bioihbjkbjnl/mcl2 huggingface dataset:
Study of Dose-dense Adriamycin Plus Cytoxan (AC) Followed by Either ABI-007 (Abraxane) or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to compare the safety of dose-dense ABI-007
      (Abraxane) 260 mg/m^2 or Taxol 175 mg/m^2 given every 2 weeks following dose-dense Adriamycin
      plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks
      throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.
    


Intervention name(s): Adriamycin and Cytoxan (AC); ABI-007; Taxol; Bevacizumab; pegfilgrastim
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide) make up the chemotherapy regimen known as AC. Adriamycin 60 mg/m^2 intravenous, plus Cytoxan 600 mg/m^2 intravenous on Day 1 of each of four 2-week cycles (weeks 1-8).; 260 mg/m^2 IV on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16); 175 mg/m^2 intravenously (IV) on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16); 10 mg/kg on day 1 of each of eight 2-week cycles (weeks 9-16), then 15 mg/kg on day 1 of each of ten three-week cycles (weeks 17-46).; 6 mg subcutaneous (SC) on day 2 for each of the first four 2-week cycles (weeks 1-8). Pegfilgrastim 6 mg SC was administered on day 2 of cycles 6-8 (weeks 11-16) during taxane treatment only if necessary.
Other intervention name(s): doxorubicin; cyclophosphamide; Abraxane; paclitaxel; Avastin®; Neulasta
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Bevacizumab; Doxorubicin; Liposomal doxorubicin; Albumin-Bound Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adjuvant therapy; Bevacizumab; Abraxane; Early stage breast cancer
Longitudinal Study of Cell Free DNA in Lung Transplant
Condition: Lung Transplant Rejection
Study type: Observational

Summary: 
      Lung transplant is a viable treatment strategy for many with end-stage lung diseases. Despite
      advances in both the surgical and medical management, lung transplant recipients experience
      episodes of allograft insult and injury that lead to dysfunction and ultimately contribute to
      graft failure. The primary noninvasive tool for monitoring the lung allograft, pulmonary
      function testing, is neither sensitive nor specific for lung allograft injury which makes the
      management of lung transplant recipients particularly challenging. A decline in pulmonary
      function tests prompts invasive procedures such as bronchoscopy with transbronchial lung
      biopsy to diagnose the cause of allograft injury, although this, too, is not 100% sensitive,
      and oftentimes patients are treated empirically for rejection when no other etiology for lung
      function decline is identified. Empiric treatment prompted by extrapulmonary drivers of
      decline in lung function may result in inappropriate exposure to risks of augmented
      immunosuppression. The purpose of this study is to determine to what extent monitoring of
      donor-derived cell free DNA in lung transplant recipients can be used as a marker of lung
      injury and stability.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with end stage lung disease who are placed on the lung transplant waitlist
        for consideration of a bilateral transplant at the University of Colorado lung transplant
        program will be recruited for participation in the study.
Surgical Treatment of Gingival Recessions
Condition: Clinical Trial; Connective Tissue; Gingival Recession; Microsurgery
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The purpose of this study was to compare the effectiveness of microsurgical and macrosurgical
      approaches on CPFs plus SCTGs for the treatment of localized gingival recession defects
      (Miller class I or II) over the course of 6 months based on clinical periodontal parameters,
      periodontal phenotypes, and the postoperative complaints and satisfaction levels of the
      patients. We hypothesized that root coverage achieved through microsurgery in Miller I or II
      gingival recessions would improve clinical periodontal outcomes and the periodontal
      phenotype, with greater postoperative comfort and aesthetic satisfaction in comparison with
      conventional macrosurgical techniques. Miller Class I and II gingival recession defects, at
      least 3.0 mm deep, were selected and randomly assigned to receive micro or macrosurgical
      techniques. Both techniques were performed using a coronally positioned flap with a
      subepithelial connective tissue graft. Plaque and gingival indices, gingival recession depth
      and width, probing pocket depth, bleeding on probing, clinical attachment level, width of
      keratinized gingiva, aesthetic score and percentage of root coverage, postoperative
      complaints, and satisfaction of the participants completing the study were evaluated at
      follow-up 1st, 3rd and 6th months.
    


Intervention name(s): surgical techniques in the treatment of localized gingival recession defects.
Intervention type(s): Procedure
Intervention description(s): Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
SP2086 Pharmacokinetic Study in Renal Insufficiency Patients
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency
      Patients.
    

Detailed description: 
      This trial adopt in a parallel, open, single dose study design. The subject was divided into
      one of five groups according to the degree of renal Insufficiency, which including normal,
      mild, moderate, severe, and end-stage. All subjects were given SP2086 50mg, and collected the
      blood samples before and after the medicine taken.
    

Intervention name(s): SP2086
Intervention type(s): Drug
Intervention description(s): all subjects were given SP2086 50mg only one time.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SP2086; Renal Insufficiency; Pharmacokinetic
Specific Oral Tolerance Induction to Cow's Milk Allergy
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Milk Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be a
      potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that
      SOTI should be started early in order to improve its efficacy and prevent CMPs sensitization
      from evolving towards persistent allergy. The aim of this study was to evaluate the safety
      and efficacy of SOTI in 2-year-old children with cow's milk allergy, as a treatment
      alternative to elimination diet.

      Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to CMPs
      were included in this multicenter study and were randomly divided into two different groups.
      Thirty children (group A: treatment group) began SOTI immediately, whereas the remaining 30
      (group B: control group) were kept on a milk-free diet and followed-up on for one year.
    


Intervention name(s): Cow's milk
Intervention type(s): Other
Keywords: Cow's milk allergy; food allergy; oral desensitization; randomized trial; specific oral tolerance induction.
Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two parts study, a single ascending dose followed by 14-days repeat dosing. The
      single ascending dose part will assess two dose levels of GSK3923868 or placebo across two
      treatment periods 1 and 2 in a single cohort of participants with a washout period of a
      minimum of 5 days after each treatment periods. The repeat dose part will assess repeated one
      dose level of GSK3923868 or placebo in treatment period 3 with up to 14 days of follow up in
      the same cohort of participants. The duration of study participation for treatment period 1,
      2 and 3 will be 6, 6 and up to 29 days (including follow up), respectively.
    


Intervention name(s): GSK3923868; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK3923868 will be administered; Placebo will be administered
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The same cohort of participants will move from Part 1 (single ascending doses treatment periods 1 and 2) to Part 2 (repeat dose treatment period 3)
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Single ascending dose; Repeat dose; Phosphatidylinositol 4-kinase beta (PI4KB) inhibitor; Chronic Obstructive Pulmonary Disease (COPD)
Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058)
Condition: Varicella
MeSH terms: Chickenpox
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the immunogenicity and safety of VARIVAX™ vaccine
      in healthy Russian children, adolescents, and adults. No formal hypothesis was tested.
    


Intervention name(s): VARIVAX™
Intervention type(s): Biological
Intervention description(s): VARIVAX™ administered by SC injection as 0.5 mL Varicella Virus Vaccine Live in sterile suspension on Day 1 (all participants) and Day 43 (adult and adolescent participants).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
First Study in Humans With GSK424887
Condition: Depressive Disorder and Anxiety Disorders
MeSH terms: Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the
      drug has on human health (safety and tolerability) and the amount of drug which gets into the
      bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to
      investigate the penetration of the drug in the human brain by using PET (Positron Emission
      Tomography) imaging technology
    


Intervention name(s): GSK424887; Placebo; PET
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): GSK424887 2mg, 10mg, 50mg, 100mg capsule; Placebo to match GSK424887 2mg, 10mg,50mg, 100mg capsule; Each subject will undergo 3 PET scans : one at Baseline and the others following dosing with GSK424887 at approximately 2h post-dose and aproximately 24 hours post-dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: NK1 antagonist and SSRI; Healthy subjects; Safety; First time in Human
Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Abraxane in patients with visceral metastases dominant metastatic breast cancer
    

Detailed description: 
      A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in patients with
      visceral metastases dominant metastatic breast cancer
    

Intervention name(s): Abraxane
Intervention type(s): Drug
Intervention description(s): 125 mg/m2, D1, D8, D15
Intervention MeSH terms: Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque Test
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to evaluate the safety of topical BOS-475 compared to topically
      applied comparator formulations and vehicle.
    

Detailed description: 
      This is a three-center, randomized, placebo- and comparator-controlled, double-blind for the
      Investigational Medicinal Products (IMPs), observer-blind for the controls, intraindividual
      comparison of all 6 treatments.
    

Intervention name(s): BOS-475; Active ingredient-free vehicle cream; Daivonex cream (calcipotriol 0.005%); Betnesol-V cream (betamethasone 0.1%)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): topical cream; topical cream; topical cream; topical cream
Intervention MeSH terms: Betamethasone; Calcipotriene; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BOS-475; antipsoriatic efficacy; safety; psoriasis plaque test
Neuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus
Condition: Gait, Unsteady; Aerobic Exercise
MeSH terms: Gait Disorders, Neurologic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of high intensity interval exercise and
      moderate intensity continuous exercise on basic gait parameters in patients with type 2
      diabetes mellitus.
    

Detailed description: 
      Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication
      that will restrain them from making exercise. 90 male or female volunteers who are suitable
      in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be
      randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1.
      group will make aerobic exercise which is in the form of high intensity interval exercise
      2.group will make aerobic exercise which is in the form of moderate intensity continuous
      exercise 3. Control group. Exercise groups will be cycling under observation in the hospital
      setting. Control group will make simple stretching exercises at home. Participants will be
      requested to complete a 3 months of exercise. They will be evaluated before and at the end of
      the 3 months of exercise with basic gait parameters such as cadence, gait speed, stride
      length, percentages of swing phase and stance phase evaluated by a wireless digital miniature
      gait analysis system.
    

Intervention name(s): Aerobic Exercise
Intervention type(s): Other
Intervention description(s): Participants will be making aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study has 3 arms.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Type 2 diabetes mellitus; exercise; aerobic; interval; continuous; gait
Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional

Summary: 
      40 allergic rhinitis patients in the acute phase will be enrolled in the study. All the
      allergic patients should be confirmed those who are over 20 years old and hypersensitive to
      house dust mite allergens confirmed by MAST test before study. All patients were treated with
      mixed formula of Chinese medicine for one months.
    

