bioihbjkbjnl/mcl2 huggingface dataset:
Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer; Chemotherapy Effect; Surgery--Complications
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      FOLFIRINOX regimen is first-line neoadjuvant chemotherapies for patients with locally
      advanced pancreatic cancer (LAPC) worldwide. However, FOLFIRINOX is not well accepted in
      China because of the high prevalence of adverse events and poor tolerance. To evaluate the
      safety and efficacy of modified-FOLFIRINOX (mFOLFIRINOX) in Chinese LAPC patients and compare
      survival between LAPC patients with mFOLFIRINOX-based preoperative therapy and LAPC patients
      who underwent surgery alone.
    

Detailed description: 
      At this institution, a mFOLFIRINOX regimen has been adopted for metastatic pancreatic cancer
      (MPC) patients and promising results obtained. The modification resulted in a significantly
      reduced prevalence of severe adverse events in MPC patients, whereas the OS and PFS were
      extended to 10.3m and 7.0m, respectively, which is similar to that for patients on a
      full-dose regimen. Therefore, the investigators further evaluated the efficacy of mFOLFIRINOX
      in LAPC patients. Here, investigators want to prospectively enroll LAPC patients who
      underwent preoperative therapy with mFOLFIRINOX from April 2014 and compared the surgical
      resectability and surgical morbidity/surgical mortality among patients with surgically
      resectable pancreatic cancer (RPC) or LAPC who underwent surgery alone retrospectively. For
      patients with LAPC, mFOLFIRINOX was administrated for several cycles until the optimal
      response was obtained and then patients were evaluated for surgery. Moreover, survival data,
      including OS and PFS, were determined.
    

Intervention name(s): modified-FOLFIRINOX
Intervention type(s): Drug
Intervention description(s): LAPC patients with mFOLFIRINOX-based neoadjuvant therapy or not was set as the main intervention
Other intervention name(s): Neoadjuvant therapy
Intervention MeSH terms: Folfirinox
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All locally advanced pancreatic cancer (LAPC) patients are diagnosed by histology to have
        pancreatic adenocarcinoma after a biopsy and prescribed mFOLFIRINOX-based neoadjuvant
        therapy at the Department of Hepatobiliary and Pancreatic Surgery of the Second Affiliated
        Hospital.
      
Keywords: FOLFIRINOX; Pancreatic cancer; Conversion surgery; Overall survival
Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial
Condition: Advanced Stage Cancer
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for
      reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo
      controlled trials have been conducted. This study evaluates the effect of melatonin in
      improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer
      patients. This is a multi-center, randomized, double-blind, placebo controlled trial
      conducted in patients with histologically proven advanced non small cell lung, breast, head
      and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment
      scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or
      matched placebo. The patients are required to take the studied drugs at night (after 21.00
      pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is
      chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT),
      adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.
    


Intervention name(s): 10 mg Melatonin; 20 mg Melatonin; Matched placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active Comparator: Drug: Melatonin 10 mg; Active Comparator: Drug: Melatonin 20 mg; Matched placebo (identical formulation and delivery, without active ingredient)
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cancer; melatonin; adjuvant therapy; quality of life; survival; adverse events; oxidative stress
The Use of a Silver Containing Dressing (Acticoat) on Wound Complication Rates Post Elective Cesarean Section
Condition: Surgical Wound Infection
MeSH terms: Wound Infection; Surgical Wound Infection; Wounds and Injuries; Surgical Wound
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of a silver containing dressing
      (Acticoat Post-Op) compared to a standard dressing (OpSite PostOp) on post elective cesarean
      section wound complications in obese women (BMI >35).
    

Detailed description: 
      Women scheduled for an elective cesarean section at term will be recruited to participate in
      this study. The investigators plan to recruit 100 women. Baseline demographic information
      will be obtained at the pre-op visit. Eligible subjects will be randomized to received a
      silver containing dressing (Acticoat PostOp) or the standard dressing (OpSite PostOp). A
      randomization table will be computer generated in blocks of 20. A sealed opaque envelope
      containing the assigned dressing will accompany the patient to the operating room. Standard
      antibiotic prophylaxis will be provided prior to skin incision. A subcuticular suture will be
      used for skin closure. At the time of skin closure, the envelope will be opened and the
      assigned dressing will be applied. The dressing will only be changed if it is saturated. The
      dressing will be removed at the time of discharge from hospital. A questionnaire regarding
      wound complications will be completed at the time of discharge from hospital, at 2 weeks
      post-op and 6 weeks post-op.
    

Intervention name(s): Acticoat PostOp; OpSite PostOp
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Complications; Cesarean Section; Wound; Infection (Following Delivery)
Determination of Sufentanil in Breast Milk of Puerpera
Condition: Cesarean Section
Study type: Interventional
Phase: Phase 4

Summary: 
      To determination of sufentanil in human breast milk during the administration of the
      sufentanil via the analgesic infusion pump and after the administration, to determine whether
      the breastfeeding after clinical anesthetic or analgesic administration has an effect on the
      infant and provide a reference for the security issues.
    

Detailed description: 
      The concentration of sufentanil in milk was determined by LC-MS /MS method( liquid
      chromatography mass spectrometry).The separation was carried on Agilent ZORBAX Eclipse Plus
      C18 column(2.1×50 mm, 3.5 μm)with a mobile phase of 10 mmol ammonium formate(A)and
      methanol(B), and the elution conditions were optimized as follows：linear gradient 0→0.30 min,
      A:B=50:50; 0.30→0.31 min, A:B=50:50→10:90; 3.00→3.10 min, A:B=10:90→50:50; 3.1→6.5min,
      A:B=50:50; The flowing rate was 0.2 mL•min-1, column temperature was 30 ℃, injection volume
      was 5 μL. ESI source was applied and operated in positive ion mode. Quantitative
      determination was performed using multiple reaction monitoring (MRM) of m/z 387.2 → m/z 238.2
      for sufentanil, and m/z 337.2 → m/z 158.2 for fentanyl.
    

Intervention name(s): Detection of sufentanil concentration
Intervention type(s): Other
Intervention description(s): Concentration of sufentanil in human breast milk was determined by LC-MS /MS method
The volume of human breast milk was detected at each fixed time point
Intervention MeSH terms: Sufentanil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no
      role in management of oral lichen planus
    

Detailed description: 
      Lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been
      shown to affect 0.5% to 2.2% of various populations. The treatment options for OLP are
      numerous and include topical and systemic agents. Steroids were found effective in management
      of OLP with contraindicated use in some systemic diseases and with multiple side effects with
      its prolonged use. Pomegranates have been known for hundreds of years for their multiple
      health benefits, including anti-inflammatory activity. The recent surge indicates that
      pomegranates and their extracts may serve as natural alternatives to drugs which can offer a
      possible management of OLP decreasing pain and discomfort associated with this chronic
      condition.The aim of this study was the evaluation of the effect of topical pomegranate
      extracts in management of oral lichen planus lesions (OLP).
    

Intervention name(s): Topical pomegranate seeds and peel extracts
Intervention type(s): Drug
Intervention description(s): Topical pomegranate seeds and peel extracts in the form of gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pomegranate, seeds, peel, topical, Oral lichen planus, pain, OHIP-14.
Antioxidation Medication for Noise-induced Hearing Loss
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Noise-Induced
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine whether oral intake of 1200mg N-Acetylcysteine/day will prevent
      temporary threshold shift in hearing among workers exposed to noise
    

Detailed description: 
      Both genetic and environmental factors contribute to noise-induced hearing loss (NIHL). The
      cellular antioxidant system appears to protect cochlear hair cells from oxidative stress due
      to noise. Previous animal studies showed protective effects of anti-oxidant medicines against
      NIHL.The objective of this study is to test the hypothesis that preventive medication of
      antioxidation is related to susceptibility to NIHL.

