Kornimate/medical-research-clean huggingface dataset:
long-term follow-up of patients treated with genetically modified autologous t cells

Conditions: Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy; Multiple Myeloma; DLBCL; ALL, Adult and Pediatric; T Cell Lymphoma

Summary: long-term follow-up of patients exposed to an auto car t cell therapy for up to 15 years following their first auto car t cell therapy infusion.

the purpose of this study is to monitor all patients exposed to an auto car t cell therapy, for up to 15 years following their first auto car t cell therapy infusion to assess the risk of delayed treatment-related saes, adverse events of special interest (aesis), monitor for emergence of replication competent retrovirus (rcr) or replication competent lentivirus (rcl), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess car transgene persistence and assess long-term efficacy. monitoring of such long-term effects of auto car t cell therapy will help to further define the risk-benefit profile of these new car t cell therapies.

Eligibility criteria:
inclusion criteria: 1. patients must have received an auto car t cell therapy on a clinical treatment study. 2. patients must have provided informed consent for long-term follow-up study prior to participation. 3. patients must be able to comply with the study requirements. exclusion criteria: 1. there are no specific exclusion criteria for this study.
comparison of the effects of nasal steroids and montelukast on olfactory functions in patients with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: the investigators aimed to evaluate by the sniffin' sticks test the effects on olfactory functions of nasal steroids and leukotriene antagonists used for allergic rhinitis.thirty patients with seasonal were included in this study. patients were randomly divided into three groups of 10 patients; group 1 received montelukast sodium and mometasone furoate therapy, group 2 received only montelukast, and group 3 only mometasone furoate. patients' olfactory functions were determined using the sniffin' sticks olfactory test before and after a month treatments. threshold, discrimination, identification, and tdi values were not significantly different among the groups before treatment. for group 1 and group 3 patients, there were statistically significant differences in threshold, discrimination, identification, and tdi values before and after treatment (p \ 0.05). according to the findings of our study, mf is superior to montelukast in improving olfactory function. although montelukast has been shown to be effective against ar symptoms, its effect on olfactory function was not demonstrated in this study.


Eligibility criteria:
inclusion criteria: * positive skin test to grass and/or tree pollens in patients with clinical history of seasonal ar for at least 1 year exclusion criteria: * patients who had received drug treatment or immunotherapy before the study were excluded. * patients with asthma, deviated nasal septum, history of nasal operation, turbinate hypertrophy, nasal polyposis or chronic nasal disorders, pregnancy, or upper airway infections were also excluded.

Keywords: montelukast sniffin' sticks test allergic rhinitis mometasone furoate
a randomized exercise trial for wheelchair users

Conditions: Spinal Cord Injury; Multiple Sclerosis; Muscular Dystrophy; Cerebral Palsy; Spina Bifida; Amputation; Arthritis; Stroke

Summary: people with mobility disabilities are at greater risk than the general population for incurring health problems. many of these conditions are preventable through behavior and lifestyle changes such as exercise and physical activity. recent evidence suggests that people with disabilities experience the same physiologic response to exercise as the general population. nonetheless, nearly three-fourths of those with disabilities report being entirely sedentary or not active enough to achieve health benefits. despite some knowledge of issues that limit physical activity among this population, few studies have investigated methods for promoting physical activity adoption among people with disabilities, including wheelchair users. the purpose of this study is to test the effectiveness of a behavioral intervention to promote physical activity adoption over 6 months and maintenance of physical activity over another 6 months by community-dwelling manual wheelchair users.


Eligibility criteria:
inclusion criteria: * be experiencing a permanent disability of at least 6 months that limits mobility sufficiently to require use of a wheelchair as the primary method of mobility outside the home * have not been moderately to vigorously physically active for the past 6 months * be willing to attend the educational workshop * receive physician approval for participation exclusion criteria include: * presence of medical conditions such as uncontrolled cardiovascular problems that the patient's physician identifies as being contraindicated for exercise * pregnancy or planning to become pregnant

Keywords: wheelchair use spinal cord injury multiple sclerosis muscular dystrophy cerebral palsy spina bifida amputation arthritis stroke
population pharmacokinetics of anti-infectious drugs in children

Conditions: Pediatrics; Ceftazidime; Ciprofloxacin; Voriconazole

Summary: the pharm a project is a french national collaborative project aiming to determine the population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric patients aged one month to five years.

the licensing process was introduced in order to ensure that medicines are safe, effective and of high quality. however, over 50% of children admitted to hospital in france and europe will receive an unlicensed or off-label medicine. this occurs for most drugs in children less than 6 years of age. they represent a particularly vulnerable subgroup of the paediatric population. there are major practical and ethical issues in relation to studying medicines in paediatric patients aged 5 years or less. * they represent only a small part of the population as compared to older children and adults, and the variation of specific types of diseases in this young subpopulation is higher than in the paediatric counterpart. there are major differences in drug disposition in the different age groups. * there is a need for suitable methodological approaches for clinical trials * there are major ethical issues it is essential, therefore, to recruit children from various regions in france in order to obtain a critical sample size of sufficient magnitude and to conduct scientific sound studies. this will be achieved by performing pharm a, a population pharmacokinetic study of three different anti infectious agents (ceftazidime, ciprofloxacin, voriconazole) and identify covariates including pharmacogenetic biomarkers that explain pharmacokinetic variability. after parental informed consent, sampling strategy will be randomized depending on the drug and the age group (2 samples in patients below 2 years and 3 samples in patients from 2 to 5 years).

Eligibility criteria:
inclusion criteria: * children aged 28 days to 11 years (\< 12 years) * receiving one of the following drugs for therapeutic reasons : ceftazidime, ciprofloxacin, voriconazole * representative for the clinician, a condition requiring the use of these molecules * informed consent signed by the two parents or legal representative * child affiliated to the national social security system exclusion criteria: not applicable

Keywords: pharmacokinetic population children ceftazidime ciprofloxacin voriconazole pediatric
besponsa injection 1 mg special investigation

Conditions: Acute Lymphocytic Leukemia

Summary: the purpose of this study is to learn about the safety and effectiveness of besponsa. besponsa is approved for treatment of relapsed or refractory cd22-positive acute lymphocytic leukemia. registration criteria for this study is all patients who starting besponsa from its launch to the market to april 30, 2020. all patients in this study will receive besponsa according to the prescriptions. patients will be followed up as follow. * 52 weeks for patients who did not have a hsct (hematopoietic stem cell transplant) within 52 weeks after starting besponsa. * up to 52 weeks after a hsct for patients who had a hsct within 52 weeks after starting besponsa.


Eligibility criteria:
inclusion criteria: * all patients prescribed besponsa exclusion criteria: * none

Keywords: drug use investigation in japan
ultrasound elastography in patients with rectal cancer

Conditions: Rectal Cancer

Summary: the aim of this study is to recruit 50 rectal cancer patients planned to receive standard radiochemotherapy. a baseline ultrasonic elastography is performed prior to radiochemotherapy and followed by re-scans two and six weeks after initiation of treatment. the objective quantitative elastography findings are compared with the trg score. the purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with mr scan results and histopathological tumor regression grade (trg score) after operation.


Eligibility criteria:
inclusion criteria: 1. patients with biopsy verified adenocarcinoma in the rectum ≤ 10 cm from the anal verge. 2. t3/4 tumor assessed by transrectal ultrasound and mr, and crmmr \< 5 mm. 3. life expectancy of more than 3 months. 4. age ≥18 years. 5. performance status ≤ 2 according to who. 6. patient able to observe protocol guidelines. 7. signed informed consent. exclusion criteria: 1. previous radiation treatment for the pelvis. 2. known distant metastases. 3. serious disease contraindicating treatment, including cardiovascular disease. 4. other malignant disease apart from curativly treated non-melanotic skin cancer and previously treated carcinoma in situ cervicis uteri. 5. pacemaker 6. other disease making the patient unfit for study participation as assessed by investigator

Keywords: ultrasound elastography rectal cancer preoperative chemoradiation
a study of telitacicept for injection (rc18) in subjects with iga nephropathy

Conditions: IgA Nephropathy

Summary: this is a phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of telitacicept for injection (rc18) in the treatment of iga nephropathy.

iga nephropathy is a kidney disease in which iga, a protein meant to defend the body against foreign invaders, accumulates in the kidneys and damages them. this study will seek to determine the safety and efficacy of telitacicept for injection (rc18) in the treatment of iga nephropathy. the study is composed of 4 parts: a screening period, a double-blind treatment period, an optional open label extension, and a follow-up period. subjects with confirmed iga nephropathy will be enrolled and randomized 1:1:1 to telitacicept 160 mg, telitacicept 240 mg, or placebo (10 per arm).

Eligibility criteria:
inclusion criteria: 1. iga nephropathy confirmed by pathological biopsy; 2. male or female aged ≥ 18 years old; 3. average 24-hour urine total protein ≥ 0.75 g/24 h 4. estimated gfr (using the ckd-epi formula) \> 30 ml/min per 1.73 m\^2; 5. stabilized aei/arb medications, diuretics, or other antihypertensive therapy. exclusion criteria: 1. patients with clinically significant abnormal laboratory tests at screening; 2. evidence of rapid egfr decrease \> 15 ml/min during screening; 3. renal or other organ transplantation prior to, or expected during, the study; 4. patients with secondary iga nephropathy; 5. patients with nephrotic syndrome, crescentic nephritis minimal change nephropathy with iga deposition, or other pathological or clinical types of renal diseases that may confound the study data interpretation; 6. patients with history of any severe unstable cardiovascular and cerebrovascular events within 12 weeks prior to screening; 7. immunocompromised individuals.

Keywords: berger disease berger's disease iga glomerulonephritis iga nephropathy primary iga nephropathy immunoglobulin a nephropathy nephritis iga type nephropathy, iga
relation between protein 13 and gestational hypertensive disorder

Conditions: Gestational Hypertension

Summary: the attendants of the clinic with a one-missed period (t0) underwent determination of baseline blood pressure (bp) measures and gave blood samples for estimation of levels of placental growth factor (plgf), soluble fms-like tyrosine kinase-1 (sflt-1) and pregnancy protein 13 (pp13). the same evaluation was repeated on the 6th, 24th, 32nd, and 36th gestational week (gw). twenty non-pregnant women gave samples as a negative control group.


Eligibility criteria:
inclusion criteria: * normotensive women who attended the clinic with a one-missed period (t0) exclusion criteria: * history of essential hypertension (htn) * renal diseases * hepatic diseases * cardiac diseases * metabolic syndrome * body mass index (bmi) \>35 kg/ m2 * congenital heart diseases
adenosine effect on persistent pulmonary vein isolation line evaluation (apple trial)

Conditions: Atrial Fibrillation; Persistent Common Pulmonary Vein

Summary: the investigators studied the effects of adenosine on the reconnection rate after successful pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant atrial fibrillation

pulmonary vein isolation has emerged as an effective therapy for paroxysmal atrial fibrillation. however, atrial fibrillation recurs in up to 50% of patients, generally because of recovery of pulmonary vein conduction. adenosine given during the initial procedure may reveal dormant pulmonary vein conduction, thereby identifying the need for additional ablation, leading to improved outcomes.

Eligibility criteria:
inclusion criteria: * diagnosed atrial fibrillation * recurrence of symptomatic atrial fibrillation in spite of antiarrhythmic drug use * written informed consent exclusion criteria: * intracardiac thrombus * pregnancy

Keywords: pulmonary vein isolation adenosin effect atrial fibrillation ablation
wound infiltration with bupivacaine/adrenalin during cesarean section and postoperative pain.

Conditions: Cesarean Section

Summary: thus study evaluates the advantage of infiltration of the surgical wound by local anesthetics in cesarean section on post operative pain relief. in the study group before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% bupivacaine and adrenalin at 1: 200,000 concentration and then closing the skin. in the control group, the skin will be closed without infiltration. our hypothesis is that subcutaneous infiltration of the surgical wound by bupivacaine + adrenalin at the end of cesarean section will reduce the intensity of post operative pain.

cesarean section is one of the most common procedures in the world. there is an advantage in preventing pain after cesarean section, as opposed to treating pain that has already started. the infiltration of surgical wounds by local anesthetics is accepted as an effective method for preventing pain after various operations. in this study women who are admitted for a cesarean section will be randomly allocated into 2 groups. in the study group after the closure of the fascia above the rectus muscles, and before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% bupivacaine and adrenalin at 1: 200,000 concentration and then closing the skin. in the control group, the skin will be closed without infiltration.

Eligibility criteria:
inclusion criteria: * cesarean section with regional anesthesia * singleton * pfannenstiel incision exclusion criteria: * cesarean section with general anesthesia * maternal liver or kidney disease * allergy to bupivacaine * allergy to adrenalin * intrauterine fetal death * major fetal malformations

Keywords: local anesthetics infiltration cesarean section pain relief
diagnostic power comparison between vocs and ctcs

Conditions: Circulating Tumor Cell; Volatile Organic Chemicals; Breast Cancer; Gastric Cancer; Diagnoses Disease

Summary: early diagnosis of malignant tumors is pivotal for improving their prognoses. circulating tumor cells (ctc) in peripheral blood and volatile organic compounds (vocs) in exhaled breath are newly developed diagnosis method. due to the low percentage of ctcs in peripheral blood of cancer patients and the surface structure of lymphocytes (especially megakaryocytes) is often confused with tumor cells, ctc has a high false positive and negative rate. in recent years, the detection of volatile organic compounds (vocs) in exhaled breath as a simple and noninvasive method has shown broad application prospects in the diagnosis of various diseases. a series of studies of vocs diagnosing solid tumors the investigators had conducted in the past decade show that vocs can not only distinguish different types of tumors, but also can make a distinction between different stages. this study was to compare ctc and vocs with clinical samples. predictive models will be built employing discriminant factor analysis (dfa) pattern recognition method. sensitivity and specificity will be determined using leave-one-out cross-validation or an independent blind test set.

200 patients with definitive diagnoses will be enrolled and the alveolar exhaled breath samples and peripheral venous blood will be collected. two blood samples and two breath samples will be collected from each patient. one blood sample will be send to ctc tests for a blind test and the other will be used for headspace vocs analyses. one breath sample was used for analysis with the nano-sensors array, and the other was used for gas chromatography coupled with mass spectrometry (gc-ms) analysis. the vocs samples were collected using sorbent tubes at a total flow through sorption trap of 200ml/min, then will be send to israel institute of technology for further test.

Eligibility criteria:
inclusion criteria: * 18-75 years * definitive diagnosis of gastric cancer, breast cancer,benign breast disease and gastric lesions * ecog(eastern cooperative oncology group) scores ≤ 2 exclusion criteria: * other palliative chemotherapy and radiotherapy for this cancer * other cancer * diabetes, fatty liver * autoimmune disease * pulmonary ventilation dysfunction

Keywords: ctcs vocs breast cancer gastric cancer diagnoses
study of oral anthocyanins on insulin resistance

Conditions: Type 2 Diabetes

Summary: dietary strategies for alleviating the metabolic complications such as diabetes associated with obesity are actively being pursued as alternatives to pharmaceutical interventions the genus vaccinium (e.g. blueberry, blaeberry, cranberry) has been used traditionally as a source of folk remedies for established diabetic symptoms, primarily as leaf or stem infusions or decoctions. berries from this family such as blaeberry (bl) and blueberry (bb) are enriched in anthocyanins, polyphenolics recognized for their ability to provide and activate cellular antioxidant protection, inhibit inflammatory gene expression, and consequently protect against oxidant-induced and inflammatory cell damage and cytotoxicity. the association of obesity with adipose tissue stress, macrophage recruitment, and inflammatory gene expression suggests that eating edible berries from this genus might provide an effective alternative or supplementary intervention to attenuate obesity- associated inflammation and the associated insulin resistance. the aim of this study is to determine the effects of anthocyanin supplementation in the form of a concentrated blaeberry extract on insulin resistance and inflammation particularly in the adipose tissue following a three week supplementation period.


Eligibility criteria:
inclusion criteria: * obese male subjects (bmi \> 30) * aged \> 40 and \< 70 years of age * type 2 diabetes; subjects controlling their diabetes by diet alone or with impaired glucose tolerance * all the obese subjects will have a waist circumference over 40 inches * all subjects must live the aberdeenshire area of scotland exclusion criteria: medical exclusion criteria: * chronic illness, including: * thromboembolic or coagulation disease, * unregulated thyroid disease, * kidney disease, * hepatic disease, * severe gastrointestinal disorders, * pulmonary disease (e.g. chronic bronchitis, copd), * alcohol or any other substance abuse, * eating disorders, * psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders), * skin conditions on the abdomen, * allergy to skin dressings, medication exclusion criteria: * oral steroids, * tricyclic antidepressants, neuroleptics, * anticoagulants, * digoxin and antiarrhythmics, * chronic use of antiinflammatories (e.g. high doses of aspirin, ibuprofen), * insulin, sulphonylureas, thiazolidinediones (glitazones), metformin

Keywords: anthocyanin blaeberries bilberries blueberries mirtoselect type 2 diabetes insulin resistance adipose tissue inflammation
vast - ventricular arrhythmia suppression trial

Conditions: Tachycardia

Summary: the purpose of vast is to determine whether the rate smoothing feature in guidant's prizm/vitality-family icds has an effect on the incidence of ventricular tachyarrhythmias.


Eligibility criteria:
inclusion criteria: * patients who receive a commercially available guidant prizm, prizm 2, or vitality avt icd * patients who sign and date a patient informed consent prior to study enrollment * patients who remain in the clinical care of physicians of their implanting center exclusion criteria: * patients who have chronic atrial fibrillation. paroxysms of af are not an exclusion criterion, but the patient must be in normal sinus rhythm at the time of randomization. if history of af is unknown or uncertain, or the patient was recently cardioverted, there must be at least 23 hours of normal sinus rhythm within the 24 hour period preceding randomization * patients who previously had an icd * patients with current indications for cardiac resynchronization therapy with defibrillation (crt-d) * patients whose life expectancy is less than 12 months due to other medical conditions * patients who are expected to receive a heart transplant during the duration of the study * patients who have or who are likely to receive a tricuspid or other valve prosthesis * patients who are currently enrolled in another investigational study of active medical therapy. each instance should be brought to guidant's clinical application research studies (cars) group to determine eligibility * patients who are younger than 18 years of age * patients who are mentally incompetent and cannot give a patient informed consent or participate in the study