bioihbjkbjnl/mcl2 huggingface dataset:
A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      The development of biomarkers will lead the dynamic of personalized medicine and fill the
      unsatisfied needs in oncology for prediction of therapeutic response.

      Molecular imaging enables non invasive quantification of biomarkers. The development of
      molecular imaging biomarkers is closely related to the development of therapeutic molecules.
      Among the potential targets, kinases offer a lot of advantages: (i) they play a central role
      in cellular regulation, (ii) numerous kinase-specific small molecule libraries exist in
      biotech and pharma industry, (iii) several kinase-targeted therapies are used in clinic
      (imatinib, sorafenib, sunitinib…) with application across a variety of therapeutic
      indications. Among the imaging technologies, the Positron Emission Tomography (PET) is the
      most sensitive and dedicated to evaluate small molecules. However few radiotracers are
      available and their specificity limits their clinical use. The IMAkinib® approach is an
      innovative method proposed to develop new PET radiotracers adapted to current medical and
      economical challenges.

      The epidermal growth factor receptor (EGFR) is an established target for the treatment of
      advanced non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitors (TKIs)
      Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved
      for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19).
      Unfortunately the majority of patients will develop a resistance to the TKI in the long term
      (6-12 months). If the mechanism of resistance is not yet fully characterized, most patients
      (50%) will acquire an additional T790M mutation of EGFR. TKI PET-imaging can provide a tool
      to determine and predict responsiveness to EGFR TKI in vivo. That is why, the investigators
      have selected and radiolabeled (18-Fluor) a compound targeting specifically EGFR mutated
      ([18F]-ODS2004436) which was further evaluated in a preclinical imaging study to determine
      the feasibility of TKI-PET. The investigators proved in vivo that [18F]-ODS2004436 a compound
      is a good candidate to evaluate the EGFR activity in human lung tumours using PET imaging.
    


Intervention name(s): Injection of [18F]-ODS2004436 radiotracer
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Controlled Feeding Experiment
Condition: Effect of Diet on Microbiome Composition
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of dietary fat, in standard formulation,
      on the composition of the human microbiome in a prospective study of normal volunteers.
      Participants will be randomly assigned to either a high fat or low fat diet for 10 days. The
      gut microbiome will be phylotyped in fecal samples as well as in bacteria adherent to the
      colonic mucosa prior to, and during the course of the dietary interventions.
    


Intervention name(s): High fat diet
Intervention type(s): Other
Intervention description(s): High fat diet and low fat diet are composed of the same food, but the portion sizes are varied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Dietary fat; Microbiome composition; Controlled feeding experiment
Early Detection of Autism Spectrum Disorder in Children
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      Rationale: Autism Spectrum Disorder (ASD) is defined by deficits in social interaction and
      communication identified before the age of 3 years. Modified Checklist for Autism in Toddlers
      (M-CHAT) is a sensitive tool for ASD screening in children 16-23 months. A limited number of
      studies with a small number of patients have documented the developmental profile of children
      with ASD during infancy. Retrospective evaluations of videotaped behavior of children with
      ASD at 8 months and at 12 months identified early signs of ASD. A few studies found early
      signs of ASD during infancy in siblings of autistic children. Data documenting the age of
      onset and regression in ASD is controversial and limited. No large prospective studies
      documented the specific developmental profile of children with ASD starting at 6 months of
      age. Defining a specific autistic pattern on a developmental screening test could help
      identify infants at risk for ASD and improve their outcome through earlier diagnosis and
      treatment. More recently, genetic tests have been shown to aid in early identification of ASD
      which facilitates earlier intervention. Genetic testing among siblings of children with
      autism can aid in identification of autism or other related disorders in the siblings.

      PURPOSE: The purpose of this study is to learn about the early signs of autism in siblings of
      children with autism spectrum disorders.

        -  The investigators will enroll siblings of children with ASD. Those siblings who
           completed the Red Flags for Communication scale (RFC) at 6 months and/or at 12 months
           and failed the RFC at 12 months will be given a genetic screening test.

