bioihbjkbjnl/mcl2 huggingface dataset:
The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
Condition: Lumbar Puncture
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The investigation aims to demonstrate the first puncture success rate, as proxy of clinical
      benefit and clinical performance, of bioimpedance spectroscopy based spinal needle guidance
      method among pediatric hemato-oncology patients requiring lumbar punctures.
    

Detailed description: 
      The primary purpose of the investigation is to demonstrate the claimed clinical benefit and
      safety of Injeq IQ-Tip™ system.

      IQ-Tip™ is similar to common spinal needles with a custom-made stylet that enables the
      real-time bioimpedance measurement at the tip of the needle. The needle is connected to the
      analyzer device, which provides real-time CSF detection during lumbar puncture from the very
      tip of the needle and by these means assists conducting the medical procedure.

      The investigation aims to demonstrate the first puncture success rate, as proxy of clinical
      benefit and clinical performance, of bioimpedance spectroscopy based spinal needle guidance
      method among pediatric hemato-oncology patients requiring lumbar punctures.

      The investigation is conducted in the pediatric hematology and oncology units of three
      Finnish university hospitals
    

Intervention name(s): IQ-Tip(tm) system
Intervention type(s): Device
Intervention description(s): Physician performs therapeutic or diagnostic lumbar puncture using Injeq IQ-Tip(tm) system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Spinal puncture; Lumbar puncture
Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination
      therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of
      chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable,
      advanced/recurrent colorectal cancer.
    

Detailed description: 
      The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination
      therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of
      chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable,
      advanced/recurrent colorectal cancer.

      This study will enroll a total of approximately 800 participants (400 per group).

      Participants will be randomized to either the mFOLFOX6 + panitumumab arm (Group P) or
      mFOLFOX6 + bevacizumab arm (Group B) at 1:1 ratio at the time of registration.

      Group P and Group B treatment regimen shown below should be administered once every two
      weeks, following dose, schedule and route of administration.

      Group P; mFOLFOX6 + panitumumab combination therapy, once every two weeks OXA: 85 mg/m2/day 1
      l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6
      mg/kg

      Group B; mFOLFOX6 + bevacizumab combination therapy, once every two weeks OXA: 85 mg/m2/day 1
      l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5
      mg/kg

      This trial is conducted by multicenter and is scheduled for 12 months as whole administration
      period.
    

Intervention name(s): oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab; oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion; oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
Intervention MeSH terms: Calcium, Dietary; Leucovorin; Bevacizumab; Panitumumab; Oxaliplatin; Fluorouracil; Calcium; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic colorectal cancer, Panitumumab, mFOLFOX6, Bevacizumab
Non-drug Treatment Study in Parkinson's Disease Patients and Healthy Volunteers to Collect Biological Samples in Order to Assess ex Vivo the Activity of Candidate Therapies and Develop Novel Analytical Methods for Biomarkers
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a non-drug study in patients with Parkinson's Disease (PD) and healthy volunteers to
      process and analyze their blood and optional cerebrospinal fluid (CSF) samples ex vivo, or
      outside of their body, to further develop researchers knowledge on LRRK2 biomarkers.
      Participants were enrolled either in Cohort A or in Cohort B. A blood sample was collected in
      each participant within a maximum of two study visits within 14 days, and an option to
      complete both visits on the same day.
    

Detailed description: 
      This study will allow researchers to assess the potency of investigational LRRK2 inhibitors,
      outside of participant bodies. It will enroll Parkinson's disease patients (LRRK2 G2019S
      symptomatic carriers and idiopathic) and healthy volunteers meeting eligibility criteria. The
      study will consist of a maximum of two study visits, a selection visit to check eligibility
      criteria, and a sample collection visit. The two visits can take place on the same day or can
      occur within 14 days of each other. Participants will be assigned to Cohort A or Cohort B,
      each include a blood sample collection, and an optional cerebrospinal fluid (CSF) collection
      in Cohort A. No investigational product, study drug, will be administered to study
      participants.
    

