Kornimate/medical-research-clean huggingface dataset:
cellular immunotherapy for patients with high risk myelodysplastic syndromes and acute myeloid leukemia

Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia

Summary: the main objective of this work is to conduct a clinical study for the development and application of a vaccine with autologous dendritic cells submitted to electroporation with wilm's tumor 1 (wt1) messenger ribonucleic acid (mrna), as an adjuvant treatment of high-risk myelodysplastic syndromes and acute myeloid leukemia, aiming to delay the progression of the disease or its relapse and increase overall and event-free survival.


Eligibility criteria:
inclusion criteria: * individuals between the ages of 18 and 70 * high-risk myelodysplasia (areb 1 or areb 2 subtypes) and acute myeloid leukemia * minimum interval of 30 days between the last cycle of chemotherapy (when it occurs) and start of immunotherapy * performance status between 0 and 3 on the who (world health organization)-ecog (eastern cooperative oncology group) scale * calculated creatinine clearance\> 30 ml / min using the cockcroft-gault formula * total bilirubin less than or equal to twice the lower limit of the normal range in the institution and aspartate aminotransferase (ast) less than or equal to twice the upper limit of normal * absence of blasts in peripheral blood * leukocyte count greater than 3000 cells / mm3, hemoglobin greater than 9.0 g / dl and platelets greater than 70,000 platelets / mm3, if possible. (if the patient does not meet these criteria for apheresis, the possibility of transfusion of blood components after leukapheresis will be proposed and the patient should sign a specific term of science on the possibility of transfusion) * normal cardiac evaluation * negative serologies for hepatitis b and c viruses and hiv * written informed consent form signed before entering the study exclusion criteria: * does not meet any of the requirements of the inclusion criteria * low risk myelodysplasia by ipss (international prognostic scoring system) or wpss (who adapted prognostic scoring system) scores * individuals with a history of any previous neoplasia, except those with prolonged clinical remission (more than 5 years) of non-melanoma skin cancers and cervical cancer in situ * pregnant or lactating women * previous immunotherapy or biological therapy
the emprint™ ablate and resect study in patients with metastatic lung tumors (empress)

Conditions: Lung Cancer

Summary: post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung tumors.

primary endpoint: dose response as indicated by ct imaging, measurement of maximum diameter and volume. secondary endpoint: assessment of complete tumor ablation immediately post-procedure.

Eligibility criteria:
inclusion criteria: * subject or authorized representative has provided informed consent. * subject is ≥18 years of age. * at least one pulmonary metastasis ≤ 3.0 cm in maximum diameter resulting from distant primary cancers or at least one recurrence of primary lung cancer ≤ 3.0 cm in maximum diameter. * subject has been confirmed by a thoracic surgeon to be a surgical candidate for resection of the tumor targeted for ablation. * subject is willing and able to comply with all aspects of the treatment and evaluation schedule. * ≥1 cm of tumor-free lung parenchyma between target tumor and pleura or fissure. exclusion criteria: * pre-procedure exclusion criteria * contraindicated for surgery. * prolonged chest infection, defined as lung consolidation that requires hospitalization and greater than 10 days of antibiotics 30 days prior to surgery. * tumor abutting main stem bronchus, main pulmonary artery branches, esophagus and/or trachea. * tumor with pleural contact. * tumors located \< 3 cm of staple lines or other metal objects. * patients diagnosed with gold stage iv emphysema. * uncontrollable coagulopathy * patients unable to tolerate discontinued use of anti-coagulants prior to and during the ablation procedure. * subject is pregnant (documented by a positive pregnancy test according to hospital standard practices) or is actively breast-feeding. * subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study. * the investigator determines that participation in the study may jeopardize the safety or welfare of the subject. * patients with implantable pacemakers and other electronic implants, in accordance with instructions for use (ifu). intraprocedural exclusion criteria \*incidental intraprocedural finding that the subject no longer meets the study eligibility criteria.

Keywords: primary, recurrent, metastatic lung tumor, ablation
tralokinumab in combination with topical corticosteroids for moderate to severe atopic dermatitis - ecztra 3

Conditions: Atopic Dermatitis

Summary: primary objective: to demonstrate that tralokinumab in combination with topical corticosteroids (tcs) is superior to placebo in combination with tcs in treating moderate-to-severe atopic dermatitis (ad). secondary objectives: to evaluate the efficacy of tralokinumab in combination with tcs on severity and extent of ad, itch, and health-related quality of life compared with placebo in combination with tcs. to assess the safety of tralokinumab in combination with tcs when used to treat moderate-to-severe ad for 32 weeks.