        -  It is the investigators goal to define a specific autistic pattern on a developmental
           screening test that could help identify sibling infants at risk for ASD and improve
           their outcome through earlier diagnosis and treatment and to evaluate if the results of
           the clinical screening test will correlate with the results of the genetic screening
           test.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Biological siblings of children with a previous expert clinical diagnosis of Autism
        Spectrum Disorder.
      
Biospecimen description: 
      Saliva will be collected
    
Keywords: autism; siblings; genetic test; screening
The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss
Condition: Muscle Disuse; Neuromuscular Electrical Stimulation (NMES); Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Subjects who are hospitalized in the ICU will be included after 24 hours of intubation during
      their ICU stay. Twice-daily Neuromuscular Electrical Stimulation (NMES) will be performed on
      one leg for 2x40 min per day to assess muscle fiber size. The investigators hypothesize an
      attenuated loss in muscle fiber size.
    


Intervention name(s): Neuromuscular Electrical Stimulation of m. quadriceps femoris; Sham-treatment: no NMES
Intervention type(s): Procedure; Procedure
Intervention description(s): Neuromuscular Electrical Stimulation of m. quadriceps femoris by using a commercially available muscle stimulator; Sham comparator
Other intervention name(s): Electrical stimulation; No electrical stimulation; the leg will be sham-treated
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Hypermetabolism in the Elderly Lung Cancer Patient
Condition: Non-small Cell Lung Carcinoma
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      Aging and cancer are two conditions associated with extensive metabolic changes that can
      cause malnutrition. However, the clinical features and the underlying mechanisms leading to
      malnutrition are different in these two cases. We therefore wonder how age can influence the
      metabolic response to cancer.
    

Detailed description: 
      During aging, among other physiological modifications, inactivity and insulin resistance
      cause a progressive muscle loss associated with a decrease in resting energy expenditure
      (REE). In cancer, loud inflammation background also provokes a decrease in muscle mass as
      well as in fat mass. However, previous studies reported an increased REE, termed
      hypermetabolism, probably linked to inflammation.

      Data concerning response to aggression in the elderly patient is scarce and even inexistent
      when it comes to cancer. The investigators hypothesize that the mitochondrial dysfunction
      that comes with aging and that decreases the ATP rendering per unit of energy-producing
      nutrient oxidized increases the amount of nutrient to be consumed in order to sustain to
      energy needs. Therefore, in this situation, elderly patients could have a higher rate or
      degree of hypermetabolism than younger patients.

      The primary objective of this study is to assess the effect of aging on the metabolic
      response to cancer assessed by resting energy expenditure measured by indirect calorimetry
      corrected by whole body fat free mass calculated from single slice CT imaging at the third
      lumbar vertebra.

      The secondary objective of this study is to point out some inflammatory or endocrine
      determinants of these energy metabolism changes in the cancer patient.

      Non-small cell lung carcinoma seems to be a relevant choice for this study because it is
      frequently associated with cachexia and the literature reports a high rate of hypermetabolism
      in this cancer.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population is selected from the patients coming for their one-day pre-treatment
        evaluation at the oncology ward of the Cochin Hospital.
      
Keywords: Aging; Hypermetabolism
Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the treatment effect of montelukast versus placebo over a 2 week
      period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an
      active comparator.
    


Intervention name(s): montelukast sodium; Comparator: loratadine; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks.; Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.; placebo tablet orally once daily at bedtime for 2 weeks
Intervention MeSH terms: Loratadine; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
High Fructose Corn Syrup
Condition: Nonalcoholic Fatty Liver Disease; Obesity
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The purpose of this research study is to learn more about how high fructose corn syrup, a
      sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without
      nonalcoholic fatty liver disease. Eligible participants will be studied before and after
      eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn
      syrup) for four weeks.
    


Intervention name(s): High fructose corn syrup diet; Standard diet (low in high fructose corn syrup)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will consume a high fructose corn syrup diet for 4 weeks. The food will be prepared by the bio-nutrition kitchen, and meals will be picked up every 3-4 days.; Subjects will consume a standard diet (low in high fructose corn syrup) for 4 weeks. The food will be prepared by the bio-nutrition kitchen, and meals will be picked up every 3-4 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Obesity; Nonalcoholic fatty liver disease; High fructose corn syrup
Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™
Condition: Relapsing Multiple Sclerosis; Clinically Isolated Syndrome
MeSH terms: Multiple Sclerosis; Syndrome; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon
      beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in
      subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).
    


Intervention name(s): Rebif
Intervention type(s): Drug
Intervention description(s): Rebif will be administered at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
Other intervention name(s): Interferon beta-1a
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsing multiple sclerosis; Clinically isolated syndrome; RMS; CIS; RebiSmart™; Rebif®; Interferon beta-1a
Colchicine for the Stability of Coronary Plaque in Acute Coronary Syndrome (COLOCT)
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Evidence from the COLCOT Trial has shown that anti-inflammatory effect of colchicine reduced
      the risk of cardiovascular events in patients with recent myocardial infarction. We
      hypothesized that this might be due to the improvement of the coronary plaque stability by
      colchicine. Optical coherence tomography (OCT) is the most precise method to detect plaque
      stability in clinical practice. Thus, the purpose of this study is to evaluate the efficacy
      and safety of colchicine on improving the stability of coronary plaque in patients with acute
      coronary syndrome.
    

Detailed description: 
      This is a single-center, randomized, double-blind, placebo-controlled clinical trial. OCT
      coronary images analyzed at an independent imaging core laboratory (Department of Cardiology,
      Second Affiliated Hospital of Harbin Medical University, Harbin, China) by blinded expert
      readers.
    

Intervention name(s): Colchicine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): colchicine is a potent anti-inflammatory drug which is currently recommended for the treatment of pericarditis and acute gout attacks, but also familial Mediterranean fever and Behçet disease. This drug acts on inflammation through inhibition of microtubule polymerization by binding free tubule dimers. Colchicine blunts monocyte and neutrophil invasion at the site of inflammation and reduces intracellular trafficking and thus the release of cytokine and production of reactive oxygen species and a variety of proteolytic enzymes.; the placebo is a drug with no chemical effects but with the same physical characteristics as the experiment drug colchine.
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to examine, in healthy subjects, the comparative
      pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical Pharmaceutical
      Laboratory Bergamo Ltda with the product Lupron Depot ® (leuprorelin), manufactured by Abbott
      Laboratories Ltd, through the strength of biological markers follicle stimulating hormone
      (FSH), luteinizing hormone (LH) and total testosterone, associated with the activity of the
      substance.

      Secondarily be observed safety (tolerability) of subjects in clinical research through the
      comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse
      events.
    


Intervention name(s): Lorelin Depot Bergamo; Lupron Depot - Abbott
Intervention type(s): Drug; Drug
Intervention description(s): Lorelin Depot Bergamo, 3,75 mg, single dose.; Lupron Depot 3,75 mg, single dose.
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Decrease serum levels of luteinizing hormone, FSH and Testosterone
Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
Condition: Tooth, Nonvital
MeSH terms: Tooth, Nonvital
Study type: Interventional

Summary: 
      The purpose of this clinical study was to compare the effectiveness of passive ultrasonic
      irrigation with that of traditional syringe irrigation on the removal of bacteria and
      endotoxin (lipopolysaccharide [LPS]) from root canals.
    

Detailed description: 
      Forty teeth with apical periodontitis were randomly allocated into two groups according to
      the irrigation protocol, passive ultrasonic irrigation (PUI, n = 20) and syringe and needle
      irrigation (NI, n = 20). Microbiological sampling was performed before (S1) and after the
      root canal preparation (S2), after the tested irrigation protocols (S3). Total bacteria
      counts were determined by a quantitative PCR (qPCR) assay; and the endotoxin levels by the
      LAL assay.
    

