bioihbjkbjnl/mcl2 huggingface dataset:
Salvage Therapy With Bevacizumab Plus Docetaxel and Cisplatin for Taiwanese Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Bevacizumab is a monoclonal antibody currently used for the treatment of colorectal cancer.
      It works by preventing the formation of new blood vessels (angiogenesis). The drug has been
      shown to inhibit vascular endothelial growth factor (VEGF) activity. Previous research showed
      positive findings in other solid tumors that had metastasized. In this study, the
      investigators are investigating the response of adding bevacizumab to conventional
      chemotherapy for metastatic breast cancer patients.
    

Detailed description: 
      Targeted chemotherapy has gradually become the mainstay of cancer treatment in present day.
      Targeted medications such as trastuzumab, bevacizumab and lapatinib have recently been more
      extensively adopted for many cancers, particularly breast cancer. Among these targeted
      medications, bevacizumab is a monoclonal antibody acting on vascular endothelial growth
      factor receptor and it works by preventing the formation of new blood vessels (angiogenesis).
      Published articles indicated that monotherapy of bevacizumab on breast cancer showed only a
      9-17% response rate, while combining with paclitaxel, the treatment outcome appeared to
      improve progression-free survival and the objective response rate. We are curious about the
      additive effect of bevacizumab on conventional chemotherapy, the toxicities induced when
      combined target therapy with conventional chemotherapy and the duration of remission that
      these treatment could achieve. In this study, we utilized bevacizumab, docetaxel plus
      cisplatin for metastatic breast cancer patients and furthermore, we are evaluated the
      treatment response, toxicities and duration of remission as our main goals.
    

Intervention name(s): Bevacizumab, docetaxel, cisplatin
Intervention type(s): Drug
Intervention description(s): Bevacizumab 8 mg/kg(over 60 minutes) on first day of first cycle, followed by 5 mg/kg on first day of the rest cycles, repeat every 2 weeks.
docetaxel 45 mg/m2(over 60 minutes) on day 1 of each cycle, repeat every 2 weeks.
cisplatin 50 mg/m2(over 4 hours) on day 1 of each cycle, repeat every 2 weeks.
Other intervention name(s): bevacizumab: avastin; docetaxel: taxotere
Intervention MeSH terms: Bevacizumab; Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bevacizumab; metastatic breast cancer; docetaxel
PRC-063 in Adolescent ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to
      evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD.
    

Detailed description: 
      This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group,
      forced-dose titration in which adolescent subjects (12 to 17 years of age inclusive) with
      ADHD will be randomized to PRC-063 (25, 45, 70 or 85 mg) or placebo for four weeks of
      double-blind evaluation of safety and efficacy. The study will have four phases: (1)
      screening and 1-week washout; (2)baseline and double-blind, forced-dose titration over a
      2-week period; (3) double-blind evaluation over a 2-week period; and (4) a 14-day safety
      follow-up. Subjects will be required to visit the site 6 times over a 5 week period.

      Screening and Washout: Subjects will be screened to establish eligibility for study
      participation. Subjects who meet eligibility requirements will undergo ADHD medication
      washout, if applicable.
    

Intervention name(s): Placebo; PRC-063 25 mg; PRC-063 45 mg; PRC-063 70 mg; PRC-063 85 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral placebo capsule; Oral 25 mg capsule - active; Oral 45 mg capsule - active; Oral 70 mg capsule - active; Oral 85 mg capsule - active
Other intervention name(s): Placebo capsule; 25 mg capsule; 45 mg capsule; 70 mg capsule; 85 mg capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open Membrane Technique as an Innovative Minimally Invasive Technique
Condition: Bone Graft; Keratinized Tissue
Study type: Interventional

Summary: 
      Sixteen patients with horizontal deficiencies in the posterior mandible were treated with
      "the Open Membrane Technique" (OMT). Dense PTFE membranes covering an allograft biomaterial
      were used without any attempt to passivate the flap. Flap closure with an open wound
      (membrane exposure) was monitored weekly for up to 6w at the time of membrane removal. At
      implant placement, soft and hard tissue gains were assessed clinically and radiographically.
      Bone cores were harvested for histological analysis from the implant preparation sites
    


Intervention name(s): Bone augmentation
Intervention type(s): Procedure
Intervention description(s): Dense PTFE membranes covering an allograft biomaterial were used without any attempt to passivate the flap
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
Condition: Lennox-Gastaut Syndrome
MeSH terms: Lennox Gastaut Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the safety of long term administration of E2080 in the patients with
      Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.
    


