Kornimate/medical-research-clean huggingface dataset:
supr study (supine versus prone treatment position in breast radiotherapy)

Conditions: Breast Cancer

Summary: a randomised, two-arm, non-blinded crossover study investigating the impact of treatment position (prone versus supine) upon reproducibility of tumour bed position in patients undergoing breast radiotherapy following excision of early breast cancer.

to establish whether or not the prone (face down) position reduces exposure of healthy tissue to radiation when compared to the supine position. to compare patient comfort and acceptability in each of the prone and supine positions. to perform a time and motion study for radiotherapy planned and delivered in each of the prone and supine positions.

Eligibility criteria:
inclusion criteria: * complete microscopic excision of early stage invasive ductal or lobular carcinoma (pt1-3b n0-1 m0) with breast preservation. * paired titanium clips marking anterior, posterior, and radial walls of excision cavity * breast cup size c or above * recommendation for whole breast radiotherapy * no requirement for nodal irradiation * ability to lie prone on breast board * for left-sided breast cancer patients, cardiac and lad doses must be ≤10% greater than those predicted for the supine position. * for all patients, the following absolute dose constraints should be met: ≤5% of heart volume to receive 18gy and ≤10% of ipsilateral lung volume to receive ≥20gy * age ≥18 * ps ≤1 * no previous radiotherapy to the affected breast * no concomitant herceptin * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. * written informed consent given according to ich/gcp before registration/ randomisation. * patients can only be randomised into this trial once.

Keywords: breast cancer radiotherapy prone position
ibogaine in the treatment of alcoholism: an open-label escalating-dose trial

Conditions: Alcoholism

Summary: approximately 5% of the world's adult population has some alcohol-related disorder, which in addition is associated with 3% of all deaths in the world. in brazil, harmful use and dependence on alcohol reach about 10% of the population, with alcohol being one of the main factors of disease and mortality. although the medications currently used have some efficacy, the adverse effects and relatively long time of treatment are factors that may reduce patients' motivation to continue taking the medication correctly. therefore, it is necessary to conduct research with new drugs for the treatment of alcoholism. ibogaine is an alkaloid present in the bush tabernanthe iboga (iboga), a plant from central africa traditionally used in countries such as gabon and cameroon. animal studies and case series suggest that one or a few doses of ibogaine significantly reduce withdrawal symptoms and the intensity of use of various drugs, including opioids, psychostimulants, and alcohol. however, there are no controlled clinical studies that have explored these effects. the aim of the present study is to evaluate the safety, tolerability and efficacy of increasing doses of ibogaine in 12 alcoholic patients. each patient will be hospitalized for 20 days and receive 3 increasing doses of ibogaine. the first 3 patients will receive oral doses of 20 to 400 mg of ibogaine in an open-label design. if the 3 higher doses (240, 320 and 400 mg) are well tolerated, the next 9 volunteers will receive these doses or placebo randomly. the volunteers will also be evaluated 7, 14 and 21 days and 1, 3, 6 and 12 months after leaving the hospital to monitor the consumption of alcohol and other drugs.


Eligibility criteria:
inclusion criteria: * literate people * diagnosis of alcoholism assessed by the structured clinical interview for diagnostic and statistical manual of mental disorders (scid-v) * history of at least two previous failed treatments for alcoholism (with drug use and / or psychotherapy) * signing the free and informed consent form. exclusion criteria: * presence of any psychiatric diagnosis (excluding alcohol / tobacco / nicotine abuse / dependence) assessed by the scid-v * presence of clinical disease (especially cardiovascular and hepatic diseases), based on interview, physical and laboratory examination (hemogram and electrocardiogram, ecg) * absence of family or personal history of bipolar disorder and psychotic disorders * absence of recent symptoms of hypomania, mania or psychosis * non-literate people * pregnant or lactating women * recent use of illicit drugs (confirmed by examination in urine).
physical evaluation and quality of life in the practice of fencing in breast cancer support

Conditions: Breast Cancer

Summary: the data collection of physical evaluations after regular practice of the fencing at patients having surgically been treated for breast cancer highlighted encouraging results both on the functional drawing, and on the improvement of the quality of life.

recent scientific works show that a regular physical activity decreases the rate of second offense of breast cancer from 20 to 50 % at the women beforehand treated for breast cancer. the objectives: * participate as a supplement to the physiotherapist in the mobilization of the operated shoulder * act in association with the surgical and medical team to release the adhesions superficial * welcome these women hurt through a participative sports project * get them a fencing adapted in a friendly atmosphere * offer them personalized exchanges * to propose a consequent energy expenditure but according to each and to the context * have a practice of the operated side * make them practise a sport with pleasure and without fatal effects by the practice of the sports activity, investigators wish to help these people upset in their life to find the joy of life, to have projects, to find some pleasure to share moments of user-friendliness. having led a fight against the disease to help them to lead a new fight of fencer happy to have a practice.

