Kornimate/medical-research-clean huggingface dataset:
adoptive transfer of pp65-specific t cells for the treatment of refractory cytomegalovirus (cmv) infection

Conditions: Cytomegalovirus Infections

Summary: to evaluate the safety and efficacy for treatment of persistent cmv infection in hematopoietic cell transplant (hct) recipients.

hct recipients who are receiving immunosuppressive agents to control graft versus host diseases (gvhd) are at high risk for serious cmv infection due to cmv reactivation or reinfection during their post-transplant period. antiviral agents used to treat cmv infection have well-known side effects such as bone marrow suppression causing cytopenia and renal toxicities. therefore, patients in a serious condition would have a higher probability of antiviral treatment-related toxicities and also increased possibility for prolonged antiviral treatment, thus development of antiviral resistance and risk of treatment failure. allogeneic hct recipients are typically lack of these cmv-specific t cells during the post-transplant period and their immune function can be further repressed especially when they are on additional immunosuppressive agents to prevent gvhd. therefore, these patients may benefit from cmv-specific t cell adoptive transfer.

Eligibility criteria:
inclusion criteria: * less than 66 years old allogeneic hct recipients who received stem cells from related cmv positive serology donors * and recipients have persistent cmv infection more than 2 weeks on antiviral treatment exclusion criteria: * hct recipients with severe graft versus host disease, grade 3 or more * or organ dysfunction (brain, heart, lung, liver, and kidney): altered mentality, extracorporeal membrane oxygenation, mechanical ventilator, increased liver enzymes 5 times above upper normal values, bilirubin level \>3 mg/dl, crcl \< 30 ml/min

Keywords: cmv t cell therapy
impact of suction in the eus-guided fine needle biopsy of solid pancreatic lesions

Conditions: Biopsy, Fine-Needle; Endosonography; Pancreatic Neoplasm

Summary: tissue acquisition by endoscopic ultrasound (eus) has become a modality of diagnosis and clinical orientation for several diseases. although tissue acquisition traditionally involves the cytological diagnosis (using fine-needle aspiration/fna), the importance of obtaining a core for histological examination (by fine-needle biopsy/fnb) has recently been recognized. currently, there is no clear establishment of the usefulness of syringe suction for the diagnostic accuracy of solid pancreatic lesions when fnb is used. because of that, the investigators aimed to compare sensitivity, sample adequacy, and diagnostic yield of solid pancreatic lesions eus-guided sampling using with and without syringe suction. the study will be conducted on a consecutive sample of patients proposed to perform eus for solid pancreatic lesions characterization, in which the clinical and imaging findings justify the need for an fnb. for each case, fnb will be performed using two punctures: one with 20ml syringe suction, and another without suction. the order in which they will be performed will be known only by the performing physician and the nursing team at the time that fnb is proposed. this information will be concealed from the pathologist responsible for sample analysis. clinical care during and after the procedure will follow the existing guidelines. participants will undergo a single clinical evaluation (at the time of endoscopy and recovery) without the need for follow-up visits.


Eligibility criteria:
inclusion criteria: * patients with 18 years of age and older; * ability to provide free and informed consent before entering the study; * imaging diagnosis of a solid pancreatic lesion that was proposed for eus characterization; * presence of sectional imaging method (ct/mri) performed within six months before randomization; * blood test (blood count and coagulation studies) compatible with the performance of invasive maneuvers; * clinical indication by the endoscopist for eus-tissue acquisition with the use of an fnb needle. exclusion criteria: * failure to provide free and informed consent; * clinically significant change in haemostasis laboratory parameters: international normalized ratio (inr) \> 1.5; activated partial thromboplastin time (aptt)\> 50 seconds; platelets \<50,000; * absence of a proper anticoagulant and/or anti-aggregate therapy discontinuation for the performance of fnb; * absence of fasting (2h without clear liquids and 6h without solid foods); * clinical suspicion of upper digestive tract obstruction; * an episode of acute pancreatitis within four weeks before echoendoscopy; * respiratory failure or hemodynamic instability; * pregnancy or breast-feeding.
rehabilitation efficacy of low-load blood flow restriction training for lateral patellar compression syndrome

Conditions: Lateral Patellar Compression Syndrome

Summary: the purpose of this study is to understand the effect of low-load blood flow restriction training on the rehabilitation effect of patients after lateral patellar compression syndrome surgery, and to observe the differences between low-load blood flow restriction training combined with conventional rehabilitation training and conventional rehabilitation training. the main question it aims to answer is: can low-load blood flow restriction training improve the rehabilitation effect of patients after surgery for lateral patellar hypertension syndrome? researchers compared conventional rehabilitation training with conventional rehabilitation training combined with low-load blood-limiting training to explore the effect of blood-limiting training combined with conventional rehabilitation training on the lower extremity function of patients after lateral patellar compression syndrome surgery, providing experimental and theoretical basis for formulating rehabilitation training programs.


