Kornimate/medical-research-clean huggingface dataset:
suppress ssi - single use negative pressure wound therapy (npwt) to reduce surgical site infections

Conditions: Surgical Site Infection; Obesity; Diabetes; Cesarean Section Complications

Summary: our goal is to provide data that will give surgeons and hospitals clear recommendations on the use of npwt for cesarean section, abdominal hysterectomy and colon surgeries in patients with diabetes and/or obesity. we also want to understand the patient experience with the dressing so that we can provide information that will enable clinicians to remove barriers to npwt use. additionally, we are seeking to use automated electronic medical record decision support to identify patients that will benefit most from the npwt.

specific aim 1: evaluate the effect of single-use npwt on ssi rates after c-section, abdominal hysterectomy, and colon procedures in at risk patients. to address this aim, we will conduct multicenter, stepped-wedge, quasi-experimental trial evaluating use of the prevenatm with 125 mm hg negative pressure for 7 days among obese (bmi \>30) and/or diabetic patients undergoing the procedures of interest. this is essentially a phase iv clinical trial as this dressing has fda approval for the indicated use. specific aim 2: investigate the patients' experience of using the npwt. to achieve this aim, we will survey a sub-set of patients to assess their knowledge of post-operative care, to identify complications associated with npwt use, and to learn how patients evaluated the device's ease of use, ease of removal, and comfort. specific aim 3: assess whether real-time decision support through machine-learning modeling can help surgeons identify patients at high risk of ssi who could benefit from nwpt or other post-surgical preventive measures. to address this aim, we will evaluate whether boosted tree modeling techniques can be used "at the bedside" via electronic medical record data feeds to tailor post-operative care and preventive care for specific patients.

Eligibility criteria:
inclusion criteria: category a and b a. patients undergoing any of the below procedures: 1. c-section 2. abdominal hysterectomy 3. colon procedures surgical procedures selected will be based on nhsn designated icd-10 pcs codes(14), with the exclusion of laparoscopic procedures. b. and either of the following medical conditions: 1. obesity, bmi \>30 kg/m2 2. diabetes type 1 or 2 criteria for a diagnosis of diabetes: diabetes noted in the problem list or the medical history or patient is taking a medication as treatment for diabetes, consistent with nhsn criteria(10). exclusion criteria: 1. age less than 18 years 2. infection present at the time of the surgery 3. laparoscopic procedures with incisions \<6cm. 4. patients using alternative npwt device other than the prevenatm with 125 mm hg negative pressure 5. prisoners

Keywords: colon surgery abdominal hysterectomy
gender-sensitive enhancement of common weight loss strategies for overweight and obesity

Conditions: Overweight and Obesity; Weight Loss; Gender

Summary: the major aim of the proposed study is to develop a gender-sensitive individually tailored add-on intervention that focusses on improving individual gender-specific sirs (subjective illness representations) in obese or overweight individuals. we will investigate whether this will improve compliance with and long-term success of common weight loss interventions. the effectiveness of this intervention in every-day-life with regard to weight-related behavioral changes and weight loss will be evaluated within a randomized controlled setting.to enhance the applicability of the intervention in every-day-life and its dissemination we plan to develop a smart-phone-based intervention.


Eligibility criteria:
inclusion criteria: 1. obesity class i or ii with subjectively experienced weight-related impairment and a current will to lose weight. 2. overweight (i.e. bmi between 25 and 29.9 kg/m²) with weight-related health problems and/or visceral adipose tissue and/or high psychosocial weight-related distress with a current will to lose weight. exclusion criteria: 1. obesity class iii (i.e. bmi \>39.9 kg/m²). 2. current (or within the last 12 months) involvement in a structured weight loss intervention. 3. insulin-dependent type 1 diabetes. 4. previous or intended bariatric surgery. 5. current psychotherapeutic treatment of weight-related health problems. 6. weight-enhancing drugs. 7. drugs which promote weight-loss (e.g. anti-obesity drugs). 8. weight-enhancing health problems which are not yet treated. 9. cancerous disease within the last five years. 10. current substance-use disorders, depression, psychosis, suicidal tendency or pregnancy. 11. severe cognitive impairments. 12. insufficient knowledge of the german language. 13. binge-eating disorder or bulimia nervosa.

