bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Probiotics Lactobacillus in the Management of Attention Deficit Hyperactive Disorder
Condition: Inattentive; Hyperactivity; Impulsivity
MeSH terms: Hyperkinesis; Impulsive Behavior
Study type: Interventional
Phase: Early Phase 1

Summary: 
      ADHD is a neurodevelopmental disorder characterized by persistent symptoms of inattention
      and/or hyperactivity and impulsivity that are present before age 18. These symptoms must be
      evident across ADHD treatment is currently based on a multimodal approach with the
      combination of psychotherapy and pharmacotherapy, but no reliable markers of treatment
      response have been identified yet and 20-35% of subjects in clinical trials may have an
      inadequate response to the treatment The gut microbiome refers to the microbial ecosystem
      found in the gastrointestinal system of the human species Probiotics are a type of beneficial
      bacteria that improve health and facilitate intestinal microbial balance Increasing evidence
      suggests that the gut microbiota plays a key role in the gut-brain communication axis by
      influencing metabolism, inflammation, the hypothalamic-pituitary-adrenal axis, and
      neurotransmission multiple domains and cause Impairment in functioning in order to meet the
      diagnostic criteria for ADHD
    

Detailed description: 
      All patients will be randomly distributed into two equal groups using a random number
      generator from computer-based randomization software. the probiotic group (n=40) received
      probiotic preparation twice daily (Lacteol Forte; Rameda, Egypt) as sachets containing 10
      billion colony-forming units (CFU) of Lactobacillus fermentum and Lactobacillus delbruekii
      for 12 weeks added to a weight-dependent dose of standard treatment (Atomoxetine), and the 40
      patients in the control group will not receive the probiotic and on a weight-dependent dose
      of atomoxetine.
    

Intervention name(s): Probiotic Formula lacteal forte
Intervention type(s): Drug
Intervention description(s): Active Comparator: Patient with attention deficit hyperactive disorder patients (n=40) will receive probiotic preparation twice daily (Lacteol Forte; Rameda, Egypt) as sachets containing 10 billion colony forming units (CFU) of Lactobacillus fermentum and Lactobacillus delbruekii for 12 weeks .
Other intervention name(s): Lacteal forte
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperactivity; Inattention; Probiotics
Predicting the Conversion From Mild Cognitive Impairment to Dementia
Condition: Mild Cognitive Impairment; Alzheimer Disease; Dementia, Vascular
MeSH terms: Alzheimer Disease; Dementia; Dementia, Vascular; Cognitive Dysfunction
Study type: Observational

Summary: 
      Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The
      investigators assume that some psychological and imaging risks may predict the conversion. In
      the current longitudinal study, psychological and imaging data of people with MCI will be
      obtained at baseline, and will be followed at 26 weeks and 52 weeks. The predictors will be
      found in comparison with controls.
    

Detailed description: 
      MCI increases the risk of later developing dementia. About 10-15% of the amnestic form of
      mild cognitive impairment will progress to Alzheimer's disease in one year. But some people
      with MCI never get worse. Others with MCI later have test results that return to normal for
      their age and education.

      To develop a new drug for the prevention of dementia(dementia due to Alzheimer's disease or
      vascular dementia), investigators need a sensitive and specific tool for recognizing patients
      who will converse to dementia. The investigators want to establish an operational diagnostic
      criteria instead of a descriptive criteria for mild cognitive impairment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with cognitive complaint living in the community.
      
Biospecimen description: 
      plasma
    
Keywords: Dementia; Alzheimer's disease; mild cognitive impairment
Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers
Condition: Addictive Behavior; Abstinence Syndrome
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether essential polyunsaturated acids (omega 3)
      are capable of reducing chocolate craving symptoms in healthy patients.

      Our hypothesis is that the omega 3 fatty acids have properties which stabilize and normalize
      neuronal functioning in many conditions, including chocolate craving.
    

Detailed description: 
      Polyunsaturated fatty acids (of the omega 3 subtype) are fundamental in human diet, as they
      are components of cellular membranes, guaranteeing their fluidity and their functions of
      separating intracellular and extracellular means and transporting several substances to and
      from cellular microenvironment.