Intervention name(s): Ultrasonic Irrigation; Non-Ultrasonic Irrigation
Intervention type(s): Device; Device
Intervention description(s): Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file; Syringe and needle irrigation with no-ultrasonic activation
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: bacterial infection; endotoxin; passive ultrasonic irrigation; root canal treatment
Topical NVN1000 for the Treatment of External Genital and Perianal Warts
Condition: Genital Warts; Perianal Warts
MeSH terms: Warts; Condylomata Acuminata
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study
      Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External
      Genital Warts and Perianal Warts
    

Detailed description: 
      This is a phase 2, multi-center, randomized, double-blind, vehicle-controlled, ascending dose
      study to assess safety, tolerability and efficacy of a topical nitric oxide releasing
      compound in subjects with external genital and perianal warts. Eligible subjects will be
      treated with a topical gel (active or vehicle) for up to 12 weeks.
    

Intervention name(s): NVN1000 8% Gel; NVN1000 16%; Vehicle; NVN1000 24%
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once and twice daily; once daily; placebo comparator; once daily
Other intervention name(s): SB206; SB206; Placebo; SB206
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: genital warts; perianal warts
Open-Label, Extension Study to 810P202
Condition: Impulsive Aggression Comorbid With ADHD in Children
MeSH terms: Aggression; Impulsive Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      Open-label, extension study for subjects that completed 810P202 to examine long term safety
      and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with
      Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).
    


Intervention name(s): Molindone
Intervention type(s): Drug
Intervention description(s): The populations will be comprised of male and female pediatric subjects from the 810P202 study. Subject will be converted to a total daily dose of 18 or 36mg of molindone (depending on weight), following enrollment into 810P203. The dosage level may be adjusted at the investigators discretion.
Intervention MeSH terms: Molindone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Prospective Registry of Patients With Congenital Penile Anomalies
Condition: Concealed Penis; Hypospadias; Phimosis; Chordee
MeSH terms: Hypospadias; Phimosis
Study type: Observational [Patient Registry]

Summary: 
      Prospective registry and biobank in pediatric patients with congenital penile anomalies
    

Detailed description: 
      According to the U.S. Center for Disease Control and Prevention, in the United States, one in
      200 babies is born with congenital penile anomalies. In Korea, there is a rapid increase rate
      among other types of congenital anomalies from 1993 to 2010, from 0.7 to 10,000 to 9.9 per
      10,000 cases. It leaves long term sequelae into adulthood even after the corrective operation
      has been performed. Some of the sequelae that patients experienced were difficulties in
      micturition, dissatisfaction with the appearance of the penis, and decreased sexual function,
      as well as psychosexual well-being.

      Despite its high prevalence, hypospadias and related penile anomalies have no specific known
      etiology and mechanisms. However, numerous studies have shown that both gene and environment
      play a significant role in making etiologies multifactorial. Furthermore, a molecular trial
      shows that both genetics and environmental factors disrupt the normal development course of
      the phallus, or penis. Penis formation, growth, or the formation of the male urogenital
      system, in general, have shown to be androgen dependent. Any defect in the androgen synthesis
      leading to androgen deficiency or receptors may play a role, specifically, in the development
      of penile anomalies.

      Pediatric patients between the ages of 0 to 18 years, with congenital penile anomalies and
      scheduled to undergo penoplasty will be enrolled. In this prospective observational study,
      our aims are to collect dartos fascia, which is a tissue in penile region, and examine
      histochemistry of the sample.
    

Intervention name(s): Penoplasty
Intervention type(s): Procedure
Intervention description(s): Modified penoplasty technique:
Degloved the penile skin and excise the inner prepuce.
Advanced penoscrotal skin to cover penile shaft
Fixed the penis base and reconstructed the penoscrotal angle
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male patients between the ages of 0 to 18 years with congenital penile anomalies and
        receiving penoplasty at the institution.
      
Biospecimen description: 
      Dartos Fascia is commonly known as subcutaneous tissue of the penis. It is located under the
      foreskin and superficially located on the outer external spermatic fascia of the scrotum and
      the axis of the penis. The primary role of dartos fascia is the mobility of the foreskin in
      the basal tissue and the blood supply from the external sinus vessels. Furthermore, it
      promotes heat loss and cools down the testicles.