Kornimate/medical-research-clean huggingface dataset:
characterization of colorectal neoplasia

Conditions: Colonic Polyp

Summary: this is a post-marketing, single-arm, prospective study investigating the use of gi genius cadx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the ce-marked gi genius cadx device. colonoscopy will be performed according to the standard practice.


Eligibility criteria:
inclusion criteria: * patients aged 40 years or older undergoing screening colonoscopy for crc * ability to provide written, informed consent (approved by ec) and understand the responsibilities of trial participation exclusion criteria: * subjects at high risk for colorectal cancer * subjects with a personal history of crc, ibd or hereditary polyposis or non-polyposis syndromes * patients with previous resection of the sigmoid rectum * patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings * patients who perform an emergency colonoscopy
mirna in sweat, a novel digital biomarker for detection of active tuberculosis (tb)

Conditions: Active Tuberculosis

Summary: the detection of mirna (non-coding ribonucleic acid) in the blood in the context of active tuberculosis is an innovative approach to the detection of new disease-specific biomarkers. the primary goal of this analysis is to define, for the first time, an mirna fingerprint for tuberculosis in sweat. samples that were collected as part of the sweatb study (nct03667742) project are examined for the occurrence of disease-specific, non-coding mirnas to define new biomarkers in the sweat. these biomarkers can be detected non-invasively and will help in the detection of patients with active tuberculosis.


Eligibility criteria:
inclusion criteria: * adult patients * ability to understand the purpose of the study, provide signed and dated informed consent by patient or his/her legal representative * in-patients with acute tuberculosis, suspected tuberculosis or other pulmonary diseases (pneumonia, bronchitis, copd) inclusion criteria healthy donors: * negative for quantiferon- tb gold plus test or elispot exclusion criteria: * written rejection of the consent for the further use of the data

Keywords: mirna mycobacterium tuberculosis next generation sequencing
thoracic oncogeriatric assessment (toga) trials

Conditions: Thoracic Neoplasms; Lung Neoplasms; Esophagus Neoplasms; Pleural Neoplasms; Thymus Neoplasms

Summary: our goal is to develop a reliable, physician and patient-friendly, pre-operative thoracic onco-geriatric assessment (toga) to predict surgical risk in geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus, modeled upon existing cga tools, including the preoperative assessment of cancer in the elderly (pace)

our proposed toga wil consist of portions of the pace and some additional screening tools, and will be applied prospectively to all patients 70 years old and above seen in the uwccc for a thoracic oncology surgery. residents of nursing homes and assisted living facilities will be eligible for this study if they are thought to be appropriate surgical candidates; other institutionalized patients will not. the preoperative toga will be performed by either drs. weigel, maloney, loconte or traynor or p.a. block. the toga includes parts of the pace, involving assessment of co-morbid illness, activities of daily living \[adl\], instrumental activities of daily living \[iadl\], geriatric depression screen \[gds\], brief fatigue inventory \[bfi\], eastern cooperative oncology group/zubrod performance status \[ps\], mini mental state exam (mmse), in addition to an american society of anesthesiologists score\[asa\] and mini nutritional assessment (mna), which were not done in the pace. the toga should take up to 25 minutes to complete (audisio, 2006), and will be done at only one time preoperativelour hypothesis is that this novel, preoperative thoracic onco geriatric assessment (toga) will serve to predict outcomes for older patients going though thoracic oncology surgery, and thus will enhance geriatric patient care through the development of concise, validated, preoperative risk stratification. our hypothesis is that this abbreviated geriatric screening tool will be a better predictor for surgical and oncologic complications after surgery than performance status alone (which is currently the only measure of fitness used in routine oncology care). in addition, we predict that parts of the toga, specifically the instrumental activites of daily living score (iadl), mini nutritional assessment (mna) and the brief fatigue inventory (bfi), will be the strongest predictor(s) of outcomes in our thoracic surgery population. the outcomes data we generate will also be important in quality improvement and standardization of preoperative risk assessment for elderly patients with thoracic malignancies.

Eligibility criteria:
inclusion criteria: * patients 70 years old and above seen in the uwccc for a thoracic oncology surgery. * residents of nursing homes and assisted living facilities will be eligible for this study if they are thought to be appropriate surgical candidates. exclusion criteria: * institutionalized deemed not to be appropriate. * prisoners

Keywords: geriatric thoracic neoplasm (patients over 70 years of age) geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus.
effectiveness of mobile applications during the administration of local anesthesia in pediatric dentistry

Conditions: Anxiety

Summary: to evaluate the mobile games' effect on patient acceptance of local anesthesia and decreasing dental pain and anxiety levels in pediatric patients.

a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: mobile application (little lovely dentist) control group: tell-show-do technique. in children aged 4-6 years who need local anesthesia for dental treatment during their first dental visit. for both groups: verbal assent from participating patients and written consent from their legal guardians will be taken. 1. taking personal data, medical and dental history. 2. diagnosis and determination of the required treatment. 3. measuring preoperative anxiety using a pulse oximeter. 4. evaluate preoperative anxiety using rms-pictorial scale. 5. using the behavior guidance technique: intervention group: allow the child to play the module simulating the required procedure. control group: tell-show-do technique is used to explain the procedure to the child 6. administration of local anesthesia and evaluation of child behaviour during the administration of local anaesthesia using venham's behaviour rating scale and frankl behaviour rating scale . 7. measuring postoperative anxiety using the pulse oximeter. 8. evaluate postoperative anxiety using rms-pictorial scale. 9. evaluate postoperative pain using the visual analog scale. in second visit (after 1 week) 1) evaluation of child behavior during the second dental visit using venham's behavior rating scale and frankl behavior rating scale. outcome: 1. ry: pre and postoperative anxiety using pulse oximeter and rms-pictorial scale. 2. ry: postoperative pain using visual analog scale, evaluation of attitude during the administration of local anaesthesia at first and second dental visits using -venham's behavior rating scale-frankl behavior rating scale. the study will be held in 2 visits.

Eligibility criteria:
inclusion criteria: * children aged 4-6 years. * children without any systemic or mental disorders. * children without any prior experience with the dental environment or treatment procedures (first dental visit). * children whose behavior could be rated as positive or negative based on the frankl behavior rating scale. exclusion criteria: * children seeking dental treatment that does not necessitate local anesthesia. * children suffering from any systemic or mental disorders. * children who are not willing to participate in the study
effect of lactobacillus plantarum 299v on symptoms of irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: in patients with ibs, will supplementation with a probiotic demonstrate symptomatic efficacy and will the probiotic influence gut microflora and thus improve clinical outcomes, as compared to no intervention.

conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, lactobacillus plantarum 299v in irritable bowel syndrome patients.

Eligibility criteria:
inclusion criteria: * fulfillment of the rome ii criteria for ibs, * availability of at least one colonoscopy within the last three years, * aged 18 or older at the time of screening, * provision of written informed consent, * commitment of availability throughout the 12 week study period. exclusion criteria: * major abdominal surgery in the past other than other than appendectomy, caesarean section, tubal laparoscopic cholecystectomy, abdominal wall hernia repair or/and hysterectomy, * current use of antibiotics, * history of organic intestinal disease, * pregnant or breastfeeding mothers, * chronic infectious disease like hiv or tuberculosis, and * unable to understand english or afrikaans.

Keywords: only constipation and diarrhea predominant no mixed or alternating types
prognostic potential of cell surface markers and pim kinases in multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to understand if small proteins found on the surface of myeloma cells (called cxcr4 and cd47) or inside the myeloma cells (pim kinases, sphingolipids, and ps6) can predict how patients will respond to chemotherapy-treatment and if a small molecule inside the myeloma cells (called pim kinase) can be used as a treatment target for myeloma. a sample from the bone marrow biopsy (a small amount of tissue removed from the body for laboratory testing) and aspirate (a small amount of fluid is removed from the body for laboratory testing) that had been done before the subject entered this study will be provided for research purposes. based on preliminary data, it is hypothesized that cxcr4, cd47, sphingolipids, and pim kinases could be used as prognostic/predictive markers and that pim kinase inhibitors provide a new agent for the treatment of multiple myeloma.


Eligibility criteria:
inclusion criteria: * a diagnosis of multiple myeloma or possible multiple myeloma who will have a bone marrow biopsy and aspirate * planned therapy with standard chemotreatment for multiple myeloma * laboratory data such as calcium, beta 2-microglobulin, albumin, creatinine and bone survey available for staging purpose. * ≥18 years old exclusion criteria: * \< 18 years old * patients who will not receive chemotreatment * patients whose treatment records are not available
efficacy and safety of floseal for the haemostasis during laparoscopic cholecystectomy in acute cholecystitis (gla)

Conditions: Cholecystitis, Acute

Summary: the aim of this study is to evaluate the effect and safety of floseal in this preliminary prospective trial with patients undergoing acute laparoscopic cholecystectomy for acute cholecystitis


Eligibility criteria:
inclusion criteria: * patients aged 18 - 65 * clinical (pain, fever \> 37.5 °c, wbc \> 10.000 / microl), and ultrasound evidence of cholecystitis * surgical indication for laparoscopic cholecystectomy * asa class i-iii * informed consent * \<72 hours from onset of symptoms exclusion criteria: * informed consent refusal * choledocholithiasis * pre surgical generalized peritonitis (clinical evaluation) * asa class \> iii * peripheral artery disease * active or past history of malignant systemic disease * pregnant or lactating females * known allergy to components floseal including bovine allergy (bovine gelatin) * known drug or alcohol abuse * patients with known diabetes, chronic renal disease and other metabolic diseases * patients in chronic cortisone treatment more than 2 years before surgery * patients on chronic use of platelet inhibitors such as aspirin, plavix, nsaid's etc.
interscalene vs. superficial cervical block vs. combination for analgesia after clavicle fracture

Conditions: Clavicle Fracture

Summary: the optimal analgesic peripheral nerve block (or combinations thereof) are undefined for clavicle fractures, the most frequent fracture in the human population. this goal of this study is to determine whether interscalene block (isb), superficial cervical plexus block (scpb), or both provide the best analgesia for lateral and midshaft clavicular fractures, respectively.

clavicle fractures are relatively common injuries that occur most often in young active males and elderly individuals. they are often a result of direct trauma to the shoulder, typically from a fall. clavicle fractures represent 5-10% of all fractures and represent the most frequent fracture in the human population. midshaft fractures account for 69-85% of the clavicle fractures, distal shaft fractures 12-28%. (1) analgesia for clavicle fractures can be challenging for anaesthetists secondary to the complex and varied innervation in this region. literature describing the innervation of the clavicle and overlying skin is heterogeneous with the c3 to c6 nerve roots being involved. the clavicle itself has been reported to be innervated either by c4 or by c5 and c6 (subclavian nerve) nerve roots. (2) regional anaesthesia for intraoperative and postoperative analgesia of clavicle fractures employs several possible, commonly used approaches. the contemporary literature surrounding the optimal regional anaesthetic technique for clavicle surgery which can provide superior postoperative analgesia and minimize systemic agents intraoperatively is lacking currently there are only small case series or case reports published. peripheral nerve blocks used to anesthetize the clavicle include scpb, isb, and combined scpb-isb. larger, systematic trials have not yet been performed to our knowledge and as recently as one year ago a call for more evidence in this area of regional anaesthesia was published in the american society of regional anesthesia and pain medicine. the purpose of this study is to compare analgesic outcomes after the common regional anesthetic techniques (isb versus scpb versus both).

Eligibility criteria:
inclusion criteria: * undergoing open reduction and internal fixation of clavicle fracture (midshaft or lateral) exclusion criteria: * lack of patient consent * contra-indication to upper extremity peripheral nerve block (eg. severe pulmonary dysfunction) * inability to lie supine for nerve block * polytrauma * pre-existing neurologic deficit in operative upper extremity * allergy to amide local anesthetic * contralateral phrenic nerve dysfunction * chronic opioid use (\>30mg daily oral morphine equivalent)
phase 3 herniorrhaphy study for postoperative analgesia (epoch 2)

Conditions: Postoperative Pain

Summary: this is a phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of htx 011 administered via local administration into the surgical site in subjects undergoing unilateral open inguinal herniorrhaphy.


Eligibility criteria:
inclusion criteria: * is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia. * has an american society of anesthesiologists physical status of i, ii, or iii. * female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives. exclusion criteria: * had any prior inguinal hernia repair. * has a planned concurrent surgical procedure. * has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. * has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. * has taken nsaids within 10 days prior to the scheduled surgery. * has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting). * has been administered bupivacaine within 5 days prior to the scheduled surgery. * has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control. * has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. * has a medical condition such that, in the opinion of the investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. * has a known history of hepatitis b, human immunodeficiency virus (hiv), or active hepatitis c. * has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the investigator, might interfere with study assessments. * had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. note: subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention deficit/hyperactivity disorder) may be eligible for participation in the study. subjects taking medical marijuana are not allowed to participate in the study. * received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives. * has undergone 3 or more surgeries within 12 months. * has a body mass index (bmi) \>39 kg/m2.

Keywords: inguinal hernia hernia hernia surgery postoperative pain herniorrhaphy
radiofrequency ablation using octopus electrodes for small hepatocellular carcinoma with no-touch technique

Conditions: Hepatocellular Carcinoma; Radiofrequency Ablation

Summary: the aim of this study is to evaluate clinical outcome of rfa for small single nodular hcc using no touch technique with separable clustered electrode (octopus) in a prospective multicenter manner participating center: seoul national university hospital, asan medical center, samsung medical center, kunkuk university hospital, st. mary's seoul hospital


Eligibility criteria:
inclusion criteria: * child-pugh class a liver function * 1 - 2.5 cm sized single nodular hcc * without history of previous hcc treatment or with evidence of no recurrence at least 2 years after previous hcc treatment exclusion criteria: * more than 2 hcc * tumor size larger than 2.5 cm * child-pugh class b or c liver function * invisible tumor even after real-time fusion us guidance * accompanied by vascular invasion or distant metastasis * presence of coagulopathy defined as platelet count \ 50%
rosehip powder for knee osteoarthritis

Conditions: Osteoarthritis

Summary: the aim of this study is to compare three combinations of preparations in a comparative trial program on rosehip powder for knee oa. the trial is a comparative, 12-week, randomized, double-blind, active-controlled trial, designed to determine the comparative efficacy and safety of these preparations in patients with pain from knee oa.

complementary or alternative therapies (incl. nutraceuticals - functional ingredients sold as powders, pills, and other medicinal forms not generally associated with food) for oa are commonly used, and it is therefore important that health care providers are aware of the evidence supporting the claims. one proposed nutraceutical which has shown promising results in oa patients, is the hip powder of rosa canina. the findings from a previous meta-analysis of rosehip powder from rosa canina for symptomatic treatment of oa was a small but potentially relevant reduction of pain and a statistically significant reduction in use of analgesics. the present study is undertaken to compare two different products, one of which is tested in two different doses, in a non-inferiority design.

Eligibility criteria:
inclusion criteria: * 40 years of age and have clinical evidence (diagnosed according to the american college of rheumatology \[acr\] criteria) and radiographic evidence of oa. * eligible patients have a self-reported pain level corresponding to at least 40 mm on a 100 mm vas when screened exclusion criteria: * patients will not be considered eligible if they are considered morbidly obese -having a body mass index (bmi) above 40 kg/m2, concurrent medical or arthritic conditions that could confound evaluation of the index joint, or coexisting disease that could preclude successful completion of the trial. * patients who already take a rosehip powder as a dietary supplement; have inability to speak danish fluently; or have a mental state impeding compliance with the program will not be considered eligible for inclusion.

Keywords: rosehip osteoarthritis pain knee rct
comparison of two surgical treatments for necrotizing enterocolitis in human infants

Conditions: Necrotizing Enterocolitis

Summary: the primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies.

this is a multi-center randomized clinical trial comparing laparotomy vs peritoneal drainage for perforated necrotizing enterocolitis. the current literature does not allow an objective comparison between these two methods. a recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated nec revealed that the degree of bias in assignment to treatment precluded an adequate determination as to the best treatment. the conclusion that only a randomized clinical trial would answer this question has led to this multi-center effort. the relative infrequency of the disease at any one neonatal center has necessitated enrollment of patients at many centers. comparison: premature neonates weighing less than 1500 grams at birth who develop perforated necrotizing enterocolitis are randomized within two birth weight blocks (\<1000 gms and 1000 - 1499 gms) for treatment with either laparotomy or primary peritoneal drainage. daily postoperative clinical care is kept uniform between the two groups by means of a critical care pathway. the primary outcome variable is mortality, i.e. death within 90 days of intervention. the main secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.

Eligibility criteria:
inclusion criteria: * birth weight less than 1500 grams * gestational age 24 -33 weeks * diagnosed with necrotizing enterocolitis based on bell stage ii or greater * bowel perforation as evidenced by free intraperitoneal air seen on abdominal radiograph, stool, bile, or pus found at paracentesis or clinical evidence of perforation in the joint opinion of the attending surgeon and neonatologist. exclusion criteria: * bilateral grade iv intraventricular hemorrhage * previous abdominal surgery * evidence of gastrointestinal anomaly (i.e. atresia, malrotation etc.)

Keywords: randomized controlled trial necrotizing enterocolitis premature infants laparotomy peritoneal drainage