bioihbjkbjnl/mcl2 huggingface dataset:
Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients
Condition: Glucose Metabolism Disorders (Including Diabetes Mellitus); Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      Patients with diabetes type 1 with poor glycemic control will be switched to insulin pump and
      FGM system (Flash Glucose Monitoring) during 6 months, correlated to the hypothesis that they
      could benefit from this intervention by being reengaged in diabetes self-management.
    

Detailed description: 
      This is a non-controlled proof of concept prospective pilot study in adults with type 1
      diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less
      than 2 SMBG /day. Patients will be switched to insulin pump and started a FGM system (Free
      Style Libre®) during 6 months, hoping this intervention can reengage patients in
      self-management, reduce HbA1c without increasing the risk of ketoacidocetosis (DKA) and
      severe hypoglycemia (SH), and keep the DTSQ (Diabetes Treatment Satisfaction Questionnaire)
      and HFS (Hypoglycemia Fear Scale) at good levels.
    

Intervention name(s): Insulin Pump and flash glucose monitoring
Intervention type(s): Device
Intervention description(s): Adults with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day. Patients will be switched to insulin pump and start a FGM system (Free Style Libre®) during 6 months.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Intervention model description: 19 patients with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day.
Primary purpose: Treatment
Keywords: Diabetes Type 1; Insulin Pump; flash glucose monitoring; hypoglycemia; ketoacidocetosis; DTSQ; HFS
Nimotuzumab in Children With Intrinsic Pontine Glioma
Condition: Diffuse Instrinsic Ponitine Glioma
MeSH terms: Glioma
Study type: Observational

Summary: 
      Determination of efficiency of nimotuzumab in children with diffuse intrinsic pontine glioma.
    

Detailed description: 
      Due to the poor prognosis of diffuse intrinsic pontine gliomas, the limited therapy options,
      the relevant portion of EGFR expression and the unexpected good response to the therapy with
      OSAG 101 in the phase II study, a phase III study was planned in newly diagnosed diffuse
      intrinsic pontine gliomas in children and adolescents. A phase II study in patients of
      recurrence/resistance high grade glioma in childhood or adolescence showed that, in
      particular, a part of the intrinsic pontine glioma response to the monotherapy with OSAG 101
      resulting in a reduction in the size of the tumour or stabilisation in the growth of the
      tumour. Together with clinical improvement, stabilisation lasted markedly over 6 months in
      two thirds of the patients. The current phase III study was scheduled to provide evidence of
      the effectiveness in the case of newly diagnosed intrinsic pontine glioma. In this study,
      OSAG 101 will be given concomitantly to the only standard therapy for this kind of tumour,
      i.e. the fractionated radiotherapy, to show effectiveness in the primary endpoint of median
      progression-free survival, the secondary endpoint of median overall survival and the side
      effect profile.

      Evidence from the median progression-free survival and the side effect profile of this
      combination met the expected results and one may consider that combination therapy of this
      therapeutic approach with other immunotherapeutic or antiangiogenic approaches and/or mild
      chemotherapy could lead to a better prognosis and quality of life for these patients.
    

Intervention name(s): nimotuzumab
Intervention type(s): Drug
Intervention description(s): monoclonal antibody
Other intervention name(s): Theraloc
Intervention MeSH terms: Nimotuzumab
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children and adolescents
      
Keywords: diffuse instrinsic ponitine glioma, brainstem
Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose
Condition: Morphinan Opioid Overdose
MeSH terms: Drug Overdose; Opiate Overdose
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which route of administration is better for
      treatment of opioid overdosed patients
    

Detailed description: 
      In intravenous drug abusers (IDUs), as a result of previous intravenous substance abuse, the
      predictable difficult cannulate exist and cause the delay administration of antidote therapy.
      Additionally, IDUs are also at increased risk of carrying blood borne infections that could
      be transmitted to healthcare workers through needle stick injuries. The investigators aimed
      to compare intranasal administration of naloxone with intravenous route.
    

