bioihbjkbjnl/mcl2 huggingface dataset:
Genetic Correlates of Wasting: a Pilot Study With Children Attending a Tertiary Feeding Clinic
Condition: Undernutrition; Eating Disorders; Underweight
MeSH terms: Malnutrition; Thinness; Feeding and Eating Disorders
Study type: Observational

Summary: 
      This is a pilot study of children attending the Glasgow feeding clinic (GFC) which looks
      after a range of children with severe feeding problems who commonly have low appetite and
      extreme thinness. The investigators want to find out if these children are more likely to
      carry genetic markers of thinness.
    

Detailed description: 
      Thinness occurs as a result of undereating, but it is not always clear why an individual
      child has not eaten enough, or how to get them to eat more. There is a need to understand the
      child characteristics that predispose to undereating and the how these operate, in order to
      design more effective treatment and prevention programmes. The Glasgow feeding clinic (GFC)
      looks after a range of children with severe feeding problems who commonly have low appetite
      and extreme thinness. The investigators want to find out if these children are more likely to
      carry genetic markers of thinness.

      The investigators will invite up to 60 families to complete a standardised online
      questionnaire (ICFET) about their child's eating behaviour and collect a saliva sample from
      their child, sent by post. The investigators will identify how many genetic markers for
      thinness each carries and relate this to their ICFET appetite scores and existing growth
      measurements as well as their feeding history.
    

Intervention name(s): Feeding clinic
Intervention type(s): Behavioral
Intervention description(s): These children have all attended a multidisciplinary feeding clinic with severe food refusal and were commonly receiving tube feeding or supplement drinks. The clinic helps children progress onto a normal oral diet
Other intervention name(s): tube weaning
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This is a heterogeneous population, united by their difficulties in eating solid food. The
        majority are, or have previously been, tube fed and around half have some learning
        disability. Thinness is very common in this group, but we will include all children,
        whatever their current growth pattern.
      
Keywords: Genetics; Child; Eating behaviour; Tube feeding; Avoidant Restrictive food intake disorder
A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo
      following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus
      (T1DM) with insulin-induced hypoglycemia. Additionally to compare the glycemic response
      observed after administration dasiglucagon with that of GlucaGen®.
    

Detailed description: 
      This was a global, multicenter, randomized, parallel, and double-blind clinical trial
      confirming the efficacy and safety of dasiglucagon for insulin-induced hypoglycemia in
      patients with T1DM. The patients were randomized 2:1:1 to receive a single subcutaneous 0.6
      mg dose of dasiglucagon, placebo, or a 1 mg dose of GlucaGen and followed for at least 28
      days after receiving treatment.
    

Intervention name(s): Dasiglucagon; GlucaGen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Glucagon analog; Native glucagon; Placebo for dasiglucagon
Other intervention name(s): ZP4207; GlucaGen HypoKit; Placebo for dasiglucagon
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dasiglucagon; Glucagon analog
Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie
Condition: Hypospadias
MeSH terms: Hypospadias
Study type: Observational

Summary: 
      We want to see if there is a relationship between exposure to pesticides and the occurrence
      of hypospade in Picard newborn .
    

Detailed description: 
      Hypospadias is the most frequent malformation of the external genital organs in the male
      infant. Incomplete virilization of the genital bud results in hypoplasia of the tissues on
      the ventral aspect of the penis, with an ectopic ureteral meatus, a curved penile shaft and
      an incompletely formed foreskin. The condition is generally isolated and the aetiology is
      unknown. The pathogenesis is complex and involves hormonal, genetic and environmental factors
      (which are probably interlinked).

      A doubling in the incidence of hypospadias over the last 15 years has emphasized the probable
      role of environment factors: in fact, certain exogenous compounds (collectively referred to
      as "endocrine disruptors" (EDs)) may modify hormonal functions and thus exert harmful effects
      on the organism or its offspring.

      The male urethra develops between the 8th and 16th weeks of gestation in an
      androgen-dependence manner. In utero exposure of the foetus to EDs may have a
      physiopathological role in the abnormal development of the male genital bud and thus in the
      development of hypospadia. These EDs are present in many different substances, such as
      pesticides.

      Many epidemiological studies have evidenced an increase in the incidence of hypospadias in
      children born to exposed parents. Furthermore, animal studies have identified a certain
      number of compounds associated with hypospadias after in utero exposure. However, human
      foetal samples have very rarely been assayed in an attempt to measure the true level of
      impregnation (i.e. the dose received). At present, it is not possible to draw firm
      conclusions with regard to the true extent of a link between EDs and the increased incidence
      of hypospadia.

      The "HypoMeco" project is a prospective case-control study.
    

