Kornimate/medical-research-clean huggingface dataset:
study of the bruton's tyrosine kinase inhibitor in subjects with relapsed or relapsed and refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the primary objective of this study is to determine the efficacy of pci-32765, both as a single agent and in combination with dexamethasone, in subjects with relapsed or relapsed and refractory multiple myeloma (mm)

bruton's tyrosine kinase (btk) is an enzyme that is present in hematopoietic cells other than t cells and is necessary for downstream signal transduction from various hematopoietic receptors including the b cell receptor as well as some fc, chemokine, and adhesion receptors, and is crucial for both b cell development and osteoclastogenesis. although down-regulated in normal plasma cells, btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. pci 32765 is a potent and specific inhibitor of btk currently in phase 2 clinical trials. the current study is designed and intended to determine the effects of pci-32765 in subjects with mm.

Eligibility criteria:
inclusion criteria: * diagnosis of symptomatic mm with measurable disease, defined here as having at least one of the following: 1. serum monoclonal protein (m-protein) ≥0.5 g/dl as determined by serum protein electrophoresis (spep) 2. urine m-protein ≥200 mg/24 hrs 3. serum free light chain (flc) assay: involved flc level ≥10 mg/dl (≥100 mg/l) provided serum flc ratio is abnormal * relapsed or relapsed and refractory mm after receiving at least 2 but no more than 5 previous lines of therapy, 1 of which must be an immunomodulator. * refractory myeloma (to most recent treatment) is defined as disease that is nonresponsive while on treatment or progressive disease within 60 days after the completion of preceding treatment. nonresponsive disease is defined as either failure to achieve minimal response or development of progressive disease while on therapy. * men and women ≥18 years of age. * ecog performance status of ≤ 1. exclusion criteria: * subject must not have primary refractory disease defined as disease that is nonresponsive in subjects who have never achieved a minor response (mr) or better with any therapy. * polyneuropathy, organomegaly, endocrinopathy, m-protein, and skin changes (poems) syndrome, osteosclerotic myeloma, or crow-fukase syndrome. * plasma cell leukemia. * primary amyloidosis. * certain exclusions on prior therapy. * anc \<0.75 x 10\^9/l independent of growth factor support. * platelets \<50 x 10\^9/l) independent of transfusion support. * ast or alt ≥3.0 x upper limit of normal (uln). * total bilirubin \>2.5 x uln, unless due to gilbert's syndrome. * creatinine \>2.5 mg/dl. * unable to swallow capsules or disease significantly affecting gastrointestinal function. * requires anti-coagulation with warfarin or a vitamin k antagonist. requires treatment with strong cyp3a4/5 inhibitors.

Keywords: pci-32765 multiple myeloma relapsed refractory multiple myeloma bruton's tyrosine kinase
the protective effect of ginkgo biloba extract on cisplatin-induced ototoxicity in humans

Conditions: Ototoxicity; Hearing Loss

Summary: the proposal of this study was to evaluate in human beings, using distortion product otoacoustic emission (dpoae) test, the action of ginkgo biloba extract (gbe761)as a possible ear protective against cisplatin (cddp) induced hearing loss.

the ototoxicity is an alteration caused by drugs that compromises the auditory and vestibular functions. the cisplatin (cddp) is a potent antineoplastic agent used for the treatment of cancer in both adults and children although it has several side effects. current opinion is that cisplatin ototoxicity occurs due to alterations in the antioxidant system of the outer hair cells (ohc) of the cochlea. the distortion-product otoacoustic emissions (dpoae) has been showed to be a sensitive test for diagnosis of ohc injury and has been used for monitoring treatment with ototoxic drugs. because of their antioxidant properties, the ginkgo biloba extract (gbe761) was evaluated in human beings as a possible ear protective against cisplatin induced hearing loss, using dpoae test.

