Kornimate/medical-research-clean huggingface dataset:
prospective validation of a pharmacological biomarker for low-dose rituximab in rheumatoid arthritis

Conditions: Rheumatoid Arthritis (RA)

Summary: evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters.

rituximab is an anti-cd20 monoclonal antibody which is effective in ra. the dose indicated in the marketing authorisation is 1000 mg twice per cycle. however, rituximab is associated with adverse events, and more specifically the risk of infection, which seems to be dose-dependent. the dose of 1000 mg once a cycle has been evaluated and is non-inferior for maintenance treatment. lower doses than 1000 mg once could also be sufficient, but there is a lack of predictive criteria to guide clinicians in their search for the minimal effective dose for a given patient. in our center, a pk-pd model including several parameters (body surface area, serum igg concentration, residual rituximab concentrations and cd4+ t-cell count) has enabled to quantify part of the concentration-effect relationship of rituximab in this indication and at standard dose (1000 mg twice at 15-day intervals). on the basis of this model, a model for predicting clinical response has been developed.with reliable prediction of clinical response. the aim of this study is to apply this model to patients receiving low-dose rituximab (1000 mg once per cycle) and to evaluate the prediction of clinical response to low-dose rituximab using this model. correlation and coefficient of determination between das28-crp observed 6 months after a second low-dose cycle and das-28 predicted by a pk-pd model taking into account gender, body surface area, igg concentration, rituximab concentration and cd4 t-cell count.

Eligibility criteria:
inclusion criteria: . age ≥ 18 years * diagnosis of rheumatoid arthritis meeting acr/eular 2010 criteria. * candidates for a low dose regimen: on standard dose rituximab and with a good clinical response according to the referring rheumatologist. no maximum duration of use of standard-dose rituximab has been defined. * in the case of co-prescription of csdmards (methotrexate, leflunomide, salazopyrine, plaquenil), the dose must have been stable for 3 months. * if corticosteroids are co-prescribed, the dose should be ≤ 10 mg/d and stable for 3 months. exclusion criteria: * other associated targeted disease-modifying therapy * sjögren's syndrome or other associated inflammatory rheumatism * fibromyalgia or other pathology having an impact on the assessment of disease activity * any active haematological disease affecting lymphocytes (chronic lymphocytic leukaemia, hodgkin's and non-hodgkin's lymphomas, lymphoplasmacytic lymphoma, t lymphoma). * opposition to data processing * no inclusion of persons covered by articles l. 1121-5 to l. 1121-8 and l. 1122-1-2 of the public health code (e.g. minors, protected adults, etc.).

Keywords: pharmacological biomarker rituximab retreatment low dose
efficacy and safety of atg-fresenius following a renal transplantation, without corticosteroids

Conditions: Renal Transplant Rejection

Summary: the main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with atg-fresenius administered in addition to standard treatment consisting of cellcept® or myfortic®/tac and without corticosteroids and a treatment consisting of cellcept® or myfortic®/tac and corticosteroids during the first year after renal transplantation.


Eligibility criteria:
inclusion criteria * signed and dated informed consent form, * end-stage renal disease, * candidates for a first transplantation, * re-transplant patients are eligible if a graft loss after transplantation was not due to immunological reasons, * availability of a heart-beating cadaveric donor up to 70 years of age with a cold ischemia time shorter than 36 hours, * male or female patients between 18 to 75 years of age inclusive, * patients able to comply with all study related requirements, * patients able to receive oral medication, * women of childbearing age with a safe contraceptive method throughout the study. exclusion criteria * women who are pregnant or breast feeding, * known human immunodeficiency virus, * hepatitis b virus or hepatitis c virus infection, * severe actual viral, bacterial or fungal infection not adequately controlled, * patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies or positive rabbit immunoglobulin skin test or known allergies to any component of the immunosuppressive drugs per protocol, * patients at high immunological risk defined as current pra \> 25% or historical pra \> 50%, * patients receiving pre-transplant immunosuppressive treatment, including corticosteroids, * patients with current or history of malignancies (exception basal cell carcinoma or squamous cell carcinoma in remission), * patients with previous transplantation except 1st graft loss due to surgical complications, * patients receiving combined transplantation, * patients with major organ dysfunctions, * serious psychiatric or psychological disorders, * pre-transplant thrombocytopenia: \< 50,000 thrombocytes/µl, pre-transplant leukopenia: \< 2,000 leukocytes/µl, * unable or unwilling to comply fully with the protocol, * participation in another study of an investigational medicinal product concurrently or within the last 30 days.

Keywords: acute rejection chronic rejection subclinical rejection renal transplantation steroid-free kidney transplantation
the modular protocol for mental health (mpmh)

Conditions: Major Depressive Disorder; Generalized Anxiety Disorder; Posttraumatic Stress Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia; Obsessive-Compulsive Disorder; Illness Anxiety Disorder

Summary: currently, our best psychological treatments for anxiety and mood disorders only focus on individual diagnoses. so, there are separate treatments for panic disorder, or depressive disorder, or social anxiety, etc. these 'diagnosis-specific' treatments work well for people whose problems fit neatly into a single diagnosis. however, they work far less well for people with complex problems involving multiple diagnoses, and 50% of patients fail to respond well to these existing treatments. the purpose of this study is to test a new psychological treatment for anxiety and mood problems (the modular protocol for mental health \[mpmh\]). instead of focusing on any single diagnosis, mpmh combines the best treatment techniques into 10 modules to target problems common across all of the different mood and anxiety diagnoses (e.g., intense emotions, negative thinking, upsetting memories, distressing habits). mpmh should therefore be a better treatment for the large numbers of individuals whose problems do not fit neatly into a single diagnosis and for whom any treatments targeting a single diagnosis would leave significant difficulties unaddressed.


Eligibility criteria:
inclusion criteria: * patients with a primary diagnosis of a unipolar mood, anxiety, stress or obsessive-compulsive disorder with at least one additional comorbid diagnosis according to the dsm-5. the criteria for diagnosis will be based on the structured clinical interview for the dsm (scid) which assesses disorders according to dsm-5 diagnostic criteria. * to be eligible participants will also need to score \>10 on either the patient health questionnaire (phq-9) or generalised anxiety disorder -7 item scale, gad-7 (see study measures above). exclusion criteria: * current/past psychosis or bipolar disorder * current full diagnosis of substance use disorder * organic brain damage * complex trauma history or recurrent self-injury requiring specialist services (as deemed by the nhs clinical care team) * current suicidality that warrants immediate clinical attention and constitutes a current risk of harm to the individual.
a clinical study of bacillus coagulans in acute graft-versus-host disease after hematopoietic stem cell transplantation

Conditions: Acute Graft-versus-host Disease

Summary: to evaluate the preventive effect of bacillus coagulans on acute graft-versus-host disease (agvhd) after hematopoietic stem cell transplantation

the study is conducted on patients after hematopoietic stem cell transplantation and the intervention is bacillus coagulans, aiming to investigate the preventive effect of bacillus coagulans on acute graft-versus-host disease after hematopoietic stem cell transplantation.

Eligibility criteria:
inclusion criteria: 1. patients are fully aware of the study, voluntarily participate and sign informed consent; 2. age: ≥18 years old; 3. patients with hematologic malignancies undergoing allo-hsct and patients with severe aplastic anemia (saa) undergoing allo-hsct were treated with myeloablative conditioning (mac). exclusion criteria: 1. refused to participate in this clinical study; 2. unable to take the drug orally; 3. allergic to bacillus coagulans; 4. people take allo-hsct with reduced intensity conditioning (ric) and nonmyeloablative conditioning (nmc);lymphoma or multiple myeloma with auto-hsct; multiple myeloma patients.
a study to evaluate thr-687 treatment for diabetic macular oedema.

Conditions: Diabetes Mellitus; Diabetic Retinopathy; Diabetic Macular Edema

Summary: this study is conducted to select the thr-687 dose level (part a of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (part b of the study).

in part a, approximately 12 subjects are planned to be randomized (1:1 allocation) to thr-687 1.2mg and thr-687 2.0mg. in part b, in the cohort of treatment naïve subjects are planned to be randomized (2:1 allocation) to thr-687 selected dose level from part a and aflibercept 2.0mg. in part b, in the cohort of previously treated subjects are planned to be randomized (1:1 allocation) to thr-687 selected dose level from part a and aflibercept 2.0mg. all subjects in the study will receive study treatment in one selected study eye only.

Eligibility criteria:
the subjects in this study will be subjects with central-involved dme (ci-dme). both treatment-naïve and previously treated subjects will be included. inclusion criteria: * written informed consent obtained from the subject prior to screening procedures * male or female aged 18 years or older at the time of signing the informed consent * type 1 or type 2 diabetes * bcva etdrs letter score ≥ 39 in the study eye * ci-dme with cst of ≥ 300µm in men (or equivalent in women), measured from rpe to ilm inclusively, on sd-oct, in the study eye * bcva etdrs letter score ≥ 34 in the fellow eye exclusion criteria: * macular edema due to causes other than dme in the study eye * concurrent disease in the study eye, other than dme, that could require medical or surgical intervention during the study period or could confound interpretation of the results * any condition in the study eye that could confound the ability to detect the efficacy of the investigational medicinal product * previous confounding medications / interventions, or their planned administration during the study * presence of iris neovascularisation in the study eye * uncontrolled glaucoma in the study eye * previously received thr-687 or any other experimental therapy for dme, in either eye * any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye * untreated diabetes * glycated haemoglobin a (hba1c) \> 12% * uncontrolled hypertension
the mordis study clinical investigational plan

