Kornimate/medical-research-clean huggingface dataset:
cd19 car-t cells for patients with relapse and refractory cd19+ b-all.

Conditions: B-cell Acute Lymphocytic Leukemia

Summary: the purpose of this study is to infusion cd19 car-t cells to the patients with relapsed and refractory cd19+ b cell leukemia, to assess the safety and feasibility of this strategy. the car enables the t cell to recognize and kill the leukemic cell through the recognition of cd19, a protein expressed of the surface of the leukemic cell in patients with cd19+ leukemia.

upon meeting the eligibility requirements and enrolling on study, subjects will be collected large numbers of peripheral blood mononuclear cells (pbmc) for the generation of the cd19 car-t cells. the t cells are isolated from the pbmc, transduced with a lentivirus to express the cd19 car as well as a truncated egfr that has no signaling capacity (noted egfrt) and expanded in vitro and then administered to subjects. subjects will have blood tests to assess safety and efficacy, and persistence of the cd19 car-t cells on week 4 after their last infusion. following the 6 months of intensive follow-up, subjects will be evaluated every 10 weeks for 1 year with a physical examination, blood tests, bone marrow aspirate, mrd and persistence of cd19 car-t. some subjects will receive cetuximab for ablation of the genetically modified t cells. criteria to receive cetuximab include acute toxicities that are life threatening.

Eligibility criteria:
inclusion criteria: * 1. 2 years to 70 years, expected survival \> 3 months; * 2. cd19 positive b-cell acute lymphoblastic leukemia; * 3. ecog \< 2； * 4. the tumor load in the bone marrow is less than 60%; * 5. cardiac function: 1-2 levels; liver: tbil≤3uln，ast ≤2.5uln，alt ≤2.5uln; kidney: cr≤1.25uln; peripheral blood: wbc ≥ 2.0×109/l, hb ≥80 g/l, plt ≥ 30×109/l）; * 6. no leukemia cells in the central nervous system; * 7. no serious allergic constitution; * 8. no other serous diseases that conflicts with the clinical program; * 9. no other cancer history; * 10. no serious mental disorder; * 11. female participants of reproductive potential must have a negative serum pregnancy test; * 12. informed consent is signed by a subject or his lineal relation. exclusion criteria: * 1. pregnant or lactating women; * 2. uncontrolled active infection, hiv infection, syphilis serology reaction positive; * 3. active hepatitis b or hepatitis c infection; * 4. recent or current use of glucocorticoid or other immunosuppressor; * 5. with severe cardiac, liver, renal insufficiency, diabetes and other diseases; * 6. participate in other clinical research in the past three months; previously treatment with any gene therapy products;
preterm labor prediction by cervical contour in ultrasound

Conditions: Preterm Labor

Summary: cervical length is a already known predictor for preterm labor. in this study the investigators want to examining the hypothesis that cervical curvature is also a predictor for preterm labor and that moderate transducer pressure influence cervical length. study population: 200 consecutive pregnant women between 14-34w, visiting in the ultrasound unit ether for routine screening or because of preterm labor. during their examination cervical length and curvature measurements will be taken. another measurement will be taken after applying moderate cervical pressure. the investigators will compere cervical contour and pressure influence between groups and according to cervical length demographic data will be taken at the time of recruitment and pregnancy outcome measures in a later telephone interview.


Eligibility criteria:
inclusion criteria: * pregnancy exclusion criteria: * cervical cerclage * pre term rupture on membrane in current pregnancy * unknown dating of pregnancy

Keywords: cervical length cervical curvature
trial of antibiotic prophylaxis in elective colorectal surgery

Conditions: Colorectal Surgery

Summary: to determine the optimal prophylactic antibiotics administration method in elective colorectal surgery

use of prophylactic antibiotics in elective colorectal surgery is essential. although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. we conducted a multicenter randomized trial of single-dose vs. three doses of the second-generation cephalosporin, cefmetazole.

Eligibility criteria:
inclusion criteria: * colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on) * elective colorectal resection exclusion criteria: * emergent operation * ileus * no resection * preoperative infectious diseases * penicillin or cephalosporin allergy * antibiotics administration before surgery * inflammatory bowel diseases * angina or myocardial infarction * renal dysfunction * diabetes mellitus * steroid administration before surgery

Keywords: antibiotics prophylaxis surgical wound infection
adefovir plus vaccination in transplant patients without hepatitis b that receive a core antibody positive liver

Conditions: Hepatitis B; Liver Transplantation

Summary: the primary purpose of this study is to evaluate the efficacy of adefovir (adv) in preventing de novo hepatitis b in patients who receive hepatitis b core antibody (hbcab) positive grafts but who are not hepatitis b surface antigen (hbsag) positive prior to transplant (hepatitis b naive patients). the second objective is to evaluate the efficacy of accelerated vaccination with hepatitis b in inducing innate immunity, thereby obviating the need for life-long antiviral therapy.

the investigators will conduct a prospective, open-label study of hepatitis b naive patients who received hbcab + livers and adefovir prophylaxis post-transplant. at one year to 18 months following transplantation, all study patients will then be vaccinated with standard hepatitis b vaccine at double dose on a monthly basis for three months, at which point they will be tested for hepatitis b surface antibody (hbsab). any study patients that have developed a sufficient antibody response (hbsab \>500 iu) will be given the option to discontinue anti-viral treatment in a monitored setting.

Eligibility criteria:
inclusion criteria: * recipients who do not have evidence of hepatitis b surface antigen, regardless of hbcab and hbsab status, who: 1. received liver transplantation with hepatitis b core antibody positive (and hbsag negative) grafts, 2. received adefovir treatment post transplantation, and 3. who have not reached the 18 month post transplantation time period. exclusion criteria: * recipients with hepatitis b surface antigen positivity prior to liver transplant. * grafts from hepatitis b surface antigen positive patients. * previous intolerance to adv therapy * recipients with pre-transplant creatinine \> 1.6 mg/dl * patients younger than 21 years of age * patients who are pregnant or breastfeeding

Keywords: vaccination immunocompromised host antiviral agents drug resistance, viral resource allocation
validation the artificial intelligence system for automatic evaluation of the extent of intestinal metaplasia

Conditions: Intestinal Metaplasia of Gastric Mucosa; Artificial Intelligence; Endoscopy

Summary: the operative link on gastric intestinal metaplasia assessment (olgim) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. but its clinical application is limited for at least biopsy samples. the endoscopic grading system (eggim) has been shown a significant correlation with the olgim. the investigators designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of im and calculate the eggim scores in endoscopy examination. this study is aimed at exploring the relevance of the eggim scores automatically evaluated by artificial intelligence and olgim scores.

gastric intestinal metaplasia(gim) is an important stage in the gastric cancer(gc). the operative link on gastric intestinal metaplasia assessment (olgim) staging systems using biopsy specimens were commonly used for histological assessment of gastric cancer risk. however, its need to take at least 4 biopsies is not clinically feasible. the endoscopic grading system (eggim) has been shown a significant correlation with the olgim. an eggim score of 5 was the best cut off value for identifying olgim stage iii/iv patients. the investigators have designed a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of im and calculate the eggim scores in endoscopy examination. this study is aimed at exploring the relevance of the eggim scores automatically evaluated by artificial intelligence and olgim scores.

Eligibility criteria:
inclusion criteria: * patients aged 40-75 years who undergo the iee examination exclusion criteria: * patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric * disorders who cannot participate in gastroscopy * patients with previous surgical procedures on the stomach * patients with contraindications to biopsy * patients who refuse to sign the informed consent form
the use of ultrasound in assessing post-prostatectomy erectile dysfunction

Conditions: Prostate Adenocarcinoma

Summary: researchers are trying to determine whether there is additional utility to using vibroelastography, a noninvasive ultrasound technique to evaluate for the presence of tissue fibrosis, in conjunction with standard penile duplex doppler ultrasound to assess erectile function (recovery) after prostate cancer surgery.


Eligibility criteria:
inclusion criteria include: * age \> 40 years * clinically localized prostate cancer (american urological association grade groups 1-2; ct1c or ct2a-b; psa \< 10) without clinic or imaging evidence of localized extra-prostatic or metastatic disease (i.e. aua low and favorable intermediate risk prostate cancer) * international index of erectile function (iief) of ≥ 21 points at baseline (no or mild erectile dysfunction) * patient-expressed interest in consultation for sexual function (erectile function) preservation/ optimization * planned bilateral nerves-paring prostatectomy exclusion criteria include: * moderate or severe ed based in iief criteria (score \< 21) * history of prior pelvic or penile surgery * current or prior androgen deprivation therapy * planned non-nerve sparing prostatectomy

Keywords: radical prostatectomy
chemical profiling of colorectal and pancreatic cancers using breath analysis - feasibility study

Conditions: Colorectal Cancer; Pancreatic Cancer

Summary: detection of colorectal and pancreatic cancers using breath analysis - feasibility study

a diagnostic prospective study with no anticipated risks or constraints. main objective: to quantify differences in exhaled breath vocs of patients with colorectal or pancreatic cancers compared with cohorts without cancer.

Eligibility criteria:
inclusion criteria: * age 18 to 85 years at the time of consent. * scheduled for colonoscopy or endoscopic retrograde cholangio pancreatography. * fasted \>6 hours, consuming water only. * able to provide informed written consent. exclusion criteria: * lacks capacity or is unable to provide informed written consent. * pregnant or lactating woman. * histologically confirmed cancer in any organ.
omics techniques in fatty liver disease

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: nonalcoholic steatohepatitis (nash) is the most common cause of chronic liver disease in western countries and one of the leading causes of liver transplantation in the world. its spectrum ranges from simple steatosis to decompensated cirrhosis, resulting from progressive fibrosis due to inflammation and cellular injury. the reasons why patients with the same degree of steatosis have different evolutions are not sufficiently known. the objective of this project is to identify biomarkers that predict disease progression, using omics techniques, which can serve to develop new therapeutic strategies.


Eligibility criteria:
inclusion criteria: * metabolic syndrome * liver steatosis detected on transient hepatic elastography performed in the last 12 months * steatosis with or without fibrosis confirmed histologically in a liver biopsy performed in the last 12 months exclusion criteria: * concurrent liver disease (other than nafld) * chronic or prolonged use of any potential hepatotoxic drug or substance * hiv infection * cancer (except basal cell carcinoma)

Keywords: nonalcoholic fat liver disease nash metabolic fat liver disease risk factors noninvasive markers transcriptomics metabolomics proteomics liver fibrosis
full pulpotomy procedure of permanent molar teeth of adults using calcium silicate-based sealer material

Conditions: Irreversible Pulpitis

Summary: this clinical study aims to assess the efficacy of using calcium silicate based sealer as a capping material after complete removal of coronal pulp tissue. the study will evaluate both the clinical and radiographic changes.

root canal treatment has always been considered the first line of treatment for carious teeth with symptomatic irreversible pulpitis for a long time. however, after the evolution of calcium silicate based materials a more conservative option, which is pulpotomy began to gain reliability, especially that it preserves the vitality of the radicular pulp, clinically simpler, less time-consuming, and more cost-effective compared to conventional root canal treatment. in this study the investigators assess the clinical and radiographic success rate of using calcium silicate based sealer as a pulp capping material in permanent molars after pulpotomy. for the best of the investigators\&#39; knowledge, there is no available clinical data on the use of calcium-silicate based sealers as a pulp capping material in pulpotomy of permanent molars with symptoms of irreversible pulpitis.

Eligibility criteria:
inclusion criteria: * vital mandibular molar teeth with mature apices. * teeth that respond positively to cold testing. * teeth without any signs of necrosis including sinus tract or swelling. * teeth with caries extending ≥ 2/3 of dentine or exposing the pulp. * teeth with symptomatic irreversible pulpitis with/without apical periodontitis. * teeth without periodontal diseases or mobility. * teeth without root resorption, detectable pulp chamber and root canal calcification or history of trauma. * patients from both genders with age range from 20 to 45 years old. * patients with good or moderate oral hygiene and without any systemic diseases. exclusion criteria: pre-operative criteria: * non-vital teeth. * teeth with irreversible pulpitis with apical periodontitis. * teeth with immature apices. * teeth with periodontal disease or mobility grade ii or iii. * teeth that are badly decayed and need post and core placement. * patients refused to continue treatment procedures or refuse to commit to periodic follow-up sessions. * non-restorable teeth. intra-operative criteria: * if hemostasis could not be achieved within 6 minutes after full pulpotomy. * teeth with partial necrosis. * no bleeding after access cavity preparation. post-operative criteria: * presence of swelling. * presence of sinus tract. * pain on percussion after the end of the first week. * pain with palpation. * pain on biting after the end of first week. * mobility of the tooth. * fracture of tooth structure that renders the tooth non-restorable. * fracture of the restoration during the evaluation. * probing depth more than 3 mm.

Keywords: pulpotomy calcium silicate-based sealer irreversible pulpitis mta
metabolic viral host properties

Conditions: HCV Infection

Summary: patients' metabolic properties may affect their immune response. this study aims to assess the effect of hosts' metabolic properties to viral infection.

blood samples were drawn from patients with gaucher disease and healthy individuals, with and without hcv. blood samples were tested for protein specific t cell proliferation, ifng and il-10 using elispot assays, serum ifng, il-2, il-6, il-10 and il-4 levels. facs analysis was used for evaluation of lymphocytes subsets.

Eligibility criteria:
inclusion criteria: * inform consent exclusion criteria: * at patients request
on open-label study in participants with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus; Connective Tissue Disease; Autoimmune Disease

Summary: the purpose of this sle study is to evaluate the long-term safety and efficacy of ly2127399 in eligible sle participants who have completed the core studies (nct01196091) (nct01205438).


Eligibility criteria:
inclusion criteria: * have completed 52 weeks of treatment in core studies (nct01196091) (nct01205438) * given written informed consent * test negative for pregnancy at the time of enrollment * agree to use a reliable method of birth control exclusion criteria: * unwilling to comply with study procedures * any condition that renders the participants unable to understand the nature and scope and possible consequences of the study * any condition that in the opinion of the investigator poses an unacceptable risk to the participants if study drug would be administered

Keywords: lupus sle systemic lupus erythematosus immune system disease
cerebrospinal fluid il-6, il-8 and pct as early marker of an intrathecal infection in neurosurgical patients

Conditions: Intrathecal Infection; External Ventricular Drainage Associated Infection

Summary: the value of csf il-6, il-8 and procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.

the value of csf il-6, il-8 and procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.

Eligibility criteria:
inclusion criteria: * external ventricular drainage * informed consent exclusion criteria: * no informed consent * prior intrathecal infection * prior systemic infection / sepsis
a study in pediatric subjects with asthma using advair hfa, advair hfa with spacer, and advair diskus

Conditions: Asthma

Summary: collect pk/pd data for this age group to compare advair diskus with advair hfa

a repeat-dose open label randomized incomplete block design in pediatric subjects with asthma, ages 4-11 years, to compare systemic exposure and pharmacodynamics of fluticasone propionate and salmeterol following advair hfa 45/21mcg(2 inhalations), advair hfa 45/21mcg(2 inhalations) with aerochamber plus spacer and advair diskus 100/50 twice daily

Eligibility criteria:
inclusion criteria: * subjects with mild asthma * no significant medical conditions at screen * weigh at least 20 kg exclusion criteria: * no clinical abnormalities at screen visit * asthma control at least 3 months prior with anti-steroidal medication only

Keywords: pediatrics advair inhaler asthma advair diskus
intrauterine balloon and postoperative estrogen therapy in the prevention of adhesion reformation after hysteroscopic adhesiolysis

Conditions: Uterine Septum

Summary: patients who want to go tcrs will randomly divided 3 groups. in group 1(100 patients), women received postoperative estrogen therapy. in group 2 (100 patients), a foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. in group 3 (110 patients), women will not receive any of the treatment (comparison group). all subjects underwent two further hysteroscopy, one and three months after the initial surgery. at the second or third look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.

the uterine septum (us) is the most common congenital uterine malformation, accounting for about 75% of mullerian anomalies. transcervical resection of septum (tcrs) has been shown in several cohort studies to improve outcome, although evidence from prospectively conducted randomized trial is lacking. tcrs is generally considered to be safe but there is a concern that it may be complicated by post-operative formation of intrauterine adhesions. some investigators therefore recommend the use of postoperative adjuvant therapies with a view to preventing adhesion formation, as in the case of hysteroscopic surgery for asherman syndrome. the adjuvant measures proposed include postoperative estrogen therapy, the placement of an intrauterine device (iud) or foley catheter in the uterine cavity. unlike the case of asherman syndrome in which these various adjuvant therapies are often used and appear to be of benefit, it is uncertain if any of these adjuvant measures are of benefit or necessary in the case tcrs. in this study, the investigators will compare the postoperative adhesion formation rates who will receive foley catheter therapies 、postoperative estrogen therapy and those who will not receive any therapies to determine the usefulness of foley catheter therapies in reducing postoperative adhesion formation.

Eligibility criteria:
inclusion criteria: * patients who will go hysteroscopic transection of uterine septum between 2016 to 2017 at the hysteroscopy center, fuxing hospital; * patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions; * written informed consent obtained. exclusion criteria: * ongoing pregnancy; * peroperative fever or infections; * malignancy; * precious pelvic inflammatory disease; * uterine fibroid (\>3cm size); * endometriosis; * contraindications for anesthesia; * not able to read and/or understand informed consent.

Keywords: uterine septum intrauterine adhesions foley balloon