Eligibility criteria:
inclusion criteria: * patients operated for the breast cancer in the hospital rene dubos * patients who have sign a consent * patients having supplied an aptitude certificate in fencing exclusion criteria: * patients who have a contraindication in the sport

Keywords: fencing, cancer
diagnosis and staging of neuroendocrine tumors (nets) utilizing 68ga-dotatoc pet/ct scan

Conditions: Neuroendocrine Tumors

Summary: the primary goal of the analysis is to estimate the diagnostic accuracy of gallium 68 (68ga) -dotatoc pet/ct for detecting neuroendocrine tumors (nets) compared to conventional imaging techniques such as magnetic resonance imaging (mri) and computerized tomography (ct). participants with histologically and/or clinically confirmed and/or suspected net will be enrolled.

this is a prospective, phase 2, single center study of participants with neuroendocrine tumors (nets). study participants will receive 68ga-dotatoc. dotatoc is a somatostatin analogue that localizes on the somatostatin receptors expressed by nets and is attached to a radioactive material called gallium 68. participants will undergo a pet/ct imaging study to investigate 68ga-dotatoc's suitability as a positron emission tomography (pet) imaging agent for nets. the radiation (imaging) dose will be 111-185 megabecquerel (mbq) (3 - 5 mci) ± 25%. all doses after labeling will be presented in buffered solution for intravenous injection. imaging will start 90 ±30 minutes after injection. sensitivity and specificity of this imaging technique will be compared with those of conventional imaging modality including ct, mri and in-111 octreoscan performed within 6-12 months before or after pet/ct.

Eligibility criteria:
inclusion criteria: * signed informed consent. * patients of either gender, aged ≥18 years. * karnofsky status ≥60. * life expectancy of at least 12 weeks. * histologically and/or clinically confirmed and/or suspicious of net. * a diagnostic ct or mri of the tumour region or suspected area within the previous 12 weeks prior to dosing day is available. * somatostatin-analogue scintigraphy scan with result (positive or negative) within the last 12 weeks. * recent blood test results up to 4-6 weeks as follows: 1. white blood cell (wbc): \>2\*109/l 2. haemoglobin: \>8.0g/dl 3. platelets: \>50x109/l 4. alanine aminotransferase (alt), aspartate aminotransferase (ast), and alkaline phosphatase (ap) each less than, or equal to, 5 times its upper limit of normal (uln) 5. bilirubin less than, or equal to, three times its uln * serum creatinine: within normal range or \<120μmol/l for patients aged 60 years or older. * negative pregnancy test in women capable of child-bearing. exclusion criteria: * known hypersensitivity to gallium 68, dotatoc or to any of the excipients of 68ga-dotatoc. * therapeutic use of any somatostatin analogue, including sandostatin® lar (long acting release) (within 28 days) and sandostatin® (within 2 days) prior to study imaging. if a patient is on sandostatin® lar a wash-out phase of 28 days is required before the injection of the study drug. * pregnant or breast-feeding women. * current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
trial of combination antifungal therapy (vori+mica vs. vori+placebo) in invasive aspergillosis

Conditions: Aspergillosis

Summary: the purpose of this study is to evaluate the therapeutic effectiveness of combination antifungal therapy (cat) of voriconazole plus micafungin versus voriconazole plus placebo equivalent as primary therapy for invasive aspergillosis (ia) in patients with hematological cancer.

patients will receive either iv micafungin 100 mg or placebo equivalent daily. intravenous (iv)voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. patients may be switched to oral voriconazole 200 mg bid provided aspergillosis response is achieved and gastrointestinal functions are intact.

Eligibility criteria:
inclusion criteria: 1. the patient or legally authorized representative has signed an informed consent/assent. assent will be obtained as required by the uams irb. 2. the patient has a diagnosis of proven or probable invasive aspergillosis and with positive aspergillus gm index (≥0.5 ng/ml) provide the patient is not receiving antibiotics, such as piperacillin-tazobactam, that are known to cause false positive gmi 3. the patient is 18 years of age or older. exclusion criteria: 1. the patient is being treated with an unlicensed investigational drug for aspergillosis. 2. the patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin b, or lipid formulation of amphotericin b) for \> 7 days immediately prior to randomization for treatment of the probable, or proven invasive aspergillosis for which the patient is being enrolled. 3. patient has invasive aspergillosis but with negative aspergillus gm index. 4. the patient is pregnant or lactating. if the patient is female and of childbearing potential, the patient must have a negative pregnancy test and avoid becoming pregnant while receiving study drug. a pregnancy test should be performed within 14 days prior to the first dose of study drug. 5. the patient has alkaline phosphatase, alt, ast or total bilirubin greater than five times the upper limit of normal. 6. the patient has hepatic cirrhosis. 7. patients with creatinine \> 3 will be enrolled only if able to receive oral voriconazole (specify oral loading dose is 6 mg/kg po q 12 hours for 24 hours) then oral maintenance 200 mg po q 12 hours). 8. the patient is on artificial ventilation, and unlikely to be extubated within 24 hours of study entry. 9. the patient has a history of allergy, hypersensitivity, or any serious reaction to the azole or echinocandin class of antifungal agents. 10. the patient has previously enrolled into this study. 11. the patient has a concomitant medical condition, which in the opinion of the investigator may create an unacceptable additional risk. 12. the patient has an active microbiologically-documented deep infection due to a non-aspergillus mold. 13. the patient has a life expectancy of less than seven days.
prognostic value of short-term follow-up biomarkers after discharge in hospitalized patients with acute heart failure