Detailed description: 
      Perennial allergic rhinitis is an important disease in traditional Chinese medicine (TCM) due
      to its high prevalence rate in Taiwan. In our previous studies, a new mixed formula of
      Chinese herbs was evaluated for the treatment of allergic rhinitis. In these studies, we
      found that immunoduoatory effects of Chinese medicine include: CD4+ T lymphocytes; Regulatory
      T cells; Dendritic cells, and Regulatory B cells. These results allow us to confirm the
      immunomodulatory effects of mixed formula of traditional Chinese medicine. In recent years,
      more and more attention has been paid to the effects of gut microbiota on immune-modulation.
      Many immunomodulaotry effects of allergic diseases were considered to be closely related to
      gut bacteria. However, the research on allergic rhinitis is still rare, especially related to
      TCM treatment. From our previous studies, it has been confirmed that TCM have an
      immunomodulatory effect on allergic rhinitis. Whether or not they are associated with gut
      microbiota changes is still unknown. This year, we compared the difference of composition and
      diversity of gut microbiota of allergic rhinitis patients and normal individual. Indeed, we
      found it were different between allergic patients and normal individuals. The results of this
      study will provide us the information to understand whether the immunemodulation of TCM
      treatment on allergic rhinitis is correlated with the changes of gut microbiota.
    

Intervention name(s): Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day
Intervention type(s): Drug
Intervention description(s): All patients were treated with mixed formula of Chinese medicine for one month
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Perennial allergic rhinitis; Gut microbiota; Mixe formula of Chinese medicine
Chemoembolization With or Without Mixing the Chemotherapy With Lipiodol for Unresectable HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

Summary: 
      TACE is considered the standard treatment for unresectable HCC on the basis of the fact that
      there are no alternative to curative procedures.But the optimal combined regimen is still
      unclear. One of the controversy is do the protocol should contain lipiodo and how to
      executer. The investigators hypothesize that TACE without mixing the chemotherapy with
      lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.
    


Intervention name(s): Embolization; Infusion of anticancer agent; Infusion of mixture of anticancer agent and lipiodol
Intervention type(s): Other; Other; Other
Intervention description(s): embolization with lipiodol and polyvinyl alcohol particles (PVA); infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water; infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water
Intervention MeSH terms: Ethiodized Oil; Antineoplastic Agents
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carcinoma,Hepatocellular; Liver Neoplasms; Therapeutic; Chemoembolization,; TACE; pharmacokinetics; Iodized Oil/administration & dosage; polyvinyl alcohol; Humans
Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Autologous stem cell transplantation may be effective treatment for primary
      systemic (AL) amyloidosis.

      PURPOSE: This phase II trial is studying how well tandem (two) autologous stem cell
      transplantation works in treating patients with primary systemic (AL) amyloidosis.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the tolerability of tandem autologous stem cell transplantation in patients
           with AL amyloidosis.

        -  Determine whether this regimen can convert a hematologic non-complete response (CR) to
           CR in these patients.

        -  Determine the overall survival of patients treated with this regimen.

      OUTLINE:

        -  First transplantation: Patients receive filgrastim (G-CSF) subcutaneously once daily
           beginning 3 days before the initiation of stem cell collection and continuing until the
           day before the completion of stem cell collection. Patients may undergo bone marrow
           harvest if an inadequate number of peripheral blood stem cells are collected.

      Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2. Patients undergo
      autologous stem cell transplantation (ASCT) on day 0.

        -  Second transplantation: Within 6-12 months after the first ASCT, patients not achieving
           a complete response receive high-dose melphalan IV over 20 minutes on days -3 and -2 and
           a second ASCT on day 0.

      Treatment continues in the absence of unacceptable toxicity.

      Patients are followed at 3 and 6 months, 1 year, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 2-3 years.
    

Intervention name(s): filgrastim; melphalan; autologous peripheral blood stem cell transplantation
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): 16 mg/kg/day for 3 days prior to stem cell collection, through day before last collection; 200 mg/kg over 2 days; autologous peripheral blood stem cell transplantation
Other intervention name(s): alkeran
Intervention MeSH terms: Melphalan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary systemic amyloidosis
The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein
      (P-gp) probe drugs as a means of predicting drug-drug interactions.
    


Intervention name(s): midazolam; caffeine; digoxin; warfarin; omeprazole; BI 187004; metoprolol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose of midazolam given as oral solution (day 1 of visits 2 and 3); single dose of caffeine given as tablets (day 1 of visits 2 and 3); single dose of digoxin given as tablets (day 3 of visits 2 and 3); single dose of warfarin given as tablets (day 1 of visits 2 and 3); single dose of omeprazole given as tablet (day 1 of visits 2 and 3); multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3); single dose of metoprolol given as tablets (day 1 of visits 2 and 3)
Intervention MeSH terms: Metoprolol; Digoxin; Midazolam; Caffeine; Omeprazole; Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment