Kornimate/medical-research-clean huggingface dataset:
peritonsillar infiltration with levobupivacaine for posttonsillectomy pain

Conditions: Pain

Summary: the investigators aimed to evaluate the effects of different concentrations of preincisional peritonsillar levobupivacaine (0.25% ve 0.5%) on postoperative pain and bleeding

72 asa i-ii patients between 3 and 12 years of age who scheduled to undergo tonsillectomy were enrolled in this randomized, prospective and placebo-controlled study. the indications for tonsillectomy were recurrent infections and tonsillar hypertrophy leading to obstructive symptoms. the patients included to the study were randomly assigned to one of the 3 groups to receive different concentrations of levobupivacaine or saline. the mean arterial pressure (map) and heart rates (hr) of all patients were recorded during the whole anesthesia and surgical procedures. the duration of anesthesia and surgery were also recorded. additional remifentanil 1 µgr kg-1 iv was administered to the patients if hr was increased by 25 % of the basal value. during postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. pain was evaluated by flacc (faces, leg, activity, cry, consolability), fprs (faces pain rating scale) ve wong-baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. total analgesic consumption during the postoperative period were recorded. if the patients had no complication, they were discharged at the postoperative 24th hour.

Eligibility criteria:
inclusion criteria: * patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to recurrent infections leading to obstructive symptoms * patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to tonsillar hypertrophy leading to obstructive symptoms. exclusion criteria: * hypersensitivity to sevoflurane, benzodiazepine, fentanyl analogues, propofol and components, paracetamol, levobupivacaine * presence of coagulation disorders and chronic diseases * presence of regular use of analgesics * presence of analgesic use within 24 hours prior to surgery * presence of upper respiratory system infection * inability to understand the pain scales, being unable to communicate.

Keywords: posttonsillectomy pain levobupivacaine
feasibility trial of the bios device for continuous glucose monitoring

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: the study is an open-label, prospective, within-subject comparison of the bios device readings versus venous blood sample glucose readings, glucose readings from a dexcom cgm and an smbg device in subjects previously diagnosed with type 1 or type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years of age; 2. subject has had a diagnosis of diabetes mellitus either type i or type ii; 3. for insulin-using subjects only: subject will not inject insulin or wear an insulin pump insertion set within a 10 cm distance of any bios device; 4. subject able to wear multiple cgm devices simultaneously; 5. subject is either a patient diagnosed with type i diabetes mellitus currently wearing a dexcom cgm device or a patient diagnosed with type ii diabetes mellitus who will agree to use a dexcom cgm device during participation in the study. there are no restrictions on the model of the dexcom cgm device. 6. subject agrees to provide a log of medications (prescription and over-the-counter) and dietary supplements (e.g., vitamins) taken during the study period, including dosage; 7. subject has a smart device that complies with the requirements listed in attachment 1 of this protocol and is willing to download and run the graphwear patient application on their device; 8. subject is able to read and understand the informed consent form and has voluntarily provided written informed consent; 9. in the principal investigator's opinion, subject is able to be compliant with provisions laid out in this protocol. exclusion criteria: 1. subjects with any physical or behavioral disorder, which, in the opinion of the principal investigator, may interfere with the use of the device or compliance with the study protocol; 2. subject has any of the following: * a skin condition that precludes wearing of the device; * a known allergy that precludes wearing of the device; * tattoos or other skin alterations that may interfere with device placement and/or operation; 3. history of substance abuse within 6 months of study start; 4. use of any illicit drugs during the duration of the study period; 5. marijuana use during the duration of the study period; 6. if female, subject is pregnant or nursing; 7. subject is on active dialysis; 8. subjects whom the principal investigator believes may not be an appropriate candidate for this device.
reproductive outcomes following uterine septum resection

Conditions: Uterine Septum

Summary: nowadays, there is little data to validate the performance of surgical hysteroscopies in the case of septate uterus, particularly in the case of incidental discoveries. clinical practice and the experience of teams leads to propose this procedure, but strong evidence for this recommendation is lacking and there is an urgent need for solid data. a recent randomized trial contradicts this recommendation, but the methodology is questionable on several points. investigators wished to associate 2 reference centers with current practice and expertise on this procedure in order to have a cohort of many patients and to have more powerful results.) investigators purpose a retrospective observational data-based study. the aim is to describe the profile of patients with a partitioned uterus in terms of obstetrical history and to study the consequences of uterine partition resection in terms of obstetrical prognosis (live births, at term, number of miscarriages or premature births). the aim of this study is to take into account the evaluation of the surgical hysteroscopy gesture by postoperative imaging with in particular the indication of a resection in several stages in case of residual postoperative septum.


Eligibility criteria:
inclusion criteria: major female (≥18 years old) to be an operating patient at the strabourg university hospital or bicetre hospital between january 2009 and december 2019. exclusion criteria: particular clinical forms of the disease, (associated enlargement metroplasties, other uterine maformations) minor patients, patients under guardianship

Keywords: uterine septum hysteroscopic septum resection metroplasty subfertility infertility preterm delivery spontaneous abortion
evaluate the efficacy and safety of fasinumab in patients with moderate-to-severe chronic low back pain and osteoarthritis of the hip or knee

Conditions: Chronic Low Back Pain; Osteoarthritis

Summary: the primary objective of the study is to evaluate the efficacy of fasinumab in relieving chronic low back pain (clbp) as compared to placebo in participants with a clinical diagnosis of moderate-to-severe non-radicular clbp and osteoarthritis (oa) of the knee or hip when treated for up to 16 weeks. the secondary objectives of the study are: to evaluate the safety and tolerability of fasinumab compared to placebo when participants with a clinical diagnosis of moderate-to-severe non-radicular clbp and oa of the knee or hip are treated for up to 16 weeks; to characterize the concentrations of fasinumab in serum over time when participants with a clinical diagnosis of moderate-to-severe non-radicular clbp and oa of the knee or hip are treated for up to 16 weeks; to evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in participants with a clinical diagnosis of moderate-to-severe non-radicular clbp and oa of the knee or hip.


Eligibility criteria:
key inclusion criteria: 1. clinical diagnosis of non-radicular moderate-to-severe clbp for ≥3 months (prior to screening visit) 2. clinical diagnosis of oa in at least 1 hip or knee joint based on the american college of rheumatology criteria with radiographic evidence of oa (k-l ≥2) at screening 3. history of inadequate relief of clbp from non-pharmacologic therapy 4. willing to undergo joint replacement (jr) surgery, if necessary 5. history of regular analgesic medication use 6. history of inadequate pain relief or intolerance to analgesics used for chronic lbp key exclusion criteria: 1. patient is not a candidate for mri 2. history of major trauma or back surgery in the past 6 months prior to the screening visit 3. history or presence of pyriformis syndrome 4. evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions 5. history or evidence on joint imaging of conditions that may confound joint safety evaluation 6. evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol 7. recent use of longer acting pain medications 8. other medical conditions that may interfere with participation or accurate assessments during the trial note: other protocol defined inclusion/ exclusion criteria apply.

Keywords: knee hip
tirelizumab combined with chemotherapy in the treatment of her-2 negative locally advanced gastric cancer

Conditions: Locally Advanced Gastric Carcinoma; HER2 Negative; Efficacy; Safety

Summary: this study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; by comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with sox/xelox chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research.


Eligibility criteria:
inclusion criteria: * the subjects voluntarily joined this study and signed an informed consent form * locally advanced gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology as her-2 negative (ct2-4n+m0 phase ii-iii) * the primary lesion can be surgically removed, and the patient is willing to receive surgical treatment * there are measurable solid tumors (efficacy evaluation standard: recist 1.1) * tumor evaluation should be conducted through ct scanning or mri within 28 days before treatment * ecog score 0-1 * life expectancy ≥ 12 months. exclusion criteria: * preoperative imaging examination indicates distant or peritoneal metastasis in patients * subjects with any known active autoimmune disease * serious cardiovascular disease * the serum of the subjects tested positive for hiv * active hepatitis b (hbsag positive and hbv-dna ≥ 10 \^ 3copies/ml) or active hepatitis c (hcv antibody positive and hcv-dna positive, requiring antiviral treatment at the same time) * known subjects with previous allergies to macromolecular protein formulations/monoclonal antibody components, or other contraindications to immunotherapy or chemotherapy * have a history of alcohol, drug, or substance abuse * individuals with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance
contribution of percutaneous endoscopic caecostomie in the management of severe constipation refractory to medical treatment

Conditions: Constipation

Summary: the investigators' study aims to compare the results of percutaneous endoscopic caecostomie (cpe) to optimal medical therapy in the treatment of patients with constipation refractory to medical treatment. the primary endpoint will be the quality of life assessed by the gastrointestinal quality of life index (giqli) at one year. the secondary endpoints are digestive symptoms, kess's constipation scores and cleveland's incontinence score, tolerance of the chait trapdoortm caecostomy catheter (ctcc) and the collection of possible complications. the patients included must meet the classification criteria of rome iii, have an elongated colonic transit time, have had a complete colonoscopy and be refractory to medical treatment including at least one stimulant laxative or suppositories or enemas retrograde.


Eligibility criteria:
inclusion criteria: * patient betwen 18 and 75 years old * chronic constipation defined by the rome iii classification * transit time with pellets made within 24 months preceding the inclusion visit indicating a transit time of at least 120 hours and/or with a neurogenic bowel dysfunction ≥ 14 for patients with spina bifida and / or spinal cord injuries. * colonoscopy made within the 5 years preceding the inclusion visit indicating the absence of colorectal organic obstacle * anorectal manometry performed within 24 months preceding the inclusion visit performed to substantiate the information on the type of constipation * giqli score \ 7, despite medical treatment of constipation including taking a laxative (stimulant laxative orally and / or suppository and / or retrograde enema) more than one times per week for at least two months. * affiliation to a social security * - chronic constipation defined by the rome iii classification * transit time with pellets made within 24 months preceding the inclusion visit indicating an increase of at least 120 hours compared to normal * colonoscopy made within the 24 months preceding the inclusion visit indicating the absence of colorectal organic obstacle * anorectal manometry performed in the 24 months preceding the inclusion visit performed to substantiate the information on the type of constipation * score giqli love \ 7, despite medical treatment of constipation including taking a laxative (stimulant laxative orally and / or suppository and / or retrograde enema) more than one times per week for at least two months. * affiliation to a social security scheme * informed consent signed exclusion criteria: * severe obesity (bmi\> 40) * history of surgical resection of colon * hypothyroidism, electrolyte disorders, insulin-dependent diabetes * acute decompensation of depressive syndrome * immunosuppressive therapy * disorders of hemostasis (tp \ 1.5, thrombocytopenia \<70,000 / mm3) * pregnant woman (positive serum beta-hcg) or breastfeeding * adults under guardianship, curatorship or under court protection * participation in another research protocol on the treatment of constipation
cerebral infarction and white substance in angiopathy cerebral amyloid

Conditions: Amyloid Angiopathy

Summary: the cerebral amyloïd angiopathy ( aac) is a disease characterized by deposits of beta-amyloid peptids in the walls of the arteries of young and average calibre of the brain and the leptomeninx. the incidence of the aac increases strongly with the age and represents a major cause of spontaneous brain haemorrhage to people over 60. the main demonstration is the lobar brain haemorrhage, the other ones are bleedings under arachnoid cortical and microbleedings leading to cognitive decline. anatomical studies reported the presence of cortical infarcts in patients having amyloïd deposits suggesting an association between asymptomatic cortical cerebral infarcts and aac. however prevalence and meaning of these infarcts in patients having an aac remain badly known because of studies on low number of patients and the rarity of radiological analyses of these infarcts .a better knowledge of these asymptomatic cortical infarcts would allow to dread better cognitive disorders(confusions) presented by these patients, and to develop preventive strategies. besides, the risk factors of severity of the aac are little studied.


Eligibility criteria:
inclusion criteria: * age\>55 * hospitalized in caen hospital and paris st joseph hospital between 1st january 2011 and 31 december 2015 for cerebral haemorrhage with mri images diagnosing cerebral amyloid angiopathy. exclusion criteria: * insufficient mri images quality without flai sequence, t2 gre * disease with same radiologic and clinical signs that cerebral amyloid angiopathy.
fdg-pet in advanced melanoma

Conditions: Recurrent Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma

Summary: this clinical trial studies how well fdg-pet/ct measures early response in patients with stage iii-iv melanoma who are receiving chemotherapy. positron emission tomography (pet)/computed tomography (ct) uses a metabolic imaging radiotracer, \[18f\]fluorodeoxyglucose (fdg), which selectively accumulates in tumors. fdg-pet/ct of advanced melanoma before, during, and after treatment may improve methods for predicting which patients may benefit from therapy.

primary objectives: i. to correlate treatment-induced changes in fdg uptake with changes in tumor size and progression-free survival (pfs) in patients receiving therapy for advanced melanoma. ii. to correlate treatment-induced changes in fdg uptake with changes in the activity and/or expression of available molecular biomarkers from patients receiving therapy for advanced melanoma. outline: patients undergo fdg-pet/ct up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84).

Eligibility criteria:
inclusion criteria: * subjects must have signed institutional review board (irb)-approved informed consent documentation * subjects must be diagnosed with histologically proven stage iv (metastatic) melanoma or stage iii with bulky disease which may or may not be amenable for surgery and are receiving therapy at present * subjects must be scheduled to begin treatment through the vanderbilt-ingram cancer center (vicc) melanoma program; this will include patients receiving standard-of-care chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to vicc clinical trials for the study of investigational agents * subjects must have measurable disease by ct or magnetic resonance imaging (mri) per response evaluation criteria in solid tumors (recist) 1.1 criteria; to comply with pet response criteria in solid tumors (percist) criteria, subjects should have at least one lesion measuring at least 2 cm in the longest diameter exclusion criteria: * subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic gonadotropin (hcg) will be performed on women of child bearing potential * subjects who have experienced allergic or other adverse reactions in response to intravenous injection of fluorinated radiotracers and other contrast media used in pet/ct * subjects incapable of giving informed written consent, for the following reasons: * inability to adhere to the experimental protocols for any reason * inability to communicate with the research team * limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders * prisoners or other individuals deemed to be susceptible to coercion

Keywords: fluorodeoxyglucose fdg pet/ct melanoma imaging biomarkers cancer imaging
biodistribution study with 186 re-labelled humanised monoclonal antibody biwa 4 in patients with adenocarcinoma of the breast

Conditions: Adenocarcinoma

Summary: the primary objectives of this study were to assess the safety and tolerability of intravenously (i.v.) administered 186rhenium (186re)-labelled bivatuzumab and to investigate the biodistribution and pharmacokinetics of 186re-labelled bivatuzumab in patients with adenocarcinoma of the breast


Eligibility criteria:
inclusion criteria: * patients must have histological or cytological confirmation of a primary adenocarcinoma of the breast * patients destined for tumour extirpation or mastectomy * patients over 18 years of age * patients younger than 80 years of age * patients who had given 'written informed consent' * patients with a life expectancy of at least 3 months * patients with a good performance status: karnofsky \> 60 exclusion criteria: * life-threatening infection, allergic diathesis, organ failure (bilirubin \> 30µmol/l and/or creatinine \> 150 µmol/l) or evidence of a recent myocardial infarction on ecg or unstable angina pectoris * pre-menopausal women (last menstruation \<= 1 year prior to study start) * not surgically sterile (hysterectomy, tubal ligation) and * not practicing acceptable means of birth control, (or not planned to be continued throughout the study). acceptable methods of birth control include oral, implantable or injectable contraceptives * women with a positive serum pregnancy test at baseline * white blood cell count \< 3000/mm³, granulocyte count \< 1500/mm³ or platelet count \< 100000/mm³. details of prior chemotherapy or radiotherapy had to be known * hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy
characterisation of 24-hour fev1-time profiles of inhaled bi 1744 cl and inhaled foradil in patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the study is intended to characterize the lung function profile of bi1744 in copd patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. each patient will receive all four treatments.


Eligibility criteria:
inclusion criteria: * patients willing to participate with confirmed diagnosis of copd * 40 years of age or older * having a 10 pack year smoking history * able to perform serial pulmonary function tests * able to use both a dpi and respimat device exclusion criteria: significant other disease * clinically relevant abnormal hematology, chemistry, or urinalysis * history of asthma * diagnosis of thyrotoxicosis * paroxysmal tachycardia related to beta agonists * history of mi within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year * active tuberculosis, cystic fibrosis, clinically evident bronchiectasis * significant alcohol or drug use * pulmonary resection * taking oral beta adrenergics * taking unstable oral steroids * daytime oxygen * enrolled in rehabilitation program * enrolled in another study or taking investigational products * pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control * those who are not willing to comply with pulmonary medication washouts