Conditions: Heart Failure

Summary: several surrogate biomarkers including natriuretic peptide(np), and growth differentiation factor-15(gdf-15) and st2 has prognostic significance in heart failure(hf), and reductions in its value may predict clinical improvement. however, there are limited data regarding the prognostic value of these biomarkers during short-term follow-up after discharge in acute decompensated heart failure. the purpose of this study is to evaluate the prognostic value of short-term follow-up surrogate biomarkers for predicting prognosis of hospitalized patients with acute decompensated heart failure.


Eligibility criteria:
inclusion criteria: the diagnosis of heart failure requires the following 1. heart failure with reduced ejection fraction ( a 'reduced' ejection fraction (ef) defined as ef \<40%): the presence of symptoms and/or signs of hf 2. heart failure with preserved ejection fraction ( a 'preserved' ef defined as ef≥ 40%) requires the all of the followings: a) the presence of symptoms and/or signs of hf b) elevated levels of natriuretic peptides (defined as b-type natriuretic peptide (bnp) \>100pg/ml and/or n terminal b-type natriuretic peptide (nt-probnp) \>300pg/ml) c) any structural heart disease (left atrial volume index ≥ 34 ml/m2, left atrial dimension ≥ 50 mm, posterior or septal wall thickness ≥ 11mm) exclusion criteria: * any severe condition limiting life less than 3 months * the patient is not ready to contact by telephone at the end of the study

Keywords: heart failure biomarkers prognosis
characteristics of cardiac tumor and the risk stratification of subsequent adverse events (unique)

Conditions: Cardiac Tumor

Summary: this study aims to retrospectively and prospectively collect clinical and biological specimen data from patients with cardiac tumors who meet the inclusion and exclusion criteria. various techniques, including general molecular biology analysis and multi-omics analysis, will be used to construct a prognostic model for cardiac tumors.

this study aims to construct a retrospective-prospective long-term follow-up cohort and management system for cardiac tumors through a multi-centre collaborative network. the duration of the study will be divided into retrospective and prospective components. the retrospective study will collect cases of cardiac tumors from 2003-2022; the prospective study is expected to collect cases of cardiac tumors from 2022-2030. the study is expected to assess the disease characteristics, progression patterns, clinical features, natural course and long-term prognosis of cardiac tumors.

Eligibility criteria:
inclusion criteria: * patients who are regularly visited and followed up in the corresponding cardiovascular center. * all patients must meet at least one of the following diagnostic criteria for cardiac neoplasms: 1. cardiac myxoma group; 2. cardiac fibroma group; 3. cardiac lipoma group; 4. cardiac hemangioma group; 5. cardiac undifferentiated sarcoma; 6. cardiac angiosarcoma group; 7. cardiac rhabdomyosarcoma group; 8. cardiac lymphoma group; 9. cardiac metastasis group; 10. other cardiac tumors group. exclusion criteria: * age \ 80 years old. * pregnant and lactating women. * the patient declined to provide informed consent to participate in the study. * none of the above was met, but the patient was temporarily unable to sign the informed consent form due to coma and other reasons, and no legal representative signed it instead. depending on the patient's condition, the patient may not be able to regain consciousness and sign the informed consent form.

Keywords: cardiac tumor disease characteristics prognosis
modeling and pharmacological targeting of genetic cardiomyopathy in children via cardiomyocytes derived from induced pluripotent stem cells (dmdstem)

Conditions: Cardiomyopathy, Familial

Summary: interventional, cross-sectional biomedical study of children with genetic cardiomyopathy and healthy children. the aim is to generate, via induced human pluripotent stem cells (hipsc), "patient-specific" cardiomyocytes (cms) (hipsc-cms) to study the molecular mechanisms of cardiomyopathies of genetic origin.

interventional, cross-sectional biomedical study of children with genetic cardiomyopathy and healthy children. the aim is to generate, via induced human pluripotent stem cells (hipsc), "patient-specific" cardiomyocytes (cms) (hipsc-cms) to study the molecular mechanisms of cardiomyopathies of genetic origin. the study will be proposed to the parents or legal guardians of the children from 0 to 17 included sent in pediatric cardiology consultation to the university hospital of montpellier as part of their usual follow-up or a health check (control) . the only direct intervention performed on the patient is a venous blood sample. the volume of blood collected will be lower than the thresholds defined in the decree of december 2nd, 2016 on minimal risks in biomedical research (3 ml).