Eligibility criteria:
inclusion criteria: * over the age of eighteen * patients that will begin treatment with cisplatin * no prior treatment with cisplatin exclusion criteria: * individuals with middle ear, cochlear or retrocochlear disease * presence of changes in pure tone audiometry and/or distortion-product otoacoustic emissions

Keywords: ear protection ginkgo biloba extract distortion-product otoacoustic emission ototoxicity cisplatin
a randomized phase ii trial of neoadjuvant chemotherapy compared with chemoradiotherapy in gastric adenocarcinoma

Conditions: Stomach Neoplasms; Neoadjuvant Therapy; Chemoradiotherapy; Chemotherapy

Summary: this prospective, randomized phase ii study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemotherapy for locally advanced gastric adenocarcinoma.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as ct3-4n0m0 or anytn+m0 * no distant metastasis in liver,lung,bone,central nervous system(cns),no peritoneal transplantation * no prior abdominal or pelvic radiotherapy * karnofsky performance status(kps)≥ 70, predictive life span no less than 6 months * patients must have normal organ and marrow function as defined below: leukocytes: greater than or equal to 3,000 g/l; platelets: greater than or equal to 100,000/mm3 .hemoglobin:greater than or equal to 10g/l .total bilirubin: within normal institutional limits; ast/alt: less than or equal to 1.5 times the upper limit; creatinine within normal upper limits * informed consent exclusion criteria: * any prior chemotherapy or other cancer treatment prior to this protocol * patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer * with any distant metastasis in liver,lung,bone,cns,or peritoneal transplantation * history of allergic reactions attributed to similar chemical or biologic complex to s-1 or xeloda or oxaliplatin * uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness * history of myocardial infarction within the past 6 months or history of ventricular arrhythmia * history of prior radiation to the abdomen * pregnant or lactating females
covid-19 and childhood cancer

Conditions: COVID-19; Childhood Cancer; Childhood Leukemia, Acute Lymphoblastic

Summary: the investigators will first examine the impact of the covid-19 pandemic on childhood cancer patients in sweden and denmark, both regarding susceptibility to severe covid-19 among long-term childhood cancer survivors, and, for those diagnosed with childhood cancer during the pandemic, whether the path through primary care to cancer diagnosis as well as short-term survival has changed. second, the investigators will study childhood cancer incidence before, during and after the pandemic with the particular aim to test the hypothesis regarding an infectious disease etiology for acute lymphoblastic leukemia.


Eligibility criteria:
inclusion criteria for studying severe covid-19 among childhood cancer survivors: * childhood cancer cases (age 0-19) diagnosed from 1971 in sweden and denmark who were alive five years after diagnosis * two different comparisons groups: five age- and sex-matched comparisons for each childhood cancer survivor as well as all siblings of the childhood cancer survivors. * all childhood cancer survivors, matched comparisons, and siblings of the survivors should be 20+ at the start of 2020. inclusion criteria for studying childhood cancer incidence and survival and number of contacts with healthcare before the childhood cancer diagnosis: - all children (age 0-19) diagnosed with cancer from 2015 in sweden and denmark exclusion criteria: * no exclusion criteria

Keywords: childhood cancer childhood cancer incidence childhood cancer survival childhood leukemia, acute lymphoblastic cohort study register study
effects of anesthetic techniques on renal function

Conditions: Congenital Heart Disease; Acute Kidney Injury

Summary: this study evaluates different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children.

acute kidney injury is one of the major complications after heart surgery, which increases the mortality of patients. therefore, early prevention and detection of acute kidney injury is particularly important. in recent years, more and more studies have shown that both sevoflurane, an inhaled anesthetic widely used in clinical practice, and propofol, an intravenous anesthetic, have protective effects on kidneys. the aim of this study was to investigate the perioperative effects of two different anesthetic techniques on renal function for pediatric cardiac surgery.