      Modern theories profess that lack of omega 3 fatty acids in western diets may be the cause of
      several deletery changes in neuronal physiology, which may cause or make worse several
      pathological conditions, such as depression, mood instability, and drug craving. The role of
      serotonin as the main lacking component in the conditions is well documented, and it is
      thought that omega 3 is important in the synthesis, transportation, and ultimately the
      activity of this neurotransmitter.

      Out theory states that supplementation with these acids can restore normal neuron balance,
      improving the condition of chocolate craving patients.
    

Intervention name(s): Flaxseed oil; Paraffin + # 2 dye
Intervention type(s): Drug; Drug
Intervention description(s): 3 g (3 capsules/day) of flax oil for a period of 8 weeks; 3 capsules of mineral oil (ineffective) for 8 weeks.
Other intervention name(s): DHA; EPA; Essential fatty acids; Mineral oil
Intervention MeSH terms: Mineral Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chocolate; craving; addiction; compulsion
Effects of Functional Electrical Stimulation in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Condition: Muscle Wasting
MeSH terms: Muscular Atrophy
Study type: Interventional

Summary: 
      Even with major advances in clinical therapy and percutaneous interventions, coronary artery
      bypass grafting (CABG) is the most common cardiac surgery performed worldwide and is an
      effective treatment in reducing symptoms and mortality in patients with coronary artery
      disease (CAD). However, CABG is a complex procedure that triggers a series of clinical and
      functional complications, such as series postoperative repercussions as muscle wasting in the
      first four hours after surgery. For quantification of changes in muscle structure and
      morphology ultrasonography has been used.

      In this context, cardiac rehabilitation program (CRP) is an essential component of care in
      CABG patients, because this intervention can prevent muscle weakness and wasting. Among
      different treatment modalities, functional electrical stimulation (FES) is a feasible therapy
      for neuromuscular activation and prevent muscle weakness and wasting in patients in phase I
      CRP, however the effect of this intervention in phase II CRP not been fully elucidated. The
      purpose of this study will to assess the effects of FES plus combined aerobic and resistance
      training on muscle thickness of quadriceps femoris, lower limbs muscle strength, functional
      capacity, QoL in in CABG patients enrolled in a phase II CR program.
    


Intervention name(s): Functional Electrical Stimulation (FES); Functional Electrical Stimulation (FES) sham
Intervention type(s): Device; Other
Intervention description(s): Participants will perform 12 weeks of FES (Neurodyn High Volt, IBRAMED, São Paulo/SP, Brasil), three times a week, frequency 25Hz, pulse rate of 200μs, ON:OFF 5:5, individual maximum tolerated intensity; minimum at strong but comfortable visible muscle contraction (without causing undue pain or discomfort to the participant). during 30 minutes nd receive aerobic exercise training and resistance exercises for upper limbs and lower limbs.; Participants will perform 12 weeks of Functional Electrical Stimulation (FES) sham (Neurodyn High Volt, IBRAMED, São Paulo/SP, Brasil), three times a week, frequency 5Hz, pulse rate of 200μs, ON:OFF 5:5, without muscle contraction during 30 minutes nd receive aerobic exercise training and resistance exercises for upper limbs and lower limbs.
Other intervention name(s): FES + combined exercise; FES sham + combined exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-11001)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This protocol represents the third in human study of TUTI-16, and is being conducted to
      gather additional safety and human immunogenicity (anti-HIV-1 Tat titers) data of
      subcutaneously administered TUTI-16.
    

Detailed description: 
      In this study, HIV-1 infected subjects on ART, with undetectable HIV-1 viral load, will be
      immunized with 1mg TUTI-16 or placebo in a randomized double blind fashion (prime and 3 week
      boost). Three weeks after the 3 week boost (week 6) ART will be stopped. HIV-1 viral load and
      CD4+ T-cell levels will be determined at defined intervals through 54 weeks (48 weeks Post
      ART discontinuation).
    

Intervention name(s): TUTI-16 (1.0 mg); Placebo
Intervention type(s): Biological; Other
Intervention description(s): Two subcutaneous injections of TUTI-16 (1.0 mg) at Day 0 and Week 3.; Two subcutaneous injections of Placebo at Day 0 and Week 3.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; vaccine; lipopeptide; Tat; TUTI-16; THYMON
A Trial of Two Daclizumab Dosing Strategies vs. No Induction Treatment With Tacrolimus, Mycophenolate Mofetil , & Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
Condition: Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine the safety and efficacy of two dosing regimens of
      daclizumab in simultaneous kidney/pancreas transplant recipients.
    

