Kornimate/medical-research-clean huggingface dataset:
secondary infusion of relma-cel injection for relapsed or refractory b-cell lymphoma

Conditions: Relapsed or Refractory B-cell Lymphoma

Summary: to observe the efficacy and safety of a second infusion of relma-cel injection in patients with relapsed or refractory b-cell lymphoma.

this study aims to collect efficacy and safety data from adult patients with relapsed or refractory large b-cell lymphoma (r/r lbcl) who receive a second infusion of relma-cel injection after initial treatment with relma-cel. the study will not include any form of grouping, and subgroup analysis will be conducted based on the actual data collected.

Eligibility criteria:
inclusion criteria: * patients have signed an informed consent form (icf). * adults diagnosed with relapsed or refractory b-cell lymphoma who have completed initial treatment with relma-cel. * patients must have undergone at least one disease assessment post-initial relma-cel treatment, and the investigator decides to administer a second treatment (including pr/pd/sd) based on clinical practice. * before the second infusion, confirm that the prepared dose of relma-cel is sufficient (recommended 80-150 x 10\^6 car-t cells), with specific dosage determined by the investigator based on patient condition and dose availability. * confirm the presence of cd19+ residual tumor tissue, if clinically permissible. * measure plasma for the absence of anti-drug antibodies (ada) to relma-cel before the second treatment. * toxicity related to lymphodepleting chemotherapy (fludarabine and cyclophosphamide), except for hair loss, must have resolved to ≤ grade 1 or returned to baseline levels before retreatment. * patients must not have experienced severe adverse reactions during the first treatment, or any adverse reactions must have resolved to baseline levels from the first treatment. exclusion criteria: * patients with hypersensitivity to active ingredients or any excipients (e.g., dimethyl sulfoxide, compound electrolyte injection, human albumin). * patients with uncontrolled systemic fungal, bacterial, viral, or other infections
esophageal and gastric diseases with robotically controlled magnetic capsule endoscopy

Conditions: Video Capsule Endoscopy; Esophageal Diseases

Summary: magnetically controlled capsule endoscopy (mcce) is an outstanding opportunity for the painless endoscopic screening of the esophagus and stomach before small bowel examiantion. further improvement in patients positioning might increase the esophageal transit time of the capsule endoscope and could improve the sensitivity and specificity of the esophageal mcce investigation. our present study aimed to compare the visualization of the esophagus (especially the z-line) with different capsule swallowing protocols.

magnetic controlled capsule endoscope (mcce) systems have been developed over the last 10-15 years to examine the upper gi tract, particularly the stomach. the new navicam mace system consists of a magnetic capsule endoscope, an external control magnet, a data recording kit and a computer workstation. with the appropriate software, allows real-time tracking and monitoring of the capsule inside the body. this method may in the near future be an optimal non-invasive method for screening gastric cancer and barrett's oesophagus in high-risk populations. esophagogastroduodenoscopy (egd) is the gold standard diagnostic test, however it is very inconvenient for patients without sedation. the aim of our present study was a feasibility study to evaluate the safety and efficacy of ankon mcce for the investigation of esophageal abnormalities in patients referred for small bowel capsule endoscopy in our endoscopy department, to develop and test a method to use mcce for esophageal examination, and to analyze the visualization of esophageal mucosa with our newly developed capsule swallowing protocol and manual capsule maneuvering.