Intervention name(s): Blood sample collection and an optional cerebrospinal fluid (CSF) collection; Blood sample collection
Intervention type(s): Other; Other
Intervention description(s): No study drug will be administered to study participants.; No study drug will be administered to study participants.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The COPENHAGEN Puberty Study
Condition: Puberty
Study type: Observational

Summary: 
      By clinical examinations and withdrawing of blood samples from a large number of healthy
      Danish children, this study will reveal if age of pubertal onset is declining. Furthermore,
      the extensive normative data will provide detailed insight into normal ranges and individual
      changes of anthropometrics and hormone levels in healthy children during childhood and
      adolescence.
    

Detailed description: 
      The COPENHAGEN Puberty Study is a combined cross sectional and longitudinal study of healthy
      Danish children.

      All children will be thoroughly examined and blood- and urine samples will be collected at
      every visit. The families fill out questionaires.

      Physical examination: Height; sitting-height; weight; circumference of waist, hip, arm;
      measurement of fatfolds (biceps, triceps, flank, subscapularis); voice-break (yes/no), blood
      pressure; pubertal staging according to Tanners classification: breast development (B1-B5),
      genitalia development boys (G1-G5), pubic hair development (PH1-PH5), axillary hair (yes/no),
      sweat (yes/no), acne (yes/no

      Urine sample: For measurement of FSH, LH and endocrine disrupters.

      Blood sample: For measurement of hormone levels (FSH, LH, estradiol, SHBG, testosterone,
      DHEAS, androstenedione, inhibin A, inhibin B, Insl3, kisspeptin, ghrelin, leptin, IGF-1,
      IGFBP3, TSH, T4, Free T4, T3, HbA1C, calcium-ion, PTH, phosphate, 25-OH-vitamine D, AMH),
      endocrine disrupters (PCB´s, dioxines, parabens, phthalates), isolation of DNA and RNA to
      evaluate relevant polymorphisms.

      Questionaire: regarding information of previous growth and health.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In the cross sectional study, all children at randomly selected schools in Copenhagen were
        invited (6203 children). 1864 accepted to participate.

        In the longitudinal study, children at two schools with the highest participating rate were
        invited to participate in the follow-up study. Ongoing recruitment was continued until at
        least 100 boys and 100 girls were enrolled in the logitudinal study.
      
Biospecimen description: 
      serum, white cells, urine
    
Keywords: Hormones; Endocrine Disrupters; Polymorphism, Genetic
Effect of a Mixture of New Probiotic Strains in Preterm Infants
Condition: Premature Infant
Study type: Interventional

Summary: 
      An interventional, randomized, double-blind, placebo-controlled study will be conducted to
      investigate the effect of a new probiotic strain Lactobacillus PS11603 & Bifidobacterium
      PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation.

      The study duration will be 2 months, which includes 8 weeks product administration.
      Participants will be randomized assigned to one of the two study groups: the control group
      with placebo consumption and a probiotic consumption group.
    

Detailed description: 
      An interventional, randomized, double-blind, placebo-controlled study will be conducted to
      investigate the effect of a new probiotic strains Lactobacillus PS11603 & Bifidobacterium
      PS10402 in 30 premature infants born within 28 weeks + 0 days to 30 weeks + 6 days of
      gestation.

      The duration of participation in the study is estimated to be 40-60 days. Participants will
      be randomized assigned to one of the two arms of the study: the control group, with placebo
      consumption, and a probiotic consumption group. The aim of the study will be investigate the
      effect of the probiotics strains in the colonization of the intestinal tract of preterm
      babies.
    

Intervention name(s): Lactobacillus PS11603 & Bifidobacterium PS10402; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Approximately 8 weeks intervention study: Participants with 0-5 days of age will start a period of 8 weeks of intervention. During this time the participants will intake one daily dose of the product that contains 1*10E9 CFU of L.salivarius PS11603 and 1*10E8 CFU of B.longum PS10402.; 8 weeks intervention study: A 8 weeks intervention period. During the 8 weeks of intervention the participants will intake one daily dose of placebo supplement.
Other intervention name(s): Lactobacillus PS11603 & Bifidobacterium PS10402 during 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects
Condition: Healthy Subjects; Hypomagnesemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The magnesium food content in the Western world is consistently reducing. Hypomagnesemia is
      common in hospitalized patients, especially in the elderly with coronary artery disease (CAD)
      and/or those with chronic heart failure. Hypomagnesemia is associated with increased
      incidence of diabetes mellitus, metabolic syndrome, mortality rate from coronary artery
      disease (CAD) and all cause. Magnesium supplementation improves myocardial metabolism,
      inhibits calcium accumulation and myocardial cell death; it improves vascular tone,
      peripheral vascular resistance, afterload and cardiac output, reduces cardiac arrhythmias and
      improves lipid metabolism. Magnesium also reduces vulnerability to oxygen-derived free
      radicals, improves human endothelial function and inhibits platelet function, including
      platelet aggregation and adhesion. The data regarding the absorption difference between
      supplemental magnesium oxide and magnesium citrate in humans is spare.
    

