bioihbjkbjnl/mcl2 huggingface dataset:
Effect of G6PD Deficiency on Red Blood Cell Storage
Condition: G6PD Deficiency
MeSH terms: Glucosephosphate Dehydrogenase Deficiency
Study type: Observational

Summary: 
      The proposed study will determine whether G6PD-deficient RBCs store differently than normal
      RBCs under standard blood banking conditions. The investigators plan to screen a large number
      of healthy male volunteers for G6PD deficiency in order to identify 10 G6PD deficient and 30
      matched normal individuals using a blood sample obtained from a finger-stick. The identified
      individuals will then be asked to donate a unit of blood that will be stored for up to 42
      days and various tests will be performed on these units during storage. At 6 weeks of storage
      a portion of the unit will be radioactively labeled and re-infused into the volunteer. Blood
      samples will be drawn before, during, and after the infusion to measure how well or poorly
      the red blood cells survive after transfusion.
    

Detailed description: 
      Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common enzyme deficiency,
      affecting approximately 400 million people world-wide. It manifests as red blood cell (RBC)
      destruction in response to oxidative stress, which can be precipitated by infection, and by
      the ingestion of certain medications and foods. The prevalence of G6PD deficiency varies
      among populations and is most commonly found in individuals from sub-Saharan Africa, the
      Mediterranean region, and south-east Asia. Although in most studies G6PD-deficient
      individuals have normal RBC survival at steady-state, this may vary based upon the G6PD
      variant present, and some individuals may have shortened RBC survival. While it is not
      routine practice to screen blood donors for G6PD deficiency, G6PD deficient donor RBCs may
      store more poorly than normal RBCs. In addition, the transfusion of stored G6PD-deficient
      RBCs may result in decreased RBC survival after transfusion compared to RBCs from normal
      donors.
    

Intervention name(s): Sodium Chromate Cr51
Intervention type(s): Drug
Intervention description(s): Sodium Chromate Cr 51 will be used to perform a red blood cell recovered study 24 hours post-transfusion.
Other intervention name(s): Chromitope
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy male volunteers will be screened for G6PD deficiency in order to identify 10 G6PD
        deficient and 30 matched normal individuals using a blood sample obtained from a
        finger-stick.
      
Biospecimen description: 
      Blood will be collected to conduct a complete blood count (CBC), testing for the presence of
      abnormal hemoglobin types (hemoglobinopathy screen), blood type and antibody screen, and
      confirmation of G6PD deficiency by measuring enzyme activity. In addition, DNA will be
      extracted and preserved for genetic testing for G6PD deficiency.
    
Keywords: transfusion; post-transfusion recovery
Effects of Oral Stimulation and Supplemental Nursing System
Condition: Breastfeeding
Study type: Interventional

Summary: 
      This study aimed to investigate the effect of oral stimulation and a supplemental nursing
      system on the time to full maternal breastfeeding and sucking success in preterm infants.
    

Detailed description: 
      This study aimed to investigate the effect of oral stimulation and a supplemental nursing
      system on the time to full maternal breastfeeding and sucking success in preterm infants. The
      sample consisted of 70 preterm babies. Oral motor stimulation and a supplemental nursing
      system were applied to the preterm infants in the experimental group, while no intervention
      was applied to those in the control group.
    

Intervention name(s): Oral motor stimulation (OMS) and The supplemental nursing system (SNS)
Intervention type(s): Device
Intervention description(s): OMS and an SNS were applied to preterm infants in the experimental group. Oral stimulation intervention provides assisted movement to activate muscle contraction and provides movement against resistance to build strength. The cheeks (internal and external), lips, gums, tongue, and palate were stimulated by finger-stroking following the protocol. OMS consisted of intra (oral region) and peri-oral stimulation (around the oral region). The OMS was administered three times a day by a nurse, from the day of initiation of oral feeding to the day of independent oral feeding 15 minutes before the feeding schedule. A bottle/container was filled with breast milk before the process and given to the baby via SNS while the baby was holding the mother's breast. The SNS consists of a syringe/container and a feeding catheter. One end of the feeding probe is inside the syringe/container, while the other end of it is fixed to the mother's nipple using plaster.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Preterm; oral stimulation; supplemental nursing system
Hemp 15 mg & 50 mg Capsule Absorption
Condition: Absorption; Chemicals
Study type: Interventional

Summary: 
      This study is intended to investigate the absorption of cannabidiol (CBD) and cannabidiol
      acid (CBD-A) in plasma from an oral delivery of a single dose of full spectrum hemp extract
      at two concentrations over a 4-hour timeline.
    

Detailed description: 
      This study is designed to determine the time to maximum plasma concentration of CBD and CBD-A
      after an oral dose of standardized full spectrum hemp extract over a 4-hour timeline. This
      study is designed to include two arms. Each arm will be delivered a different concentration
      of standardized full spectrum hemp extract, either 15 mg or 50 mg. Throughout the course of
      the study all participants will be asked to provide four (4) plasma samples, 10 randomly
      selected participants will be asked to provide five (5) plasma samples. Samples will then be
      evaluated using a validated LC-MS/MS method to develop a blood concentration time curve in
      order to determine time to reach maximum blood concentration. This trial is double-blinded
      with two arms enrolling only healthy individuals. The participants randomized for a fifth
      blood draw will be randomly selected from these two arms.
    

Intervention name(s): 15 mg/g Full Spectrum Hemp Extract; 50 mg/g Full Spectrum Hemp Extract
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): HPMC capsules containing full spectrum standardized hemp extract in liquid form.; HPMC capsules containing full spectrum standardized hemp extract in liquid form.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Fluoride Varnish Randomized Clinical Trial
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or
      twice a year with counseling to counseling alone in preventing early childhood caries (ECC)
      (tooth decay in children under the age of five).
    

Detailed description: 
      This project was a prospective, randomized clinical trial (RCT) among initially caries-free
      children from about six months old (when primary teeth erupt) up to age three at two public
      health facilities in San Francisco, one serving a primarily Latino and one a primarily Asian
      population. The RCT 1) Compared the efficacy of once or twice/year fluoride varnish (FV)
      application and counseling to counseling alone in preventing early childhood caries (ECC); 2)
      Assessed pre-intervention salivary markers (biologic and chemical), behavioral and
      demographic factors as predictors of ECC; 3) Compared the efficacy of these interventions
      between sites serving different ethnic populations with a high prevalence of ECC; and 4)
      Determined the salivary fluoride release profile following exposure to fluoride varnish.
    

Intervention name(s): Fluoride Varnish
Intervention type(s): Device
Intervention description(s): 0.1 mL (1 drop) applied on each of 2 arches
Other intervention name(s): Duraphat® (Colgate Oral Pharmaceuticals)
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Early Childhood Caries
Compaction Total Hip Arthroplasty (THA) Bilateral
Condition: Coxarthrosis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      This is a prospective, randomized study comparing two different bone preparation techniques
      for insertion of a porous coated titanium cementless femoral stem. Patients receiving a
      bilateral total hip replacement are randomized to conventional broaching on one side and
      compaction on the other side.

      Hypothesis: Compaction results in significantly less stem migration [evaluated by
      radiostereometric analysis (RSA)], less peri-prosthetic bone mineral density (BMD) loss
      [evaluated by dual energy x-ray absorptiometry (DEXA)], and a higher Harris hip score after
      two years.
    


Intervention name(s): Bone preparation technique: compaction; Bone preparation technique: broaching
Intervention type(s): Procedure; Procedure
Other intervention name(s): No other names.; No other names.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: THA
Impact of HLA-E Overexpression by Tumor Cells on the Biology of TIL in Colorectal Cancer
Condition: ColoRectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Accumulating evidences suggest that colorectal cancer (CRC) progression is not solely
      determined by the genetic abnormalities of the tumor cells but also by the host response.
      Indeed, recent studies in CRC have associated improved survival with a high number of
      tumor-infiltrating (TIL) memory and cytotoxic T lymphocytes, suggesting a link between tumor
      progression and in situ T cell response. Gene expression profiling studies have clearly
      isolated a well-known subgroup of CRC characterized by microsatellite instability (MSI) CRC,
      associated with a strong immune response signature involving both Th1/cytotoxic and immune
      evasion pathways. Moreover, the investigators have previously shown that HLA-E/β2m is
      overexpressed by tumor cells in roughly 20% of CRC and is associated with a worse prognosis,
      most likely due to NK and T effector cell functions upon engagement with the inhibitory NK
      receptor CD94/NKG2A. However, our recent results on an enlarger cohort of patients suggest
      that if this observation holds true for MSS CRC, HLA-E over-expression is inversely
      associated with a good prognosis in MSI CRC. Thus, the phenotype and function of TIL,
      depending on the MSI/MSS status of CRC have to be precised. The investigators hypothesized
      that in MSI CRC, known to express a high number of MSI-H related frameshift peptides which
      represent a pool of tumor specific antigens, HLA-E could present peptides to TCR of non
      conventional CD8+ HLA-E-restricted alpha-betaT cells (also expressing CD94), then inducing a
      strong antitumor cytolytic activity. Therefore, the aim of this project is to determine the
      exact phenotype, function and specificity of the CD94+ TIL in CRC, depending on both the
      HLA-E and the MSI/MSS status of tumor cells. These results could impact the clinical practice
      as anti-NKG2A monoclonal antibodies or frameshift peptide based immunotherapy that could be
      promising new therapeutic options in CRC patients.
    


