bioihbjkbjnl/mcl2 huggingface dataset:
Healthy and Affordable Protein Rich Foods for African Market
Condition: School Feeding Programs and Nutrition Supplements
Study type: Interventional

Summary: 
      This study is to gather information on school feeding programs and to measure the effect on
      linear growth and cognitive performance when providing a high-quality milk protein source or
      a combination of a high-quality milk protein source and rice proteins as a nutritional
      supplement to school children in Ghana. Children will receive a meal with a protein powder
      supplement with vitamins and minerals mixed into it. Participation is expected to last for 9
      months.

      1200 Children aged 6-7 years attending school will be enrolled throughout twenty primary
      schools (60 per school). Participants will be randomized to one of four groups: Control:
      Vitamins/minerals-200 mg premix contain the required micronutrients as per UNICEF
      recommendations.

      For groups 1-3 the same vitamin/mineral mix will be used along with Group 1.
      Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the
      sugar lactose.

      Group 2. Vitamins/minerals + Milk/plant Protein (8.75g)-the milk protein is a skim milk
      protein powder and the plant protein is a rice protein concentrate and the sugar lactose.

      Group 3. Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein
      powder with the sugar lactose.

      At baseline measurements-weight,height,mid-upper arm circumference,and body composition will
      be taken, fasting blood spot test will be administered to measure levels of Insulin and
      insulin like growth factor and other metabolic test, and computer based cognitive testing.
      Demographic information will be collected along with a dietary survey. Primary outcomes are
      cognitive performance on standardized tests and change in height-for-age z-score over the
      supplementation period, 9 months total. Questionnaires will be administered to collect
      demographic data and dietary information.

      At the mid-point all measurements will be taken again and cognitive testing will be repeated.

      At the end of the study all measurements will be taken again, cognitive testing repeated,
      blood spot samples taken again, and a short survey will be administered about the protein
      powders.
    


Intervention name(s): protein powder supplement; Vitamins/minerals
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy
Condition: Rectal Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Observational

Summary: 
      Treatment for locally-advanced rectal adenocarcinoma includes preoperative radiochemotherapy
      before surgery with total mesorectal excision in order to reduce tumor infiltration,
      facilitate oncologic surgery and improve survival. About fifty percent of these patients are
      good responders i.e. their tumor infiltration reduces in the rectal wall and regional lymph
      nodes in order to be graded ypT0 to T2 N0 after pathologic assessment (so called
      downstaging). At the opposite, bad responders (ypT3-4 and/or N+) are not sensitive to
      standard preoperative radiochemotherapy, and their survival is poor than good responders.
      Until now, response to preoperative radiochemotherapy cannot be anticipated before
      pathological assessment of surgical specimen. Proteomic analysis of sera from good and bad
      responders to preoperative radiochemotherapy could allow identification of early biomarkers
      of tumor response, and subsequently adaptation of treatment to increase preoperative
      treatment efficiency and survival in most patients.
    

Detailed description: 
      Good or bad responders to preoperative radiochemotherapy for locally-advanced rectal
      adenocarcinoma cannot be anticipated before pathological assessment of rectal specimen. The
      purpose of this prospective monocentric study is to look for early seric biomarkers
      predictive of tumor response (good and bad responders) in patients treated by preoperative
      radiochemotherapy (45 Gy) for rectal adenocarcinoma using a proteomic approach. All patients
      with locally-advanced rectal adenocarcinoma will be enrolled. Sequential samples of sera will
      be collected before, during preoperative treatment and before surgery, and analysed using a
      MALDI-TOF-TOF method. Proteomic analysis will be correlated to pathological response in order
      to identify potential early biomarkers of tumor response.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patient with rectal carcinoma
      
Biospecimen description: 
      whole blood
    
Keywords: tumor response; rectal adenocarcinoma; preoperative radiochemotherapy; Proteomic analysis; MALDI-TOF-TOF; rectal adenocarcinoma, tumor response after preoperative radiochemotherapy
Child and Infant Learning Project
Condition: Craniosynostosis
MeSH terms: Craniosynostoses
Study type: Observational

Summary: 
      To learn more about the cognitive and motor development of infants and young children born
      with a craniofacial defect called craniosynostosis.
    

Detailed description: 
      In the first phase of this multi-site, 10-year longitudinal study, infants with one of four
      types of single-suture craniosynostosis were recruited: sagittal, metopic, right unilateral
      coronal, and left unilateral coronal. A case-matched "control" group of healthy, normal
      infants was also followed. This study, which is now in its second phase, is following this
      same cohort of children at the age of 7 years.
    

Intervention name(s): neurobehavioral development
Intervention type(s): Behavioral
Intervention description(s): observational study of infant and child development
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with single-suture craniosynostosis between the ages of 2 months and 3 years were
        recruited and followed during phase 1. This same chort of children are now being followed
        at the age of 7 (phase 2). See eligibility criteria section for more information.
Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes (RESET-IT Main Trial)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive
      deterioration in the function of the pancreatic beta-cells, which are the cells that produce
      and secrete insulin (the hormone primarily responsible for the handling of glucose in the
      body). The investigators propose a randomized controlled trial to determine whether
      intermittent intensive insulin therapy is an effective therapeutic strategy that can preserve
      pancreatic beta-cell function and maintain glycemic control early in the course of type 2
      diabetes.
    

Detailed description: 
      In this study, eligible patients with type 2 diabetes will be randomized to either
      intermittent insulin therapy or not, on a background of metformin, after first undergoing a
      short course of intensive insulin therapy. The hypothesis under study is whether intermittent
      insulin therapy can preserve beta-cell function.
    

Intervention name(s): Metformin alone; Metformin + Intermittent Insulin Therapy
Intervention type(s): Drug; Drug
Other intervention name(s): metformin; metformin,; basal insulin glargine and pre-meal insulin lispro
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: beta-cell function,; type 2 diabetes,; intermittent insulin
PEAK Study (Physical Exercise and Activity in Kids)
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to study the effect of formal exercise training on motor
      function and overall physical fitness in children with arthritis. A 12-week comprehensive
      exercise program will be used. Formal exercise training will be compared to Qi gong.
    

Detailed description: 
      Childhood arthritis is a common and often debilitating disease. Children with arthritis are
      less active than their peers, and consequently they often have poor physical fitness. This
      study follows up our pilot study, in which we showed that exercise training can be safely
      carried out in children who have arthritis.

      We plan to randomly assign 80 children with arthritis to one of two groups. The experimental
      group undergoes a vigorous exercise training program consisting of twelve weekly supervised
      sessions as well as twice weekly at home sessions using an exercise video. The control group
      also has twelve supervised sessions and two home sessions. However, their exercises are
      non-strenuous, based on Qi gong. All children have comprehensive fitness testing before and
      after the training at the exercise lab at the Hospital for Sick Children.

      If we show that fitness exercise leads to improved motor function and improved ability to
      carry out activities of daily living, then we will change the way in which we provide therapy
      for childhood arthritis. We hope that this study will lead to an improved quality of life for
      children with arthritis.
    

Intervention name(s): Aerobic and Qi gong Exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Juvenile Rheumatoid Arthritis,; Randomized Control Trial,; attention placebo,; exercise testing,; aerobics,; Qi Gong,; exercise video,; activities of daily living,; quality of life,; economy of walking,; fitness; pediatrics
Probiotics to Enhance Immunogenicity of Influenza Vaccine in Healthy Adults
Condition: Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the food supplement called Lactobacillus
      rhamnosus GG (LGG) may help boost the effectiveness of the nasal flu vaccine. Preliminary
      data from several studies of healthy volunteers suggest that LGG boosts the immune response
      to vaccines. Fifty-two subjects will be recruited into the study, all will receive the nasal
      flu vaccine. Twenty-six will receive capsules that contain LGG, 26 will receive placebo
      capsules. Blood and nasal specimens will be collected weekly for four weeks and at eight
      weeks to evaluate the initial mucosal and systemic immune response to the immunization. This
      study will provide preliminary data on whether the immune response of healthy adults to the
      nasal influenza vaccine can be boosted by LGG.
    


