Kornimate/medical-research-clean huggingface dataset:
gi organ tracking via balloon applicators

Conditions: Esophageal Cancer; Kidney Cancer; Larynx Cancer; Liver Cancer; Lung Cancer; Digestive Organs--Cancer; Intrathoracic--Cancer; Respiratory Organs--Cancer; Pancreas Cancer; Small Intestine Cancer; Stomach Cancer; Colon Cancer; Rectal Cancer

Summary: the hypothesis of this study is that an occlusion balloon catheter placed in the stomach via an oral or nasogastric route will be safe and permit tracking of the stomach during radiation therapy.


Eligibility criteria:
inclusion criteria: * scheduled to receive intra-thoracic or abdominal radiation therapy. it is not required that the stomach be in the radiation field. * at least 18 years of age. * ecog performance status ≤ 1 * ability to understand and willingness to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable). exclusion criteria: * prior trauma or surgical intervention that would alter the anatomy of the upper airs (nasogastric route), esophagus or stomach. * previous complete or partial surgical resection of the esophagus, stomach, or duodenum. * presence of implantable devices (e.g., automatic internal cardiac defibrillator, cardiac or gastric pacemaker).

Keywords: gastric balloon
vitamin d status and supplementation in athletes

Conditions: Vitamin D Deficiency

Summary: the objectives of this study are 1) to assess the prevalence of vitamin d deficiency in a group of sub elite athletes and 2) to identify seasonal changes in vitamin d status and the effect that supplementation may have during the course of a year. the study is a double blinded parallel study design.

study population: 175 elite/ sub elite athletes, male and female, aged 18-60y, from a variety of sport disciplines

Eligibility criteria:
inclusion criteria: * athletes * 19-60y exclusion criteria: * subjects who take vitamin d supplements

Keywords: dose-response study
preclinical evaluation of multimodal therapeutic strategies in intestinal irradiation and inflammatory bowel disease from organoids

Conditions: Radiation Enteritis; Inflammatory Bowel Diseases

Summary: this study is carried out in patients with ibd and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). it aims the generation and culturing of organoids from digestive biopsies recovered from healthy and/or pathological (inflammatory) ileal and/or colonic mucosa during an ileo-colonoscopy. these cultures will make it possible to validate the organoid production method used in the context of the research (primary objective). in a second phase (secondary objectives), the study will aim to setup a screening tool by irradiating the organoids (step one) and then evaluate in vitro the regenerative activity of treatments dedicated to improve inflammatory bowel diseases and acute radiation enteritis (step two).


Eligibility criteria:
inclusion criteria: - group 1: active ibd * 18 years old or older * assured ibd diagnosis (crohn's disease/ulcerative colitis) according to european crohn's and colitis organisation (ecco) 2019 consensus criteria * active ibd (harvey-bradshaw score of 4 or above for crohn's disease or partial mayo score of 3 or above for ulcerative colitis) * indication to perform a coloscopy * written consent for study participation obtained or - group 2: inactive ibd * 18 years old or older * assured ibd diagnosis (crohn's disease/ulcerative colitis) according to ecco 2019 consensus criteria * inactive ibd (harvey-bradshaw score below 4 for crohn's disease or partial mayo score below 3 for ulcerative colitis) * indication to perform a coloscopy * written consent for study participation obtained or - group 3: control * 18 years old or older * indication to perform a coloscopy to detect polyp * no known bowel disease * written consent for study participation obtained exclusion criteria: * inability to understand, read, sign informed consent and/or express consent * person subject to legal protection (curator, guardianship or safeguard of justice), * deprivation of liberty by judicial or administrative decision, * non-affiliation to a social security scheme or non-beneficiary of such a scheme * pregnant, parturient, breastfeeding women * contraindication to performing biopsies * participation in other therapeutic research that may modify the behavior of intestinal cells (for example, drug research for the treatment of ibd) * anticoagulant treatment or bleeding disorder * person subject to a judicial safeguard measure * people hospitalized without consent

Keywords: colonoscopy
biomarkers in blood and tissue samples from patients with epstein-barr virus-positive hodgkin lymphoma

Conditions: Lymphoma; Nonneoplastic Condition

Summary: rationale: studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial studies biomarkers in blood and tissue samples from patients with epstein-barr virus positive hodgkin lymphoma.

objectives: * evaluate germline dna from patients with epstein-barr virus positive (ebv+) and hodgkin lymphoma (hl) for inducible t-cell kinase (itk) mutations. * examine the effects of itk mutations on expression of the itk protein. * determine whether itk mutations correlate with specific clinical or histopathological features of hl. outline: archived blood and tumor tissue samples are analyzed for germline dna expression and inducible t-cell kinase (itk) mutations by pcr, ihc, flow cytometry, and western blotting, and ebv-encoded rna (eber) using in situ hybridization. each patient's data, such as date, sex, age, tumor stage and histology at diagnosis, treatment received, response to treatment, development of recurrent disease, date of last follow-up, and outcomes are also collected.