Eligibility criteria:
inclusion criteria: * children with congenital heart disease * \<3 years of age exclusion criteria: * preoperative renal insufficiency; * renal malformation, kidney absence

Keywords: propofol,sevoflurane
l218car19 in patients with relapsed/refractory b-cell lymphoma

Conditions: Relapsed/Refractory B-cell Lymphomas

Summary: l218car19 is a kind of chimeric antigen receptor t-cell immunotherapy targeting cd19 on b cells. the goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of l218car19 in patients with b-cell lymphomas who have received at least two lines of systemic treatment.


Eligibility criteria:
inclusion criteria: * age 18-75 years at the time of inclusion * written informed consent * patients with relapsed/refractory cd19 positive b-cell lymphomas, who have received at least two lines of treatment * with measurable disease * ecog ps 0-2 at protocol entry * estimated life expectancy of 3 months or longer * hemoglobin ≥ 8 g/dl (≥5 mmol/l); platelets ≥ 75 x 10e9/l; absolute neutrophil count ≥ 1.0 x 10e9/l; platelets ≥ 50 x 10e9/l permitted if documented bone marrow involvement; serum bilirubin ≤ 1.5 x upper limit of normal (uln), or ≤3 x uln if elevation is due to hepatic involvement by lymphoma; serum glutamic-oxaloacetic transaminase (ast) and/or serum glutamic-pyruvic transaminase (alt) ≤ 2.5 x uln, or ≤ 5 x uln if elevation is due to hepatic involvement by lymphoma; serum creatinine ≤ 1.5 x ulnb; left ventricular ejection fraction (lvef) ≥ 50% * women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 6 months after the administration of study drug; male patients must use contraception for the duration of the study and 6 months after the administration of study drug if his partner is of childbearing potential exclusion criteria: * patients with heart disease: atrial fibrillation; history of class iii or iv new york heart association (nyha) heart failure, myocardial infarction or other significant cardiac disease within 12 months of screening; lvef\<50%; clinical significant pericardial effusion; long qt syndrome * history of severe pulmonary function impairment * with other uncontrolled malignancy * with active bacterial, viral, or fungal infections * with uncontrolled autoimmune disease or congential immunodeficiency * hiv antibody positive patients * known severe hypersensitivity to biological product * patients with known active central nervous system (cns) disease, including lymphoma cns involvement * patients with prior car-t therapy * history of allogeneic stem cell transplantation * history of autogeneic stem cell transplantation within 6 months of screening * history of major surgery within 4 weeks of screening * patients receiving live (attenuated) vaccines within 6 weeks of screening * pregnant or lactating women, or pregnant plan within 12 months * involvement of cardiac tissue by lymphoma * with emergency due to oncothlipsis * unwillingness or inability to comply with the protocol * deemed 'unfit' by the treating physician
retrospective study of ovarian cancer patients with brain metastasis

Conditions: Ovarian Cancer; Brain Metastases

Summary: ovarian cancer, especially epithelial ovarian carcinoma, has the highest mortality rate among the gynecologic malignancies. the majority of patients with epithelial ovarian carcinoma are diagnosed at advanced stage which has the overall survival rates of only 19-30%. as the advance in the managements which prolonged the overall survival, metastatic lesion in rare location such as brain was noted in few patients of ovarian cancer in recent years. in the retrospective study, the investigators will review the medical records of the ovarian cancer patients with brain metastasis in the investigators hospital to investigate the incidence, clinical courses, optimal managements and possible prognostic factors in the rare condition.

the ovarian cancer patient treated at the department of obstetrics and gynecology of the national taiwan university hospital were retrospectively collected. the cancer registration database was searched for the patients with ovarian carcinoma who brain metastases were also diagnosed. the medical records of these patients were reviewed with particular attention to the results of histo-pathological and radiologic reports. patients with other synchronous primary brain tumor were excluded. the initial management of primary tumor, including the surgery and adjuvant chemotherapy, and the clinical courses and disease status, such as remission, recurrence and progression, were all carefully reviewed. the intra-cranial lesions were all diagnosed by imaging studies, including brain computed tomography (ct) and magnetic resonance imaging (mri) scans. therapeutic strategies for the metastatic lesions in the brain were also reviewed. all statistical analyses were performed using the spss 13.0 statistical software for windows. p\<0.05 was defined as statistical significance. survival was measured from the time of initial diagnosis of brain metastasis until the date of death or last contact, and was presented by kaplan-meier curves.

