bioihbjkbjnl/mcl2 huggingface dataset:
Reading Disability in Children With NF1
Condition: Neurofibromatosis Type 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Dyslexia
Study type: Interventional

Summary: 
      A national, multicenter, randomized, transverse clinical trial, estimating the existence of
      phonological deficits in children with NF1 children compared with control children without
      NF1 with the same reading level.
    

Detailed description: 
      To determine the phonological and visio -spatial performances at the NF1 children.
    

Intervention name(s): Neuropsychological assessments
Intervention type(s): Other
Intervention description(s): Neuropsychological assessments:
Intelligence Quotient (WISC-IV)
Reading tests (reading accuracy, reading speed, reading comprehension and strategy):
Alouette test, Lobrot test, Odedys test. Visio-spatial skill (JLO, Thurston, Corsi tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: NF1; children; reading disabilities
Comparison Between Splint and Laser in Patients Without Disc Displacement With Reduction
Condition: TMJ Disc Disorder
Study type: Interventional

Summary: 
      Stabilization splint therapy and Low-level laser therapy may serve as non-invasive
      intervention for painful temporomandibular disorders, but its efficacy is still debated. This
      study compared the effect of stabilization splint and low-level laser therapy alone or in
      combination in patients with painful chronic closed lock of temporomandibular joints disc
      displacement without Reduction 42 patients diagnosed with chronic closed lock of disc
      displacement without reduction were allocated equally and randomly into three treatment
      groups: group I received combined stabilization splint and low- level laser therapy, group II
      received low - level laser therapy and group III received stabilization splint. They were
      evaluated at baseline and one week, two weeks, four weeks, three months, and six months after
      the intervention.
    

Detailed description: 
      Objectives: Stabilization splint therapy and low- level laser therapy may serve as
      non-invasive intervention for painful temporomandibular disorders, but its efficacy is still
      debated. This study compared the effect of stabilization splint and low- level laser therapy
      alone or in combination in patients with painful chronic closed lock of temporomandibular
      joints disc displacement without Reduction.

      Patients and methods: 42 patients diagnosed with chronic closed lock of disc displacement
      without reduction were allocated equally and randomly into three treatment groups: group I
      received combined stabilization splint and low-level laser therapy, group II received
      low-level laser therapy and group III received stabilization splint. They were evaluated at
      baseline and one week, two weeks, four weeks, three months, and six months after the
      intervention. Time of being normal was also evaluated.
    

Intervention name(s): stabilization splint; laser therapy; stabilization splint and laser therapy
Intervention type(s): Device; Device; Device
Intervention description(s): upper acrylic splint rest on the maxillary teeth and had flat surface; The laser apparatus had a hand piece on which either a specially designed optic prism was attached to transfer laser energy to the tip of the prism; the stabilization splint used in combination of treatment with laser therapy
Other intervention name(s): upper acrylic full arch splint; Low-level laser therapy; splint combined with low level laser therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel clinical trial
Masking: None (Open Label)
Primary purpose: Health Services Research
Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers
Condition: Renal Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the similarity of major pharmacokinetic parameters
      after a single intravenous administration of JT1801 and NESP® in chinese healthy male
      volunteers. And to evaluate the safety, immunogenicity and pharmacodynamic characteristics of
      JT1801 and NESP® in chinese healthy male volunteers
    


Intervention name(s): JT1801 60ug; NESP 60ug
Intervention type(s): Drug; Drug
Intervention description(s): JT1801, 60ug, IV injection; NESP, 60ug, IV injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective
      study will examine the efficacy and safety of rituximab in participants who had previously
      received rituximab in terms of everyday medical practice. Efficacy and safety of rituximab
      will be determined 24 weeks after receiving the first infusion, 24 weeks after the second
      infusion repeated courses of treatment (if the participants receive another course of
      rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the
      participants receive third course of rituximab). Protocol does not specify the criteria for
      initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab
      will be administered at the discretion of treating physician according to approved label.
    


Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Rituximab will be administered at the discretion of treating physician according to approved label. Protocol does not specify/enforce the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab.
Other intervention name(s): MabThera
Intervention MeSH terms: Rituximab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants receiving rituximab no longer than 4 weeks for the treatment of rheumatoid
        arthritis before the start of study.
Glycemic Response of a Commercial Food Bar
Condition: Glucose and Insulin Response
Study type: Interventional

Summary: 
      The purpose of this study is to examine the glucose and insulin response to a food bar.
    

Detailed description: 
      Fitjoy is a commercially available food bar marketed as having a low glycemic index and being
      relatively high in dietary fiber. The fiber contained within this product is
      isomalto-oligoshaccaride (IMO) which is a food ingredient with a relative sweetness level
      equal to approximately 60% of sucrose. Chemically, IMO is a mixture of glucose oligomers with
      alpha - (1-6) - linkages. To date, no research has been performed on the glycemic response to
      ingesting IMO in combination with other constituents. Therefore the purpose of this study is
      to determine the glycemic index of the Fitjoy bar.
    

Intervention name(s): Commercially Available Food Bar; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Fitjoy Bar; Dextrose Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, cross-over administration of supplements with approximately 5-10 days between testing sessions.
Masking: None (Open Label)
Primary purpose: Health Services Research
Reliability for the Detection of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)
Condition: Infertile Men
MeSH terms: Infertility
Study type: Observational

Summary: 
      It is proposed to measure sperm DNA damage by sperm chromatin dispersion test. This
      measurement helps to better diagnose male infertility and seems easy to apply in routine.
      However, the reliability of this method needs to be evaluated before applying for clinical
      practice in andrology laboratory.
    

Detailed description: 
      The aim of this study is to measure the inter and intra-observer reliability for the
      measurements of sperm DNA damage by sperm chromatin dispersion test (halosperm). The gold
      standard to measure sperm DNA damage is TUNEL (Terminal desoxynucleotidyl end labelling)
      method. However, this method is not easy to apply in routine. Therefore we investigate to
      analyse the inter-method reliability between sperm chromatin dispersion test and TUNEL.
    

Intervention name(s): HALOSPERM
Intervention type(s): Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        infertile men
Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
Condition: Ototoxicity; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Ototoxicity
Study type: Observational

Summary: 
      RATIONALE: New ways to find out about hearing loss after treatment with chemotherapy may
      improve the ability to plan cancer treatment and may help patients live more comfortably.

      PURPOSE: This clinical trial is assessing ear damage in young cancer patients treated with
      cisplatin.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the optimal criteria for determination of ototoxicity in younger cancer
           patients treated with cisplatin.

        -  Determine the feasibility of including ultrahigh frequency and evoked otoacoustic
           emission testing as adjunctive measures of ototoxicity.

        -  Determine the feasibility and necessity of central review of audiometry data.

      OUTLINE: This is a multicenter, prospective, cohort study.

      Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic
      emission testing) before the first course of planned cisplatin, before each subsequent course
      of cisplatin, and 4 weeks after the last dose of cisplatin.

      Patients who are scheduled to receive hematopoietic progenitor stem cell transplantation
      undergo hearing tests before the transplantation and 4 weeks after transplantation.

      PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.
    

Intervention name(s): management of therapy complications
Intervention type(s): Procedure
Intervention description(s): Undergo hearing tests
Other intervention name(s): complications of therapy, management of
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients planning to undergo treatment with any cisplatin-containing therapeutic regimen
        for cancer or planning to enroll on clinical trial ACCL0431
      
Keywords: ototoxicity; unspecified childhood solid tumor, protocol specific
Role of CXCR2 Ligands/CXCR2 Biological Axis in Pancreatic Cancer
Condition: Chronic Pancreatitis; Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms; Pancreatitis; Pancreatitis, Chronic
Study type: Observational

Summary: 
      The investigators hypothesize that the CXCR2 ligands/CXCR2 biological axis plays an important
      role in promoting angiogenesis in PC; and that the genetic changes and the microenvironment
      of the tumor regulate the expression of CXCR2 ligands/CXCR2 in PC in order to potentiate
      their angiogenic phenotype. A corollary of this hypothesis is that the cell surface receptors
      (CXCR2) and the intracellular signaling pathways that mediate the angiogenic responses
      induced by ELR+ CXC-chemokines are potential targets for novel therapeutic interventions in
      PC.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary Care
Pharmacotoxicology of Trichloroethylene Metabolites
Condition: Congenital Lactic Acidosis
MeSH terms: Acidosis; Acidosis, Lactic
Study type: Interventional

Summary: 
      To establish the relationship between human MAAI haplotype and DCA and tyrosine metabolism.
      This aim test the postulates that MAAI haplotype determines, and thus can predict,1)
      dose-dependent DCA kinetics and biotransformation.
    