Intervention name(s): Rufinamide
Intervention type(s): Drug
Intervention description(s): The target dosage is approximately 45 mg/kg/day, taken orally twice a day.
Other intervention name(s): E2080, BANZEL
Intervention MeSH terms: Rufinamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Seizures
Effects of Shenkang Decoction on Creatinine and Blood Urea Nitrogen in Chronic Renal Failure Hemodialysis Patients
Condition: Chronic Renal Failure; Hemodialysis
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To explore the clinical effect of Shenkang Decoction in chronic renal failure (CRF) patients
      with hemodialysis (HD).
    


Intervention name(s): Shenkang decoction
Intervention type(s): Drug
Intervention description(s): Given Shenkang decoction on the basis of the above treatment. Shenkang decoction prescription: 15 g of semen cuscutae, herba epimedii and pericarpium arecae. 20 g of Eucommia ulmoides Oliv., radix astragali, codonopsis pilosula, salvia miltiorrhiza, tuckahoe, atractylodes macrocephala, Chinese yam, honeysuckle, polyporus umbellatus and dandelion. 15 g of safflower. 12 g of processed Fuzi. 10 g of Radix phytolaccae and sage. Golden cherry son 20 g and puzzle kernel 15 g were added to patients with frequent proteinuria and nocturia took. Yellow cypress 15 g was added to patients with damp-heat in lower-Jiao. The decoction pieces were purchased from the Traditional Chinese Medicine and Pharmacy Department of the First People's Hospital of Zunyi City. They were decocted by computer automatic decocting machine (model) and divided into 150 mL / bag, taken orally, once in the morning, noon and evening, 3 times / day, 1 bag / time, one pair a day. Treatment lasted for 10 - 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Beneficial Effects of Lactobacillus Reuteri DSM 17938 Supplementation on Asthmatic Children
Condition: Airways Allergic Inflammation of Asthmatic Children
MeSH terms: Asthma; Inflammation
Study type: Interventional

Summary: 
      Objective The aim of the trial is to evaluate the beneficial effects of the oral
      administration of the probiotic L. Reuteri (Reuterin®) on the airways allergic inflammation
      in children with mild to moderate persistent asthma.

      Study design This is a randomized, double-blind, placebo controller trial. 50 children will
      be enrolled (age range 6-14 years), affected by mild to moderate persistent asthma based on
      the GINA Guidelines and allergic to acarus (Dermatophagoides farinae and D. pteronyssinus
      ++/+++). At the enrollment period all children have to show asthmatic symptoms and to be
      under antileukotrienes treatment (Montelukast 5mg/die) based on the GINA Guidelines. Any
      inhaling corticosteroids therapies have to be stopped 8 weeks before the trial beginning.

      Patients will be randomly divided into 2 treatment groups:

      Group A: 25 patients will take antileukotrienes + L. reuteri drops (108 CFU = 5 drops daily).

      Group B: 25 patients will take antileukotrienes + placebo. At the enrollment period (T0),
      after the 1st and the 2nd month of supplementation (T1 and T2), and also 1 month after the
      supplementation end (T3), all patients will be clinically evaluated through spirometry, FeNO
      determination and exhale condensate analysis.

      During the entire trial period the number of asthmatic exacerbations and the use of beta-2
      antagonists will be monitored by a diary properly examined at T1, T2 and T3.

      All children will be enrolled at the Asthma and Infant Respiratory Physiopathology unit
      "Michele Miraglia del Giudice" of the "F. Fede" Pediatric Department.

      The analysis of the inflammatory markers on the exhaled condensate will be performer at T1,
      T2 and T3 in the Pharmacology unit of the Experimental Medicine Department.

      During the trial it will be possible to administer only salbutamole MDI if it needed. If
      patients will be administered with any systemic corticosteroids they will exit from the
      trial.