Keywords: gender overweight obesity intervention smartphone-app
tapentadol clinical practice in belgium

Conditions: Severe Pain Syndromes

Summary: multicenter observational study to determine the long-term tolerability and analgesic effectiveness of oral tapentadol in patients suffering from severe pain syndromes, refractory to other strong opioids.

tapentadol, a centrally acting analgesic. it is indicated in europe "for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics" (ir formulation/oral solution) and "for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics" (sr formulation). tapentadol is reimbursed in belgium since may 1, 2018. the reimbursement was obtained through an article 81 procedure (chapter iv) which means that the reimbursement is currently restricted to the time frame of the contract and that during that period certain questions and uncertainties regarding the use of tapentadol in a belgian setting need to be answered. in order to answer the questions raised by the belgian healthcare authorities, this study will be performed evaluating the application of oral tapentadol in routine clinical practice in belgium. the study is conceived as a nation-wide multicentre prospective non-interventional trial. the primary endpoint and secondary endpoints of this study are guided by the questions that need to be answered during the course of the contract reimbursement, as established by the belgian health authorities.

Eligibility criteria:
inclusion criteria: * subjects should be capable of giving their informed consent; * males and females, 18 years and older; * patients suffering from severe pain; * pain symptoms refractory to strong opioids (in previous treatment); * due to side effects * due to insufficient analgesic effectiveness * due to opioid induced hyperalgesia. exclusion criteria: * severe renal and/or hepatic insufficiency; * known and/or strong suspicion of allergy to tapentadol; * previous treatment with tapentadol; * presence of any condition for which tapentadol is contraindicated as per its approved labelling information in belgium; * the patient has no access to a mobile phone and web browser. during the study, an online system is used to receive messages (sms and e-mail) for the completing of the online assessments (through web browser).
safety study of adv-specific t-cells in paediatric patients post allo-hsct

Conditions: ADV Infection Post Allo-HSCT

Summary: human adenovirus-specific t-cells can persist and augment impaired adenovirus immune response post allogeneic haematopoietic stem cell transplant, and reduce the requirement for antiviral therapy without toxicity or increasing the occurrence of graft versus host disease. this is a phase i/iia open-label safety study, assessing the effects of administering adenovirus-specific t-cells (cytovir adv) to paediatric patients post haematopoietic stem cell transplant.


Eligibility criteria:
inclusion criteria: patients: 1. age 16 years or younger 2. scheduled to undergo an allogeneic hsct with an unrelated donor, mismatched unrelated donor, mismatched family donor or haplo identical donor 3. the subject (or legally acceptable representative) must give informed consent (and assent for subjects ≥ 12 years). all subjects will have a parent or guardian provide informed consent and the subject will provide witnessed verbal assent 4. negative serology for hiv 1 + 2, hepb, hepc, syphilis, hcg. donors 1. meets requirements of directive 2004/23/ec as amended and the uk statutory instruments pursuant therein 2. negative serology for hiv 1 + 2, hepb, hepc, syphilis, hcg 3. passed medical assessment for stem cell donation 4. hdadv seropositive 5. signed informed consent 6. age 16 years or older exclusion criteria: patients 1. pregnant or lactating females 2. co-existing medical problems that would place the patient at significant risk of death due to gvhd or its sequelae 3. human immunodeficiency virus (hiv) infection donors 1. pregnant or lactating females 2. (assessed prior to apheresis) platelets \< 50x109/l
atorvastatin in preventing nasopharyngeal carcinoma patients receiving radiotherapy from carotid stenosis

Conditions: Nasopharyngeal Carcinoma; Radiation Therapy Complication

Summary: patients with head and neck cancer who underwent irradiation have a higher risk of developing severe carotid stenosis, and eventually develop to transient ischemic attack or stroke. however, it's still not clear whether early intervene in vascular risk factors is benefit for patients after radiotherapy. our study aimed to evaluate the feasibility and safety of atorvastatin for preventing npc patients after radiotherapy from severe carotid stenosis. in a randomized, double-blind, placebo-controlled trial, about 324 nasopharyngeal carcinoma (npc) patients will be enrolled from six centers in guangdong province and randomized 1:1 to atorvastatin group or placebo group.

it is a randomized, double-blind, placebo-controlled trial, about 324 nasopharyngeal carcinoma (npc) patients will be enrolled from six centers in guangdong province and randomized 1:1 to atorvastatin group (20mg per night, totally 2 years) or placebo group. all patients will be followed up for 2 years. ultrasound and transcranial color doppler (tcd) will be used to evaluate the changes of intima-media thickness (imt) and occurrence of plaque formation of carotid arteries. safety will be monitored every 6 months.

Eligibility criteria:
inclusion criteria: * patients must have received radiation therapy for histologically confirmed nasopharyngeal carcinoma. * prior irradiation \<3 years prior to study entry. * male or fertile women who are willing to take contraception during the trial. * age 40-65 years old. * carotid stenosis \< 50%. * ldl-c between 100mg/dl（2.5mmol/l）and 190mg/dl（4.9mmol/l）. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * history of bleeding related to tumor or radiotherapy during or after radiation. * evidence of tumor invasion to major vessels(for example the carotid artery). * severe complications, such as history of stroke, myocardial infarction, liver diseases, thyroid dysfunction, inadequately controlled hypertension and epilepsy. * familial hypercholesterolemia. * taking lipid-lowing drugs. * aspartate aminotransferase(ast) or alanine aminotransferase(alt) \>upper limits of normal (uln), creatinine \>uln. * allergic history of atorvastatin.

Keywords: nasopharyngeal carcinoma radiotherapy carotid stenosis atorvastatin
a study of pf-06438179 (infliximab-pfizer) and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis (reflections b537-02).

Conditions: Rheumatoid Arthritis

Summary: the study will assess the efficacy and safety of pf-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.


Eligibility criteria:
inclusion criteria: diagnosis of rheumatoid arthritis based on 2010 acr/eular criteria for at least 4 months. at least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline. hs-crp equal or greater than 10 mg/l. must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks. exclusion criteria: evidence of untreated or inadequately treated latent or active tb. evidence or history of moderate or severe heart failure (nyha class iii/iv) infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.

Keywords: phase 3 infliximab rheumatoid arthritis
microbial keratitis in cairo university hospitals

Conditions: Infective Keratitis

Summary: the aim of the study was to identify the incidence of infective keratitis presenting to the ophthalmology emergency department at cairo university hospital, the risk factors and the bacterial/fungal spectrum causing the ulcers and to determine the best possible empirical therapy followed by specific therapy after obtaining culture results.


Eligibility criteria:
inclusion criteria: * patients presenting at the casualty who are clinically diagnosed as infectious keratitis , of all age groups and including both genders. exclusion criteria: patients presenting with clinical picture suggestive of * viral keratitis solely without superimposed secondary infection. * non infectious keratitis as peripheral ulcerative keratitis ( e.g. mooren's ulcer, marginal keratitis, autoimmune keratitis )

Keywords: corneal ulcer microbiological profile fungal keratitis bacterial keratitis infective keratitis antimicrobial susceptibility
efficacy of metformin in lean women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: insulin resistance is an important feature of the polycystic ovary syndrome,and patiens are successfully treated with the insulin sensitizing agent metformin. the insulin resistance of lean patients with the syndrome is debated. in this study, we will study the change in insulin resistance, metabolic and hormonal factors after 3 months of metformin treatment in lean pcos women.


Eligibility criteria:
inclusion criteria: * pcos (rotterdam criteria) * bmi \< 27 * no medication for 3 months exclusion criteria: * pregnancy * lactation * other endocrinologic disease
sensor optimization of cardiac resynchronization therapy response

Conditions: Heart Failure

Summary: the sensor optimization of cardiac resynchronization therapy (crt) response (socr) study is a multicenter, prospective, non-randomized acute feasibility study that is being conducted to determine if subcutaneous heart sounds and/or intracardiac impedance can acutely identify the optimal atrioventricular (av) pacing intervals and optimal left ventricular (lv) electrodes in patients indicated for cardiac resynchronization therapy.


Eligibility criteria:
inclusion criteria: * subject must be undergoing implant of a new or replacement/upgrade medtronic crt-p or crt-d device for approved indications. * subject is implanted or will be implanted with an right ventricular (rv) lead that supports bipolar pacing and sensing (e.g. a bipolar pace/sense lead or a true bipolar defibrillation leads) * subject (or subject's legally authorized representative) must be willing to give informed consent * subjects must be at least 18 years of age exclusion criteria: * subject has congenital heart disease * subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure * subject has unstable coronary artery disease * subject cannot undergo transvenous catheterization * subject has a mechanical tricuspid or aortic valve prosthesis or history of significant structural tricuspid or aortic valvular disease * subject requires dual chamber cardiac pacing or single chamber (ventricular) pacing at rest for rate control * subject has a recent echocardiogram (within prior 6 months) which revealed the presence of an lv thrombus * subject is pregnant * subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from medtronic study manager
data collection of pillcamtm sb3 capsule endoscopy and device-assisted enteroscopy routine care procedures (gps study)

Conditions: Small Intestine Disease; Small Intestine Cancer; Small Intestinal Ulcer Bleeding; Small Intestine Obstruction; Small Intestine Adenocarcinoma; Small Intestine Polyp

Summary: a prospective, multicenter, post-market, minimal risk, observational study designed to collect pillcamtm sb3 capsule endoscopy (ce) procedures and subsequent device-assisted enteroscopy (dae) procedures data (double balloon enteroscopy (dbe), single balloon enteroscopy (sbe) and spiral enteroscopy (se)) in medical centers in the united states (us).

a prospective, multicenter, post-market, minimal risk, observational study designed to collect up to 60 pillcamtm sb3 ce procedures and subsequent dae procedures data (double balloon enteroscopy (dbe), single balloon enteroscopy (sbe) and spiral enteroscopy (se)) in up to 6 medical centers in the united states (us). the data will be collected from subjects who underwent standard of care (soc) pillcamtm sb3 ce procedure and were referred to a subsequent soc dae. in addition, relevant surgical, endoscopic and histology reports as well as radiological data (such as ct, magnetic resonance enterography (mre) images and reports) may be collected retrospectively 6 months prior to enrollment and prospectively 3 months post enrollment, when applicable. in addition, up to 400 pillcamtm sb3 ce procedures data may be collected from subjects who underwent sb3 procedure (not necessarily followed by dae) and abnormal sb findings were indicated in their ce report. study duration is up to 3 years from initial institutional review board (irb) approval. collected data will include pillcamtm raw data, videos and reports, as well as dae reports, videos and histology reports (when applicable). demographic data will also be collected to provide a description of the study population characteristics and disposition. all the collected data will be de-identified by delegated and authorized sites' team members, in a manner that is untraceable by the sponsor. the data will be used by medtronic gastrointestinal research and development (r\&d) team in collaboration with third parties, including but not limited to external physicians and r\&d partners, as applicable, for development of an artificial intelligence (ai) software system to apply to endoscopy procedures, as well as for sb pathologies detection development and validation.

Eligibility criteria:
inclusion criteria: 1. adult male and female subjects (≥18 years) 2. the subject underwent a soc pillcamtm sb3 ce procedure and is referred to a subsequent dae procedure(s), as part of the routine care or the subject underwent a soc pillcamtm sb3 ce procedure (not necessarily followed by a dae) and abnormal findings were indicated in the ce report (optional). 3. the subject received an explanation and understands the nature of the study and provided oral consent. exclusion criteria: 1. the subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
effort-based decision-making and cpapadherence

Conditions: Obstructive Sleep Apnea; Adherence

Summary: obstructive sleep apnoea is the most common sleep disorder in general population, and is often associated with cognitive deficit, mood disorders, hypertension, diabetes mellitus, excessive daytime somnolence, nicturia and an increased cardiovascular and metabolic risk. the gold standard of treatment is continuous positive airway pressure (cpap), but the adherence is often poor. the aim of our study is to investigate the effort based-decision making in patients with osa, pre and post cpap treatment, as a possible cause of poor adherence.

obstructive sleep apnea is a very common disease in general population (24% males; 9% females), characterized by frequent partial or total upper-airway collapse, intermittent hypoxia, arousal from sleep, change in blood pressure, excessive daytime sleepiness, cardiovascular and metabolic diseases, psychological and cognitive consequences. the gold standard treatment is continuous positive airway pressure (cpap), but the adherence is often poor. poor therapy adherence might be partially explained by executive deficits, decreasing the ability to plan and pursue longsighted behaviors entailing immediate costs/efforts. we investigate the cognitive function, in particular effort based-decision making and the relationship with excessive daytime somnolence and other cognitive function in a group of osa patients and in control group. we assess cognitive function in osa patients at the diagnosis moment and after six months of cpap use.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * ahi±15 exclusion criteria: * bmi ≥ 35 kg/m2 * mmse \<24 * complex sleep apnoea * sleep disorder * psychiatric disorder

Keywords: apnoea effort based decision making rehabilitation adherence
cardiovascular protective effect of spironolactone in hemodialysis

Conditions: Hemodialysis

Summary: the purpose of the present study is to determine if spironolactone is safe and effective in the treatment of cardiovascular complications in hemodialysis patients.

cardiovascular complications are common in dialysis patients and comprise up to 50% of deaths in end-stage renal disease population. hypertension and left ventricle hypertrophy occur in more than 70% of patients undergoing long-term hemodialysis therapy, and both contributes to mortality and morbidity.recent clinical trials in chronic heart failure and post miocardial infarct heart failure patients have demonstrated a beneficial effect of a mineralocorticoid receptor blocker spironolactone, in adittion to standard therapy (rales and ephesus studies). the aim of the present study is to evaluate spironolactone treatment in hemodialysis patients.

Eligibility criteria:
inclusion criteria: chronic hemodialysys (\> 3 months) anuria (diuresis \<200 ml/day) - exclusion criteria: liver failure insulin dependent diabetes treatment with adrenergic beta blockers or agonists treatment with converting-enzime blocker or angiotensin receptor antagonists cancer -

Keywords: hemodialysis aldosterone heart failure spironolactone