Kornimate/medical-research-clean huggingface dataset:
physiopathology of prosthetic joint infections

Conditions: Prosthetic-joint Infection

Summary: this study aim to explore cellular responses of bone and immune cells to bacterial infections observed in patients with prosthetic joint infections. the investigators will analyze clinical data and tissue samples collected from patients undergoing surgery as part of their usual care for prosthetic joint infections. these research will be conducted on three different hospitals in paris: lariboisière (ap-hp), cochin (ap-hp) and croix saint-simon.

the number of prosthetic joint infections (pji) new cases in france is estimated at 2000/2500 cases per year. pji, mainly caused by staphylococci, are serious infections responsible for significant morbidity result of inflammation and bone destruction (osteomyelitis). despite optimal medical and surgical management, a risk of failure and recurrence exists, which varies depending on the situation. in addition to the deterioration in patients' quality of life, the economic cost for the health care system is very high, in particular because of prolonged hospitalizations, complex treatments, and frequent readmissions. thus, the adequate management of pji is a major public health issue. in this context, new therapeutic approaches are urgent medical needs for the management of patients with pji. thus, the identification of the biological mechanisms (immunology, microbiology, bone physiology) underlying these infections is essential. indeed, the impact of bacterial infections on bone homeostasis is poorly documented. although several biological mechanisms have been suggested the host-pathogen interaction and the close links between bacterial infection and biological response of bone cells to microorganisms and their environment warrant to be explored.

Eligibility criteria:
inclusion criteria: * 18 years-old and older * patient eligible for lower limb revision surgery (revision surgery for infected or non-infected prosthesis) * patient affiliated to a social security system * oral consent to the research exclusion criteria: * na

Keywords: prosthetic joint infection prosthesis loosening staphylococcus osteoblast immune system microenvironment
visual performance intraocular lens (iol) micropure 1.2.3.

Conditions: Cataract; Lens Opacities

Summary: the clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, ce approved monofocal intraocular lens micropure 1.2.3. (physiol, liège, belgium).

the examinations consist of visual acuity data, contrast sensitivity exams, slitlamp examinations and posterior capsule opacification (pco) grading. follow up will be up to 24 months postoperative.

Eligibility criteria:
inclusion criteria: * cataractous eyes with no comorbidity * availability, willingness and sufficient cognitive awareness to comply with examination procedures * signed informed consent exclusion criteria: * irregular astigmatism * age of patient \< 45 years * regular corneal astigmatism \> 0.75 d on study eye as measured by an automatic keratometer (regularity determined by the topography of the keratometry) * difficulty for cooperation (distance from their home, general health condition) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...) * any ocular comorbidity * history of ocular trauma or prior ocular surgery including refractive procedures * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * complicated surgery

Keywords: intraocular lens monofocal cataract physiol
imaging based dosimetry for individualized internal emitter therapy

Conditions: Non-Hodgkin's Lymphoma

Summary: the goal of this study is to develop imaging based methods to accurately determine the energy absorbed (absorbed dose) by tumor tissue and bone marrow after radioimmunotherapy with i-131 tositumomab . the administration of the radioactive, iodine-131 labeled, monoclonal antibody i-131 tositumomab, (also known as bexxar) is part of the patient's clinical treatment protocol. for the absorbed dose measurement, investigators at the university of michigan are evaluating a new nuclear medicine spect/ct imaging system . this new camera combines a ct imaging system in addition to a nuclear medicine spect scanner. ct scans allow the doctors to see a high quality picture of your internal organs. the nuclear medicine spect scanner allows the doctors to see the uptake of the radioactive i-131 including the tumor sites. the improved imaging using the spect/ct enables more accurate calculation of the energy absorbed by tumor tissue and bone marrow. using the results from these calculations and clinical follow up data, the researchers will investigate the relationship between the absorbed dose to the tumor and the patient's tumor response as well as the relationship between the absorbed dose to the bone marrow and the bone marrow toxicity. these relationships can potentially be used in the future by doctors to help determine how much radioactive i-131 to administer to each patient to get optimal results.


Eligibility criteria:
inclusion criteria: * • clinically stable patients undergoing i-131 tositumomab (bexxar) for treatment of non-hodgkin lymphomas exclusion criteria: * • clinical instability * patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed * refusal to provide informed consent * patients who are pregnant

Keywords: spect/ct dosimetry radiation absorbed dose non-hodgkin's lymphoma i-131 tositumomab radioimmunotherapy
methadone for emergence delirium in children undergoing outpatient strabismus surgery

Conditions: Emergence Delirium; Strabismus

Summary: strabismus surgery for children is a very common procedure, with a high incidence of emergence delirium in the recovery room. pain is often implicated in delirium. the primary aim of this study is to determine whether a single, intraoperative dose of methadone for outpatient ambulatory pediatric strabismus surgery reduces postoperative delirium.


Eligibility criteria:
inclusion criteria: * asa i/ii children undergoing outpatient strabismus surgery exclusion criteria: * anything not meeting the above
study of tarceva and targretin in stage i-ii lung cancer

Conditions: Carcinoma, Non-small-cell Lung

Summary: the purpose of this study is to learn the effects on lung cancer of 2 new drugs, tarceva and targretin, given in combination before surgical removal of the tumor. tarceva is approved by the food and drug administration (fda) for lung cancer. targretin is approved for the treatment of cutaneous t-cell lymphoma. this combination of drugs is experimental.

erlotinib 150mg and bexarotene 400mg/m2 will be administered orally for 7-9 days prior to thoracotomy. plasma samples will be collected on the day before surgery and along with tissue samples on the day of the thoracotomy. analyses will be done on the resected specimen and it will be compared to the pre-study diagnostic specimen.

Eligibility criteria:
inclusion criteria: * resectable stage i or ii non-small-cell lung cancer * prior tissue biopsy (not cytology) available for research analysis * adequate hepatic and renal function exclusion criteria: * prior chemotherapy or radiotherapy

Keywords: tarceva targretin non-small cell lung cancer carcinoma, non-small cell lung cancer nsclc
phase iii study comparing two methods of cardioplegia in aortic valve surgery custodiol-n versus custodiol

Conditions: Aortic Valve Disease; Coronary Artery Disease (CAD)

Summary: the objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, htk cardioplegic solution (custodiol) and custodiol-n in patients undergoing aortic valve surgery. the study design is a prospective, double blind, multicenter, randomized, phase iii comparison study intended to demonstrate superiority in surgical outcome between custodiol and custodiol-n as determined by ck-mb peak value 4-24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac troponin t, occurrence of comorbid events postoperatively (e.g., myocardial infarction).


Eligibility criteria:
inclusion criteria: * patients \>/= 30 and \</= 85 years of age * male or female with aortic valve disease * able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study * women of childbearing potential (ie, those who have not undergone a hysterectomy or who have not been post-menopausal for at least 12 consecutive months) must test negative for pregnancy prior to bypass surgery. exclusion criteria: * history of recent (\< 6 weeks) q-wave myocardial infarction * left ventricular ejection fraction \< 25% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning \[muga\], or 2-d echo) * patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery * pregnant or lactating patients * patients who have participated in any other investigational studies within 30 days previous to enrollment * patients in cardiogenic shock (defined as a systolic bp \< 90 mmhg for over one hour despite inotropic and chronotropic support) * patients with severe chronic obstructive lung disease (fev1 \< 50%) * previous cardiac valvular disease (clinical relevant) * gfr \<60 ml/min * planned ross-procedure, mitral valve surgery, aortic valve reconstruction, double valve surgery, other concomitant operations excluding coronary artery bypass surgery or closing a patent foramen ovale * evidence of severe organic (e.g. cirrhosis of the liver) or psychiatric disease by history or physical examination * history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrollment.

Keywords: aortic valve disease coronary bypass surgery cardioplegic solutions
determinants of the long-term success of bariatric surgery

Conditions: Morbid Obesity; Bariatric Surgery Candidate

Summary: the management of obesity is based on a multidisciplinary approach and justifies the use of surgery in patients with the most severe forms. surgery for obesity or bariatric surgery generally allows rapid and significant weight loss however it is associated with significant risks, and its long-term results remain heterogeneous and unpredictable. long-term data will clarify the role of different types of bariatric surgery in surgical strategy, improve patient information and identify predictors of failure in order to provide personalised and tailored surgery for each candidate .

currently, there is insufficient data to determine the persistence over time of the positive results of bariatric surgery on weight loss. moreover, there is no consensus or criteria for choosing one surgical weight loss procedure over another. the best choice for one patient may not be the most appropriate for another. the results of this project will allow to better select obese patients likely to benefit from bariatric surgery, and to further personalise the management of severe obesity.

Eligibility criteria:
inclusion criteria: * patients who received bariatric surgery 5 years ago. exclusion criteria: * refusal to participate in the study, * unable to receive informed information, * unable to participate in the study
transplantation of autologous bone marrow or leukapheresis-derived stem cells for treatment of spinal cord injury

Conditions: Spinal Cord Injury

Summary: this is a double-armed, phase i/ii trial aims to compare bone marrow and leukapheresis as sources for purified, autologous cd34+ and cd133+ stem cells (scs), to be utilized in treatment of patients with chronic complete spinal cord injuries (sci). the study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells into the injured spinal cords of patients.

spinal cord injury (sci) leads to apoptosis of oligodendrocytes at the injury site resulting in demyelination and neuronal degeneration. this degeneration causes severe functional sensory and motor mutilations that remain an immense challenge to physicians and in which stem cell (sc) transplantation represents a viable alternative. this study is a phase i/ii trial aimed at describing a method for treating patients with chronic complete spinal cord injuries (sci) by utilizing autologous, purified cd34+ and cd133+ stem cells (scs). the study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells in treated patients during a 5-year follow-up period.

Eligibility criteria:
inclusion criteria: * patients suffering from chronic spinal cord injury * age of injury ranging from 6-60 months prior to enrollment in this study. * ability and willingness to regularly visit jordan orthopedic and spinal center for post operation follow up. * traumatic injury of spinal cord with complete or partial damage confirmed by mri. exclusion criteria: * injuries less than 6 months old or more than 60 months old * non-traumatic injuries (sci due to inflammation, autoimmune diseases) * patients less than 5 or older than 50 years * patients suffering from other conditions, including chronic neurological diseases, diabetes mellitus, cardiac/kidney/liver disorders, previous strokes, and previous surgeries unrelated to spinal cord injury.
effects of oral iron supplementation on vaccine response in iron deficient kenyan women

Conditions: Iron Deficiency Anemia

Summary: iron deficiency (id) anemia (ida) is a global public health problem, with the highest prevalence in africa. vaccines often underperform in low- and middle- income countries (lmic), and undernutrition, including id, likely plays a role. recent studies have shown the importance of iron status in vaccine response. intravenous iron given at time of vaccination improved response to yellow fever and covid-19 vaccines in ida kenyan women. whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. also, timing of oral iron treatment needs further investigation. the co-primary objectives of this study are to assess 1) whether ida in kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination). we will conduct a double-blind randomized controlled trial in southern kenya to assess the effects of iron supplementation on response to three single-shot vaccines: johnson \& johnson covid- 19 (jj covid-19), the quadrivalent meningococcal vaccine (menacwy) and the typhoid vi polysaccharide vaccine (typhim vi). women with ida will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (feso4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as feso4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. women in all groups will receive the jj covid-19 vaccine, the menacwy and the typhim vi vaccine on day 28. cellular immune response and serology will be measured at 28 days after vaccination in all groups.


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent for participation in the trial * female aged 18-49 years * moderate anemia (hb \ 40 mmol/mol haem) * anticipated residence in the study area for the study duration exclusion criteria: * major chronic infectious disease (e.g., hiv infection); * major chronic non-infectious disease (e.g., type 2 diabetes, cancer); * chronic medications; * use of iron-containing mineral and vitamin supplementation 2 weeks prior to study start; * covid-19 vaccine or confirmed covid-19 infection within the past 2 years * menacwy vaccine in the past * typhoid vaccine in the past * pregnant (confirmed by rapid test during screening) or lactating. * malaria (confirmed by rapid test) à study start will be postponed

Keywords: iron deficiency anemia vaccine response women of reproductive age
compare continuing lamivudine plus adefovir or adefovir versus switching to entecavir plus adefovir in patients with lam-resistant chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study is to compare efficacy and safety of continuing lamivudine plus adefovir or adefovir versus switching to entecavir plus adefovir in patients with lam-resistant chronic hepatitis b who have suboptimal response to lamivudine plus adefovir or adefovir


Eligibility criteria:
inclusion criteria: * chronic hepatitis b * age ≥ 20 year old * currently taking lamivudine and adefovir combination therapy or adefovir monotherapy for chronic hbv infection for 24 weeks * proven lamivudine resistant mutation * hbv dna levels at screening ≥ 15 iu/ml * females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test * patient is able to give written informed consent prior to study start and to comply with the study requirements exclusion criteria: * a history or current of decompensated cirrhosis or hepatocellular carcinoma * currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy * co-infected with hcv or hiv * a history of organ transplantation * pregnant or breast-feeding * current clinically relevant of abuse of alcohol or drugs. * significant immunocompromised, gastrointestinal, renal(serum creatinine ≥ 1.5 mg/dl), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy * malignancy in previous 5 years
targeted left ventricular lead placement, comparison of active fixation bipolar and passive quadripolar pacemaker leads

Conditions: Heart Failure

Summary: a prospective, randomized and patient-blinded trial comparing an active fixation left ventricular lead with quadripolar passive left ventricular leads. the leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. the patients were followed up for 12 months.

a prospective, randomized and patient-blinded trial. the objective was to compare an active fixation left ventricular lead with quadripolar passive left ventricular leads. the left ventricular segment with latest mechanical activation was identified as target segment by radial strain speckle-tracking echocardiography.the leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. the clinical outcomes were assessed by echocardiography, change in new york heart association (nyha) functional class and minnesota living with heart failure questionnaire (mlhfq). the patients were followed up for 12 months.

Eligibility criteria:
inclusion criteria: * left ventricular ejection fraction (lvef) ≤ 35 % * nyha 2-4 * electrocardiogram : left bundle branch block (lbbb) and qrs duration \>120 ms or non-lbbb and qrs duration ≥150 ms * optimal medical treatment. exclusion criteria: * upgrade procedures due to ventricular pacing * no written consensus

Keywords: cardiac resynchronization therapy
seroprevalence study to evaluate the persistence of anti-leptospira antibody in subjects vaccinated with spirolept® vaccine

Conditions: Leptospirosis

Summary: the study aims to assess antibody persistence induced by spirolept® vaccination in subjects who received at least 4 doses (2 doses two weeks apart and 2 booster doses) and no more than a total of 8 doses (2 doses two weeks apart and 6 booster doses).

this is a seroprevalence, phase iv, multi -center study to evaluate anti-leptospira antibody persistence in subjects who have received at least the 2nd booster (4 vaccine doses) and no more than the 6th booster (8 vaccine doses) of spirolept® vaccine. the study will be conducted at the occupational health centre of companies employing workers at risk of leptospirosis for their occupational activities. study participants will be selected from the company occupational health centre database where each employee is registered. all workers are regularly followed-up and their medical and vaccination history recorded. subjects selection will occur according the number of booster doses received (having received at least the 2nd booster and no more than the 6th booster). after they have signed the informed consent form, subjects will be recruited into the study and if all inclusion and exclusion criteria are met they will be taken a blood sample. anti-leptospira igg antibody will be measured by a validated elisa. other assay may be performed to further characterize anti-leptospira antibodies. data on subject demographics, relevant medical history, vaccination dates, and blood collection will be recorded in an appropriate case report form. the study does not include any vaccination.

Eligibility criteria:
inclusion criteria: * adults of both genders aged 18 to 65 years * high risk occupational subjects to leptospirosis having received at least 4 (2 initial doses and 2 booster doses) and no more than 8 (2 first doses and 6 booster doses) doses of spirolept® * previous spirolept® vaccination dates documented * to be affiliated to a health insurance plan * having signed the informed consent form exclusion criteria: * had an acute infection during the 3 weeks before study enrollment * subject with documented hiv or hepatitis a, b, c * immunosuppressive treatment (chemotherapy, corticosteroids \> 20mg/day, biological agents) * subject with progressive malignancy requiring specific treatment * previous documented leptospirosis

Keywords: leptospirosis
glucose-induced glucagon-like peptide 1 (glp-1) secretion in nafld patients compared to healthy controls

Conditions: Non Alcoholic Fatty Liver Disease; Non Alcoholic Steatohepatitis

Summary: the incretin effect is impaired in patients with type 2 diabetes mellitus (t2dm), thus glp-1 receptor agonists are used for the treatment of t2dm. insulin resistance is a pathophysiologic hallmark of non-alcoholic fatty liver disease (nafld). the incretin effect in patients with nafld has not been studied. the aim of this study is to quantify glp-1 secretion in response to oral glucose tolerance test (ogtt) in patients with nafld compared to healthy controls. the results of this study will expand the knowledge of the pathophysiology of nafld and serve as a rational for potential future treatment strategies.

primary endpoint: glp-1 response to oral glucose secondary endpoints: glucose and insulin responses to oral glucose challenge

Eligibility criteria:
inclusion criteria: * biopsy proven nafld or nash exclusion criteria: * additional concomitants liver disease * t2dm * alcohol consumption \>40g/d for male subjects and \>20g/d for female subjects

Keywords: nafld nash glp-1