Kornimate/medical-research-clean huggingface dataset:
car-nk targeted cd19 for r/r b-cell malignancies

Conditions: Adult Relapsed/Refractory B-cell Hematologic Malignancies

Summary: this is a single-centre, single-arm and open-label study to investigate the safety and efficacy of jd010 in adult patients with relapsed or refractory b cell hematologic malignancies. jd010 injection is a cd19-targeted chimeric antigen receptor modified natural killer cells (car-nk) derived from a healthy donor


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, no gender or race; 2. expected survival period ≥ 3 months; 3. eastern cooperative oncology group (ecog) performance status score of 0 to 2; 4. confirmed relapsed/refractory b-cell malignancies and tumor cells expressing cd19; 5. adequate organ function: a. liver function: alt≤3×uln, ast≤3×uln, total bilirubin≤2×uln; b. coagulation function: international normalized ratio (inr) or activated partial thromboplastin time (aptt) ≤ 1.5×uln; c. renal function: serum creatinine≤1.5×uln or creatinine clearance rate ≥30ml/min; d. cardiac function: left ventricular ejection fraction (lvef) ≥ 50%; 6. women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.; 7. informed consent/assent: all subjects must have the ability to understand and the willingness to sign a written informed consent. exclusion criteria: 1. central nervous system involved; 2. known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide; 3. systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids); 4. any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: hbv, hcv, hiv, syphilis infection, or active pulmonary tuberculosis. 5. history of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines; 6. patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment; 7. women who are pregnant (urine/blood pregnancy test positive) or lactating; 8. suffering from a serious autoimmune disease or immunodeficiency disease; 9 suffering from mental illness; 10. known alcohol dependence or drug dependence; 11. according to the investigator's judgment, the patient has other unsuitable grouping conditions.
analysis of the real-world prescription pattern of palbociclib combination therapy with aromatase inhibitor as a first line therapy in metastatic breast cancer patients using the national health insurance claims data in south korea

Conditions: Metastatic Breast Cancer

Summary: the objective of this study is to evaluate the real-world prescription patterns of palbociclib in breast cancer (bc) patients who were treated with palbociclib in combination with ai as a 1st line of therapy using the national health insurance claims data in south korea.


Eligibility criteria:
inclusion criteria: * patients who were prescribed with palbociclib in combination with ai for at least 1 cycle during the index period * patients who were diagnosed with bc during the index period exclusion criteria: * male * prescribed with palbociclib during 12-month period preceding the index date

Keywords: hormone receptor positive (hr+) human epidermal growth factor receptor 2 negative (her2-) metastatic breast cancer (mbc)
prospective registry of young-adult patients diagnosed with pancreatic cancer

Conditions: PDAC - Pancreatic Ductal Adenocarcinoma

Summary: the objective of the present registry is the creation of a prospective registry collecting clinico-pathological and genomic data, along with survival outcomes, of individuals diagnosed with pdac at or before the age of 55 years old. this registry is intended with the aim of using collected data for future clinical trials, both prospective and retrospective.


Eligibility criteria:
inclusion criteria: * age ≤55 years old at the time of diagnosis of pancreatic cancer * age ≥ 18 years * written informed consent obtained. exclusion criteria: * any pancreatic neoplasm other than pancreatic cancer (e.g. cholangiocarcinoma, ampullary cancer,duodenal cancer, non-invasive mucinous cystic neoplasm, pancreatic intra-epithelial neoplasia 1 and 2, non-invasive intraductal papillary mucinous neoplasm, serous cystic neoplasm, pseudo papillary solid tumor, neuroendocrine tumor) * absence of informed consent. * age \ 55 years old at the time of diagnosis of pancreatic cancer
a trial comparing treatment with the springfusor infusion pump to the iv magnesium sulfate regimen

Conditions: Preeclampsia

Summary: the trial will test the equivalence of a repeat bolus protocol of magnesium sulfate administered by the springfusor® controlled pump to a continuous intravenous regimen. the goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the continuous intravenous and springfusor repeat bolus regimens. the study will also document the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.