Intervention name(s): Intranasal naloxone; Intravenous
Intervention type(s): Drug; Drug
Intervention description(s): spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness; Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid; overdose; naloxone; intranasal
Extension Study for Patients Entered Into Study Infacort 003
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3, open-label, single-group, non-randomised, observational study of the safety and
      biochemical disease control of Infacort® in neonates, infants and children with adrenal
      insufficiency and congenital adrenal hyperplasia who had completed study Infacort 003. All
      subjects who had satisfactorily completed study Infacort 003 were offered the opportunity to
      take part in Infacort 004.
    

Detailed description: 
      A Phase 3, open-label, single-group, non-randomised, observational study of the safety and
      biochemical disease control of Infacort® in neonates, infants and children with AI who had
      completed study Infacort 003 (EudraCT number 2014-002265-30). All subjects who had
      satisfactorily completed study Infacort 003 wiere offered the opportunity to participate in
      study Infacort 004 at or after their final visit of study Infacort 003. Subjects received the
      usual clinically-appropriate dose (since bioequivalence has been demonstrated with
      conventional hydrocortisone), as determined by the Investigator, which was administered
      according to usual clinical practice - generally 3 or 4 times a day. Subjects could continue
      to be treated in this study until they met the study withdrawal criteria, until Infacort® was
      commercially available locally (which has now been achieved), or until the Sponsor decided to
      discontinue the study.
    

Intervention name(s): Infacort®
Intervention type(s): Drug
Intervention description(s): Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (C) Semaglutide Tablets
Condition: Healthy Volunteers; Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study two different tablets for oral use of a known investigational medicinal
      product, called semaglutide, will be tested. Besides semaglutide, the current version of the
      tablet contains 300 mg SNAC and 3 helping agents, while the new version of the tablet
      contains 300 mg SNAC and only one helping agent. Both are for the treatment of diabetes.
      Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some
      countries. Semaglutide cannot yet be prescribed as a tablet. The aim of this study is to find
      out if the dosage strength of the current formulation of semaglutide can be reduced in the
      new tablet formulation. For this purpose, it will be measured how much semaglutide is taken
      up in the body from the two (2) different tablet formulations each with three (3) different
      dosage strengths. Participants will get semaglutide in the current tablet formulation and in
      a new formulation - in which order they receive the two different formulations is decided by
      chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment
      periods (i.e. treatment for a total of 12 weeks). The tablets should be taken in the morning
      together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no
      food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing
      participants must wait 30 minutes before they may eat or drink. At home, they must take their
      breakfast 30-45 minutes after dosing.
    


Intervention name(s): Oral semaglutide
Intervention type(s): Drug
Intervention description(s): Oral semaglutide current formulation and oral semaglutide new formulation, each in 3 different strengths, administered once daily during 6 treatment periods, each lasting 12 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso
Condition: Plasmodium Falciparum Infection
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation trial
      of Sanaria's irradiated sporozoite vaccine (PfSPZ vaccine). The primary objective of this
      protocol is to determine the safety and reactogenicity of the PfSPZ Vaccine in
      malaria-experienced healthy adults. The study duration shall be 34 months and subject
      participation duration shall be 15-26 months.
    

Detailed description: 
      This study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation trial
      of Sanaria's irradiated sporozoite vaccine (PfSPZ vaccine). The primary objective of this
      study is to determine the safety and reactogenicity of the PfSPZ Vaccine in
      malaria-experienced healthy adults. The secondary objective is to evaluate vaccine-induced
      anti-CSP antibody immune responses. The study duration shall be 34 months and subject
      participation duration shall be 15-26 months.
    

