bioihbjkbjnl/mcl2 huggingface dataset:
Sunitinib in Treating Patients With Newly Diagnosed Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before
      surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
      removed.

      PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with
      newly diagnosed stage II or stage IIIA breast cancer that can be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the feasibility of neoadjuvant sunitinib malate in patients with newly
           diagnosed, resectable stage II-IIIA breast cancer.

      Secondary

        -  Determine the nature, severity, and frequency of adverse events in patients treated with
           this drug.

        -  Determine the response rate in patients treated with this drug.

        -  Evaluate markers of angiogenesis (e.g., VEGF receptor, platelet-derived growth factor
           receptor, circulating plasma VEGF, sVEGFR-2, sVEGFR-3, sKIT, and tumor vascularity) both
           pre- and post-treatment.

        -  Examine the role of both host- and tumor-specific genes pertaining to response and
           toxicity.

        -  Compare tumor vascular parameters pre- and post-treatment using DCE-MRI.

        -  Compare cell death and tumor microcirculation pre- and post-treatment using
           contrast-enhanced spectroscopic and microbubble contrast-enhanced ultrasound.

        -  Compare tumor metabolic activity pre- and post-treatment using fludeoxyglucose F 18-PET.

      OUTLINE: This is a multicenter study.

      Patients receive oral sunitinib malate once daily for 14-21 days in the absence of disease
      progression or unacceptable toxicity.

      Tissue samples are obtained by needle biopsy at baseline and once between days 14-21. Blood
      samples are collected at baseline, once between days 14-21, and at 4 weeks post-treatment for
      pharmacodynamic and other studies. Markers of angiogenesis (VEGF receptors, platelet-derived
      growth factor receptor, VEGF, sKIT, and tumor vascularity) are detected by
      immunohistochemistry. DCE-MRI and fludeoxyglucose F 18-PET are conducted for research studies
      at baseline and once between days 14-21.

      After completion of study treatment, patients are followed at 4 weeks.
    

Intervention name(s): sunitinib malate; immunohistochemistry staining method; laboratory biomarker analysis; pharmacological study; needle biopsy; neoadjuvant therapy
Intervention type(s): Drug; Other; Other; Other; Procedure; Procedure
Intervention MeSH terms: Sunitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: male breast cancer; stage II breast cancer; stage IIIA breast cancer
Clinical Trial of Expanded and Activated Autologous NK Cells to Treat Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine wether activated and expanded autologous Natural
      Killer cells (NKAEs) are effective in the treatment of patients with multiple myeloma on
      second or later relapse. NKAEs are used in combination with anti-myeloma drugs such as
      lenalidomide or bortezomib.
    

Detailed description: 
      It is expected to enroll 10 to 15 patients within 18 months. Patients have to achieve stable
      disease after induction therapy. Peripheral blood from patients will be collected every cycle
      (n=4) to produce NKAEs under Good Manufacturing Practice (GMP) conditions peripheral blood
      mononuclear cell (PBMCs) will be co-cultured with a genetically modified cell line
      (K562-mb15-41BBL) and 100 IU/ml interleukin-2.

      Treatment consists of 4 cycles of anti-myeloma consolidation treatment with two infusions of
      NKAEs every day 1 and 8 of each cycle. Usually, chosen treatment regime will be bortezomib
      (Velcade) or lenalidomide (Revlimid). These treatments are used to be combined with
      corticosteroid medications which needs to be suspended before NKAEs infusions. A washout
      period of 2 weeks is required.

      NKAEs dose of cells will be constant, 7.5x106/kg. There will be an interim analysis
      intra-cohort one week after the first batch of two infusions. If at the analysis no grade IV
      adverse effect is observed we will proceed to the second cycle and the inclusion of other
      patients.
    