Eligibility criteria:
inclusion criteria: exhibit systolic blood pressure \> 160mm hg or a diastolic pressure \> 110 mm hg (at two times over 30 minutes) (a single higher pressure could be accepted if the clinical team felt that magnesium sulfate therapy should be initiated without waiting 30 minutes). exhibit proteinuria \> 1+; have not given birth, or be \ 18 years of age give informed consent for study participation exclusion criteria: eclamptic or seizing at the time of enrollment received magnesium sulfate therapy 24h prior to study enrollment known serum creatinine \>1.2 mg/dl. (subject may be enrolled prior to knowledge of serum creatinine but would be withdrawn if \>1.2 mg/dl in order to have a proper dose adjustment.

Keywords: magnesium sulfate
bedside ultrasonography in acute patients with suspected kidney involvement

Conditions: Hydronephrosis; Pyelonephritis; Urosepsis

Summary: the aim of this study is to evaluate the accuracy and implications of the diagnoses and treatment determined by bedside ultrasonography (b-us) of the kidneys compared to current clinical assessment. potentially diagnosing patients faster and avoiding missing conditions leading to readmission or unnecessary radiation from computed tomography (ct). this study evaluates the use of b-us as a supplement to clinical evaluation, in an unselected group of patients in the emergency department (ed) with signs of kidney involvement. the b-us of the kidneys is performed by a medical student certified in this technique. the evaluation will be based on data collected from a danish hospital (odense university hospital, ouh) in autumn 2018.


Eligibility criteria:
inclusion criteria: * suspicion of urinary tract infection and one or more of the following: * flank pain * fever * symptoms when voiding * creatinine elevation or 20% elevation from known creatinine level elevation exclusion criteria: * age \< 18 years * radiological ultrasonographic examination already performed * patients who are not able to consent

Keywords: bedside ultrasonography emergency department
positron emission tomography and ct scan in predicting response in patients with metastatic melanoma or kidney cancer who are undergoing cellular adoptive immunotherapy on a surgery branch clinical trial

Conditions: Kidney Cancer; Melanoma (Skin)

Summary: rationale: diagnostic procedures, such as positron emission tomography and computed tomography scan (done before and after cellular adoptive immunotherapy), may help doctors predict a patient's response to treatment and help plan the best treatment. purpose: this phase ii trial is studying how well positron emission tomography and computed tomography scan predicts response in patients with metastatic melanoma or kidney cancer who are undergoing cellular adoptive immunotherapy on a surgery branch clinical trial.

objectives: primary * measure changes in metabolic activity at visceral sites during the acute treatment phase of adoptive cell transfer (act) using positron emission tomography (pet)/ct fusion imaging in patients with metastatic melanoma or renal cell cancer. * measure changes in metabolic activity at metastatic sites during the acute treatment phase of act using pet/ct fusion imaging. * compare the changes in metabolic activity at visceral and metastatic sites in patients treated with intravenous vs intra-arterial tumor-infiltrating lymphocyte infusions. secondary * correlate response of individual metastases with these metabolic alterations. outline: this is a pilot study. patients are stratified according to treatment (intravenous \[iv\] tumor-infiltrating lymphocytes \[til\] after a nonmyeloablative preparative regimen vs intra-arterial \[ia\] til after a nonmyeloablative preparative regimen vs iv til after a myeloablative preparative regimen with chemotherapy and total-body irradiation). patients undergo positron emission tomography with fludeoxyglucose f 18 (fdg-pet)/ct fusion imaging at baseline (before starting til infusion), once between days 1-4 after til infusion, and once between days 5-8 after til infusion. projected accrual: a total of 70 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of 1 of the following: * melanoma * renal cell cancer * metastatic disease * measurable disease by ct scan or mri * enrolled in a surgery branch protocol utilizing 1 of the following variations of adoptive cell transfer of tumor-infiltrating lymphocytes (til): * intravenous (iv) til after a nonmyeloablative preparative regimen (e.g., nci-99-c-0158) * intra-arterial (ia) til after a nonmyeloablative preparative regimen (e.g., nci-99-c-0158) * iv til after a myeloablative preparative regimen with chemotherapy and total-body irradiation (e.g., nci-04-c-0288) patient characteristics: * ecog performance status 0-2 * no history of or treatment for diabetes mellitus * no hypersensitivity or allergy to fludeoxyglucose f 18 * weight ≤ 350 lbs (136 kg) * not pregnant or nursing * negative pregnancy test prior concurrent therapy: * see disease characteristics * no treatment with both iv and ia til

