Kornimate/medical-research-clean huggingface dataset:
evaluation of the feasibility of developing personalized breast cancer radiotherapy assistive device with 3d printing

Conditions: Breast Neoplasms; Breast Cancer; Left Sided Breast Cancer

Summary: breast cancer is the most common malignancy among women worldwide. for early stage breast cancer, adjuvant radiotherapy is essential to minimize loco-regional disease recurrence. however, significant portions of the heart and the lungs are exposed to low dose radiation during radiotherapy, which result in stochastic side effects among breast cancer survivors. inspired by 3d printing technology, we approached this issue with an in-house made personalized breast holder system (persbra). persbra is composed of a 3d-printed plastic holder covering the whole breast and an air-filled interface. its main function is to reproducibly adjust the breast position to decrease heart and lung radiation exposure in tangential fields. here we propose to measure the performance of persbr in terms of radiation dosimetry in 50 patients receiving scheduled whole breast irradiation. for customized persbra, body shape of the patient with or without a bustier corset will be captured with a handheld 3d scanner and input into a 3d printer for persbra design and manufacturing. a participant will receive two more ct scans in addition to the simulation scan with persbra in place before the first and the sixth fractions of irradiation. these images will be analyzed for dosimetric parameters in the presence/absence of persbra as well as position reproducibility. the data will provide proof-of-principle evidence for the clinical utility of persbra and will facilitate its further refinement.

1. patients with early breast cancer or ductal carcinoma in situ treated with breast conservation surgery. 2. adjuvant radiotherapy to the breast is part of the patient's initial treatment plan. 3. non-contrast ct scan is a routine procedure for the patient's radiotherapy treatment planning.

Eligibility criteria:
inclusion criteria: * patients with early breast cancer or carcinoma in situ after partial mastectomy have decided to receive adjuvant radiation therapy for the breast on the affected side, and use non-contrast computed tomography to obtain localized images is part of the original treatment plan. exclusion criteria: * clinical diagnosis or pathological diagnosis has lymph node metastasis, lymph node micrometastasis, or lymph node tumor cells. * the clinical diagnosis is likely to have metastatic cancer. * pregnant women. * be younger than 20 years old. * the subject was unable to read and understand the subject consent form written in chinese and complete the informed consent procedure.
pi3k delta inhibitor in relapsed / refractory autoimmune hemolytic anemia patients after receiving two or more lines of therapy

Conditions: Autoimmune Hemolytic Anemia; Failure of Two Rounds of Treatment

Summary: this is a prospective, multicenter, single-arm, pilot study. the aim of this study is to evaluate the efficacy and safety of linperlisib, the pi3k delta inhibitor for autoimmune hemolytic anemia patients who failed the second line therapy.


Eligibility criteria:
inclusion criteria: * male or female age ≥ 18 years * diagnosis of primary warm antibody hemolytic anemia (aiha). * hemoglobin \< 100g/l * refractory to or relapsed after at least 2 prior treatment line. * ecog performance status ≤ 2 * willing and able to comply with the requirements for this study and written informed consent. exclusion criteria: * neutrophils counts \< 0.5×10\^9/l or platelet counts \< 50 x 10\^9/l * diagnosis of any of the following diseases: cold agglutinin disease, cold agglutinin syndrome, mixed aiha, paroxysmal cold hemoglobinuria (pch). * diagnosis of the active stage of the connective tissue or systemic autoimmune rheumatic diseases (sards) * history of lymphoproliferative neoplasms * had other inherited or acquired hemolytic diseases. * secondary aiha caused by drugs or infection * previously received organ or stem cell transplantation. * had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors * patients with hbv, hcv, hiv or other infections that require treatment. * abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that alt and ast are 2.5 times higher than the upper limit of normal values * renal impairment: creatinine clearance \<60ml/min * any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract. * had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury. * received rituximab in 6 weeks before enrollment. * received attenuated vaccine 4 in weeks before enrollment * participation in another clinical trial within 4 weeks before the start of this trial * have an allergy to linperlisib or any other part of this medicine. * previously treated with other pi3kδ inhibitor. * pregnant or breast-feeding patients * patients considered to be ineligible for the study by the investigator for reasons other than the above
preoperative pain catastrophizing and intraoperative analgesia consumption

Conditions: Catastrophizing Pain; Pain

Summary: this observational study aims to evaluate the relationship between the pain catastrophizing scale (pcs) and intraoperative analgesia consumption in patients undergoing laparoscopic cholecystectomy. during the preoperative period, patients will complete the pain catastrophizing scale, the beck depression inventory, and the beck anxiety scale. during the intraoperative period, analgesia nociceptive index (ani) electrodes will be placed, and remifentanil dosing will be adjusted accordingly. the correlation between preoperative pain catastrophizing scale scores and intraoperative remifentanil consumption will be analyzed.


Eligibility criteria:
inclusion criteria: * patients with asa scores of i-iii * patients with turkish literacy skills. * patients scheduled for elective laparoscopic cholecystectomy. exclusion criteria: * patients unwillingness to participate in the study. * conversion of surgery from laparoscopic to open surgery. * patients undergoing emergency laparoscopic cholecystectomy.

Keywords: pain
data analysis for drug repurposing for effective alzheimer's medicines (dream)- propranolol/carvedilol versus atenolol/bisoprolol/sotalol

Conditions: Hypertension

Summary: this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

this is a non-randomized, non-interventional study that is part of the dream study of brigham and women's hospital. dream is led by dr. madhav thambisetty, md, phd, chief of the clinical and translational neuroscience section, laboratory of behavioral neuroscience, national institute on aging (nia) intramural research program. this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility criteria:
please see https://docs.google.com/spreadsheets/d/1ltzhhv6avmkpbbsp_9c0dtq0xmmbc00d4jarid5ovaa/edit?usp=sharing or appendix a (https://drive.google.com/drive/folders/1a-1urt73kvyweov8l0cemdngaqyeiudt?usp=sharing) for full code and algorithm definitions. medicare timeframe: 2008 to 2019 (end of data availability). inclusion criteria: * 1. aged \>/= 65 years on the index date * 2. enrollment in medicare part a, b, and d with no hmo coverage for 365 days prior to and including cohort entry date * 3. at least 1 inpatient claim or 2 outpatient claims with hypertension diagnosis recorded in 365 days prior to drug initiation exclusion criteria: * 1. prior history of dementia measured anytime prior to cohort entry date * 2. prior history of nursing home admission in the 365 days prior to the cohort entry date * 3. prior use of propranolol, carvedilol and atenolol, bisoprolol, sotalol * 4. use of propranolol, carvedilol and atenolol, bisoprolol, sotalol concomitantly on index date
omnia efficacy on body fat mass reduction

Conditions: Overweight

Summary: the purpose of this clinical trial is to evaluate the safety and efficacy of a food supplement omnia compared to a placebo in reducing the body fat mass in 70 overweight subjects during 12 weeks treatment.

overweight and obesity represent a serious public health issue. these conditions are characterized by an abnormal or excessive accumulation of body fat mass and they are related to an increase risk of developing chronic diseases such as cardiovascular, diabetes, arthrosis and certain kind of cancer (breast; colon). it's thus necessary to find new products able to counteract both overweight and obesity. omnia is a food supplement based on a phaseolus vulgaris extract. it has pancreatic amylase inhibition properties. in the following clinical trial, omnia will be administrated to a group of overweight subjects in order to evaluate its efficacy on reducing the body fat mass. its action will be compared to a placebo administered to a second group of overweight volunteers with the same modalities as omnia.

Eligibility criteria:
inclusion criteria: * 25≤ bmi\<30 kg/m2 * excess of fat mass * food habits : 3 meals a day and a glucides intake equivalent to at least 40% of daily energy (i.e.: glucides intake at each meal) * able to give a written or verbal informed consent * affiliated or beneficiary of social security exclusion criteria: * weight loss/gain \> 2kg within the preselection period (2 weeks) * abnormal blood results at v0 * physical activity (sport; lifestyle) modification planned or ongoing during the trial * severe pathologies/disorders (bulimia; anorexia; diabetes; cancer...) emerging * pregnancy during the study * consent withdrawal * allergy to omnia * observance \<60% * investigator or promotor decision

Keywords: body fat mass reduction
safety and efficacy trial of ipilimumab versus pemetrexed in non-squamous non-small cell lung cancer

Conditions: Lung Cancer - Non Small Cell

Summary: the purpose of this trial is to determine whether ipilimumab will prolong survival when compared to pemetrexed in subjects with nonsquamous, non-small cell lung cancer.


Eligibility criteria:
for additional information, please contact the bms oncology clinical trial information service at 855-216-0126 or email mycancerstudyconnect@emergingmed.com. please visit www.bmsstudyconnect.com for more information on clinical trial participation. inclusion criteria: * non-squamous, non-small cell lung cancer * recurrent/stage iv non-small cell lung cancer (nsclc) * eastern cooperative oncology group (ecog) 0 or 1 * not progressing after 4 cycles of a platinum-based first line chemotherapy exclusion criteria: * brain metastases (unless stable) * autoimmune diseases
human insulin analogs: evaluation of inflammatory mrna expression of macrophages and endothelial function of short-acting insulin - hermes pilot study

Conditions: Type 2 Diabetes Mellitus

Summary: the planned hermes study is to investigate and compare the effects of insulin glulisine, insulin aspart and regular human insulin on postprandial nitrotyrosine concentrations and several clinical and laboratory markers of postprandial endothelial cell function, sub-clinical inflammation and cardiovascular risk in patients with type 2 dm. the primary parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a biomarker for oxidative stress. as vascular data on insulin glulisine vs. insulin aspart are missing, it is not possible to calculate sample size and statistical power. therefore the goal of the hermes-pilot-study is to generate preliminary data for statistical considerations and estimations on the probability of success of hermes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * stable bot (basal oral therapy) with insulin glargine + ≥ 2 oha (oral hypoglycemic agents except for tzd) for a minimum of three months before entering the study * hba1c ≤ 8.5% * age between 30 and 75 years inclusively * body mass index ≤ 40 kg/m2 * patient consents that his/her family physician will be informed of trial participation exclusion criteria: * type 1 diabetes mellitus * unspecific infection or inflammation (hscrp \>10mg/l in poc test) * use of thiazolidinediones within the last 3 months prior to study start * retinopathy, hepatic or renal dysfunction or clinically relevant other major diseases * history of drug or alcohol abuse within the last five years prior to screening * history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures * history of severe or multiple allergies * treatment with any other investigational drug within 3 months prior to screening * progressive fatal disease * hepatic (alat and/or asat \> 3 times the normal reference range), renal (creatinine \> 1.3 mg/dl in women and \> 1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator * pregnant or lactating women * sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (iuds), sexual abstinence or vasectomized partner * lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
early neonatal respiratory distress: changes in level iib hospital over a period of one year

Conditions: Neonatal Respiratory Distress Syndrome

Summary: respiratory distress is one of the first hospital grounds during the neonatal period. the clinical presentation and severity vary by gestational age and cause. she reports to various etiological factors as maternal, neonatal or sometimes entangled. the symptomatic management has benefited from organizational progress (perinatal care) and techniques, including antenatal steroids, the use of exogenous surfactant and non-invasive ventilation early, so that the use of intubation is less frequent. the short-term evolution of patients with early respiratory distress is based on gestational age, cause and initial management.

main objective: to describe the care and short-term respiratory become newborns 32 weeks gestation or older with early and persistent respiratory distress to 2 hours of life (h2) over a period of one year in a type iib motherhood. methodology : design: retrospective, descriptive, single-center, non-interventional performed in the saint joseph neonatal unit. study duration: 1 year (01/05/2013-04/30/2014). acquisition of data: the patients were selected from the hospitalization reports of infants by taking the following key words: respiratory distress, invasive and noninvasive ventilation, intubation, exogenous surfactant, pneumothorax. data collected: * obstetric data: * mode of delivery: route of delivery, presentation at birth. * maternal morbidity. * antenatal corticosteroids in infants less than 34 weeks. * neonatal data: * gestational age * birth weight * cord ph * apgar m5 * the terms of the allocation: * tracheal intubation * ventilation modes (controlled mechanical ventilation (vmc), non-invasive ventilation (niv), nasal cannula), the maximum reached fio2 (fraction of inspired oxygen), ventilation time for each ventilation mode. these different methods were studied in the delivery room during hospitalization (in intensive care and neonatal intensive care "nicu"). * the place of hospitalization: resuscitation and / or nicu. * the transfer to the nicu resuscitation if necessary. * received drugs (exogenous surfactant, antibiotics, caffeine) * the successful primary diagnosis.

Eligibility criteria:
inclusion criteria: * gestational age (a) ≥ 32 sa * birth weight (pn) ≥ 1000 g * respiratory distress appeared in the first 2 of life and non-limiting in h2. exclusion criteria: * ag \<32 sa * pn \<1000g * malformation diagnosed ante or immediate postpartum justifying a specific urgent care. * respiratory distress appeared before h2 and h2-limited before, whatever the company therapeutic. * respiratory distress appeared after h2.
gluten ingestion biomarkers in patients w gluten sensitivity and healthy controls peptides in patients with non-celiac gluten sensitivity and healthy patients: a placebo-controlled study

Conditions: Non Celiac Gluten Sensitivity

Summary: non-celiac gluten sensitivity (ncgs) is an emerging clinical entity defined as the presence of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved by a gluten free diet (gfd) in patients without celiac disease or wheat allergy. the pathologic mechanism of the disorder is unknown, and there are no known biomarkers or associated histopathologic findings. in this prospective, randomized controlled trail, we are investigating the utility of patient reported symptom questionnaires, as well as stool gluten and urine quantification tools in patients with ncgs and healthy controls.