      At the enrolment period all patients will receive the completed information on the trial and
      the informed consent will be properly signed.
    


Intervention name(s): Antileukotrienes + Lactobacillus reuteri; Antileukotrienes + Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Montelukast (5mg/die) + 1000000000 CFU per day (5 drops) for 2 months; Montelukast (5mg/die) + 5 drops of placebo daily for 2 months
Intervention MeSH terms: Leukotriene Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthmatic children
Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study
Condition: Hoarseness
MeSH terms: Hoarseness; Dysphonia
Study type: Observational [Patient Registry]

Summary: 
      Early diagnosis and appropriate treatment of hoarseness is known to improve quality of life
      and treatment outcomes. Therefore, appropriate research on the incidence of hoarseness after
      surgery is necessary. In this study, investigator aim to investigate incidence of hoarseness
      after spine surgery and the correlation between the Voice Handicap Index (VHI)-10, used as a
      criterion, and acoustic parameters, while also validating the efficacy of our research
      methods.
    

Detailed description: 
      The primary outcome of this study is the incidence of hoarseness on the day of surgery.

      The secondary outcomes include the incidence of hoarseness at one month after surgery, as
      well as examining the correlation between acoustic parameters, risk factors, and the
      occurrence of hoarseness.

      Investigator conducted a comparative analysis of risk factor for hoarseness in patients with
      different VHI-10 scores on the day of surgery and 30 days after surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Age range is 20 to 80 years old. Patients who require surgical treatment for degenerative
        spine conditions and visit at Seoul National University Hospital. Patients who voluntarily
        consent to participate in the study
      
Keywords: hoarseness; spine surgery
DNA Chip Based Prognosis of Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      The purpose of the study is to determine whether a DNA chip, designed by Medical Prognosis
      Institute (MPI), can provide an accurate prognosis for survival of NSCLC (adeno-, squamous
      and large cell lung cancer).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population consist of subjects being examined for NSCLC at Roswell Park Cancer
        Institute (US), University of Alabama (US), Copenhagen University (DK), Odense University
        Hospital (DK) and Aarhus University Hospital (DK)
      
Biospecimen description: 
      post resection specimen
    
Keywords: NSCLC
ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the activity of the combination ZD1839,
      docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by
      estimating the objective response rate (complete response [CR] and partial response [PR]) at
      study closure.
    


Intervention name(s): ZD1839 (IRESSA™); Docetaxel; Cisplatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Docetaxel; Gefitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and Neck Neoplasms; Cancer of Head and Neck; Head and Neck Cancer; Head Cancer; Neck Cancer
Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions
Condition: Refractive Errors
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      At the Aravind Eye Hospital (AEH) in Madurai, India, patients ages 18-40 receiving treatment
      for refractive error who choose to enroll in the study will be evaluated using subjective
      refraction and objective refraction, by way of the QuickSee autorefractor. Patients will then
      be randomized into one of two treatment plans: receive glasses from objective measure first
      then subjective measure second, and vice versa. After one week of wearing the first pair of
      glasses, patient preferences are assessed, and glasses are switched. After a week of wearing
      the second pair of glasses from the alternate measurement method, patient preferences are
      again assessed. Patients may then decide which pair patient like best. This is a double
      blind, case-crossover clinical trial.
    


Intervention name(s): QuickSee refractive error assessment + glasses
Intervention type(s): Other
Intervention description(s): QuickSee refractive error assessment + glasses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Short Term Growth in Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Main objective:to assess short term growth in children with atopic dermatitis during
      treatment with tacrolimus 0.1% and mometasone furoate 0.1%. A singl blind randomised cross
      over trial including 20 children. The study consists of 5 periods: run in, treatment(1),wash
      out, treatment(2) and run out. Each period 14 days where the children will use tacrolimus
      ointment tvice daily, mometasone furoate once daily or moisturizer (in run in wash out and
      run out)
    


Intervention name(s): tacrolimus ointment 0.1%; mometasone furoate 0.1%
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mometasone Furoate; Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin
Condition: Skin and Connective Tissue Diseases
MeSH terms: Connective Tissue Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Bovine Lung Surfactant is used as standard therapy for reducing alveolar surface tension in
      preterm infants. Here the drug is administered via airways.