Intervention name(s): NKAE cells infusion; Lenalidomide; Bortezomib
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.; Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.; Bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.
Other intervention name(s): NKAE infusion; Activated and expanded autologous NK cells infusion; Revlimid; Velcade
Intervention MeSH terms: Lenalidomide; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent multiple myeloma; NK cells; cell therapy; NKAE; Relapsed multiple myeloma
Comparing the ADR With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy
Condition: Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Interval (missed) cancers and lower than expected mortality reduction of proximal colon
      cancers in the United States and elsewhere after screening colonoscopy drew attention to
      quality indicators. Missed adenomas which are more likely to be in the proximal colon may be
      contributing factors. An independent predictor of the risk of interval cancers is adenoma
      detection rate. In pilot observations, the investigators showed that water exchange enhanced
      adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized
      controlled trial will compare water exchange with water immersion and traditional air
      insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that
      compared with air insufflation and water immersion, water exchange produces a significantly
      higher adenoma detection rate in the right colon
    

Detailed description: 
      All of the procedures will be recorded and stored as digital files.
    

Intervention name(s): Air insufflation; water immersion; water exchange
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Insufflation during colonoscopy including insertion phase; Water will infused during insertion phase and removed during withdrawal phase of colonoscopy; Water will infused and removed during insertion phase of colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: adenoma detection rate; colonoscopy; water exchange
Study of Postoperative 3D-CRT/IMRT in Hepatocellular Carcinoma
Condition: Hepatocellular Cancer
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Interventional

Summary: 
      Hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some
      patients can not receive radical resection. Such patients have high risk of recurrence. Tumor
      resection and postoperative radiation is an option for such patients to achieve radical
      treatment and radiation may reduce local recurrence.
    

Detailed description: 
      Patients with risk factors of recurrence receive postoperative radiotherapy using intensive
      modulated radiation therapy (IMRT) or three-dimensional conformal radiation therapy (3DCRT).
      The clinical target volume includes tumor bed. The dose will be 50-60Gy/25-30f. Overall
      survival, local-recurrence free survival, disease free survival and toxicity need be
      observed.
    

Intervention name(s): postoperative radiotherapy
Intervention type(s): Radiation
Intervention description(s): IMRT or 3DCRT, 50-60Gy to the tumor bed
Other intervention name(s): adjuvant radiotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; postoperative radiotherapy
Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation
Condition: Ischemia Reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall purpose of this study is to evaluate the safety, pharmacokinetics and preliminary
      efficacy of a five-days post-operative course of Treprostinil in liver transplant patients.

      The hypothesis of this study is that Treprostinil can be safely administered post-operatively
      in liver transplant patients. Once safety is documented future studies will address its
      ability to ameliorate or prevent reperfusion mediated dysfunction of the liver graft and
      thereby reduce morbidity, leading to shorter hospital stays as compared to historical
      controls.
    

Detailed description: 
      Prostaglandin-class drugs, including prostacyclin and its analogs, could represent an
      important advance toward the goal of reducing transplant related morbidity, mortality and
      associated costs by minimizing the effect of ischemia and re perfusion injury of the liver
      graft. Additionally, the reduction in serum creatinine and reduced need for post operative
      dialysis observed in some studies has implications in protecting the kidneys from the
      nephrotoxic affects of the immunosuppressant agents, especially during the early
      post-operative period. Routine use of prostaglandins (PGE1 and PGI2), however, was limited by
      its instability and short half life.

      Treprostinil, as a prostanoid (prostacyclin analog), is expected to facilitate restoration of
      the blood supply to the revascularized graft and provide the well-characterized protective
      effects of this class of compounds in liver transplant patients. Treprostinil has the
      advantage of a longer elimination half-life than other prostanoids previously tested in these
      patients. Treprostinil is expected to significantly protect the graft from ischemia and re
      perfusion injury.

      This is a pilot study to evaluate the safety, pharmacokinetics and preliminary efficacy of
      Treprostinil in orthotopic liver transplant patients as a first step to evaluate its use in
      prevention of ischemia and reperfusion injury of the grafted liver.
    