Eligibility criteria:
inclusion criteria: - patients referred for small bowel capsule endoscopy in any indication exclusion criteria: * known or suspected stricture in the gi tract * previous surgery with bowel anastomosis * swallowing complaints * dementia * implanted cardioverter defibrillator * inability to sign the informed consent

Keywords: capsule endoscopy magnetically assisted capsule endoscopy mcce esophagus non-invasive endoscopy
clinical study to evaluate the possible efficacy and safety of levocetirizine in patients with diabetic kidney disease

Conditions: Diabetic Nephropathies

Summary: the prevalence of diabetes mellitus is increasing worldwide, and its complications are one of the leading causes of mortality from non-communicable diseases. due to the high prevalence of diabetes and because 30-40% of diabetic patients \[both type 1 (t1dm) and type 2 (t2dm) diabetes mellitus\] develop kidney dysfunction, diabetic nephropathy (dn) is the main cause of end-stage renal disease worldwide. the renin-angiotensin-aldosterone system (raas), endothelin, and urotensin ii are vasoactive hormones that have been extensively studied as other mediators although their relation to diabetic nephropathy is still speculative.


Eligibility criteria:
inclusion criteria: * age between 40 and 65. * both genders will be included. * type ii diabetes mellitus confirmed by glycosylated hemoglobin a₁c. * diagnosis of diabetic nephropathy, which will be defined as persistent albuminuria with urinary albumin creatinine ratio (uacr) range \[30-300 mg /gm\], confirmed on at least two occasions 3-6 months apart, with or without decline in glomerular filtration rate at screening and receiving angiotensin receptor blockers (arbs) and sodium-glucose cotransporter 2 (sglt2) inhibitors therapy. * hemoglobin a₁c ranges from 6.5% to 10% with regular use of insulin and or/oral hypoglycemic drugs. exclusion criteria: * other types of diabetes mellitus * uncontrolled hypertension (blood pressure ≥ 180/110). * urinary tract infection. * severe anemia (hemoglobin ˂10). * critically ill patient. * past operation, past history of trauma, heavy exercise. * severe renal failure (e gfr ˂ 30ml/min/1.73 m2). * systemic inflammatory and autoimmune diseases. * malignancy. * pregnancy and lactating women. * other causes of chronic kidney disease.
tavi pacer: a two-step risk score for prediction of permanent pacemaker implantation after tavi.

Conditions: Pacemaker; TAVI; Risk Score

Summary: the need for permanent pacemaker implantation (ppmi) remains one of the most frequent complications after transcatheter aortic valve implantation (tavi). this study aimed to develop a novel, two-step risk score to predict ppmi probability after tavi and to implement it into a user-friendly website. our risk score addresses the gap in existing data on current prosthesis generations and provides a new and clinically motivated approach to calculating the risk for ppmi.


Eligibility criteria:
inclusion criteria: * patients undergoing tavi at deutsches herzzentrum der charité between january 2019 and december 2020 exclusion criteria: * previous device implantation * valve-in-valve procedure * patients who had received an allegratm valve (nvt ag, morges, switzerland), a lotus edgetm valve (boston, scientific, natick, massachusetts), or a centeratm valve (edwards lifesciences, irvine, california)

Keywords: transcatheter aortic valve replacement aortic stenosis pacemaker implantation risk score electrocardiogram risk stratification
physical activity in youth: implications for reversing risk factors for type 2 diabetes

Conditions: Abdominal Obesity

Summary: in this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise versus resistance exercise) without calorie restriction on total and regional adiposity, and risk of type 2 diabetes in overweight children and adolescents.


Eligibility criteria:
inclusion criteria: * healthy overweight (bmi \>-95th) youth between 12 and 18 years of age * waist circumference \>-75th percentile * sedentary (no structured exercise \>2 times/week for past 6 months) * non-smokers, non-diabetic, no medical conditions * weight stable for past 3 months exclusion criteria: * smokers, * diabetic, * psychiatric disorders, * syndromatic obesity

Keywords: childhood obesity abdominal obesity visceral fat insulin resistance liver fat skeletal muscle lipid fitness
two-layer method preservation and resuscitation of the cadaveric pancreas before transplantation

Conditions: Graft Pancreatitis

Summary: the purpose of this project is to compare the effect of oxygenated preservation of the pancreas before transplantation using the "two-layer method" (tlm) against outcomes previously experienced with organs preserved using only standard university of wisconsin (uw) storage solution. it is our hypothesis that tlm preservation will reduce the frequency and severity of complications of pancreas transplantation, increase the number of organs acceptable for transplantation, and spare individual patients and their families suffering and hardship.