Eligibility criteria:
inclusion criteria: * age 18 and above. * diagnosis of ad as defined by the hanifin and rajka (1980) criteria for ad. * history of ad for ≥1 year. * subjects who have a recent history of inadequate response to treatment with topical medications. * ad involvement of ≥10% body surface area at screening and baseline. * stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation. exclusion criteria: * subjects for whom tcs are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator. * active dermatologic conditions that may confound the diagnosis of ad. * use of tanning beds or phototherapy within 6 weeks prior to randomisation. * treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation. * treatment with tcs, topical calcineurin inhibitors (tci), or topical phosphodiesterase 4 (pde-4) inhibitor within 2 weeks prior to randomisation. * receipt of any marketed biological therapy (i.e. immunoglobulin, anti- immunoglobulin e) including dupilumab or investigational biologic agents within 3 months or 5 half-lives, whichever is longer prior to randomisation. * active skin infection within 1 week prior to randomisation. * clinically significant infection within 4 weeks prior to randomisation. * a helminth parasitic infection within 6 months prior to the date informed consent is obtained. * tuberculosis requiring treatment within the 12 months prior to screening. * known primary immunodeficiency disorder.
on-premise and remote robotic neurointervention

Conditions: Cerebrovascular Disease

Summary: this study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the remedy robot for on premise and remote robotic neurointervention.

this is a prospective, single-arm, single-center study to evaluate the safety and effectiveness of the remedy robot for patients with a clinical indication for neurointervention.

Eligibility criteria:
inclusion criteria * the patient is ≥ 18 years of age * the investigator deems the patient appropriate for manual and robotic-assisted neurointervention. * the patient or their substitute decision-maker has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. exclusion criteria: * patients currently pregnant or breastfeeding. * people with any of the following vascular history: * known congenital aortopathy, connective tissue disorder or vasculopathy * known arterial dissection of any kind * bleeding diathesis * use of warfarin, iv heparin, clexane, fondaparinux or any new oral anticoagulants (noacs) or direct oral anticoagulants (doacs) people with any of the following medical history: * active malignancy * known contrast allergy * height \> 190cm
ag combined with immunotherapy and sbrt in patients with potentially resectable pancreatic cancer

Conditions: Pancreatic Carcinoma

Summary: the objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.

due to the hidden onset and rapid progression of pancreatic cancer, most patients are already locally advanced or have distant metastasis at the time of diagnosis and lose the opportunity for surgery. even among operable patients, about 50% will have recurrence and metastasis one year after surgery. therefore, more and more evidence supports neoadjuvant therapy for patients with high risk factors for resectable pancreatic cancer, and conversion therapy followed by surgery for patients with borderline resectable and locally advanced pancreatic cancer. therefore, the objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.

Eligibility criteria:
inclusion criteria: 1. age \>= 18 years； 2. eastern cooperative oncology group (ecog) score of 0-1; 3. pancreatic cancer confirmed by histology or cytology; 4. potentially resectable pancreatic cancer documented by contrast enhanced ct (or mri) scan; 5. hematological indexes: neutrophil count \>= 1.5 x 10\^9/l hemoglobin \>= 10g / dl platelet count \>= 100 x 10\^9/l; biochemical indicators: total bilirubin \ = 60ml / min. 6. participants of childbearing age need to take appropriate protective measures (contraceptive measures or other methods of birth control) before entering the group and during the test; 7. signed informed consent; 8. follow the protocol and follow-up procedures. exclusion criteria: 1. have received systematic anti-tumor treatment. 2. previous history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (ta and tis) or other malignant tumors that have received radical treatment (at least 5 years before enrollment). 3. active bacterial or fungal infection (\> = level 2 of national cancer institute common toxicity criteria (nci-ctc), version 3.0). 4. human immunodeficiency virus (hiv), hepatitis c virus (hcv), hepatitis b virus (hbv) infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases considered by researchers to be out of the group. 5. autoimmune diseases or immune defects who are treated with immunosuppressive drugs. 6. pregnant and lactating women. pregnant women of childbearing age must be tested negative within 7 days before entering the group. 7. drug abuse, clinical or psychological or social factors make informed consent or research implementation affected. 8. allergic to programmed cell death protein-1 (pd-1) monoclonal antibody immunotherapy drugs.
infrared camera for brain mapping during surgery