      The 53 noise-exposed workers from steel industries in Taiwan will be recruited, and divided
      into N-Acetylcysteine (NAC)(Acetine, 1200mg/day) group and placebo one. The duration of
      medication is 2 weeks initially. After washout for 2 weeks, the kinds of medications in these
      2 groups will be crossover and used for 2 weeks. Firstly, questionnaires interview about
      noise exposure, smoking, alcohol drinking, drug habit history and calculation of Body Mass
      Index (BMI) will be done. The following methods would be performed individually after
      medication. With detailed local examination with otoscope, these subjects receive hearing
      tests by pure-tone audiometry (PTA) and distortion product otoacoustic emissions (DPOAE)
      before and after their daily works. The possible confounding factors including background
      noise, solvent, heavy metals, carbon monoxide and temperature in the workplaces will be
      assessed. The amount of noise exposure is evaluated by personal dosimeter. Early morning,
      Blood samples will be collected. Deletion polymorphisms in the Glutathione S-transferase
      (GST)T1 and GSTM1 genes will be determined. Statistical analysis will be performed to
      evaluate the relation between intake of anti-oxidant medicine and noise-induced temporal
      threshold shift (TTS).

      The expected results of this study are to determine whether anti-oxidant supplements protect
      workers from noise-induced TTS.

      We anticipate that these human studies might help elucidate the relative importance of
      anti-oxidant enzymes as risk factors for NIHL.
    

Intervention name(s): N-acetylcysteine (NAC); glucose
Intervention type(s): Drug; Drug
Intervention description(s): 600mg twice daily for 2 weeks; 1 gm glucose capsule
Other intervention name(s): acetin (600mg); Sugar
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: noise; hearing loss; temporary threshold shift
A Study of Bumetanide for the Treatment of Autism Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators are going to carry out a randomized double-blind placebo-controlled trial
      to study the efficiency and mechanism of bumetanide on the treatment of children with Autism
      Spectrum Disorder.
    

Detailed description: 
      In consideration of the increasing number of autistic children and poor intervention effect
      in China, it is an urgent to find some effective medicine. Some studies have reported
      bumetanide, a classic diuretic, could improve autistic behaviors in both animal model and
      humans; while the efficiency of bumetanide on Chinese autistic chilren is unkonwn and the
      underlying mechanisms remain unfolding. The investigators aim at investigating whether
      bumetanide would improve the clinical symptoms in Chinese children with autism within a safe
      dosage and further study the physiological mechanism beneath.The investigators will regularly
      assess the participants' autism-related symptoms during medication, as well as the adverse
      effects of each patient. The investigators will carry out genome-wide association analysis
      (GWAS) from blood sample, related metabolites in nervous system and compare the concentration
      of the neurotransmitter in autistic brain before and after 3 months' treatmeat,and also will
      collect the EEG signal in autistic chilldren when the participants performing certain tasks
      before and after 3 months' treatment.
    

Intervention name(s): Bumetanide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): bumetanide tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm; placebo tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm
Intervention MeSH terms: Bumetanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Physical Exercise and Depressive Symptoms in Moderately or Severely Depressed Adults
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study is a comparative trial comparing the time course of depressive symptoms between
      moderately and severely depressed participants over a 10-week long exercise program
    

Detailed description: 
      Sixty depressed French adults (34 with symptoms of moderate intensity and 26 with symptoms of
      severe intensity as defined by the PHQ-9 cutting scores) voluntarily participated in our
      comparative trial.

      A control group (waiting list) of n = 16 including 8 severely depressed and 8 moderately
      depressed participants received no physical exercise.

      For the remaining 44 participants (26 with moderate-intensity depressive symptoms and 18 with
      high-intensity depressive symptoms), two weekly Nordic Walking sessions of 1h were performed
      for 10 consecutive weeks.

      Depressive symptoms were assessed using standard self-report questionnaires at various time
      points: 1/ enrollment (using the PHQ-9), and then (2) just before the beginning of the
      exercise intervention (pre-intervention; using the BDI-II), 2/ at the end of Week 5
      (mid-intervention; using the BDI-II), and 3/ the day following the end of the exercise
      program (post-intervention)
    

Intervention name(s): Nordic Walking
Intervention type(s): Behavioral
Intervention description(s): Nordic Walking (NW) is an aerobic physical activity where regular walking is enhanced by the addition of the active use of specifically designed NW poles. The physical strain is distributed in a balanced way to various muscle groups of the whole body.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open randomized controlled trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: add-on treatment
Study of the Safety of QRH-882260 Heptapeptide
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of orally administered QRH-882260, a
      topically administered Cy5-labeled heptapeptide specific for epithelial growth factor
      receptor (EGFR).
    