two-layer method (tlm) preservation consists of a storage chamber containing a layer of highly oxygenated, water-immiscible liquid perfluorocarbon (perfluorodecalin, c10f18) surmounted by a layer of conventional uw (or similar) organ preservation solution. the perfluorocarbon is sufficiently dense (\~2 g/ml) that the pancreas floats on top of it, in contact with both layers. the perfluorocarbon combines low toxicity with an oxygen content 75 times greater than the uw solution used in standard pancreas storage. when preserved under these conditions, the pancreas absorbs oxygen by diffusion and steadily consumes it, supporting sufficient aerobic metabolism to maintain tissue atp concentrations at near-physiologic levels and prevent, or even reverse, pancreas anoxic injury. in animal models of pancreas ischemic and storage injury, tlm preservation has been strikingly successful at improving the outcome of both islet isolation and pancreas transplantation.

Eligibility criteria:
inclusion criteria: * listed for pancreas transplantation at the university of nebraska medical center exclusion criteria: * ineligibility for medical/surgical/psychosocial reasons for listing for pancreas transplantation at the university of nebraska medical center.

Keywords: pancreas transplantation graft pancreatitis two-layer method organ preservation
intestinal microsporidiosis in french heart transplant recipients (carmic)

Conditions: Microsporidiosis Intestinal; Heart Transplant Infection

Summary: the investigators propose to carry out a national retrospective study to collect epidemiological, biological, clinical and therapeutic data on microsporidiosis among heart transplant patients.

microsporidia constitute a large family of intracellular eukaryotes infecting a wide range of hosts, ranging from insects to mammals and birds. within this group, some species are responsible for intestinal syndromes manifested by abundant watery diarrhea, which can be particularly severe in immunocompromised individuals. in the 1980s, hiv-positive patients at the aids stage represented the primary population at risk. nowadays, the most frequently affected patients among immunocompromised individuals are solid organ transplant recipients, for whom the management of this infection can be challenging. a neglected pathology until a few years ago, epidemiological data describing intestinal microsporidiosis in solid organ transplant recipients are scarce. the invesigators previously published the first data in kidney and liver transplant recipients. here the investigators propose to carry out a national retrospective study to collect epidemiological, biological, clinical and therapeutic data on heart transplant patients.

Eligibility criteria:
inclusion criteria: * heart transplant patients diagnosed with intestinal microsporidiosis * diagnosis made before december 31, 2024 in france (metropolitan france and overseas territories) exclusion criteria: -patient opposition

Keywords: microsporidiosis enterocytozoon bieneusi encephalitozoon intestinalis encephalitozoon hellem solid organ transplant heart transplant
a trial examining the efficacy of escitalopram oxalate upon depressive symptoms and fatigue in hiv seropositive women

Conditions: Depression; HIV

Summary: to determine the efficacy of escitalopram in treating depression in hiv seropositive women.

to determine the efficacy of escitalopram in treating depression in hiv seropositive women.