Detailed description: 
      The arms of the study involves determining the haplotype of individuals enrolled. Then
      participants were divided into two groups based on their genotype. The groups include a
      genotype with an EGT alle and a group of genotype without an EGT alle. All subjects first
      took a low dose of DCA 2.5ug/kg for 5 days then wait 30 days and take a therapeutic dose of
      DCA 25mg/kg for 5 days On the first day and on the 5th day of taking DCA kinetics were be
      done. A total of 16 blood samples were obtained through an intravenous catheter. Urine
      collection will also occur.

      Population pharmacogenetic analysis of MAI allelic frequencies and the GC or LC-MS/MS
      techniques for blood or urinary metabolites were used in this investigation. Pharmacokinetic
      data was used to determine metabolism rate of DCA for each allele
    

Intervention name(s): Dichloroacetate (DCA); Genetic Marker on Chromosome 14q24.3
Intervention type(s): Drug; Genetic
Intervention description(s): Dichloroacetate 2.5.ug/kg will be administered for five days in the clinical research center. On day 5 with the dose of DCA a pharmacokinetics test will be performed for 24 hours. 30 days later the individuals will return to the clinic and receive Dichloroacetate 25mg/kg (clinical dose) for five days. On day 1 and day 5 Pharmacokinetics will be performed to determine the relationship between DCA metabolism and haplotype.; Individuals were genotyped at the beginning of the study and their haplotypes were defined. The study is looking at individuals with genetic markers on Chromosome 14q24.3 to determine if there will be a difference in how the DCA will be metabolized.
Other intervention name(s): genotype; Genetic Marker; Haplotypes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: DCA; Dichloroacetate; Trichloroacetate
Blood Nitrate/Nitrite Concentrations Following Acute Ingestion of Resync in Men and Women
Condition: Healthy
Study type: Interventional

Summary: 
      This study evaluates acute ingestion of the dietary supplement Resync on blood
      nitrate/nitrite concentrations in a sample of men and women. This will be a crossover trial
      in which participants take all 4 conditions: 1) 7.5g Resync, 2) 15g Resync, 3) 20g
      Resync+collagen, 4) placebo.
    

Detailed description: 
      The product known as Resync contains a blend of nitrate-rich foods including beetroot, red
      spinach, turmeric, ginger root, and aronia berry extracts. Resync is sold commercially and
      marketed as an ergogenic aid and/or exercise recovery aid. Manufacturers of Resync recommend
      users take this product 60-90 minutes before an athletic event or 30-90 minutes after
      exercise. Resync bases these claims on prior studies investigating the individual
      ingredients' abilities to increase blood nitrate/nitrite levels; however, there are no
      clinical trials on the finished product itself.

      The purpose of this pilot study is to determine the impact of acute, single ingestion of
      Resync products on blood nitrate/nitrite concentration in a sample of men and women. This
      will be a crossover trial in which participants take all 4 conditions: 1) 7.5g Resync, 2) 15g
      Resync, 3) 20g Resync+collagen, 4) placebo.
    

Intervention name(s): Resync; Resync + Collagen; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): The product known as Resync contains a blend of nitrate-rich foods including beetroot, red spinach, turmeric, ginger root, and aronia berry extracts. Resync is sold commercially and marketed as an ergogenic aid and/or exercise recovery aid.; 17g Collagen + 2g Resync + 1g Carbohydrate; 12oz water + food coloring
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-blind, pre-post ingestion, control
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Resync; Nitrate; Nitrite; Healthy
Effects of Acetate and Alcohol on Brain Function
Condition: Cerebral Blood Flow; Brain Function
Study type: Interventional

Summary: 
      This study plans to learn more about how alcohol and its metabolite, acetate, affect the
      brain.
    

Detailed description: 
      This study plans to learn more about how alcohol and its metabolite, acetate, affect brain
      function.
    