Eligibility criteria:
disease characteristics: * diagnosis of hodgkin lymphoma (hl) meeting the following criteria: * epstein-barr virus-positive (ebv+) hl as assessed by positive ebv serology, elevated levels of ebv genome in the blood or tumor tissue following quantitative polymerase chain reaction (pcr) and/or evidence of ebv positivity of pathology samples (eber+ or lmp+) and, when possible, mixed cellular histology * young age (\< 10 years) at diagnosis * presence of hemophagocytic lymphohistiocytosis (hlh) patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: childhood hodgkin lymphoma childhood mixed cellularity hodgkin lymphoma hemophagocytic lymphohistiocytosis epstein-barr virus infection
pre-operative window of adjuvant endocrine therapy to inform rt decisions in older women with early-stage breast cancer

Conditions: Breast Cancer Female

Summary: this is a prospective multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (er+) breast cancer. these individuals will be treated with 3 months of pre-operative endocrine therapy (pre-et) with assessment of tolerance to the endocrine therapy by patient reported outcome (pro) measures (patient surveys).

this single arm pilot study evaluates the use of pre-operative endocrine therapy in women with early stage er+ breast cancer who are 65 years or older and are scheduled to have breast conservation surgery (bcs). the purpose of this study is to see if tolerance of pre-operative endocrine therapy helps inform decisions on whether or not to omit radiation. participants will be treated with the novel approach of 3 months of pre-operative endocrine therapy, so that the participants and providers will have some indication of tolerance prior to making a decision about radiation omission. tolerance of the endocrine therapy will be assessed by patient reported outcome (pro) measures during neoadjuvant and adjuvant endocrine therapy treatment periods. breast cancer participants and their surgical oncologists will be asked their preference regarding radiation therapy before starting endocrine therapy and again pre-operatively. they will make a determination regarding radiation therapy as per standard care. the hypothesis is that knowledge of tolerance of endocrine therapy will influence the decision by the patient and the surgical oncologist whether or not to elect radiation omission.

Eligibility criteria:
inclusion criteria (summary): * ecog performance status 0-2 * diagnosed with anatomic stage i, er positive, pr positive or negative, and her2 non amplified invasive breast cancer and clinically negative nodes; any invasive breast cancer histologic subtype may be enrolled * tumor size ≤ 2 cm * patient has elected bcs as surgical choice * eligible to receive tamoxifen or an aromatase inhibitor * ability to take oral medication and be willing to adhere to the endocrine therapy for the 3 month period prior to bcs exclusion criteria (summary): * prior or current use of endocrine therapy for breast cancer * history of ipsilateral breast radiation * pregnancy or lactation * has a known additional malignancy that is progressing or requires active treatment. exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * current or planned use of a strong cyp2d6 inhibitor (e.g. fluoxetine, paroxetine) and is not able to receive an endocrine therapy agent that does not use the cyp2d6 pathway

Keywords: breast cancer endocrine therapy radiation letrozole anastrozole exemestane tamoxifen survey questionnaire geriatric
leveraging technological advancements to improve the treatment of trichotillomania

Conditions: Trichotillomania (Hair-Pulling Disorder); Trichotillomania; Hair Pulling

Summary: this project will examine the effect using the keen 2 on hair pulling styles (automatic and focused), the severity of hair pulling behaviors, and related psychiatric symptoms. given that the keen2 is anticipated to increase awareness of pulling behavior (but not necessarily change pulling behavior), the investigators hypothesize that the keen 2 will increase awareness of pulling behaviors and reduce automatic pulling behavior. the investigators will explore reductions in overall hair pulling severity and related psychiatric symptoms.

novel technologies present one solution to help identify and reduce automatic pulling behaviors associated with trichotillomania (ttm). the keen 2 is one such novel technology, which is a bracelet which gives the user alerts in the form of a vibration when the user is engaging in hair pulling behavior. thus, using the keen 2 could positively increase the awareness of automatic pulling behaviors, which is largely unaffected by existing evidence-based treatments like hrt. this information would be advantageous for the scientific community to determine the possible benefit of this approach to help individuals with ttm. this project will examine the effect using the keen 2 on hair pulling styles (automatic and focused), the severity of hair pulling behaviors, and related psychiatric symptoms. given that the keen2 is anticipated to increase awareness of pulling behavior (but not necessarily change pulling behavior), the investigators hypothesize that the keen 2 will increase awareness of pulling behaviors and reduce automatic pulling behavior. the investigators will explore reductions in overall hair pulling severity and related psychiatric symptoms.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older; 2. meet diagnostic criteria for ttm using the tdi-r 3. have a mgh-hps total score ≥ 12 at baseline; (3) have an "automatic" pulling score ≥ 15 on the mist; (4) able to wear the keen2 device for four weeks; (5) able to attend three study visits; (6) unmedicated or a stable dose of psychiatric medication for 8 weeks prior to enrollment; (7) be english speaking. exclusion criteria: 1. an inability to complete rating scales, and 2. an inability to attend study visits
this is a retrospective study on the use of cenobamate as adjunctive treatment in patients suffering from epilepsy in early access program in germany, france and uk

