Kornimate/medical-research-clean huggingface dataset:
safety of ertapenem in beta-lactam allergic patients.

Conditions: IgE-Mediated Hypersensitivity; Allergy

Summary: the purpose of this study is to assess cross-reactivity and tolerability of ertapenem in patients with ige-mediated allergy to at least one beta-lactam molecule.

ertapenem is a new carbapenem, stable to dehydropeptidase which has a broad antibacterial activity. ertapenem exhibits a bactericidal mode of action and it has a long half-life of 4.5 hours; for this reason it can be developed as a single daily dose carbapenem. in literature, no cases of ige-mediated allergy to ertapenem have been described until now. however, a single study put in evidence a 47% rate of cross-reactivity between imipenem-cilastatin and beta-lactams in a group of patients affected by ige-mediated allergy to these drugs. for this reason carbapenem administration to beta-lactam allergic patients has always been considered potentially harmful. other studies reported lower cross-reactivity rates (from 7 to 11%) between imipenem-cilastatin and beta-lactams but patients of these studies did not undergo any allergy testing in order to demonstrate the pathogenesis of the reactions. recent studies put in evidence that imipenem has a very low cross-reactivity rate with other beta-lactams and they have a very good tolerability among patients with ige-mediated allergy to beta-lactams: romano et al. found a cross-reactivity rate of 0.9% between imipenem and penicillins in 112 penicillin-allergic patients (mean age 44.56 ± 15.66 ys.); atanasković-marković et al. found a cross-reactivity rate of 0.8% in 124 paediatric patients (age range 3-14 ys.) between imipenem and penicillins. in both groups imipenem was well tolerated by patients with negative allergy testing. meropenem showed to have a good tolerability too in penicillin allergic patients: romano et al. found a cross-reactivity rate of 0.9% between penicillins and meropenem in penicillin-allergic patients (mean age 47.83 ± 15.8); atanasković-marković et al. found a cross-reactivity rate of 0.8% in 109 paediatric patients (age range 3-14 ys.) between meropenem and penicillins. in both groups meropenem was well tolerated by patients with negative allergy testing. no data regarding the cross-reactivity of ertapenem with other beta-lactams and its tolerability among patients with ige-mediated allergy beta-lactams are available in literature. aim of the study on the basis of those data, we decided to investigate the cross-reactivity of ertapenem with other beta-lactams in patients suffering from ige-mediated allergy to at least one beta-lactam molecule and its tolerability in a group of a patients with negative allergy testing with ertapenem.

Eligibility criteria:
inclusion criteria: * ige-mediated allergy to at least one beta-lactam molecule exclusion criteria: * positive allergy testing to ertapenem * chronic diseases * treatment with beta-blockers * pregnancy

Keywords: ige-mediated allergy beta-lactams ertapenem cross-reactivity immediate-type skin tests intravenous tolerance tests
reletex versus standard of care therapy for post-operative nausea control in patients undergoing foregut surgery

Conditions: Nausea and Vomiting Post-foregut Surgery

Summary: the effect a reletextm device has on postoperative nausea and vomiting when used with ondansetron after foregut surgery will be studied. a reletextm device is a fda approved wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to decrease nausea and vomiting. the investigators will randomize 100 patients who are having a fundoplication for either gastroesophageal reflux disease (gerd), paraesophageal hernia, or heller myotomy for achalasia into two groups. a control group will receive scheduled ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan as needed. the treatment group will wear a reletextm wrist band after surgery for 7 days. these patients will also get scheduled ondansetron and phenergan as needed, like the control group. the investigators will compare nausea, retching, and the amount of supplemental nausea medication used between the two groups. the patients will be provided a diary to document their nausea, retching, and medication use. the hypothesis of this study is that use of the reletextm device will reduce post-operative nausea and vomiting, and will reduce post-operative use of anti-emetic medications in patients who have undergone foregut surgery.


Eligibility criteria:
inclusion criteria: * age 18-85 * planned fundoplication * willingness to comply with randomization and follow-up protocol * english speaking exclusion criteria: * \ 85 * chronic nausea requiring medical treatment * planned concomitant procedures * pacemaker or automatic internal cardiac defibrillator

Keywords: nausea vomiting post-operative foregut surgery
bilateral uterine artery ligation in reducing incidence of postpartum hemorrhage in cesarean section

Conditions: Post Partum Hemorrhage

Summary: the patients were recruited from women attending labor ward to undergo cesarean section.


Eligibility criteria:
inclusion criteria: * women with one or more of the following conditions undergoing cesarean section for obstetric indication were included: * maternal anemia (not less than 7 gm %). * macrosomic baby \>4kgs. * twin pregnancy and high order pregnancy. * polyhydramnios. * grand multipara. * previous history of atonic postpartum hemorrhage. * prolonged vaginal delivery. * emergency cesarean. * chorioamnionitis. exclusion criteria: * - placenta previa. * patients with bleeding tendency (congenital or acquired) * ante-partum hemorrhage. * patients with no risk for uterine atony.
a clinical study using autologous bone marrow stem cell for diabetes related vascular complications

Conditions: Peripheral Vascular Disease; Ischemia; Diabetic Foot

Summary: stem cell therapy has been a new and effective therapy in recent years for diabetic foot.this study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments. stem cell therapy has been a new and effective therapy in recent years for diabetic foot. combined with the previous studies of our research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 or type 1 * age between 18-80 years * chronic foot ulcer more than 6 weeks * no sufficient response to best standard care delivered for six weeks. * pad up to fontaine stage iii or iv period * cli with the ankle brachial index (index ankle-brachial, abi) \<0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, tcpo2) \<30mmhg exclusion criteria: * hba1c \>12% * hemoglobin \<10 mg/dl * creatinine clearance rate \<30ml/min * systemic bacterial, viral infections (mei du, hepatitis, cytomegalovirus infection, hiv, b19 infection, herpes virus infection) and sepsis * have accepted the treatment of stem cells or growth factors * have a history of malignant disease * pregnancy * mental illness history * abnormal coagulation function * allergic reaction * severe cardiac insufficiency (iii-iv nyha) * using vasoactive substances
analysis of adverse events in anesthesia using artificial intelligence

Conditions: Allergic Reaction

Summary: the interest of health databases in anesthesia is no longer to be demonstrated. the aim of this research was to develop a natural language processing approach to establish a classification of adverse events observed during the perioperative period and to facilitate their analysis: the main objective of the study was to identify what a "naïve" unsupervised model would discover based on adverse event (ae) descriptions. our second goal was to identify apparently unrelated events whose combination could favor the occurrence of an ae


Eligibility criteria:
inclusion criteria: * minors and adults having had an allergic reaction associated with care * having had an adverse event reported by an anesthetist between january 01, 2009 and june 30, 2020 exclusion criteria: - patient not meeting the inclusion criteria

Keywords: allergic reaction adverse events health database natural language processing
study in healthy volunteers to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of cs0159

Conditions: Primary Sclerosing Cholangitis (PSC)

Summary: the whole study includes 2 parts. both the sad study and mad study are randomized, double-blinded, and placebo-controlled studies, conducted in healthy subjects, to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics profiles of cs0159. the sad part also involves a pilot food effect (fe) study, designed to assess the food effect on single-dose pk profile in healthy subjects.

a total of 48 healthy subjects will be allocated to 1 of 6 cohorts (cohort a1\~a6) in the sad study, each cohort including 8 subjects (6 subjects will receive investigational new drug (ind) product and 2 receive placebo). each subject in fasted state will be randomly assigned to receive a single oral dose of cs0159 or placebo.to ensure the safety for all sad cohorts (including a3 in both treatment periods). the mad study will enroll 32 healthy subjects, allocated to 1 of 4 cohorts (cohort b1\~b4) and each cohort including 8 participants (6 subjects will receive ind products and 2 receive placebo). subjects will be randomly assigned to orally receive the ind product or placebo.

Eligibility criteria:
inclusion criteria: 1. healthy male and non-pregnant female volunteers 2. in good health, determined by having no clinically significant findings from medical history, physical examination, 12-lead ecg, vital signs measurements, and clinical laboratory evaluations exclusion criteria: 1. subjects with special dietary requirements and cannot follow a uniform diet. 2. pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial. 3. any subject with sars-cov-2 infection, based on a positive polymerase chain reaction for sars-cov-2. 4. history or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.
the 24 hour effects of remedial exercises with and without compression therapy on breast cancer-related lymphedema

Conditions: Lymphedema, Breast Cancer

Summary: the aim of this study to investigate 24 hours of effects of remedial exercises with and without compression therapy on severity of lymphedema and symptoms of the lymphedema the present study is designed as a non-drug clinical trial. the patients will complete two remedial exercise sessions, one without and one with compression in a randomized order separated by a 3-day wash-out period.the main questions it aims to answer are 1. the 24 hour effects of remedial exercises with and without compression therapy on the severity of lymphedema are different in individuals with lymphedema associated with breast cancer surgery. 2. the 24 hour effects of remedial exercises with and without compression therapy on the symptoms of lymphedema are different in individuals with lymphedema associated with breast cancer surgery.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of unilateral arm lymphedema related to breast cancer disease- age between 18 and 75 years * 2 cm or greater difference between the affected and unaffected arms in women with breast cancer related lymphedema * at least 12 months after breast cancer surgery end exclusion criteria: * current recurrence of breast cancer * bilateral involvement * active infection * presence of metastases * diabetes mellitus * hypertension * pre-existing neuromusculoskeletal and neurological conditions * edema due to other reasons (e.g., primary lymphedema, lung and heart diseases)

Keywords: compression therapy lymphedema exercise
characterization of the microbiome in cutaneous t cell lymphoma

Conditions: Cutaneous T Cell Lymphoma

Summary: investigators plan to perform a pilot study that aims to characterize the microbiome of human cutaneous t cell lymphoma patients and compare this to the microbiome of age and sex matched controls.


Eligibility criteria:
inclusion criteria: * group 1: patients with stage ia-iia cutaneous t cell lymphoma * group 2: patients with stage iib and above cutaneous t cell lymphoma * group 3: patients with cd30+ lymphoproliferative disorder including lymphomatoid papulosis and cutaneous anaplastic large cell lymphoma * group 4: patients with plaque psoriasis with bsa\>5% on routine phototherapy per standard of care * group 5: patients with moderate to severe atopic dermatitis on routine bleach bath therapy per standard of care * group 6: healthy individuals without the above skin conditions, similar age and sex distribution to the patients with cutaneous t cell lymphoma * all groups: subjects who are age 18-89 years of age at time of enrollment * all groups: subjects who are able and willing to give informed consent for this study and the dermatology tissue acquisition and biorepository (stu00009443). exclusion criteria: * all groups: subjects who are younger than 18 years of age or older than 90 years of age * all groups: subjects who are unable to give consent * patients currently on systemic antibiotics or recent (within past 4 weeks) exposure to systemic antibiotics * we will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.
effects of transcranial direct current stimulation (tdcs) on neuropathic symptoms following burn injury

Conditions: Burn Injury; Chronic Pain; Pruritus; Itching

Summary: the purpose of this study is to see the effects of transcranial direct current stimulation (tdcs) on the pain and itching associated with burn injury. this study is part of the boston-harvard burn model system. the investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after initial course of stimulation. the subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation. if a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.


Eligibility criteria:
inclusion criteria: * providing informed consent to participate in the study * age 18 or older * burn injury with pain and/or itch that is moderate to severe * burn injury occurring at least 3 weeks prior to enrollment exclusion criteria: * subjects with burns in scalp in the area of electrode placement * psychiatric disorders that have led to hospitalization within the past 6 months or signs of suicidality * learning disorders that may prevent patient's ability to complete assessments * unstable conditions preventing travel to study site * current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tdcs treatment: carbamazepine, oxcarbazepine, phenytoin * contraindications to tdcs including implanted metal plates in the head or implanted brain medical devices * pregnancy at time of enrollment * history of other neurological conditions associated with structural anatomical changes (i.e. stroke, brain injury, parkinson's)

Keywords: transcranial stimulation direct current
intraventricular administration of intracranial infections caused by （carbapenem-resistant gram-negative bacilli）crgnb

Conditions: Intracranial Infections

Summary: this clinical trial aims to compare two methods of administering polymyxin b for treating severe brain infections caused by carbapenem-resistant gram-negative bacteria (crgnb). the two methods are: 1) delivering polymyxin b directly into the brain (intracranial administration) and 2) combining this with an intravenous (iv) infusion. the goal is to determine which approach is more effective in clearing the infection, improving patient outcomes, and influencing the concentration of polymyxin b in the cerebrospinal fluid (csf). participants in this study will be monitored for both effectiveness and safety, with a focus on csf polymyxin b levels, to find the best treatment strategy for these challenging infections.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, regardless of gender. 2. patients with cerebrospinal fluid (csf) cultures showing carbapenem-resistant gram-negative bacteria (such as klebsiella pneumoniae, acinetobacter baumannii, pseudomonas aeruginosa) and polymyxin mic ≤ 0.5 µg/ml. 3. diagnosed with intracranial infection and have been receiving polymyxin b treatment for at least 5 days, with an external ventricular drain (evd) in place for continuous drainage. exclusion criteria: 1. patients with known allergy to polymyxin b or other severe allergic histories that may affect the study. 2. pregnant women or other conditions that the investigator deems unsuitable for participation in the study.

Keywords: polymyxin b intracranial administration carbapenem-resistant gram-negative bacteria intracranial infection
study of endoscopic versus open surgery for urinary reflux

Conditions: Vesicoureteral Reflux

Summary: this study seeks to compare outcomes after anti-reflux surgery (ars) for correction of low-grade vesicoureteral reflux (vur). it is a randomized controlled open-label trial of conventional open anti-reflux technique versus endoscopic anti-reflux technique with injection of dextranomer/hyaluronic acid copolymer (deflux). primary endpoint will be resolution of vur at initial cystogram after ars. secondary outcomes will include incidence of postoperative uti, resolution of vur at 1-year cystogram after ars, surgical complications, and quality of life measures after ars.


Eligibility criteria:
inclusion criteria: * age \<12 years * unilateral or bilateral primary vur * grade 2 or 3 (vcug) or grade 2 (rnc) vur in at least 1 ureter * recommended for surgical correction of vur by urologist exclusion criteria: * grade 4 or 5 (vcug) or grade 3 (rnc) vur * secondary vur (neurogenic bladder, exstrophy, or other causes of secondary vur) * ureterocele * periureteral diverticulum * complete duplication of duplex collecting system on side with vur * prior ars, either open or endoscopic, regardless of success or failure * history of other prior urinary tract surgery other than circumcision * solitary functional kidney * congenital or acquired immunodeficiency * chronic renal insufficiency or renal failure
simplifying treatment and monitoring for hiv (stream hiv)

Conditions: HIV/AIDS; HIV-1-infection

Summary: this study seeks to determine the clinical efficacy and cost effectiveness of implementing an integrated model for hiv monitoring using point of care (poc) tenofovir (tfv) adherence testing and poc viral load (vl) monitoring in improving art adherence, maintaining durable vl suppression, and improving retention in care among hiv-positive individuals initiating first-line tenofovir disoproxil fumarate (tdf)-based art in south africa.

this study will be a two-arm, open-label, randomized controlled superiority trial at an hiv clinic in durban. hiv-positive individuals aged 16 years and above, who are initiating a tenofovir-based, first-line art will be randomized to receive poc vl testing and poc tfv adherence testing, versus standard-of-care (soc) viral load testing. the schedule for vl testing and management of vl test results will follow south african guidelines for hiv vl testing after art initiation. 540 participants will be randomized (1:1) at art initiation into the intervention arm (routine poc tfv adherence testing with poc vl monitoring) or the standard-of-care (soc) arm (no objective tfv adherence testing and soc vl monitoring). participants will be followed to compare concentrations between study arms at 24 weeks after art initiation and a composite outcome of vl suppression and retention in care between the study arms at 72 weeks after art initiation. the study will use process evaluation data, interviews and focus groups with patients and staff to assess implementation of the poc assays. micro-costing will be conducted to estimate intervention costs.

Eligibility criteria:
inclusion criteria: * hiv-positive * ≥16 years old * initiating a tdf-based, first-line art regimen * do not self-report being on an art regimen in the prior month * willing/able to provide written informed consent exclusion criteria: * does not plan to continue receiving hiv care at the cdc clinic * per the decision or opinion of the pi (for example, a clinically significant acute or chronic medical condition or circumstances that would make the patient unsuitable for participation or jeopardize the safety or rights of the participant

Keywords: point-of-care test tenofovir adherence hiv viral load
18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography (18-fdg tep-ct ) in the diagnosis of the degeneration of intraductal papillary mucinous tumor of the pancreas

Conditions: Tumor

Summary: the aim of the study is to evaluate whether the tep-ct can be sensitive and specific in identifying degenerated intraductal papillary mucinous tumor of the pancreas.the results will be compared to those obtained by the pathological analysis of the removed piece of pancreas.

before surgery is undertaken, a 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography (18-fdg tep-ct ) will be performed. the primary outcome of this study is to compare results of the tep-ct with those obtained by the pathological analysis of the removed piece of pancreas.

Eligibility criteria:
inclusion criteria: * adults with age equal or above 18 * patients diagnosed with intraductal papillary mucinous tumor with surgical indication and for whom it will be possible to have the pathological analysis of the removed piece of pancreas. * if woman being of childbearing potential, woman taking contraceptive measures * patient able to understand benefits and risks of protocol * subject affiliated to french health insurance (social security) * informed consent form signed exclusion criteria: * patients not fulfilling inclusion criteria * pancreatic surgery or radiotherapy in the pancreatic zone within 4 the months preceding the tep-ct * chemotherapy within 2 the months preceding the tep-ct * acute pancreatitis within 2 the months preceding the tep-ct * pregnant women or breast-feeding women refusing to temporary stop it * diabetes not equilibrated (checked by glycemia and glycosylated hemoglobin (hba1c) at inclusion) or fasting blood glucose below 7mmol/l (126 g/l before the tep) * patients with claustrophobia * patients not accepted under the anesthesia point of view

Keywords: 18 fluoro deoxy glucose positrons emission tomography combined with computed tomography, patients with intraductal papillary mucinous tumor of the pancreas intraductal papillary mucinous pancreas