Conditions: Adenoma

Summary: to demonstrate the use of wavstat4 system during colonoscopy in identifying diminutive colorectal lesions (e.g. hyperplastic polyps) that can be resected and discarded (or even left in-situ) without adverse clinical impact.

to demonstrate the performance of the wavstat4 optical biopsy system when used at multiple centers. endpoint targets are based on the asge pivi recommendations on real-time endoscopic assessment of the histology of diminutive colorectal polyps. * primary endpoint: to demonstrate potential of the wavstat4 optical biopsy system to predict adenomatous histology with a npv \> = 90% for diminutive colorectal lesions. * secondary endpoint: to show that use of the wavstat4 system used to determine histology of colorectal polyps ≤5 mm in size, when combined with the histo- pathologic assessment of polyps \>5 mm in size, provides a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps.

Eligibility criteria:
inclusion criteria: * male and female \> 18 years * standard indication for colonoscopy or crc screening or follow-up examination after the diagnosis of one or more established polyps or polypectomy (analysis of polyps other than the intended polypectomy) * written informed consent exclusion criteria: * inflammatory bowel disease * hereditary/genetic polyposis syndromes

Keywords: adenomatous colorectal lesions colorectal polyps polyps
impact of darbepoetin alfa on exercise tolerance and left ventricular structure in subjects with symptomatic congestive heart failure (chf) and anemia

Conditions: Congestive Heart Failure; Anemia

Summary: the purpose of this study was to evaluate the effect of treatment with darbepoetin alfa on peak oxygen consumption (peak vo2) in subjects with symptomatic chf and anemia.


Eligibility criteria:
inclusion criteria: - symptomatic chf for at least 3 months - reduced left ventricular ejection fraction - stable heart failure medication - peak vo2 less than or equal to 16 ml/kg/min - hemoglobin concentration between 9.0 and 12.0 g/dl exclusion criteria: - hypertension - unstable angina pectoris or recent myocardial infarction - likely to receive cardiac transplant - unable to do cardiopulmonary exercise testing - major organ transplant (e.g., lung, liver, heart) or renal replacement therapy (e.g., dialysis) - recent or current treatment for malignancy - systemic hematologic disease - anemia due to acute or chronic bleeding - recent epogen® or darbepoetin alfa therapy - recent blood transfusion

Keywords: chronic heart failure congestive heart failure low hemoglobin anemia chf symptomatic congestive heart failure (chf)
intraurethral lidocaine after endourology procedures

Conditions: Dysuria

Summary: many urological conditions are diagnosed and treated with the use of endourology procedures. unfortunately, dysuria is a common patient complaint following these procedures. intraurethral lidocaine instillation is regularly used prior to office-based endourology procedures to alleviate dysuria, as well as, discomfort during the procedure.. studies have confirmed that office-based procedures using intraurethral lidocaine have resulted in less patient reported dysuria. many endourology procedures are done under general anesthesia such as urinary stone treatments or resection of bladder tumors. there is a paucity of data regarding the use of intraurethral lidocaine at the conclusion of these procedures evaluating patient reported dysuria. we have designed a prospective, randomized, placebo controlled trial to evaluate the role of intraurethral lidocaine instillation following endourology procedures in the anesthetized patient.


Eligibility criteria:
inclusion criteria: adult patients, age 18 and older scheduled to undergo endourologic procedure to include ureteroscopy, rigid diagnostic cystoscopy, bladder biopsy, laser lithotripsy, cystolithalopaxy, and transurethral resection of bladder tumor in the operating room under general anesthesia. - exclusion criteria: active urinary tract infection, current dysuria symptoms, pregnant females, urethral stricture disease, indwelling foley catheter, and history of pelvic radiation -
internal and predictive validity of epworth sleepiness scale to evaluate vigilance of patient treated for obstructive sleep apnea syndrome.

Conditions: Obstructive Sleep Apnea Syndrome

Summary: presently, there isn't any international recommendation to evaluate vigilance in obstructive sleep apnea syndrome. the french society of sleep research and medicine (sfrms) recommend evaluating professional driver with a mwt but no recommendation exists for other patients. after a minimal treatment of 4 weeks, the physician has to evaluate the drowsiness risk of these patients using either an objective test like the mwt or a subjective one. in the university hospital amiens-picardie, since the 01/01/2015, every patient with an obstructive sleep apnea syndrome diagnosed by a polysomnography or a ventilatory polygraphy had a mwt after 4 weeks of treatment. at each time of the evaluation, epworth sleepiness scale, tiredness score of pichot, and depressive score of beck are performed.