Detailed description: 
      This is a Phase IA study of the safety of an orally administered QRH-882260 heptapeptide for
      detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans.
      The investigators intend to enroll 10 evaluable subjects. The investigators expect to be able
      to enroll about 1-2 subjects per week, so the study should take about 1-2 months to complete.

      Interested, healthy subjects ages 25-100 who respond to recruitment advertising and appear to
      be eligible based on a screening questionnaire will be scheduled for a study visit at MCRU.
      At the study visit, the subjects will review and sign the informed consent and eligibility
      will be confirmed. If eligible, subjects will provide a blood sample for clinical labs and a
      urine sample for urinalysis. A baseline EKG will be recorded. A negative urine pregnancy test
      for women of child-bearing potential is required to be eligible. Eligible subjects will
      consume the reconstituted QRH-882260 heptapeptide. After 5 minutes, subjects will drink a
      minimum 4-8 ounces of tap water. Subjects will remain in MCRU for observation for 30 minutes.
      Vital signs and an EKG will be recorded after 30 minutes. Subjects are required to have
      repeat blood draw for clinical labs and urinalysis within 24 to 48 hours after QRH-882260
      heptapeptide ingestion. The study team will conduct a follow up phone call to verbally assess
      toxicity after post-ingestion labs (within 7 days).
    

Intervention name(s): QRH-882260
Intervention type(s): Drug
Intervention description(s): The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation of the QuantiFERON-TB Test.
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

Summary: 
      To compare the results of the investigational test to the currently approved QuantiFERON-TB
      Gold In-Tube test.
    

Detailed description: 
      To compare the sensitivity of the CST001 assay to the QuantiFERON-TB Gold assay in patients
      with bacteriologically confirmed and untreated TB disease.
    

Intervention name(s): CST001
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with bacteriologically confirmed and untreated TB disease.
      
Keywords: Tuberculosis; TB
Celiac Disease Prevention With Probiotics
Condition: Celiac Disease in Children
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      Background/Aim: Celiac disease is a common immune-mediated disorder, and the only currently
      available treatment is a gluten-free diet. Recent studies have shown several probiotics to
      carry properties that might positively influence the immunological activity in celiac
      patients.

      The aim of the present study is to investigate how daily consumption of probiotics would
      affect levels of tissue transglutaminase autoantibodies (tTGA), markers of celiac disease
      autoimmunity in the periphery, as compared to placebo in children at genetic risk for celiac
      disease.

      Methods: Between 2012 and 2015, 90 children were recruited from two ongoing prospective
      celiac disease screening studies at the Skåne University Hospital, Sweden. Participants were
      randomized to either daily consumption of 2 lactobacilli strains or placebo for the duration
      of 6 months.

      Blood samples were drawn at 0, 3 and 6 months and analyzed for both IgA-tTGA and IgG-tTGA
      using radioligand binding assays.
    


Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Can 3D Kinematic Parameters Assess the Symptomatic and Functional Severity of KOA?
Condition: Osteoarthritis,Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      There is little study focusing on kinematic parameters in the assessment of the symptomatic
      and functional severity of knee osteoarthritis (KOA). The purpose of this study is to
      evaluate the correlations between kinematic parameters and the severity of symptoms and
      functions in patients with KOA.
    


Intervention name(s): Observational procedure
Intervention type(s): Procedure
Intervention description(s): All the patients will undergo a standard observational procedure: i) diagnosed with KOA; ii) take a radiographic examination (x-ray); iii) assessed by WOMAC; iv) take an physical examination to avoid other disease; iv) take a gait examination on a treadmill in barefoot.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All the patients diagnosed with KOA will be recruited via hospital advertisements in this
        study.
      
Keywords: Osteoarthritis, Knee; WOMAC; gait; kinematics