopressin release at the level of spinal cord dorsal horn and hypothalamus.

      As far as we know, there is only one study about the effect of chronic hypertension on
      postoperative pain and none with acute hypertension. We therefore decided to conduct a
      randomized controlled trial to evaluate the effect of acute hypertension on postoperative
      morphine's requirements.
    

Intervention name(s): SBP 20-30% over baseline; SBP 20-30% under baseline
Intervention type(s): Other; Other
Intervention description(s): Patients were assigned to receive a phenylephrine infusion in order to maintain systolic blood pressure (SBP) 20% to 30% over the baseline. The upper limit of systolic blood pressure is 165 mmHg.; Patients were assigned to receive a phenylephrine infusion in order to maintain systolic blood pressure (SBP) 20% to 30% below the baseline. The lower limit of systolic blood pressure is 75 mmHg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: analgesia, postoperative;; analgesics opioid;; hyperalgesia;; remifentanil;; hypertension.
Almonds and Diabetes Management
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This trial examined the impact of acute and chronic almond ingestion on indicators of glucose
      control (postprandial glycemia and hemoglobin A1c). Hypotheses:

        1. Almonds will stimulate the secretion of GLP-1 in healthy adults and in adults with T2D
           The investigators were not able to demonstrate a relationship between GLP-1 secretion
           and almond consumption. Individuals with T2D were characterized with significantly
           greater GLP-1 secretion than the non-diabetic control subjects.

        2. Acute ingestion of almonds will decrease the postprandial glycemia and insulinemic
           responses in healthy controls and in individuals with T2D The investigators data support
           the hypothesis: almond consumption by individuals with T2D did attenuate postprandial
           glycemia; however, almond consumption did not alter glycemia in non-diabetic control
           subjects

        3. Chronic almond ingestion for 12 weeks will reduce fasting glucose (FG) and A1c
           concentrations in individuals with T2D The investigators data demonstrated modest
           beneficial effect of almond consumption on A1c in individuals with T2D. Almond
           consumption was also associated with modest weight loss as compared to the control
           treatment (low fat cheese sticks).
    


Intervention name(s): Almonds
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Caudal Volumes on the Anatomical Spread of Caudals in Children
Condition: Asa 1 and 2 Patients for Elective Surgery Requiring Caudal as Part of Their Care
Study type: Interventional
Phase: Phase 1

Summary: 
      Radiological study into the anatomical spread of caudal local anaesthetic in children age 1-7
    


Intervention name(s): caudal volume 1; caudal volume 2; caudal volume 3
Intervention type(s): Drug; Biological; Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Investigation of Milk Peptides on Postprandial Blood Glucose Profile
Condition: Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      Aim of the study is to investigate the effect of two different dosages of milk peptides on
      postprandial blood glucose profile in prediabetic subjects compared to placebo. This will be
      investigated in a cross-over double blind randomized placebo controlled study design.
      Additionally, long term effects on glucose status, insulin sensitivity and postprandial blood
      glucose profile will be investigated in a follow up 6-week open label phase with the low dose
      only.
    


Intervention name(s): Low dose milk peptide; High Dose milk peptide; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): what is the effect of milk peptides 1400mg on postprandial glycemia after a meal rich in carbohydrates (75g); what is the effect of milk peptides 2800mg on postprandial glycemia after a meal rich in carbohydrates (75g); what is the effect of placebo on postprandial glycemia after a meal rich in carbohydrates (75g)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double blind cross over and open for the phase II of the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Phase Ⅱ Clinical Study Trial of Felbinac Trometamol Injection in China
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, randomized, double-blind, placebo-controlled, dose-exploratory phase II
      clinical trial to evaluating the efficacy and safety of Felbinac Trometamol Injection in the
      treatment of moderate to severe pain after surgery.Main purpose is preliminary evaluation the
      effectiveness of Felbinac Trometamol Injection in the treatment of moderate and severe pain
      after surgery.Secondary purpose is to explore the dosage regimen of Felbinac Trometamol
      Injection in the treatment of moderate and severe pain after surgery, and provide data
      support for later clinical trial.
    