Eligibility criteria:
inclusion criteria: * patients with ovarian cancer and brain metastasis * patients ovarian cancer from national taiwan university hospital exclusion criteria: * none
neurobehavioral functioning in pediatric brain tumor patients after proton beam radiation treatment

Conditions: Brain Tumor; Central Nervous System Neoplasms

Summary: the aim of this study is to follow up with all of the pediatric brain tumor patients who received proton beam radiation therapy at massachusetts general hospital (mgh) for which there is baseline neuropsychological testing in order to measure changes, if any, in neurobehavioral functioning (executive skills, emotional/behavioral functioning, and adaptive abilities) and their use of special education services at one year or more post-treatment. the investigators will also correlate neurobehavioral data with pertinent clinical information. participation will be maximized through the use of mail-in, parental- and self-report questionnaires.

the purpose of this study is to longitudinally examine neurobehavioral functioning outcomes and use of special education services in brain tumor and cns tumor patients treated with proton radiation at mgh. furthermore, we seek to correlate neurobehavioral data with pertinent clinical information. we anticipate better neurobehavioral functioning to be associated with use of protons (vs. photons, as reported in the literature). we also anticipate the need and utilization of special education services to be lower in brain and cns tumor patients treated with protons (vs. photons, as reported in the literature). lastly, we anticipate greater neurobehavioral deficits in patients whose proton radiation treatment involved the craniospinal axis compared to those who received proton radiation to the involved field.

Eligibility criteria:
inclusion criteria: 1. children diagnosed with brain or cns tumors and treated with proton radiation therapy at the mgh francis h. burr proton center since september 2002 2. patients received baseline neurocognitive testing at mgh 3. patients ≤25 years at the time of diagnosis 4. tumor location in the brain or cns 5. radiation treatment consisted of only proton radiotherapy 6. no prior radiation exposure or chemotherapy exclusion criteria: 1. patients receiving treatment with palliative intent 2. patients who do not wish to participate 3. patient is deceased at ≥1 year follow-up

Keywords: proton radiation cns tumors brain tumors neurobehavioral functioning
effects of rehabilitation for patients with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea of Adult

Summary: in previous review study, it was hypothesized that a comprehensive rehabilitation can combine both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the osa patients with oropharyngeal muscle dysfunction or ventilator drive instability. to develop a comprehensive rehabilitation model is of innovative care strategy in this study.

background: obstructive sleep apnea (osa) is a prevalent sleep-related breathing disorder, which was characterized by repetitive events of complete and partial obstructions of the upper airway. the pathogenesis of osa is interacted by multiple factors, primarily including upper airway (ua) anatomic impairment, ventilatory drive instability, and oropharyngeal muscle dysfunction. however, studies have proven prior oropharyngeal exercise was designed for those osa patients with oropharyngeal muscle dysfunction. unlike prior oropharyngeal exercise, comprehensive rehabilitation should emphasize the cardiorespiratory regulation capability in addition to oropharyngeal function. objectives: therefore, the purpose of this study is to explore both the clinical and biological effects of our comprehensive rehabilitation, we used psg data as clinical effect and biomarker of inflammation expression as biological effect. methods: thirty subjects with moderate or severe osa (ahi≥15) were randomized into intervention group (n=15) and control group (n=15). in intervention group, a 12-week-intervention of out-patient rehabilitation program included oropharyngeal muscle training, threshold respiratory muscle training, and therapeutic exercise. anticipated outcomes: the preliminary results would demonstrate promisingly clinical effects and biological effects of our comprehensive rehabilitation model. therefore, the further studies should emphasize the methods to differentiate diagnosis for the indicated patients with oropharyngeal muscle dysfunction or ventilatory drive instability.

