bioihbjkbjnl/mcl2 huggingface dataset:
DHFR 19 bp Deletion Polymorphism and Folic Acid Utilization
Condition: Characterize rs70991108 Polymorphism of DHFR Gene
Study type: Observational

Summary: 
      A genetic variation in the gene for the protein dihydrofolate reductase (DHFR) that is
      necessary to utilize folic acid (a synthetic form of the B vitamin folate found in
      supplements and fortified food), increases the risk for breast cancer in multivitamin users
      and, when present in mothers who used folic acid supplements during pregnancy, increases the
      risk for cancer of the eye of their children. The aim of the proposed research is to
      understand how a common genetic variation in the gene for DHFR affects the function of this
      protein and the ability of the body to use folic acid.
    

Detailed description: 
      A 19bp deletion polymorphism of intron 1 of dihydrofolate reductase (DHFR 19bpdel) increases
      the risk for breast cancer, and retinoblastoma of the offspring, in folic acid supplement
      users. Folic acid is a synthetic form of folate present in fortified foods and supplements
      that must be converted to tetrahydrofolate by DHFR to enter the metabolism. Individuals
      homozygous for DHFR 19bpdel have higher prevalence of unmetabolized folic acid in plasma and
      lower incorporation of folic acid into tissues. How the DHFR19bpdel (17% homozygosity in US)
      affects DHFR activity and folate metabolism to increase cancer risk is not understood.
      Studies on this topic are urgent in the light of mandatory folic acid fortification in the US
      and other countries. The objective of this project is to characterize the effect of DHFR
      19bpdel on DHFR activity and folate pathway reactions and to determine if the effect of DHFR
      19bpdel can be alleviated with folinic acid, which is a folate source that need not be
      converted by DHFR. The specific aims of this project are to 1] Determine expression of DHFR
      mRNA and protein, splicing of intron 1 and enzyme activity in white blood cells from 3 DHFR
      genotypes. 2] Determine the effect of DHFR 19bpdel and folic acid or folinic acid
      concentration on cell growth, and folate pathway reactions in white blood cells in
      homozygotes for DHFR 19bpdel and those who lack the polymorphism. Results of this study will
      guide measures to reduce this modifiable cancer risk associated with DHFR 19bpdel.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy pre-menopausal females aged 21-45 from Metro Boston area
      
Keywords: Folate, DHFR
Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine
Condition: Psychotic Disorders
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive
      episodes during the course of psychotic disorders
    

Detailed description: 
      Major depressive episodes (MDE) frequently occur during the course of schizophrenic
      psychoses, both as as "post-psychotic" depressions, and also independently from psychotic
      episodes. A number of clinical studies reported the application of different antidepressive
      substances, such as Imipramine, Reboxetine or Venlafaxine. In general, the treatment of
      schizophrenic patients with antidepressive drugs can be considered as necessary and save,
      resulting in therapeutic guidelines of different psychiatric societies. However, since 5 to
      10 % of the schizophrenic patients commit suicide, there is still much effort necessary in
      order to improve the treatment of affective symptoms in schizophrenic psychoses.The recently
      introduced antidepressive substance Duloxetine selectively inhibits as a SSNRI the reuptake
      of serotonine and noradrenaline from the synaptic cleft. Duloxetine was proven as
      antidepressive, anxiolytic and analgetic in a series of multi-centre, placebo-controlled
      investigations. Based on these considerations and on successful experiences in single case
      reports we aim to investigate the therapeutic effects of duloxetine in patients with lifetime
      diagnoses of the schizophrenic spectrum.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia,; schizoaffective disorder,; major depressive episode,; combination,; duloxetine
Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles
      of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with
      continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous
      glucose infusion. The order of treatment session will be randomised.

      Hypotheses:

        1. Secretion of endogenous insulin depends on exogenous insulin supply

        2. Secretion of endogenous insulin is depends on plasma glucose levels
    

Detailed description: 
      There are a screening visit and two treatment sessions:

      Session A: Treatment with Insulin Aspart 1.5 IE/time overnight without intravenous glucose
      infusion Session B: Treatment with Insulin Aspart 1.5 IE/time overnight with intravenous
      glucose infusion.
    

Intervention name(s): Insulin Aspart 100 IE/ml
Intervention type(s): Drug
Intervention description(s): 1.5 IE/hour/subject/visit. Each vist takes 10 hours
Other intervention name(s): NovoRapid 100 IE/ml
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes mellitus, endogenous insulin
Study of Gesture and Executive Functions in Children With High Intellectual Potential
Condition: High Intellectual Potential; Children
Study type: Interventional

Summary: 
      The main objective of this study is to determine whether children with high intellectual
      potential have gestural and / or executive difficulties compared to control children.
    


