Kornimate/medical-research-clean huggingface dataset:
phase i study of cd19-car-t2 cells for patients with chemotherapy resistant or refractory cd19+ acute leukemia

Conditions: Acute Leukemia

Summary: the purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor 19 (cd19-car-t2 cells) infusions in patients with chemotherapy resistant or refractory cd19+ acute leukemia.


Eligibility criteria:
inclusion criteria: * patient with relapsed and/or refractory cd19 positive b-cell acute leukemia * eastern cooperative oncology group (ecog) performance status 《 3 * alt/ ast 《 3x normal * bilirubin \< 2.0 mg/dl * creatinine \< 2.5 mg/dl and less than 2.5x normal for age * lvef》 45% * accept white blood cell collection * provide informed consent exclusion criteria: * previous treatment with investigational gene or cell therapy medicine products * solitary extramedullary relapse * active hepatitis b , hepatitis c or hiv infection * uncontrolled active infection * presence of grade 2-4 acute or extensive chronic gvhd * active cns involvement: epilepsy, paresis, aphasia, stroke, severe head trauma, * dementia, parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc. * any uncontrolled active medical disorder that would preclude participation as outlined. * received non-diagnostic purposes major surgery within the past 4 weeks * participated in any other clinical study within the past 4 weeks * used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist. * pregnancy or breast-feeding women * use of prohibited drugs: * steroids: therapeutic doses of steroids must be stopped \> 72 hours prior to cd19-car-t2 cells infusion * allogeneic cellular therapy: any donor lymphocyte infusions (dli) must be completed \> 4 weeks prior to cd19-car-t2 cells infusion * gvhd therapies: any drug used for gvhd must be stopped \> 4 weeks prior to cd19-car-t2 cells infusion * chemotherapy: i. the following drugs must be stopped \> 1 week prior to ctl019 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: hydroxyurea, vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate \ 4 weeks prior to ctl019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside \> 100 mg/m2, anthracyclines, cyclophosphamide), excluding the required lymphodepleting chemotherapy drugs * any situation that may increase the risk of the test or interfere with the test results

Keywords: leukemia cart cd19 chemotherapy resistant chemotherapy refractory cd19 + lymphoma
first-line intraperitoneal cisplatin and etoposide chemotherapy for ovarian cancer

Conditions: Bulky Stage IIIC and IV Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Summary: the purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.

this exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in the first-line therapy for ovarian cancer.

Eligibility criteria:
inclusion criteria: * age ≥18 years to ≤ 75 years. * epithelial ovarian cancer with pathology confirmed stage iiic or iv, expect for lymph node metastasis alone * optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 1cm * available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection. * ecog performance 0-2. * no more than 3 cycles of chemotherapy prior to surgery. * laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil count greater than 1,500/mm3; platelet count greater than 100,000/mm3. hepatic: bilirubin less than 1.25 times upper limit of normal (uln); bilirubin \< 2.0, sgpt less than 2 times uln. renal: creatinine less than 1.6 mg/dl, or creatinine clearance greater than 40 ml/min. * comply with intraperitoneal chemotherapy and follow-up. * written informed consent. exclusion criteria: * low-malignant potential ovarian tumor. * laboratory testing insufficiency. hemoglobin \ 1.6. * bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; platelet count less than 80,000/mm3. * active infection. * clinically significant gastrointestinal abnormalities. * active coronary artery disease, cerebrovascular disease, restrictive or obstructive pulmonary disease, or congestive heart failure. * other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up. * prior invasive malignancies within the last 5 years showing activity of disease.

Keywords: ovarian cancer intraperitoneal chemotherapy
study on the difference of axilo-rectal temperature in appendicitis

Conditions: Appendicitis; Gastroenteritis

Summary: the investigators are studying prospectively the difference in axilo-rectal temperature in patients with acute appendicitis and using as a control group patients consulting with acute gastroenteritis at our emergency unit.