Intervention name(s): Felbinac Trometamol Injection; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump.
One dose at 8h and 16h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).the drug was given 3 times,3 times/day,once every 8 hours.; Placebo diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump.
One dose at 8h and 16h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).the drug was given 3 times,3 times/day,once every 8 hours.
Intervention MeSH terms: Biphenylylacetic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Zinc Intake on Essential Fatty Acid Metabolism
Condition: Inflammation; Oxidative Stress; Dyslipidemias
MeSH terms: Dyslipidemias; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of different dietary zinc intakes on
      fatty acid metabolism and other zinc biomarkers
    

Detailed description: 
      This research is a dietary intervention study designed to evaluate the effect of progressive
      changes in Zn intake on fatty acid metabolism and to correlate those changes with biomarkers
      of dyslipidemia and insulin resistance. The main objective is to validate plasma fatty acid
      metabolism as a biomarker of inadequate Zn intake in subjects consuming identical diets with
      specific Zn content. The relative sensitivity of some fatty acid enzyme activities will also
      be compared to the DNA strand breaks. In addition to the primary objectives, correlations in
      enzyme activity with changes in fat metabolism, namely circulating triglyceride and
      cholesterol, will be determined. This will enable the determination of the effect of a low Zn
      intake on various aspects of dyslipidemia. Similar correlational analyses will be performed
      with clinical measures of inflammation and insulin resistance.
    

Intervention name(s): Diet Zinc
Intervention type(s): Other
Intervention description(s): 4 mg zinc from zinc biofortified wheat, was added to a controlled diet; 25 mg supplemental zinc was given during the final recovery period
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia
Condition: Critical Lower Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional

Summary: 
      The present randomized study proposed to compare the immediate postoperative and 2-year
      clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel
      critical lower limb ischemia.
    


Intervention name(s): long surgical bypass; Hybrid approach
Intervention type(s): Procedure; Procedure
Intervention description(s): long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.; Hybrid approach including bypass and endovascular revascularization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
Condition: Ureaplasma Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Ureaplasma Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether intravenous azithromycin is effective in
      eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks
      gestation.
    

Detailed description: 
      The study design will be a double-blind, placebo-controlled clinical trial to test the
      efficacy and safety of azithromycin 20 mg/kg x 3 days to eradicate Ureaplasma spp from the
      respiratory tract of preterm infants 24 weeks 0 days to 28 weeks 6 days gestation exposed to
      positive pressure ventilation. The primary outcome will be survival with microbiological
      eradication of Ureaplasma defined as survival to discharge or transfer with 3 negative
      cultures obtained post-therapy. Secondary outcomes will include physiologic BPD at 36 weeks
      post-menstrual age (PMA), overall mortality, incidence of co-morbidities of prematurity such
      as intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis,
      bacterial and fungal nosocomial infection, pulmonary air leak, patent ductus arteriosus,
      retinopathy of prematurity, number of days of positive pressure ventilation, number of days
      of oxygen supplementation, use of postnatal steroids, and use of non-study antibiotics. At 6
      and 18 months adjusted age, a pulmonary outcome questionnaire will be administered by phone
      or in person interview. At 18-22 months adjusted age, neurodevelopmental outcomes will be
      assessed by 1) Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III); 2)
      Amiel-Tison neurologic examination; 3) Gross Motor Function Classification System; and 4)
      medical record review for hearing impairment with or without amplification and vision
      impairment (vision <20/200).
    

Intervention name(s): Azithromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Azithromycin intravenous 20 mg/kg every 24 h x 3 days; D5W
Other intervention name(s): Zithromax; equal volume of 5% dextrose water
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ureaplasma parvum; Ureaplasma urealyticum; prematurity; bronchopulmonary dysplasia; azithromycin
Effectiveness of Ultrasonography and The Cole Formula on the Evaluation of the Appropriate Endotracheal Tube Size
Condition: Intubation
Study type: Interventional

Summary: 
      In this study the effectiveness of the use of Cole formula and USG were compared in
      determining the number of the appropriate uncuffed ETT to be used for clinically adequate
      ventilation.
    

Detailed description: 
      Aim: The goal of this study was to evaluate the effectiveness of the Cole formula and
      ultrasonography in determining endotracheal tube size for paediatric surgery patients.

      Material and methods: ASA I-II pediatric patients (n=110) in the age range of 2-10 years,
      planned to undergo elective surgeries under general anesthesia with endotracheal entubation,
      were enrolled in this study. Once patients were properly positioned after premedication and
      anesthesia induction, the subglottic diameter was measured using ultrasonography, and
      endotracheal tube (ETT) size was also calculated with the Cole formula. Subsequently patients
      were entubated with uncuffed ETT with sizes based on the patient's age in compliance with
      current clinical guide lines. To ensure adequate ventilation, the tube was replaced with an
      ETT of larger or smaller diameter as needed. The ETT was fastened after the placement ring
      had passed through the vocal cords and breath sounds were confirmed to be equal by
      auscultation. The size of the used ETT was compared with the size estimated from the
      subglottic diameter measured by ultrasonography to the size calculated with the Cole formula
    

Intervention name(s): Intubation
Intervention type(s): Procedure
Intervention description(s): elective surgeries under general anesthesia with endotracheal entubation formula or USG asisted
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Electronic Linkage for Inflammatory Bowel Disease to Deliver Joint Access to Health Reports
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      This study evaluated the extent to which a shared health record facilitated better
      communication, increase individual responsibility for health care and reduce demand for
      health resources.

      The study made individualised reports available to patients and General Practitioners and
      gave much more detail about participants chronic disease and treatments, and evaluated its
      effectiveness in a randomised controlled feasibility trial.

      One third of patients received care as usual, two thirds of patients received the
      intervention.
    

Detailed description: 
      Chronic illness is a major cause of health problems. Self-management programmes can improve
      care and reduce healthcare resource use, but rely on well educated patients who are able to
      take responsibility for their care, have effective communication with health care providers,
      and easy access to appropriately triaged services.

      This study utilised Inflammatory Bowel Disease as an exemplar of chronic disease management.

      To inform the intervention the investigators held a focus group with patients who told the
      investigators about their concerns relating to education, care planning and communication
      about their condition. The participants expressed a preference for individualised information
      about their care, and plans of what to do if symptoms increase.

      The investigators departmental electronic patient record (GeneCIS), was extended to provide
      personalised, educationally enriched information to each participant about their Inflammatory
      Bowel Disease. The investigators customised GeneCIS to develop output reports i.e.: "My
      History", "My plan" and "My Update", that attach specific educational information to the
      detailed, structured clinical data held on the system, and shared this with participants and
      their General Practitioner.
    

Intervention name(s): Health reports
Intervention type(s): Other
Intervention description(s): Participants were sent 3 sets of individualised, educationally enriched health reports about their diagnosed inflammatory bowel disease history, care plan and updates on their recent health status, results or encounters with health care services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Electronic health records; Health records personal
Evaluate Safety, Tolerability and Pharmacokinetics of Fadanafil （XZP-5849）in Chinese Healthy Adult Male Subjects
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety , tolerability, and pharmacokinetics of
      ascending single dose Fadanafil （XZP-5849）in Chinese healthy adult male subjects. This is the
      first XZP-5849 clinical study
    

Detailed description: 
      XZP-5849 is a selective phosphodiesterase (PDE5) inhibitor. The proposed randomized Phase 1
      trial is a double-blind, placebo-controlled, single ascending dose study in approximately 66
      Chinese healthy adult male subjects. The study consists of 8 cohorts (1 cohort per dose
      level). Each subject will participate in only one cohort.
    

Intervention name(s): Fadanafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose; Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose
Other intervention name(s): 5849
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 8 dose groups within 12.5mg~500mg for single dose tolerability study to carrried out from low-dose group to high dose group
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy Subject; PK Study; Tolerability; Safety Evaluation