bioihbjkbjnl/mcl2 huggingface dataset:
Rotational Thromboelastometry Activated Transfusion In Trauma Trial
Condition: Trauma
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to
      fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of
      blood products, effects on coagulation and inflammatory mediators, and how these strategies
      affect post resuscitation adverse events.
    

Detailed description: 
      This is an open labeled study as the VE guided resuscitation will be based on the visible VE
      results. Aim 1 will compare the number of blood products utilized in each resuscitation
      strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation
      strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will
      determine if the different resuscitation strategies have an effect on post resuscitation
      adverse events.
    

Intervention name(s): Thromboelastometry guided transfusion
Intervention type(s): Procedure
Intervention description(s): Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rotational thromboelastometry; viscoelastic test; coagulopathy; trauma; hemorrhage
Evaluation of an Intervention for Adolescent Girls in Karnataka
Condition: Secondary School Entry and Completion; Child Marriage
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      This cluster Randomised Control Trial is evaluating an intervention to support adolescent
      girls from marginalised communities in northern Karnataka State, South India to complete
      secondary school, thereby reducing their vulnerability to HIV infection from early marriage
      and entry into sex work at young ages. The intervention will test innovations to address both
      supply and demand side barriers to girls' completion of secondary school, and will have
      long-term educational and livelihood benefits, in addition to reducing vulnerability to HIV.

      School-based constraints will be addressed by improving academic outcomes through teacher
      training and academic support to students; addressing gender-related and skill-based gaps
      among teachers; training of local female teachers; and increasing the content knowledge of
      secondary school teachers. Demand side barriers will be addressed by reducing economic
      pressures that households face to withdraw girls' from school; building appreciation and
      value of girls' education; building family and community accountability for school
      attendance; creating safe spaces for girls and strengthening their agency; and engaging boys
      in promoting and supporting girls' education.

      Primary stakeholders will include teachers and students, especially adolescent girls in the
      school (7th to 10 the standard) from marginalized communities. Secondary stakeholders will
      include school development and management committees (SDMCs), families, boys and the
      communities that are served by the schools. 80 village clusters (40 intervention; 40 control)
      were randomly selected from 125 village clusters in Bagalkote and Vijayapura districts. The
      intervention will be implemented with village communities and high schools in 40 village
      clusters in Bagalkote and Vijayapura districts. The intervention will be implemented in
      collaboration with the Department of State Educational Research and Training (DSERT),
      Karnataka; the Adolescent Education Cell, Government College of Teachers' Education (CTE),
      Jamkhandi; and the Institute for Advanced Studies in Education (IASE), Gulbarga.
    


Intervention name(s): Multi-level, structural and norms-based intervention
Intervention type(s): Behavioral
Intervention description(s): Receive multi-level, structural and norms-based intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: adolescent girls; female sex work; age at marriage; retention in school; sexual debut; India; Karnataka
Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With Metformin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of Metformin administered over two weeks
      on the peak plasma glucose concentrations following administration of BMS-754807.
    

Detailed description: 
      Primary Purpose: Other - Protocol designed to evaluate pharmacodynamics following
      administration of two compounds
    

Intervention name(s): BMS-754807 (IGR-IR/IR Inhibitor); Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17; Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      We aim to assess the influence of chronic insomnia on the neuroendocrine regulation of the
      glucose and lipid metabolism to more clearly define the metabolic derangements associated
      with chronic insomnia and to prove that chronic insomnia is associated with increased levels
      of stress hormones, cytokines and impaired insulin sensitivity.
    

Detailed description: 
      Sleep fragmentation has previously been shown to result in activation of the stress axis as
      indicated by enhanced cortisol and catecholamine release and a proinflammatory state mirrored
      by increased concentrations of proinflammatory cytokines such as IL-6 and TNFa. Therefore
      sleep deprivation is associated with a similar pattern of endocrine and proinflammatory
      alterations that may promote the insulin resistant state. Thus, it is of paramount interest
      to clearly define the metabolic alterations in patients with primary insomnia.

      Patients with with suspected primary insomnia will be recruited from the sleep clinic at the
      University Hospital Basel and by newspaper ads. Primary insomnia will be diagnosed by a
      polysomnographic study and the exclusion of secondary causes such as depression, sleep apnea
      and restless legs syndrome. Eligible patients will be admitted to the CRC for metabolic
      studies, including baseline blood samples for the measurement of hormones, cytokines and
      adipokines, a euglycemic-hyperinsulinemic clamp study for the assessment of glucose turnover
      and insulin sensitivity and in vivo NMR studies to determine intrahepatic and
      intramyocellular lipid content.