Conditions: Focal Onset Seizure; Epilepsy

Summary: cenobamate is a newly-fda and ema approved drug used to treat -focal-onset seizures in adult patients. the aim of the current study is to analyse retrospectively the overall effectiveness and tolerability of cenobamate from real-world data collected in patients who partecipated in the early access program (eap) and were treated with cenobamate as adjunctive asm.

cenobamate is a new approved drug used to treat -focal-onset seizures in adult patients. this novel tetrazole-derived carbamate seems to act primarily by two mechanisms that are commonly associated with epilepsy: cenobamate acts as a positive allosteric modulator of the gabaa ion channels and is effective in reducing repetitive neuronal firing by inhibition of voltage-gated sodium channels, although the complete mechanism of action is currently unknown. in clinical trials, cenobamate showed also low toxicity and adverse drug reaction profile. in european union (eu), cenobamate received the marketing authorisation, valid throughout the eu, in march 2021. starting from september 2020 an eap was initiated with cenobamate as adjunctive asm in several eu countries such as germany, france, and uk. real-world data are of importance to understand and confirm the efficacy and safety profile of drugs outside of the clinical trial setting. the aim of the current study is to analyse the overall effectiveness and tolerability of cenobamate from real-world data in a large series of patients treated with cenobamate as adjunctive asm. as a consequence, a retrospective collection and analysis of the data of the patients who participated in the eap, according to the authorization received from the local regulatory or ethic authorities, was conducted.

Eligibility criteria:
inclusion criteria: * data from adult patients diagnosed with epilepsy with fos participating in the eap with cenobamate as adjunctive treatment, according to the authorization received from the local regulatory or ethic authorities will be collected and analyzed. * available data will be collected after obtaining consent from patient/legal representative to the processing of personal data according to the general data protection regulation (gdpr) and applicable local regulation exclusion criteria: * patient enrolled in other clinical trial during the eap. * patient aged less than 18 years old. * patient with specific syndrome (e.g. lgs and dravet)

Keywords: epilepsy fos cenobamate retrospective early access program europe
study to evaluate avacopan in combination with a rituximab or cyclophosphamide-containing regimen, in children from 6 years to < 18 years of age with aav.

Conditions: Vasculitis

Summary: the main objective of this study is to explore the efficacy of avacopan in participants affected by aav.


Eligibility criteria:
inclusion criteria: * male and female children and adolescents from 6 to \< 18 years of age * clinical diagnosis of granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa), consistent with chapel-hill consensus conference definitions (jennette et al, 2013) * newly diagnosed or relapsed aav with positive test for anti-pr3 or anti-mpo antibodies * at least 1 pvas major item, at least 3 pvas nonmajor items, or at least the 2 renal items of proteinuria and hematuria. * egfr \> 15 ml/min/1.73 m2 (using modified schwartz equation per central lab guidelines) * participants must have a bodyweight of ≥ 15 kg at day 1. exclusion criteria: * any other known multisystem autoimmune disease including eosinophilic granulomatosis with polyangiitis (churg-strauss), systemic lupus erythematosus , iga vasculitis (henoch-schönlein), rheumatoid vasculitis, sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis * alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study * any medical condition requiring or expected to require continued use of immunosuppressive treatments, including corticosteroids that may cause confoundment with study assessments and study conclusions.

Keywords: pediatric avacopan tavneos®
fosfomycin plus imipenem for treatment of infective endocarditis

Conditions: Infective Endocarditis

Summary: the study evaluates the efficacy and safety of fosfomycin and imipenem for the treatment of methicillin-resistant staphyloccocus aureus infective endocarditis in comparison to vancomycin, the standard therapy.


Eligibility criteria:
inclusion criteria: * suspected methicillin-resistant staphyloccocus aureus infective endocarditis on a native valve, prosthetic valve or pacemakers´s electrode or defibrillators with definitive or probable diagnosis by the modified duke criteria (li j, et al. clin infect dis. 2000). * patients over 18 years. exclusion criteria: * patients who did not sign informed consent. * patients with active consumption intravenous drug. * patients with emergent surgery criteria (\<72 hours). * patients or cardiogenic shock. * patients with antibiotic active against mrsa over 72 hours or they may need another antibiotic active against mrsa than those in the study. * patients with chronic renal failure on hemodialysis who received empirical treatment with vancomycin as a single dose and have a valley ≥ 15 mcg / ml on the third day. * patients with mrsa strains resistant to fosfomycin (mic\> 64 mg / l) (\ 2 mg / l) or with an mic to vancomycin of 2 mg / l. * patients with any formal contraindication to be treated with study drugs * patients treated with any investigational drug within 30 days prior to entering the study.

Keywords: infective endocarditis
cornell university-micronutrient initiative calcium supplementation study

Conditions: Preeclampsia

Summary: the world health organization (who) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake. this study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related recommendations.

this study is a non-inferiority trial that compares the effect of a dosing strategy involving lower overall dose and fewer administrations per day to the current who recommendation. the comparator arm, regimen b, prescribes 3 doses per day (consistent with current who standard) and was found to be burdensome in qualitative studies. the experimental arm, regimen a, prescribes 2 doses per day and has been associated with greater satisfaction. on face value regimen a should result in 33% less amount of supplement ingested than regimen b. however, we hypothesize that the difference in amount ingested, when rolled out in routine practice will be much less than that because the lower dose regimen results in higher levels of adherence. we hypothesize that the difference in amount consumed will be negligible or will not exceed 15%. hence, we hypothesize that regimen a is not inferior to regimen b in terms of total amount of supplement ingested (within a 15% margin of inferiority).

Eligibility criteria:
inclusion criteria: * attendance at anc clinic in a primary care facility in kakamega north exclusion criteria: * gestational age \< 16 weeks, * gestational age \> 30 weeks, * dietary or medicinal consumption of adequate calcium (according to the screening survey), * intention to leave study community before 8weeks from date of interview

Keywords: adherence calcium supplementation prevention of preeclampsia adherence to calcium supplementation
intramuscular versus intravenous prophylactic oxytocin for hemorrhage after vaginal delivery

Conditions: Postpartum Hemorrhage

Summary: intramuscular versus intravenous prophylactic oxytocin for the third stage of labour following vaginal delivery: a randomised controlled trial

prevention of postpartum haemorrhage is essential in the pursuit of improved health care for women. in this study investigators aimed to compare intramuscular oxytocin with intravenous oxytocin for the routine prevention of postpartum haemorrhage in women who deliver vaginally.in some countries, intravenous access can not be provided easily . intramuscular application is faster , easier and tougher enforcement requires less skill and equipment . for this reason, less educated , which can be applied by those offering health services .

Eligibility criteria:
inclusion criteria: 1. research volunteers, the undersigned, pregnant women 2. only with vaginal delivery (episiotomy and perineal tears can) 3. \> 34 weeks or more will be 4. cephalic presentation will be 5. at low risk of postpartum hemorrhage exclusion criteria: 1. \<18 years 2. multiple pregnancies 3. the presence of uterine myoma 4. having postpartum hemorrhage in previous pregnancies 5. placenta previa, polyhydramnios 6. more than four parity 7. fetal macrosomia 8. hb \<9mg/dl 9. preeclampsia 10. uterine anomalies 11. receiving anticoagulant therapy, suspected coagulopathy 12. \> 42 weeks of pregnancy 13. oxytocin allergy -

Keywords: postpartum hemorrhage oxytocin vaginal delivery prophylactic
anesthetic and perioperative risk assessment before programmed surgery: anesthetic teleconsultation versus face-to-face anesthesia consultation.

Conditions: Telemedicine; Anesthesia; Consultation, Remote

Summary: the anesthesia safety decree made it compulsory in 1994 to carry out a pre-anesthesia consultation before any operative or interventional act. with the inclusion of telemedicine in the public health code then the publication of addendum 6 in 2018 and finally the derogatory decree in march 2020, it is possible to perform and bill for pre-anesthesia consultation via telemedicine. the consultation is always followed by a pre-anesthetic visit upon admission of the patient the day before or the day of the operation to verify the information recorded during the consultation and the patient's state of health. this identifies elements omitted during the pre-anesthesia consultation (face-to-face or remotely) and reduces the risks of potential postponement. the study investigators hypothesize that there would be no difference in the quality of the information given, the collection of medical, paramedical and medication elements and the evaluation of the operative risk in anesthesia consultation via teleconsultation versus face-to-face. the critical points are the medication reconciliation of the patient's treatments, the overall assessment of the operative risk and anticipated difficulty of access to the airways (mouth opening: ≥ or \<35 mmm).


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * patient with scheduled surgical intervention (outpatient or hospitalization) at the nîmes university hospital requiring a preoperative anesthesia consultation. * patient with computer equipment at home allowing the use of the téléo software (computer equipment with web cam, audio and microphone or smartphone). exclusion criteria: * the subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient who has already had an anesthesia consultation for surgery within the previous 6 months. * emergency or radiology and / or interventional surgery (eg. gastroscopy, biopsy under scanner, etc.).