Kornimate/medical-research-clean huggingface dataset:
neonatal spinal anesthesia: effects of the addition of clonidine

Conditions: Spinal Anesthesia; Neonates

Summary: this prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. this study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection.

ex premies and term neonates are two subgroups investigated separately. the overall objective is to validate lengthening of spinal anesthesia in newborns in order to avoid "rescue" general anesthesia that occur in 20-40 % of patients with plain bupivacaine.

Eligibility criteria:
inclusion criteria: * newborns less than 60 weeks old post-conceptional, former premature or not * newborns requiring inguinal hernia or lower limbs surgery, * infants needing no more critical care assistance * informed consent of parents exclusion criteria: * spinal malformation, * coagulopathy, * critical hemodynamics, * uncontrolled neurologic or metabolic pathology. * infection at injection point.

Keywords: spinal anesthesia neonates clonidine post operative apnea
handheld ecg tracking of in-hospital atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this is a single center, open label, randomized control trial to assess the efficacy of a one-lead ecg handheld device (zenicor) for the detection of previously unknown atrial fibrillation (af) in hospitalized patients. all patients admitted to the internal medicine department of the hospital fribourg throughout the study period will be screened for study enrollment. patients \< 18 years, with known or previously documented atrial fibrillation, patients with a cardiac pacemaker, and implantable cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the present trial. the study population will consist of approximately 800 patients in each group at the university of fribourg medical center. patients must meet all eligibility criteria for inclusion into the study. patients allocated to the treatment group will undergo twice daily monitoring with the handheld zenicor ecg. additional recordings will be obtained whenever patients notice palpitations. recordings will be obtained in the presence of specially trained nurses. the recordings will then be validated through a web-based interface offered by zenicor. the one-lead ecgs will be reviewed by the investigating physicians through the web-based analysis service (zenicor-ecg doctor system) to assess the presence of atrial fibrillation. the primary end point of the study is the percentage of newly detected atrial fibrillation at 6 months


Eligibility criteria:
inclusion criteria: * all patients admitted to the internal medicine department of the university and hospital fribourg throughout the study period will be screened for study enrollment. exclusion criteria: * patients with known or previously documented atrial fibrillation, patients with a cardiac pacemaker, and implantable cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the present trial.

Keywords: screening zenicor
18f-fapi-04 pet/ct and pet/mr in patients with various types of malignant tumors

Conditions: Cancer; FAP

Summary: to evaluate the potential usefulness of 18f-fapi-04 positron emission tomography/computed tomography (pet/ct) and positron emission tomography/magnetic resonance imaging （pet/mr）for the diagnosis of primary and metastatic lesions, detection of recurrence or assessment of pathologic response in various types of cancer.

subjects with various types of cancer underwent 18f-fapi-04 pet/ct and pet/mr imaging either for an initial assessment, recurrence detection or assessment of pathologic response. tumor uptake was quantified by the maximum standard uptake value (suvmax) and tumor to background (tbr). using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy of 18f-fapi-04 pet/ct and pet/mr were calculated.

Eligibility criteria:
inclusion criteria: patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include mri, ct, tumor markers and pathology report); patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the clinical research ethics committee. exclusion criteria: patients with non-malignant lesions; patients with pregnancy; the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
mri dwi none-gaussian model predicting early response to immunotherapy in digestive system malignancies: a prospective observational study

Conditions: Immunotherapy; Digestive System Neoplasm

Summary: this is a prospective two cohorts observational study aimed to investigate the predicting value of mri none-gaussian model in digestive malignancies patients who received single agent pd-1/pd-l1 inhibitor or combined immunotherapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years, ecog 0-1, expected survival ≥3 months; * pathologically confirmed digestive system adenocarcinoma, including but not restricted to gastric adenocarcinoma, colorectal cancer, pancreatic adenocarcinoma et al; * pathologically confirmed pd-l1 expression, or mmr-deficient (dmmr)/microsatellite instability (msi-h) or high tumor mutation burden (tmb-h) or other indication for immunotherapy; * at least one target lesion, if there is no target lesion the thickness of cavity viscera lesion should exceed 1cm; * patients will receive single agent pd-1/pd-l1 inhibitor, or combined immunotherapy such as: lenvatinib, enrotinib or herceptin; * screening laboratory values must meet the following criteria: hemoglobin ≥ 9.0 g/dl; neutrophils ≥ 1500 cells/ μl; platelets ≥ 100 x 10\^3/ μl; total bilirubin ≤ 2.0 x upper limit of normal (uln); aspartic transaminase (ast) and alanine transaminase (alt) ≤ 2.5 x uln without, and ≤ 5 x uln with hepatic metastasis; serum creatinine ≤1.5 x uln, and serum creatinine rate \>50μmol/l; activated partial thromboplastin time (aptt)、international normalized ratio (inr), prothrombin lime (pt)≤1.5×uln; * echocardiography: left ventricular ejection fraction≥50% * volunteer participate, signed written informed consent form. exclusion criteria: * claustrophobia or other contraindication for mri testing; * received prior anti-pd-1/pd-l1 or other immune checkpoint inhibitors; * combined immunotherapy contains chemotherapy agent; * contain other histology component except adenocarcinoma； * hypersensitivity after other monoclonal antibody infusion； * coexist other malignancy in last five years; * active autoimmune disease, or who received systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 2 weeks of first dose; * cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage; * obvious bleeding tendency or had ctcae≥3 grade； * subjects are eligible with clinically controlled and stable neurologic function ≥ 4 weeks, which is no evidence of cns disease progression; subjects with spinal cord compression and cancerous meningitis are not eligible； * vaccination within 28 days of the first administration of trial treatment.

Keywords: mri dwi digestive system malignancies early response
sepraspray™ laparoscopic myomectomy study

Conditions: Laparoscopic Myomectomy

Summary: the purpose of this research study is to obtain preliminary data of the safety and effectiveness of sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. we will compare treatment with sepraspray as a adhesion prevention barrier after laparoscopic myomectomy versus no adhesion barrier.


Eligibility criteria:
inclusion criteria: * the patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and sll. exclusion criteria: * pregnant/lactating women. * the patient has a history of hypersensitivity to exogenous carboxymethylcellulose products and/or hyaluronic acid. * the patient's procedure resulted in entry of the endometrial cavity, or entry of the bowel including appendectomy.
incidence of hypoglycemia in pregnant ladies with or without gestational diabetes fasting ramadan

Conditions: Pregnancy in Diabetic

Summary: the physiological change in food and sleep pattern during ramadan impacted hypoglycemia risks among pregnant women. few studies investigated the incidence of hypoglycemia pregnant women with or without diabetes during fasting in ramadan in saudi arabia. this study aims to understand the glucose variability in pregnant women during fasting ramadan in saudi arabia.

women with normal pregnancy will be compared to women with gestational diabetes on diet or metformin alone during fasting ramadan. they will be monitored and will be observed for incidence of hypoglycemia using continuous glucose monitoring devices.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old. 2. pregnant women without diabetes. 3. pregnant women with diabetes (pregestational and gestational) on diet +/- metformin. 4. dedicated to applying a continuous glucose monitoring (cgm) device. exclusion criteria: 1. age below18 years 2. pregnant women with diabetes on insulin (type 1 and type 2 diabetes) 3. renal and liver impairment. 4. adrenal insufficiency 5. psychiatric diseases.

Keywords: pregnant, gestational diabetes, fasting
circulating micrornas as biomarkers of sepsis

Conditions: Sepsis

Summary: microrna has been demonstrated to play a crucial role in regulating cell processes. recently, microrna was identified to exist in human serum or plasma, and it might be related to certain diseases. several micrornas are involved in sepsis, such as mir-146, mir-155, and so on. but whether serum mir-146 is present in serum of septic patients remains unknown. the present study was designed to identify the existence of specific micrornas, which might be new markers for sepsis and its prognosis.


Eligibility criteria:
inclusion criteria: * patients who develop sepsis and undergo abdominal surgery * patients who develop sirs after cardiac surgery with cardiopulmonary bypass exclusion criteria: * patients with a primary diagnosis of acute pancreatitis * patients with cirrhosis or renal dysfunction * patients with dyscrasia * patients with autoimmunity diseases * patients with severe cardiac and pulmonary diseases * patients with hematological diseases * patients who had organ dysfunction after cardiac surgery with cardiopulmonary bypass

Keywords: sepsis microrna
a phase ii study of radiation therapy, paclitaxel poliglumex, and carboplatin in stage iii non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the treatment of unresectable stage iii non-small cell lung cancer along with radiation therapy in a multi-institutional trial. consolidation chemotherapy with paclitaxel poliglumex and carboplatin will follow the completion of chemoradiation.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented nsclc, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas). * eligible disease stages: inoperable iiia and selected iiib * local radiation oncologist must approve patient eligibility prior to entry on study. * patients must have measurable disease. * prior therapy: * ≥ 2 weeks since formal exploratory thoracotomy. * no prior chemotherapy or radiation therapy for nsclc. * ecog performance status 0-1 * required initial laboratory values (must be submitted within 16 days prior to registration): * granulocytes ≥ 1,500/µl * platelets ≥ 100,000/µl * calculated creatinine clearance ≥ 20 cc/min * bilirubin \< 1.5 mg/dl * ast (sgot) \< 2 x uln * inr \> 0.8 \ 2.0 \< 3.0. exclusion criteria: * currently active second malignancy other than non-melanoma skin cancers. patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse. * pregnant or nursing because of significant risk to the fetus/infant. * age \<18 years. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * no hiv-positive patients receiving combination anti-retroviral therapy. because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy * one-second forced expiratory volume (fev1) \<50% or hemoglobin-corrected carbon monoxide diffusion capacity (dlco) \<50% of predicted, as measured within 21 days of study entry * symptoms of esophageal dysfunction (dysphagia, odynophagia, or inability to swallow solid food) within 4 weeks prior to study randomization. patients must not require prophylactic placement of percutaneous enterogastrostomy (peg) tube or other non-oral nutritional supplement methods * weight loss of \> 10% in the past 3 months.
depot naltrexone treatment of opioid dependent parolees

Conditions: Opioid Dependence

Summary: this is an investigation involving the use of a long-acting, injectable form (depot) of naltrexone as a treatment for persons who have a history of opioid dependence, with up to 40 on parole/probation and 20 non-parolees. the test is a pilot study of up to 60 subjects treated with 6 months of depot naltrexone plus psychosocial treatment .

this is a two phase study. phase 1 is complete and phase 2 is not yet recruiting.

Eligibility criteria:
inclusion/exclusion criteria. to be eligible to participate, participants must: * sign an informed consent form; * be between the ages of 18 and 55; * have a diagnosis of opioid dependence according to dsm ivtr criteria; and * be in good general health as determined by complete physical examination and laboratory tests; * have been assigned to a probation/parole period of at least six months; (except those participants not on parole/probation, see note below); and * have a negative result for urinary opioids and must self report being at least 3 days opioid free. participants may have a diagnosis of alcohol dependence so long as they do not have severe alcohol dependence that requires medical supervision for alcohol withdrawal. participants with the following characteristics will be excluded from study participation: * current severe alcohol dependence that requires medical supervision for alcohol withdrawal; * current psychosis, dementia, mental retardation, or history of schizophrenia; * significant clinical abnormalities in hematology, chemistry, or urinalysis; * significant clinical cardiovascular, neurological, hepatic, renal, pulmonary, metabolic, endocrine, or gastrointestinal disorders; * female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using birth control (oral contraceptives, barrier (diaphragm or condom) plus spermicide, or levonorgestriel implant); * subjects who have taken an opioid antagonist within the prior 6 months; and * current diagnosis of chronic pain disorder.
prospective randomized study of brain protection during aortic arch replacement

Conditions: Aneurysm of Aortic Arch

Summary: the purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery.

the purpose of the clinical trial is to assess the best method of protecting the brain during long periods of circulatory arrest. the significance of this project will be to determine which method of brain protection (1) retrograde brain perfusion or (2) perfusion of the right subclavian artery with antegrade perfusion of the brain protects against brain injury after total arch replacement. thus reducing the risk of stroke or neurocognitive deficits in patients undergoing this critical surgical procedure.

Eligibility criteria:
inclusion criteria: * undergoing a total arch replacement * less than 75 years old exclusion criteria: * ef less than 35% * pt shows evidence of major illness e.g. severe hepatic disease, severe renal failure, active cancer or major infection * pt unable to complete preop neuro assessment * pt is unwilling or able to complete followup requirements * pt is already enrolled in other new device or drug protocols that have not completed the primary endpoint or that clinically interferes with study endpoint * pt is a female who is pregnant or lactating * pt has history of stroke
oral therapeutic education in stimulated parkinsonian patients

Conditions: Parkinson Disease; Oral Infection

Summary: the effect of periodontal disease on the general condition of patients remains today underestimated in parkinson's disease. the bucco-park project aims to carry out an exploratory study of oral therapeutic education on the clinical evolution and fate of the microbiota of patients undergoing brain stimulation surgery. during the study, patients will follow the standard care pathway alone or combined with an oral therapeutic education. biological samples will assess how the microbiota of these patients will be impacted. bucco-park aims to optimize the care of parkinson's patients by integrating oral care.

patients included will be randomized in one of both defined groups : experimental group, in which patients will receive an oral education or control group, in which patient only follow the traditional care pathway. patients will be included in the trial before surgery after medical examination and life quality and oral environment evaluations. oral therapeutic education for patients randomized in experimental group will be performed at inclusion, and 6, and 12 months after surgery. for all patients, an oral examination, an assessment of the quality of life and oral, fecal and blood samples will be carried out at inclusion, and 6 and 12 months after surgery.

Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease for whom deep brain stimulation surgery (indifferent target) has been indicated for their parkinson's disease * affiliated to a system of social security; * having at least 10 natural teeth (treated or not) * having received oral and written information on the protocol and having signed a consent to participate in this research. exclusion criteria: * pregnant or lactating women; * persons of legal age subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty; * patients who do not speak french (both written and spoken); * patients whose oral status is considered incompatible by the dental surgeon investigator with entry into the study (history of major maxillofacial surgery, presence of drugs that may cause gingival hypertrophy 2 or gingival bleeding 3).

Keywords: oral microbiota parkinson brain stimulation surgery oral therapeutic
the effect of an individualized education intervention on pain following inguinal hernia repair surgery

Conditions: Pain

Summary: pain after inguinal hernia repair surgery is common with more than 50% of patients reporting moderate to severe acute pain following surgery. analgesics are helpful in managing this pain but patients can be reluctant to take analgesics due to potential adverse effects such as nausea, vomiting or constipation. patients may also be concerned about addiction to analgesics or they may believe that experiencing moderate to severe pain after surgery is to be expected. the purpose of this study is to investigate the impact of an individualized education program regarding pain and management of adverse effects on pain after inguinal hernia repair surgery.

there is clear evidence that patients who have undergone ambulatory inguinal hernia (ihr) repair have significant pain following surgery. inguinal hernia repair has been identified as one of the most painful ambulatory surgery procedures, with 98% of patients reporting pain 24 hours following ihr surgery, and 54% of patients experiencing moderate to severe pain in the first 72 hours. despite experiencing continued pain, patients do not always take the prescribed analgesics. analgesics are helpful in managing post-operative pain but may have adverse effects, including nausea, vomiting or constipation, which are often not managed. almost half of all patients who undergo ambulatory surgery experience these adverse effects with 45% experiencing constipation and 46% experiencing nausea and/or vomiting in the first 48 hours after surgery. as well, patients may have concerns about addiction, or asking for help to manage their pain and may believe that moderate to severe pain is to be expected, contributes to healing and therefore is to be tolerated following surgery. patients are expected to manage this pain and adverse effects of analgesics at home. minimal research has been found regarding interventions to manage pain following ambulatory surgery, and none found specifically for patients undergoing inguinal hernia repair. the purpose of this trial is to investigate the impact of an individualized pre-operative pain education intervention that includes a booklet with telephone support pre-operatively and after discharge home versus usual care for patients having ihr surgery. the primary outcome will be worst pain on movement in the past 24 hours and the secondary outcomes will be pain related interference, pain quality, analgesic use and adverse effects, and patient satisfaction and concerns with pain management.

Eligibility criteria:
inclusion criteria: * male * able to speak, read and understand english, * have telephone access. * are scheduled for a unilateral inguinal hernia repair. exclusion criteria: * patients scheduled for a repeat ihr on the same surgical side * patients who have emergency surgery. * patients undergoing bilateral inguinal hernia repair.

Keywords: post-operative pain inguinal hernia repair surgery patient education
the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma

Conditions: Thyroid Cancer, Papillary

Summary: the aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma.

the aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma. primary outcome is the surgical completeness, recurrence rate, and successful ablation rate. secondary outcomes are the incidence of postoperative complications and ptc stage. the enrolled patients were randomly assigned to control group and intervention group (1:1 allocation).

Eligibility criteria:
inclusion criteria were as follows: 1. patients aged 20 to 70 years old 2. patients diagnosed with ptc or suspicious for ptc on fine needle aspiration or core needle biopsy 3. patients with no evidence of lnm before and during surgery(cn0) 4. patients with no evidence of distant metastasis(cm0). exclusion criteria were as follows: 1. patients suspected of advanced ptc(clinically t3 or t4) such as invasion of peripheral organs on preoperative examination 2. patients who have previous history of cervical radiation therapy or surgery. 3. pregnant women 4. uncontrolled diabetes, hypertension, or chronic renal failure 5. aspirin or anticoagulant medication within 7 days 6. other clinical trial participation within 30 days 7. radiation exposure to the head and neck 8. previous operation to the neck 9. advanced thyroid cancer including adjacent organ invasion