Intervention name(s): Treprostinil
Intervention type(s): Drug
Intervention description(s): The Treatment Phase will begin at the initiation of Treprostinil after induction of anesthesia for the transplant surgery and continues throughout the surgery and for approximately a total of 120 hours.
Treatment phase activities include:
• Initiation of Treprostinil after the patient is hemodynamically stable following transplant surgery. (Treprostinil dosing will follow a standard 3 + 3 phase 1 design.
Other intervention name(s): Brand name: REMODULIN
Intervention MeSH terms: Treprostinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liver transplantation; treprostinil
Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block
Condition: Transversus Abdominis Plane Block
Study type: Interventional

Summary: 
      In this study, dexmedetomidine and tramadol were added as adjuvant to bupivacaine in
      transversus abdominis plane block (TAP), intraoperative hemodynamics, opioid consumption,
      muscle relaxant use, postoperative analgesic effects and side effects (such as
      nausea-vomiting) were evaluated.
    

Detailed description: 
      The study was carried out with 60 ASA I-II class participants aged 20-60 years who underwent
      laparoscopic cholecystectomy at Van Yuzuncu Yıl University Faculty of Medicine. Preoperative
      evaluation was made before the operation, routine laboratory analyzes were taken, the
      participants were informed about the study, and their written consent was obtained.
      Participants were randomized into two groups.

        -  Group T (Adjuvant Tramadol): 40 mL of 0.250% bupivacaine + 1.5mg/kg and a maximum of 100
           mg tramadol adjuvant

        -  Group D (Adjuvant Dexmedetomidine): 40 mL of 0.250% bupivacaine + 0.5 mcg/kg and a
           maximum of 50 mcg dexmedetomidine adjuvant Standard general anesthesia was applied.
           After intubation, bilateral subcostal TAP block was performed by the same
           anesthesiologist, demographic data were recorded. Intraoperative vital signs of the
           participants (pulse, non-invasive blood pressure and peripheral oxygen saturation
           measurement), additional opioid and muscle relaxant needs, and complications were
           recorded. Extubation was performed after standard decurarization with atropine and
           neostigmine. Postoperative side effects (nausea, vomiting, pruritus, shivering),
           postoperative additional analgesic need, and 0 hour (Modified aldrete score ≥9 time was
           accepted as 0 hour), 3rd hour and 6th hour Visual Analogue Scale (VAS) scores were
           evaluated and recorded.
    

Intervention name(s): Dexmedetomidin + bupivacaine; Tramadol + Bupivacaine
Intervention type(s): Procedure; Drug
Intervention description(s): dexmedetomidine was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP); tramadol was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)
Intervention MeSH terms: Tramadol; Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized controlled trial
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Transversus abdominis plane block; adjuvant; Dexmedetomidine; Tramadol
Children With Aluminium Contact Allergy: Oral Exposure Study
Condition: Contact Dermatitis; Contact Allergy; Aluminum Allergy
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact; Hypersensitivity
Study type: Interventional

Summary: 
      Aluminium allergy is predominantly seen in children with small itchy nodules in the skin
      after vaccinations, so-called granulomas. We want to do an exposure study where aluminium
      allergic children have to eat aluminium pancakes for a short period of time. The purpose is
      to investigate whether a worsening of the children's symptoms can be detected, both itching
      of the granuloma, allergic rash on the skin and also the symptoms that are not measurable,
      such as headache, stomach ache and general agitation. We also want to examine the
      concentration of aluminium in the urine, which reflects the absorption of aluminum from the
      gastrointestinal tract.
    

Detailed description: 
      Parents of aluminium allergic children have reported that children may react with increased
      itching of their granulomas, skin symptoms in the form of redness, itching and rash, as well
      as symptoms such as headache, abdominal pain and agitation, by ingesting aluminium-containing
      foods.

      Children are predominantly exposed to aluminium via the diet as they do not yet use
      aluminium-containing cosmetic products, stomach acid medicines or deodorants. The amount of
      aluminium in children's diet varies between 0.22-0.90 mg/kg body weight/week, depending on
      their age. In older children and adults, the intake is less related to the aluminium in
      infant formula, breakfast cereals and dried fruit, which is consumed more by children than
      adults.