      The data obtained in insomnic patients will be compared to those of a control group matched
      for age, sex, BMI, menopausal status and physical activity selected from the general
      population.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        outpatient clinic, general population
      
Biospecimen description: 
      plasma and serum samples
    
Keywords: insomnia; glucose metabolism; insulin resistance
Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection
Condition: Cytomegalovirus Infections
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates
      with symptomatic congenital cytomegalovirus infection with central nervous system disease.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating
      institution.

      Patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12
      hours for 6 weeks.

      Patients are followed at weeks 1-4 and 12, months 6, 12, 24, 36, 48, and 60, and yearly
      thereafter until puberty (when possible).
    

Intervention name(s): ganciclovir
Intervention type(s): Drug
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate
Allocation: Randomized
Primary purpose: Treatment
Keywords: congenital cytomegalovirus infection; cytomegalovirus infection; herpesvirus infection; immunologic disorders and infectious disorders; neonatal disorders; rare disease; viral infection
Diurnal Ramadan Fasting on Appetite Hormone and Metabolic Profile Among Lean, Obesity, Diabetics
Condition: Fasting; Gut Hormone
Study type: Interventional

Summary: 
      Diabetes Mellitus individuals are known to have dietary rules, namely regulating the amount,
      type and time of eating. Ramadan fasting seems to be beneficial for people who want to reduce
      their weight, but it is not easy for diabetic patients. Because of its distinctive features,
      Ramadhan induces changes in eating habits, calorie consumption, sleeping patterns, and daily
      physical activity, which may contribute to changes in hunger-satiety responses and glicemic
      control. Examining changes in gut hormones during Ramadan fasting may reveal whether this
      observance could change glucose metabolism in diabetics without triggering the undesirable
      effect of gluconeogenesis. The proportions of fat, protein, and carbohydrate in meals vary
      between outside and within Ramadan. Alterations in timing and composition meal during Ramadan
      lead to reduced food intake may affect gut hormones and metabolic responses. The aim of this
      study to determine whether the effect of Ramadan fasting differed in people with DM patients,
      pre-DM and healthy individuals, with respect to gut hormones, body composition, metabolic
      parameters, and glycemic control
    

Detailed description: 
      The experimental study was performed during and after Ramadan fasting in 2021 (April to May)
      in Semarang, Indonesia. The present study was performed using the quasy-experimental method
      by pre-post measurement of three experimental groups (diabetics, Obese and healthy subjects)
      selected using the purposive sampling methods
    

Intervention name(s): diurnal fasting
Intervention type(s): Behavioral
Intervention description(s): subject conduct fasting in Ramadan for 30 days
Other intervention name(s): ramadan fasting
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: three arm parallel group with 45 subjects:
fasting in lean group
fasting in obese group
fasting in diabetics group
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gut hormones; metabolic parameters; obesity; lean; diabetics; ramadan fasting
A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety
      of warfarin in healthy male volunteers.
    


Intervention name(s): fimasartan, warfarin
Intervention type(s): Drug
Intervention description(s): Warfarin(1d) Fimasartan(8d-16d) Fimasartan + Warfarin(11d)
Intervention MeSH terms: Warfarin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: fimasartan; drug interaction
Bioequivalence of Two Lispro Formulations
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare how the body treats 2 different forms of insulin lispro and how they
      affect blood sugar levels.
    

Detailed description: 
      The 2 formulations of insulin lispro will be referred to here as:

      Lispro A

      Lispro B
    

Intervention name(s): Insulin lispro A; Insulin lispro B
Intervention type(s): Drug; Drug
Intervention description(s): 20 units (U) subcutaneously (SC).; 20 U subcutaneously (SC).
Other intervention name(s): LY275585; LY275585
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insulin; lispro
Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3
Condition: Bioavailability of Vitamin D
Study type: Interventional

Summary: 
      The aim of the study was to compare the profiles of 25-hydroxyvitamin D serum concentration
      in healthy adults after 4 weeks of using vitamin D supplementation either in a liposomal or a
      traditional formulation.
    

Detailed description: 
      The study will be randomized, cross-over, participants will be randomly assigned to one of
      the study groups: A) the group receiving vitamin D3 in traditional formulation B) the group
      receiving vitamin D3 in liposomal formulation. The day before the start of supplementation
      (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation, participants will
      have their blood drawn. Then, after a wash-out period of 2 months, the groups will be
      switched. Participants will again receive daily supplementation with vitamin D3 for 4 weeks.
      Blood will be drawn before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2)
      after the start of supplementation.
    

Intervention name(s): Liposomal Vitamin D; Traditional Vitamin D
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2000 IU of cholecalciferol in liposomal formulation; 2000 IU of cholecalciferol in traditional formulation
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Liposovit-D; Vitamin D; Cholecalciferol
Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      52 patients that had previously participated in the RDBPC study of intralymphatic
      immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were
      eligible for an open follow up 5-6 years after treatment.
    