Eligibility criteria:
inclusion criteria: * patients treated by cpap for obstructive sleep apnea syndrome exclusion criteria: * central apnea syndrome * central hypersomnia
validity, reliability and reproducibility of plain radiographic measurements after total hip arthroplasty

Conditions: Osteoarthritis of the Hip

Summary: in total hip arthroplasty (tha), radiographic preoperative planning and postoperative evaluation of acetabular component, femoral offset (fo) and leg length discrepancy (lld) require good validity, interobserver reliability and intraobserver reproducibility. questions/purposes: (1) evaluate the validity of the sundsvall method of fo measurement by comparing it to a standard fo measurement method. (2) evaluate the interobserver reliability and intraobserver reproducibility of measurement of fo, lld, acetabular cup inclination and anteversion. 90 patients with primary unilateral osteoarthritis (oa) were included in this prospective study. on postoperative radiographs fo by the sundsvall method, fo by a standard method, lld, acetabular cup inclination and anteversion were measured. the interobserver reliability and intraobserver reproducibility were made by three independent observers. the validity and degree of prediction of sundsvall method are measured by comparing its results with the standard method.


Eligibility criteria:
inclusion criteria: * unilateral total hip replacement with either a cemented lubinus sp ii system (link, germany) or an uncemented cls stem and triology cup (zimmer, u.s.a). exclusion criteria: * patient with secondary (oa), previous spinal, pelvic, or lower limb injuries or fractures were excluded.

Keywords: osteoarthritis, hip, radiograpghic measurements femoral offset leg length discrepancy cup anteversion cup inclination
effectiveness of modified ophthalmic draping method in preventing carbon dioxide accumulation in patient undergoing eye surgery under local anesthesia

Conditions: To Prevent Hypercarbia Under the Opthalmology Drape During Surgery.; To Prevent Hypothermia During Opthalmology Surgery.

Summary: the investigators hypothesize that this modified ophthalmic draping will reduce the accumulation and rebreathing of carbon dioxide during eye surgery.

majority of eye surgery has been widely done under local anesthesia provided by the ophthalmologist with or without sedation.the surgical drapes used often covers the patients face and beyond in order to maintain sterility of the surgical field. this can lead to accumulation of carbon dioxide under ophthalmic drapes due to the exhaled carbon dioxide escapes incompletely through the drapes;hence results in an increase of carbon dioxide in the ambient air surrounding the patient's head.this causes an increase in arterial carbon dioxide partial pressure and thus hyperventilation and patient discomfort with restlessness and unable to stay still during the surgery. in recent years,several types of ophthalmic drapes have been produced.this study is look for possible difference in accumulation of carbon dioxide under the standard ophthalmic drapes compared to the modified draping.

Eligibility criteria:
inclusion criteria: - asa physical status i,ii or iii,adult aged 40 to 80 years old,scheduled to undergo elective eye surgery under local anaesthetic at ummc will be enrolled in this study. exclusion criteria: * pre-existing pulmonary disease,psychological disorders,neurological disorder and patient required sedation.
study title: food rx

Conditions: Diabetes; High Blood Pressure; Obesity; Hypertension; Heart Diseases; Stroke; TIA; Osteoarthritis; Cancer

Summary: researchers are trying to determine if subjects with lack of access to healthy food and a long term health problem, are helped by a weekly box of healthy groceries and nutrition education.

participants that have a chronic preventable disease and food insecurity will be offered enrollment in the study. once all participants are enrolled, they will be given weekly boxes of food which includes materials for a nutritious recipe and extra fruit and vegetables for a total of 6 weeks. the snap-ed educator and ship public health coordinator will be present at food pick up to answer questions about the boxes, food preparation, etc. they will be given the option of participating in grocery store and farmer's market tours, as well as sign up for text messaging of nutrition information and recipes. at the end of 6 weeks, they will be asked to participate in a focus group. at baseline, 3 months and 6 months, they will be asked to complete a survey on lifestyle behaviors and food choices.

Eligibility criteria:
inclusion criteria: * adult patients that have been identified as having food insecurity based on a two question screening tool, and * also has one of more of the following chronic diseases: * hypertension, * heart disease, * stroke/tia, * dm 2, * cancer/history of cancer, * obesity * osteoarthritis exclusion criteria: * pregnant women * children