bioihbjkbjnl/mcl2 huggingface dataset:
Thoracic Paravertebral Block : Effect on Acute Pain and Chronic Pain of Hepatectomy With Right J-shape Subcostal Incision
Condition: Hepatectomy; Analgesia; Nerve Block
Study type: Interventional

Summary: 
      This prospective, randomized study,control study aims to compare the analgesic effect,opioids
      consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al.
      single-injection TPVB +continuous(pulsatile infusion) TPVB and intravenous patient-controlled
      analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal
      incision.
    


Intervention name(s): single-injection TPVB + continuous TPVB; Philip CX50 Ultrasound Scanner; PAJUNK Contiplex S Catheter; single dose ropivacaine; continuously infusion of ropivacaine; Morphine given as IPCA
Intervention type(s): Procedure; Device; Device; Drug; Drug; Drug
Intervention description(s): Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.; The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning; 2mg/kg ropivacaine in saline with 1:200,000 adrenaline, 25ml in total
given immediately after the correct position of the tip of the needle has been confirmed; 0.2% ropivacaine, pulse dosadge: 0.125ml/kg/pulse, 1pulse/h at a rate of 6ml/minutes
given through the catheter inserted in the T8 paravertebral space following the single dose; bolus: 2mg, lock time: 10min, 1h limitation: 8mg
Intervention MeSH terms: Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Assessment of Complete Response MRI Criterion After Neoadjuvant Therapy in Locally Advanced Rectal Cancer
Condition: Rectal Neoplasms
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      Standard care for locally advanced rectal cancer consists in a neoadjuvant therapy followed
      by surgery. Morbidity and mortality remain high after rectal surgery, and often linked with
      quality of life impairment. 10 to 30% present a pathological complete response after
      neoadjuvant therapy. Some surgical teams propose "watch and wait" approach for patients
      selected with clinical complete responses criterion. The problem is to be sur the response is
      complete. MRI seems to be accurate to select complete responders. We will try to find MRI
      criterion of complete responses.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Digestive surgery department
      
Keywords: MRI; Complete response
Strongest Families Ontario (Formerly the Family Help Program)
Condition: Oppositional Defiant Disorder; Behaviour Disorder
MeSH terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Strongest Families (formerly Family Help)is an evidence-based, distance health education
      model for families who have children with behavioural difficulties. The principal research
      question is "Does Strongest Families, a 12-week, home-based program of interactive readings,
      instructional videos, homework projects, and weekly "coaching" telephone calls out perform
      the care families typically experience when referred to a mental health service?". The
      investigators hypothesize that children randomized to Strongest Families intervention will
      show a significantly greater reduction in externalizing behaviour problems than those
      randomized to a Control (usual care). In addition, parents randomized to Family Help will
      report a greater improvement in parenting skills and a greater reduction in symptoms of
      emotional distress (i.e., feeling of anxiety, depression, and stress) than parents in the
      Control condition. Finally, families randomized to Family Help will use fewer mental health
      services than Controls.
    

Detailed description: 
      Our project is designed to help families and children with mild or moderate symptoms early,
      before problems become worse and more difficult to treat.

      The Strongest Families Program is a distance parenting program that was developed at the
      Centre for Research in Family Health at the IWK Health Centre in Halifax, Nova Scotia. Most
      families are able to manage these problems if they are given the skills to do so. The
      Strongest Families "Parenting the Active Child" Distance Program is done over the telephone;
      families do not have to travel to a centre to receive help. This program includes a handbook,
      videos and weekly phone calls between the parent and non-professional'coach'. The coach
      provides support to families, answer questions and guide parents as they learn the skills.
      Strongest Families has helped hundreds of families in Nova Scotia.
    

Intervention name(s): Strongest Families Intervention (formerly Family Help)
Intervention type(s): Behavioral
Intervention description(s): Distance HEALTH education intervention focussed on skill learning for parents
Other intervention name(s): formerly the Family Help Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Behavioural intervention; Distance intervention; Parenting intervention
Evaluation of Pain During Hysterosalpingography With The Use Of Balloon Catheter Versus Metal Cannula
Condition: Pain During Hysterosalpingography
Study type: Interventional

Summary: 
      The aim of this study is to compare the metal cannula routinely used in our clinical practice
      with intrauterine hysterosalpingography catheter as a probable alternative device in a
      prospective, single-blinded, randomized study.
    


Intervention name(s): Balloon catheter; metal cannula
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Hysterosalpingography; balloon catheter; metal cannula; pain assessment
Effects of Inulin on Satiety and Food Intake
Condition: Obesity
Study type: Interventional

Summary: 
      To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.
    

Detailed description: 
      Based upon a slower digestion and the fermentation in the intestinal tract, food containing
      soluble dietary fibres, such as inulin, is hypothesized to be more satiating, and to limit
      energy intake, in humans. Does supplementation of inulin (at 2 dosages) versus placebo over
      13 consecutive days in normal to overweight men and women, lead to an increase in satiety, a
      reduction in food intake and stronger postprandial increases in GLP-1 and PYY?
    

Intervention name(s): inulin; inulin; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 10gram/day inulin for 13-day treatment; 16gram/day inulin for 13-day treatment; 16gram/day maltodextrin (placebo) for 13-day treatment
Other intervention name(s): oligofructose; oligofructose; maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: overweight
Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy
Condition: Refractory Cancer; Metastatic Cancer; Recurrent Cancer; Unresectable Carcinoma; Solid Tumor, Adult; Advanced Cancer; Advanced Solid Tumor
MeSH terms: Neoplasms; Neoplasm Metastasis; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and preliminary efficacy of SNK01
      (autologous natural killer cell), as a single agent and in combination with avelumab or
      pembrolizumab, for the treatment of subjects with advanced and/or metastatic refractory
      cancer that has failed three or more prior lines of conventional standard of care therapy.
    


Intervention name(s): SNK01; Avelumab; Pembrolizumab
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Patient-specific ex vivo expanded autologous natural killer cells; Avelumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death-ligand 1 (PD-L1).; Pembrolizumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death receptor-1 (PD-1).
Other intervention name(s): Bavencio; Keytruda
Intervention MeSH terms: Pembrolizumab; Avelumab
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Natural killer cell; NK cell; Expanded natural killer cell; Immunotherapy; Cancer; Metastatic cancer; Advanced solid tumor; Refractory cancer; Recurrent cancer; Unresectable carcinoma; Solid tumor; Neoplasms
Bioequivalence Trial of a New Opioid Combination Compared to Reference
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate bioequivalence of a new formulation to a
      reference
    


Intervention name(s): Opioid
Intervention type(s): Drug
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders
Condition: Computer Vision Syndrome; Sleep Disorder; Mood Disorders
MeSH terms: Sleep Wake Disorders; Syndrome; Mood Disorders
Study type: Interventional

Summary: 
      Previous research has shown the efficacy of CROCUVIS+® dietary supplement, based on saffron
      extract, in the proper functioning of visual health, for example, against the development of
      glaucoma. The main objective of this study is to evaluate the efficacy of CROCUVIS® in
      computer vision syndrome, sleep and mood disorders in a sample of university students who use
      digital devices.
    


Intervention name(s): Saffron extract (Crocus sativus); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily intake of one tablet for 42 days.; Daily intake of one tablet for 42 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Validation of the In-utero Transmission of Probiotics
Condition: In Utero Drug Exposure
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot project aims at confirming the in-utero transmission of probiotics, from the
      mother to the baby. Women aged 18 to 42 years, with a single pregnancy, considered low risk
      will be approached for this study. Women will take the investigational products between 34
      weeks of pregnancy up to 10 days post-partum. Investigational products are probiotics (5
      bacterial strains) compared to placebo.
    

Detailed description: 
      Rational: Studies have shown that probiotics given to babies can reduce perinatal
      complications. A change of practice should therefore be introduced in the management of
      premature newborns. However, one could assume that probiotic administration before birth
      could be as effective if not more. Indeed, one could hypothesise that when the newborn is
      exposed to probiotics earlier, the protective effect is potentially increased.

      Objective: This pilot project aims at confirming the in-utero transmission of probiotics,
      from the mother to the baby.

      Population: Women aged 18 to 42 years, with a single pregnancy, considered low risk will be
      approached for this study Products under study: Probiotics containing 5 bacterial strains
      (total of 12 million colony-forming unit / day) vs. Placebo.

      Procedure: At 32-33 weeks, participants will complete questionnaires (medical, obstetrical,
      socio-demographic data) and will be randomized (double-blind) in one of the 2 following
      groups:

      Group A: taking probiotics every day from the 34th week of pregnancy until delivery; taking
      placebo for 10 days after delivery.

      Group B: taking placebo every day from the 34th week of pregnancy until delivery; taking
      probiotics for 10 days after delivery.

      Follow-up: All women will complete a logbook to monitor the study products intake and monitor
      side effects until the end of the study (10 days postpartum).

      Samples: maternal stool samples, vaginal secretions, stool (and meconium) as well as breast
      milk (and colostrum) will be taken at different times of the study to confirm the presence of
      probiotics and transmission between the mother and the baby.
    

Intervention name(s): Natural products: Probiotics; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Probiotics intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum; Placebo intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2-arms randomized crossover pilot study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: probiotic; in-utero transmission; pilot study
rhGAA in Patients With Infantile-onset Glycogen Storage Disease-II (Pompe Disease)
Condition: Glycogen Storage Disease Type II; Pompe Disease; Acid Maltase Deficiency Disease; Glycogenosis 2
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease; Metabolic Diseases; Deficiency Diseases; Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Glycogen Storage Disease Type II ("GSD-II"; also known as Pompe disease) is caused by a
      deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally,
      GAA is used by the body's cells to break down glycogen (a stored form of sugar) within
      specialized structures called lysosomes. In patients with GSD-II, an excessive amount of
      glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle,
      which prevents their normal function. This study is being conducted to evaluate the safety
      and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme
      replacement therapy for GSD-II. Patients diagnosed with infantile-onset GSD-II who are
      greater than 6 months old, but less than or equal to 36 months old will be studied.
    


Intervention name(s): Myozyme
Intervention type(s): Biological
Intervention description(s): 20 mg/kg to 40 mg/kg qow
Other intervention name(s): Alglucosidase alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glycogen Storage Disease Type II; GSD-II; Pompe Disease
Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Neuralgia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will be conducted in three parallel groups receiving oxycodone, levodopa or
      placebo, administered as an add-on therapy, in addition to the usual antiparkinsonian
      treatment. As this study focuses on chronic central neuropathic pain caused by PD, the
      effects of study treatments will be evaluated after a 10-week treatment period
    

Detailed description: 
      The treatment period (11 weeks) will be divided into three periods:

        1. A titration phase of two weeks, during which of the doses of the treatments will be
           gradually increased in three steps:

           Level 1 (from D1 to D5):

             -  Oxycodone: 10 mg PR/day bid (5 mg PR/5 mg PR)

             -  Levodopa: 100 mg/day bid (50 mg/50 mg)

           Level 2 (from D6 to D10):

             -  Oxycodone: 20 mg PR/day tid (10 mg/0 mg/10 mg)

             -  Levodopa: 150 mg/day tid (50 mg/50 mg/50 mg)

           Level 3 (from D11to D15):

             -  Oxycodone: 40 mg PR/day tid (20 mg/0 mg/20 mg)

             -  Levodopa: 200 mg/day tid (100 mg/50 mg/50 mg)

        2. A fixed dose period: the level 3 dose will be maintained for 8 weeks (from D16 to D71).
           The study treatment will be administered as an add-on therapy, with the usual
           antiparkinsonian treatment. If patients have side effects at the level 3 dose, a return
           to the level 2 dose will be authorized.

        3. A withdrawal period: The dose of the study treatment will gradually be reduced, over an
           eight-day period:

      For patients treated with the level 3 dose for 8 weeks: decrease to the level 2 dose over the
      first 3 days (from D72 to D74) ; then a decrease to the level 1 dose over the next 3 days
      (from D75 to D77). The treatment will be stopped completely on D78. The last visit will take
      place on D79, 2 days after the end of treatment.

      For patients treated with the level 2 dose: decrease to the level 1 dose over the first 3
      days (from D72 to D74), with stopping of the treatment on D75. The last visit will take place
      on D79, 5 days after the end of treatment.
    

Intervention name(s): PR Oxycodone; Levodopa; Oxycodone Placebo; Levodopa placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PR Oxycodone; Levodopa; Placebo of PR Oxycodone
Other intervention name(s): PR Oxycontin; Modopar
Intervention MeSH terms: Oxycodone; Levodopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase II Study of Gleevec/Imatinib Mesylate (STI-571, NCS 716051) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas
Condition: Neurofibromatosis
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Neurofibroma, Plexiform
Study type: Interventional
Phase: Phase 2

Summary: 
      THe primary objective is to estimate the response rate at 6 months to Gleevec® in patients
      with plexiform neurofibromas
    

Detailed description: 
      This is an open-label Phase II Study to determine the efficacy of Gleevec® in
      neurofibromatosis (NF1) patients with plexiform neurofibromas with the secondary goals of
      determining the toxicity, and tumor markers in this genetically defined population. The
      rationale for this study arises from the response of human and murine NF1 cells to Gleevec®
      in vitro and the response of a single NF1 patient treated with Gleevec® for airway
      compression by a plexiform neurofibroma with a dramatic response not previously seen in NF1
      therapy. The plan of therapy will include oral dosing of Gleevec® at 440 mg/m^2/day (max 800
      mg/day) for pediatric subjects and 800 mg/day for adult patients. (with 25% dose reduction
      for significant toxicity). Treatment will continue for 6 months with an option to continue as
      long as the patient remains on study provided the patient shows benefit from treatments with
      Gleevec® and there are no safety concerns.
    

Intervention name(s): Gleevec
Intervention type(s): Drug
Intervention description(s): Gleevec® will be dosed orally 440 mg/m^2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gleevec
Impact of Pharmaceutical Care in Diabetics Patients
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug
      treatment and to improve their quality of life. This study will measure the impact of
      pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single
      blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the
      intervention group will be held the pharmacotherapeutic follow using a methodology called the
      practice of pharmaceutical care, which identifies and resolves problems related to drugs. The
      primary outcome is glycated hemoglobin, and secondary outcomes are baseline glucose, total
      cholesterol and its fractions (for example LDL), all these measures will be made in the
      intervention group and control group. Patients will be followed for 24 weeks, and the
      outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95% and a
      significance of p <0.05, and will use the Student t test, chi-square analysis of variance
      (ANOVA) and others if necessary. Expects good results and serve as a model for other
      researchers.
    


Intervention name(s): Intervention: Pharmaceutical Care
Intervention type(s): Behavioral
Intervention description(s): Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Pharmaceutical Care; Diabetics patients; Clinical trial
Ante-hypophyseal Dysfunctions in Children Following Moderate to Severe Traumatic Brain Injuries
Condition: Moderate to Severe Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      Annual incidence of severe traumatic brain injuries (TBI) varies from 180 to 300 out of
      100.000. Mortality or severe sequelae risk is increased 8 fold after a TBI. Studies in adults
      showed an ante-hypophyseal deficit in 28 to 68 % of patients with a TBI. The most common
      deficit is Growth Hormone Deficit (GHD); followed by gonadotropic and corticotropic
      (AdrenoCorticoTropic Hormone (ACTH)) insufficiencies. Thyrotropic deficits
      (Thyroid-Stimulating Hormone (TSH)) are less frequent. From a pathophysiological point of
      view, the lesional mechanism responsible for hypopituitarisms would be a damage of
      hypophyseal vessels or hypothalamic-pituitary vessels. The frequency of pituitary deficits
      and the potential beneficial effects of replacement therapy on quality of life, tiredness,
      loss of energy and productivity, justify the systematic detection of the deficits in patients
      with moderate to severe TBI.

      Study hypotheses :

      At the present time, the lack of data in children does not give us the opportunity to affirm
      that one part of the symptoms showed by children with post-TBI neuropsychological sequelae,
      are linked to pituitary deficiency and that they can be improved with a replacement therapy.

      Firstly, it is essential to better understand the natural history of post-TBI pituitary
      deficiencies, studying the connexion between observed deficiencies in acute and late phase of
      sequelae.
    


Intervention name(s): Biological and behavioral explorations
Intervention type(s): Other
Intervention description(s): Blood dosages:
biochemistry
pituitary gland
somatotropic axis
corticotropic axis
gonadotropic axis
thyrotropic axis
antidiuretic axis
Questionnaires and scales (quality of life, Vineland Adaptive Behavior Scales (VABS)-II)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Traumatic brain injury; Paediatrics; Hypopituitarism