Intervention name(s): acetate; alcohol
Intervention type(s): Drug; Drug
Intervention description(s): acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan; a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.
Other intervention name(s): ethanoate; ethanol
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia
Condition: Cesarean Delivery
Study type: Interventional

Summary: 
      Several factors influence the extension of anesthetic mixture during spinal anesthesia
      including anesthetic gravity, body position, drug volume, and drug-delivering velocity.
      However, the effect of temperature of anesthetic mixture on the cephalad sensory blockade is
      hitherto unknown. The investigators hypothesized that different temperatures of the
      anesthetic mixture had different velocity of extension after spinal anesthesia. In addition,
      previous studies suggest that parturients have relative higher sensitivity to temperature.
      Herein the investigators proposed that the temperature of anesthetic mixture had more
      extensive effect on the cephalad sensory blockade with spinal anesthesia for cesarean
      delivery.
    


Intervention name(s): bupivacaine/fentanyl/morphine
Intervention type(s): Drug
Intervention description(s): Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
Intervention MeSH terms: Fentanyl; Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Temperature; Spinal anesthesia; Cesarean section; Cephalad sensory blockade; Regional anesthesia
Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and
      Megace 800mg/20ml in healthy male volunteers under fed condition.
    


Intervention name(s): Megace 800mg/20ml; DW-ES(B) 625mg/5ml
Intervention type(s): Drug; Drug
Intervention description(s): Megestrol acetate 800mg/20ml, Suspension, Single dose; Megestrol acetate 625mg/5ml, Nano suspension, Single dose
Other intervention name(s): Megestrol; Megestrol Acetate; Megestrol; Megestrol Acetate
Intervention MeSH terms: Megestrol; Megestrol Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Self-management and Quality of Life in Individuals With Type 2 Diabetes Mellitus
Condition: Pre-Existing Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study was conducted in order to study the effect of the training given according to
      social-cognitive learning theory (SCLT) upon diabetes self-management and quality of life
      among type 2 diabetes mellitus individuals.
    

Detailed description: 
      The study was done as a randomized-controlled experimental study at Internal Diseases
      Polyclinics of Afyonkarahisar Public Hospital between November 2021 and August 2022. The
      study was completed with 60 patients -experimental group (30 patients) and control group (30
      patients)- who met inclusion criteria. The data were gathered using Information Request Form
      and Metabolic Variables Form, Diabetes Self-Management Scale (DSMS) for Type 2 Diabetic
      Patients, Multidimensional Scale of Perceived Social Support (MSPSS), Type 2 Diabetes
      Mellitus Self-Management Questionnaire (SMQ), WHOQOL-BREF (WHO- Quality of Life Scale- Short
      form). A theoretical and practical training based on SCLT was provided to the experimental
      group for the first five weeks -one module for each week- through power point presentations
      and afterwards, SMS reminders were sent every fifteen days for seven weeks and at the end of
      the twelfth week the training was completed. The control group received a standard training
      from diabetes nurse. The data were assessed using statistical methods.
    

Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): Educate the patients who suffer from Type 2 Diabetes Mellitus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Type 2 Diabetes; Social Cognitive Learning; Diabetes Self-management; Quality of Life
Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)
Condition: Chronic Kidney Disease Stage 3 and 4
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      Part 1: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 μg
      paricalcitol capsules in children ages 10 to 16 years with moderate to severe chronic kidney
      disease (CKD Stages 3 and 4).

      Part 2: To determine the safety and efficacy of paricalcitol capsules as compared to placebo
      in decreasing serum intact parathyroid hormone (iPTH) in children ages 10 to 16 years with
      moderate to severe chronic kidney disease with an initial 12 weeks of double-blinded study
      drug followed by a minimum of 12 weeks of open-label active drug.
    

Detailed description: 
      The study consists of two parts. Part 1 is an open-label single-dose, non-fasting,
      multicenter study to evaluate the pharmacokinetics (PK) of paricalcitol capsules in 12
      children ages 10 to 16 years with CKD Stages 3 and 4. Part 2 of this study will be conducted
      as a 12 week randomized double-blind, placebo-controlled study, followed by 12 weeks
      open-label treatment. Participants active or enrolled under amendment 5 will enter a
      follow-up period and have study visits every 4 weeks until the final participant reaches Week
      24.
    

Intervention name(s): Paricalcitol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Paricalcitol capsules taken with water.; Placebo capsules taken with water
Other intervention name(s): Zemplar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Reduction of parathyroid hormone levels in pediatric patients with Chronic Kidney Disease Stage 3 and 4