Intervention name(s): Non interventional study
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Major patients treated surgically for colorectal cancer at the Nantes University Hospital
        or the West Institute of Cancerology
      
Biospecimen description: 
      20 mL of Blood, a tumor fragment and a fragment of colonic mucosa
Study to Evaluate Impact of School-based Influenza Vaccination on School Populations
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      Rates of confirmed influenza illness in vaccinated and non-vaccinated children will be
      compared between schools with and without vaccination programs. The investigators hypothesize
      that in addition to lowering rates of influenza in vaccinated children, raising vaccination
      rates by 30-40% through school-based vaccination programs will decrease incidence of
      influenza in non-vaccinated children attending those schools compared to non-vaccinated
      children in schools with low vaccination rates.
    

Detailed description: 
      This prospective cohort study will evaluate rates of virologically confirmed influenza in
      children attending schools with and without school-based vaccination programs. Eight schools
      (4455 students) in two school districts matched for size, race/ethnicity, socioeconomic
      status, and location will serve as intervention and control schools. During influenza season
      defined by local surveillance data, nasal/throat swabs will be obtained for rapid influenza
      detection assays from all children with fever and respiratory symptoms identified by teachers
      for evaluation in the school nurse's office. Absent children will be offered testing at a
      central location within the schools' communities.Rates of confirmed influenza illness in
      vaccinated and non-vaccinated children will be compared between schools with and without
      vaccination programs. Rates of absenteeism also will be evaluated. The investigators
      hypothesize that in addition to lowering rates of influenza in vaccinated children, raising
      vaccination rates by 30-40% through school-based vaccination programs will decrease incidence
      of influenza in non-vaccinated children attending those schools compared to non-vaccinated
      children in schools with low vaccination rates.
    

Intervention name(s): School-based influenza vaccination program
Intervention type(s): Biological
Intervention description(s): School-based influenza vaccination program
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; influenza vaccination; school-based vaccination
Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of
      Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to
      healthy at-risk adults.
    


Intervention name(s): Men ACWY CRM; 4CMenB
Intervention type(s): Biological; Biological
Intervention description(s): A single dose of a 0.5 mL injectable solution; All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal disease; prevention; vaccination
Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant OCD
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      OCD is a chronic condition with a high rate of poor responders to conventional treatments,
      such as antidepressants and psychotherapy. Chronic symptoms can lead to important social
      impairment and suffering for patients and families.

      The present study aims to investigate if the addition of transcranial magnetic stimulation
      can provide enhanced response to conventional treatment.

      Transcranial magnetic stimulation is a noninvasive technique that can influence specific
      areas of the brain and has very few side effects.
    

Detailed description: 
      The treatment with transcranial magnetic stimulation requires attendance to hospital daily
      sessions for 6 consecutive weeks. Each session lasts up to 30 minutes.

      Side effects include scalp discomfort and mild headache. No anesthesia is required.

      Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat
      depression symptoms with positive results. The present technique has never been employed in
      previous studies, but risks are insignificant
    

Intervention name(s): repetitive transcranial magnetic stimulation (rTMS)
Intervention type(s): Procedure
Intervention description(s): 30 daily sessions: each with 40 trains of 5 seconds at 10Hz, with a 25 second inter-train interval, at an intensity of 110% of motor threshold. Site: Right Dorsolateral Prefrontal Cortex
Other intervention name(s): TMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obsessive-Compulsive Disorder; rTMS; Transcranial Magnetic Stimulation; treatment; randomized controlled trials
Surgery Plus Radiation Therapy With or Without Chemotherapy in Treating Children With Primitive Neuroectodermal Tumors of the CNS
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It
      is not yet known whether undergoing surgery plus radiation therapy is more effective with or
      without chemotherapy for primitive neuroectodermal tumors of the CNS.

      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus radiation
      therapy with or without chemotherapy in treating patients who have primitive neuroectodermal
      tumors of the CNS.
    

Detailed description: 
      OBJECTIVES: I. Determine whether chemotherapy utilizing carboplatin, vincristine,
      cyclophosphamide, and etoposide improves the prognosis for children with primitive
      neuroectodermal tumors of the central nervous system when given after surgery and before
      radiotherapy. II. Assess prospective factors that may determine ultimate prognosis in this
      patient population. III. Determine the quality of survival of these patients on both
      treatment regimens.

      OUTLINE: This is a randomized study. Patients undergo surgical removal of the primary tumor.
      Following surgery, patients are randomized to receive radiotherapy alone (arm I) or
      chemotherapy followed by radiotherapy (arm II). Arm I: Patients begin receiving radiotherapy
      as soon as possible after surgery, within 28 days. Radiotherapy is administered 5 times a
      week for 6 weeks. Arm II: Within 28 days of surgery, patients receive vincristine IV on days
      1, 7, 14, 21, 28, 35, 42, 49, 56, and 63. Carboplatin IV is administered over 1 hour on days
      1, 2, 42, and 43. Etoposide IV is administered over 1 hour on days 1-3, 21-23, 42-44, and
      63-65. Cyclophosphamide IV is administered over 4 hours on days 21 and 63. As soon as
      possible after chemotherapy, patients receive radiotherapy as in arm I. Quality of life is
      assessed every 3 months for the first year and annually thereafter. Patients are followed
      every 6 weeks for the first year, every 3 months for the second year, every 4 months for the
      third year, and every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): carboplatin; cyclophosphamide; etoposide; vincristine sulfate; surgical procedure; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Etoposide; Vincristine
Primary purpose: Treatment
Keywords: untreated childhood supratentorial primitive neuroectodermal tumor; recurrent childhood supratentorial primitive neuroectodermal tumor
Pharmacokinetics and Metabolism of 14 Carbon [14C]-GSK3640254
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-center, single group, non-randomized, two-period, single
      sequence, mass balance study which will enroll 6 healthy male participants. This study will
      assess the pharmacokinetics, balance/excretion, and metabolism of GSK3640254 in humans using
      [14C]-radiolabeled drug substance administered as an intravenous (IV) infusion and via the
      oral route. The study will also provide an assessment of GSK3640254 absorption, metabolism
      and excretion following administration of a [14C]-radiolabeled oral suspension. Each
      participant will be involved in the study for up to 10 weeks which will include a screening
      period, two treatment periods (treatment Periods 1 and 2) separated by a washout of at least
      13 days between oral doses, and a follow-up visit 7-14 days after the last assessment in
      treatment Period 2.
    


Intervention name(s): GSK3640254 Oral tablet; [14C]-GSK3640254 intravenous infusion; [14C]-GSK3640254 powder
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK3640254 will be available as white film-coated round tablets to be administered via oral route with meal in the morning with 240 milliliter (mL) of water at room temperature.; [14C]-GSK3640254 will be available as clear, colorless solution free from visible particulates to be administered via the IV route.; [14C]-GSK3640254 will be available as white powder to be reconstituted into a suspension with 25 mL of vehicle before dosing so as to administer 85 mg dose with meal in the morning.
Intervention model: Single Group Assignment
Intervention model description: Participants will receive non-radiolabeled GSK3640254 oral tablets concomitantly with radiolabeled [14C]-GSK3640254 administered as an IV infusion in treatment Period 1 and radiolabeled [14C]-GSK3640254 as an oral suspension in treatment Period 2.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human Immunodeficiency Virus (HIV); GSK3640254; Pharmacokinetics; Radiolabeled; Mass balance