Intervention name(s): Lactobacillus rhamnosus; placebo control; Influenza Virus Vaccine Live, Intranasal
Intervention type(s): Dietary Supplement; Dietary Supplement; Biological
Intervention description(s): 2 capsules by mouth 2 times a day for 28 days. Each capsule contains 1x10^10 LGG organisms.; 2 capsules by mouth twice a day for 28 days; intranasal spray, 0.1ml per nostril, one time dose
Other intervention name(s): Culturelle; FluMist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza; vaccines; probiotics; LGG
Preventative/Preemptive Adoptive Transfer of Peptide Stimulated CMV/EBV Specific T-cells in Patients After Allogeneic Stem Cell Transplantation
Condition: Patients Undergoing Allogeneic Stem Cell Transplantation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In patients after allogeneic stem cell transplantation reactivation of latent herpesviruses
      such as Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) is a frequent and life threatening
      complication requiring antiviral treatment. The underlying problem is a severe suppression of
      the donors immune system after transplantation into the patient. Herpesviruses such as CMV
      and EBV persist after primary infection life long in the host and therefore require constant
      immunological control. This control is largely provided by the T-cell compartment of the
      immune system. After allogeneic stem cell transplantation the T-cell compartment requires a
      long time for its reconstitution since only a small fraction of the donor T-cells are
      transplanted. During this time Herpesviruses can reoccur due to the lack of effective T-cell
      control.

      This study therefore aims at reconstituting the T-cell compartment with CMV and EBV specific
      T-cells at an early time point after allogeneic stem cell transplantation. It is mainly a
      phase I study to demonstrate that these in vitro generated T-cells can be applied safely in
      this patient population. The study also aims at demonstrating the efficacy of CMV/EBV
      specific T-cells by monitoring viral reactivation and use of antiviral drugs. The hypothesis
      is, that CMV/EBV specific T-cell can be applied safely and do not result in graft versus host
      disease and that they successfully prevent reactivation of CMV and EBV after adoptive
      transfer in patients after allogeneic stem cell transplantation.
    


Intervention name(s): CMV/EBV specific T-cell
Intervention type(s): Biological
Intervention description(s): Peptide stimulated allogeneic T-cells with dual specificity for CMV and EBV
Other intervention name(s): T cell
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: CMV; Cytomegalovirus; EBV; Epstein Barr Virus; virus; T cell; adoptive transfer; transplantation; allogeneic
Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture
Condition: Distal Radius Fracture
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate function, pain and radiographic evaluation in
      patients treated with volar locked plating versus Hoffman II bridging external fixation in
      patients with extraarticular distal radius fractures, AO/OTA type A
    

Detailed description: 
      We have designed a randomized prospective study for comparison of volar locked plating versus
      Hoffman II bridging external fixation in patients with extraarticular dislocated distal
      radius fractures AO/OTA type A3. On the basis of power analysis a total of 160 patients are
      to be included in this project. The follow-up period is 1 year and evaluation is based on
      x-ray analysis, grip strength, range of motion, pain and satisfaction with the treatment (
      PRWE, Quick-DASH)
    

Intervention name(s): Volar locked plating; Hoffman external fixator
Intervention type(s): Device; Device
Intervention description(s): Operative treatment of distal radius fracture with volar locking plate; Patients with distal radius fracture operated with Hoffman external fixator
Other intervention name(s): DVR Anatomic plate, Hand Innovations, De Puy; Bridging Hoffman II Compact, Stryker
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Distal radius fracture
Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
Condition: Refractory Leukemia; Acute Myelogenous Leukemia
MeSH terms: Leukemia; Neoplasm Metastasis; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was to evaluate the efficacy and safety of single agent oral panobinostat in
      patients who have refractory de novo or refractory secondary AML.
    


Intervention name(s): Panobinostat/LBH589
Intervention type(s): Drug
Intervention MeSH terms: Panobinostat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myeloid leukemia; AML; relapsed acute myeloid leukemia; refractory AML; refractory de novo AML; refractory secondary AML; secondary AML; AML following myelodysplastic syndrome (MDS); AML following antecedent hematological disorder (AHD); AML resistant to therapy
Testosterone Replacement in Metabolic Syndrome and Inflammation
Condition: Hypogonadism; Metabolic Syndrome; Obesity; Erectile Dysfunction
MeSH terms: Erectile Dysfunction; Metabolic Syndrome; Hypogonadism; Syndrome; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypogonadism (HG) frequently complicates the Metabolic Syndrome (MetS), whether testosterone
      replacement (TRT) is beneficial has not been clearly ascertained. This study was designed to
      address the effects of TRT on insulin resistance, body composition and pro-inflammatory
      status in naïve patients with MetS and HG.
    

