bioihbjkbjnl/mcl2 huggingface dataset:
Efficiency And Tolerance Of Hazelnut Oral Immunotherapy Protocol In Hazelnut Allergic Children
Condition: Allergy, Nut; Pediatric ALL
MeSH terms: Nut Hypersensitivity
Study type: Observational

Summary: 
      Prevalence of food allergy in the world has been inscreasing in recent years. Among nut
      allergy, hazelnut allergy is the most widespread in Europe and particularly in France. The
      current treatment for hazelnut allergy is based on eviction and wearing of an emergency kit
      with adrenaline auto-injector pens, to be used in the event of severe anaphylactic reaction.
      Oral immunotherapy (OIT) is a treatment that is now increasingly being offered as an
      alternatice to eviction. There are few published data concerning hazelnut OIT in Europe,
      where its consumption is nevertheless very high.

      The main objective of our study is to evaluate the clinical efficacy of the hazelnut OIT
      protocol, implemented since 2015 in the pneumology and allergology-paediatric department of
      the Mother and Child Hospital in Bron, in hazelnut allergic children under 18 years old.

      The secondary objectives will be to evaluate the biological efficacy and clinical tolerance
      of the protocol.

      The study is retrospective and observational, and is based on the collection of medical data
      from patient records.
    


Intervention name(s): Clinical and biological characteristics
Intervention type(s): Other
Intervention description(s): Age at beginning of IOT
Sex
Atopic and non atopic Comorbidities
Sensitization to aero-allergens
Sensitization to trophallergens
Stage of severity of the elicited reaction
Hazelnut Specific IgE + Cor a 1,8,9,14 before IOT and during follow up
Hazelnut skin prick test before IOT and during follow up
Adverse effects of IOT and their stage (in hospital and at home)
Use of adrenaline auto-injector (in hospital and at home)
Maintenance dose
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children aged under eighteen. With hazelnut allergy (convincing clinical history and
        positivity of hazelnut skin prick test history or specific IgE) Under IOT hazelnut protocol
        in Pneumology/allergology-paediatric department of the Mother and Child Hospital in Bron
      
Keywords: Hazelnut; Oral Immunotherapy; Children; Protocol; Efficiency; Tolerance
Ascertaining Diagnosis Classification With Elicited Speech
Condition: Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Depressive Disorder; Anxiety Disorders; Personality Disorders; Attention Deficit Hyperactivity Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Attention Deficit Disorder with Hyperactivity; Anxiety Disorders; Psychotic Disorders; Personality Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders
Study type: Observational

Summary: 
      Cross-sectional observational study of the relationship between speech patterns and
      psychiatric symptoms and disorders.
    

Detailed description: 
      Major psychiatric disorders often occur together in the same patient and it can be difficult
      to distinguish between disorders with overlapping symptoms. The majority of patients with
      mental illness receive treatment in settings where it is not feasible to conduct detailed
      diagnostic interviews or neuropsychiatric testing. A cost-effective and efficient tool is
      needed for accurate diagnosis. Looking at language is an efficient way of making sense of the
      brain because it is easily observed and reflects brain circuitry. Automated natural language
      processing (NLP) can help us do this objectively, efficiently, and with high sensitivity. The
      investigators aim to use linguistic features extracted using natural language processing to
      aid in diagnostic classification and in predicting dimensional symptoms. This will be done by
      obtaining clinical diagnoses, language samples, and self-report scales from 604 participants
      with a variety of psychiatric symptoms. Adolescents will also be included and the
      investigators will try to predict diagnosis in adolescents using models that were built on
      adult data.
    

Intervention name(s): Winterlight Speech Assessment
Intervention type(s): Behavioral
Intervention description(s): Digital assessment of speech and language abilities
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients whose treatment team believes they would be appropriate for a research study will
        be approached by research staff and the research project will be explained to them in
        detail. Inpatients will be approached during their admission and after initial
        stabilization. Outpatients will be approached before or after their scheduled appointments.
        Educational seminars regarding this study may be held to inform clinicians and staff of our
        goals and protocol. Potential participants will be made aware that declining participation
        will not affect their care. Informed consent will be obtained from all those interested in
        participating in the study.
      
Keywords: Psychiatry; language; natural language processing; digital health
Repeated Controlled Human Schistosoma Mansoni Infection
Condition: Schistosomiasis; Schistosoma Mansoni
MeSH terms: Schistosomiasis; Schistosomiasis mansoni
Study type: Interventional

Summary: 
      A group of 24 healthy volunteers are challenged one or three times with 20 male Schistosoma
      mansoni cercariae to investigate whether this leads to protection and to identify potential
      correlates of protection
    


Intervention name(s): Schistosoma mansoni infection; Placebo mock infection
Intervention type(s): Biological; Biological
Intervention description(s): 20 viable male Schistosoma mansoni cercariae of the Puerto Rican strain; Placebo mock infection with water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
L. Casei DG® in Patients With Irritable Bowel Syndrome.
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      To assess the effect of L. casei DG® (Lactobacillus paracasei CNCMI1572; Enterolactis® plus)
      on abdominal symptoms and gut microbiota metabolism/composition in non constipated patients
      with IBS (Irritable Bowel Syndrome). Patients will be randomized to receive L. casei DG®
      capsules, b.i.d. for 12 weeks the a 4 weeks Follow Up period will follow.
    


Intervention name(s): L.casei DG; PLACEBO
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): (At least 24 billion live cells per capsule)
1 capsule, b.i.d. for 12 weeks; 1 capsule, b.i.d. for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Regenexx™ SD Versus Exercise Therapy for ACL Tears
Condition: Anterior Cruciate Ligament Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The primary objective of this study is to compare the improvement in subject-reported
      clinical outcomes for Regenexx SD vs. Exercise Therapy treatment of partial and complete,
      non-retracted knee ACL ligament tears, from baseline to 3 months, with continued evaluation
      of efficacy and durability up to 24 months.

      Secondary objectives include evaluation of MRI evidence of tendon repair; incidence of
      post-operative complications, adverse events, re-injections, and surgical intervention;
      change in pain score and use of pain medications.
    

Detailed description: 
      Prospective, randomized, controlled to include 25 subjects treated with Regenexx SD and 25
      subjects treated with exercise therapy alone with the exercise group crossing over to the
      injection group at 3 months.

      Subjects will have a partial or complete, non-retracted ACL ligament tear as evidenced with
      MRI.

      Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of
      exercise therapy and take part in follow-up visits for two years following treatment. A
      preoperative visit will occur at the time of enrollment; follow-up visits will occur at the
      clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection.

      The primary endpoint analysis will be conducted once all subjects reach the 3 month endpoint.
      Subjects will continue to be followed through the 2 year endpoint with data analysis
      performed at the 1 year and 2 year time points.
    

Intervention name(s): Regenexx SD; Exercise Therapy
Intervention type(s): Procedure; Other
Intervention description(s): stem cell treatment; exercise therapy control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACL; Anterior Cruciate Ligament; ACL Tear; Anterior Cruciate Ligament Tear; Partial ACL Tear
A Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure
Condition: Ischemic Cardiomyopathy; Non-ischemic Cardiomyopathy; Heart Failure; Cardiomyopathies
MeSH terms: Heart Failure; Cardiomyopathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to assess whether MYDICAR can reduce the frequency and/or delay
      heart failure related hospitalizations in persons with advanced heart failure when added to
      their maximal and optimized therapy.
    


Intervention name(s): AAV1/SERCA2a (MYDICAR); Placebo
Intervention type(s): Genetic; Genetic
Intervention description(s): Single intracoronary infusion 1 x 10^13 DNase Resistant Particles (DRP) MYDICAR; Single intracoronary infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiomegaly; Heart Diseases; Cardiovascular Diseases
Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal Carcinoma
Condition: Metastatic Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different
      Combinations (with chemotherapy or AZD5069) in Patients with Metastatic Pancreatic Ductal
      Adenocarcinoma
    

Detailed description: 
      This is a Phase Ib and II open-label, multi-center study to evaluate the safety,
      tolerability, pharmacodynamics, and antitumor activity of MEDI4736 in combination with
      chemotherapy or AZD5069 in patients with pancreatic ductal adenocarcinoma (PDAC). This study
      will consist of 2 independent cohorts.
    

Intervention name(s): MEDI4736 in combination with nab-paclitaxel and gemcitabine; MEDI4736 in combination with AZD5069
Intervention type(s): Drug; Drug
Intervention description(s): MEDI4736 in combination with nab-paclitaxel + gemcitabine chemotherapy regimen via IV infusion; MEDI4736 via IV infusion and oral AZD5069
Intervention MeSH terms: Paclitaxel; Gemcitabine; Durvalumab; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic Ductal Adenocarcinoma, PDAC, immunotherapy, PDL1, AZD5069, MEDI4736
Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Persistence of seroprotective antibody concentrations & immunological memory shown by the
      ability to mount a response to a challenge dose of HBV vaccine
    


Intervention name(s): hepatitis B vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prophylaxis for hepatitis B disease
Adults With Attention Deficit Hyperactivity Disorder (ADHD): Validation of a Clinical Interview and Screening Instruments in French
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5%
      of adults worldwide. This condition is under-recognised in France and other European
      countries and, therefore, under-diagnosed.

      As part of the European Network for Adult ADHD, the investigators translated into French a
      structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators
      also translated rating scales such as the ASRS and the WURS. Validation studies are rare in
      France.

      The aim of this study is to include two groups of 50 adults whether they have or not ADHD
      with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as
      implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to
      fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale
      (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a
      screening tool for ADHD in childhood with respect of the Utah criteria). The investigator
      will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the
      past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence
      of ADHD in adults will be computed.
    


Intervention name(s): questionary; questionary
Intervention type(s): Other; Other
Intervention description(s): Subjects have to fill out a booklet of questionnaires; Subjects have to fill out a booklet of questionnaires
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Touble; deficit; attention; hyperactivity; Touble deficit attention with hyperactivity
Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.
Condition: Adenomatous Polyps
MeSH terms: Adenoma; Adenomatous Polyps
Study type: Interventional

Summary: 
      This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection
      rate at colonoscopy. This study involved patients undergoing elective screening or
      surveillance colonoscopy.

      Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before
      undergoing a second colonoscopy by the alternate method. The primary outcome measure was the
      detection rate for adenomas between patients who underwent Endocuff first and patients who
      underwent regular colonoscopy first.
    


Intervention name(s): EndoCuff-assisted colonoscopy; Standard Colonoscopy
Intervention type(s): Device; Device
Intervention description(s): Adenoma detection rate
Other intervention name(s): EC-assisted colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.
Condition: Cirrhosis; Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the
      mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal
      syndrome, hepatic encephalopathy, gastrointestinal bleeding, sepsis and hepatocellular
      carcinoma) of patients with cirrhosis of the liver secondary to HCV infection in comparison
      with placebo, during 96 weeks of treatment.
    


Intervention name(s): Viusid (nutritional supplement); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Viusid three sachets daily during 96 weeks; Placebo three sachets daily during 96 weeks
Other intervention name(s): Nutritional supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Cirrhosis of the liver; Mortality; Complications; Health-related quality of live; Hepatocellular carcinoma; Nutritional supplement
Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions
Condition: Insomnia
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem
      Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fed conditions using
      a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
    


Intervention name(s): Zolpidem
Intervention type(s): Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Home Based Treatment for Drug Use in Early Adolescents
Condition: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder; Conduct Disorder; Substance Abuse
MeSH terms: Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare two programs to see if they are helpful in preventing the use of
      substances in adolescents with attention deficit-hyperactivity disorder (ADHD), oppositional
      defiant disorder (ODD), or conduct disorder (CD). One of the programs involves working with
      adolescents and their parent(s) in their home. The other program involves working with
      adolescents and their parent(s) in an office setting.
    

Detailed description: 
      In this study phase, 36 patients with a disruptive behavior disorder (DBD - i.e., attention
      deficit-hyperactivity disorder, oppositional defiant disorder, conduct disorder) and use or
      abuse of one or more substances will be randomly assigned to treatment using either a
      standard treatment for DBDs in this age group or the newly developed HBT treatment. Treatment
      outcomes for the 24 patients assigned to receive HBT will then be compared to outcomes for
      the 12 patients assigned to receive standard DBD treatment.

      Specific aims of Phase II include:

        1. finalizing the HBT treatment manual and measures of treatment fidelity, therapist
           competence, and treatment satisfaction;

        2. generating estimates of treatment effect sizes for substance use, disruptive behavior,
           and functional status outcomes, as pilot data for a larger efficacy study, and

        3. comparing treatment satisfaction for the two treatment groups.

      We hypothesize that HBT will lead to significantly lower rates of disruptive behaviors,
      substance use, and SUDs than with standard treatment, as well as greater concomitant
      improvements in impairment.
    

Intervention name(s): Adolescent Skills Parent Management Parent-Adol Negotiation; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Acute treatment for 12 weeks followed by three monthly booster sessions.; Standard outpatient treatment for behavioral problems and substance use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Oppositional Defiant Disorder; Conduct Disorder; Substance Use; Drug and Alcohol Use
First in Human, Single Ascending Dose Study
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to evaluate the safety and tolerability of single ascending oral
      doses of INV-101 in healthy adult subjects.
    


Intervention name(s): INV-101
Intervention type(s): Drug
Intervention description(s): subjects will be randomized 3:1 ratio
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Whole-body Vibration and Manual Ability
Condition: Body Weight; Vibration; Motor Activity
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Purpose: To evaluate the short-term effects of whole-body vibration (WBV), using
      reciprocating plate technique, on manual ability performance in healthy younger.

      Material and methods: 38 healthy young volunteers were randomized to WBV group (N=19; 6 men,
      13 women; mean age 21, 3.8yrs) or control group (N=19; 6 men, 13 women; mean age 20.5,
      3.5yrs). The subjects in the WBV group performed one series of five consecutive repetitions
      of 60 sec unsynchronised WBV (Zeptoring, Scisen GmbH, Germany; 4 Hz, amplitude 3mm) with a
      1-min pause between administrations, three times a week. The controls did not receive any
      training. Both groups were evaluated at baseline and after intervention, in the Rey Juan
      Carlos University´s Gait Analysis Laboratory. Four outcome measures of Purdue Pegboard test
      (PPT): preferred hand (PH), non-preferred hand (NPH), both hands (BH) and assembly (A) was
      performed baseline and 5 min after intervention.
    


Intervention name(s): Whole-body vibration (WBV)
Intervention type(s): Device
Intervention description(s): Whole-body vibration (WBV) is a novel neuromuscular therapeutic intervention that has recently been developed since in the mid-1960s. Hagbart and Eklund showed in human experiments that a reflex muscle contraction can result as a consequence of applying vibrations to the muscular-tendon system. The subjects stand on a platform that generates stochastic vibrations at a frequency between 1-12.5 Hz.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment