Kornimate/medical-research-clean huggingface dataset:
systemic lupus erythematosus and accelerated aging

Conditions: Systemic Lupus Erythematosus

Summary: the study aims at evaluating the phenomena of immune system aging in patients with systemic lupus erythematosus.

systemic lupus erythematosus (sle) is a chronic systemic autoimmune disease characterized by a breakdown of tolerance against nuclear antigens. thanks to improvements during the last decades in diagnosis, therapeutics and medical care, the lifespan of sle patients has remarkably increased. however, standardized mortality ratio are still high in this population, with an increased mortality and morbidity associated with cardiovascular events and infectious events. interestingly, these conditions are more commonly found during old age in the general population, raising the question of the presence of an acceleration of the aging process in sle patients. it has been demonstrated that the aging of the immune system, i.e. immunosenescence, is a key player in the development of many age-related diseases. the acceleration of immunosenescence, as it is observed during chronic viral infections for example, could favor the premature occurrence of clinical manifestations of accelerated aging. the exact contribution of such phenomenon in the context of sle has, so far, never been explored. here, the investigators propose to perform a comprehensive study of the phenomena of immune system aging in patients with sle in comparison to age-matched healthy controls. the study will recruit 50 sle patients followed in bordeaux university hospital. among classical disease activity information, blood samples will be collected at study visit to extensively evaluate immune system aging. fundamental research will be realized on patients' samples. patients will be included within their usual follow-up. no extra visit will be needed, and blood samples will be drawn at the same time as those drawn for clinical purposes.

Eligibility criteria:
inclusion criteria: * male or female; * age between 18 and 60 years; * lupus patient : diagnosis of systemic lupus erythematosus according to acr or slicc criteria; * being affiliated to health insurance; * willing to participate and to sign informed consent. exclusion criteria: * pregnant or breastfeeding women; * persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent

Keywords: systemic lupus erythematosus aging
acuta: acupuncture in test anxiety

Conditions: Test Anxiety; Experimental Setting (Trier Social Stress Test TSST)

Summary: test anxiety is a well-known phenomenon in general population, but only few scientific advances have been made in order to fully understand and prevent this circumstance. the number of students which use neuro enhancement to improve their performance and to prevent test anxiety, is increasing. a us-survey estimated that almost 7% of students in us universities have used prescription stimulants against anxiety, and that on some campuses, up to 25% of students had used them in the past year. acupuncture might act as an alternate. several trials could demonstrate, that different forms of acupuncture could relieve symptoms of pre-exam anxiety syndrome significantly and that this therapy was highly safe. in special, the investigation of single point effects in test anxiety could be of general interest. the acupuncture point with the most convincing evidence up to date is heart 7. yet, its effectiveness has mainly been chosen in combination with other acupuncture points and not as single remedy in test anxiety. therefore we establish a trial investigating the immediate needling effects at heart 7 on the reduction of test anxiety. therefore qe implemented a validated stress test, the trier social stress test tsst, which is known to provoke serious stress responses in healthy subjects. 24 medical students with test anxiety in there history will be randomised to two interventional groups (verum acupuncture and laser acupuncture), being treated and then pass this test. main outcome is the increase of cortisol in saliva, which is the standardized measure of stress response used in this paradigm.


Eligibility criteria:
inclusion criteria: * test anxiety in the clinical history * male medical students 3rd to 5th year * compliance * age \> 18 years * smoking cessation for 24 hours exclusion criteria: * severe physical or psychical illness * psychiatric record in medical history * continuous uptake of antipsychiatric medication, tranquilizers or neuro-enhancers * acupuncture treatment within the last 4 weeks * hang-over * drug consumption * smoking (\> 5 cigarettes/ day)

Keywords: acupuncture test anxiety neuroenhancer placebo
recurrent gbm with maximal neurosurgical removal and treatment with iort

Conditions: Glioblastoma; GBM; Recurrent GBM

Summary: the purpose of this study is to assess the safety and efficacy of the xoft axxent ebx system when used for single-fraction iort for recurrent glioblastoma. iort using the xoft axxent ebx system is no worse than (non-inferior) gliasite radiation therapy when used as stand-alone radiation treatment immediately following maximal safe neurosurgical resection in patients with recurrent glioblastoma multiforme (gbm).

device description: the xoft axxent electronic brachytherapy system is a device that delivers radiation at a high dose rate. it is designed for use with axxent applicators to treat lesions, tumors, and conditions in or on the body where radiation is indicated. the axxent system and applicators are fda cleared under 510(k)s k050843, k072683, k090914 and k122951. the purpose of this trial is to assess the overall survival of patients treated with the xoft axxent ebx system for single-fraction iort following maximal neurosurgical resection of recurrent glioblastoma. a historical comparison will be made for surgical excision and gliasite radiation therapy (chan 2005), which resulted in a median os of 9.1 months. radiation is delivered to the target tissue (adjacent to the resection margins). it avoids treatment delays and eliminates weeks of post-surgical radiation therapy during which residual cancer cells might proliferate.

Eligibility criteria:
inclusion criteria: 1. potentially-resectable, histologically proven recurrent gbm 2. subject must be ≥ 18 years of age 3. subject must have a karnofsky performance score ≥ 70% 4. subject must have had a t1 weighted 3d mri with gadolinium enhancement within fourteen (14) days prior to surgery 5. women of child-bearing potential must have a negative pregnancy test within one week of iort treatment 6. subjects of child-bearing potential must agree to use adequate contraceptive precautions and not to breastfeed (if applicable) exclusion criteria: 1. more than three relapses 2. subject has multi-centric disease 3. subject has tumors in or near (less than 10mm from tumor margin) critical brain structures, that would exclude sufficient dose delivery to the tumor: such as: 1. optic chiasm 2. optic nerve 4. women who are pregnant or nursing. women with child-bearing potential or sexually active men that are not willing/able to use medically acceptable forms of contraception 5. subject has contraindications for mri with or without gadolinium injections 6. subject has contraindications for anesthesia or surgery 7. subject is on another therapeutic clinical trial concurrently 8. subject had previous radiation for gbm less than 3 month earlier 9. prior history of standard dose of central nervous system (cns) of more than 60 gy intra-operative exclusion criteria 1. frozen section does not show any sign of malignant tissue 2. dose at any organ at risk will exceed 10 gy including: 1. chiasm 2. optic nerve

Keywords: glioblastoma gbm recurrent gbm recurrent glioblastoma iort intra-operative radiation therapy
study of paclitaxel in patients with ovarian cancer

Conditions: Epithelial Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Summary: rationale: paclitaxel is one of the most widely used human anticancer agents. paclitaxel has a low degree of solubility and cremophor el is typically used as the solubiliser. cremophor el is known to cause hypersensitivity reactions that can be life-threatening. as paclical® does not contain cremophor el, hypersensitivity reactions can be expected to be less. purpose: to study the efficay and safety of two different formulations of paclitaxel, paclical® and taxol®.


Eligibility criteria:
inclusion criteria: * histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. * patients relapsing \> 6 months after end of first line or second line treatment including platinum based therapy. prior therapy and duration of response will be documented in the crf for descriptive analysis. * ca 125 \>2 x upper normal limit (unl) documented at two occasions, with more than one week interval, according to appendix i, patient groups a and b, measurable/non- measurable disease. * age \> 18 years * eastern cooperative oncology group (ecog) performance score 0-2 * life expectancy \>12 weeks * patient has blood counts at baseline of: * absolute neutrophil count (anc) \>1,5 x 109 / l. * platelet count \>100 x 109 / l * haemoglobin (hb) ≥9g/dl (can be post transfusion) * alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) \< 2 x unl * total bilirubin ≤1.5 x unl. * adequate renal function defined as serum creatinine \< 2.0 mg/dl or 177μmol/l. * alkaline phosphatase (alp) \< 2.5 x unl * signed informed consent obtained exclusion criteria: * patient has peripheral neuropathy of grade ≥ 2 per nci-ctcae version 3.0 * surgical procedure due to progressive disease within 4 weeks of any of the ca-125 measurements * patient receiving concurrent hormonal, immuno-, or radiotherapy. treatment must have stopped for at least 4 weeks before start of drug treatment (day 1, cycle 1). * bowel obstruction at screening * tumours of other origin or histology * patient of child-bearing potential, not practising adequate contraception, or pregnant or lactating women * patient has a history of severe allergy or severe hypersensitivity to study drugs * any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs, e.g. heart, lung or kidney disease, suspicion of brain metastasis or mental disorder to make the patient unable to participate in the study * participation in an investigational drug study within 4 weeks prior to study treatment (day 1, cycle 1)

Keywords: ovarian cancer
6th month ewl% after sleeve gastrectomy to get a better sleep quality

Conditions: Sleep Disturbance; Obesity, Severe; Surgery

Summary: obesity, caused by caloric intake over output, has become a global health problem. the relationship between sleep and obesity is widely discussed in the literature. little is known regarding the compliance of sleep quality and patients' weight loss. this study aimed to review how sleep quality is affected by bariatric surgery, examine whether compliance with sleep quality can be predicted after bariatric surgery, and assess its correlation with excess weight loss.

a cross-sectional study was conducted among patients that underwent bariatric surgery (laparoscopic sleeve gastrectomy). sleep quality was assessed using the pittsburgh sleep quality index (psqi) scale preoperatively and at the 6th postoperative month. survey data were recorded and psqi scores were calculated. a psqi global score above 5 indicates poor sleep quality. the participants were divided into two groups good sleep quality and poor sleep quality. descriptive statistics and spearman correlations were applied. logistic regression analysis was performed to predict sleep quality.

Eligibility criteria:
inclusion criteria: patients who underwent lsg for morbid obesity after being considered suitable for bariatric surgery by multidisciplinary evaluation were included in this study. patients with aged 18-65 years, bmi \> 40 and bmi \> 35 and comorbid disease were included. exclusion criteria: patients treated for sleep disorders have been excluded.

Keywords: laparoscopic sleeve gastrectomy pittsburgh sleep quality index obesity
a study to determine the optimal dose of tildrakizumab (sch 900222/mk-3222) for the treatment of moderate-to-severe chronic plaque psoriasis (p05495) (mk-3222-003)

Conditions: Psoriasis

Summary: this is a response-driven study of tildrakuzumab for the treatment of moderate to severe chronic plaque psoriasis. the primary study hypothesis is that one or more doses of tildrakizumab will be superior to placebo for the treatment of psoriasis.

each participant will be enrolled in the trial for approximately 72-76 weeks. each participant will receive assigned treatment at weeks 0 and 4 in part i. at week 16, the dosage of treatment the patient is assigned to may be adjusted based on the psoriasis area and severity index (pasi) 75 response (responder vs non-responder). participants will receive study medication once every 12 weeks during part 2 (weeks 16 to 52); no participants will receive placebo in part 2. part 3 is an observational period and each subject will continue to be monitored on a monthly basis through week 72. subjects will not receive any study medication during part 3.

Eligibility criteria:
inclusion criteria: * adult participants (≥18 years of age) with a diagnosis of moderate-to-severe chronic plaque psoriasis (defined by ≥10% body surface area \[bsa\] involvement, "moderate" or greater score on the physician's global assessment \[pga\] scale, and pasi score ≥12 at baseline) * participants must have a diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by interview and confirmation of diagnosis through physical examination by investigator) and be considered candidates for phototherapy or systemic therapy. participants with psoriatic arthritis may be included in the study exclusion criteria: * nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis * participants who will require oral or injectable corticosteroids during the trial * presence of any infection requiring treatment with systemic antibiotics within 2 weeks prior to screening, or serious infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous antibiotics within 8 weeks prior to screening * participants with evidence of active or untreated latent tuberculosis (tb) according to screening criteria specified in the protocol. (prophylactic treatment for latent tb as per local guidelines must be initiated at least 4 weeks prior to treatment with study medication) * previous exposure to any agents targeting interleukin-12 (il-12) and/or interleukin-23 (il-23) * participants with prior exposure to two or more tumor necrosis factor (tnf) antagonists with discontinuation due to lack of efficacy.
gestational diabetes: insulin or oral hypoglycemic agents?

Conditions: Gestational Diabetes Mellitus

Summary: gestational diabetes mellitus takes place in 2 steps. first, it is the consequence of insulin resistance due to the modifications of the pregnancy hormonal environment, and second, of the deficiency of the beta cells of the pancreas to respond by a sufficient insulin secretion. this physiopathology is closely connected to the one of type 2 diabetes. insulin, indeed, can remedy these 2 etiologies, but it is logical to think about using oral hypoglycemic agents which have been created to treat them: they are a natural choice because they improve insulin sensitivity (metformin, a biguanide) or insulin secretion (glyburide, a sulfonylurea). it also seems natural to use them in combination, glyburide being added to metformin if needed. our general research hypothesis is that: in pregnant women with gestational diabetes mellitus, using both oral hypoglycemic agents (glyburide added to metformin if needed) allows a glycemic control comparable to the one obtained with insulin, but with a better acceptability from women and a better health status, diabetes treatment satisfaction and well-being and a reduced postnatal depression.


Eligibility criteria:
inclusion criteria: * women, * age ≥ 18 yrs, * with gestational diabetes at 24-28 weeks (canadian diabetes association (cda) criteria), * who need a pharmacological treatment following the failure of the diet and exercise, * to understand and read french or english. exclusion criteria: * known type 1 or type 2 diabetes, * treatment interfering with glucose metabolism, * allergies to one of the components of the treatment, * hepatic or hematologic diseases.

Keywords: gestational diabetes mellitus treatment insulin metformin glyburide
prediction of future risk in patients with controlled asthma

Conditions: Asthma

Summary: the optimal score to predict unfavourable outcome in well-controlled asthma patients who are undergoing a step-wise down-titration of their medication is still lacking. thus, a study is warranted to prospectively develop a prognostic system -easy to perform (suitable for use in the clinical rather the research setting)- for asthmatic patients in this clinical setting. hypothesis: a simple score system can accurately predict clinical deterioration of asthma in well-controlled patients who are undergoing a step-wise down-titration of their medication according to international guidelines. methods the investigators designed a prospective, multicenter, observational study at five centers in cities across spain. the patients group (n = 225) will be evaluated to produce a clinical prediction rule for loss of control. the investigators will consider the following variables in the risk factor analysis: documented history of previous bronchial obstruction (fev1/fvc \< 70%), coefficient of variation (cv) of morning peak expiratory flow (pef), history of exacerbations, fraction of exhaled nitric oxide (feno), asthma control test (act), act item 3 and adherence. the score model will be prospectively validated in an independent set of 113 patients.


Eligibility criteria:
inclusion criteria: * adults (age between 18 and 80. * asthma under control during the last 3 months. * treated with a combination of ics and long-acting beta-agonist (laba. * classified as "moderate asthma" by their attending physician. exclusion criteria: * active smoking. * pregnancy. * treatment with oral corticosteroids, omalizumab or immunotherapy.

Keywords: asthma
collection of human liver biopsy and whole blood samples from t1dm, tp or pp patients for potential use for insulin producing cells in future clinical studies

Conditions: Type 1 Diabetes; Pancreatectomy; Hyperglycemia

Summary: in this study, liver samples will be collected, processed and stored in a specialized, clinical grade, cell bank for potential future clinical use. a set of ex-vivo immunogenicity and transdiffrentiation tests will be carried to confirm the ability of this cryopreserved cell batch to be used as clinical grade raw material. biopsies will be collected during tp or pp with the assumption that some of the patients (especially pp patients will not go through islets autotransplantation) will develop brittle diabetes, thus orgenesis therapy can provide them in the long run, a treatment. in terms of t1dm the purpose is to have available clinical grade raw material for cell replacement therapy. the collected liver samples will be proliferated (up to passage 4) for future use. a portion of the stored cells will be utilized in a small-scale process to test possible immunogenicity performed on the collected blood sample. the assay will provide data whether immunomodulation treatment will be required in the future clinical trials. also the transdffrentiated cells (aips) will be tested according to release criteria relevant for clinical ipc production. liver biopsy donors will be contacted upon approval of the consecutive study and will have study recruitment priority. the donors can refuse to participate in the future study or may not need the therapy, however, their biopsies will be stored for a potential use if required, after the therapy is approved.


Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 70 years old, inclusive. * for t1dm - patients with history of established t1dm undergoing an elective abdominal surgery with an easy access to the liver * patients undergoing total or partial pancreatectomy * female patients who agree not to breastfeed during the study up to at least seven days after the study is completed. * for t1dm - receiving multiple daily insulin injections or insulin pump therapy. * for t1dm - hba1c ≤10%. * willing to sign the study informed consent document. * in good general health with no infections, or concomitant medical conditions that would influence the outcome of the trial, at the discretion of the investigator and the sponsor. exclusion criteria: * received any investigational product within 30 days of admission into this study or plan to participate in any other clinical study during the conduct of this study. * received methotrexate or other rheumatoid disease modifying agents within the last 6 months. * administration of a live vaccine 30 days prior to screening. * no evidence of liver cirrhosis or nonalcoholic steatohepatitis (nash, grade 3 and above) within the last month. * patients diagnosed with liver viral infections such as hbv, hcv, hiv * patients diagnosed with cmv (defined by igm positive).
anatomic reconstruction of the patellofemoral joint

Conditions: Knee Replacement Surgery

Summary: the investigators posit that it would be advantageous to reproduce the height of the entire patellofemoral joint in order to maintain the lever arm of the quadriceps mechanism at its preoperative level. failure to do this may cause the quadriceps mechanism to be inefficient. for example the quadriceps mechanism would have to work harder if the total patellofemoral (pf) height is diminished. alternatively, diminished motion or increased patellar strain may occur if the overall pf height is increased. the investigators theorize that either of these sizing errors could lead to anterior knee pain. the purpose of this study is to compare the clinical outcomes between two surgical techniques: 1) a technique of reproducing the total pf joint on both sides of the articulation (group 1) and 2) the traditional technique of reproducing only the patellar thickness on one side of the joint (group 2).

there is no consensus on the source of the anterior pain or the most efficacious treatment. multiple etiologies have been theorized concerning the cause of this problem including tibiofemoral instability, patellofemoral (pf) instability, pf maltracking and patella stress fractures. it has been reported that patellofemoral forces are associated with anterior knee pain. moreover, it has been reported that a correlation exists between the tension of the quadriceps muscle and the forces on the patella. in a biomechanical, cadaver study, browne et al. found that a longer extensor moment arm reduced the tension on the quadriceps and reduced the patellar forces.

Eligibility criteria:
inclusion criteria: 1. patients presenting for a primary total knee replacement who have failed conservative medical management. 2. total knee replacement includes patella resurfacing. 3. patient is willing and able to understand, sign, and date the study specific patient informed consent, to volunteer participation in the study. 4. patient is psychosocially, mentally, and physically able to comply with the requirements of the study including post-op clinical evaluations and completion of questionnaires. exclusion criteria: 1. patients presenting for a unicompartmental knee replacement. 2. patients presenting for a revision total knee replacement. 3. total knee replacement does not include patella resurfacing. 4. patients with angular deformity greater than 15 degrees. 5. patients with subluxation/dislocation of the patella. 6. patients with severe patellar bone loss.