Intervention name(s): clinical examination in neurology; neuropsychological examination; anamnestic elements
Intervention type(s): Other; Other; Other
Intervention description(s): This examination is based on the movement of the child in a standing position (forward and backward on a straight line, jumping on a foot ...), seated (visual continuation ...) and elongated (tone, patellar and achillian reflexes, superficial sensitivity ...) . This makes it possible to evaluate all the neurological systems.; This examination is based on the use of standardized psychometric tools and validated with children, usually used in clinical practice.; Several elements will be collected during the clinical interview to inform the history of the child's development, such as neonatal data (term of pregnancy, APGAR score ...), age of appearance of the first words , seating, walking, possible care, level of education ans level of education of the parents.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Case-control study, monocentric.
Masking: None (Open Label)
Primary purpose: Other
Dynamic Stretching Training and Muscle Tendon Unit
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a 5-week dynamic stretching
      exercise training on muscle-tendon unit of gastrocnemius muscle.
    

Detailed description: 
      Muscle stretching is a common practice applied in warm-up process to enhance performance in
      sports and to prevent or decrease the risk of sports injury. Muscle stretching is also used
      for therapeutic purposes in many clinical conditions.

      It is generally performed in either static or dynamic manner. The effects of stretching
      depend on the type, duration and timing of stretching. However, the acute and chronic effects
      of a stretching can be different in the same muscle.

      Recent studies suggest that static stretching has adverse effects on performance, reduces
      maximal muscle force and is not successful in preventing non-contact injuries, as believed
      so. Dynamic type is reported to improve flexibility and range of motion better. But there is
      still debate over which prescription provides the best results in terms of flexibility,
      power, performance or injury protection. And the answer to the question what happens to the
      viscoelastic properties of a muscle when it is stretched dynamically for some period of time
      has not been clearly established.

      This study is planned to investigate the effect of a 5-week dynamic stretching exercise
      training on muscle tendon unit of gastrocnemius muscle. The effects of the training program
      will be assessed by ultrasound.
    

Intervention name(s): stretching exercise
Intervention type(s): Other
Intervention description(s): dynamic stretching exercises with 5 repetitions, each lasting 45 seconds, for 5 days a week and 3 times a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dynamic stretching training; muscle tendon unit; ultrasound
Methylphendidate Treatment of Cocaine Dependent Patients With Attention Deficit Hyperactivity Disorder - 3
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to demonstrate the feasibility of methylphenidate (MPD) as
      effective and safe in the outpatient treatment of cocaine-dependent patients with a comorbid
      DSM-IV diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), to demonstrate the
      ability of each site to participate in a subsequent anticipated controlled trial of MPD
      (recruitment and execution), and to gather preliminary data on the ability of sweat patches
      to detect episodes of cocaine use.
    

Detailed description: 
      Forty-one participants were enrolled into this multi-site, outpatient, open-label, ten-week
      trial. Participants were scheduled to attend three visits per week to allow safety and
      efficacy measures to be taken. In addition, participants were given two hours of individual
      substance abuse therapy during the first four weeks, and one hour per week during the last
      six weeks, of the trial. All participants were started on a total daily dose of 20 mg MPD.
      The total daily dose was then increased to a maximum daily dose of 60 mg (20 mg TID) or to
      the maximum dose tolerated by the participant.
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cocaine dependence
A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment
Condition: Healthy; Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will determine if there are differences in how dacomitinib is absorbed and
      eliminated between healthy subjects and subjects with mild and moderately impaired hepatic
      function.
    


Intervention name(s): dacomitinib; dacomitinib; dacomitinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.; Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.; Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dacomitinib; PF-00299804; hepatic impairment; pharmacokinetics
X-rays Trauma Request's by the Triage And Intake Nurse Intake and Referral Nurse:
Condition: Limb Injury
Study type: Interventional

Summary: 
      The number of consultations in emergency departments is increasing day by day, and the time
      to treat patients is getting longer. Different French studies have shown a significant
      reduction in the time spent in the emergency department after the implementation of the
      national protocol for the delegation of early radiography prescriptions. The investigators
      hypothesised that an early request for a standard X-ray by the intake and referral nurse in
      the case of isolated trauma to the extremities of a limb (from the knee to the toes and from
      the shoulder to the fingers) enables a reduction in medical management time and,
      consequently, in the time spent in the emergency department for the patient.
    

Detailed description: 
      This study is divided into two steps to three month.

        -  The first step of the study corresponds to the current standard of care (SoC) in the
           emergency department of Orléans. In this first step, the intake and Referral Nurse (IRN)
           will carry out the usual triage and refer the participant to the appropriate emergency
           department before being appointed by the physician. The radiography will be requested
           after the medical consultation.

        -  In the second step, the intake and referral nurse will carry out the usual triage and
           then request one, or more, radiography(ies) depending on the standard protocol. This
           ensures that the physician has access to the imaging before the consultation with the
           patient. If necessary, the X-ray technician is authorized to refuse the exams or
           complete the request, the choice of the incidence is up to him/her according to the
           intake and referral nurse.
    