Detailed description: 
      Two oral preparations of magnesium are available in Israel:

        1. Magnesium Diasporal (magnesium citrate, elemental magnesium 98.6 mg), PROTINA GMBH,
           ISMANING, Germany

        2. Magnox 520 TM (magnesium oxide, 520 mg elemental magnesium), Naveh Pharma Ltd., Israel.

      The data regarding the absorption difference between the two supplemental magnesium
      preparations (magnesium oxide and magnesium citrate) in humans is spare.

      Primary objective: To find out the absorption of magnesium citrate compared to magnesium
      oxide in healthy subjects with no apparent heart disease.
    

Intervention name(s): Magnesium oxide; Magnesium citrate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 520 mg of elemental magnesium q.d.; Magnesium citrate , 98.6 mg of elemental magnesium t.i.d.
Other intervention name(s): Magnox 520 TM; Magnesium Diasporal
Intervention MeSH terms: Magnesium citrate; Magnesium Oxide; Levulinic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Magnesium; nutrition; platelets; aggregation
A Phase II/III Study of Sargramostim
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, placebo-controlled, double-blind, group comparison, multicenter study
      to evaluate the efficacy and safety of inhalation administration of sargramostim for 5 days,
      in principle (up to 10 days) as Add-on treatment to the standard treatment in COVID-19
      patients.
    


Intervention name(s): Sargramostim; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 250 μg/vial of sargramostim will be dissolved in 4 mL of physiological saline and 125 μg of which will be administered using inhaler twice daily in approximately 10-15 minutes.; 2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes.
Other intervention name(s): Leukine
Intervention MeSH terms: Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Combined Fatty Acid Supplementation and Eccentric Exercise Training on Exercise Performance
Condition: Exercise-induced Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The aim of the study is to determine whether fish oil (specifically omega-3 long chain
      polyunsaturated fatty acids [EPA-DHA]) supplementation can enhance eccentric resistance
      exercise performance when combined with a resistance exercise training study. The
      investigators aim to establish the potential mechanisms that might mediate performance
      changes at a cellular level.
    


Intervention name(s): Fish Oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fish Oil Capsule; Olive Oil capsule manufactured to mimic fish oil capsule
Other intervention name(s): n-3 PUFA, Omega-3; Olive Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Blood Biomarkers in Suicidal Behaviour
Condition: Major Depression
MeSH terms: Depressive Disorder, Major
Study type: Interventional

Summary: 
      Suicidal behavior (SB) is a major public health problem in France, with more than 10,000
      suicides and 220,000 suicide attempts per year.

      According to the commonly accepted model for understanding suicidal behavior, individuals who
      carry a suicidal act when subjected to stress factors (environmental stress, depression,
      substance ...) are those which have a specific vulnerability.

      These vulnerabilities can be considered as clinical parameters (propensity to despair,
      aggressive and/or impulsive traits), neurobiological parameters (dysfunction of the
      serotonergic system, ...) and cognitive parameters (taking disadvantageous decision ...).
      Suicidal vulnerability is partly underpinned by genetic factors. The interest of current
      researches is to identify biomarkers that will improve the opportunities for early
      identification of subject with a risk for SB. Numerous scientific studies, including
      post-mortem studies of the brains of suicide completers, have established a link between
      dysregulation of the ribonucleic acids editing (RNA) of certain genes, the enzymatic activity
      of Adenosine deaminases acting on RNA (ADARS) responsible for this edition and suicidal
      behavior. A prospective study is needed to quantify and qualify in the blood of depressed
      patients (with or without a history of suicide) and healthy controls, the editing changes and
      the expression and alteration of the activity of ADARS.
    