Detailed description: 
      Bakground: Intralymphatic immunotherapy has been proposed as a new, more effective, modality
      for allergy immunotherapy. With ultrasound- guided injections into the lymph node the
      allergen is injected directly to the secondary lymphoid organ to stimulate the immune system.
      The protocol that has been used so far is three injections with one month interval. The
      effect have been evaluated in several studies with limited sample sized and the effect have
      been estimated to be in the same range as after conventinal subcutaneous immunotherapy. No
      long term follow up have been performed.

      Objective: To investigate if the clinical improvement and immunological alterations is
      maintained 5-6 years after ILIT with two concomitant allergens, birch and grass.

      Methods: 52 patients that had previously participated in the RDBPC study were asked to
      participate in this open follow up.
    

Intervention name(s): ALK Alutard 5-grasses and birch; ALK Diluent
Intervention type(s): Drug; Drug
Intervention description(s): Intralymphatic injections; intralymphatic injections
Other intervention name(s): Grass and birch allergen with aluminum adjuvant; Human albumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients
Condition: Critically Ill Black Patients
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      To answer the question whether a non-invasive haemaglobin measurement is clinically useful,
      reliable and accurate as compared to taking a blood sample and checking the haemaglobin level
      at the laboratory or in a blood gas analyser. This study will take place in a
      multi-disciplinary ICU of critically ill patients.
    

Detailed description: 
      A presenting sample of 150 patients requiring admission to ICU will be enrolled. These will
      include paediatric, trauma, adult medical and adult surgical patients. Informed consent will
      be obtained. Baseline demographic data, vital signs, Massey pigmentation score, and severity
      of illness scores will be calculated, as well as finger deformity, if present, nail polish or
      acrylics, smoking habits, finger diameter of finger measured, comorbidities and medications.
      Patients will be admitted in the usual way, and admission bloods will be sent to the
      laboratory as per usual protocol. Enrolled patients will in addition have their Haemaglobin
      and Plethysmography Index (measure of perfusion) measured non-invasively using the Masimo
      Pronto-7 handheld device. Note of concurrent medications, blood products and vital signs will
      be recorded at each measurement. Each patient will have measurements done 8 hourly (between
      1-5 measurements per patient). Concurrent arterial blood gas samples will be taken in a
      heparinised syringe and performed on ABL radiometer blood gas analyser.. An additional EDTA
      blood sample shall be taken at each Pronto measuring point which will be measured at the
      laboratory on a Sysmex cell counter. Analysis of data will assess precision and accuracy,
      trend accuracy, and effect of pigmentation, vasopressors and other medication on the results
      of the non-invasive co-oximetry estimation of haemaglobin.
    

Intervention name(s): non invasive co-oximetry haemaglobin measurement
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Propofol and Isoflurane on Pulmonary Vascular Resistance
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that there is no difference between the effects of isoflurane
      and propofol anaesthesia on pulmonary vascular resistance (PVR).
    


Intervention name(s): propofol and isoflurane
Intervention type(s): Drug
Intervention description(s): both drugs administered at age-related dose and titrated to effect. maximum dose of propofol 15 mg/kg/hr, maximum dose of isoflurane 1.5 MAC
Intervention MeSH terms: Propofol; Isoflurane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: propofol; isoflurane; pulmonary hypertension; congenital heart disease
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda
Condition: Child Malnutrition; Infant Morbidity
MeSH terms: Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether 14 days nutritional supplementation with
      Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection
      will prevent malnutrition and reduce the frequency of morbidity.
    

Detailed description: 
      similar to MSF-nutcon 03 : NCT01154803
    

Intervention name(s): Dietary Supplement: Nutrition supplement with RUTF or MNP
Intervention type(s): Dietary Supplement
Intervention description(s): 14 days nutritional supplementation with either
a fortified high quality food(RUTF), 1 sachet/day, 500 kcal and multi micronutrients
a multi micronutrient powder (MNP), 2 sachets per day, no calories, twice recommended daily intake
a placebo (to MNP), 2 sachets per day , no calories, no micronutrients, containing micronutrient carrier
Other intervention name(s): Other Names:; RUTF: Nutriset; MNP: MixMe, DSM; Placebo: DSM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to compare Concerta Extended Release tablets with Metadate CD
      capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD
      symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a
      simulated classroom. The treatments were blinded and the effects were compared with a
      Placebo.
    


Intervention name(s): Methylphenidate Extended Release Capsules
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ADHD; Methylphenidate; Metadate CD; Concerta; COMACS; Attention Deficit Hyperactivity Disorder (ADHD)
Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder
Condition: Sleep Disturbances
MeSH terms: Dyssomnias; Parasomnias; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep
      disturbances.
    


Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): 2-3 mg/day, once daily, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgment.
Intervention MeSH terms: Brexpiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment