bioihbjkbjnl/mcl2 huggingface dataset:
RNA and Heat Shock Protein Biomarkers in Radiation-induced Fibrosis in Breast Cancer
Condition: Breast Carcinoma; Fibrosis
MeSH terms: Breast Neoplasms; Fibrosis; Radiation Fibrosis Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to seeking a molecular signature of pathological radiation
      induced fibrosis based on the response of skin fibroblasts after irradiation, comparing two
      groups of patients distinguished by their individual radiosensitivity. The signature will
      integrate recent insights in terms of alternative splicing of mRNAs and level of expression
      of non-coding RNAs, particularly long non-coding RNAs, snRNAs, snoRNAs and microRNAs. In each
      group each expression patterns of candidate HSP proteins potentially predictive of
      pathological radiation induced fibrosis (HSP27, HSP70, αβ crystalline) in the serum and on
      cell culture will be characterized.
    


Intervention name(s): skin biopsies; blood samples
Intervention type(s): Other; Other
Intervention description(s): Biopsies (12 G) will be performed :
in non-irradiated breast skin
in irradiated breast skin; blood samples are collected:
10 ml in EDTA tube
2,5 ml in PAXgene Blood RNA tube
4 ml in EDTA tube
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Skin biopsy; Radiotherapy; RNA biomarker; HSP biomarker; Exon junction array; Gene expression; Radiosensitivity prediction
Responsiveness of Endoscopic Evaluation in UC
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      The purpose of this study of this study is to assess the responsiveness and validity of CIMS
      (Central Image Management System)-based endoscopic evaluation of UC (Ulcerative Colitis)
      clinical disease activity by measuring:

      The responsiveness central reader endoscopic EIs [(Endoscopic Indices) (MMCS (Modified Mayo
      Clinic endoscopy Subscore), UCEIS (Ulcerative Colitis Endoscopic Index of Severity) MBS
      (Modified Baron Score)] to clinical change from baseline to week 6 in a prospective trial of
      a treatment of known efficacy in UC.
    

Detailed description: 
      This study will evaluate the responsiveness central reader based EIs for assessing clinical
      disease activity. Endoscopic images will be obtained from recent large multicenter randomized
      clinical trial and assessed using utilizing CIMS readers using EIs (MMCS, UCEIS, MBS) and a
      VAS (visual analog scale). The primary efficacy endpoint of this trial was clinical and
      endoscopic remission at week 6, with a secondary endpoint of endoscopic and clinical
      remission at week 10. For the same subjects, clinical data will be obtained including a
      modified UCDAI (Ulcerative Colitis Disease Activity Index). Central readers are blinded to
      clinical scores.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population contained a broad spectrum of endoscopic and clinical activity. At
        entry patients had active disease defined by the presence of a modified UCDAI score between
        4 and 10.
      
Keywords: disease activity; central reader; endoscopic indices
Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction
Condition: Child Comfort; Morphine; Intensive Care Units; Pediatric
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective is to assess the efficacy of Alfentanil for pain in children treated by
      tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the
      current standard treatment.
    


Intervention name(s): Alfentanil; Sufentanil
Intervention type(s): Drug; Drug
Intervention description(s): dosage form: injectable drug, opioid analgesic morphine, intravenous drug.
Dosage: 10μg/Kg, dilution: 1 ml = volume equivalent to 66μg or 10μg/kg = 1.43μg/kg fentanyl.
Frequency and duration: 2 bolus injection before 2 tracheal suctions at 0 and 4 hours respectively.; dosage form: injectable drug, opioid analgesic morphine, intravenous drug.
Dosage: intravenous drug to 0,15 µg/Kg : Blisters of 10 ml, box of 20. MERCK
Frequency and duration: 2 bolus injection before 2 tracheal suctions at 0 and 4 hours respectively.
Intervention MeSH terms: Sufentanil; Alfentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COMFORT B score; Bis score
Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic
      control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes
    


Intervention name(s): liraglutide; placebo; liraglutide; liraglutide; glimepiride; metformin; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.6 mg/day, s.c. (under the skin) injection; Glimepiride placebo, capsules; 1.2 mg/day, s.c. (under the skin) injection; 1.8 mg/day, s.c. (under the skin) injection; Capsules, 4.0 mg/day; Tablets, 1.5-2.0 g/day; Liraglutide placebo, s.c. (under the skin) injection
Intervention MeSH terms: Metformin; Liraglutide; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Reduced Target Delineation and Radiation Doses Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the efficacy and safety of sequential chemoradiotherapy with regimen of
      docetaxel, cisplatin and fluorouracil and reduced target delineation and radiation doses IMRT
      for patients with locoregionally advanced nasopharyngeal carcinoma
    

Detailed description: 
      Although concurrent chemoradiation is the standard treatment modality for locally advanced
      nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment
      related toxicities have become an obstacle to be overcome. Besides, a common problem in
      locally advanced NPC is the narrow gap between the tumor and critical normal structures,
      which makes dose optimization difficult. Considering that significant tumor shrinkage may
      occur during induction chemotherapy, and incidences of distant metastases may be reduced by
      adjuvant chemotherapy, this study was designed to explore the efficacy and safety of
      sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and
      reduced target delineation and radiation doses IMRT for patients with locoregionally advanced
      NPC.
    