      The use on skin to stimulate the wound healing has not yet been tested in humans, i.e. it is
      not yet approved for the treatment of wound healing disorders. In the planned clinical trial
      Lung Surfactant is used the first time for the local treatment of skin lesions in humans. No
      substance related side effects were observed during the application via airways in neonates.

      The innovative idea to use lung surfactant for skin wound healing derived from two
      observations. First, when the skin is injured, the barrier protecting the moist body surface
      from the dry environment is discontinued and in part lost.

      Lung surfactant has several characteristics that might be beneficial for treatment of chronic
      cutaneous wounds.
    


Intervention name(s): Surfactants; Saline Solution
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pulmonary Surfactants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wound healing; Bovine Lung Surfactant; SATOSU
Muscle Analyze In Patient With Disc Herniation
Condition: Disk Herniated Lumbar
MeSH terms: Intervertebral Disc Displacement
Study type: Observational

Summary: 
      This study which was planned to investigate the factors affecting m. erector spinae (ES), m.
      multifidus (MF), m. psoas major (PM) and m. quadratus lumborum (QL), which stabilize the
      lumbar region in the case of disc herniation. In this study, the effects of disc herniation,
      herniation severity, age, and spinal biomechanics were investigated.
    

Detailed description: 
      This study was carried out on 330 individuals with and without lumbar disc herniation. All
      individuals were divided into 3 groups according to their age. The inclusion criteria: Having
      only disc degeneration and not having any other neurological or orthopedic disease. Patients
      who had previous spinal surgery, patients with lumbar scoliosis, spondylolisthesis or
      structural defect in the sacrum were excluded from the study.
    

Intervention name(s): Magnetic Resonance Imaging
Intervention type(s): Diagnostic Test
Intervention description(s): Muscle analysis by Magnetic Resonance Imaging
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients without disc herniation, severe disc degeneration and spondylolisthesis were also
        withdrawn from the System and included in the control group. 80 individuals with aged
        between 20-70 years included control group.
Validation of 70-gene MammaPrint Profile in Japanese Population
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      By using gene-expression profiling, Van't Veer and colleagues developed a 70-gene prognosis
      profile, MammaPrint, to identify breast cancer patients who are at low risk of developing
      distant metastases and therefore might safely be spared chemotherapy. The aim of this study
      is to evaluate the prognostic value of the 70-gene Mammaprint profile in Japanese women with
      node-negative breast cancer.
    

Detailed description: 
      Frozen tumor samples from 140 node-negative, breast cancer patients aged between 29 and 70
      years at diagnosis are hybridized on MammaPrint array. Patients were treated with breast
      conserving therapy or mastectomy with axillary lymph node dissection between December 1998
      and August 2001 at Osaka Medical Center for Cancer and Cardiovascular Diseases. Samples are
      evaluated by gene expression profiling for the 70-gene MammaPrint profile and classified as
      genomic high risk or genomic low risk.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Breast cancer patients, node-negative, treated with breast conserving therapy or mastectomy
        with axilary lymph node dissection at Osaka Medical Center for Cancer and Cardiovascular
        Diseases.
      
Keywords: microarray; gene expression profiling; MammaPrint; breast cancer
A Phase I Study of Epitinib(HMPL-813) in Patients With Advanced Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Epitinib (HMPL-813) is a selective EGFR tyrosine kinase inhibitor. Epitinib has demonstrated
      strong inhibitory effects on multiple tumors with overexpressed EGFR or sensitive EGFR
      mutations in pre-clinical setting. This first-in-human study is conducted to assess the
      maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), safety and tolerability,
      pharmacokinetics (PK), and preliminary anti-tumor activity of Epitinib.
    


Intervention name(s): Epitinib
Intervention type(s): Drug
Intervention description(s): The starting daily dose is 20 mg. Dose escalation will follow daily dose of 40 mg,80 mg, 120 mg, 160 mg, 200 mg, and 250 mg. A 3+3 design applies to this study. Patients will continue taking Epitinib until they experience intolerable adverse events or their diseases are confirmed to be progressed.
Other intervention name(s): HMPL-813
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety, PK