Kornimate/medical-research-clean huggingface dataset:
a hepatitis b vaccine challenge study after previous vaxelis® vaccination (v419-013)

Conditions: Hepatitis B

Summary: the purpose of this study is to demonstrate the durability of protection against hepatitis b virus (hbv) infection approximately 8-9 years after vaccination with vaxelis®. this is an estimation study, and no formal hypothesis testing was performed.


Eligibility criteria:
inclusion criteria: * is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator. * has participated in protocol v419-007 and received a 3 + 1 vaxelis® schedule or participated in protocol v419-008 and received a 2 + 1 vaxelis® schedule. * the participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study. exclusion criteria: * has a history of diagnosis (clinical, serological, or microbiological) of hbv infection. * has a known or suspected impairment of immunological function (e.g., human immunodeficiency virus (hiv), splenectomy). * has a known hypersensitivity to any component of the study vaccine. * has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic system. * has a bleeding disorder contraindicating intramuscular vaccinations. * has received any hepatitis b vaccine after participation in protocol v419-007 or v419-008. * is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or sponsor staff directly involved with this study.
global performance evaluation of the ams continuum™ device

Conditions: Prostate Cancer

Summary: 1. to evaluate device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure. 2. to assess clinical outcomes of the device in facilitating the vesico-urethral anastomosis following a radical prostatectomy.

radical prostatectomy (rp) is the most utilized surgical treatment option for localized prostate cancer due to the multi-focal nature of the disease. rp is most suitable for otherwise healthy men whose cancer is limited to a small area. the rp procedure involves removing the prostate gland, seminal vesicles and nearby lymph nodes. one of the most technically challenging and critical aspects in all of these surgical approaches is reconstruction of the interrupted urinary tract by hand sewing the vesico-urethral anastomosis. this is where the bladder neck is sewn to the urethra after the prostate has been removed. continuum™ (study device) is to be used as part of the rp procedure by facilitating the approximation of the bladder neck and urethral stump. the device brings together and holds the tissue in place until adequate natural healing of the vesico-urethral anastomosis occurs thereby minimizing extravasation. the device also provides a conduit for drainage of urine from the bladder out the urethra during tissue healing. the concept of the continuum™ device and the feasibility of its operation have been successfully tested in animal and human studies. pilot clinical studies in the united states (g060095) found that the majority of subjects who received and were discharged with the device demonstrated a water-tight vesico-urethral anastomosis at the first device removal visit. additionally, no unanticipated adverse device effects (uades) were reported. the focus of the proposed study is to further verify the performance of the device in global research centers.

Eligibility criteria:
inclusion criteria: * all males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study exclusion criteria: * if contraindicated for surgery * inability to understand the study or a history of non-compliance with medical advice * unwilling or unable to sign an informed consent form (icf) * a history of: 1. recurrent urinary tract infections (uti) 2. recurrent stricture disease * neurological disease with a history of bladder dysfunction (e.g., parkinson's disease) * uncontrolled insulin-dependent diabetes * chemotherapy within the past 6 months * non-topical steroid use within the past 6 months * allergy to nitinol, nickel, titanium or silicone

Keywords: prostate cancer radical prostatectomy vesico-urethral anastomosis
active informed consent: a new solution to improve and objectively test the patient understanding of complex surgical procedures proposals

Conditions: Spine Disease; Urologic Diseases

Summary: this is an interventional, non-pharmacological, randomized controlled superiority study (rct), multicenter, open label, parallel group. the aim is to evaluate the effectiveness of a new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for spinal or urological surgery.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * presence on waiting list for planned spinal (instrumented vertebral arthrodesis) and urological (radical prostatectomy) surgeries * understanding of the italian language (in fact, it is believed that the percentage of non * italian mother-tongue patients is minimal and therefore not impacting the study) * ability to access computer tools - exclusion criteria: * age \< 18 years * inability to self-determine * urgency/emergency of intervention
hearing loss and dizziness in patients receiving oxaliplatin for solid tumors

Conditions: Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: understanding how oxaliplatin affects hearing loss, dizziness, and peripheral neuropathy may improve the ability to plan effective treatment for patients receiving oxaliplatin for solid tumors. purpose: this clinical trial is studying hearing loss and dizziness in patients receiving oxaliplatin for solid tumors.