Eligibility criteria:
inclusion criteria: * patients with acute appendicitis * patients with acute gastroenteritis * patients older than 15 years of age exclusion criteria: * other acute abdominal diseases

Keywords: appendicitis gastroenteritis temperature fever acute abdomen axilo-rectal temperature in appendicitis axilo-rectal temperature in gastroenteritis
an immunogenicity and safety study of gardasil® in chinese subjects (v501-030)(completed)

Conditions: Papillomavirus Infections

Summary: this is a china registration study. a randomized, double-blind, placebo-controlled immunogenicity and safety study in chinese female participants aged 9 to 45 years and male participants aged 9 to 15 years. approximately 600 participants will be randomized in a 1:1 ratio to receive either vaccine or aluminum-containing placebo. each participant received one injection at each visit at day 1, month 2, and month 6. vaccine or placebo was given as a 0.5-ml intramuscular injection. serum will be collected from all participants to evaluate immune response against anti-human papillomavirus (hpv) 6/11/16/18 with luminex assay. at month 2, month 6, month 7, subjects will be evaluated for any new medical condition or health concerns and serious adverse experiences throughout the study. the primary objective is to evaluate the vaccine-induced serum anti-hpv 6, 11, 16 and 18 antibody titers following 3-dose regimen of gardasil® compared with placebo.


Eligibility criteria:
inclusion criteria: * healthy female participants aged 9-45 years old and male participants aged 9-15 years old * participants agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes * not pregnant now (as demonstrated by a negative urine beta-human chorionic gonadotropin (beta-hcg) test) for post-pubertal female participants

Keywords: hpv infections
self-sampling and human papillomavirus (hpv)-testing for unscreened women in cervical cancer prevention

Conditions: Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Summary: scientific context high-risk types of human papillomavirus (hpv) are the causative agents for cervical cancer. cervical cancer screening strategies rely on periodic papanicolaou (pap) testing. it's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. in france, it now seems that the screening strategy could be optimized. the two main ways are to reach the 7 million underscreened women (mass screening, self-sampling for hpv dna testing) and to improve the screening test (hpv dna testing, computer-assisted cytology). self-collected vaginal samples (scvs) for hpv dna testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. currently, there is no french data on the scvs for hpv dna testing. the goal of this study is to determine the performance and acceptability of a population-based strategy using self-collected vaginal samples for hpv dna testing to reach women who are not participating in cervical cancer screening. description of the project this project (apache-1) is a part of a project called apache. apache-1 will be dedicated to the scvs technical validation and to the comparison between different transports medium. nine hundred women will be recruited from the 20 to 65 years consultants in the tours university hospital (chru of tours) and in the irsa (health centre for routine medical checkup). each woman will collect 2 scvs with a nylon flocked swab (copan® microrheologics™). the first scvs will be put in a vial which contains a liquid medium. the second scvs will be put in a dry vial. then during the speculum examination the physician will collect a cervical sample with a rovers® cervex-brush™ and then rinse it into a vial containing préservcyt ™. a blind hpv dna testing and genotyping (inno-lipa hpv genotyping ™ extra) will be performed in the virology laboratory of the chru of tours on all samples (scvss and cervical samples performed by a physician). the performance of the scvs to detect cervical hpv infection will be assessed (gold standard test = hpv dna testing on cervical samples collected by the physician). in a second time (apache-2), the researchers will investigate to what extent offering home obtained scvs leads to participation of unscreened women. apache-2 will be registered on clinicaltrials as another project.


Eligibility criteria:
inclusion criteria: * women between 20 and 65 exclusion criteria: * menstruation * pregnant * inability to give informed consent * vaccinated against hpv 16 and 18 * total hysterectomy * treatment of cin 1, 2 or 3 * abnormal smear in the past year * smear in the past 2 years * virgin

Keywords: mass screening polymerase chain reaction vaginal smears
temperature skin check after cryotherapy application

Conditions: Body Temperature Changes

Summary: the aim of this study was to reheat the skin in different ethnic groups after application of cryotherapy.