Intervention name(s): Artesunate; PfSPZ Vaccine; Placebo
Intervention type(s): Drug; Biological; Other
Intervention description(s): Four tablets of 50mg each, totaling 200mg will be given in a single calendar day; PfSPZ is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.; Placebo
Intervention MeSH terms: Artesunate
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Adults; Burkina Faso; malaria; PfSPZ Vaccine; Placebo; Randomized
Kinetics of Etheric Oils, Smart Textiles vs. Ointment
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine whether the application form of etheric oils
      (camphor, cineol and menthol) causes changes in the concentration of this agents in the
      exhaled air. The second aim of the study is to determine differences in the subjective
      convenience of the application forms. We will test an commercial ointment application vs.
      smart textiles. Smart textiles are new high-tech products with the unique possibility to
      combine the textiles with functional products e.g. pharmaceutical agents.
    

Detailed description: 
      On the first appointment recruitment investigations will take place. After the person is
      enrolled to the study, the first determination of substances concentration in exhaled air and
      the convenience grade of the application form being exposed to will be achieved (study day
      1). After a 7 days lasting washout phase on study day 2 newly determination of substances
      concentration and convenience grade of the other application will be assessed. Each study day
      will have an approximate duration of 11 h. During this time 9 samples of the persons exhaled
      air will be collected.
    

Intervention name(s): smart textiles containing menthol, camphor, cineol
Intervention type(s): Drug
Intervention description(s): application to skin
Intervention MeSH terms: Camphor; Menthol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: common cold; organic chemicals; menthol; cineole; camphor; etheric oils; alternative medicine; smart textiles
The Teen Marijuana Check-Up
Condition: Cannabis Abuse; Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This behavioral research is an efficacy trial evaluating an intervention called "The Teen
      Marijuana Check-Up" with non-treatment seeking adolescent marijuana users.
    

Detailed description: 
      Three hundred adolescents who smoke marijuana (ages 14-19), recruited in four Seattle-area
      high schools, will be enrolled in the trial. Participants will be recruited either through
      in-class presentations focusing on marijuana or via referrals from school staff. They will
      first be assessed regarding use of marijuana, alcohol, and other drugs, as well as pertinent
      attitudes and goals. Participants will then be randomly assigned to one of three conditions.

        -  The experimental intervention is a two-session motivational enhancement treatment. A
           personalized feedback report, containing information from the participant's assessment
           as well as normative comparison data, is reviewed, with the Health Educator employing
           motivational interviewing strategies intended to enhance motivation for reduction or
           cessation of marijuana use. Specific goals for change and behavior change strategies are
           discussed with participants who wish support to change their marijuana use.

        -  The comparison condition involves two educational sessions focusing on the health and
           behavioral effects of marijuana.

        -  The third condition (delayed treatment control) involves a minimal baseline assessment
           followed three months later by a reassessment interview. Those assigned to this
           condition will then be given their choice of either active treatment.

      Following completion of their two intervention sessions, participants in the two active
      treatments will be offered an additional four sessions of cognitive-behavioral skills
      training in which the focus is strategies in quitting marijuana. All participants will be
      reassessed at 3 and 12 months following their initial assessment interviews.
    

Intervention name(s): Motivational enhancement therapy; Marijuana education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Personal feedback with counselor using motivational interviewing strategies.; Information about health and behavioral effects of marijuana use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cannabis; marijuana
Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      This is an evaluation of celiac-specific patient reported outcome instruments in celiac
      disease patients.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Biopsy proven celiac disease patients
      
Keywords: Celiac Disease; Coeliac Disease; Celiac Sprue; Keilakia Disease
The Effects of Oral Dipyridamole Treatment on the Innate Immune Response During Human Endotoxemia
Condition: Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional
Phase: Phase 4

