Kornimate/medical-research-clean huggingface dataset:
biobank and register of patients with agresive tumors for translational and analytical research

Conditions: Malignant Solid Tumors; Primary Brain Tumor; Melanoma; Soft Tissue Sarcoma; Colorectal Cancer; Kidney Cancer; Prostate Cancer

Summary: the investigators will collect biosamples of patient blood and tumour tissue for further immunological analysis of blood cell subpopulations, immunosupressive factors concentration, hla expression an lymphocytes and tumour tissue, and and cancer testis antigenes expression on tumour cells, as well as clinical data on patient's stage, therapy, response and demographics. possible prognostic and predictive dynamic biomarkers will be discovered for individualisation of treatment strategies


Eligibility criteria:
inclusion criteria: * signed inform consent * histolgically verified solid tumour * receiving systemic therapy for neoplasm * has archival tumour tissue * provide biosamples with living tumour tissue or blood samples for immunologic assessment exclusion criteria: * concurrent lymphoprolipherative disorder * patients after stem cell or bone marrow thansplantation * incomplete informaton on previous cancer history or medical history * patients with known primary immunodeficiency * patients receiving immunosupressive therapy for concurrent illness * pregnant patients
infracalcaneal peppering injection technique for chronic plantar fasciitis

Conditions: Chronic Plantar Fasciitis

Summary: although no single treatment has shown superiority, short-term pain relief may be offered via a targeted local corticosteroid injection (csi), used often in combination with local anesthetic (la), which may reduce plantar fasciitis symptoms for up to 1 month. moreover, administering a csi is relatively quick and easy for any provider to perform, though it is not without potential deleterious side effects and risks, including fibroblast degradation, fat pad atrophy, skin depigmentation, and even plantar fascia rupture.

research performed in other musculoskeletal disorders (e.g. lateral epicondylitis) suggest that the "method" (i.e peppering vs single bolus deposition) of injection is more favorable than the steroid itself, though evidence for this positive effect in plantar fasciitis is rather scarce. injection via peppering is a minimally invasive percutaneous technique which involves repeatedly fenestrating the pathologic site (i.e. plantar fascia) via hypodermic needle insertion at the tender area, then sequentially injecting a substance, withdrawing, redirecting, and reinserting all without emerging from the skin. though hypothetical, this technique is thought to disrupt the degenerative process of plantar fasciitis (pf), encouraging both localized bleeding and fibroblastic proliferation and stimulating a local inflammatory response that would trigger the body's own reparative mechanism, leading to recovery.

Eligibility criteria:
inclusion criteria: * men and women 18 years of age and older * patient reported history of plantar heel pain and confirmed clinical tenderness of pain with direct palpation of the medial calcaneal tubercle on baseline exam * diagnosis of chronic plantar fasciitis, defined for study purposes as symptoms greater than or equal to 6 weeks in duration exclusion criteria: * individuals less than 18 years of age * pregnancy * history of receiving a local heel injection (i.e. corticosteroid injection (csi) or other injectate) within the last 3 months * prior heel trauma or surgery * allergy to local corticosteroid or local anesthesia

Keywords: corticosteroid injection infracalcaneal peppering injection plantar fasciitis
apparent life threatening events, sudden infant death syndrome and muscarinic receptors

Conditions: Apparent Life-Threatening Event in Infants Under One Year of Age

Summary: apparent life-threatening events (alte) in infants often lead to severe neurological complications or to sudden death. in such situations, cardio-pediatricians and intensive care physicians have no specific diagnosis or treatment. in a recent translational research (inserm-dhos), our team has reported a myocardiac abnormality in a rabbit model of vagal hyperreactivity which is also present in the human hearts of infants deceased from sudden death, i.e. increased m2 muscarinic receptors (m2r) density associated with compensative increased enzymatic activity and overexpression of acetylcholine esterase (ache). in a recent phrc-i study (article in preparation), these abnormalities have also been observed in the blood of patients, infants as well as adults, exhibiting severe vagal syncopes. we observed, even more importantly, similar abnormalities in infants under 1 year of age with very severe idiopathic alte (ialte) compared with normal subjects and with patients who presented alte with identified etiologies (jama pediatric, 2016 may). the aim of this present study is to validate the overexpression of m2r as a marker of risk of ialte in infant under 1 year.


Eligibility criteria:
inclusion criteria: * infant aged between 28 days and 12 months, presenting severe syncope(s) requiring medical management, hospitalized in a pediatric intensive care unit or pediatric emergencies * consent signed and dated by the legal representatives * patients affiliated to a social security system exclusion criteria: * infant with known cardiovascular, neurologic, infectious, toxic or metabolic pathologies before enrollment (before the syncope) * subject on medication for more than 3 months before enrollment * impossibility to clearly inform the legal representatives (comprehension problems) * subject in exclusion period for clinical trial (previous or current study)

Keywords: apparent life-threatening event alte sudden infant death
influence of acupuncture to ocular microcirculation in patients with diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine the influence of specific eye acupuncture to the ocular microcirculation in diabetic and healthy subjects.

diabetes is combined with severe vascular damage at the different stages of the disease, causing reduction in retinal perfusion. acupuncture is supposed to regulate the perfusion. we propose a study to evaluate the effect of acupuncture to the vascular auto regulation in patient with diabetes, compared to healthy people without vascular or retinal diseases. the perfusion of the retinal vessel will be examined by retinal vessel analyzer (rva), heidelberg retinal flowmeter (hrf) and the ocular blood flowmeter (obf) before, during and after standardized specific acupuncture at healthy volunteers and patients with diabetes.

Eligibility criteria:
inclusion criteria: * persons over 18 years, men or women, diabetic diagnostics within the last year exclusion criteria: * medical use of anticoagulative substances, use of dorzolamide, use of immunosuppressive medication * psychiatrics, epileptics
switching strategy with raltegravir + abc / 3tc in controlled hiv-1 infection

Conditions: HIV Infections

Summary: retrospective observational study, multicentric with spanish hospitals, in which a switching or change strategy with ral and abc / 3tc guidelines was used, in the48 weeks before the start of the study, in order to determine parameters of effectiveness and security.

the study consists of a 4-weeks data recording period, during which the follow-up information recorded by physicians in electronic or paper medical history will be analyzed from patients who opted for a change to that study pattern (ral and abc / 3tc).

Eligibility criteria:
inclusion criteria: * patient with chronic infection with hiv-1. * patients older than 18 years. * patients in art in whom ral + abc / 3tc has been initiated in at least 48 weeks prior to the start of the study. * to have used the ral + abc / 3tc as a switching or change strategy * hiv virological control (cv ≤ 50 copies / ml) for at least 24 weeks prior to initiation of study regimen exclusion criteria: * naive patients who have started treatment with this regimen * absence of digital or physical records of visits made for consultation * patients who underwent treatment change within 48 weeks prior to study initiation
safety and efficacy study of regulatory t cell therapy in liver transplant patients

Conditions: End-stage Liver Disease

Summary: 'thril' aims to explore the feasibility, safety and efficacy of tr002, a regulatory cell therapy, as adjunct immunosuppressive treatment in the context of liver transplantation

stage i: to evaluate the safety of administering tr002 to liver transplant recipients. stage ii: to evaluate the efficacy of tr002 administration in allowing for the discontinuation of immunosuppressive therapy in liver transplant recipients.

Eligibility criteria:
inclusion criteria: * able to give informed consent * adult patients with end-stage liver disease listed for primary liver transplant; * calculated meld score ≤ 25 at time of transplantation exclusion criteria: * hiv or rna-positive hepatitis c virus infection; * autoimmune liver disease * previous organ transplant * ebstein virus and/or cytomegalovirus sero-negativity * chronic use of systemic immunosuppressants * hepatocellular carcinoma outside milano criteria * leukocytes \<1.5x10\^9/l and/or platelets \<50x10\^9/l.
a long-term follow-up study of subjects with gaucher disease who previously received avr-rd-02

Conditions: Type 1 Gaucher Disease

Summary: this is a multicenter, multinational long-term follow-up study to assess the long-term safety and durability of effect of avr-rd-02 treatment in subjects who previously received avr-rd-02 treatment (single dose administration).

subjects who received avr-rd-02 in the preceding treatment study and who meet all eligibility criteria may participate in the avro-rd-02-ltf01 study. for individual participating subjects, the baseline visit for the avro-rd-02-ltf01 study will coincide with the subject's last visit in the preceding treatment study, whenever feasible. subjects will be asked to return for study visits at approximately 6-month intervals for the first 4 years of the study and then annually thereafter for 10 years (for a total follow-up of 14 years in this study), during which time periodic safety and efficacy assessments will be performed to assess measures of safety, engraftment, and clinical response after avr-rd-02 treatment.

Eligibility criteria:
inclusion criteria: * subject must have been enrolled and received avr-rd-02 as single dose administration * subject must be willing and able to provide written informed consent for the avro-rd-02-ltf01 study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures. exclusion criteria: * subject is currently enrolled in an avrobio-sponsored avr-rd-02 treatment study.

Keywords: gaucher guard1
predicting icu mortality in ards patients

Conditions: Acute Respiratory Distress Syndrome

Summary: the investigators are planning to perform a secondary analysis of an academic dataset of 1,303 patients with moderate-to-severe acute respiratory distress syndrome (ards) included in several published cohorts (nct00736892, nct02288949, nct02836444, nct03145974), aimed to characterize the best early model to predict duration of mechanical ventilation and mortality in the intensive care unit (icu) after ards diagnosis using machine learning approaches.

the acute respiratory distress syndrome (ards) is a severe form of acute hypoxemic respiratory failure in critical care units worldwide. most ards patients requiere mechanical ventilation (mv). few studies have investigated the prediction of mv duration and mortality of ards. for model description, the investigators will extract data from the first two icu days after diagnosis of moderate-to-severe ards from patients included in the de-identified database, which includes 1,303 mechanically ventilated patients enrolled in several observational cohorts in spain, coordinated by the principal investigator (jv), and funded by the instituto de salud carlos iii (isciii). the investigators will follow the tripod guidelines and machine learning tecniques will be implemented (random forest, xgboost, logistic regression analysis, and/or neural networks) for development of the prediction model, and the accuracy will be compared to those of existing scoring systems for assessing icu severity (apache ii, sofa) and the pao2/fio2 ratio. for external validation, the investigators will use 303 patients enrolled in a contemporary observational study (nct03145974). the investigators will evaluate the accuracy of prediction models by calculating the respective confusion matrices and several statistics such as sensitivity, specificity, positive predictive value, and negative predictive value for mortality and duration of mv. investigators will select the best probabilistic model with a minimum number of clinical variables.

Eligibility criteria:
inclusion criteria: * berlin criteria for moderate to severe ards exclusion criteria: * postoperative patients ventilated \<24h; brain death patients.

Keywords: outcome mechanical ventilation intensive care unit machine learning
analgesia by transversus abdominis plane nerve block in patients undergoing liver resection.

Conditions: Liver Cancer, Adult

Summary: the indications liver cancer surgery currently booming due to the increase in surgical techniques and instruments for a more secure resection of liver tissue with a significant reduction in bleeding or surgical complications. this allowed to expand surgical indications in the most fragile patients so assuming optimized anesthetic care. so far, the technique of analgesia reference to this surgery remains administration of morphine analgesia via a device controlled by the patient (pca) for epidural analgesia is against-indicated because of induced bleeding disorders by surgery. rafi then mcdonnell in 2007 have described a new technique of loco regional anesthesia, the abdomen of the transversus abdominis plane (tap) nerve block(tap), which allows selective anesthesia of the abdominal wall. but parietal pain related muscular and nervous sagging surgical approach represent a significant share of post operative pain. this study proposes an evaluation of the abdomen transverse blocks in hepatectomy.


Eligibility criteria:
inclusion criteria: * hepatectomy or segmentectomy exclusion criteria: * sepsis uncontrolled current * overdose in anticoagulant during general anesthesia * thrombocytopenia \<50 g / dl * severe renal impairment: cockcroft \<30 ml / min * history of ventricular arrhythmia serious unexplained .\* * allergy to local anesthetics of the amide * contraindication to remifentanil and morphine * hypovolemia
research integration in women, infants, and children

Conditions: Body Weight Changes

Summary: wic is a governmental program that provides healthy foods, nutrition education and referrals to other health and social services. with the goal of applying for a future grant to expand the dissemination of smartloss® within the wic program, feedback from wic staff and wic clients must be solicited to better understand the burden and barriers of integrating these kinds of programs and with wic participants.

participants will complete a 15 minute online survey. wic staff will be eligible to complete the wic staff survey and wic clients will be eligible to complete the wic client survey. this is a qualitative research study designed to identify the receptiveness of implementing a weight management program in the wic program and the barriers to weight management intervention as described by wic staff and wic clients.

Eligibility criteria:
inclusion criteria: * individuals who are at least 18 years old * have been employed or volunteered at a wic clinic or dhh in louisiana for at least 6 months in the past 2 years or received wic services during pregnancy or postpartum or have had a child who received wic services in the past 2 years exclusion criteria: * less than 18 years old

Keywords: women infants and children survey
trial comparing different medical devices for infragenual dilatation

Conditions: Diabetic Angiopathies; Intermittent Claudication

Summary: this study is a comparison of different medical devices for infragenual dilatation.

dilatation and recanalisation of the distal veins (infragenual popliteal artery, tibiofibular trunc, posterior tibial artery, anterior tibial artery) by classical balloon dilatation or cutting balloon with or without stenting or by endovascular laser. this intervention happens only once; the duration of the intervention depends on the procedure and the original injuries(30 - 120 minutes).

Eligibility criteria:
inclusion criteria: * diabetes type i or ii with diabetic angiopathy stage iib to iv (fontaine) * atherosclerotic patients with distal angiopathy stage iib to iv (fontaine) exclusion criteria: * acute ischemia * multisegmentaric damage above the knee * sepsis: acute respiratory distress syndrome (ards), c-reactive protein (crp) \> 30, white blood cell (wbc) \> 25,000 * acute myocardial infarction (ami) during the last 14 days * operative contraindication * life expectancy \< 2 years * blue toe syndrome (micro-embolisation)
sequential trial of g17dt for the treatment of advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: compare the effect of g17dt with that of placebo on the survival of subjects with advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: * subjects with a histologically or cytologically confirmed diagnosis of pancreatic carcinoma, who were not eligible for tumor resection with curative intent (i.e., stage ii, iii, or iv disease) * male or female subjects over 18 years of age * subjects with a life expectancy of at least 2 months * kps score of ≥60% * written informed consent exclusion criteria: * previous, concomitant, or anticipated use (up to week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy * previous (during the 4 weeks before the study), concomitant, or anticipated use (up to week 12) of immunosuppressants. however, for systemic \[i.e., oral or injected\] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.) * history of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix * known immunodeficiency * females who were pregnant, planning to become pregnant, or lactating (women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.) * subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to week 12 during this study * previous g17dt treatment * hematological indicators as follows: * hemoglobin \<9.5 g/dl * neutrophils \<2.0 × 109/l * platelets \<100 × 109/l * any other condition or circumstance that might have the following results: * worsen if the subject participated in the study * reduce the subject's ability to comply with the protocol * confound the interpretation of the study results
a study of gw679769 compared to placebo in women with overactive bladder

Conditions: Incontinence, Urinary and Urinary Bladder, Overactive; Overactive Bladder

Summary: this is a phase iia study to evaluate the efficacy, safety and tolerability of gw679769 vs placebo on symptoms of urgency with urge incontinence, frequency and nocturia associated with overactive bladder in women.

a twelve-week randomized, double-blind, placebo-controlled, parallel group, forced titration, proof of concept study to assess the efficacy, safety and tolerability as well as the pharmacokinetic profile of 60 mg and 120 mg of gw679769 administered once daily vs placebo in women with overactive bladder

Eligibility criteria:
inclusion criteria: * female subjects with overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain. * must not be pregnant. * must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol. * body weight in the range of = 45 kg and \<100 kg. exclusion criteria: * stage iii/iv pelvic organ prolapse with or without cystocele. * history of interstitial cystitis or bladder related pain. * subjects with stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history. * history of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within six months of screening. * subjects with urinary incontinence due to causes other then detrusor over activity (e.g., overflow incontinence). * nocturnal enuresis only. * urinary retention, or other evidence of poor detrusor function. * history of prior anti-incontinence surgery. * history of radiation cystitis or a history of pelvic irradiation. * electrostimulation, biofeedback, or bladder training therapy (behavioral therapy) during the previous month prior to screening, or the intention to initiate such therapies during the study. pessaries and implants are also excluded. * participated in any clinical trial of an investigation drug that may affect urinary function within 3 months of enrollment into the study. * received any investigational product within 30 days of enrollment into the study.

Keywords: overactive bladder
phase ii study of oxaliplatin and taxotere in metastatic bladder cancer

Conditions: Bladder Cancer

Summary: to combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in bladder cancer.

to test the combination of oxaliplatin chemotherapy in combination with taxotere chemotherapy in patients with advanced bladder cancer who have failed one prior chemotherapy.

Eligibility criteria:
* patient population type: advanced muscle invasive bladder cancer * prior therapy: one prior therapy for advanced disease * disease: measurable disease * ecog performance: 0,1 * indication: histologically proven carcinoma of the bladder * for female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception * allergies: no known allergy to one of the study drugs * patient status: * no cns metastases * no peripheral neuropathy \> grade1 * no other serious concomitant illness * fully recovered from any prior therapy * informed consent: patient and doctor have signed informed consent * lower age limit: lower age limit \>18 * upper age limit: upper age limit \<70 * anc: anc \>1500/mm3 or wbc \> 3000/mm3 * platelets: platelets \>100,000/mm3 * creatinine: creatinine \<1.8mg/dl * bilirubin: bilirubin \<=2.0 x uln * sgpt: sgpt (alt) \<=1.5 x uln (\<4xuln if liver metastases present) * rbc: hemoglobin \> 9.0g/dl * cardiovascular: no active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months * patients with metastatic cancer of the urothelial tract (tcc, adenocarcinoma) * no prior exposure to oxaliplatin * no cytotoxics or radiation 4 weeks prior to enrolling on protocol * pt/ptt normal