Eligibility criteria:
inclusion criteria: * diagnosis of major depression based on dsm-iv criteria; * age 18-70 years; * greater than 15 on madrs for severity of depression; * hiv seropositive; * no new antiviral medications over the past 2 months; * involved in active treatment for hiv disease, * negative serum pregnancy test * those subjects who are actively being treated for depression but show no improvement as defined by self-reported failure to improve with current treatment or residual depression as demonstrated by a madrs of 15 or greater will be asked to participate in the study as well. exclusion criteria: * the presence of an active and significant psychiatric disease other than major depressive disorder as diagnosed on mini in the last 3 months; * meeting dsm-iv criteria for an axis i disorder within the last three months, or meeting criteria for substance abuse within the last 12 months; * current pregnancy or lactation if breast feeding; * history of hypersensitivity, intolerance, or contraindication to lex; * baseline creatinine of 2.5 or greater; * patients taking anticoagulants; * history of diagnosed gastric or duodenal ulcer; * history within past year of bleeding or clotting diathesis; * lifetime history of myocardial infarction or cerebrovascular accident; * history of surgery within the past 3 months; * inability to follow study procedures or complete the study; * the use of any antidepressant medications within 5 half-lives of randomization; * women of child-bearing potential who will not agree to use approved means of birth control during the trial; * other reason that the primary investigator believes that the subject will be unable to complete trial or has medical/psychiatric contraindications to the trial. * individuals who are currently being treated for depression and show significant improvements in their depression such that discontinuing their current antidepressant therapy would likely have negative clinical consequences will be excluded from participating in this study. * individuals who are or become suicidal will be excluded from this study.

Keywords: depression hiv
dalpiciclib combined with letrozole in neoadjuvant treatment of stage ⅱ-ⅲ hr-positive/her2-negative breast cancer

Conditions: Solid Tumor

Summary: this is a single-arm, open-label, exploratory clinical study

this is a single-arm, open-label, exploratory clinical study initiated by the investigator to evaluate the objective response rate (orr), efficacy, and safety of dalpiciclib combined with letrozole in the neoadjuvant treatment of stage ⅱ-ⅲ hr+/her2- breast cancer.

Eligibility criteria:
inclusion criteria: * 1. postmenopausal women aged ≥18 years, the definition of postmenopausal: 1. the patients with the history of bilateral oophorectomy, or age ≥ 60 years; or 2. age \ 10%), her2 -negative invasive breast cancer regardless of pr expression level. immunohistochemistry (ihc) score of 0+, or 2+ confirmed by pathology laboratory and negative in situ hybridization (ish) test (her-2/cep17 ratio \<2.0); 3. treatment-naive patients with stage ⅱ-ⅲ tumors whose tumor staging meets the criteria of the 8th edition of the american joint committee on cancer (ajcc) staging; exclusion criteria: * 1. received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) 2. concurrently receiving any other anti-tumor therapy that those specified in the protocol; 3. bilateral breast cancer, inflammatory breast cancer, or occult breast cancer; 4. stage ⅳ breast cancer;
covid-19 in polish ice swimmers.

Conditions: Covid19; SARS-CoV Infection; Resistance, Disease; Hypothermia; Hypothermia Due to Cold Environment

Summary: ice swimming is an increasingly common phenomenon in poland. it has been confirmed that it has a beneficial effect on health by increasing the natural non-specific immunity to infections. in the face of the current severe acute respiratory syndrome coronavirus 2 (sars-cov-2) pandemic causing coronavirus disease 2019 (covid-19), researchers decided to use a survey to check the incidence of covid-19 among polish ice swimmers, as well as recent ailments. then, the researchers will compare the obtained results with epidemiological data for poland.researchers will also investigate the relationship between susceptibility to sars-cov-2 infection and the blood group and rh factor among ice swimmers.

the research tool is an original questionnaire compiled by a team of experts conducting the study. the survey includes questions about sociodemographic data, such as age and gender and blood type in ab0 system with rh factor, and questions about the frequency of ice swimming, the duration of a single session, and since when respondents have been ice swimming. there was also a question about the respondents' compliance with the restrictions and recommendations related to the pandemic and contacts with people with confirmed sars-cov-2 infection. in the survey, researchers ask about the infectious symptoms experienced during the pandemic and about being diagnosed with covid-19 or its exclusion. people who have been ill are asked about the place of treatment. the questionnaires are collected in traditional form, on the internet and as scans of documents. each survey was completely anonymous. the obtained statistical data will be compared with official data on new covid-19 cases and recoveries at the same time. official data are published by the ministry of health and earlier also by sanitary and epidemiological stations. the main aim of the study was to determine whether ice swimming also increases resistance to sars-cov-2 and covid-19.

Eligibility criteria:
inclusion criteria: * ice swimmers exclusion criteria: * not active ice swimmers

Keywords: ice swim immune system immunity temporarily cooling down
fluorescence spectroscopy guided surgery

Conditions: Low Grade Glioma (LGG); High Grade Glioma (HGG)

Summary: intraoperative surgical fluorescence microscopy is a useful technique for the surgical resection of glioma. however the accuracy of this method is limited by its too low sensitivity. fluorescence spectroscopy has the potential capacity to overcome the current limitations of conventional fluorescence guided surgery by increasing the sensitivity: in a pilot study on brain tumor biopsies, fluorescence spectroscopy was shown to measure two-peaked 5-ala-induced protoporphyrin ix (ppix) fluorescence emission spectrum which clearly enables to distinguish the solid component of glioblastomas from low grade gliomas and infiltrative component of glioblastomas. this innovative method could become in future a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. however, those preliminary ex-vivo results have to be confirmed in a feasibility in-vivo study on human.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old * clinical signs and history of the disease in favor of a hgg, lgg * mri study in favor of a hgg, lgg, meningioma or brain metastasis * affiliated to or beneficiary of a social security system (or equivalent). * patients who have provided written informed consent for the study exclusion criteria: * previous life-threatening allergic reactions and known hypersensitivity * pregnant or lactating or not using effective contraception; * restricted renal function define by a creatinine clearance \< 30ml/min * patients under a beta-blockers treatment * contraindication to do an mri (pace-maker) * contraindication to the use of 5-ala : known hypersensibility to 5-ala or to porphyrin, acute or chronic porphyria * minor or adult ward of court (under guardianship or trusteeship) * no affiliation to a social security system (or equivalent). * patients who express opposition to participation in the study.

Keywords: glioma fluorescence spectroscopy
greater occipital nerve and cervical region injection in patients with trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: the aim of this study is to investigate the efficacy of greater occipital nerve block and cervical injections with lidocaine

after being informed about the study and potantiel risks, all patients giving informed consent will undergo randomization in 1:1 ratio to 1% lidocaine or 0.9% saline groups

Eligibility criteria:
inclusion criteria: * classical trigeminal neuralgia exclusion criteria: * secondary trigeminal neuralgia

Keywords: trigeminal neuralgia greater occipital nerve block lidocaine
low intensity shock wave therapy (li-eswt) for erectile dysfunction in post radical prostatectomy patients not responding to pde5 inhibitors (li-eswt)

Conditions: Erectile Dysfunction

Summary: low intensity shock waves (lisw) have been proven in animal studies to induce local growth of new blood vessels. the investigators hypothesized that lisw therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply (damage that can occur after radical prostatectomy in addition to neural damage or solely) that do not respond to oral therapy (pde-5 inhibitors).


Eligibility criteria:
inclusion criteria: * prior prostatectomy surgery * ed of more than 6 months * rigidity score \< 3 during pde5i therapy * non- hormonal, neurological or psychological pathology stable heterosexual relationship for more than 3 months exclusion criteria: * any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities * clinically significant chronic hematological disease * anti-androgens, oral or injectable androgens * radiotherapy in pelvic region

Keywords: erectile dysfunction ed pde5 inhibitors li-eswt
effect on cognitive performance and safety/tolerability of ssr180711c in mild alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the primary objective of the study is to assess the effect of 3 doses of ssr180711c on cognitive performance in patients with mild alzheimer's disease (ad). other objectives are to assess the safety/tolerability of ssr180711c in patients with mild ad.


Eligibility criteria:
inclusion criteria: * outpatients with diagnosis of mild ad exclusion criteria: * concomitant or previous treatment by acetylcholinesterase inhibitors and/or memantine * medical condition which may interfere with the study * history of epileptic seizures * lens opacity * lack of reliable caregiver the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: alzheimer cognitive