Eligibility criteria:
inclusion criteria: 1. aged 30-60 years with a visual analog scale (vas) score ≥3; 2. diagnosed with lateral patellar compression syndrome confirmed by mri and clinical evaluation, having undergone arthroscopic lateral retinacular release surgery; 3. presenting postoperative reduction in thigh circumference on the affected side, accompanied by quadriceps muscle atrophy and decreased muscle strength; 4. minimum postoperative duration of ≥2 weeks, with signed informed consent and demonstrated ability to comply with the study protocol. exclusion criteria: 1. patients with concomitant fractures or other ligament injuries (including those with prior acl reconstruction); 2. individuals presenting with severe osteoarthritis or rheumatoid arthritis; 3. those with medical histories of deep vein thrombosis, coagulation disorders, vascular diseases, or diabetes mellitus; 4. subjects with active infections, malignancies, current pregnancy, or psychiatric disorders.

Keywords: lateral patellar compression syndrome patellofemoral joint ll-bfrt
ati-450 plus methotrexate (mtx) versus placebo plus mtx in participants with moderate to severe active rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: this study evaluates ati-450 plus mtx versus placebo plus mtx in participants with moderate to severe active ra who have had an inadequate response to mtx alone.

this is a phase 2b, randomized, multicenter, double-blind, parallel group, placebo controlled, dose ranging study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ati-450 plus mtx versus placebo plus mtx in participants with moderate to severe active ra who have had an inadequate response to mtx alone.

Eligibility criteria:
inclusion criteria: * able to comprehend and be willing to sign the institutional review board (irb)/independent ethics committee (iec) approved participant icf prior to administration of any study-related procedures. * diagnosis of adult-onset ra as defined by the 2010 american college of rheumatology/european league against rheumatism (acr/eular) classification criteria. * have active moderate to severe ra at screening. * a minimum of 12 weeks on mtx with a stable mtx dose. exclusion criteria: * current acute or chronic immunoinflammatory disease other than ra which may impact the course or assessment of ra. * uncontrolled non-immunoinflammatory disease that may place the participant at increased risk during the study or impact the interpretation of results (eg, previous malignancy, recurrent infection, previous venous thromboembolism). * participant has experience with \> 2 biologics, \> 1 jak inhibitor, or a combination of 1 biologic experience and 1 jak inhibitor. * currently receiving corticosteroids at doses \> 10 mg/day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of screening.

Keywords: rheumatoid arthritis ra
a study to evaluate the safety and efficacy of sm03 in patients with rheumatoid arthritis receiving methotrexate

Conditions: Rheumatoid Arthritis

Summary: this study evaluated the safety and efficacy of sm03 compared to placebo in patients with active rheumatoid arthritis(ra) receiving methotrexate


Eligibility criteria:
inclusion criteria: * adult patients 18-75 years of age. * rheumatoid arthritis (ra) for ≥ 12 months, diagnosed according to the revised 1987 american college of rheumatology (acr) criteria for the classification of rheumatoid arthritis. * moderate to severe active ra with swollen joint count (sjc) ≥ 8 (66 joint count), and tender joint count (tjc) ≥ 8 (68 joint count) at screening and baseline. * at screening, either c-reactive protein (crp) ≥ 0.6 mg/dl (6 mg/l), or erythrocyte sedimentation rate (esr) ≥ 28 mm/hour, or morning stiffness of joint for ≥ 45 minutes * inadequate response to methotrexate, having received and tolerated at a dose of 7.5-20 mg/week for ≥ 12 weeks, at a stable dose over the past 4 weeks. exclusion criteria: * rheumatic autoimmune disease other than ra. * use of any biological dmards for ra within past 6 months. * concurrent treatment with any disease modifying anti-rheumatic drug (dmard) other than methotrexate * active infection, or history of serious or chronic infection
a clinical trial analyzing effects of prokinetic drug on the blood glucose in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: with the improvement of living level, the incidence rates of diabetes, obesity, and hypertension in china increased quickly, which are 11.6%, 7.1% and 18.8% respectively, according to the newly investigated data. the clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. glp-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. it was reported that beside its hypoglycemic and losing weight effects, activator of glp-1 receptor could decrease blood pressure and improve lipid metabolism. sleeve gastrectomy can improve the level of blood glucose and serum lipid of type 2 diabetic rats by ameliorate insulin level and insulin resistance, which may be related with the change of gastrointestinal hormones such as ghrelin and glp-1. so, intervention of gastrointestinal tract and gastrointestinal hormone secretion may be a new therapy for glycolipids disorder and vascular complications. but, it is lack of evidence-based medicine proof on the relationship between prokinetic drug and glycolipids metabolism. so, the investigators designed a prospective, randomized, double-blinded, placebo control study, and try to evaluate the effects of prokinetic drug (mosapride) on the blood glucose and serum lipid in type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * male or female, age between 30-65 years old * type 2 diabetes * duration of diabetes less than 5 years and pancreatic function be in compensated stage. * 7%≤hba1c≤9% * patients are able to control diet and exercise by themselves in intervention period. exclusion criteria: * type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage iv diabetic nephropathy, or acute diabetic complications. * type 2 diabetes using insulin, glp-1 analogues or dpp-iv inhibitors). * heart function in nyha grade ii-iv or history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months. * hypohepatia (ast or alt is two times higher than the upper limit) or history of cirrhosis, hepatic encephalopathy, esophageal varices or portal shunt. * renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome. * chronic obstructive pulmonary disease (copd), chronic respiratory failure or hyoxemia. * acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction. * fertile woman without contraceptives. * any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs. * allergic to or have contraindication to the intervention drugs.

Keywords: mosapride blood glucose serum lipid
reflective testing for early diagnosis of pituitary dysfunction

Conditions: Pituitary Dysfunction

Summary: early detection and management of pituitary dysfunction reduces the morbidity that ensues as a consequence of missed or delayed diagnosis of this condition, and which may result in life-threatening events and increased mortality. the investigators study will explore the use of reflex strategies within the laboratory in capturing suspicious pituitary function test results from primary care patients and following these up with appropriate reflective testing. subsequently patients identified from these results to have a possible underlying piuitary dysfunction will have an alert sent to their family physician prompting referral to the endocrine team for further investigation and management.


Eligibility criteria:
inclusion criteria: * patients from primary care found to have one or more abnormal pituitary function test picked up by the laboratory information system in the clinical chemistry laboratory. exclusion criteria: * patients with known pituitary dysfunction or on medication that may affect pituitary function tests.
optimizing psychotherapy for anxiety disorders

Conditions: Anxiety Disorders

Summary: anxiety disorders are highly prevalent and are associated with a high burden of disease, costs and individual impairment worldwide. psychotherapy, especially cognitive behavioral therapy (cbt), is the first line treatment for anxiety disorders. cbt is effective in modifying dysfunctional cognitions and reducing avoidance behavior, thus leading to a lasting reduction of symptoms. even though cbt is generally effective, around 50% of patients do not benefit sufficiently from this treatment. the current study aims at optimizing the treatment of anxiety disorders by identifying predictors of treatment response. multiple (neuro-)psychological, biological, genetic and behavioral variables will be combined into a comprehensive prediction model of treatment outcome. knowledge on predictors can then be used to improve therapy on an individual patient level.


Eligibility criteria:
inclusion criteria: * aged between 18-65 years * one of the following primary axis i disorders according to the diagnostic and statistical manual of mental disorders (dsm): panic disorder with or without agoraphobia; social anxiety disorder; anxiety disorder not otherwise specified, adjustment disorder with anxiety, adjustment disorder with mixed anxiety and depression; specific phobia; generalized anxiety disorder * if on medication if on medication or in other types of treatments, patients must be willing to remain stable on their treatment for the duration of the acute phase/therapy of the study * not currently receiving other psychotherapeutic treatment for anxiety or another condition * fluent german * provision of written informed consent exclusion criteria: * concomitant psychotherapy * medical relative contraindications involve conditions that impede thorough exposure, e.g. cardiovascular diseases, autoimmune diseases or pregnancy * current or past schizophrenia, psychosis, or bipolar disorder * current suicidal ideation. * current substance/alcohol dependence or abuse * cluster a or b personality disorder * pregnancy (for women)

Keywords: anxiety cognitive behavior therapy transdiagnostic treatment prediction
performance of ultrasound in the early diagnosis of vocal cords paralysis

Conditions: Thyroidectomy; Paralysis of Vocal Cords

Summary: thyroid and parathyroid surgery concerns around 50 000 patients a year in france. one of its main complications is paralysis of vocal cords, and the consequences can be serious. in this study, the main gold is to evaluate diagnostic performances of ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications.