Intervention name(s): meconium; self questionnaires to parents
Intervention type(s): Other; Other
Intervention description(s): to evaluate internal exposure to pesticide; to evaluate external exposure to pesticide
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        parent-child triads as cases (male newborns with hypospadias) and parent-child triads as
        controls (male newborns without hypospadias)
      
Biospecimen description: 
      meconium
    
Keywords: Hypospadias; newborns; pesticide; Picardie
NOX-E36 First-in-Human (FIH) Study
Condition: Chronic Inflammatory Diseases; Type 2 Diabetes Mellitus; Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first time NOX-E36 will be administered to man. The principal aim of this study
      is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous
      (IV) and subcutaneous (SC) doses to healthy male and female subjects. This information,
      together with the pharmacokinetic and pharmacodynamic data, will help establish the doses,
      dosage regimen and route of administration suitable for multiple dose administration to
      healthy volunteers, followed by the studies in the patient population.
    


Intervention name(s): NOX-E36; NOX-E36; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg; single SC doses, at safe and tolerable dose level
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: monocyte chemoattractant protein-1 (MCP-1); L-oligonucleotide aptamer; Spiegelmer
Early Phase 2 Clinical Study of TS-142 in Patients With Insomnia Disorder
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind
      comparative study.
    


Intervention name(s): TS-142; Dose-matched Placebo to TS-142
Intervention type(s): Drug; Drug
Intervention description(s): Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule); Participants received single dose-matched placebo to TS-142 (oral capsule)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Critical Care Ultrasound Guided Weaning
Condition: Weaning Failure
Study type: Observational

Summary: 
      Weaning patients from the ventilator in the intensive care unit is sometimes difficult
      because of three main interrelated etiologies: impaired lung, heart or diaphragm function. In
      this context, ultrasonography performed during tests for extubation of patients may enable
      the diagnosis of cardiac dysfunction, loss of pulmonary aeration, diaphragm dysfunction, and
      venous congestion, thereby reducing the number of failures in extubation.

      The combination of TTE (Trans Thoracic Echocardiography), LUS (Lung Ultrasound), DUS
      (Diaphragmatic ultrasound) and VEXUS (Venous excess Ultrasound) may enable the identification
      of the etiology of weaning failure and reduce the number of extubation failures by enabling
      the development of an appropriate treatment strategy. With this study, it is aimed to
      contribute to the literature in this sense.
    

Detailed description: 
      The aim of this study is to reduce the number of extubation failures by defining the etiology
      of weaning failure and developing appropriate treatment strategies by using intensive care
      ultrasonography applications in combination (defining cardiac, pulmonary, diaphragmatic and
      venous congestion).

      Most patients can be extubated after the first SBT (spontaneous Breathing Trial). A patient
      who fails extubation is automatically classified as difficult weaning, and intensive care
      professionals frequently encounter patients who are difficult to wean from mechanical
      ventilation.

      Before performing a new SBT following a failed SBT, the cause of the failure should be
      determined and an appropriate treatment strategy developed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The researchers aimed to predict the success and failure of extubation and measure the
        associated ultrasound indices with the combined ultrasound-guided weaning protocol in all
        critically ill patients over the age of 18 who remain on mechanical ventilator for more
        than 24 hours and are thought to be ready for weaning. Evaluations will be made just before
        the spontaneous breathing trial and at the end of the spontaneous breathing trial in
        critically ill patients undergoing mechanical ventilation.
Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea; Sleep Apnea; OSA
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to
      characterize the clinical performance during a single night of therapy with a FRESCA mask
      compared with a single night of therapy with their existing nasal Continuous Positive Airway
      Pressure (CPAP) mask.
    

Detailed description: 
      Obstructive Sleep Apnea (OSA) is a common chronic disorder and the most common of all sleep
      disorders. OSA can occur in any age group, but prevalence increases between middle and older
      age. Over the last two decades the prevalence of sleep disordered breathing seems to be
      increasing in both men and women, likely due to increasing rates of obesity. Relative
      increases reported are between 14% and 55% depending on the subgroup. For men, the current
      prevalence estimates of moderate to severe sleep-disordered breathing are 10% for 30 to 49
      year-olds and 17% for 50 to 70 year-olds. For women, the corresponding prevalence estimates
      are 3% and 9%.

      Common consequences of OSA include daytime sleepiness, extreme daytime fatigue, slow reaction
      time, moodiness, belligerence and vision problems. OSA is also linked to hypertension,
      increased cardiovascular morbidity, type 2 diabetes, neurocognitive dysfunction and possibly
      cancer.

      The study is a prospective, comparative, open label, randomized crossover assignment,
      multi-center pivotal study.

      Up to forty-five (45) subjects will be enrolled. It is desirable to have the subject
      population distributed across the OSA severity criteria range.

      The purpose of this study is to demonstrate that the FRESCA mask is non-inferior to a CPAP
      nasal mask in maintaining AHI and ODI during a single night of PSG assessment.
    

Intervention name(s): FRESCA mask first night; CPAP Mask first night
Intervention type(s): Device; Device
Intervention description(s): FRESCA nasal mask first night; CPAP Nasal Mask first night
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella)
Condition: Mumps; Rubella; Measles
MeSH terms: Measles; Rubella; Mumps
Study type: Observational

Summary: 
      On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a
      mumps seroconversion much lower (71%) than the expected 95%, according to the package insert.
      This could indicate that a substantial proportion of children was not protected after MMR
      dose.
    

Detailed description: 
      Given the above and considering: (1) future clinical study with the MMR vaccine produced
      entirely in Bio-Manguinhos/Fiocruz from technology transfer from GlaxoSmithKline (GSK), (2)
      the importance to the National Immunization Program (NIP) to provide the population a MMR
      vaccine to ensure high protection against mumps, similar to what occurs with measles and
      rubella components, it was considered essential to conduct a preliminary immunogenicity
      assessment of the MMR vaccine produced by BioManguinhos.
    

Intervention name(s): MMR (Mumps, Measles and Rubella)
Intervention type(s): Biological
Intervention description(s): MMR (Mumps, Measles and Rubella)
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children 12-23 months and 29 days old, in the routine of PNI in health units in the city of
        Rio de Janeiro.
      
Biospecimen description: 
      Whole blood
Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg
Condition: Demyelinating Polyneuropathy
MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Interventional
Phase: Phase 3

Summary: 
      Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a challenge because
      disease may generate important disability in patients including young adults. Randomized
      trials showed that corticosteroids, plasma exchanges and intravenous immunoglobulin (IVIg)
      can reduce impairment on a short term period but the treatment of a chronic disease doesn't
      agree with it. Corticosteroids and IVIg are the first line CIDP treatments. No study permits
      to demonstrate the superiority of one treatment to the other. Long term adverse effects of
      corticosteroids and IVIg cost are the respective limitation of their use. The investigators
      scheduled to recruit 40 CIDP patients in 23 French centres to receive either 0,8mg/kg/day of
      prednisone progressively tapered over 6 months or a monthly 2g/kg cure of IVIg during 6
      months. Patients will be followed during 6 months after the treatment.
    


Intervention name(s): Immunoglobulin perfusion; Prednisone
Intervention type(s): Drug; Drug
Intervention description(s): patient who received monthly 2g/kg intravenous cure of immunoglobulin; patient who received 0,8mg/kg/day of prednisone progressively tapered over 6 months
Intervention MeSH terms: Prednisone; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic inflammatory demyelinating polyneuropathy; immunoglobulin; prednisone
Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy of three regimens of pegylated
      interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in
      participants with acute hepatitis C. After 12 weeks of observation from disease onset,
      participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN
      monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3)
      a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the
      treatment period, participants will enter a 12-month follow-up.
    


Intervention name(s): Pegylated interferon alfa-2b; Ribavirin
Intervention type(s): Biological; Drug
Intervention description(s): 1.5 ug/kg/week SC for 12 or 24 weeks; Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
Other intervention name(s): SCH 54031, PegIntron; SCH 18908, Rebetol
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan
Condition: Stroke; Cardiovascular Death; Nonfatal Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational [Patient Registry]

Summary: 
      The objective of this five-year prospective observational follow-up study is to examine the
      additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of
      cardiovascular events in high-risk patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primiary care clinic and hospital
To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild
      to moderate active ulcerative colitis after 8 weeks of treatment.
    


Intervention name(s): Budesonide (6 mg); Budesonide (9 mg); Mesalazine (3,600 mg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.; Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.; Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.
Other intervention name(s): FE 999315; FE 999315
Intervention MeSH terms: Budesonide; Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative colitis; FE999315; Mesalazine; Colitis; Colitis, Ulcerative
The Effect of Periodontal Treatment on Psoriasis
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases; Psoriasis
Study type: Interventional

Summary: 
      There is a relationship between psoriasis and periodontal disease. This relationship may be
      double-sided.
    

Detailed description: 
      The aim of this randomized controlled clinical study was to determine the effect of
      non-surgical mechanical periodontal treatment on psoriasis. The study population consisted of
      92 periodontitis patients with psoriasis who had untreated periodontal disease. Two
      randomized groups were formed from these patients. Immediate periodontal treatment (test
      group, n = 46) and delayed periodontal treatment (control group, n = 46). Clinical
      periodontal measures, saliva interleukin 2, interleukin 6 and secretory immunoglobulin A
      levels and PASI scores were performed at baseline and 8th week in control and test group.
    

Intervention name(s): Psoriatic measurements; Non-surgical periodontal treatment; saliva samples
Intervention type(s): Other; Other; Other
Intervention description(s): Psoriasis Area and Severity Index (PASI) was performed baseline and after 8 weeks. Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.; Non-surgical periodontal treatment was performed baseline and after 8 weeks. Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.; Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Psoriasis
Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a
      single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day
      for 7 days
    

Detailed description: 
      The study consists of a 7-day double-blind Treatment Period (Day 0 to Day 6)
    

Intervention name(s): Vortioxetine infusion 25 mg; Vortioxetine tablets 10 mg/day; Placebo infusion; Placebo tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 mg/mL, concentrate for solution for infusion, 25 mL (25 mg) administered in 250 mL saline over 2 hours as single dose for 7 days; 10 mg, tablets, oral administration once daily; concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose; oral administration once daily
Other intervention name(s): Brintellix ®
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment