Kornimate/medical-research-clean huggingface dataset:
immunization of patients with metastatic melanoma using the gp100 peptide preceded by an endoplasmic reticulum insertion signal sequence

Conditions: Melanoma; Neoplasm Metastasis

Summary: patients with metastatic melanoma who are hla-a201+ will be immunized with a modified peptide from the gp100 molecule that contains a signal sequence designed to improve peptide presentation by antigen presenting cells. this peptide called gp100:es209-217 (210m) will be administered either alone or in combination with high or low dose il-2. patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.

patients with metastatic melanoma who are hla-a201+ will be immunized with a modified peptide from the gp100 molecule that contains a signal sequence designed to improve peptide presentation by antigen presenting cells. this peptide called gp100:es209-217 (210m) will be administered either alone or in combination with high or low dose il-2. patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.

Eligibility criteria:
any patient age greater than or equal to 18 with measurable metastatic melanoma who has failed standard treatment and has an expected survival of greater than three months will be considered. serum creatinine of 2.0 mg/dl or less. bilirubin 1.6 mg/dl or less. wbc 3000/mm(3) or greater. platelet count 90,000 mm(3) or greater. serum ast/alt less then two times normal. ecog performance status of 0 or 1 or 2. patients of both genders must be willing to practice effective birth control during this trial. no patients who are undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer. no patients who have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease. patients with cardiovascular disease will be eligible to receive peptide in ifa alone. no patients who require steroid therapy. no patients who are pregnant (because of possible side effects on the fetus). no patients who are known to be positive for hepatitis bsag or hiv antibody (because of possible immune effects of these conditions). no patients who have any form of primary or secondary immunodeficiency. (the experimental treatment being evaluated in this protocol depends on an intact immune system. patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).

Keywords: antigen cancer immunotherapy
biomarker study in pancreatic neuroendocrine tumours

Conditions: Neuroendocrine Tumors

Summary: the biology of pancreatic neuroendocrine tumors can change during the disease course. this evolution of disease can manifest through increases in tumor proliferation rate, resistance to medical therapy and/or a change in tumor hormone secretion. this study aims to characterize how the biology of pancreatic neuroendocrine tumors change over time, measured by; patient symptoms, biochemistry, contrast enhanced computed tomography, fdg-pet and core needle biopsy with histopathological analysis (ki67 index and tumor cell differentiation). uptake on 18f-fdg-pet will be correlated directly to tumor cell proliferation rate. fraction of patients with spatial heterogeneity in fdg uptake as well as metachronous changes in all collected data will be documented. biomaterial from whole blood and core needle biopsies will be characterized on the molecular level, and those findings will be integrated to the above specified clinical parameters.


Eligibility criteria:
inclusion criteria: * age ≥18 years * informed consent * who performance status ≤2 * progressive disease (as defined by the local investigator) or newly diagnosed disease (defined as prior to medical or oncological intervention except for somatostatin analogue treatment). * pathology confirmed diagnosis of pancreatic or duodenal neuroendocrine tumour who g1-g3. o exception: in newly diagnosed patients with high suspicion of pnet based on clinical and radiological parameters where tissue sample have not yet been obtained. these patients may be included and subsequently excluded if pathology cannot confirm net. * biopsy procedure not associated with inappropriate risk as determined by the responsible physician. exclusion criteria: * patient does not consent * permanent risk factors for biopsy * long term treatment with anticoagulant that cannot be temporarily paused without unacceptable risk. * permanent coagulation disorder * pregnancy or no contraceptive in fertile women.
comparative study between surgical and non surgical treatment of anismus in patients

Conditions: Obstructed Defecation; Anismus; Constipation

Summary: comparative study between surgical and non surgical treatment of anismus in patients with symptoms of obstructed defecation. anismus is a significant cause of chronic constipation. this study came to compare the results of bfb training , btx-a injection and pdpr in the treatment of anismus patients. patients and methods: seventy two anismus patients fulfilled rome ii criteria for functional constipation were included in this study. all patients underwent anorectal manometry, balloon expulsion test, defecography, and electromyography activity of the eas. all patients had non relaxing puborectalis muscle.. the patients were randomized into three groups. group i patients received biofeedback therapy, two times per week for about 1 month. group ii patients were injected with btx- a. group 111 partial division of puborectalis was done. follow up was conducted weekly in the first month then monthly for about 1 year.

key words: obstructed defecation, chronic constipation, puborectalis, pelvic floor

