Kornimate/medical-research-clean huggingface dataset:
cd19-targeted car t cells （jwcar029） for primary refractory diffuse large b cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: this is a phase i, open-label, single-arm, multicenter study to assess the safety and efficacy of jwcar029 in adult primary refractory dlbcl subjects in china

this is a phase i, open-label, single-arm, multicenter study conducted in adult subjects with primary refractory dlbcl in china to evaluate the safety, efficacy, pharmacokinetics(pk), pharmacodynamics(pd) of jwcar029 and collect immune response after jwcar029 treatment. one dose level of 1.0 x 10\^8 car+ t cells is adopted in this study. all sujects will be followed for 2 years after jwcar029 infusion.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old; 2. sign on the informed consent; 3. subject must have histologically confirmed diffuse large b lymphoma and primary refractory with first-line therapy; 4. subjects have accessible pet-positive lesion and have measurable ct-positive lesion according to lugano classification; 5. eastern cooperative oncology group (ecog) performance status of 0 or 1; 6. adequate organ function; 7. adequate vascular access for leukapheresis procedure; 8. subjects who have previously received cd19 targeted therapy must confirm that lymphoma lesions still express cd19; 9. women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of jwcar029; 10. males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of jwcar029 exclusion criteria: 1. subjects who have received second-line treatment or above 2. cd19 negative 3. primary cns lymphoma; 4. history of another primary malignancy that has not been in remission for at least 2 years; 5. subjects has hbv, hcv, hiv or syphilis infection at the time of screening; 6. deep venous thrombosis (dvt)/pulmonary embolism (pe), or dvt/pe requires anti-coagulation within 3 months prior to signing the icf; 7. subjects with uncontrolled systemic fungal, bacterial, viral or other infection; 8. presence of acute or chronic graft-versus-host disease (gvhd); 9. history of any serious cardiovascular disease or presence of clinically relevant cns pathology; 10. pregnant or nursing women; 11. subjects using of any chemotherapy, corticisteriod, experiment agents, gvhd therapies, radiation, allo-hsct or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; 12. uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; 13. received car t-cell or other genetically-modified t-cell therapy previously.

Keywords: primary refractory
a multicenter trial of a shared decision support intervention for patients offered implantable cardioverter-defibrillators

Conditions: Heart Failure, Systolic; Heart Failure

Summary: the investigators goal is to assess real-world effectiveness of patient decision aids (ptda) for high-risk decisions using the implantable cardioverter-defibrillator (icd) as a model.

the investigators propose the decide-icd trial: a type ii effectiveness implementation hybrid trial of the investigators icd ptdas. the investigators will use a 6-site stepped-wedge design, with implementation guided by normalization process theory® and evaluation guided by the re-aim framework. the investigators aim to evaluate reach and effectiveness of the icd ptdas using a pragmatic, stepped-wedge design on decision quality (knowledge and value-concordance) and psychosocial outcomes. * hypothesis 1a: ptdas will reach over 50% of eligible patients. * hypothesis 1b: icd ptdas will be effective in improving decision quality in real-world practice. * hypothesis 1c: better informed patients will have lower anxiety, higher rates of planning for the possibility of deactivation, and increased identification of a surrogate decision maker. the investigators propose 3 a priori hypotheses: * the decision aids will have a differential effect on the decisions of participants by age (\>= 70 years old vs \<70 years old); * the decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic); * the decision aids will have a differential effect on the decisions of participants by the type of device they are considering (icd vs icd replacement vs crt-d). along with these hypotheses, we recognize that other important covariates exist, such as health literacy and education level.

Eligibility criteria:
inclusion criteria: * 18 years or older * english-speaking (videos and surveys have only been validated in english) * patients have been offered a primary prevention icd for initial implant, reimplantation, or crt with defibrillation exclusion criteria: * prisoners

Keywords: shared decision making; defibrillator
study of cisplatin in cervical cancer stage ivb

Conditions: Cervical Cancer

Summary: this is a single arm, open-label study in women from china who have advanced (stage ivb) recurrent or persistent cervical cancer to ⑴assess the response rate (i.e., cr + pr) of cisplatin combined with topotecan in treatment of advanced (stage ivb) recurrent or persistent cervical cancer; ⑵assess the toxicities of ct regimen in treatment of cervical cancer. prior to treatment, written informed consent should be obtained from all patients. eligible patients will be assigned to ct regimen. the ct regimen is topotecan 0.75 mg/m2 iv during 30minutes days 1, 2, and 3; followed by cisplatin 50 mg/m2 iv on day1, repeated every 21 days. the study will consist of two phases: the safety run-in phase and study phase.


Eligibility criteria:
inclusion criteria: * women with advanced recurrent or persistent carcinoma of the uterine cervical who were unsuitable candidates for curative treatment with surgery and/or radiotherapy. * histologic types included squamous, adenosquamous, and adenocarcinoma of the cervia. * patients must be at least 18 years old. * measurable and/or evaluable disease parameters will be documented and recorded using clinical evaluation (and using ct for pathologic nodes when present). * life expectation greater than 3 months. * patients must have adequate organ function. * patients without history of sensitivity to camptothecin or platinum. * patients who are non-child-bearing potential, or consistent and correct use of methods of birth control from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of observational medication. * performance status 0 to 2; to have recovered from the effects of recent surgery, chemoradiotherapy, or radiotherapy; and to be free of clinically significant infection. * written informed consent exclusion criteria: * patients with uncontrolled infections. * patients with concurrent severe medical problems unrelated to the malignancy which would expose the patient to extreme risk. * patients who received another investigational drug within 30 days prior to study entry. * patients who are receiving concurrent other chemotherapy, hormonal, immunotherapy or radiotherapy. radiotherapy for palliation of related bone metastases is permitted. * patients with a history of allergic reactions to compounds chemically related to topotecan or platinum. * patients who are pregnant or lactating * concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin.
a study evaluating near-infrared zone ii imaging in sentinel lymph node mapping in breast cancer patients

Conditions: Breast Cancer; Sentinel Lymph Node

Summary: this study aims for evaluating near infrared zone ii imaging in sentinel lymph node mapping in breast cancer patients.

multi-wavelength fluorescence has been surveyed in various fields of surgery. however, it was still under investigation, and has not been matured for clinical use. this study will evaluate near infrared zone ii spectrums for breast cancer patient undergoing sentinel lymph node mapping with near-infrared fluorescence navigation.

Eligibility criteria:
inclusion criteria: * breast cancer, adults exclusion criteria: * patient aged \< 20 years old * primary lesion without indication of sentinel lymph node biopsy in current guidelines (low-risk ductal carcinoma in situ or metastatic breast cancer) * patient who is allergic to primary tracers (including tc99m and blue dye) * patient who is allergic to indocyanine green

Keywords: indocyanine green image-guided surgery multispectral fluorescence imaging
effects of brain stimulation during nocturnal sleep on memory consolidation in patients with mild cognitive impairments

Conditions: Mild Cognitive Impairment, So Stated

Summary: the beneficial effect of nocturnal sleep on memory consolidation is well-documented in young, healthy subjects. especially, periods rich in slow-wave sleep (sws) have shown a memory enhancing effect on hippocampus-dependent declarative memory. slow oscillatory activity typically occuring during sws has been implicated in the consolidation effect. recent evidence in young healthy subjects suggest that the sleep-associated consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of sws in humans (0,7-0,8 hz) during sws. if patients with amnestic mild cognitive impairments (mci)- usually characterized by initial difficulties in hippocampus dependent memory functions - benefit from transcranial slow oscillatory stimulation (tsos) during nocturnal sleep as well has not been studied so far. the primary aim of the present study is to investigate the influence of a weak slow oscillating brain stimulation (tsos) on declarative memory consolidation applied during periods of nocturnal sws in mci patients.


Eligibility criteria:
inclusion criteria: * amnestic and amnestic plus mci-patients: 1. concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time) 2. objective evidence of memory impairment; additional cognitive domains may be affected as well; 3. preservation of independence in functional abilities 4. no dementia * age: 50-90 years exclusion criteria: * untreated severe internal or psychiatric diseases * epilepsy * other severe neurological diseases eg., previous major stroke, brain tumour * dementia * contraindications to mri

Keywords: mild cognitive impairment dementia mci brain stimulation tsos tdcs sleep memory memory consolidation
nabothian cyst protects or facilitates against cervical cancer

Conditions: HPV Infection; Nabothian Cyst; Cervical Cancer

Summary: aim of the study to asses the realition between hpv infection, nabothian cyst and cervical intraepithelial lesions or cervical cancer

nabothian cysts are one of the common gynecological pathologies. they rarely have clinical significance. transvaginal ultrasonography and magnetic resonance imaging are the most useful imaging methods for cervical cystic lesions.hpv infection is the most important factor which can cause cervical malignancy and premalignant lesions. in women between 30-65 years of age hpv-dna testing, is used as a screening test in turkey. in this research, the aim is to examine whether there is a connection between naboth cysts and hpv infection in the cervix. during the examination, the swab sample required for hpv pcr testing will be taken. the number and size of naboth cysts with vaginal usg will be noted. if the patient had colposcopy / leep (loop electrosurgical excision procedure), the result will be investigated and noted.

Eligibility criteria:
inclusion criteria: to have naboth cyst and/or hpv positivity must be willing and able to provide informed consent comply with the study protocol between 25-65 age range exclusion criteria: to refuse participate in our research the age under 25 and over 65 ovarian, endometrial and vulvar malignancies without both naboth's cyst and hpv positivity to have leep/cervical conization before history of cervical dysplasia
ct scans in guiding the treatment of patients with prostate cancer who are undergoing radiation therapy

Conditions: Prostate Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. multiple ct scans may improve the accuracy of radiation therapy for prostate cancer. purpose: phase i trial to study the effectiveness of multiple ct scans in guiding the treatment of patients who have prostate cancer and are undergoing radiation therapy.

objectives: * compare the accuracy of radiotherapy delivery using multiple ct scans to guide patient positioning vs the standard portal image guided procedure in patients with prostate cancer undergoing external beam radiotherapy. * determine the reduction in the proportion of patients with large target positioning errors using the ct-guided procedure. * determine organ motion and setup errors over the course of radiotherapy in order to develop efficient clinical intervention strategies in these patients. outline: patients undergo radiotherapy over 9 weeks. patients undergo a ct scan immediately prior to receiving radiotherapy on treatment days 3-8 and then weekly thereafter. on 3 different days, patients also undergo ct scan immediately after radiotherapy. if the ct scans indicate a correction that exceeds the action level currently in effect, then beginning with the next treatment, the patient's position with respect to the radiation field is adjusted. projected accrual: a total of 25 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * undergoing external beam intensity-modulated radiotherapy for prostate cancer * able to maintain treatment position for about 40 minutes patient characteristics: age: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * see disease characteristics surgery: * not specified

Keywords: stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer stage iv prostate cancer recurrent prostate cancer
clarithromycin versus azithromycin in treatment of mild covid-19 infection

Conditions: Covid19

Summary: the current study was conducted at qena governorate, egypt, during the period from may 2020, to july 2020. the study included 305 covid-19 cases diagnosed by pcr, patients were randomly assigned to one of three study limps, azithromycin 500 mg/24 h for 7 days, clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, all three groups received only symptomatic treatment for control of fever and cough

the current study was conducted at qena governorate, egypt, during the period from may 2020, to july 2020. the study included 305 covid-19 cases diagnosed by pcr, patients were randomly assigned to one of three study limps, azithromycin 500 mg/24 h for 7 days, clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, all three groups received only symptomatic treatment for control of fever and cough. all study participants underwent full clinical evaluation including duration of fever, cough, dyspnea, anosmia or git symptoms, c-reactive protein (crp), serum ferritin, d-dimer, complete blood count (cbc), non-contrast chest computed tomography (ct) which was repeated 2 weeks after the start of treatment. the azithromycin group included, 107 patients, mean age 45.8 ±18 years, 73 male and 34 female, the clarithromycin group included 99 patients mean age 46.1±19 years, 68 males and 31 female, the control group included 99 patients, with mean age 41.1 ± 18 years, 73 male and 28 female.

Eligibility criteria:
inclusion criteria: * covid-19 cases * oxygen saturation \> 93% * age \>18 years exclusion criteria: * patients \<18 years, * patients with oxygen saturation \< 93%, patients with * diabetes mellitus or * heart failure, * patients on chemotherapy or immunosuppressive therapy

Keywords: azithromycin clarithromycin covid-19
tea, esb and paravertebral block during single-lung ventilation for lung resection

Conditions: Lung Diseases; Pain, Acute

Summary: thoracotomy operations are known to be painful surgical procedures, so providing effective intraoperative and postoperative analgesia is so important for all anaesthesiologists. ineffective pain management interferes with deep breathing, coughing, and remobilization resulting in atelectasis and pneumonia. ultrasound-guided esp block is a myofascial plane block that provides analgesia for thoracic or abdominal segmental innervation depending on the level of the injection site. thoracic epidural analgesia (tea) is considered the gold standard analgesic technique for thoracic surgeries. but the invasiveness of this technique, the rare but serious neurologic complications and the failure rates up to 30% are the disadvantages of epidural analgesia

the aim of this study is to compare the effect of different blocks as tea, erector spinae block or paravertebral block on improving peri-operative analgesia and post-operative outcome in pulmonary resection in adult patients.

Eligibility criteria:
inclusion criteria: * aged between 18 to 70 years old for elective lung resection. with american society of anesthesiology physical status (asa-ps) i-iii exclusion criteria: * total pneumonectomy * hepatic or renal dysfunction. * contraindications for epidural anesthesia as coagulopathy and neurological and spinal deficits. * emergency cases
analytical performances and clinical impact of the roche cobas® liat influenza a/b & rsv assay in the management of adult and pediatric patients attending the emergency room

Conditions: Influenza Viral Infections; RSV Infection

Summary: molecular techniques for respiratory virus detection have already shown benefits in terms of sensitivity gained in comparison to conventional techniques. recent progress has made it possible to shorten turnaround time (tat) and to allow delivery of results in a timely manner, especially in comparison to cell culture and direct fluorescence assays (dfa). however, the cost of these molecular assays is usually not taken in charge by public health insurance system. this could be partly explained by the fact that molecular techniques have not clearly shown cost-effectiveness. results of molecular tests for influenza viruses and rsv, if delivered rapidly, in the emergency room (er), would most likely help avoid antibiotic use and ancillary test prescription, improve antiviral prescription and shorten length of stay in the ward by facilitating discharge or cohorting of hospitalized patients. the goal of this study is to assess the performances of roche cobas® liat influenza a/b \& rsv assay, to appraise its clinical impact and to evaluate its cost effectiveness.


Eligibility criteria:
inclusion criteria: * either a pre-test indication of hospitalization * or an underlying situation at risk of respiratory complication following influenza infection
an eight-week study evaluating the efficacy of two fixed doses (250 mg twice daily and 100 mg twice daily) of ssr149415 in patients with major depressive disorder

Conditions: Depressive Disorder

Summary: the purpose of the study is to evaluate the efficacy of ssr149415 in the treatment of major depressive disorder, defined as a change from baseline to visit 7 in the hamilton depression rating scale. to evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.to evaluate plasma concentrations of ssr149415.


Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder, recurrent, as defined by diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria (296.3) and confirmed by the semi-structured mini international neuropsychiatric interview (mini) exclusion criteria: * total score of less than 24 on the madrs. * ham-d total score less than 18. * duration of the current depressive episode less than 1 month or greater than 2 years. * patients with a history or presence of bipolar disorders or psychotic disorders. * patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence. * patients who have used the following prior to entry into acute phase: antipsychotics within 3 months, fluoxetine within 1 month, maois within 2 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week. the investigator will evaluate whether there are other reasons why a patient may not participate

Keywords: depression antidepressive disorders controlled clinical trial
the utility of performing brain ct scan in non trauma patients at the pediatric emergency unit

Conditions: Convulsions; Increased Intracraneal Pressure

Summary: pediatric patients are admitted to the emergency room for diverse causes, beside trauma, patients can present with convulsions, suspicion of brain tumor or increased intracranial pressure. in most of the cases a brain ct is performed even before physical examination by a skilled neurologist. the amount of radiation that the children are exposed is equivalent to 100 plain chest x rays. the purpose of this tudy is to examinate in a retrospective study what were the indications for ct study and what was the incidence of relevant abnormal findings that required emergency intervention or referral.


Eligibility criteria:
inclusion criteria: * all patients in the pediatric age that underwent brain ct scan in the pediatric emergency room exclusion criteria: * patients with recent history of trauma

Keywords: brain ct scan pediatric emergency room
ui-ewd for endoscopic hemostasis of bleeding peptic ulcers and bleeding after emr/esd

Conditions: Upper Gastrointestinal Bleeding

Summary: ui-ewd (nextbiomedical co, incheon, south korea), a new hemostatic powder for endoscopic treatment of high-risk bleeding peptic ulcers and bleeding after esd/emr.

ui-ewd (endoscopic wound dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect and safety in endoscopic application will be verified. this study has been designed to observe comparing ui-ewd versus the submucosal epinephrine injection for endoscopic hemostasis of bleeding peptic ulcers and bleeding after emr/esd.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of bleeding peptic ulcer and active bleeding after esd/emr exclusion criteria: * coagulation disorder (plt \ 2) * connot stop taking the antiplatelet drug, nsaid, anticoagulant drug, and aspirin during endoscopic treatment and after 72h endoscopy
ocular responses to short and long-term lens wear

Conditions: Ametropia

Summary: the purpose of this study was to determine whether ocular surface sensitivity to pneumatic, mechanical and chemical stimulation would be affected by the use of the combination of a specific silicone hydrogel lens material with two lens care products over a four week period.


Eligibility criteria:
inclusion criteria: * is at least 17 years old and has full legal capacity to volunteer; * is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction; * is a current soft lens wearer and wears contact lenses six or more days/week; * has clear corneas and no active ocular disease. exclusion criteria: * has any clinically significant blepharitis or dry eye; * has undergone corneal refractive surgery; * is aphakic; * has any active ocular disease; * has any systemic disease affecting ocular health; * is using any systemic or topical medications that may affect ocular health;

Keywords: eye diseases