Intervention name(s): Reduced Target Delineation and Radiation Doses
Intervention type(s): Radiation
Intervention description(s): The target volumes were delineated according to the treatment protocol defined as follows: the GTV of the primary tumor (GTV-P) included retropharyngeal lymph nodes, considering the common phenomena of integration, and the rest involved lymph nodes that were defined as GTV-N. For the GTV-P, involved retropharyngeal lymph nodes and intracavity lesions were delineated according to the post-IC volume, whereas the remainder of the involved tissues (eg, pterygopalatine fossa) were delineated according to the pre-IC volume of the primary lesion as shown by MRI. Post-IC volumes of involved neck lymph nodes were used for GTV-N delineation.
The prescribed dose was 66 Gy to tumors above the slices of skull base or below the orapharynx with less than 5 mm retropharyngeal lymph nodes, or 70.4 Gy to tumors in other slices.
Other intervention name(s): Drug: TPF regimen comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion)
Intervention MeSH terms: Cisplatin; Docetaxel; Fluorouracil
Intervention model: Single Group Assignment
Intervention model description: Drug: TPF regimen comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion) Radiotherapy：Reduced Target Delineation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal Carcinoma; Reduced Target Delineation and Radiation Doses; Sequential chemoradiotherapy
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assessed the immunogenicity and safety of two vaccination regimens that employed
      either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two
      groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2
      doses of the primary vaccination course. At 5 months of age, they received either the
      DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib
      vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV
      vaccine at birth and at 1 month of age.
    


Intervention name(s): Infanrix-Hexa
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Canagliflozin in T1DM (Type 1 Diabetes Melitus) After Interruption of Continuous Subcutaneous Insulin Infusion
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study will be an open-label, cross-over study as subjects will be studied under both
      study conditions - suspension of subcutaneous insulin infusion via pump during treatment with
      insulin alone (control) vs. suspension of subcutaneous insulin via pump during treatment with
      insulin and canagliflozin.
    

Detailed description: 
      The study will consist of 4 visits: an enrollment/screening visit, a control visit with pump
      suspension prior to treatment with canagliflozin, a visit with pump suspension while on
      canagliflozin and an end of study visit. Each of the pump suspension visits will be
      approximately 20-hour overnight admissions to the Hospital Research Unit (HRU).
    

Intervention name(s): canagliflozin; basal interruption without canagliflozin
Intervention type(s): Drug; Other
Intervention description(s): basal interruption with canagliflozin; basal interruption
Other intervention name(s): Invokana
Intervention MeSH terms: Canagliflozin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional

Summary: 
      There is a major clinical need for an inexpensive topically-applied product that can inhibit
      the growth of the dermatophytes that cause nail fungus. Chesson Labs has developed LIQUICURE
      with a longer drying/curing time that will allow better nail penetration or adsorption.
      Though the product may have inherent antimicrobial activity, the product does not contain a
      drug or antimicrobial agent.

      Consistent use of LIQUICURE as described will clear fungal nail infection. Clearing of nail
      fungal infection is defined by negative dermatophyte culture and visual improvement in nail
      characteristics within six months, with few, if any product-related adverse events.
    


Intervention name(s): LIQUICURE
Intervention type(s): Device
Intervention description(s): Topical treatment, 1 time/day, 5 days/week
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Toenail; Fungus; Onychomycosis; Dermatophyte
Insulin Glulisine in Diabetes Mellitus, Type 2
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      The primary study objective is to demonstrate superior efficacy of an intensified insulin
      regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin
      regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint.

      Secondary objectives:

      Secondary study objectives are to compare the intensified insulin regimen with insulin
      glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of
      blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting
      plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic
      events, adverse events, change of late diabetes complications, weight, body-mass-index,
      course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria,
      standard lab and quality of life/treatment satisfaction.
    


Intervention name(s): Insulin Glulisine; Insulin Therapy; Insulin Glargine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): insulin glulisine 3 x daily (TID) subcutaneously 15 min before the start of a meal; NPH (70%) plus regular insulin or insulin aspart (30%); 1 x daily (OD) subcutaneously at any time (but every day at the same time) according to BG
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma (UF-STO-LUNG-003)
Condition: Squamous Cell Lung Carcinoma
MeSH terms: Carcinoma; Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a non-randomized, open label, sequentially enrolling phase II study with a Simon
      two-step enrollment design to evaluate the activity of TAS-102 in previously treated
      unresectable or metastatic squamous non-small cell cancer after progression through or
      intolerance to prior systemic therapy. The trial therapy of TAS-102 is to be administered
      orally at 35 mg/m2 each dose twice daily. The primary objective of the trial is to determine
      the progression-free survival, in months, of subjects receiving TAS 102 for the treatment of
      unresectable or metastatic recurrent squamous non-small cell lung cancers.
    


Intervention name(s): TAS-102
Intervention type(s): Drug
Intervention description(s): Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals.
Days 6 through 7: Rest
Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.
Days 13 through 28: Rest
Other intervention name(s): Lonsurf
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung; metastatic; carcinoma
Busulfan Pharmacokinetic Analysis and GST Pharmacogenetic Profile in Adults Undergoing Hematological Stem Cell Transplantation
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      The correlation between Busulfan Pharmacokinetics in AML transplanted patients and their GST
      (A1,T1,M1 and P1), MDR-1 genetic profile. If a pre-genetic testing of those genes can be
      utilized as biomarkers of SOS and/or HGVHD. This study is not an interventional study it is
      only checking the GST gene and MDR-1 gene
    

Detailed description: 
      BU levels are largely unpredictable, patients are often exposed to the toxic effects of
      inappropriate drug regimens before dose modifications can be made. Although the importance of
      TDM cannot be over emphasized, it entails trial and error and does not allow for pre-
      treatment dose optimization. This study, which provides an integration of genetic and
      pharmacokinetic data analysis of patients preconditioned for HSCT with high dose oral BU,
      aims to define biomarkers predictive of poor BU metabolism and clearance to prevent potential
      drug toxicity.This study is not an interventional study, only investigates the GST and MDR-1
      genes in correlation with the "routine" Busulfan AUC done during the preparative regimen in
      HSCT for AML patients.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults suffering from AML who were selected to be treated by Hematological Stem Cell
        Transplantation
      
Biospecimen description: 
      Peripheral Blood was used for DNA extraction
    
Keywords: Pharmacokinetics; Busulfan; Polymorphism; GST; MDR-1(p-Glycoprotein); Acute Myeloid Leukemia adult patients
Study of Analgesics Drug and Human Milk Transfer in Mature Milk, to Avoid Breastfeeding Cessation Without Scientific Probes
Condition: Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk
Study type: Observational

Summary: 
      The purpose of this study is to determine whether ibuprofen and ketoprofen do not enter into
      mature breastmilk that could allowed breastfeeding during a long time
    

Detailed description: 
      Analgesics are frequently used to prevent and treat pain and inflammatory disease.

      Due to a lack of information on drug's human milk transfer, breastfeeding is sometimes
      contraindicated. Mothers are advised to either stop breastfeeding or if they don't, not to
      treat themselves. Since the fatal neonatal case with codeine during breastfeeding, analgesics
      are being reviewed. Ibuprofen seems to have the best benefit-risk ratio during the
      post-partum period. However there are no pharmacologic data about the use of ibuprofen during
      breastfeeding, after the colostrum phase.

      This study aims to determine the relative infant dose (RID) of ibuprofen in human mature
      milk. Considering the increased interest in NSAIDs in light of the codeine case, this is an
      important information. It will help health practitioners when advising and treating
      breastfeeding women.
    

Intervention name(s): analgesic measure
Intervention type(s): Other
Intervention description(s): ibuprofen and ketoprofen measured into breast milk
Intervention MeSH terms: Analgesics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Lactarium, Maternal care, Consultant of Lactation
      
Biospecimen description: 
      human breast milk
    
Keywords: Analgesics; Ibuprofene; Ketoprofene; Breastmilk; Relative Infant Dose; Theoric Infant Dose
Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to demonstrate that a ketoacid supplement in patients with stage III
      to IV chronic renal failure, reduces the excretion of urinary urea nitrogen
    

Detailed description: 
      Patients with an estimated glomerular filtration rate of less than 25 ml/kg/min, not on renal
      substitution therapy, without important concomitant diseases and aged between 40 and 70
      years, will be invited to participate in the study. They will be randomly assigned to a group
      that will receive receive a supplement of ketoacids (Ketosteril) 1 tablet containing 630 mg
      of ketoacids every 5 kg of body weight and a diet containing 25 to 35 kcal/kg and 0.3
      g/protein per day or to a group receiving placebo and a diet containing 25 to 35 kcal/kg and
      0.6 g/protein per day. The intervention will last 16 weeks. At baseline and the end of the
      intervention a blood sample will be obtained to measure creatinine, urea nitrogen and
      cystatin C. Also a spot urine sample will be obtained to measure urea nitrogen and creatinine
      excretion. The compliance with the dietary prescription and the ketoacid or placebo
      supplement will be assessed every 2 weeks.
    

Intervention name(s): Ketoacids; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks; Provision of placebo capsules similar to active supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assgned to receive the ketoacid supplement or placebo
Masking: Single (Participant)
Primary purpose: Treatment
Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate consistency of accelerated insulin absorption and
      onset-of-action and shortened duration of action for bolus insulin infusions after
      pretreatment with 150 units (U) of Hylenex® (recombinant human hyaluronidase PH20 [rHuPH20])
      injection at the time of infusion set insertion compared to sham injection.
    


Intervention name(s): Sham Injection; Recombinant human hyaluronidase PH20; Insulin aspart; Insulin lispro
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): rHuPH20; PH20; Hylenex; Novolog; Aspart; Humalog; Lispro
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Continuous Subcutaneous Insulin Infusion (CSII)