Keywords: stage iv renal cell cancer stage iv melanoma recurrent melanoma recurrent renal cell cancer
a phase iii study of re-irradiation in recurrent glioblastoma

Conditions: Recurrent Glioblastoma

Summary: the investigators hope to improve overall median survival of patients with recurrent glioblastoma by investigating continuous low-dose daily temozolomide plus or minus five treatments of re-irradiation.

this is a stratified study for patients with recurrent intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation presenting radiographic progression or recurrence of tumour. patients are stratified by extent of resection, time to re-irradiation and re-irradiation volume.

Eligibility criteria:
inclusion criteria: * histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation * radiographic evidence of tumour progression or recurrence * 18 years or older * ecog 0 - 2 * signed informed consent form exclusion criteria: * tumour progression or recurrence within 3 months of initial concurrent chemoradiation * 6 or more cycles of tmz administered following chemoradiation at initial diagnosis * more than one prior course of salvage chemo for recurrent disease * prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years * prior head or neck rt except for t1 glottic cancer

Keywords: recurrent glioblastoma re-irradiation continuous low-dose temozolomide
chronic asthma study in 2- to 5-year-old patients (mk0476-072 )

Conditions: Asthma

Summary: a study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.


Eligibility criteria:
inclusion criteria: * patient has history of physician diagnosed asthma * patient is in otherwise good stable health * patient is able to chew a tablet exclusion criteria: * patient is hospitalized * patient and/or parent of guardian intends to move or vacation away from home during the course of the study * patient had any major surgical procedure within 4 weeks before the study * patient had active sinus disease within 3 weeks before the study * patient had required intubation for asthma in the past * patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study * patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study
exercise intensity for down syndrome children

Conditions: Down Syndrome

Summary: the current study aimed to determine the appropriate exercise intensity for the rehabilitation of children with down syndrome.

two groups of down syndrome children were recruited. one group received mild-intensity treadmill training while the other received moderate-intensity treadmill training. eccentric knee extensors and ankle plantar flexors peak torques were assessed before and after the intervention. also, functional mobility was assessed for both groups before and after the intervention. the within and between-subjects effect was used to analyze the obtained data before and after the intervention. isokinetic dynamometer and the time up and go test were used for evaluation.

Eligibility criteria:
inclusion criteria: * independent walking * intelligence quotient range from 40 to 70 * right dominant foot * body mass index from 50 to 75 exclusion criteria: * chronic diseases * congenital anomalies * involved in any competitive sport * previous injury to the lower limb
spinal epidural lipomatosis: a case report and review of the literature

Conditions: Spinal Stenosis

Summary: introduction lumbar spinal epidural lipomatosis (sel) is a rare condition defined by an excessive deposition of adipose tissue in the lumbar spinal canal. the objective of this case report is to document a clinical case of sel presenting within a multidisciplinary spine clinic and to compare our clinical findings and management with the current literature. case presentation a 51-year-old female presented at a spine clinic with low back pain, bilateral leg pain and difficulty walking. mr imaging of the lumbar spine showed l4-l5 and l5-s1 degenerative disk disease with evidence of severe central canal stenosis due to extensive epidural lipomatosis. the patient was initially advised to lose weight, undergo a course of physiotherapy, and consult with the pain clinic. because of lack of improvement, the patient was scheduled for l4-s1 posterior spinal decompression and l4-l5 posterior spinal instrumented fusion. discussion the discussion will include the diagnosis of sel, imaging appearance, its risk factors, etiology and management. conclusion this case report describes a case of lumbar spinal stenosis due to sel with neurological symptoms. some risk factors have also been identified in the literature. mri is considered as the reference standard for its diagnosis. the therapeutic approach of patients with sel is not standardized. thus, reporting and investigating the diagnostic process and treatment of this patient will positively contribute to better management for other future patients.


Eligibility criteria:
inclusion criteria: * adults patient with a clinical diagnosis of spinal epidural lipomatosis (mri and clinical diagnosis) exclusion criteria: * absence of clinical diagnosis of spinal epidural lipomatosis
flibanserin for the treatment of hypoactive sexual desire disorder in postmenopausal women in north america

Conditions: Sexual Dysfunctions, Psychological

Summary: the objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of hypoactive sexual desire disorder (hsdd) in naturally postmenopausal women.


Eligibility criteria:
inclusion criteria: * naturally postmenopausal women of any age with at least one ovary * diagnosis of hypoactive sexual desire disorder, generalized acquired type,of at least six months duration * stable, monogamous heterosexual relationship for at least one year * willing to discuss sexual issues * willing to engage in sexual activity at least once a month * normal pap smear * normal mammogram * normal uterine lining * able to comply with daily use of handheld data entry device exclusion criteria: * sexual dysfunctions other than hsdd, such as sexual aversion disorder, substance-induced sexual dysfunction, dyspareunia, vaginismus, gender identity disorder, paraphilia and sexual dysfunction due to a general medical condition * partner with inadequately treated organic or psychosexual dysfunction * sexual function impaired by psychiatric disorder * sexual function impaired by gynecological disorder * major depression * suicidal behavior or ideation * major life stress that could impair sexual function * substance abuse
transtympanic ringer's lactate for the prevention of cisplatin ototoxicity

Conditions: Hearing Loss

Summary: cisplatin and carboplatin induce ototoxicity manifested as sensorineural hearing loss, tinnitus, and/or vestibular disturbances. ototoxicity is induced via damage to inner ear structures by reactive oxygen species. previous animal studies demonstrated that transtympanic injection of ringer's lactate (rl) provided near complete otoprotective effect against cisplatin. the purpose of this study is to determine if transtympanic administration of ringer's lactate via a pressure equalising (pe) tube in patients undergoing platinum based chemotherapy treatment will prevent tinnitus, vestibular dysfunction and hearing loss especially at high frequencies. pre- and post- chemotherapy treatment audiometry will be measured and statistically analysed for significance.


Eligibility criteria:
inclusion criteria: * patients over the age of 14 * patients undergoing platinum based chemotherapy * patients who agree to participate in the study exclusion criteria: * patients unable to provide consent * patients with head and neck cancer * patients undergoing radiation of the head and neck * patients who develop a tympanic perforation * patients with persistent otorrhea

Keywords: ringer's lactate cisplatin ototoxicity hearing loss
the effects of vitamin b-6 and coenzyme q10 status on oxidative stress, antioxidant capacities, and inflammatory responses in patients with liver cancer

Conditions: Hepatocellular Carcinoma.

Summary: carcinoma is the leading cause of worldwide. hepatocellular carcinoma (hcc) is the second cause of cancer mortality in taiwan. vitamin b-6 and coenzyme q10 has been recognized as antioxidants and anti-inflammatory nutrients in recent clinical studies. the purposes of this study are going to investigate the relation of vitamin b-6 and coenzyme q10 with the indicators of oxidative stress, antioxidant enzymes activities and the inflammatory markers in patients with stage 1 and stage 2 hcc. the study is designed as an intervention study. the investigators will recruit hcc patients with stage 1 and stage 2 (n = 150) who are identified by liver biopsy. hcc subjects are randomly assign to placebo, vitamin b-6 (50 mg/d), coenzyme q10 (300 mg/d), and vitamin b-6 plus coenzyme q10 supplements groups. intervention is going to administration for three months. the concentrations of vitamin b-6, coenzyme q10, oxidative stress indicators, antioxidant enzymes activities, antioxidant vitamins (vitamin a and e), and inflammatory markers are going to be analyzed. the results would provide more information nutrients for clinical physicians and dietitians for considering suggesting patients with hcc using vitamin b-6 or coenzyme q10 supplementation to improve their clinical outcomes.


Eligibility criteria:
inclusion criteria: - the hcc patients with stage 1 and stage 2 (n = 150) who are identified by liver biopsy. exclusion criteria: * age \< 20 years old. * the patients who had heart, renal, gestational, diabetes, or other metabolic diseases. * under the medications which may interfere the vitamin b-6 or coenzyme q10 concentrations, such as phenobarbital, phenytoin, cycloserine, pyrazinamide, isoniazid, (thio)semicarbazide, hydramitrazine, phenelzine, carbidopa, levodopa, hydralazine, steroids, penicillamine, ,statin, or warfarin. * the women who are during pregnancy or lactation. * the women who are taking the oral contraceptives. * the subjects who are taking the dietary supplements, such as vitamin b-6, coenzyme q10, or other antioxidant vitamins.
study to evaluate the efficacy, safety, tolerability and pharmacokinetics of azd1386 in patients with osteoarthritis (oa) of the knee

Conditions: Pain

Summary: the primary aim of this study is to investigate if azd1386 is efficacious as an analgesic in patients with osteoarthritis of the knee and at what dose. this will be done by comparing the effect of azd1386 to placebo ("inactive substance") on pain.


Eligibility criteria:
inclusion criteria: * patients with oa of the knee * male or non pregnant females 40 and 80 years old exclusion criteria: * a current diagnosis of another form of arthritis, in addition to oa * history, and/or presence of somatic disease, which may interfere with the objectives

Keywords: phase ii pain
a long-term study to examine the effects of cp-945,598 on weight loss and safety

Conditions: Obesity

Summary: the purpose of this study is to examine the long-term weight loss and safety of cp-945,598 in obese adults

the cp-945,598 program was terminated on november 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the cb1 class and likely new regulatory requirements for approval. no safety issues were involved in the termination decision.

Eligibility criteria:
inclusion criteria: * obese adults with a body mass index \> or = 30 kg/m2; \> or = to 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia exclusion criteria: * pregnancy * diabetes * adults with serious or unstable current or past medical conditions
efficacy of electrical pudendal nerve stimulation for neurogenic lower urinary tract dysfunction

Conditions: Spinal Cord Injuries; Lower Urinary Tract Symptoms; Dysuria; Incontinence

Summary: the main goal to treat early nluts is to relieve lower urinary tract syndrome and prevent from late complications. the present study is to evaluate the efficacy of electrical pudendal nerve stimulation (epns) and transanal/transvaginal electrical stimulation (tes) in nlutd.the study design consists of a non-randomized, parallel controlled trial. a total of 60 eligible patients will be involved and divided into epns or tes group according to their location of medical treatment. the primary endpoint is lower urinary tract syndromes (iciq-fluts/mluts). the second endpoint is assessment of daily life qol (iciq-lutsqol), and residual urine volume.


Eligibility criteria:
inclusion criteria: * age 18+ years; * diagnosed as nlutd; * incomplete spinal cord injury (sci), including but not limited to conus medullaris syndrome, cauda equina syndrome, etc.; * radical pelvic surgery: including but not limited to total hysterectomy etc.; * informed consent signed. exclusion criteria: * anatomical bladder outlet obstruction (e.g., prostate enlargement, tumors); * nlutd induced by stroke, multiple sclerosis, hiv, diabetes mellitus, drug, and inflammation or tumor of central nervous system etc.; * lower urinary tract infections; * unwillingness to participate.

Keywords: pudendal nerve modulation transanal/transvaginal electrical stimulation