Summary: 
      During sepsis and septic shock the immune response can be overwhelming leading to excessive
      tissue damage, organ failure and death. Ideally, the inflammatory response is modulated
      leading to both adequate protection to invading pathogens as well as limitation of an
      exuberant immune response. In the last few years adenosine is proposed to have a central role
      in the modulation of inflammation. In unfavorable conditions such as hypoxia, ischemia or
      inflammation adenosine is quickly up-regulated; with concentrations up to tenfold in septic
      patients. Many animal studies have shown that adenosine is able to attenuate the inflammatory
      response and decrease mortality rates. Therefore, pharmacological elevation of the adenosine
      concentration is an potential target to attenuate inflammation and limit organ injury.
      Dipyridamole, an adenosine re-uptake inhibitor is able to increase the adenosine
      concentration and limit ischemia-reperfusion injury. In order to study the effects of
      dipyridamole on the inflammatory response we aim to use the so called human endotoxemia
      model. This model permits elucidation of key players in the immune response to a gram
      negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel
      therapeutic strategies in a standardized setting.
    


Intervention name(s): Dipyridamole; Placebo; LPS
Intervention type(s): Drug; Drug; Other
Intervention description(s): Oral treatment with dipyridamole 200 mg twice daily during seven consecutive days; Placebo twice daily during seven consecutive days; The LPS derived from E. coli O:113 2ng/kg iv will be injected in 1 minute at a dosage of 2 ng/kg body weight.
Other intervention name(s): Persantin retard; Human endotoxemia
Intervention MeSH terms: Dipyridamole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Adenosine; Endotoxin; Innate Immunity; Dipyridamole
Effect of Intake in Bioactive Molecules From Natural or Pasteurised Milk on Gut Maturation in Very Premature Newborns
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      It seems important to correlate real consumption in bioactives molecules of natural milk
      versus pasteurized with gut maturation in very preterm infants during small enteral feeding
      protocol. This objective will be reached through a clinical trial.
    

Detailed description: 
      One hundred infants born between 28 and 30 weeks of gestational age will be enrolled in our
      clinical trial in two neonatal units of Marseille; they will receive small enteral feeding
      protocol with natural or pasteurized milk (according to the Neonatology Department). Infants
      monitoring will be conducted from birth until 32 weeks of gestational age through
      extra-uterine growth, dietary type evolution and determination of gut maturation markers
      levels in blood (Triglycerides and Cholesterol, PUFA, GLP-2, I and L-FABP, Gastrin,
      Citrullin) and faeces (Calprotectine). We will also look for new biological markers of
      intestinal growth, via metabolomic approach. Consumption of bioactives molecules (PUFA,
      sphingomyelin, sCD14, insulin, leptin, lactoferrin, sphingomyelinase acid and BSSL activity)
      will be quantified in milk 24h-representative samples received by each newborn. The benefits
      on digestive tract physiology evolution due to the molecules consumption will be observed
      from the 32nd week until the 36th week or the end of hospitalization.
    

Intervention name(s): blood samples , feces samples; blood samples, feces samples
Intervention type(s): Other; Other
Intervention description(s): After the 32nd week until the 36th week or the end of hospitalization,infants received mother's native milk or substitute.; After the 32nd week until the 36th week or the end of hospitalization,infants continued mother's native milk or received substitute.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: kidney-transplant recipients
A Trial to Compare the Effectiveness of Two Rehabilitation Programs for Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study was to compare the effectiveness of two rehabilitation programs
      (one month) in patients with multiple sclerosis. The first program is combined with
      physiotherapy, endurance training and resistance training. The second one is physiotherapy in
      private practice. Another purpose is to assess the length of the benefits of the combined
      program.
    

Detailed description: 
      This study will include 240 patients with a diagnosis of Multiple Sclerosis and with an
      Expanded Disability Status Scale ≤ 5. Patients will be divided into 2 groups, according to a
      randomization design. At recruitment (J0), after rehabilitation (M1) and at follow up (M3 and
      M6) each patient will be tested for the primary and secondary outcomes.
    

Intervention name(s): Combined program; Physiotherapy in private practice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Combined program with physiotherapy, endurance training and resistance training; Physiotherapy in private practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Rehabilitation; Chronic evolutive disease; Physiotherapy; Resistance training; Endurance training