Intervention name(s): Radiography request by nurse; Radiography request by physician
Intervention type(s): Procedure; Procedure
Intervention description(s): Intervention group with radiography requested by the IRN instead of the physician. The radiography will be interpreted by the physician afterwards, according to current practice; The physician prescribed the X-ray, the X-ray technician carries out the imagery and the physician interprets it afterwards
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Traumatology; Personnel delegation; Nurse specialists; Radiography; emergency department; intake and referral nurse
Pharmacokinetics of Lopinavir/Ritonavir at Three Different Doses.
Condition: Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir
      over a 12-hour dosing interval, following administration to male and female HIV-negative
      healthy volunteers of:

        1. Lopinavir/ritonavir 400/100 mg twice daily

        2. Lopinavir/ritonavir 200/150 mg twice daily

        3. Lopinavir/ritonavir 200/50 mg twice daily
    

Detailed description: 
      Data during the development of lopinavir/ritonavir showed that lower drug doses had similar
      efficacy to the standard dose of 400/100mg twice daily. Lower drug doses are also associated
      with limited toxicity and cost.

      The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir
      following administration to male and female HIV-negative volunteers of 400/100mg, 200/150mg
      and 200/50mg lopinavir/ritonavir twice daily. Each dosing phase will last for 7 days and each
      phase will be separated by a 7-day wash-out period. Pharmacokinetic evaluations will be made
      over a 12-hour interval at the end of each dosing phase.

      Healthy subjects as determined by their medical history and physical examinations will be
      eligible to participate in the study. HIV-positive subjects will not be recruited as there is
      a risk that HIV-resistant mutations will be selected by an experimentally reduced dose of
      lopinavir/ritonavir. There is no reason to presume that there is any meaningful difference in
      the metabolic processing of lopinavir/ritonavir between HIV-infected and HIV-uninfected
      people.
    

Intervention name(s): lopinavir/ritonavir
Intervention type(s): Drug
Intervention description(s): Each participant received three sequential doses of lopinavir/ritonavir: 400/100 mg twice daily (2 heat-stable 200/50 mg tablets BID), 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID), and 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.
Other intervention name(s): Meltrex; Ritonavir
Intervention MeSH terms: Ritonavir; Lopinavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; ART; HAART; Pharmacokinetics; Lopinavir/ritonavir; Lower dose selection
Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes
Condition: Plasma Homocysteine; HbA1c Level
MeSH terms: Diabetic Nephropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      Homocysteine levels have been found elevated in T1DM patients with Diabetic nephropathy (DN)
      due to several causes, including dietary deficiencies. Hyperhomocysteinemia induces renal
      injury and is associated with increasing urinary albumin excretion(UAE). Therefore, the
      investigators performed a randomized-controlled trial of oral supplementation with vitamin B
      complex as an adjuvant therapy for nephropathy in pediatric patients with T1DM and assessed
      its relation to homocysteine levels, glycemic control, microalbuminuria and cystatin C as a
      marker of nephropathy.
    

Detailed description: 
      This trial included 80 vitamin B12-deficient T1DM patients with nephropathy, despite oral
      angiotensin-converting enzyme inhibitors . Enrolled patients aged 12-18 years with at least 5
      years disease duration and HbA1c ≤8.5%. Patients were randomly assigned into two groups;
      intervention group who received vitamin B complex once daily orally . The other group did not
      receive any supplementation and served as a control group. Both groups were followed-up for
      12 weeks with assessment of plasma homocysteine, HbA1c, cystatin C and UAE.
    

Intervention name(s): Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM); Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) once daily; Patients in placebo group received placebo that were similar in appearance to Vitamin B complex tablets and the administered dose was as the same schedule as Vitamin B complex.
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomly assigned into two groups; intervention group who received vitamin B complex once daily orally and control group who did not receive B complex
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults
Condition: Delirium
MeSH terms: Delirium; Neuroinflammatory Diseases
Study type: Observational

Summary: 
      (From NIH reporter) Each year >16 million older Americans undergo anesthesia and surgery, and
      up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of
      postoperative thinking and memory deficits. Although distinct from delirium, POCD (like
      delirium) is associated with decreased quality of life, long term cognitive decline, early
      retirement, increased mortality, and a possible increased risk for developing dementia such
      as Alzheimer's disease. Understanding the etiology of POCD will likely help promote
      strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes
      POCD, but little work has directly tested this theory in humans. The preliminary data of this
      team strongly suggest that there is significant postoperative neuro-inflammation in older
      adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre-
      and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients
      over age 65. This will allow the investigators to evaluate the role of specific
      neuro-inflammatory processes in POCD and its underlying brain connectivity changes.
    

Detailed description: 
      Each year >16 million older Americans undergo anesthesia and surgery, and up to 40% of these
      patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative
      thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is
      associated with decreased quality of life, long term cognitive decline, early retirement,
      increased mortality, and a possible increased risk for developing dementia such as
      Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies
      to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but
      little work has directly tested this theory in humans. The preliminary data of this team
      strongly suggest that there is significant postoperative neuro-inflammation in older adults
      who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and
      post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over
      age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory
      processes in POCD and its underlying brain connectivity changes.
    

Intervention name(s): Millipore biomarker assay plate
Intervention type(s): Device
Intervention description(s): Millipore biomarker assay plate CSF cytokine assays as well as CSF flow cytometry
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Surgical patients age 60 and above, as described above.
      
Biospecimen description: 
      CSF, Blood/Serum