Kornimate/medical-research-clean huggingface dataset:
the diagnostic methods of early postoperative flare-up of crohn's disease

Conditions: Crohn's Disease

Summary: crohn's disease is a chronic inflammatory transmural bowel disorder characterized by high rate of postoperative anastomotic complications and recurrences. surgery itself can influence immunologic function and trigger inflammatory response, which may result in the flare of crohn's disease soon after surgery (within one month), especially near the anastomosis. early flare-up of crohn's disease can negatively impact the outcomes of operation. however, due to the the complexity of perioperative period and dangerous of invasive examine, it is difficult to distinguish disease flare from postoperative complications. in this study, the investigators aim to development a diagnostic method of flare-up within one month after surgery, which can help us to detect and then treat disease flare in time.

hbi score, serum crp, esr, wbc, hb, plt, il-6，pct and fecal calprotectin will be monitored within one month after resection.

Eligibility criteria:
inclusion criteria: * patients undergoing intestinal resection of all macroscopic disease, with an endoscopically accessible anastomosis, exclusion criteria: * patients have an anastomosis which is endoscopically inaccessible by standard colonoscopy; * patients withs persisting macroscopic abnormality after surgical resection; * patients with an end stoma (ileostomy or colostomy); * patients are not suitable to undergo endoscopy because of co-morbidities or an unwell clinical state; * patients who are unable to give informed consent; * patients who are pregnant

Keywords: diagnostic techniques digestive system
lung epicheck biomarkers development study

Conditions: Lung Cancer

Summary: this study is part of the development of a non-invasive lung cancer screening test which aim to identify early-stage lung cancer in patients at high risk for lung cancer.

this is a prospective, multi-center, observational nonsignificant risk study aimed to collect blood and clinical data from primary lung cancer and control subjects to characterize various biomarkers that will discriminate between lung cancer and control subjects.

Eligibility criteria:
inclusion criteria - cases: * age 50-80 years * subjects who are currently smoking or former smokers, with at least 20 pack-years * subjects with either a high suspicion for lung cancer, with planned biopsy or surgery to establish a definitive diagnosis within 60 days after enrollment or treatment naive lung cancer patients confirmed by pathology. exclusion criteria - cases * known diagnosis or treatment of cancer from any kind in the past 5 years, except of fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix and except from the current lung cancer inclusion criteria - uspstf risk * age 50-80 years * subjects who are currently smoking or former smokers, with at least 20 pack-years exclusion criteria - uspstf risk - known diagnosis or treatment of cancer of any kind in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix inclusion criteria - healthy controls * age 20-80 years * never smoker or current / previous smoker \< 20 pack year history exclusion criteria - healthy controls * known diagnosis or treatment of cancer of any kind in the past (lifetime), except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix. * not previously diagnosed with a lung lesion highly suspicious for cancer * under follow up or work up for any lesion suspicious for any type of cancer * presenting with fever with body temperature 100.4°f (38°c) or higher * acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw * pregnancy * any history of blood product transfusion within 30 days prior to blood draw

Keywords: lung cancer screening
safety & efficacy wc3011 (estradiol vaginal cream) in the treatment of vulvovaginal atrophy in postmenopausal women

Conditions: Postmenopausal Vulvovaginal Atrophy

Summary: study if wc3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.


Eligibility criteria:
inclusion criteria: * postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness exclusion criteria: * hypersensitivity to estrogen and/or progestin therapy * known or suspected premalignant or malignant disease (except successfully treated skin cancers) * manifestation of or treatment for significant cardiovascular disease, congestive heart failure, stroke or ischemic attacks * insulin-dependent diabetes mellitus * increased frequency or severity of headaches while on hormone or estrogen therapy * drug or alcohol addiction within last 2 years * participation in a clinical trial within 30 days * smoking ≥ 15 cigarettes daily * uncontrolled hypertension - systolic blood pressure (bp) ≥ 160 mmhg or diastolic bp ≥ 95 mmhg

Keywords: postmenopausal women, vaginal dryness
phenotypic characterization tumor-infiltrating lymphocytes at diagnosis and after chemotherapy in ovarian cancer

Conditions: Ovarian Cancer Stage IIIC; Fallopian Tube Cancer Stage IIIC; Fallopian Tube Cancer Stage IV; Ovarian Cancer Stage IV

Summary: this is a monocenter, interventional, non-randomized study among women patients with an ovarian or tubal cancer who will receive a surgery or adjuvant chemotherapy treatment, or a neo-adjuvant chemotherapy then surgery +/- adjuvant chemotherapy. the planned interventions are collection of biological samples at different times. the study will aim to describe the immunological profile at diagnosis in terms of phenotypic : pbmcs (peripheral blood, mononuclear cells) in peripheral blood, tils (tumor-infiltrating lymphocytes) in ascites and in carcinomatosis.

participants will receive the following interventions because they are enrolled in the study: blood sample collection * at diagnosis, before chemotherapy (pre-ct) * after chemotherapy (post-ct) two additional blood samples will be collected in each patient : one at diagnosis and one at the end of chemotherapy. the aim of this study is to describe the immunological profile at diagnosis in terms of phenotypic : pbmc in peripheral blood, tils in ascites and in carcinomatosis, in patients treated for peritoneal carcinomatosis of ovarian or tubal origin. the treatment has to be a surgery and an adjuvant chemotherapy, or a neo-adjuvant chemotherapy followed by a surgery +/- adjuvant chemotherapy. other objectives of the study include: * evaluate the association between the immunological profile at diagnosis and the characteristics of the disease at diagnosis (histological type, extension) * evaluate the prognostic value of the immunological profile at diagnosis in terms of clinical response to neoadjuvant chemotherapy (for patients with interval surgery) * evaluate the polarization of the immune response induced by chemotherapy, describing the phenotypic changes in the different types of samples (blood, +/- ascites, +/- carcinomatosis) after chemotherapy in comparison with samples at diagnostic * evaluate the association between these immunological phenotypic changes and the clinical response to chemotherapy in patients receiving neoadjuvant chemotherapy * collect biological material for peritoneal carcinomatosis for subsequent biological analyzes

Eligibility criteria:
inclusion criteria: * 18 years old or more * presenting a carcinomatosis with suspicion of ovarian cancer or tubal cancer, under a diagnostic laparoscopy * stage iiic or initial pleural iv * planned treatment with surgery and adjuvant chemotherapy, or neo-adjuvant chemotherapy followed by surgery +/- adjuvant chemotherapy * having been informed and signed the informed consent of this study * affiliated with a social security scheme exclusion criteria: * stage iv with visceral metastases (pulmonary, hepatic ...) * contraindication to surgery and / or chemotherapy * pregnant or lactating woman * patient under guardianship or curatorship

Keywords: ovarian cancer tubal cancer immunological profile pbmc tils carcinomatosis hgsoc
prognostic impact of noncardiac comorbidities in heart failure patients

Conditions: Heart Failure, Diastolic; Heart Failure, Systolic

Summary: to better understand the public health prognostic impact of noncardiac chronic illnesses, we explored the attributable risk of noncardiac comorbidities on outcomes between heart failure patients with reduced ejection fraction (hfref) and heart failure patients with preserved ejection fraction (hfpef) in a large contemporary heart failure (hf) population the adjusted hazard ratio (hr) and the population attributable risk were used to compare the contributions of 15 noncardiac comorbidities to adverse outcome. the comorbidities that contributed to high attributable risk were: anemia, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, and peripheral artery disease. these findings were similar for hfref and hfpef groups. interaction analysis confirmed similar results.


Eligibility criteria:
inclusion criteria: * all consecutive heart failure patients with left ventricular ejction fraction available before or within 3 months from the index visit exclusion criteria: * we excluded all patients who had severe primary left-sided valvular disease
treatment study of metronidazole to treat dientamoebiasis in children

Conditions: Dientamoebiasis

Summary: introduction: dientamoeba fragilis (df) is a commonly occurring intestinal protozoan that is considered a possible cause of infectious gastrointestinal disease in adults and children. df has a particular high prevalence in children, and it is suspected that children present more symptoms in infection than adults. however, evidence of causality is lacking, treatment regimens are largely untested in controlled trials, and the most commonly used antibiotic against df in denmark, metronidazole, has never been tested against placebo. main objective: to determine the clinical effect of metronidazole in df-infected children with gastrointestinal complaints, where no other aetiology is known and no other gastrointestinal pathogens could be shown.


Eligibility criteria:
inclusion criteria: * patients with samples investigated at statens serum institut. * faecal sample (index) positive for dientamoeba fragilis (df) by realtime pcr, within \< 7 days. * no faecal samples positive for df within the period: 3 months prior to and up to index-sample. * telephone interview to parents no later then 14 days after result from index-sample. * age 3-12 years old. * place of residence: island of zealand, incl. capital region. * symptoms consistent with gastrointestinal infection of df: either 1) ≥ 2 episodes of diarrhea per week or 2) ≥ 2 episodes of stomach ache per week or 3) ≥ 2 of the following symptoms: anorexia, failure to thrive, anal itching, excessive flatulence, other change in bowel movements. exclusion criteria: * expected non-compliance. * objection to subject participation from referring physician. * underlying illness or comorbidity, incl. known gastrointestinal illness (both infectious and non-infectious), but excluding constipation. * known liver disease or intolerance/allergy to metronidazole. * positive screening for other intestinal pathogens, which may explain subject symptoms. * treatment with metronidazole outside of study within study period. * weight \> 50 kg

Keywords: children parasite intestinal treatment rct
cold snare polypectomy for small bowel polyps in patients with peutz-jeghers syndrome

Conditions: Peutz-Jeghers Syndrome; Small Bowel Polyp

Summary: this study aims to evaluate the feasibility and safety of cold snare polypectomy for removing 5-9mm small intestinal polyps in patients with peutz-jeghers syndrome (pjs),in order to provide some reference for clinical strategy of endoscopic treatment of small intestinal polyps in pjs patients, and may prolong the follow-up period of pjs patients intervals.


Eligibility criteria:
inclusion criteria: * age 8-60, male or female. * diagnosed with peutz-jeghers syndrome * undergo enteroscopy for small bowel polypectomy. exclusion criteria: * absence of at least one study polyp (5-9mm stubby pedicle, wide pedicle and sessile small bowel polyps); * be evaluated during enteroscopy for requiring surgical intervention (such as endoscopically difficult to handle giant polyps, intussusception, etc.)； * with more than 50 polyps ≥1cm found in this enteroscopy examination; * the polyp has been confirmed to be malignant by pathology, or highly suspicious of malignant transformation under endoscopy; * receiving anticoagulant therapy during this treatment; * unable or unwilling to provide informed consent.
medication related osteonecrosis of the jaws (mronj) in a cohort of patients treated by antiresorptive drugs

Conditions: Osteonecrosis of the Jaw; Osteonecrosis Due to Drugs, Jaw; Osteonecrosis Due to Drug; Bisphosphonate-Associated Osteonecrosis; Bisphosphonate-Associated Osteonecrosis of the Jaw

Summary: the objective of this prospective observational study is to investigate the incidence of medication related osteonecrosis of the jaws (mronj) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of mronj and to identify any systemic as well as local risk factors.

antiresorptive drugs are widely used for the prevention and treatment of numerous diseases involving the skeletal system. in particular, they have been shown to be effective in reducing the incidence of skeletal events in oncohematologic patients. specifically, bone represents a highly affected site of metastatic cancer (i.e., bone metastases from solid tumors of various origins--breast, prostate, renal; multiple myeloma). in the united states, approximately 400,000 individuals suffer from bone metastasis. the most frequent skeletal complications in patients with bone metastases (referred to as sre - skeletal-related events - in the international literature) include pathologic fractures, spinal cord compression, malignant hypercalcemia, and the need to undergo radiation therapy or surgery on the bone lesion.the introduction of anti-bone resorption drugs (bisphosphonates and denosumab) has reduced the rate of skeletal complications by 30-50% so they are indicated in the management of the oncohematology patient. the objective of this prospective observational study is to investigate the incidence of medication related osteonecrosis of the jaws (mronj) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of mronj and to identify any systemic as well as local risk factors.

Eligibility criteria:
inclusion criteria: * patients with specific prescription to initiate therapy with antiresorptive drugs exclusion criteria: * previous head and neck radiotherapy
compare sequential and quadruple therapy for the eradication of helicobacter pylori in korea

Conditions: Helicobacter Pylori Infection

Summary: 1. to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of helicobacter pylori in korea. 2. to evaluate the effect of h. pylori eradication therapy on the symptom improvement of functional dyspepsia

emerging evidence shows that the eradication rate of proton pump inhibitor (ppi)-based triple therapy for the first-line treatment of helicobacter pylori has decreased. the reason for the decrease in the efficacy of ppi-based triple therapy is mainly due to the increase in the resistance against clarithromycin. sequential therapy seems to be more effective than the ppi-based triple therapy, however, the eradication rate of sequential therapy in korea, which is mostly under 80%, is still not satisfactory. modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained ppi, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in korea and amoxicillin is more easy to take in comparing with metronidazole. therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of helicobacter pylori in korea. in addition, previous studies reported that h. pylori infection also associated with functional dyspepsia (fd) and recommended h. pylori eradication in patients with fd. however, until now, there was no randomized prospective study in korea, therefore the another aim of this study is to evaluate the effect of h. pylori eradication therapy on the symptom improvement of fd.

Eligibility criteria:
inclusion criteria: * male and female korean adult (aged ≥ 18 years) * patients who diagnosis of h. pylori infection by any of following three methods * positive rapid urease test (clotest) * histologic evidence of h. pylori by modified giemsa staining * positive 13c-urea breath test exclusion criteria: * age under 18 years * previous eradication treatment for h. pylori * patients who took any drug which could influence the study results such as proton pump inhibitor, h2 blocker, mucosal protective agent and antibiotics * history of gastrectomy * advanced gastric cancer or other malignancy * abnormal liver function or liver cirrhosis * abnormal renal function or chronic kidney disease * other severe concurrent diseases * previous allergic reactions to the study drugs * pregnant or lactating women

Keywords: helicobacter pylori
determination of the optimal dose of ephedrine in intraoperative arterial hypotension of newborns and infants up to 6 months of age.