Eligibility criteria:
inclusion criteria: * 60patients fulfilled rome ii criteria for functional constipation * all patients were unresponsive to laxatives or enema use exclusion criteria: * pregnant patients * patients with sphincteric defect * any patient proved to have colonic inertia by colon transit time * any patient with previous history of pelvic surgery e.g. mesh rectopexy * duhamel operation were excluded

Keywords: obstructed defecation constipation puborectalis
tissium™ atraumatic hernia repair system (tahrs) pilot study

Conditions: Hernia

Summary: the purpose of this study is to capture preliminary clinical safety and performance on the tahrs


Eligibility criteria:
key inclusion criteria: 1. subject is 18 years old or older; 2. patient willing and able to provide a signed patient informed consent form; 3. has a midline primary ventral, umbilical or incisional hernia; 4. scheduled for a laparoscopic ipom hernia repair; 5. hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect key exclusion criteria: 1. patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures); 2. bmi \> 40; 3. patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day; 4. patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent; 5. patient is pregnant, plans to become pregnant during the study period, or is breastfeeding; 6. patient with type 1 or uncontrolled type 2 diabetes mellitus; 7. patient has more than one hernia defect (to be confirmed intraoperatively);
study comparing tetrathiomolybdate vs standard treatment in primary biliary cirrhosis

Conditions: Primary Biliary Cirrhosis

Summary: the university of michigan is conducting a study investigating a potential new treatment aimed at slowing/halting progression of primary biliary cirrhosis. this will be a 2 arm double blind study in which half of the patients will be randomly selected to receive a placebo (capsule with no active ingredient) and half will receive the new treatment drug, tetrathiomolybdate. neither the patient nor the treating physician will know which arm the patient is in. the length of the study for each patient is 24 months of drug therapy. lab draws will be necessary weekly for the first 6 weeks of the study, followed by every other week for 3 weeks, and then monthly for the remainder of the 2 year period. in addition, intermittent history and physicals and urine samples will also be necessary. there is no cost to you for any experimental treatment. all patients in both arms will continue on ursodiol and receive standard of care treatment


Eligibility criteria:
inclusion criteria: * generally medically healthy * age 18 and older * documented primary biliary cirrhosis * alkaline phosphatase \> 137 exclusion criteria: * severe liver decompensation * requirement for renal dialysis * pregnancy or nursing * meld score \> 15 (13-15 will require a physician's clinical judgment) * uncontrolled congestive heart failure * severe diabetic neuropathy * severe pulmonary disease * advanced cancer * requirement for steroid therapy * uncontrolled ascites, variceal hemorrhage or spontaneous bacterial peritonitis * pregnant or nursing

Keywords: copper ceruloplasmin tetrathiomolybdate
penetrating abdominal injuries from the battle of mosul

Conditions: Penetrating Abdominal Trauma; War Injury

Summary: the battle of mosul was characterized by the use of improvised explosive devices, human shields and suicide bombers in an urban setting. it is unclear whether this type of warfare cause more extensive abdominal injuries to civilians than combatants. all patients admitted with penetrating abdominal injury subjected to an exploratory laparotomy at emergency hospital, erbil, between october 17, 2016 and july 16, 2017 will be included. differences in demographics, injury mechanism, time since injury, clinical status on arrival, intraoperative findings, postoperative complications and outcome will be studied.

study rationale the battle of mosul was characterized by the use of improvised explosive devices, human shields and suicide bombers in an urban setting. it is unclear whether this type of warfare cause more extensive abdominal injuries to civilians than combatants. understanding of the correlation between the severity of abdominal injuries, type of warfare and population affected is of importance when planning for surgical care in a conflict setting. aim to assess whether civilians obtain more extensive abdominal injuries than combatants in an urban battle characterized by the use of indiscriminate weapons. study design an observational retrospective cohort study with longitudinal data collection. all patients admitted with penetrating abdominal injury subjected to an exploratory laparotomy at emergency hospital, erbil, between october 17, 2016 and july 16, 2017 will be included. differences in demographics, injury mechanism, time since injury, clinical status on arrival, intraoperative findings, postoperative complications and outcome will be analysed. primary objective differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants. secondary objectives differences in surgical treatment given, postoperative complications and outcome between patients with prior surgical treatment of their injury and patients without prior surgical treatment. differences in surgical treatment given, postoperative complications and outcome between patients who receive surgical treatment less than 24 hours from injury and patients who receive surgical treatment more than 24 hours from injury will be analysed. statistical methods differences between groups will be analysed using t-test and regression models.

Eligibility criteria:
inclusion criteria (all must be fulfilled): * penetrating abdominal injury * subjected to an exploratory laparotomy at emergency hospital, erbil, iraq * between october 17, 2016 and july 16, 2017 exclusion criteria (all must be fulfilled): * patients who received treatment several times will only be counted as one patient * between october 17, 2016 and july 16, 2017

Keywords: war injury penetrating abdominal trauma exploratory laparotomy improvised explosive device mosul
observational study to evaluate the effectiveness and safety study of the dexcom g4™ continuous glucose monitoring system

Conditions: Diabetes

Summary: the purpose of this study is to evaluate the effectiveness and safety of the dexcom g4 system when used as an adjuvant to blood glucose testing. device performance will be primarily evaluated in terms of the proportion of glucose values within a pre-specified range compared to reference values. safety data of the g4 system will also be collected vis-a-vis adverse event reporting characterized by the incidence and severity of serious adverse device events, and adverse device events experienced by study participants.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older; 2. have been diagnosed with insulin-requiring diabetes 3. abstain from injecting insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear; 4. insert sensors on their own and wear 2 systems simultaneously; 5. use only the blood glucose meter provided for all blood glucose measurements performed during sensor wear and not allow others to use this meter during the study; 6. participate in one in-clinic session comprising of fingersticks per hour and have blood draws for the entire in-clinic session; 7. have an intravenous catheter inserted for 4 blood draws per hour 8. willing to perform smbg during home use with the meter provided; 9. refrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion; 10. speak, read, and write english; 11. willing and able to be compliant with provisions laid out in this protocol. exclusion criteria: 1. have extensive skin changes/diseases that preclude wearing devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites; 2. allergy to medical-grade adhesives; 3. pregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion, 4. dialysis treatment; 5. hematocrit that is outside the range of 30-55% at screening visit;
the effect of liposomal bupivacaine on post operative pain and narcotic use after bariatric surgery

Conditions: Bariatric Surgery Candidate; Pain, Postoperative

Summary: this study is prospective, randomized trial in which the efficacy of liposomal bupivacaine (exparel®) is compared to standard bupivacaine local surgical site injection in reducing total iv and oral morphine equivalents required after laparoscopic bariatric surgery. liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the course of three days. having a long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5-hour half-life. in some studies, the use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery. this has not yet been studied in bariatric patients and the use of liposomal bupivacaine can potentially improve patient post-operative pain control, decrease narcotic use, decrease hospital length of stay and readmission rates and improve patient satisfaction after bariatric surgery.


Eligibility criteria:
inclusion criteria: * all patients undergoing elective laparoscopic sleeve gastrectomy or roux-en-y gastric bypass surgeries. * fulfills nih criteria for bariatric surgery exclusion criteria: * patients deemed not a candidate for laparoscopic bariatric surgery * patients with previous bariatric or gastric surgeries. * bmi \ 60 kg/m2 * preoperative inability to ambulate and confined to wheelchair. * american society of anesthesiologist (asa) score \>3 * concurrent ventral hernia repair or intraoperative extensive lysis of adhesions * not able to understand informed consent, or unwilling to sign consent. * not able to understand and read english * currently pregnant or lactating. * age \ 65 * patients intolerant of opiates, nsaids, acetaminophen or local anesthetics. * patients requiring opiate use within 30 days prior to time of surgery. * patients with reported use of narcotics greater than 2 weeks in preceding year before surgery. * patients with history of substance abuse, alcohol addiction * patients with diagnosis of chronic pain, history of fibromyalgia, chronic regional pain syndrome (dystrophic pain syndrome). * bupivacaine use within 96 hours before operation * prisoners * bariatric surgery operation \>3 hours. * more than 5 laparoscopic incision sites used during surgery, conversion to open operation, placement of a feeding tube or drain. * patients with renal failure or hepatic failure.

Keywords: anesthetics, local liposomal bupivacaine bupivacaine postoperative complications roux-en-y gastric bypass sleeve gastrectomy laparoscopic bariatric surgery
comparison of first sense breast exam® to the university of toledo mammography and biopsy results

Conditions: Breast Cancer

Summary: first sense medical®, llc is a medical device company developing a novel breast cancer screening tester called the first sense breast exam® tester. this radiation free tester is being developed to produce data which will be analyzed by therma-scan reference laboratory. when the tester is in production, a test will take approximately 7 minutes and will be performed in a doctor's office.

this study is designed to evaluate the first sense breast exam® test and the analysis by therma-scan. the first sense breast exam® test is an adjunct to a mammogram. currently, mammography is the standard of care in screening for breast cancer, and manual thermology is an adjunctive screening method. all of the study costs will be incurred by the sponsor and the subject will incur no costs to participate in the study. the first sense tester is a non-significant risk device where the tester's imaging camera makes no contact with the subjects during the entire procedure.

Eligibility criteria:
inclusion criteria: * female, over the age of 18 years of age. * asymptomatic women and women who are being screened for breast abnormality. * women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and fs/ts system. * not pregnant or breast feeding. * signed informed consent. exclusion criteria: * subject does not meet inclusion criteria, noted above. * use of niacin or niacin patch. * use of nitroglycerin. * subject experienced a fever of 102°f or higher within thirty-six (36) hours of the study. * patients with any prior breast surgery (implants, reduction, lumpectomy, mastectomy, mastopexy, reconstruction and incisional biopsies.). * history of breast cancer
using polyglycolic acid mesh prevents cerebrospinal fluid leakage

Conditions: Pituitary Tumor; Cerebrospinal Fluid Leakage

Summary: the papers propose a new method to prevent postoperative cerebrospinal fluid leakage. doctors use the absorbable polyglycolic acid (pga) and fibrin glue to repair in surgery, prevent cerebrospinal fluid leakage and reduce the necessity of postoperative lumbar drainage after surgery. this study will analyze the changes in cerebrospinal fluid leakage in patients with pituitary tumors and skull base tumors after surgery, and further understand the effectiveness of neoveil , as the basis for the development of new treatments.

neoveil, the main component, is polyglycolic acid (pga), which is a kind of absorbable material, and is made into a soft and tension non-woven material by special processing with good tissue compatibility and degradability. in the human body, its strength will gradually decrease due to hydrolysis, and will eventually be absorbed and metabolized. in the process of absorption, at first its strength is reduced, then the mass will gradually decrease, and it will be completely absorbed after about 15 weeks. at present, the united states, europe, australia, china and south korea have been marketed, it is applied to the spine , pituitary tumors , skull base tumors and aneurysm surgery,etc. inthe related field of neurosurgery in foreign countries. it can prevent the leakage of cerebrospinal fluid, and reduce the postoperative hospital stay and the probability of complications after surgery. there is a license from the tfda. in clinical, it can be used in the sutures of parts or fragile organs that do not need to be healed for a long time, such as the lung, liver, and digestive tract, by suture (thick slice and tube type) or adhesion (sheet) in the tissue, it can strengthen the compressive ability of the local tissue, prevent the suture thread from splitting the suture tissue, prevent the lung tissue from leaking, reduce the blood and fluid leakage from the surgical site, and reduce the postoperative hospital stay and after the operation the complication rate .

Eligibility criteria:
a. inclusion criteria 1. patients with primary or recurrent pituitary tumors require endoscopic nasal surgery. b. exclusion criteria 1. patients with pituitary gland tumors who do not receive surgical treatment. 2. patients with other brain tumors. 3. patients allergic to polyglycolic acid (pga). 4. patients who have had previous radiation therapy or chemotherapy.

Keywords: pituitary tumor endoscopic transnasal transsphenoidal csf leakage
transcranial direct current stimulation - tobacco use disorder

Conditions: Tobacco Use Disorder

Summary: this study aims to detect how transcranial direct current stimulation (tdcs) affects smokers' inhibitory control, craving and consumption of tobacco goods.

participating smokers are to receive anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex (rdlpfc) for 20 minutes on five consecutive days. neuropsychological tests on inhibitory control and interviews on smoking habits and craving will be applied before and after the first stimulation as well as after the fifth stimulation. after a follow-up period of three days, smoking behaviour will be assessed in a telephone interview. changes in inhibitory control and smoking behaviour will be compared between an active and a sham stimulation group.this way the effects of transcranial direct current stimulation on tobacco use disorder are to be clarified.

Eligibility criteria:
inclusion criteria: * tobacco use disorder * normal or correctable eyesight * sufficient ability to communicate with the investigators, to answer questions in oral and written form * fully informed consent * written informed consent exclusion criteria: * withdrawal of the declaration of consent * exclusion criteria for tdcs (metal implants in the head, acute eczema, known epilepsy) * severe internal, neurological or psychiatric comorbidity * pharmacotherapy with psychoactive substances within the last 14 days * axis-i disorder according to icd-10 and dsm 5 (except tobacco use disorder) * positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine) * pregnancy

Keywords: transcranial direct current stimulation