Detailed description: 
      Over two years, 600 participants will be recruited:

        -  225 subjects with current major depressive episode and an history of suicide attempt
           (depressed suicide attempters)

        -  225 subjects with current major depressive episode but with no personal history of
           suicide attempt (affective controls)

        -  150 subjects with no history of psychopathology whole life (healthy controls)

      Each patient will attend a total of 3visits during a follow-up period of 6 months +/- 15 days
      (inclusion, visit at 3 and 6 months).
    

Intervention name(s): Blood sample for genetic purpose
Intervention type(s): Other
Intervention description(s): All the participants will performed the same evaluations and blood analysis :
A clinical assessment by psychiatrist
Self report questionnaires for the assessment of a potential mood disorder and history of SB, moral/physical pain, personality traits…
A neuropsychological assessment for the evaluations of cognitive performances
A routine blood sampling to the realization of a standard blood test
A specific blood sampling (PAXgene® tubes) to extract total RNA of blood cells and measure the expression of ADARS RNA and editing of the PDE8A transcript.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Psychiatry; Depressive disorder; Suicidal behavior; Genetics
Oxytocin and Social Cognition in Schizophrenia
Condition: Social Cognition; Social Anxiety; Emotional Intelligence
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective: Social Cognition and Emotional Intelligence have been shown to be deficient in
      patients with schizophrenia and these are not remediated by antipsychotic medications or
      psychosocial interventions. Social cognition is associated with functional outcome, an
      important step in striving for recovery in this population. The hormone and neurotransmitter,
      oxytocin, which has been associated with social bonding and trust has been shown to improve
      measures of some aspects of social cognition in humans. The study will assess the effect of
      acute administration of intranasal oxytocin on measures of social cognition and functioning
      as well as on emotional intelligence and symptoms.

      Study population: The study population will include patients with a DSM-IV diagnosis of
      schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6
      weeks. We will enroll a total of 30 subjects (N=15 placebo and N=15 oxytocin groups).

      Experimental design and methods: After a one week lead in phase, participants will undergo 3
      weeks of oxytocin (20 IU BID) or placebo administration (double blind) in addition to their
      existing medication regimen. Outcome measures will be administered during the lead in phase,
      and at the end of the study drug administration phase (under the acute effect of OT). The
      primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
      and the Maryland Assessment of Social Competence (MASC). Secondary measures include rating
      from the domains of social cognition (emotion perception, attributional style, theory of mind
      and social perception), symptom rating and measures of social anxiety and quality of life.
      Side effects and symptoms will be measured weekly.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oxytocin given as 20 IU BID; Placebo given as 20 IU BID
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social Cognition; Schizophrenia; Oxytocin
GLP-1 Infusion and Long-Time Fasting
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion
      in a glucose dependent way. Below normal plasma glucose levels the effects of GLP-1 stop and
      the risk of hypoglycemia is small. However no results exits on the effects pharmacologically
      relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in
      healthy people after a fasting period when a glucose load is administered. The risk of
      hypoglycemia when GLP-1 is administered will be evaluated during these two conditions.
    

Detailed description: 
      GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion
      dependent on a normal plasma glucose.It also inhibits gastric emptying and has a trophic
      effect on the pancreatic beta-cells. Below normal plasma glucose levels the effects of GLP-1
      stop and the risk of hypoglycemia is small.The counter regulatory response to hypoglycemia
      has been shown to be preserved during GLP-1 infusion. However no results exits on the effects
      pharmacologically relevant doses of GLP-1 during long-time fasting. There seems to be a risk
      of hypoglycemia in healthy people after a fasting period when a glucose load is administered.
      The risk of hypoglycemia when GLP-1 is administered will be evaluated during these two(48
      hours of fasting followed by a glucose-load)conditions in healthy men.

      Also the effect on 24 hour blood pressure will be evaluated.
    

Intervention name(s): Glucagon-like-peptide-1 (7-36) amide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Continuous, subcutaneous GLP-1 at a dose of 4.8 pmol/kg/min for 51 hours; continuous subcutaneous placebo infusion at a dose of 4.8 pmol/kg/min for 51 hours
Other intervention name(s): GLP-1
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GLP-1; fasting; hypoglycaemia