Kornimate/medical-research-clean huggingface dataset:
effect of perioperative intravenous lidocaine on postoperative quality of recovery in patients undergoing spine surgery

Conditions: Pain

Summary: acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the patient. the investigators seek to determine if the addition of systemic lidocaine can improve the quality of recovery after spine surgery and reduce the requirement for opiate therapy.

consented patients will be randomized to either saline group or lidocaine group. general anesthesia will be induced as it would normally be done in any patient undergoing spine surgery. once the patient is positioned for the surgery bolus followed by the infusion of either the study drug or the placebo will be administered. the infusion will be stopped at the end of surgery and the patient will be transferred to the post anesthesia care unit. post operative pain score will be evaluated for the first 24 hrs and also the amount of pain medications used will be recorded. at the end of 24 hours quality of recovery will be assessed using a qor-40 questionnaire.

Eligibility criteria:
inclusion criteria: 1. patients age 18-80 yrs; 2. american society of anesthesiology physical status i, ii or iii; and 3. patients undergoing thoracic or lumbosacral spine surgeries with or without instrumentation via the posterior approach with planned admission to the post anesthesia care unit after surgery- exclusion criteria: 1. allergy to any of the study medications or anesthetic agents used in the study; 2. american society of anesthesiology physical status iv; 3. spine surgery with the expected duration of surgery being more than 4 hours as determined by the attending surgeon; 4. history of severe hepatic dysfunction with liver enzymes elevated to more than 3 times the normal or international normalized ratio of more than 2 and renal dysfunction with gfr less than 60 ml/min 5. history of previous spinal fusion or instrumentation; 6. diagnosis of cancer of the spine; 7. history of surgery for abscess or osteomyelitis; 8. history of cardiac dysrhythmia or heart block; 9. history of chronic heroin or methadone use; 10. preoperative use of any systemic corticosteroid; 11. history of seizure disorder; and 12. patient inability to properly describe postoperative pain to investigators (dementia, delirium, psychiatric disorder).

Keywords: quality of recovery spine surgery intravenous lidocaine
use of the napoleon to improve polyp measurement in gastroenterology fellows

Conditions: Colonic Polyp

Summary: this is a clinical trial assessing gastroenterology fellows' accuracy of colonic polyp measurement using a micro-tech endoscopic polyp measurement device named napoleon. the study will evaluate the feasibility of napoleon as a polyp measurement device. investigators will collect data on inpatient and outpatient colonoscopies performed by fellows at nyu langone health, nyu langone hospital brooklyn, bellevue hospital center, and manhattan va medical center from may 2021 - may 2022 for 150 patients. investigators will include all colonoscopies with polyps done in adults age 45 and above. for each colonoscopy, a fellow will first visually estimate the polyp size and then measure the polyp with napoleon. investigators will calculate the difference in polyp measurement between visual assessment and using napoleon for each fellow year and compare differences among fellow years. investigators will evaluate for changes in fellows' accuracy of polyp measurement with subsequent uses of napoleon. investigators will determine the proportion of cases with a change in the recommended surveillance interval based on polyp size. a survey will be given to all fellows to assess the level of ease with using napoleon.


Eligibility criteria:
patients: inclusion criteria: 1. adult age 45 and above 2. undergoing a colonoscopy performed by a gastroenterology fellow 3. willingness and ability to provide informed consent exclusion criteria: 1. history of not tolerating prior colonoscopies well or difficult colonoscopies (e.g. high sedative requirement) 2. undergoing a diagnostic colonoscopy for inflammatory bowel disease or other known inflammatory/infectious process an individual who meets any of the following criteria during the colonoscopy will be excluded from participation in this study: 1. colonoscopy without polyps 2. polyps not removed in entirety 3. polyps with indeterminate size an individual who meets any of the following criteria after the colonoscopy will be excluded from participation in this study: 1. hyperplastic or non-adenomatous polyps on pathology report fellows inclusion criteria: 1. nyu gastroenterology fellow 2. willingness and ability to provide informed consent exclusion criteria: 1. not deemed to be medically trained and ready to perform a colonoscopy by supervising gastroenterology attending
study to assess the safety & reactogenicity of gsk biologicals' dtpa/hib vaccine when given at 3, 4 and 5 months of age

Conditions: Tetanus; Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria

Summary: this study will evaluate the safety and reactogenicity of gsk biologicals' diphtheria tetanus acellular pertussis/haemophilus influenzae type b vaccine given to chinese infants at 3, 4 and 5 months of age.


