bioihbjkbjnl/mcl2 huggingface dataset:
Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of oral progesterone supplementation in
      preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy
      period, and its side effect.
    


Intervention name(s): dydrogesterone; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Duphaston
Intervention MeSH terms: Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Cognitive Training for Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is evaluating the effects of two brain training exercises on: memory, cognitive
      processing and depression symptoms.
    

Detailed description: 
      There is an urgent public health need to develop more effective and well tolerated treatments
      for patients with major depressive disorder (MDD); cognitive training interventions aiming to
      modify cognitive and affective processing abnormalities underlying MDD represent a promising
      new strategy. This research project translates a well established cognitive bias in major
      depressive disorder (MDD), working memory bias, into a novel intervention target. In a
      double-blind, randomized, controlled study, MDD participants undergo 4 weeks of cognitive
      training sessions, with two sessions per week.
    

Intervention name(s): Cognitive Training A; Cognitive Training B
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive training; Depression
L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and tolerability of L-asparaginase
      monotherapy as salvage treatment in patients with NK/T cell lymphoma
    

Detailed description: 
      The prognosis of patients with progressive and recurrent NK/T cell lymphoma is poor partially
      due to lack of effective treatment. L-asparaginase was reported to be effective in this
      setting by several case reports. The investigators aim to evaluate the efficacy and toxicity
      of L-asparaginase monotherapy in a prospective phase II study.
    

Intervention name(s): L-asparaginase
Intervention type(s): Drug
Intervention description(s): L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles
Other intervention name(s): L-asp
Intervention MeSH terms: Asparaginase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients
Condition: Glycemic Control
MeSH terms: Aggression
Study type: Interventional
Phase: Phase 1

Summary: 
      entGlycemic control has been found to improve clinical outcomes following Coronary Bypass
      Surgery. This study tests the hypothesis that obtaining tighter glycemic control(80-120mg/dl)
      as opposed to more moderate control (120-180mg/dl) will further improve outcomes.
    

Detailed description: 
      150 diabetic patients will be randomized to achieve aggressive glycemic control (80-120mg/dl)
      vs moderate control (120-180mg/dl) using intravenous insulin infusions beginning at
      anesthetic induction and continuing for 18 hours following surgery.
    

Intervention name(s): IV Insulin drip; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl; IV insulin drip to keep serum glucose between 80-120mg/dl.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose, Insulin
Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the activity of UR-63325 in a model of allergic
      rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise
      healthy.
    


Intervention name(s): UR-63325; Fluticasone propionate nasal spray; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): UR-63325; Fluticasone propionate nasal spray; Placebo to UR 63325 and fluticasone propionate nasal spray
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of Amino Acids to Enhance Anabolism After Home-based Exercise
Condition: Amino Acids, Essential; Metabolism; Exercise
Study type: Interventional

Summary: 
      An adequate quantity of lean body mass is vital for optimal health and performance, and is
      accrued when net protein balance (NPB) is positive. Amino acids are the building blocks of
      protein, and when consumed following resistance exercise, significantly improve NPB.

      However, no study has investigated how a supplement of all of the essential amino acids (EAA)
      affects NPB following resistance exercise in a free-living, home-based setting, particularly
      when compared to a supplement of branched-chain amino acids (BCAA).

      Therefore, the purpose of this study is to determine the impact of a novel EAA supplement on
      anabolism (e.g., NPB) as compared to BCAA and placebo supplements following home-based
      resistance exercise.
    


Intervention name(s): Novel essential amino acid supplementation; Branched-chain amino acid supplementation (BCAA); Isocaloric carbohydrate supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): This intervention will determine the impact of EAA+ on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.; This intervention will determine the impact of the BCAA supplement (to be compared to EAA+) on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.; This intervention will determine the impact of an isocaloric carbohydrate placebo supplement (to be compared to EAA+) on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In a randomized, counterbalanced order, participants will receive all treatments arms (essential amino acids, branched-chain amino acids, and placebo).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Home-based resistance exercise; Protein synthesis; Net protein balance; Protein breakdown; Essential amino acids; Branched-chain amino acids; Protein metabolism
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety and immunogenicity of GSK Biologicals'
      influenza vaccine GSK2340272A.
    


Intervention name(s): GSK investigational vaccine GSK2340272A; GSK investigational vaccine GSK2340269A
Intervention type(s): Biological; Biological
Intervention description(s): Two intramuscular injections; Two intramuscular injections
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza infection; GSK Bio's influenza vaccine GSK2340272A
Yogurt for Prevention of Chronic Inflammation
Condition: Obesity; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The objective of this study is to conduct a randomized cross-over dietary intervention in
      adult women who are overweight or obese to compare how yogurt and a control food affect
      biomarkers of inflammation and intestinal health.
    