Conditions: Epilepsy; Neurologic Manifestations

Summary: it is extremely important to identify and distinguish healthy brain tissue from diseased brain tissue during neurosurgery. if normal tissue is damaged during neurosurgery it can result in long term neurological problems for the patient. the brain tissue as it appears prior to the operation on ct scan and mri is occasionally very different from how it appears during the actual operation. therefore, it is necessary to develop diagnostic procedures that can be used during the operation presently, the techniques used for intraoperative mapping of the brain are not reliable in all cases in which they are used. researchers in this study have developed a new approach that may allow diseased brain tissue to be located during an operation with little risk. this new approach uses nfrared technology to locate the diseased tissue and identify healthy brain tissue. the goal of this study is to investigate the clinical use of intraoperative infrared (ir) neuroimaging to locate diseased tissue and distinguish it from normal functioning tissue during the operation.

it is important during neurosurgical procedures to identify and preserve eloquent functional cortex adjacent to a resectable lesion. resection of a lesion infiltrating vital cerebral cortex can be associated with postoperative neurological deficits if the surgeon cannot clearly distinguish between the infiltrating borders of a lesion and surrounding functionally eloquent tissue. spatial relationships between a lesion and surrounding normal brain can change significantly from those determined by preoperative methods such as ct and mri scans. necessary intraoperative interventions such as cerebrospinal fluid drainage, osmotic diuresis and lesion debulking cause quantitatively unpredictable brain shift in three dimensions. therefore functional localization in real time that can be performed in the operating room is desirable. however, intraoperative real-time functional mapping techniques now available cannot be used in many surgical situations and are not sufficiently reliable in all cases in which they are used. we have developed an intraoperative approach that may permit reliable lesion localization and brain functional mapping in real time with minimal risk. this approach makes use of infrared technology to identify functionally active eloquent cortex and may differentiate abnormal tissue from normal cortex. the goal of this study is to investigate the clinical use of intraoperative infrared (ir) neuroimaging to differentiate intracranial lesions from surrounding normal functionally important tissue in real time. reliable real-time intraoperative functional mapping of eloquent cortex adjacent to lesions by this technique would improve the safety and effectiveness of many neurosurgical procedures.

Eligibility criteria:
adult patients who will be undergoing craniotomy for lesions such as tumor, epileptic focus, vascular malformation or infection. adult patients who are able to provide informed consent.

Keywords: cortical localization optical imaging thermal imaging
effect of pyridoxine on behavioral adverse events of levetiracetam

Conditions: Epilepsy; Pyridoxine; Behavior Problem

Summary: this study is a two-arm parallel group randomized double-blind placebo-controlled trial with the aim of investigating pyridoxine effect on behavioral side effects of levetiracetam in adult patients with epilepsy.


Eligibility criteria:
inclusion criteria: * age≥18 years * patients with epilepsy * patients who are treated by levetiracetam (levebel, cobel darou) in recent month * complaint of behavioral problem * patient's consent for participation exclusion criteria: * history of known psychiatric disease * pregnancy * incidence of psychotic side effects including hallucination, psychosis, suicidal idea or attempt * treatment with psychiatric medications * alcohol or drug abuse * mental retardation to the degree that intervenes comprehension and response to questionnaire
c-control: efficacy and safety of therapy with rosuvastatin in statin-naive and in statin-switched patients

Conditions: Hypercholesteremia

Summary: the study explores efficacy and safety of the lipid-lowering therapy with crestor in statin-naive patients and in patients with previously unsuccessful statin therapy. this study was designed to investigate the dynamic of the lipid parameters and therapy tolerability during 8-10 weeks treatment with crestor


Eligibility criteria:
inclusion criteria: * patients with hypercholesteremia who was never treated with statins before * patient with hypercholesteremia who was treated with a statin (other then rosuvastatin) but because of its adverse effects/insufficient action was switched to therapy with crestor exclusion criteria: * none

Keywords: hyperlipidemia rosuvastatin efficacy tolerability crestor therapy
pancreatic anastomosis after duodenopancreatectomy

Conditions: Pancreatic Anastomotic Leak; Pancreatic Neoplasms

Summary: a national, multicenter, randomized, prospective, parallel group clinical study to evaluate two therapeutic strategies (invaginating pancreatogastric anastomosis versus blumgart anastomosis).

background: postoperative pancreatic fistula is currently the most frequent complications after duodenopancreatectomy. there are currently no rct comparing two of the most frequently used method of pancreato-enteric anastomosis (invaginating pancreatogastric anastomosis versus blumgart anastomosis) hypothesis: in patients with resectable pancreatic and periampullary tumors, performing a blumgart (ab) anastomosis for pancreatoenteric reconstruction after duodenopancreatectomy decreases the rate of postoperative pancreatic fistula (ppf) compared to to pancreatogastric anastomosis. main goal: to comparatively evaluate the rate of ppf in patients with pancreatic and periampullary tumors undergoing cephalic duodenopancreatectomy after reconstruction with blumgart anastomosis or pancreatogastric anastomosis.