Conditions: Intraoperative Arterial Hypotension; Infant, Newborn

Summary: the incidence of arterial hypotension under general anesthesia using sevoflurane is particularly high in newborns and infants up to 6 months of age. a decrease of 20% of the initial mean blood pressure (mbp) is the definition of significant arterial hypotension in adults and children. in adults, intraoperative arterial hypotension is associated with an increase of intraoperative mortality and a certain neurological morbidity. in infants under 6 months of age, neurological disorders have been reported following general anesthesia. neurotoxicity of hypnotics is often incriminated as should be the episodes of arterial hypotension. current management of hypotension uses vascular filling with crystalloids and vasopressive amines in second intention. dopamine is the most frequently used amine. ephedrine can also be used. ephedrine is particularly interesting because of its action on both α and β receptors and its mode of administration: one dose and peripheral access. only one study is available in children from birth to adulthood; it demonstrates a lower hemodynamic response in infants than in adults, when administered a low dose of ephedrine (0.1 to 0.2 mg/kg). a recent retrospective cohort suggests an under efficacy of low doses and the use of higher doses than those recommended. the primary objective is to determine the optimal dose of ephedrine (dose of ephedrine associated with a difference of proportion of newborns/infants in therapeutic success of 55%) compare to the reference dose of 0.1mg/kg as a first line treatment of intraoperative arterial hypotension. secondary objectives: * return to a mbp superior to 38mmhg post ephedrine administration. * to assess occurrence of hypoxemic events during anesthesia. * to assess tolerance of ephedrine. one hundred and twenty newborn and infants up to 6 months of age will be recruited in 3 sites of the rhone alpes auvergne area over 24 months.


Eligibility criteria:
inclusion criteria: * newborns or infants \< 6 months of age, * boys and girls, * premature or not, * requiring general anesthesia induced by sevoflurane * who presents during anesthesia a decrease of blood pressure superior to 20% of the basal mbp (measured prior to surgery) despite of vascular filling with sodium chloride 0.9% (10ml/kg during 10 min). * written, informed consent obtained from the 2 parents exclusion criteria: * allergy to ephedrine. * emergency surgery. * patient having previously received other vasopressive amines. * use of other indirect sympathomimetic drug such as phenylpropanolamine, phenylephrine, pseudoephedrine and methylphenidate. * premedication with clonidine * congenital heart disease * iv-induced anesthesia.

Keywords: pediatric intraoperative arterial hypotension ephedrine general anesthesia
carbon ion radiation therapy in the treatment of mucous melanomas of the female lower genital tract

Conditions: Malignant Melanoma; Gynecologic Cancer

Summary: the present monocentric prospective phase 2 study aims to reproduce the results obtained at nirs thus offering the possibility of obtaining a promising rate of progression-free survival (pfs) and local control (lc) in patients diagnosed with mucosal melanoma of lower genital tract. systemic treatment with immunotherapy is not the subject of this study but is allowed both in the neoadjuvant and sequential regimens. melanomas have always been considered poorly radiosensitive. it is now accepted that high let (linear energy transfer) particle beams, such as carbon ions, can offer a biological advantage, compared to photons treatment, in radio-resistant neoplasms treatment, thanks to their higher biological efficacy (rbe) against tumours with a low α/ ß ratio. in addition, carbon ions have the physical advantage of an inverted depth deposition profile compared to photons, allowing then a steep dose gradients that ensure increased sparing of adjacent healthy organs at risk (oars).

patients with primary gynaecological melanoma, non-metastatic, non-suitable for surgery, and not previously subjected to conventional radiotherapy can be enrolled in the trial, according to selection criteria. after requested baseline exams, the patient undergoes to simulation phase for the carbon ion radiation therapy, according to study constraints. the patient will then receive immunotherapy not concomitant to cirt. the response is evaluated through recist criteria. pfs is the primary endpoint, calculated from the end of cirt to date of disease progression or death or last follow up.

Eligibility criteria:
inclusion criteria: * histological diagnosis * absence of skin extension * n + (only if confined to the groin and pelvis) * age between 20-80 years * ecog 0-2 * no evidence of metastasis * at least 5 mm away with rectum and bladder wall * no previous rt * written informed consent * patient's ability to understand the characteristics and consequences of the clinical trial * molecular characterization/ mutational state * disease staging (baseline exams) exclusion criteria: * hip prosthesis, or metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan * psychic or other disorders that may prevent informed consent * previous invasive tumor unless patient has been disease free for at least 3 years * contraindication to mri * pregnancy or breastfeeding in progress

Keywords: hadrontherapy, gynecological melanoma