objectives: * define the prevalence of audiometrically detectable hearing loss in patients with solid tumors treated with oxaliplatin. * describe the association of chemotherapy-induced peripheral neuropathy (cipn) and audiometrically detectable hearing loss in these patients. * describe the association of cipn and patient self-reported scales including, peripheral neuropathy scale, hearing handicap inventory for adults, and dizziness handicap inventory. outline: this is an exploratory study. patients will complete three self-reported questionnaires including the peripheral neuropathy scale, hearing handicap inventory for adults, and dizziness handicap inventory. patients will also be asked a series of questions regarding symptoms or complaints about hearing changes, tinnitus, and dizziness that they may have experienced prior to, during, and after completion of chemotherapy. patients will also undergo a hearing test. projected accrual: a total of 60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of solid tumor * received an oxaliplatin-containing chemotherapy regimen within the past 15 months\* note: \*if oxaliplatin was omitted from the patient's most recent chemotherapy regimen due to ototoxicity, the patient is still eligible for participation in this study * no known cns metastases patient characteristics: * no history of spinal injuries * ecog performance status 0-3 * no history of chronic renal failure * no known hiv/aids prior concurrent therapy: * see disease characteristics

Keywords: neurotoxicity unspecified adult solid tumor, protocol specific
low protein diet, gut microbiome and chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: chronic kidney disease (ckd) is a worldwide public health dilemma because of close association with multiple comorbidities, demanding high cardiovascular events, mortality and expensive medical cost. novel and effective therapeutic measures remain urgently needed to reduce burden and impact of disease. advanced renal failure can profoundly alter the biochemical milieu of the gastrointestinal tract leading to a leak gut. application of 16s rrna gene analysis identified an increase of clostridia, actinobacteria, and gammaproteobacteria in hemodialysis patients and decrease of bifidobacterium and lactobacillus in peritoneal patients. this altered microbiome consequently affect production of indole or phenol derived uremic toxins leading to renal damage. our preliminary results indicated reduced number and diversity of intestinal microbes ckd patients compared to normal. different dietary nutrients can affect the gut microbiome and derive several deleterious metabolites leading to metabolic disarrangement. clinically, low-protein diet should be prescribe to renal patients to preserve renal function and high fat content are usually recommended to avoid caloric malnutrition to dietary restriction. the changes of diet-microbiome-metabolite interaction are large unknown with this dietary manipulation. the aims of this study is to determine the renal progression-associated gene and taxonomic alterations bymetagenome-wide association studies and the functional characterization of gut microbiome in ckd patients receiving different low-protein or high-fat diets. the results of the study will provide insight on the exact role of dietary manipulation in ckd patients from gut-renal cross talk.


Eligibility criteria:
inclusion criteria: 1. . patients aged 30-90 years with diagnosis of ckd (defined as abovementioned). 2. . sign the inform consent and agree to participate in this study. 3. . compliant to low protein diet (defined as protein intake \<0.8 g/kg/day) for 4 weeks assessed by 24h urine urea estimates, before enrollment exclusion criteria: 1. . history of any malignancy, liver cirrhosis, intestinal operation, irritable bowel syndrome, cardiovascular disease (defined as myocardial infarction, documented q wave on ekg, unstable angina, coronary artery disease with stenosis \> 75%, congestive heart failure with ejection fraction \< 50% and cerebrovascular disease) in the past 3 months. 2. . history of or infection disease requiring admission in the past 3 months or, concomitant antibiotics use. 3. . concomitant use of probiotics or prebiotics. 4. . pregnancy. 5. . renal transplant recipients.
impact of prevnar 13 on ear infections in children

Conditions: Acute Otitis Media; Mastoiditis

Summary: prevnar (7 valent pneumococcal conjugate vaccine \[7vpnc\]) has been shown to be effective against ear infections in children. prevnar 13 is a new vaccine that is similar to prevnar. it is expected that the effectiveness of prevnar 13 against ear infections in children will be similar to that observed following prevnar. pfizer has committed to conduct a postmarketing study of the impact of prevnar 13 in reducing ear infections among children.


Eligibility criteria:
inclusion criteria: * case eligibility should be based on microbiologic data and should be reviewed and documented by an appropriately qualified member of the investigator's study team before cases are included in the study database. * s pneumoniae identified from middle ear fluid or mastoiditis sample. * specimen obtained from children aged up to 18 years. exclusion criteria: * as this is an observational, laboratory based database study, there are no exclusion criteria

Keywords: acute otitis media prevnar 13 streptococcus pneumoniae
shiga microalbuminuria reduction trial-2

Conditions: Type 2 Diabetes Mellitus; Hypertension

Summary: the purpose of this study is to compare the effects of a direct renin inhibitor (dri), aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes under strict blood pressure control with angiotensin receptor blocker (arb).


Eligibility criteria:
inclusion criteria: * segment: outpatients * hypertension: taking an anti-hypertensive treatment or indicating mean sitting sbp/dbp more than130/80 mmhg * type 2 diabetes: diagnosed by ada criteria or under an anti-diabetic drug treatment * microalbuminuria: 10 \< and \< 300 mg/gcr * informed consent: patients who understand well about this study based on own voluntary will and can give a written consent exclusion criteria: * sever hypertension (over 180/110 mmhg), malignant hypertension and secondary hypertension * type 1 diabetes * patients whose investigator regards as difficult to comply with study protocol in reference to the package insert of aliskiren * patients who have history of operation in gastrointestinal tract surgery, and anamnestic or concurrent gastrointestinal disorders, which may interfere with drug absorption * serum potassium \> 5.6 meq/l (hyperkalemia) * urinary microalbumin \ 300 mg/gcr * patients who participated in another clinical study within three months

Keywords: hypertension albuminuria direct renin inhibitor angiotensin receptor blocker type 2 diabetes
deep sedation in catheter ablation of atrial fibrillation

Conditions: Atrial Fibrillation; Atrial Fibrillation, Paroxysmal or Persistent; Deep Sedations; Conscious Sedation

Summary: the current practice of anesthesia for atrial fibrillation catheter ablation （ca） procedure is inconsistent, including general anesthesia, deep sedation, and conscious sedation.due to the nature of deep sedation, it has been continuously gaining its position as one of the crucial components in standard practices of atrial fibrillation ablation during the last decade. currently, a considerable number of procedures have been done using conscious sedation. previous studies explored the benefits obtained from the employment of deep sedation in af ablation procedures, mainly focused on pain reduction and intra-procedural safety. however, the benefits on long-term rhythmic outcomes, peri-procedural safety as well as benefits on procedural parameters and peri-procedural experiences from patients/ablators/lab staff have yet not to be thoroughly studied. we plan to conduct a prospective, multicenter, randomized, controlled trial to evaluate the benefits of deep sedation in catheter ablation of paroxysmal and persistent af in multiple prospective, i.e., quantified intraprocedural patients / physicians / lab staffs / mapper clinical specialist experiences, and the procedure safety.


Eligibility criteria:
inclusion criteria: ● patients diagnosed with af (paroxysmal, persistent, or long-standing) at 18-75 years old who are eligible for the ca procedure exclusion criteria: * has received ca procedure for af or atrial septal defect repair before enrollment * left atrial diameter (lad) ≥55 mm or thrombosis in the left atrium; * egfr\<30ml/min/1.73㎡ * a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack \[tia\]) * acute or severe systemic infection * intolerant to sedation or with a history suggestive of sleep apnea * bmi \> 35 kg/㎡ * has contraindications to procedural sedation or refused to participate in this trial * congenital heart disease, thyroid dysfunction, severe hepatic insufficiency (child-pugh classification b-c), severe coagulation dysfunction (international normalized ratio (inr) \> 1.5 or partial activated prothrombin time (aptt) prolonged by ≥ 10 seconds, or plasma prothrombin time (pt) prolonged by ≥ 3 seconds, or fibrinogen (fib) ≤ 1.5 g/l), or active bleeding * pregnant women, breastfeeding women or women who plan to become pregnant during the study period, those who have a positive pregnancy test result during the screening period * life expectancy \< 12 months * those who have participated in other clinical drug trials within 3 months prior to enrollment * those who are known to be allergic to any of the ingredients such as lidocaine, propofol, soybeans, peanuts, etc. * those who, in the judgment of the investigator, are not suitable for this clinical study (e.g., not in line with the treatment that the research participants the treatment, research participant compliance, etc.).

Keywords: deep sedation conscious sedation catheter ablation atrial fibrillation
effects of the low-level laser therapy on inflammatory profile of the patients with coronary artery bypass surgery

Conditions: Cardiovascular Diseases

Summary: cardiovascular diseases are the leading causes of morbidity and mortality in brazil and surgical procedures to treat these disorders have grown dramatically in recent years. since the first heart surgery in successful open field in humans, conducted in 1953 by john lewis, many techniques have been used to improve the outcome of surgery and reduce their side effects. the low-level laser therapy (lbp) has been widely used in clinical practice for pain relief purposes, reducing inflammation and stimulating tissue healing. however, the effect of this therapy has been little elucidated in patients with cardiac disease. the objective of this study is to evaluate the effect of low level laser therapy on the inflammatory profile and cardiac tissue healing markers of patients in the postoperative period of cabg surgery.

this study will be conducing in a large hospital that is reference in cardiovascular diseases treatments. 38 patients will be randomized for placebo or 6j low-level laser therapy (lllt). the inflammatory profile and cardiac tissue will be assessment before and after de lllt.

Eligibility criteria:
inclusion criteria: * patients after elective coronary artery bypass surgery, hemodynamically stable, without ischemic changes and / or complex arrhythmias on the electrocardiogram, between 45 and 75 years of age, who have performed the first surgery exclusion criteria: * patients with decompensated heart failure; other associated surgery; presence of any comorbidity such as: unstable angina; sequel of stroke; photosensitivity; use of cardiac pacemaker; diabetes mellitus (due to the negative effect of diabetes on wound healing).
hyaluronic acid for the prevention of endocavitary synechiae after myomectomy

Conditions: Patients With an Indication for Myomectomy or Polymyomectomy

Summary: prevendo is a prospective, multicenter, pilot, and randomized study in 2 parallel arms and single blind, evaluating the proportion of endometrial synechiae 6 weeks after surgery in patients undergoing abdominal myomectomy or polymyomectomy, according to the application or not of an anti-adhesion gel (hyalobarrier® gel endo)

myomas are a common pathology affecting a large population of women of reproductive age. depending on their location and the patient's symptoms, surgical removal of fibroids may be indicated. interstitial or subserous myomas are accessible through the abdominal route (laparotomy or minimally invasive surgery). the impact of this surgery on the endometrial cavity and the risk of post-surgery synechiae is poorly understood, although it is essential, especially in a population of women wishing to preserve their fertility. in order to reduce and prevent endometrial synechia formation, we suggest prevendo study which consist in the systematic intracavitary placement of an anti-adhesion gel (hyalobarrier® gel endo) immediately after surgery in patients undergoing abdominal myomectomy or polymyomectomy (laparotomy, laparoscopy, robot-assisted laparoscopy) and the evaluation of the proportion of endometrial synechiae 6 weeks after surgery in patients during diagnostic hysteroscopy performed 6 weeks after surgery.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. of childbearing age 3. indication of myomectomy / polymyomectomy by laparotomy / laparoscopy / robot-assisted laparoscopy 4. figo 2 to 6 classification myomas exclusion criteria: 1. history of intra uterine synechia treatment 2. uterine malformation 3. patients under legal protection measure (guardianship or curatorship) or under security measure 4. pregnant or breastfeeding women 5. absence of health insurance; or patient with ame 6. absence of free, informed and written consent 7. endometrial synechia before operation (grade 1-3) (assessed by systematic diagnostic hysteroscopy) 8. patient with upper genital infection 9. hypersensibility to hyaluronic acid

Keywords: synechia myomas myomectomy polymyomectomy gynaecology
does surface tell us about the invasive front in colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to investigate the invasive front in growth mode (expanding or infiltrative) and dedifferentiation (tumor budding) and comparing these with the tumor surface (polypose or flat) + / - ulceration in surgical specimens at colorectal cancer.

timetable: from 1 august 2013 to 31 july 2014. organisational arrangements: the project is deleted from the pathology department, roskilde hospital, and surgical department, roskilde hospital. inclusion criteria all colorectal surgical specimens having cancer were the patient did not receive neoadjuvant treatment received in the pathology department in accordance with current guidelines with the cutting of the tumor area in parallel slices and photographed, so there is macroscopic photo documentation. microscopic tumors classified as adenocarcinoma of glandular type, mucinous adenocarcinoma, signet ring cell carcinoma. when the specimens is received at the department of pathology and is included in the study the pathologist report is registered in a local database.

Eligibility criteria:
inclusion criteria: * all surgical preparations from patients with colorectal cancer that did not receive neoadjuvant treatment received in the pathology department in accordance with current guidelines with the cutting of the tumor area in parallel slices and photographed, so there is macroscopic photo documentation. microscopic tumors classified as adenocarcinoma of glandular type, mucinous adenocarcinoma, signet ring cell carcinoma. exclusion criteria: * all surgical preparations from patients with colorectal cancer where the patient received neoadjuvant therapy or when surgery preparation could not be received by current guidelines and all preparations where it is not possible to obtain macroscopic image of the parallel slices. microscopic tumors that can not be classified as adenocarcinoma of the glandular type, mucinous adenocarcinoma or signet ring cell carcinoma excluded.

Keywords: colorectal cancer surface invasive front tumor budding
quality of life after liver resection

Conditions: Liver Diseases; Liver Neoplasms

Summary: patients with malignant diseases are increasingly receiving more extensive hepatic resections, with im-proved preoperative and postoperative care leading to a reduced postoperative morbidity and mortality. in this setting, postoperative quality of life may become as important as overall patient survival. in this study we will be investigating the effect of the initial disease for which hepatic resection was carried out on short- and long-term quality of life.

background: due to advances in operative methods and perioperative care, mortality and morbidity following major hepatic resection have decreased substantially, making long-term quality of life (qol) an increasingly prominent issue. objectives: we plan on evaluating whether postoperative diagnosis is associated with long-term qol and health in patients who require hepatic surgery for benign or malignant diseases and how qol evolves with time. method: qol will be evaluated using the european organization for research and treatment of cancer quality of life questionnaire core-30 and the liver-specific qlq-lmc21 module. all patients requiring hepatic surgery aged \>18 years will be included in the study. qol evaluation is carried out preoperatively and at set intervals postoperatively.

Eligibility criteria:
inclusion criteria: * patients with planned liver resection exclusion criteria * patients with biopsy of the liver only * inability of understanding the questionnaire

Keywords: quality of life liver neoplasms surgical procedures, operative