thyroid and parathyroid surgery concerns around 50 000 patients a year in france. one of its main complications is paralysis of vocal cords. indeed, the anatomy of the thyroid and its close location with the recurrent laryngeal nerve (responsible for the vocal cord movement) involves a possible lesion or inflammation of the nerve during the surgical procedure. this complication is common, affecting around 10% of thyroid or parathyroid patients following surgery. this complication can be reversible, with a speech therapy or a specific endoscopic treatment by an otolaryngologist. currently, a postoperative screening is performed by nasofibroscopy in the recovery room to directly visualize vocal cord mobility. this examination may be painful or badly tolerated by some patients. recent studies have highlighted the performance of ultrasound in this diagnosis. the protocol for these studies included an ultrasound distant of the intervention, while it is known that vocal cord paralysis may have earlier consequences. in this study, the investigators would like to evaluate diagnostic performances of vocal cords ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications. the main limitation of vocal cord ultrasound is mainly related to surgery. surgery creates anatomical rearrangements, so the secondary objective of this study will be to test whether the preoperative visualization is predictive of a good postoperative visualization.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years * scheduled surgery of total or partial thyroidectomy or parathyroidectomy * patient been informed and given his/her written consent to participate * patient affiliated to a social security scheme exclusion criteria: - patient under tutorship or curatorship

Keywords: thyroidectomy paralysis of vocal cords ultrasound
a phase i study of ono-4538hsc in subjects with advanced or metastatic solid tumors

Conditions: Advanced or Metastatic Solid Tumors

Summary: this is a multicenter, open-label, uncontrolled, phase i study to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ono-4538hsc administered subcutaneously in participants with advanced or metastatic solid tumors. this study consists of the tolerability confirmation part to determine the recommended dose for japanese participants by evaluating the dlts and the expansion part to evaluate the safety and pharmacokinetics and to explore the efficacy.


Eligibility criteria:
inclusion criteria: 1. patient with advanced or metastatic solid tumors 2. patients have an ecog performance status of 0 to 1 3. patients with a life expectancy of at least 3 months \[tolerability confirmation part\] 4. patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available \[expansion part\] 5. patients who are refractory or intolerant to standard therapy, or for whom no standard therapy is available, or for whom monotherapy with intravenous nivolumab is indicated according to the package insert exclusion criteria: 1. patients with a complication or history of severe hypersensitivity to any antibody product 2. patients with severe complication
hypnosis for sleep quality for individuals with mild cognitive impairment

Conditions: Mild Cognitive Impairment; Poor Quality Sleep

Summary: with the long-range goal to identify an efficacious and practical intervention to improve sleep for individuals with mci, this pilot study will enroll 20 individuals with mci into either a self-administered hypnosis for sleep program or a sham white noise hypnosis program. participants will practice hypnosis delivered via audio recording once per day in their own home for 7 weeks. upon completion of the study, insight will be gained regarding accrual, retention, and feasibility of the intervention and measures. data from this pilot study is essential to inform and plan a future r01 proposal to determine the efficacy of the self-administered hypnosis intervention to improve sleep quality and duration, as well as other benefits, with individuals with mild cognitive impairment.

study objectives aim 1: determine the accrual, retention, adherence and feasibility, and randomization to the self-administered hypnosis program among individuals with mci. feasibility will be determined by (1) drop-out rate, (2) participants' rating of the program, and (3) participants' rating of treatment satisfaction. adherence will be determined through at-home practice logs. essential experience on accrual and retention data as well. aim 2: determine feasibility of measures: psqi, actigraphy recordings, and sleep diaries to assess sleep quality and duration, as well as feasibility of secondary self-report outcome measures of insomnia severity, stress, cognition, and pain among individuals with mci. aim 3: determine perceptions of hypnosis and potential barriers for the mci population and feedback. participant selection and recruitment plan a sample of approximately 20 individuals with mild cognitive impairment, both male and female, who suffer from poor sleep will be enrolled in the study. a screening checklist will be used for screening participants who are interested. potential participants will be identified (1) via advertisements and press releases, (2) via physician and health care provider referral, support groups (3) and (4) targeted mailings. participant's eligibility will be determined by criteria listed on a screening checklist. the investigator has used these strategies in prior studies and has demonstrated ability to accrue the required number of participants.

Eligibility criteria:
inclusion criteria: * self-report of mci (a score of less than or equal to 3 on the memory complaint scale30) and a score between 7-18 on the montreal cognitive assessment (moca) - blind version 8.121 * self-reported sleep duration of less than or equal to 6 hours per day/night as indicated on the psqi * signed informed consent exclusion criteria: * use of any prescription or over-the-counter therapy for sleep * severe or unstable medical or psychiatric illness * current use of hypnosis for any condition * inability to speak or understand english