it is a clinical randomized cross-sectional. this study was approved by the ethics committee of the universidade paulista - unip under protocol number 125 608 of 18/10/2012. the study included 24 subjects randomly recruited from both sexes and from four different ethnic groups: white, brown, black and asian with different ages, individuals intolerant to cold, suffering any change in skin sensitivity, illness from infectious diseases or previously diagnosed to respond negatively to the use of cold were excluded. the survey was conducted in the clinic physiotherapy universidade paulista - unip in light and airy ambience, with recording of the mean daily temperature in degrees celsius planned for the capital of são paulo by newsletter climatempo available and accessed http://www.climatempo.com.br/previsao-do-tempo/cidade/ before all applications, the average temperature obtained in the days from the application was 21.93° celsius. for obtaining of personal data and anthropometric evaluations, a data sheet prepared by the authors to self-fulfillment, and then calculated the bmi of subjects, if in doubt, check the height and body mass was performed before the application of cryotherapy. participants were divided into 4 groups of different ethnicities - white, brown, black and asian; ethnicity was proven through the birth certificates of volunteers, according to the classification described by the brazilian institute of geography and statistics - ibge. all participants were maintained in supine position for 20 minutes to rest and stabilization of body temperature, sleep after receiving an application through the cold thermal bag thermo gel ® brand size "p" consisting of a cellulose-based gel for subsequently receiving of cryotherapy in the middle third of the right thigh and left earlier, leaving 15-20 cm from the anterior superior iliac spine - asis side tested, depending on the stature of the individual being assessed and 5 cm away from the surface to be evaluated, according to manufacturer's instructions. the temperature was verified on site described before, during and after applications of cryotherapy which lasted for 30 minutes and then recorded. to check the temperature after application of cryotherapy was used a thermometer brand cason ® infrared thermometer ac 380 (- 32 º c 380 º c).

Eligibility criteria:
inclusion criteria: * belong to ethnic groups requested exclusion criteria: * suffering any change in skin sensitivity, illness of an infectious nature or previously diagnosed diseases that respond negatively to the use of cold

Keywords: skin temperature ethnic groups cryotherapy
to explore the efficacy and safety of surgical treatment for constipation, as well as the changes of postoperative intestinal motility, flora, nutritional status and other indicators

Conditions: Constipation; Surgical Treatment

Summary: chronic constipation is a heterogeneous disease with multiple symptoms, and its incidence is on the rise in many countries. it has become a common disease affecting the quality of life. when these patients fail to respond to standardized and systematic non-surgical treatment, and the relevant examination suggests that there are surgical indications, surgical treatment should be considered. tthe objective of this study was to explore the efficacy and safety of surgical treatment for constipation, as well as the changes in postoperative nutrition, intestinal motility, intestinal flora and quality of life.


Eligibility criteria:
inclusion criteria: * disease duration more than 6 years; * wexner constipation score \>15; * no response to medical treatment, biofeedback and fecal microbiota transplantation; * according to the surgical indications; * all patients were informed of this study and signed the informed consent. exclusion criteria: * suffering from mental disorders or cognitive impairment; * with malignant tumors; - * with history of gastrointestinal surgery; * complicated with other organ dysfunction; * with immune system diseases.
bone microstructure after gastrectomy evaluating by using hr-pqct

Conditions: Osteoporosis; Sarcopenia; Gastric Cancer

Summary: osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. the aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (hr-pqct) in the long course after gastrectomy. in total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

the patients after gastrectomy loss appetite and decrease the weight. total gastrectomy especially cause severe sarcopenia and metabolic change. osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. the primary tools for assessing volumetric density and bone structure are quantitative computed tomography (qct) and more recently, high-resolution peripheral quantitative computed tomography (hr-pqct). however the validation of osteoporosis with hr-pqct before and after gastrectomy remain elusive. the aim of the present study was to evaluate osteoporosis by using hr-pqct before and after after endoscopic resection, distal gastrectomy, and total gastrectomy in the patients with gastric cancer.

Eligibility criteria:
inclusion criteria: * planning esd, dg, or tg due to gastric cancer * provide signed informed consent exclusion criteria: * pregnancy * current use of the following osteoporosis agents; teriparatide, denosumab, and bisphosphonate * hyperthyroidism * hyperparathyroidism * present malignancy (except in situ carcinoma) * any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy * other diseases which affect bone metabolism * any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures * received \> 3 months (or equivalent) of osteoporosis treatment * currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
effect of non-surgical periodontal treatment on hba1c in type 2 diabetic patients

Conditions: Chronic Periodontitis; Type 2 Diabetes Mellitus

Summary: the main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of hba1c in patients with type 2 diabetes mellitus (t2dm). this study is a 6-month, single-masked, randomized clinical trial.a total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: treatment group, control group.

background: periodontitis and diabetes are both highly prevalent conditions, and the association between these two common diseases has been recognised by dental professionals for many years. aim: the main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of hba1c in patients with type 2 diabetes mellitus (t2dm). methods: this study is a 6-month, single-masked, randomized clinical trial.a total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: treatment group (tg) (oral hygiene instructions (ohi) + scaling and root planing (rar) using ultrasound device and gracey curettes); control group (cg) (ohi + supragingival removal of plaque and calculus with ultrasonic device). cg patients receive salvage therapy if a significant worsening of their periodontal status and / or metabolic observed. periodontal assesment (probing pocket depth (ppd), gingival index (gi), and plaque index (pi)) and systemic assesment (random blood sugar, glycosylated hemoglobin (hba1c), and salivary cytokines) and bacterial asessment at baseline and 3, 6 months after treatment is performed. there will be a single examiner, blind and calibrated to improve reproducibility. the investigators' hypothesis is that non-surgical periodontal treatment reduces hba1c, improving metabolic control in patients with dm

Eligibility criteria:
inclusion criteria were: * diagnostic of t2dm (diagnosed at least 1'5 years prior the study). * presence of generalized chronic periodontitis (with at least 9 teeth present and more than 30% of locations with probing depth (pd) and clinical attachment level (cal) ≥4mm). exclusion criteria included: * patients who received antibiotics the last 15 days, or for a period longer than 10 days the last three months. * having received non-surgical periodontal treatment within the past 6 months. * pregnancy * significant change of medication for diabetes during the course of the study * evidence of other serious systemic disease (asa iii or iv) which may influence periodontal disease.

Keywords: dental root planing and scaling periodontal disease type 2 diabetes mellitus glycosylated hemoglobin a
deshydrat : assessment of the prevalence of dehydration among 9 to 11 year-old children

Conditions: Dehydration

Summary: the aim of the study is to determinate the prevalence of moderate dehydration among children aged 9 to 11 who are going to school.

many children have a limited caloric intake at the breakfast with a limited amount of water intake. there is no data about the prevalence of dehydration in children who are regularly going to school in france.

Eligibility criteria:
inclusion criteria: * healthy child aged 9 to 11 years old. exclusion criteria: * individual with illness * individual with past history of gut or metabolic diseases * past history of renal disease. * child whom parents decline to participate
determinants of rehabilitation outcomes in survivors of primary subarachnoid haemorrhage

Conditions: Subarachnoid Hemorrhage, Spontaneous

Summary: a retrospective, observational single centre study of electronic medical records of discharged patients who were admitted to from 1 january 2015 to 31 december 2018. period of data collection was from 5 august 2019 to 15 september 2019.

the objectives of this study were to describe a local cohort of acute sah survivors during inpatient rehabilitation at a single tertiary rehabilitation centre in singapore and identify early predictors impacting discharge rehabilitation outcomes.

Eligibility criteria:
inclusion criteria: * 1. spontaneous, first-ever sah diagnosed by admitting neurosurgeons and confirmed on neuroimaging (ct or magnetic resonance imaging) 2. transferred from acute care facilities or admitted from clinics to ttsh rc 3. ages between 21 - 85 years 4. duration of sah to rehabilitation admission ≤6 months exclusion criteria: * 1. no radiological evidence of sah 2. traumatic sah 3. previous diagnosis of sah 4. main reason for admission into ttsh rc was not for inpatient rehabilitation (e.g. wound care, medical or social admission)
a study of patients treated with the journey deuce bicompartmental knee system

Conditions: Osteoarthritis

Summary: this is a prospective, multicenter, consecutive clinical study of the journey deuce knee system and is intended to evaluate the safety and effectiveness of the new device.

the objectives of this study are to assess the safety and effectiveness of the journey deuce bicompartmental knee system. patients will be examined clinically at time intervals throughout the study duration. exams will include completion of clinical assessment, x-rays, and completion of patient questionnaires.

Eligibility criteria:
inclusion criteria: * patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement. * patient is 30 to 75 years of age, inclusive. * patient is willing to consent to participate in the study by signing and dating an irb-approved consent form. * patient plans to be available for follow-up through five years postoperative. exclusion criteria: * patient is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders. * patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder (i.e. chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or patients with acquired immunodeficiency syndrome (aids). * patient has inflammatory arthritis (e.g. rheumatoid arthritis) * patient has bmi greater than or equal to 40. * patient has had major knee surgery in the past i.e. hto, unicondylar knee replacement, failed fracture fixation. * patient has an active infection, local or systemic. * patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and followup (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as parkinson, multiple sclerosis, etc.). * patient has acl deficiency in the study knee. * patient has hip arthritis and/or replacement. * patient has lateral compartment disease. * patient is pregnant or plans to become pregnant during the course of the study. * patient has a known sensitivity to materials in the device.

Keywords: deuce journey deuce knee pain osteoarthritis bicompartmental femoral medial