Detailed description: 
      The purpose of the study is to determine the safety and efficacy of two dosing regimens of
      daclizumab as an adjunctive immunosuppressive agent in simultaneous kidney/pancreas
      transplant recipients receiving tacrolimus, mycophenolate mofetil, and steroids as primary
      maintenance immunosuppression.
    

Intervention name(s): Daclizumab
Intervention type(s): Drug
Intervention description(s): daclizumab 1 mg/kg/dose every 14 days for 5 doses
Intervention MeSH terms: Daclizumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kidney transplant; Pancreas transplant; Daclizumab; Tacrolimus; Mycophenolate mofetil; Steroids; Immunosuppression; Acute allograft rejection
Neural Correlates of Empathogenic and Affiliative Actions of Oxytocin
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin
      has prosocial effects. However, the neural substrates of these effects are still unclear. The
      investigators hypothesized that a single dose administration of oxytocin should increase
      empathogenic and affiliative responses and that these effects are mediated by an increased
      insula activity.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 24 IU; 3 puffs per nostril, each with 4 IU OXT
Other intervention name(s): Oxytocin: Syntocinon-Spray, Novartis
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Male Volunteers
Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life
Condition: Healthy Term Infants
Study type: Interventional

Summary: 
      Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein
      concentrations over the first year of life
    

Detailed description: 
      The overall objective of this study is to assess growth and biomarkers of energy and protein
      metabolism in healthy term infants fed with two different study formula regimens from birth
      to 12 months of age and to follow up the infants to 4 years of age.
    

Intervention name(s): Formula regimen 1; Formula regimen 2
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
PK of Pacritinib in Patients With Mild, Moderate, Severe Renal Impairment and ESRD Compared to Healthy Subjects
Condition: Myelofibrosis
MeSH terms: Renal Insufficiency; Primary Myelofibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 open label, single dose, 5 parallel-group study in which a single 400 mg
      dose of pacritinib will be administered orally to patients with renal impairment (mild,
      moderate, severe, and patients with ESRD requiring hemodialysis) and sex-, age- and
      weight-matched healthy subjects.Patients with ESRD will receive a single 400 mg dose of
      pacritinib during 2 different treatment periods: Dialysis and Inter-Dialysis. The primary
      objective of the study is to evaluate the pharmacokinetics and safety of pacritinib in renal
      impairment.
    

Detailed description: 
      Groups 1, 2, and 3 will consist of 8 patients each with mild, moderate, or severe renal
      disease, respectively, based on their estimated glomerular filtration rate (eGFR, calculated
      by the Modification of Diet in Renal Disease [MDRD] study equation). Each of these patients
      will receive a single 400 mg dose of pacritinib.

      Group 4 will consist of 8 patients with ESRD requiring hemodialysis who have been on a stable
      dialysis regimen for at least 6 months. In this cohort only, patients will participate in 2
      treatment periods, Dialysis and Inter-Dialysis, separated by a 14-day period between
      pacritinib administration. In the Dialysis Treatment Period, a single 400 mg dose of
      pacritinib will be administered 4 hours prior to each patient's normally scheduled
      hemodialysis. In the Inter-Dialysis Treatment Period, a single 400 mg dose of pacritinib will
      be administered immediately after the end of the patient's normally scheduled hemodialysis
      session.

      Group 5 will consist of 8 healthy subjects enrolled to match the sex-, age-, and weight of
      the patients with mild, moderate, and severe renal impairment and patients with ESRD enrolled
      in the study. Healthy subjects will be administered a single 400 mg dose of pacritinib.
    

Intervention name(s): Pacritinib
Intervention type(s): Drug
Intervention description(s): Group 1, 2, 3, and 5 will be administered single oral 400-mg dose of pacritinib. Subjects in the Group 4 received a single 400-mg dose of pacritinib during two different treatment periods: Dialysis and Inter-Dialysis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy subjects
A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
Condition: Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the
      safety and efficacy of AK102 in patients with heterozygous familial hypercholesterolemia
      (HeFH).The primary objective of this study is to evaluate the efficacy of AK102 in patients
      with HeFH.
    


Intervention name(s): AK102; Placebo; Statins and/or Ezetimibe
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection; Lipid-lowering therapies
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HeFH; LDL-C
Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The effect of perineural dexamethasone administered as an adjuvant in prolonging the duration
      of analgesia continues to be under debate. The investigators performed a prospective
      randomized study to evaluate the effect of perineural dexamethasone in different
      concentrations in postoperative analgesia in femoral nerve block for anterior cruciate
      ligament reconstruction.
    

Detailed description: 
      After Ethics committee approval, 75 patients American Society of Anesthesiologists score
      (ASA) I-III were randomized at the end of surgery into 3 groups of 25 patients each who
      underwent femoral nerve block: group A with 20 ml ropivacaine 0,5% and 20 ml lidocaine 1%;
      group B with 20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 4 mg dexamethasone; group C with
      20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 8 mg dexamethasone.

      All groups received postoperative analgesia when visual analog scale (VAS) over 3 (by
      request), with IV Perfalgan 1 g and morphine (loading dose 0.1 mg/kg and titration until VAS
      under 3, followed by subcutaneous (SC) administration of 1/2 of total loading dose on demand
      for the following 24 hours (h) .

      Efficacy was evaluated by the time interval from performing the block until the first
      analgesic dose required, the total amount of morphine in the first 24 h postoperative, the
      patient satisfaction and the neurological side effects.
    

Intervention name(s): Dexamethasone phosphate; Paracetamol; Morphine; Lidocaine; Ropivacaine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation; After the block regression, at the first analgetic request the patients received the analgesia protocol; After the block regression, at the first analgetic request the patients received the analgesia protocol; At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation; At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other intervention name(s): Decadron; Perfalgan; Morphine Sulfate; Xylocaine; Naropin
Intervention MeSH terms: Acetaminophen; Dexamethasone; Lidocaine; Morphine; Ropivacaine; Dexamethasone 21-phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Emotional Information Processing in Attention Deficit Disorder With or Without Hyperactivity
Condition: Attention Deficit Disorder With Hyperactivity; Attention Deficit Disorder Without Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The aim of this study is to analyse explicit and implicit emotional information processing
      abilities in children with attention deficit disorder with or without hyperactivity
    

Detailed description: 
      The main symptoms of Attentional Deficit Hyperactivity Disorder (ADHD) are inattention, motor
      agitation and impulsivity. However, other dysfunctions affecting the quality of life remain
      poorly studied: lack of understanding and management of emotions, focus on the local aspects
      of a visual scene limiting the ability to assign a general meaning to the scene and
      alteration of long-term memory encoding. This study aims to analyse these difficulties using
      different tasks requiring processing of rich and varied everyday images, having high
      ecological validity. It involves the participation of 56 boys and girls with ADHD, aged 7 to
      12 years. A first phase examines the immediate understanding of images using two tasks:
      semantic categorization (Experiment 1) and emotional evaluation (Experiment 2) of images with
      positive, negative or neutral emotional valence, and depicting real environments (natural vs.
      manufactured contexts) or foreground objects pasted into a noise background (inanimate
      objects vs. animals vs. people. In each trial, one context image and one object image are
      presented briefly and simultaneously, one in each visual field. In order to be appropriately
      understood in both their semantic and emotional contents, context images will require more
      global processing, while object images will require more local, detailed processing. Their
      semantic (Exp. 1) and emotional (Exp. 2) consistency is manipulated. A week later, the
      participants have to perform a memory task requiring old/new recognition in a two-alternative
      forced choice (2AFC) paradigm that presents in each trial a pair of images (one old, one new)
      having the same emotional valence (Exp. 3). The study will characterize the specificities of
      processing and representing visual emotional information in ADHD children. The results will
      be compared with those from a previous study we conducted with the same methodology on
      neuro-typical children (controls).
    

Intervention name(s): Semantic group; Emotional group
Intervention type(s): Other; Other
Intervention description(s): The "semantic task" has to categorise semantically (i.e., type of contexts or type of objects) one image at each trial.; The "emotional task" has to evaluate the emotional content (i.e., neutral, positive or negative) of one image at each trial.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science