Eligibility criteria:
inclusion criteria: * patients aged 35-65 with or without surgery had difficulty accepting or adhering cpap exclusion criteria: * bmi\<32 * smoking or alcoholism * severe allergic rhinitis * stroke history * cvd * severe restricted or obstructive pulmonary disease * hypothyroidism * dm or htn without stable control * psychiatric disease * co-existing non-respiratory sleep disorders

Keywords: obstructive sleep apnea oropharyngeal rehabilitation cardiopulmonary rehabilitation
intraosseous prp for knee osteoarthritis: pilot study

Conditions: Knee Osteoarthritis

Summary: the aim of this study was to assess a novel approach to treating severe knee osteoarthritis by targeting synovialmembrane, superficial articular cartilage, synovial fluid, and subchondral bone by combining intra-articular injections and intraosseous infiltrations of platelet rich plasma.this study explored a new strategy consisting of intraosseous infiltrations of platelet rich plasma into the subchondral bone in combination with the conventional intra-articular injection in order to tackle several knee joint tissues simultaneously.


Eligibility criteria:
inclusion criteria: * patients of both sexes aged 40 to 77 years. * predominant internal tibiofemoral knee osteoarthritis. * joint pain above 2.5 vas points. * radiographic severity degrees 3 and 4 according to ahlbäck scale. * values of body mass index between 20 and 33. * possibility for observation during the follow-up period. exclusion criteria: * bilateral knee osteoarthritis which requires infiltration in both knees. * values of body mass index \> 33. * polyarticular disease diagnosed. * severe mechanical deformity (diaphyseal varus of 4∘ and valgus of 16∘). * arthroscopy in the last year prior to treatment. * intra-articular infiltration of hyaluronic acid in the past 6 months. * systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis). * poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%). * blood disorders (thrombopathy, thrombocytopenia, and anemia with hb \< 9). * undergoing immunosuppressive therapy and/or warfarin. * treatment with corticosteroids during the 6 months prior to inclusion in the study.
a study of amg 706 or bevacizumab, in combination with paclitaxel chemotherapy, as treatment for breast cancer

Conditions: Breast Neoplasms; Breast Tumors; Breast Cancer; Locally Recurrent and Metastatic Breast Cancer

Summary: to determine if treatment with paclitaxel plus amg 706 is superior to paclitaxel plus amg 706 placebo in subjects with her2 negative locally recurrent or metastatic breast cancer. also to estimate differences between treatment with paclitaxel plus amg 706 and paclitaxel plus bevacizumab.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease. * measurable disease by recist guidelines. * tumor (primary or metastatic) must be her2 negative. * adequate organ and hematologic function. exclusion: * taxane treatment within 12 months prior to registration. * prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted). * prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease. * current or prior history of central nervous system metastases. * peripheral neuropathy ≥ grade 2 (ctcae v3.0) at registration. * history of arterial or venous thrombosis within 1 year prior to registration. * history of bleeding diathesis or bleeding within 14 days of registration. * uncontrolled hypertension (systolic \>145 mmhg; diastolic \>85 mmhg). * clinically significant cardiac disease within 12 months of registration. * known hiv positive, hepatitis c positive or hepatitis b surface antigen positive. * prior treatment with vegfr targeted therapies.

Keywords: amg 706 paclitaxel metastatic breast cancer antiangiogenic bevacizumab
retrospective study of the survival of patients suffering from hiv-related progressive multifocal leukoencephalopathy

Conditions: Progressive Multifocal Leukoencephalopathy

Summary: retrospective medical chart review of hiv-infected patients diagnosed with progressive multifocal leukoencephalopathy


Eligibility criteria:
inclusion criteria: * hiv infected patients * diagnosed with progressive multifocal leukoencephalopathy * minimal follow-up of one year or patient deceased less than one year after diagnosis exclusion criteria: * loss of follow-up within 12 months after diagnosis