      With this study, we want to create an exposure study where children have to eat pancakes for
      a limited period of time, where aluminium has been used as baking soda, and for two control
      periods eat pancakes without aluminium.

      Any symptoms occurring during periods could be used to investigate whether children with
      aluminium allergies generally react after intake of aluminium-containing foods and whether as
      such it is a consequential condition in some children or whether it is isolated cases. It is
      a very important issue to clarify with a view to proper advice, both with regard to the
      possible avoidance of specific foods and in the case of future vaccinations.
    

Intervention name(s): sodium aluminium phospate (SALP); Aluminium-free pancake
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 pancake daily for 4 days; 1 pancake daily for 4 days, without aluminium
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double blinded cross over study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: vaccination granuloma; aluminium; contact allergy; exposure
The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment
      of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of
      velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy.
      In addition, the study will be used to evaluate the psychometric properties of the
      Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure.
    


Intervention name(s): Velusetrag; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): TD-5108
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gastroparesis; Diabetic; Idiopathic
Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia (AML)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      This was a non-interventional, retrospective registry study, utilizing electronic health
      record (EHR) data collected in the hospital district of Helsinki and Uusimaa (HUS).
      Real-world health care resource utilization (HCRU) of AML patients was characterized.
    

Detailed description: 
      Adult patients (18 years or older) with the inclusion diagnosis, AML (ICD-10 C92.0), between
      1.1.2013 - 30.6.2020 were followed from the index date (first ever record of the inclusion
      diagnosis) until the end of follow-up (30.6.2020), or death. This study did not involve any
      contacts to patients.

      The study inclusion period was changed from 1.1.2013 - 30.6.2020 specified in the protocol to
      1.1.2016 - 30.6.2020 due to lack of medication data from pre-2016.
    

Intervention name(s): Midostaurin
Intervention type(s): Drug
Intervention description(s): Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.
Other intervention name(s): Rydapt
Intervention MeSH terms: Midostaurin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients (18 years or older) with Acute Myeloid Lukemia
      
Keywords: Acute myeloid leukemia,; midostaurin,; healthcare resource utilization
Comparison of Apexification and Regenerative Endodontic Therapy: a Retrospective Study
Condition: Regenerative Endodontic; Apexification; Fractals
Study type: Observational

Summary: 
      In this study, the effects of mineral trioxide aggregation (MTA) apexification and
      regenerative endodontic treatment (RET) methods on periapical healing was compared with
      fractal analysis (FD) and periapical index (PAI).
    

Detailed description: 
      The fractal dimension analysis of each radiograph was performed using the box-counting method
      proposed by White and Rudolph [1] (Figure 1). All periapical radiographs in high resolution
      Jpeg format to be included in the study was converted to tagged image file formats (TIFF).
      Each ROI at 18 x 19 pixels and 2 mm from the radiographic apex was selected, cropped and
      amplified. "Gaussian Blur" was used to eliminate the brightness changes due to soft tissues
      and variable bone thicknesses. The resulting image was then be subtracted from the original
      image. Bone marrow spaces and trabeculae were separated from each other by adding 128 gray
      values to each pixel location. The fractal dimension was calculated after the binary,
      etching, dilate, inversion and skeletonization operations were done.

      This study was carried out on the radiographic records of patients who applied to Istanbul
      University Faculty of Dentistry, Department of Pedodontics, who had at least one immature
      incisor treated with MTA apexification and RET method, and who had at least one-year
      follow-up radiographs.

      Cases in which all endodontic treatments were performed by the same pedodontist (GK) were
      examined.
    

Intervention name(s): Regenerative endodontics
Intervention type(s): Procedure
Intervention description(s): Regenerative endodontic procedure with 3 Mix-MP
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The database of patients who underwent apexification treatment by a single operator (GK) at
        Istanbul University Faculty of Dentistry, Department of Pedodontics was examined.