Kornimate/medical-research-clean huggingface dataset:
dce-mri and mbi in assessing tumor response to chemotherapy in patients with triple negative breast cancer

Conditions: Estrogen Receptor Negative; HER2/Neu Negative; Progesterone Receptor Negative; Triple-Negative Breast Carcinoma

Summary: this early phase i trial studies how well dynamic contrast enhanced molecular resonance imaging (dce-mri) and technetium-tc99m sestamibi molecular breast imaging (mbi) work in assessing tumor response to chemotherapy in patients with triple negative breast cancer (tnbc) who are undergoing chemotherapy. investigational imaging scans such as mbi and dce-mri may help researchers predict which patients may respond to treatment.

primary objectives: i. to determine the predictive value of advanced imaging modalities tc99m sestamibi (technetium tc-99m sestamibi) molecular breast imaging (mbi) and dynamic contrast enhanced (dce) magnetic resonance imaging (mri) for neoadjuvant chemotherapy (nac) response in triple negative breast cancer (tnbc). secondary objectives: i. to evaluate and compare the ability all imaging modalities including standard of care digital mammogram (dm) and ultrasound (us) as well as novel modalities dce-mri and mbi to assess and predict response to neoadjuvant chemotherapy (nac) in patients with triple negative breast cancer (tnbc). exploratory objectives: i. to determine effect of molecular subtype of tnbc on diagnostic performance of different types of imaging modalities in predicting treatment response. ii. to determine the utility of dynamic tc99m sestamibi mbi and dce-mri together with molecular profiling to identify a subgroup of chemoresistant tnbc patients. outline: patients undergo dce-mri over 45-60 minutes. patients receive technetium tc-99m sestamibi via injection, and after 5 minutes patients undergo mbi scan over 1 hour. both dce-mri and mbi are performed at the time of enrollment, at the end of anthracycline therapy, and at the conclusion of nac before surgery. all patients also undergo standard of care imaging with dm and us (at the same time points if the treating doctor chooses to do so).

Eligibility criteria:
inclusion criteria: * the patient has proven tnbc, defined by standard pathologic assays as negative for estrogen receptor (er) and progesterone receptor (pr) (\< 10% tumor staining) and negative for human epidermal growth factor 2 (her2) (immunohistochemistry \[ihc\] score \< 3, gene copy number not amplified) * tnbc patients who are previously untreated and enrolled in the prospective institutional review board (irb) approved clinical trial: 2014-0185 * patients who are able to understand and give consent to participating in the study exclusion criteria: * is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother * has lesions involving chest wall * has known allergy to tc99m sestamibi * has known contraindications to mri * has contraindication to mri contrast
a pharmacogenetic investigation of antipsychotics in schizophrenia and schizophrenia-like psychoses

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: an individual's genetic make-up is known to determine their response to antipsychotic medication. genetic markers that determine efficacy and side effects of medication may be identified and used to predict treatment outcome. the study is a naturalistic study of routinely prescribed antipsychotics using outcome measures undertaken as part of the routine clinical care of the cohort. these clinical data are linked with genetic information obtained from dna and rna from blood samples undertaken as part of the study. no alteration is made to the subjects treatment regime or medication. the study is a two stage investigation: * the first stage involves the collection of a databank of clinical information and blood samples for dna and rna extraction from patients treated with antipsychotic medication. * the second stage is a molecular genetic investigation of treatment-related genetic factors that may contribute to response prediction and predisposition to side effects. from these genetic studies pharmacogenetic prediction tests will be validated and/or developed.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained * dsm-iv diagnosis must be one of: * schizophrenia * schizophreniform * schizoaffective * delusional disorder * brief reactive psychosis * psychosis not otherwise specified * ethnic origin of both parents must be known * a minimum of 6 weeks continuous treatment completed with the given antipsychotic, prescribed at least at minimum recommended doses * prospectively collected outcome data available (pre-treatment and after at least 6 weeks on treatment) exclusion criteria: * significant psychiatric or medical co-morbidity including history of: * head injury with loss of consciousness * seizures * neurological disorder * mental retardation (dsm-iv) * drug or alcohol dependence (dsm-iv) * serious physical illness e.g. malignancy, hepatic/renal insufficiency * concomitant psychotropic medication that may influence ratings * concomitant antipsychotics, antidepressants or mood stabilisers prescribed for \>2 weeks during the antipsychotic treatment period rated

Keywords: pharmacogenetic dna rna antipsychotic olanzapine risperidone quetiapine personalized medicine
comparison of standard cystoscopy with carbon dioxide cystoscopy

Conditions: Bladder Injury; Ureter Injury; Surgical Injury; Complication of Surgical Procedure

Summary: for the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared.

it was aimed to investigate whether routine cystoscopy with carbon dioxide is a safer and faster method for the evaluation of lower urinary tract injuries compared to standard saline cystoscopy. in addition, with this study, it will be studied whether bladder bleeding or intra-bladder masses can be evaluated more quickly and clearly.

Eligibility criteria:
inclusion criteria: 1. laparoscopic hysterectomy for benign reasons planned patients 2. the operation will be performed in our hospital 3. reporting preoperative endometrial and cervical samplings as benign 4. after discharge, control examinations will be carried out in our hospital. exclusion criteria: 1. abdominal, robotic or vaginal hysterectomies 2. malignant reporting of preoperative cervical and endometrial samplings 3. patients do not want to participate in the study

Keywords: laparoscopic hysterectomy lower urinary tract injury cystoscopy
case-control-study on the breast cancer risk of mirena® compared with copper iuds

Conditions: Breast Cancer

Summary: the objective of this study is to determine the breast cancer risk of mirena® users compared to copper intrauterine device (iud) users in a community-based case-control study.

this is a community-based case-control study in germany and finland. cases will be identified from cancer registries, tumor centers and breast centers. matched controls will be accrued from the same region as the case came from. breast cancer cases and their controls are women under 50 years of age without known history of malignancies. cases are women with a breast cancer who are younger than 50 years of age at cancer diagnosis. the breast cancer was diagnosed between january 2000 and december 2007. only alive cases and cases in a sufficiently good health status to be interviewed are eligible for the study. controls are women without a breast cancer diagnosis who are younger than 50 years of age at the time of the interview. about 3 controls matched by year of birth and region will be allocated to each case. a standardized questionnaire will be used for all breast cancer cases and controls. the questionnaire will be mailed to cases and controls. study participants will be asked for their informed consent. data confidentiality according to national laws will be ensured by the field organizations.

Eligibility criteria:
inclusion criteria: * cases: women with a breast cancer who are younger than 50 years of age at cancer diagnosis * controls: women without a breast cancer diagnosis who are younger than 50 years at the time of the interview exclusion criteria: * women who are not willing to participate

Keywords: breast cancer
effectivity and safety of ultrasound-guided percutaneously laser ablation for refractory neoplasms

Conditions: Refractory Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of ultrasonography (us) -guided laser ablation liver, kidney, pancreas, lung and retroperitoneal tumors, the investigators used preoperative and postoperative us/ceus/ct/mri to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. intraoperative us/ceus/ct would be applied to monitor ablation lesions.


Eligibility criteria:
inclusion criteria: * patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), * patients with child-pugh a/b, * patients with plt ≥ 50\*10e9/l and pt ≤ 20s. exclusion criteria: * patients with blood coagulation dysfunction, childpugh ≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.

Keywords: ultrasonography-guided laser ablation
saxagliptin triple oral therapy

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.

a 24-week, multicentre, randomised, double-blind, placebo-controlled phase iiib study to evaluate efficacy and safety of saxagliptin in combination with metformin and sulfonylurea in subjects with type 2 diabetes who have inadequate glycaemic control with combination of metformin and sulfonylurea

Eligibility criteria:
inclusion criteria: * written informed consent * males or females with type 2 diabetes with inadequate glycaemic control (hba1c \> or = 7% and \< or = 10%) despite being on combination of metformin and sulfonylurea for at least 8 weeks prior to visit 1 * bmi \< or = 40 kg/m2 exclusion criteria: * symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with \> 10% weight loss in 3 months prior to entry, or other signs and symptoms * history of diabetic ketoacidosis or hyperosmolar non-ketotic coma * current or prior use within 3 months of visit 1 of insulin, ddp4 inhibitor, glp-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea) * treatment with cyp3a4 inducers and/or potent cyp3a4/5 inhibitor * estimated crcl \< 60 ml/min at visit 2 * chf (nyha class iii or iv) and/or lvef \<40% * active liver disease and/or significant abnormal liver function defined as ast and/or alt \> 3 x uln and/or bilirubin \> 2.0 mg/dl at visit 2. * creatine kinase \> or = 10 x uln at visit 2

Keywords: type 2 diabetes inadequate glycaemic control saxagliptin metformin sulfonylurea triple oral therapy
effects of dairy- and berry-based snacks on postprandial glucose metabolism in older people

Conditions: Postprandial Hyperglycemia

Summary: malnutrition or its risk is common among older people. to maintain adequate nutrition, increased meal frequency is important. in addition to main meals, regular consumption of nutrient- and energy-dense snacks is recommended. the study examines the post-meal responses to dairy- and berry-based snacks tailored for older people. the plasma concentrations of glucose, insulin and free fatty acids are measured during three hours after snack consumption. in addition, subjective satiety responses and heart rate variability are recorded.


Eligibility criteria:
inclusion criteria: * home-dwelling exclusion criteria: * smoking * type 1 diabetes * type 2 diabetes treated with oral medications or insulin * cognitive impairment * antibiotic medication within the past 3 months * blood donation within the past month

Keywords: older people nutrition dairy berries postprandial glucose insulin
study to evaluate safety and immunologic biomarker of rapamune in patients with stable renal transplant recipient

Conditions: Acute Rejection of Renal Transplant

Summary: for patients who meet the inclusion criteria and who agree to participate in this study, the investigators sampled peripheral blood 10cc and performed the analysis for immunologic profile just before the conversion of immune suppressant. at 1 month, 6 month, and 1 year from the conversion of immune suppressant (cni to rapamune), the investigators performed tha analysis fo immune profile again. during the study period, the interval of the visit of subclinic and the kinds of laboratory test (blood and urine test) would not change compared to before the start of this study.


Eligibility criteria:
inclusion criteria: 1. renal transplant recipient who has passed at least 10 years 2. no acute rejection episode during the previous 6 months 3. no change of prescription of immune suppressants 4. normal allograft function (mdrd egfr \> 80 ml/min/1.73 m2) 5. change of allograft function less than 10 % of baseline value durant the previous 1 year 6. no proteinuria and hematuria exclusion criteria: 1. patients who donut want to participate in this study 2. patients who should continue immune suppressant due to another cause (e/g combined autoimmune disease)
the effect of protein supplement on lean body mass in patients with pneumonia

Conditions: Community-acquired Pneumonia

Summary: the purpose of this clinical trial is to reduce the patient's loss of lean body mass by protein supplementation during hospitalization and 60 days after hospital discharge. also, the study aims to reduce the risk of readmission to the hospital due to relapse or complications and thereby improving the overall health for the patients. the intervention group will receive protein supplementation during hospitalization and after discharge, while the control group will continue their normal diet.

infections are globally the biggest cause of mortality. in denmark community acquired pneumonia is one of the most common causes for infections in patients. mortality in pneumonia has been stable high over the past 10 years. therefore, it is relevant to look at improving the prognosis of these patients. after a longer period of hospitalization, patients generally have a poor condition with loss of body weight and lean body mass. hereafter, patients must often undergo a longterm rehabilitation period and they become inactive and fatigue. this is a threat for the patients, due to the fact that there is a higher risk of complications and readmissions. proteins are the body's building blocks. thus, supplementing patients with a daily higher protein content, it is believed to reduce their loss of lean body mass, and thereby reduce the total loss of body weight as well. protein supplementation together with vitamin- and mineral supplementation is thought to improve all these health risk markers for the patients. methods: inclusion: 40 men and women \>60 years hospitalized with community acquired pneumonia intervention: the patients will be randomized to either the control- or intervention group. they will receive the same treatment and care, the only difference is that the patients in the intervention group will receive protein- and vitamin supplementation.

Eligibility criteria:
inclusion criteria: * hospitalized patients with community acquired pneumonia * \>60 years * patients who are able to speak and understand danish exclusion criteria: * patients with hospitalized acquired pneumonia * patients with septic shock * patients with an active cancer and in cancer treatment * patients in dialysis * icu patients * patients unable or unwilling to give informed consent

Keywords: pneumonia community acquired pneumonia protein lean body mass weight loss readmission infection
rapid device testing protocol for parkinson's disease

Conditions: Parkinson Disease; Healthy

Summary: this is an 8 week observational study to evaluate the feasibility of using remote monitoring technologies in future studies of pd. the study will 2 clinical evaluations (one initial, one final), and an 8-week monitoring period including 4 virtual visits where participants will use a combination of digital devices (emerald touchless sensor system with associated ankle accelerometer, iphone, apple watch, ipad, fitbit aria, fitbit versa, withings blood pressure monitor connect, and/or withings sleep mat) during their daily lives.


Eligibility criteria:
inclusion criteria: participants with pd * at least 30 years of age * clinical diagnosis of pd by a neurologist or other movement disorder specialist as reported by the participant, with current motor symptoms * able to ambulate independently (assistance of minor walking aids such as a cane is permitted, but depending on a walker for ambulation is not) * have a bmi of 33 or below calculated by participant reported height and weight at the time of screening * have a care partner who meets the study's inclusion criteria * able to read, understand, and provide written informed consent in english * able, either alone or with a care partner, to operate digital devices * have reliable wifi in their home and the ability to connect new devices to their home wifi care partners * at least 18 years of age * able to read, understand, and provide written informed consent in english * able to operate digital devices * care partner for the participant with pd enrolled in the study * lives with the participant with pd enrolled in the study * able to ambulate independently (assistance of minor walking aids such as a cane is permitted, but depending on a walker for ambulation is not) * willing to exclude pet from the participant's bedroom at night for the duration of the study exclusion criteria: participants with pd * any non-pd forms of parkinsonism * active psychiatric disorders that affect the ability to complete study tasks * any other medical condition that is the primary cause of the present movement disorder * cognitive dysfunction (score \> 7 on the six-item cognitive impairment test) * considered by the investigator to be an unsuitable participant * live in a household with more than three people * unwilling to exclude pet from their bedroom at night for the duration of the study care partners * cognitive dysfunction (score \> 7 on the six-item cognitive impairment test) * considered by the investigator to be an unsuitable participant
impact of covid-19 pandemic and social distancing on mental health of chronic inflammatory rheumatism affected patients

Conditions: Covid19; Rheumatic Fever; Mental Disorder

Summary: recent studies have highlighted the consequences of covid-19 pandemic and social distancing on mental health of individuals. the aim of this study is to evaluate those consequences within a sample of inflammatory chronic rheumatism affected patients, taking into account the well-known key role of stress in the set-up of such diseases.

the previous h1n1 and sras-1 pandemics, that required to containment and quarantine, have lead to the emergence of mental symptoms such as stress, anxiety, insomnia... the french coconel study during the covid pandemic have shown the major psychological impact of this crisis on the population, leading to stress and fears. stressful life events are well-known factors of chronic inflammatory rheumatisms set-up or flare. the aim of this study is therefore to evaluate the psychological impact of covid-19 pandemic on chronic inflammatory rheumatism (cir) affected patients. a case-control prospective multicentric study will be performed on 212 cir patients versus 106 controls to compare the stress level in each group. patient reported outcomes will be evaluated, using electronic questionnaires, as well as classical clinical informations on cir evolution during a 6-months follow-up period. an ancillary study on 100 patients will also be realized to quantify cytokine serum levels and determinate transcriptomic profiles.

Eligibility criteria:
for the cases: inclusion criteria: * adult patient (age over 18 years old) * patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus, still disease, scleroderma...) * patient without any language difficulty * affiliated to an health insurance system * and who agree to participate in the study for controls : inclusion criteria: * adult patient (age over 18 years ol * patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period, * patient without any language difficulty, * affiliated to an health insurance system, * and who agree to participate in the study. for cases and controls : exclusion criteria: * pregnant or lactating patient * psychiatric patient * patient under guardianship or other legal protection regimen.

Keywords: covid19 chronic inflammatory rheumatism stress patient reported outcomes
the effect of clip-traction on esd resection time.

Conditions: Adenoma Colon

Summary: patients scheduled for an endoscopic submucosal dissection(esd) in the colorectum will be randomized to the use of a traction device(consisting of an endoscopic clip with a loop of dental floss secured in the lesion to be removed, another clip will anchor the loop to adjacent bowel wall) or a standard esd.

patients with an adenoma or an early colorectal cancer treatable with endoscopic submucosal dissection will be randomized to the use of a traction device or a standard esd. location, morphology and size of the lesion will be recorded. time of the procedure will be measured using a stopwatch

Eligibility criteria:
inclusion criteria: * a lesion in the colon or rectum suitable for removal by the esd technique exclusion criteria: * dementia * inability to understand the written study information
quercetin in coronary artery by-pass surgery

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to test the anti-inflammatory and anti-senescence effects of quercetin during coronary artery by-pass graft surgery.

after being informed about the study and the potential risk, all patients giving written informed consent will be randomized in a double-blind manner (participant and investigators) on 1:1 ratio to receive quercetin (500 mg twice daily) or placebo (twice daily) starting 2 days before a coronary artery by-pass graft surgery and for the duration of their hospitalization but up to 10 days (i.e. up to 7 days post-surgery). blood (5 ml) will be collected the first morning after recruitment (t-1), 24h post-surgery (t1), day 4 post-surgery (t2) and day of hospital discharge for blood analyses. during the surgery, if a discarded segment of mammary artery is available, it will be collected for laboratory work. health status will be assessed during the follow-up visit 8 to 12 weeks post-surgery.

Eligibility criteria:
inclusion criteria: * to be able to speak french or english; * to be able to give free and enlighten consent; * be hospitalized and waiting for a cardiac surgery of revascularization; * to have had a myocardial infarction (mi) within the past 30 days or to be in a state of stable angina before the surgery. exclusion criteria: * to be in a stable state without mi in the last 30 days; * have a cardiac surgery concomitant to the cardiac surgery of revascularization; * have an infection in the last 30 days; * to have renal insufficiency (gfr less than 30); * to have a liver disease (ast, alt or bilirubin ˃ 2x normal values); * to have a known cirrhosis; * to have a past history of breast cancer or other tumors estrogen-dependent; * to be intolerant to flavonoids, niacine or ascorbic acid; * take quinolone; * need for a quinolone during post-op; * not being able to give a free and enlighten consent; * not being able to speak french of english; * take quercetin as a supplement.

Keywords: inflammation endothelium senescence vascular reactivity