Intervention name(s): Yogurt; Control food
Intervention type(s): Other; Other
Intervention description(s): Low-fat flavored yogurt; Low-fat flavored soy pudding
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: yogurt; obesity; intestine
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 702843 Administered Subcutaneously to Healthy Volunteers
Condition: Thalassemia
MeSH terms: Thalassemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of
      IONIS TMPRSS6-Lrx Administered Subcutaneously for up to 44 Healthy Volunteers
    


Intervention name(s): IONIS TMPRSS6-Lrx; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Ascending single and multiple doses of IONIS TMPRSS6-Lrx administered subcutaneously; Saline .9%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Thalassaemia, IONIS TMPRSS6-Lrx
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The study intends to establish proof of concept for a fractional dose schedule under
      conditions of natural exposure in children 5-17 months old at first vaccination. The study
      also aims to establish the role of third dose spacing in a fractional dose schedule, describe
      the effect of an earlier full fourth dose at Month 14 and describe the effect of multiple
      fractional or full yearly doses.
    

Detailed description: 
      The current study intends to establish proof of concept (POC) for a fractional dose schedule
      under conditions of natural exposure. The study will be conducted in children 5-17 months old
      at first vaccination living in areas of mid to high malaria transmission, in line with the
      age group recommended by the World Health Organization (WHO) for the implementation of the
      RTS,S/AS01E vaccine. Results from this study will be critical in informing future
      possibilities for the development of vaccine-based strategies which, in combination with
      other interventions, may contribute to the malaria elimination agenda.
    

Intervention name(s): RTS,S/AS01E (Full dose); RTS,S/AS01E (1/5th dose); Rabies vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Subjects will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).; Subjects will receive intramuscular injection of RTS,S/AS01E (1/5th dose: 0.1 ml).; Subjects will receive intramuscular injection of rabies vaccine (0.1 ml).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: falciparum, efficacy; RTS,S/AS01; malaria vaccine; safety; Malaria; immunogenicity; infants
Ultrasound of the Diaphragm in ICU Patients
Condition: Critically Ill
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically
      ill patients admitted in a teaching hospital intensive care unit will be evaluated with
      diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical
      course of these patients.

      Vascular surgery patients (aortic abdominal surgery) might also be included and assessed with
      diaphragm ultrasound before and after surgery irrespectively of the need of intensive care
      unit. On December 2014 the Etical committee approved an amendment to include the possibility
      to study elective aortic abdominal surgery patient to assess the relationship between surgery
      related diaphragmatic dysfunction and postoperative respiratory complications.
    


Intervention name(s): diaphragm ultrasound
Intervention type(s): Other
Intervention description(s): we'll perform diaphragm ultrasound in ICU critically ill patients
Other intervention name(s): echography of diaphragm
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult critically ill patients
      
Keywords: ultrasound; diaphragm; intensive care; critical care
Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population
Condition: Visual Acuity
Study type: Interventional

Summary: 
      The study is a bilateral, single-masked, single-arm, 3-visit dispensing study. There will be
      one study treatment, with the subject being in the treatment for approximately 12-16 days.
    


Intervention name(s): Toric Multifocal etafilcon A with PVP
Intervention type(s): Device
Intervention description(s): Investigational
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lipopolysaccharide (LPS) Challenge in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      LPS Challenge in Individuals with Major Depressive Disorder
    

Detailed description: 
      The aim of this project is to understand the biological differences between two distinct
      subtypes of depression, patients with and without inflammation as defined by c-reactive
      protein (CRP). Using a double-blinded, parallel group, placebo-controlled design,
      participants will be phenotyped before and after a low-dose lipopolysaccharide (LPS)
      challenge designed to perturb the immune system and trigger a transient, mild inflammatory
      response. This experimental design will allow for the delineation of the homeostatic
      mechanisms underlying sensitivity to inflammation-related depression. Low-dose LPS has been
      used by multiple groups to safely induce transient inflammatory responses in humans.
    

Intervention name(s): Lipopolysaccharide; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Lipopolysaccharide (LPS) derived from E. Coli group O 113:H10:K negative; Saline solution
Other intervention name(s): Endotoxin, CCRE; Saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Mood Disorder; MDD; Endotoxin; MRI; CRP
Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Background: Down syndrome (DS) has unique physical, motor and cognitive characteristics.
      Despite cognitive and motor difficulties, there is a possibility of intervention based on the
      knowledge of motor learning. However, it is important to study the motor learning process in
      individuals with DS during a virtual reality task to justify the use of virtual reality to
      organize intervention programs. The aim of this study was to analyze the motor learning
      process in individuals with DS during a virtual reality task. Methods: A total of 40
      individuals participated in this study, 20 of which were with DS (24 males and 8 females,
      ranging between 11-28 yrs.) and 20 typically developing individuals matched by age and gender
      to the individuals with DS. To examine this issue, we used software that uses 3D images and
      reproduced a coincidence timing task.
    


Intervention name(s): Virtual reality
Intervention type(s): Behavioral
Intervention description(s): Evaluation of observational motor learning using virtual reality
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Virtual Reality
Effects of Salvinorin A on Brain Function
Condition: Drug Effect
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will investigate the effects of salvinorin A on human brain activity and
      connectivity using functional magnetic resonance imaging (fMRI) methods. An inhalation route
      of administration will be used as it is the most common route for contemporary use of Salvia
      divinorum, a plant containing salvinorin A.
    

Detailed description: 
      Volunteers will undergo two experimental sessions that include the inhalation of salvinorin
      A. The first session will be completed in a comfortable space furnished as a living room, and
      the second session will be conducted within a magnetic resonance imaging (MRI) scanner.
    

Intervention name(s): Salvinorin A
Intervention type(s): Drug
Intervention description(s): Salvinorin A, blinded doses
Other intervention name(s): salvia, salvia divinorum
Intervention MeSH terms: Salvinorin A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Copeptin in Adolescent Participants With Type 1 Diabetes and Early Renal Hemodynamic Function
Condition: Diabetes Mellitus, Type 1; Nephropathy; Diabetic Nephropathies; Juvenile Diabetes; Diabetes Mellitus Complication; Autoimmune Diabetes; Type 1 Diabetes Mellitus
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Complications
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Over 1.25 million Americans have type 1 diabetes (T1D), increasing risk for early death from
      cardiorenal disease. The strongest risk factor for cardiovascular disease (CVD) and mortality
      in T1D is diabetic kidney disease (DKD). Current treatments, such as control of hyperglycemia
      and hypertension, are beneficial, but only partially protect against DKD.

      Hyperfiltration is common in youth with T1D, and predicts progressive DKD. Hyperfiltration is
      also associated with early changes in intrarenal hemodynamic function, including increased
      renal plasma flow (RPF) and glomerular pressure. Intrarenal hemodynamic function is strongly
      influenced by the renin-angiotensin-aldosterone system (RAAS), which is also considered a key
      player in the pathogenesis of DKD. Preliminary data demonstrate differences in intrarenal
      hemodynamic function and RAAS activation in early and advanced DKD in T1D. However, the
      pathophysiology contributing to the differences observed in RAAS activation and intrarenal
      hemodynamic function in T1D are poorly defined Animal research demonstrates that arginine
      vasopressin (AVP) acts directly to modify intrarenal hemodynamic function, but also
      indirectly by activating RAAS. Preliminary data suggest that elevated copeptin, a marker of
      AVP, which predicts DKD in T1D adults, independently of other risk factors. However, no human
      studies to date have examined how copeptin relates to intrarenal hemodynamic function in
      early DKD in T1D. A better understanding of this relationship is critical to inform
      development of new therapies targeting the AVP system in T1D. Accordingly, in this study, the
      investigators propose to define the relationship between copeptin and intrarenal hemodynamics
      in early stages of DKD, by studying copeptin levels, renal plasma flow, and glomerular
      filtration in youth (n=50) aged 12-21 y with T1D duration < 10 y.
    


Intervention name(s): Aminohippurate Sodium Inj 20%; Iohexol Inj 300 mg/mL
Intervention type(s): Drug; Drug
Intervention description(s): Diagnostic aid/agent used to measure effective renal plasma flow (ERPF); Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
Other intervention name(s): Aminohippuric acid; Para-aminohippurate (PAH); Sodium 4-amino hippurate (PAH) inj 20% 2g/10 mL; omnipaque 300
Intervention model: Single Group Assignment
Intervention model description: All study participants will receive the same intervention.
Masking: None (Open Label)
Primary purpose: Diagnostic
Laboratory Study of Early Tumor Markers in the Peripheral Blood of Glioblastoma Multiforme Patients
Condition: Glioblastoma Multiforme; Healthy Volunteers
MeSH terms: Glioblastoma
Study type: Observational

Summary: 
      The purpose of this study is to determine if tumor cells can be detected in the blood of
      patients diagnosed with a brain tumor.
    

Detailed description: 
      Despite aggressive therapies, Glioblastoma Multiforme (GBM) is rapidly fatal. GBMs are
      increasingly recognized for occasionally metastasizing through the peripheral blood to
      distant locations. This research study involves the detection and novel characterization of
      human GBM (hGBM) circulating tumor cells (CTCs) within the peripheral blood of brain tumor
      patients by identifying their unique cell surface antigen profile, determining an optimal
      isolation protocol, and quantitatively and qualitatively reporting the yield and
      characteristics.
    

Intervention name(s): GBM Patients; Normal Controls
Intervention type(s): Other; Other
Intervention description(s): 2 teaspoons of blood will be collected during select clinic visits.; 2 teaspoons of blood will be collected once.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited during routine interactions with the investigators.
      
Keywords: GBM; Brain Tumor; Brain Neoplasm; Control; Normal Control; Volunteer