Eligibility criteria:
inclusion criteria include * patients \> 18 years of age * patients willing to maintain gluten free diet for 6 weeks exclusion criteria (ncgs): * patients \< 18 years of age * patients with positive serology suggestive of celiac disease and/or biopsy-proven celiac disease and/or human leukocyte antigen (hla) dq2 or dq8 positivity. * patients with a diagnosis of inflammatory bowel disease * patients with a diagnosis of acute gastroenteritis * patients who are pregnant * type 1 diabetes mellitus exclusion criteria (healthy controls): * ncgs * celiac disease * inflammatory bowel disease * irritable bowel syndrome * acute gastroenteritis * patients who are pregnant * type 1 diabetes mellitus
first-in-man study of single ascending dose of a new drug for neurological disorders

Conditions: Healthy Subjects

Summary: the primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy male adults


Eligibility criteria:
inclusion criteria: * signed informed consent * healthy on the basis of physical examination, electrocardiogram and laboratory tests. * a subject who has a female partner of childbearing potential or a pregnant partner agrees to use a condom in combination with spermicide or a condom, respectively, from screening, during the entire study, and for at least 3 months after (the last) study drug intake * body mass index (bmi) of 18.0 to 29.9 kg/m2 (inclusive) at screening and day -1. * systolic blood pressure (sbp) 100-140 mmhg, diastolic blood pressure (dbp) 50-90 mmhg, and pulse rate 50-90 bpm (inclusive), measured after 5 min in the supine position at screening and at day -1. exclusion criteria: * history or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment * previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions * any cardiac condition or illness with a potential to increase the cardiac risk of the subject based on medical history, physical examination, or electrocardiogram (ecg) evaluations * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
assessment of the impact of intestinal gas emission quality on the postoperative course after abdominal surgery

Conditions: Postoperative Complication; Recovery, Physiological

Summary: the recovery of transit after surgery is an important parameter in postoperative evaluation. it generally reflects simple postoperative outcomes and allows the patient to return home. the quality of gas recovery after surgery has not been studied to our knowledge, but it is not uncommon for an operated patient to emit some gas considered as a recovery of transit when it is ultimately a false transit preceding a postoperative ileus. furthermore, intestinal gases and their composition reflect the intestinal microbiota. this microbiota has been shown to be predictive of the appearance of an operative complication. as the analysis of this microbiota cannot be carried out routinely, it is important to be able to use a reflection of this microbiota in routine practice and to correlate it with the surgical outcomes. intestinal gas therefore seems to be the tool of choice. the main objective is to evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality. the secondary objectives are to compare the quantity and quality of gases pre- and post-operatively and to define a predictive score for surgical complications, based on the number and quality of post-surgical gases. data regarding gas transit are collected by the patient in a questionnaire the two days before the surgery and until the patient leaves hospital (or until day 15 post-operative if the patient is still hospitalized). data regarding possible complications ((defined according to dindo-clavien as any deviation from the expected postoperative outcomes within 90 days following surgery) are collected throughout the hospital stay (day 0 : surgery to day 15 post-operatively), during the post-operative consultation (day 30) and during a telephone call to the patient (day 90). the expected results are to highlight a correlation between the quality/quantity of gases and post-operative outcomes. a predictive score for complications could then be proposed and validated during this study.


Eligibility criteria:
inclusion criteria: * patients ≥18 years old * indication for open or laparoscopic abdominal surgery * whose expected length of stay is ≥ 2 days non inclusion criteria: * patients requiring a stomy on the initial surgery * need for immediate postoperative intensive care * emergency surgery * patient not knowing how to read or write * poor understanding of the french language * person deprived of liberty by judicial or administrative decision * person subject to psychiatric care under duress * person subject to a legal protection measure * person unable to express consent * person objecting to participating in research exclusion criteria: -immediate post-operative intensive care

Keywords: transit surgery abdomen stool gas
grafted patients' anxiety report

Conditions: Autologous Transplant Indication

Summary: autograft is a technique requiring several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. in this study, level of anxiety will be reported weekly throughout hospitalizations for autologous transplant, to detect the most stressful period.

autograft is one of hematological malignancies treatment, such as lymphoma and myeloma. this technique requires several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. according to the medical and scientific report of the biomedicine agency in 2016, 3 043 patients were involved in an autologous transplant, which represents a significant number of patients potentially exposed to these types of anxiety. that is why it will be interesting in this study to report weekly the level of anxiety throughout their hospitalization for the autologous transplant, to detect the most stressful period. a validated questionnaire will be used: the had (hospital anxiety and depression) scale of anxiety and depression.

Eligibility criteria:
inclusion criteria: * autograft indication according to the multidisciplinary concertation meeting exclusion criteria: * incapacity to complete surveys

Keywords: autograft anxiety protected environment