Eligibility criteria:
inclusion criteria: * patients over 18 years old. * diagnosis of pancreatic and periampullary tumor pathology that requires pancreatoduodenectomy * signature of informed consent by the patient or his legal representative exclusion criteria: * patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery. * patients in whom tumor resection is ultimately not achieved due to intraoperative evidence that the tumor is locally advanced, unresectable. * patients with macroscopic residual tumor (r2). * high risk patients with severe pathology (asa iv) according to the american association of anesthetists.
a clinical efficacy study of an oral tyrosine kinase inhibitor of vegfr-2 given in combination with chemotherapy

Conditions: Lung Neoplasms

Summary: the purpose of this study is to determine whether cp-547,632, an oral vegfr-2 tyrosine kinase inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is effective in the treatment of advanced stage non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iiib (inicluding those with pleural effusion), iv or recurrent non-small cell lung cancer (nsclc). * bidimensionally measurable disease \>2cm x 1 cm by conventional ct scan or \>1 cm x 1cm by spiral ct scan. exclusion criteria: * no tumors in close proximity to major veins or arteries. * no sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease. * no evidence or history brain metastases.
prospective national cohort evaluating predictive biomarkers of resistance to immunotherapy in patients with msi/dmmr metastatic colorectal cancer (coresim)

Conditions: Colorectal Cancer Metastatic; Microsatellite Instability-High Colorectal Cancer

Summary: the keynote 117 phase iii trial demonstrated the superiority of pembrolizumab (anti-pd1 monoclonal antibody) versus chemotherapy +/- targeted therapy in first-line treatment of dmmr/msi metastatic colorectal cancer (mcrc). however, primary resistance to pembrolizumab was observed in approximately 20-30% of patients treated in the keynote 177 study. therefore, the identification of biomarkers predictive of resistance to immunotherapy for dmmr/msi mcrc is necessary to better select patients who benefit the most from immunotherapy, and those for whom other therapeutic approaches should be favored.

the primary endpoint is the identification of predictive factors of resistance to pembrolizumab in first-line treatment of msi and/or dmmr metastatic colorectal cancer coresim is a retrospective and prospective multicenter national french cohort. national recruitment will be carried out in all french centers, including the ffcd, ageo, gercor, and unicancer, representing more than 150 centers and most french sites, public and private hospitals. in france, pembrolizumab for first-line treatment of patients with msi mcrc was accessible via its compassionate use in february 2021, then its reimbursement was effective in june 2023 patients treated with pembrolizumab will be included prospectively on the start date of the study, i.e. on february 2024; patients treated since february 2021 via compassionate use of pembrolizumab will be included retrospectively a total of 600 patients are expected. the theoretical duration of inclusion is set at 2 years. all patients will be followed up for 3 years.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * histologically confirmed colorectal adenocarcinoma with unresectable metastasis(s) receiving immunotherapy as first-line treatment with pembrolizumab * tumor with microsatellite instability determined by immunohistochemistry (loss of expression of mlh1, msh2, msh6 and/or pms2) and/or by molecular biology (msi-h on microsatellite analysis from tumor dna according to practice routine of the center) exclusion criteria: * patients with another concomitant cancer at the time of diagnosis requiring systemic treatment or impacting prognosis according to the medical team. * previous treatment with anti-pd1 or anti-pdl1. * previous treatment with chemotherapy +/- targeted therapy for msi/dmmr metastatic colorectal cancer. * contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining non-opposition or consent; inability to be followed in the same center throughout the follow-up period for geographical reasons). * pregnant women * persons under court protection or under protective supervision (guardianship or curatorship) * opposition to participation in the study.

Keywords: immunotherapy resistance
feldenkrais vs back school for treating chronic low back pain: a randomized controlled trial

Conditions: Chronic Low Back Pain

Summary: the purpose of this study study is to determine whether the feldenkrais method is effective on pain control, functional recovery and quality of life in patients with chronic low back pain by comparing it with a back school program.


Eligibility criteria:
inclusion criteria: * presence of chronic nonspecific low back pain for at least three months; * subjects aged between 18 and 80 years. exclusion criteria: * presence of acute low back pain; * low back pain due to other causes (vertebral fractures, spondylolisthesis, herniated discs, lumbar canal stenosis); * cns and/or pns disorders; * systemic inflammatory disease (eg rheumatoid arthritis); * systemic infectious disease; * neoplastic disease; * previous surgery; * cognitive impairment; * pregnancy.

Keywords: low back pain quality of life rehabilitation exercise