Eligibility criteria:
group 1 : child with genetic cardiomyopathy inclusion criteria * child from 0 to 17 years old included * bearer or at risk of cardiomyopathy of genetic origin. written and informed consent of parents or guardians of legal guardians * affiliation or beneficiary of a social security scheme criterion of non-inclusion . cardiomyopathy of non-genetic origin (metabolic, toxic, malformative, etc.) group 2 : healthy child inclusion criteria * children aged 0 to 17 years old * normal assessment: clinical examination, ecg, echocardiography * written and informed consent * affiliation or beneficiary of a social security scheme criterion of non-inclusion * heart, muscle or respiratory disease * treatment with cardiac resonance * other chronic diseases (diabetes, neuropathy, kidney failure, tumor)

Keywords: cardiomyocytes induced pluripotent stem cells genetic cardiomyopathy
validation and evaluation of the french version of a hearing loss screening questionnaire in adults aged 60 years old and more

Conditions: Hearing Loss

Summary: nowadays in france, there is no organized screening of the hearing loss in the elderly; however, it is a very common disease and simples tests to perform to detect it exist. lots of studies use surveys to identify deaf people; but physicians often consider them too sensitive and less specific because lots of people were classified into " deaf " people meanwhile they have a subnormal tonal audiogram. now, it's known that it corresponds to the "hidden hearing loss" concept: it's defined as an auditive disturbance in a noisy ambiance in people with a normal tonal audiometry; corresponding to infraclinical cochlear lesions. these lesions, if detected early, can be prevented to avoid an audition degradation in time. the aim of the study is to determinate the values of sensitivity and specificity of the hhie-s survey translated into french, so it could be used as a screening method of hearing loss in the elderly and as a prevention of cochlear damages.

the hhie-s survey is one of the more used in studies to screen hearing loss in elderly. it has never been validated in french: that's why investigatosr want to test it on the french population, to determine its performance characteristics (sensitivity and specificity). secondary, investigators study think that people that have high score on the hear loss screening survey, but a normal tonal audiometry have actually a hidden hearing loss. this corresponds to infraclinical cochlear lesions that we want to reveal thanks to a new audiometric test: an audiometry in a noisy ambiance. the study will take place in a research audiometric room in the department of ent in bordeaux. patients will fill a medical survey the hhie-s survey translated into french and perform a tonal audiometry test and after it a " speech in noise " audiometry test (vrb in french). the duration os study is one unique session of 45 minutes including patient information and consent.

Eligibility criteria:
inclusion criteria: * are 60 years old and more * are able to express their consent * are affiliated to the french social security exclusion criteria: * have known hearing problem of any kind * have performed an audiogram within the past 6 months * have required medical examination for any hearing problem * have had ear surgery of any kind (except form myringotomy tube during the childhood) * have mental or physical serious injury(ies), which results an impossibility to fill a survey and perform an audiogram * are under protection schemes

Keywords: hearing loss screening elderly hidden hearing loss speech in noise audiometry hhie-s survey
preoperative score of inguinal hernias. is it useful to predict outcomes

Conditions: Inguinal Hernia

Summary: to analyze and validate a preoperative score of difficulty of inguinal hernias and its correlation with postoperative outcomes


Eligibility criteria:
inclusion criteria: * male sex * age \> 18 years * primary inguinal hernia * unilateral hernia * elective surgery exclusion criteria: * recurrent inguinal hernia

Keywords: inguinal hernia preoperative score kingsnorth score
a prospective, mono-country and multi-center study to observe safety and effectiveness of adalimumab in korean intestinal behcet's disease(bd) patients

Conditions: Intestinal Behcet's Disease (BD)

Summary: this study evaluates the safety profile and effectiveness of adalimumab in korean intestinal behcet's disease (bd) patients in routine clinical practice.


Eligibility criteria:
inclusion criteria: * subjects must be an adult \>= 19 years * subjects who are eligible to be treated with adalimumab for intestinal behcet's disease in accordance with the approved label in korea * subjects provide written authorization form for use/disclose of personal health data prior to participating in this study exclusion criteria: * subjects who are contraindicated to any anti-tnf agent * female subjects who are pregnant or breast feeding * subjects who are participating in other interventional clinical trials

Keywords: intestinal behcet's disease (bd) adalimumab safety effectiveness amore study