Detailed description: 
      The features of Metabolic Syndrome (MetS) include abdominal obesity, atherogenic
      dyslipidemia, raised blood pressure, insulin resistance or glucose intolerance. These
      symptoms are also frequently found in hypogonadal men.

      Adipose tissue and androgens in male obesity are reciprocally linked. Total and free
      testosterone (T) are decreased in proportion to the degree of body fatness while T regulates
      insulin sensitivity and body composition. As a consequence, hypoandrogenism carries an
      additional independent risk for cardiovascular and metabolic disorders. Men with type 2
      diabetes mellitus (T2D) exhibit lowered T levels that are inversely correlated to HbA1c. In
      addition, abdominal adiposity causes an impairment of testicular steroidogenesis that is
      directly linked to circulating adipokines; enhanced cytokine release from
      macrophage-infiltrated adipose tissue is pivotal to the pathogenesis of insulin resistance
      and atherosclerosis. Both MetS and T2D share with hypogonadism such a proinflammatory state.

      For this reason we performed a randomized controlled trial on the effects of TRT on insulin
      resistance and circulating inflammatory markers in a cohort of middle-aged men with mild
      hypogonadism and MetS at first diagnosis, that were not taking medications known to influence
      the investigated outcomes. We established strict criteria for enrollment and used a
      physiological replacing therapy.

      Given that testosterone replacement therapy (TRT) determines a reduction of body fat mass
      paralleled by an increase in fat free mass (6), and that TRT exerts an anti-inflammatory role
      inhibiting interleukins (IL), in particular the IL-6 gene (14), it remains to be established
      whether these independent effects also reflect in an improvement in insulin resistance.
    

Intervention name(s): Testosterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Testosterone transdermal gel 50 mg/day (5 gr); Placebo transdermal gel (5 gr)
Other intervention name(s): Androgel; Testogel
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adiponectin; Resistin; Adipocytes; Testosterone; Aging; HOMA-IR; Insulin; Hypogonadism; Metabolic Syndrome; Obesity; Erectile Dysfunction
Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      This randomized controlled trial compares two regimens of topical therapy:

        -  tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day

        -  combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four
           times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three
           times/day.

      Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are
      evaluated for

        -  corneal edema

        -  conjunctival hyperemia

        -  anterior chamber (Tyndall) reaction.

      The investigators purpose was to evaluate the benefit of adding a non-steroid agent to an
      antibiotic/steroid combination after uneventful phacoemulsification. Adopting a weekly
      follow-up, to gain insight into the optimal duration of postoperative treatment and to
      examine whether risk factors for inflammation exist.
    

Detailed description: 
      Patients were randomized to: i) tobramycin 0.3% - dexamethasone 0.1% one drop qid (TD group,
      n=72, 28 days) and ii) combination of tobramycin 0.3% - dexamethasone 0.1%, one drop qid,
      plus Ketorolac tromethamine 0.5%, one drop tid (TD-K group, n=73, 28 days). Patients
      undergoing vitrectomy due to posterior capsule rupture were excluded. On days 7, 14, 21, 28,
      the frequency of inflammation-related signs [corneal edema, conjunctival hyperemia, anterior
      chamber (Tyndall) reaction], as well as the best corrected visual acuity (BCVA) were
      measured. On day 21, logistic regression was performed to evaluate risk factors for
      inflammation.
    

Intervention name(s): Drug: Tobramycin 0.3% - Dexamethasone 0.1%; Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine
Intervention type(s): Drug; Drug
Intervention description(s): one drop four times per day; Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day
Other intervention name(s): Tobradex; Acular
Intervention MeSH terms: Tobramycin; Tobramycin, Dexamethasone Drug Combination; Dexamethasone; Dexamethasone acetate; Ketorolac; Ketorolac Tromethamine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment