Kornimate/medical-research-clean huggingface dataset:
immunomonitoring and multiple myeloma: impact of lenalidomide on immune checkpoint expression

Conditions: Multiple Myeloma

Summary: the myeloma microenvironment is the target of many drugs in development, and it is unclear how they can be combined with reference treatments such as lenalidomide. this pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated mm patients. blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers. this study will provide rational guidance for future combination therapies with lenalidomide.

with the significant increase in the number of therapeutic combinations targeting the tumour microenvironment, it is crucial to better understand the effect of reference myeloma treatments on the different immune populations present in the tumour in order to rationally optimise the combination with new strategies under development. in addition, the identification of biomarkers in the circulating blood that can predict/monitor the impact of new therapies on the immune response is a major challenge. this pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated mm patients. blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.

Eligibility criteria:
inclusion criteria: * patient with newly diagnosed multiple myeloma; * patient not eligible for intensive treatment; * patient for whom first-line treatment with lenalidomide-dexamethasone will be initiated; * patient accepting the performance of an additional myelogram at the end of the 1st treatment cycle. * patient aged 18 years or older; * patient who has given free, informed and written consent; * patient affiliated to a social security scheme * for women of childbearing age, use of effective contraception exclusion criteria: * patient with relapsed multiple myeloma; * patient eligible for intensive treatment; * patient for whom chemotherapy involves treatment other than lenalidomide-dexamethasone; * patient with a contraindication to lenalidomide treatment * pregnant or breastfeeding woman; * person subject to legal protection (safeguard of justice, curatorship,guardianship) or person deprived of liberty.
metabolomics of liver regeneration following partial hepatectomy in healthy living liver donors

Conditions: Liver Insufficiency

Summary: the pi will study metabolism during liver regeneration in living liver donors

samples of blood and urine will be collected from study participants at defined timepoints. the samples will be evaluated to study the metabolism of the regenerating liver after a portion of the liver has been donated from a living donor.

Eligibility criteria:
inclusion criteria: 1. potential donor must be in excellent medical and psychological health. 2. potential donor must be between the ages of 18 and 60. 3. must have a compatible blood type to the recipient. 4. must have health care coverage for non-donor related health issues that arise post donation 5. recipient and donor must have compatible body size. 6. donors body mass index (bmi) must be less than 30. 7. all previous donor abdominal surgeries will be reviewed on a case by case basis by the surgeon. exclusion criteria: 1. positive blood test for human immunodeficiency virus, hepatitis c virus, hepatitis b virus 2. the size of the donor liver is not large enough to safely resection and still retain enough volume to function normally after the surgery. 3. liver biopsy show liver cirrhosis or early stages of hcc. - -

Keywords: living liver donor
duration of blockade of peripheral nerves with bupivacaine depending of the adjuvants

Conditions: Postoperative Pain; Peripheral Neuropathy; Fractures of the Upper Limb; Fracture of the Lower Limb (Except Hip), Initial Encounter; Intraoperative Hypotension; Intraoperative Hypertension; Pain Syndrome; Anesthesia; Anesthesia, Local; Local Anesthetic Systemic Toxicity

Summary: the main aim of the investigator's study is to propose combination of local anesthetics and adjuvants that provides both adequate anesthesia during surgery and prolonged post-operative analgesia.

peripheral nerve plexuses blocks are performing as a component of analgesia in patients undergoing orthopedic surgery on the upper or lower extremities. patients are divided into two groups depending on the adjuvant to the local anesthetic: 1st group - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02%; group 2 - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02% and epinephrine 0.00018%. the duration of the blockade is estimated by puncturing the skin with a needle. the intensity of pain is assessed at 6, 12, 24 and 36 hours after blockade using visual analog scale (vas). the amount of narcotic anesthetic used in the postoperative period is also recorded. in addition, patients underwent electromyography of the innervation area of the blocked nerve before the surgery and 24 and 36 hours after surgery.

Eligibility criteria:
inclusion criteria: * all patients undergoing upper or lower extremity orthopedic surgery exclusion criteria: * diabetes mellitus; * diseases of the peripheral nerv system

Keywords: regional anesthesia pain management local anesthetic electromyography
the association of clinical symptom clusters with underlying mechanisms in functional gastrointestinal disorders

Conditions: Functional Gastrointestinal Disorders

Summary: functional gastrointestinal disorders (fgid) are amongst the most common causes of abdominal pain and dysfunction seen in clinical practice, affecting between 10 to 15% of most populations (1). fgid are defined by symptoms without demonstrable underlying organic pathology (2). within the currently used rome definitions of fgid, there is a broad range of gastrointestinal and multi-organ symptoms, indicating heterogeneous underlying pathophysiological mechanisms (3). there is evidence of central nervous system and motility dysfunction, dysbiosis, as well as immune activation in various subgroups of patients with fgid (2). most mechanistic studies have been performed in small and heavily selected groups of patients. consequently, the link between different symptomatic subgroups of patients and underlying mechanisms is unclear and unconfirmed in larger and representative patient cohorts. fgid patients with different underlying pathologies are likely to benefit from divergent specific treatments, even if they fall within the same rome classification of fgid. discrete clusters of clinical characteristics in a large cohort of patients with fgid will be sought using hypothesis-free cluster analysis and latent-class analysis models. associations to underlying mechanisms will be examined using data from fermentable sugar breath, blood and stool tests. this will allow recommendations regarding improved mechanistic-based classifications of patients with fgid, with potential for more effective mechanistic-based treatments. the investigators will use coded clinical and medical history characteristics obtained by standardized questionnaires and laboratory and breath test results from all successive patients above the age of 18 years referred to the gastroenterology group practice in the last 10 years for diagnosis and treatment of fgid for statistical analysis the data is stored in a database, without any personal identifiers. explorative statistical analysis will be performed in approximately 5000 patients.


Eligibility criteria:
inclusion criteria: * male and female patients * have fgid at time of referral based on rome iii criteria * age over 18 years exclusion criteria: * evidence of organic disease. * age below 18 years * documented refusal to allow data use

Keywords: irritable bowel syndrome functional dyspepsia
vegetarian diet and innate immunity in patients with myocardial infarction and in healthy volunteers (fresh-mi study)

Conditions: Myocardial Infarction

Summary: the goal of this clinical trial is to assess the effect of a vegetarian diet on innate immunity of patients with a recent acute myocardial infarction and healthy participants. also, we will assess the willingness to adapt a more vegetarian eating habit. study subjects will follow a vegetarian diet for five weeks, whereafter a stabilisation period of six weeks will follow. then, participants will follow to the other dietary intervention for five weeks. blood will be drawn at given time points to analyse inflammatory parameters.

we will perform a proof-of-concept study according to a prospective randomized open label blinded endpoint (probe) design. patients with an acute myocardial infarction (ami) and their healthy life partners / spouses will be randomly assigned to an immediate vegetarian diet or their habitual diet. patients with ami will be stratified for non-st-elevation myocardial infarction (nstemi) or st-elevation myocardial infarction (stemi). the dietary intervention will start one week after the index event and will comprise a period of five weeks. after a stabilisation phase (six weeks), to assure normalisation of the inflammatory response secondary to the acute myocardial infarction, patients and their spouses will follow the other dietary intervention arm. then, half of them will start directly with the other dietary intervention and half of them will start after a period of five weeks. blood samples will be taken at the time points. also, all participants will be asked to complete a questionnaire at baseline, after twelve weeks and at nine months follow-up. infarct size as assessed by cardiovascular magnetic resonance (cmr) imaging will be used to adjust cytokine levels.

Eligibility criteria:
inclusion criteria for patients: * acute myocardial infarction (stemi/nstemi) with a clear culprit lesion on angiography and successful primary percutaneous coronary intervention (pci) \<1 week before randomisation * body mass index between 18.5 and 35 kg/m2 * written informed consent inclusion criteria for healthy volunteers (life partners / souses) * body mass index between 18.5 and 35 kg/m2 * written informed consent exclusion criteria for patients and healthy volunteers: * already on a vegetarian or vegan diet * previous myocardial infarction * diabetes mellitus * medical history of any disease associated with immune deficiency (either congenital or acquired, including chemotherapy, chronic steroid use, organ transplant) * use of immunomodulatory drugs * vaccination less than one month before start of intervention * clinically significant infections within 1 months prior to start of intervention (defined as fever \>38.5 degrees celsius) * active malignant haematological disease * known eating disorder (e.g., anorexia nervosa, bulimia nervosa) exclusion criteria for healthy volunteers - use of lipid lowering therapy
phase i/ii study to test the safety and efficacy of tvi-brain-1 as a treatment for recurrent grade iv glioma

Conditions: Glioma; High Grade Astrocytoma; Glioblastoma Multiforme

Summary: tvi-brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. tvi-brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.

tvi-brain-1 involves several steps. first, the patient's cancer will be surgically removed to provide cells for the vaccine. second, the patient will be vaccinated twice with those cells and gm-csf. third, the patient's blood will be filtered for white cells which will then be cultured and stimulated to reach a higher (killer) activity level. fourth, the activated white blood cells will be infused into the patient's bloodstream so that they will be able to attack the cancer. finally, the entire process starting with vaccination will be repeated, for a total of two rounds of therapy.

Eligibility criteria:
inclusion criteria: * age \> 18 * informed consent * diagnosis of grade iv glioma with progression following standard treatment. * must be able to tolerate surgery to provide tumor tissue for vaccine. * must be able to produce viable vaccine from tumor tissue. * eastern cooperative oncology group (ecog) performance status must be \< 2 or karnofsky performance status must be 70 or greater. * negative hiv test. * negative for hepatitis b and c virus. * respiratory reserve must be reasonable. * sufficient renal function. * satisfactory blood counts. * negative pregnancy test for women of childbearing potential. exclusion criteria: * surgically removed cancer reveals that it is not grade iv glioma. * concomitant life-threatening disease. * active autoimmune disease. * currently receiving chemotherapy or biological therapy for the treatment of cancer. * currently receiving immunosuppressive drugs for any reason. * prior treatment with avastin or other anti-angiogenesis treatment within 6 months. * prior treatment with gliadel wafers. * corticosteroids beyond peri-operative period. * psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.

Keywords: brain neoplasms central nervous system neoplasms brain diseases neoplasms nervous system neoplasms glioblastoma astrocytoma nervous system diseases central nervous system diseases glioma recurrent astrocytoma recurrent glioma cancer vaccine immunotherapy killer t cells activated t cells gm-csf low dose il-2 activated lymphocytes
comparison of bioabsorbable and steel screw for the treatment of hallux valgus with chevron osteotomy

Conditions: Hallux Valgus

Summary: hallux valgus is the most common deformity of forefoot and the patients would suffer pain and disable of walking and wearing normal shoes. chevron osteotomy of the first metatarsal is widely used for the treatment of mild or medium hallux valgus. it is a "v" sharp osteotomy that can decrease the intermetatarsal degree of first-second metatarsal by pushing the distal side of osteotomy laterally.a 2.5mm or 3.0mm steel cannulated screw is usually used for the fixation of the osteotomy side to provide stability.however,there are some shortcomings of steel screws such as rejection of internal fixation or the financial cost of the second surgery of fixation taken-out. to obviate these shortcomings of steel screws, bioabsorbable screw fixation may be an alternative method for chevron osteotomy. this trial is a randomized, prospective, controlled, parallel experimental design, to compare the clinical and radiographic outcomes of bioabsorbable screw versus steel screw for the treatment of hallux valgus with chevron osteotomy. the patients will be randomized to two groups, one treated with bioabsorbable screws while the other treated with steel screws.data collection for the outcomes measures will occur pre-op,immediate post-op and then 6 weeks, 12 weeks, and at 1 years post operation. the clinical outcomes measure are the vas (visual analogue scale) score and aofas (american orthopedic foot and ankle society) forefoot score.the radiographic outcomes measures are the ima (intermetatarsal angle) and the hva (hallux valgus angle)


Eligibility criteria:
inclusion criteria: 1. hallux valgus treated with distal chevron osteotomy 2. age between 18-70 exclusion criteria: 1. hallux valgus treated with other procedure (scarf,ludloff,lapidus,etc) 2. age \ 70 3. rheumatoid 4. osteoporosis -

Keywords: hallux valgus chevron osteotomy bioabsorbable screw steel screw
maraviroc compassionate use

Conditions: Human Immunodeficiency Virus Type 1

Summary: the objective of this study is to provide maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with ccr5-tropic hiv-1 with urgent unmet medical needs and who, in the opinion of the physician, require maraviroc to form a viable regimen.

this study was cancelled prior to enrollment.

Eligibility criteria:
inclusion criteria: * patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective hiv-1 treatment regimen. * have only ccr5-tropic hiv-1 virus * cd4+ cell count \< 200 cells/mm3 exclusion criteria: * cxcr4- or dual/mixed-tropic hiv-1 virus * patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness * patients who are pregnant or breast feeding an infant or planning to become pregnant.

Keywords: maraviroc compassionate use
a study of ly3841136 compared with placebo in adult participants with obesity or overweight

Conditions: Obesity; Overweight and Obesity

Summary: the main purpose of this study, performed under the master protocol w8m-mc-cwmm (nct06143956), is to investigate weight management efficacy and safety with ly3841136 compared with placebo in adult participants with obesity or overweight. the study will last about 64 weeks and may include up to 17 visits.


Eligibility criteria:
inclusion criteria: w8m-mc-laa1 * are males and females who agree to abide by the reproductive and contraceptive requirements w8m-mc-cwmm: * have a bmi ≥27 kg/m² * have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss) exclusion criteria: w8m-mc-laa1 * have any prior diagnosis of diabetes mellitus except gestational diabetes. * have any of the following cardiovascular conditions within 6 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure (chf). * have a history of acute or chronic pancreatitis. * have an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline. w8m-mc-cwmm * have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening. * have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma. * have poorly controlled hypertension. * have a history of symptomatic gallbladder disease within the past 2 years * have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease. * have a lifetime history of suicide attempts.

Keywords: overnutrition hormones chronic weight management
optimized posterior left atrial wall ablation strategy for peaf

Conditions: Persistent Atrial Fibrillation

Summary: this is an open-label, multicenter, randomized parallel-controlled clinical trial. the study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (psaf).

this is an open-label, multicenter, randomized parallel-controlled clinical trial. the study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (psaf). the main content of the research includes comparing three approaches through randomization: pulmonary vein isolation (pvi) alone, pvi plus pulse field ablation (pwi), and pvi plus anatomical and potential-guided ablation, to evaluate their effects on reducing the recurrence rate of atrial fibrillation. the study is designed with three groups: the pvi-alone group, the pvi + pwi group, and the pvi plus anatomical and potential-guided ablation group.

Eligibility criteria:
inclusion criteria * patients aged ≥18 years. * patients undergoing their first ablation procedure for psaf. * persistent atrial fibrillation (af): defined as episodes lasting ≥7 days and ≤3 years (including those requiring pharmacological or electrical cardioversion ≥7 days). * atrial fibrillation symptoms that are intolerant to at least one antiarrhythmic drug (aad). * at least one episode of psaf must have been documented within the last 2 years by methods such as ecg, holter monitoring, loop recorder, telemetry, remote telemonitoring (ttm), or implanted devices prior to enrollment in this study. * patients must be capable and willing to provide written informed consent to participate in the study. * patients must be willing and able to comply with all study follow-up requirements. exclusion criteria: * paroxysmal af: defined as episodes lasting \&lt;7 days (or resolved with medication/electrical cardioversion within \&lt;7 days). * patients with long-standing persistent af: defined as persistent af lasting \&gt;3 years. * patients who have never attempted/pursued cardiac rhythm restoration or sinus rhythm. * contraindication to systemic anticoagulation. * pregnancy. * advanced renal or hepatic failure. * severe valvular heart disease or cyanotic congenital heart disease. * hypertrophic cardiomyopathy.

Keywords: pulmonary vein isolation pulse field ablation anatomical and potential-guided ablation posterior left atrial wall ablation
dose ranging study to evaluate the efficacy and safety of sar153191 (regn88) in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: primary objective: - to evaluate the efficacy of sarilumab in participants with ankylosing spondylitis (as) using the assessment in as working group criteria (asas) 20% response criteria (asas20) secondary objectives: * to demonstrate that sarilumab was effective on: * assessment of higher level of response \[asas 40% response criteria (asas40)\] * partial remission * disease activity * range of motion * magnetic resonance imaging (mri) of the spine * to assess the safety and tolerability of sarilumab in participants with as as well as the pharmacokinetic profile of sarilumab in participants with as

the duration of participation in this study for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-weeks double-blind treatment period and 6-weeks safety follow-up period.

Eligibility criteria:
inclusion criteria: * diagnosis of as according to the new york modified criteria * participants must had an adequate trial of at least 2 different non-steroidal anti-inflammatory drugs (nsaids) taken for at least 2 weeks in each case and, on a stable dose for ≥2 weeks or be intolerant to nsaids * participants must had active as for ≥3 months before screening and active disease must be present at screening and at baseline; active as being defined by: * bath ankylosing spondylitis disease activity index (basdai) score of ≥4 (numerical rating scale 0-10) * total back pain score ≥4 (numerical rating scale 0-10) participants treated with corticosteroid must be on a stable dose for ≥2 weeks prior to baseline participants treated with the disease modifying anti-rheumatic drugs (dmards) hydroxychloroquine, sulfasalazine and methotrexate (mtx) must be on stable dose ≥12 weeks prior to baseline exclusion criteria: * \<18 years old or ≥75 years old * complete fusion of the spine * past history of non response to any anti-tumor necrosis factors (tnfs) treatment or non response to any other biological treatment for as * any past or current treatment with anti-tnf's or any biological agent within 3 months prior to screening * treatment with dmards except for hydroxychloroquine, sulfasalazine and mtx * mtx \>25 mg/week * hydroxychloroquine \>400 mg/day * sulfasalazine \>3 g/day * treatment with oral prednisone or equivalent corticosteroids \>10 mg/day within 6 weeks prior to screening * use of intramuscular or intra-articular corticosteroids within the last 4 weeks before screening * previous treatment with cyclosporine, azathioprine the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.