Eligibility criteria:
inclusion criteria: * a male or female between, and including, 90 and 120 days of age at the time of the first vaccination written informed consent obtained from the parent or guardian of the subject exclusion criteria: * subjects with known exposure to diphtheria, tetanus, pertussis and/or haemophilus influenzae disease can not participate, subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or haemophilus influenzae type b (hib) diseases can not participate.
combination study of deferasirox and erythropoietin in patients with low- and int-1-risk myelodysplastic syndrome.

Conditions: Low and Int 1-risk Myelodysplastic Syndrome

Summary: the primary purpose of this trial was is to assess the effect of treatment with deferasirox combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with low- and int-1-risk myelodysplastic syndrome. the addition of deferasirox to erythropoietin can lead to a potential synergism with the reduction of reactive oxygen species, through both the nf-kb pathway and the control of free toxic iron. this may create a better environment in the bone marrow for a better response with erythropoietin. this study was designed to test in a prospective way the combination of deferasirox with erythropoietin in terms of their effect on hematopoiesis.

this study did not meet the original enrollment objective of 60 patients and was terminated without extending enrollment past original planned lpfv of 31-oct-2016.

Eligibility criteria:
key inclusion criteria: * patients who had low- and int-1-risk myelodysplastic syndrome * documented diagnosis of the following: myelodysplastic syndrome that lasted ≥ 3 months and \< 3 years disease must not have been secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases * a hemoglobin \< 10 g/dl and ≥ 8 g/dl * history of transfusions \< 10 rbc units and must not have been rbc transfusion dependent * 300 ng/ml \< serum ferritin \< 1,500 ng/ml (values within 10% difference above 1500 ng/ml or 10% difference below 300 ng/ml could have been accepted at the investigator's discretion. * endogenous erythropoietin levels \< 500 units/l * serum creatinine ≤ 1.5 times upper limit of normal (uln) * creatinine clearance above the concentration limit in locally approved prescribing information (pi). patients with creatinine clearance between 40 and less than 60 ml/min, who did not present with additional risk factors that might impair renal function, were eligible at the discretion of the investigator key exclusion criteria: * patients who had mds with isolated del(5q) * patients who had received prior epo treatment or other recombinant growth factors regardless of the outcome (patient who had received prior epo treatment or other recombinant growth factors for less than 4 weeks and not within 3 months before screening without a documented response are allowed) * patients who had received steroids or immunosuppressive therapy for the improvement of hematological parameters (stable steroid treatment for adrenal failure or chronic medical conditions, and intermittent dexamethasone as antiemetics were allowed). * b12 and folate deficient patients with and without clinical symptoms (patients were rescreened after successful therapy of b12 and folate deficiency) * uncontrolled seizures or uncontrolled hypertension

Keywords: myelodysplastic syndrome mds myelodysplasia blood disorder cytopenias low blood counts progressive bone marrow failure adult icl570 deferasirox erythropoietin erythropoiesis nf-kb pathway hematopoiesis.
smarttarget: biopsy

Conditions: Prostatic Neoplasms; Diagnostic Techniques and Procedures

Summary: the purpose of this study is to determine how well smarttarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer. the diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the disease location. transperineal mapping biopsies overcome this by systematically samples the entire gland but are very intensive and time consuming to perform. an alternative method is to perform targeted prostate biopsies where an mri prior to biopsy can be used to inform doctors about the location of the disease. this is a difficult procedure to perform as it requires the surgeon to mentally translate the location of disease on mri image to the live ultrasound seen in theatre. smarttarget may help this procedure by providing guidance to the location of the disease by fusing the mri image onto the live ultrasound, thereby providing the clinician a target to biopsy. this trial will compare the outcomes of "visually directed biopsies" with those directed by smarttarget


Eligibility criteria:
inclusion criteria: * previous trus biopsy with clinical indication for repeat biopsy * discrete lesion on mpmri scoring 3, 4 or 5 on pi-rads scale * an understanding of the english language sufficient to understand written and verbal information about the trial and consent process * signed informed consent exclusion criteria: * men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months * men with an irreversible coagulopathy predisposing to bleeding * men who are unability to undergo transrectal ultrasonography * men who have had previous radiation therapy to the pelvis * men who have had hifu, cryosurgery, thermal, irreversible electroporation, photodynamic, photothermal therapy, or microwave therapy to the prostate. transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality is permitted * men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging * men who are unable to give informed consent

Keywords: prostatic neoplasms diagnostic techniques and procedures magnetic resonance imaging ultrasonography biopsy image fusion
a trial investigating the pharmacokinetic and pharmacodynamic properties of fiasp in geriatric and younger adult subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body)properties of fiasp (faster-acting insulin aspart) in geriatric and younger adult subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * male or female aged 18-35 years (both inclusive) (younger adult group) or below or equal to 65 years (geriatric group) at the time of signing informed consent * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index (bmi) 18.5-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) * not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
thromboprophylaxis for patients in icu with covid-19

Conditions: Covid19; Anticoagulant Therapy; Thrombosis

Summary: the respiratory distress that goes with covid-19 infection has been related to a procoagulant state, with thrombosis at both venous and arterial levels, that determines hypoxia and tissue dysfunction at several organs. the main sign of this thrombotic activity seems to be the d-dimers, that have been proposed to identify patients with poor prognosis at an early stage. knowledge on how to prevent or even treat this procoagulant state is scarce. covid-19 patients may be out of general thromboprophylaxis recommendations, and recent studies suggest a better prognosis in severe covid-19 patients receiving anticoagulant therapy with low molecular weight heparin (lmwh). however, the lmwh efficacy and safety, mainly in patients admitted to an intensive care unit, remains to be validated.

many reports have postulated a procoagulant state along with the respiratory distress caused by coronavirus sars-cov2. a complex physiopathology has been proposed trying to explain this profile, mainly based on the thromboinflammatory concept, with thrombosis at both venous and arterial levels. microvascular thrombi impair the blood flow all over the body, with a vascular shunt due to capillary obstruction, that determines hypoxia and tissue dysfunction at several organs, being the lung the more affected one. although d-dimers (dd) are not specific indicators of clot formation, its elevation, in combination with other parameters (hyperfibrinogenemia, mild thrombocytopenia) may suggest a systemic coagulation activation with an increase of thrombin generation and fibrinolysis. in fact, in a retrospective chinese analysis, a dd higher than 1000 ng/ml was proposed to identify patients with poor prognosis at an early stage. nevertheless, knowledge on how to prevent or even treat this procoagulant state is scarce. thromboprophylaxis with low molecular-weight heparin (lmwh) is recommended in most medical patients admitted to the hospital and in nearly all patients in an intensive care unit (icu). but covid-19 patients may be out of these recommendations, and some treatment schemes has been proposed, although how to decide the suitable lmwh for each clinical situation is controversial. recent retrospective studies suggest a better prognosis in severe covid-19 patients receiving anticoagulant therapy with lmwh. however, the lmwh efficacy and safety, mainly in covid-19 patients admitted to the icu, remains to be validated.

Eligibility criteria:
inclusion criteria: * confirmed sars-cov2 infection from a respiratory tract sample using a polymerase chain reaction assay. * admitted to icu exclusion criteria: * non-confirmed sars-cov2 infection * no data at first day icu admission * patient with do-not resuscitate orders * patient who did not meet the outcomes of death or icu discharge by the time of study completion date

Keywords: covid19 low molecular weight heparin thromboprophylaxis anticoagulant treatment thrombosis
a study to investigate the long-term safety of zx008 (fenfluramine hydrochloride) oral solution in children and adults with epileptic encephalopathy including dravet syndrome and lennox-gastaut syndrome

Conditions: Dravet Syndrome; Lennox Gastaut Syndrome; Epileptic Encephalopathy

Summary: this is an international, multicenter, open-label, long-term safety study of zx008 in subjects with dravet syndrome, lennox-gastaut syndrome or epileptic encephalopathy

this is an international, multicenter, open-label, long-term safety study of zx008 in patients with epileptic encephalopathy, including dravet syndrome or lennox-gastaut syndrome. subjects eligible for participation are those with dravet syndrome who are currently enrolled in study zx008-1503, or those with lennox-gastaut syndrome who have successfully completed study zx008-1601-part 2, and are candidates for continued treatment with zx008 for an extended period of time, or those with dravet syndrome, lennox-gastaut syndrome, or another epileptic encephalopathy who have completed participation in another zogenix-sponsored study and have been invited to participate in this study.

Eligibility criteria:
inclusion criteria: * male or nonpregnant, nonlactating female * satisfactory completion of a core study * has a rare seizure disorder, such as epileptic encephalopathy and has successfully completed another zogenix-sponsored clinical trials with zx008 * subject's caregiver is willing and able to be compliant with study procedures, visit schedule and study drug accountability exclusion criteria: * current cardiac valvulopathy or pulmonary hypertension that is clinically significant * moderate or severe hepatic impairment * receiving monoamine oxidase inhibitors, serotonin agonists, serotonin antagonists, and serotonin reuptake inhibitors within 14 days of receiving zx008
robotic decompression of the pudendal nerve in pudendal neuralgia

Conditions: Robotic Decompression

Summary: primary purpose: show the pain improvement 3-month after robotic laparoscopic pudendal nerve decompression for pudendal neuralgia. primary outcomes: pain evaluated on a vas before surgery and 3-month after surgery or surveillance improvement is considered if pain decreased by at least 3/10 points on the vas. secondary purposes: * improvement of quality of life * study of mri performance to predict pudendal nerve entrapment topography * show the feasibility and safety of robotic pudendal nerve decompression


Eligibility criteria:
inclusion criteria: * age 18 - 70 years old * pudendal neuralgia according to nantes criteria * pudendal nerve entrapment reachable with robotic transperitoneal approach exclusion criteria: * bilateral pain * history of pain ≥ 18 months
a study of paclitaxel/carboplatin with or without cdp791 in patients with lung cancer

Conditions: Carcinoma; Non-Squamous Non-Small-Cell Lung Cancer

Summary: a 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour effects (part 2), of cdp791 combined with carboplatin and paclitaxel.

this is a two part study to investigate the safety and anti-tumour effects of standard chemotherapy, plus an investigational drug (cdp791), in patients with advanced non small cell lung cancer. in part one, patients receive carboplatin and paclitaxel chemotherapy together with one of 2 doses of cdp791. the main aim of this part is to investigate safety and tolerability of carboplatin/paclitaxel plus cdp791. if part one confirms that the combination of drugs is safe and well tolerated, 156 patients will enter part 2. they will be randomized to receive either carboplatin/paclitaxel (c/p) alone, or c/p plus one of 2 doses of cdp791. the main aim of this part of the study is to compare the anti-tumor effects of cdp791 plus c/t with those of c/t alone. participants will receive up to six cycles of chemotherapy with or without cdp791. those whose disease stabilizes, or responds, will be eligible to continue to receive cdp791. participants in the c/t alone arm whose disease progresses will be eligible to receive cdp791 monotherapy. participants will be followed up longterm, so that survival can be measured.

Eligibility criteria:
inclusion criteria: inclusion criteria: * male and female subjects with stage iiib (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), stage iv, or recurrent non-squamous, non-small-cell lung carcinoma. * the subject must be aged 18 years or above. * the subject must have ecog performance status of 0 or 1 and a life expectancy of at least three months. * subjects will have measurable disease. * the subject must be able to understand the information provided to them and to give written informed consent. * female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the investigator. * male subjects must be using a method of contraception judged reliable by the investigator. exclusion criteria: * subjects with squamous cell lung carcinoma. * subjects with lung lesions located centrally in the chest that involve major blood vessels. * concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. subjects with previous malignancies are eligible provided that they have been disease free for five years or more. * presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of screening visit, tuberculosis or epilepsy. * subjects known to be infected with hepatitis b or c virus or hiv 1 or 2. * any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent). exclusion criteria:

Keywords: non-small-cell-lung cancer carboplatin paclitaxel vegf monoclonal antibody
application value of ctcs detection for advanced gastric cancer patients

Conditions: Circulating Tumor Cells; Gastric Cancer

Summary: evaluating the application value of a new circulating tumor cell detection method for advanced gastric cancer patients in prediction of the prognosis and early evaluation of the result of postoperation adjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: subjects eligible for enrollment must meet all of the following criteria: 1. provide signed informed consent. the subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the independent ethic committee (iec)/institutional review board (irb) prior to the initiation of any study-specific procedures 2. men or women aged \>= 18 years and \<=75 years. 3. eastern cooperative oncology group performance status (ecog) \<= 2. 4. histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction. 5. metastatic disease or locally advanced disease not amenable to curative surgery. 6. radiographically assessable, non-measurable disease or measurable disease as per recist criteria. 7. life expectancy of at least 12 weeks with tumor and at least 5 years without tumor from the time of enrollment. 8. no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix. 9. no prior chemotherapy for advanced disease. - exclusion criteria: subjects meeting any of the following criteria must not be enrolled in the study: 1. gastric carcinoid, sarcomas, or squamous cell cancer. 2. pregnant or lactating females. 3. significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent. 4. active hepatitis b or c or history of an hiv infection. 5. active uncontrolled infection. -

Keywords: gastric cancer; circulating tumor cells; prognosis