Kornimate/medical-research-clean huggingface dataset:
optimization of prostate biopsy - micro-ultrasound versus mri

Conditions: Prostate Cancer

Summary: optimum is a study designed to compare the ability of ultra-high resolution transrectal micro-ultrasound (microus) and multiparametric mri (mpmri)/us fusion to guide prostate biopsy.

the purpose of the clinical investigation plan and study protocol is to present information for the optimum clinical investigation, including the scientific basis for the study, the procedural details, the exactvu high resolution micro-ultrasound system, its safety details, and administrative details. it has been designed in such a way as to optimize the scientific validity and reproducibility of the results of the study in accordance with current clinical knowledge and practice so as to fulfill the objectives of the investigation.

Eligibility criteria:
inclusion criteria: * men indicated for prostate biopsy due to elevated prostate specific antigen and/or abnormal digital rectal examination * no history of prior prostate biopsy * no history of genitourinary cancer, including prostate cancer * 18 years or older * no contraindications to biopsy * no contraindications to mpmri * no history of mpmri for clinical investigation of prostate cancer within 12 months prior to screening and enrollment in the study exclusion criteria: * history of prior prostate biopsy * history of genitourinary cancer, including prostate cancer * contraindications to biopsy * contraindications to mpmri

Keywords: prostate prostate biopsy micro-ultrasound
asunaprevir/daclatasvir safety surveillance in japanese patients with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the primary objective of this study is: to evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of dcv/asv dual therapy in japanese patients chronically infected with hcv gt-1.

time perspective: other - for patients who are treated before the contract between bristol-myers kabushiki kaisha (bmkk) and the treating physician is initiated, patient data will be collected retrospectively after the contract is signed. data will be collected prospectively for patients who initiate dcv/asv treatment after the contract is initiated patient registry study - yes; 48 weeks (treatment: 24 weeks, follow up: 24 weeks)

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * patients who are initiating dcv and asv treatment for the first time under the approved indications, dosage, and administration will be included in this study

Keywords: hcv
awareness, care & treatment in obesity management - an observation in mainland china

Conditions: Obesity

Summary: action china is a cross-sectional, observational, descriptive, and exploratory survey-based study without collection of laboratory data. the study is not related to any specific treatment options or pharmaceutical product. collection of data will be performed via quantitative online survey by a third-party vendor. the goal of this study is to provide insights to drive awareness around the needs of people living with obesity (plwo) and health care professionals (hcps) involved in obesity treatment and management.


Eligibility criteria:
inclusion criteria: plwo: 1. informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. male or female, aged above or equal to 18 years at the time of signing informed consent 3. lives in mainland china and is native chinese 4. current bmi based on self-reported height and weight of at least 28 kg/m\^2 as per mainland china definition of obesity(16) (calculated using an algorithm within the survey instrument) hcps: 1. informed consent obtained before any study related activities (study-related activities are any procedure related to recording/collection of data according to the protocol) 2. male or female, aged greather than or equal to18 years at the time of signing informed consent. 3. physician with a license to practice 4. specialty is not surgeon (including general, bariatric or plastic surgeon) 5. practices in mainland china with at least 5 years in clinical practice 6. spends at least 50% of time in direct patient care (as opposed to surgical procedures, office procedures or research/administrative tasks) 7. has seen at least 100 patients in the past month 8. has seen at least 10 patients needing weight management (defined as a patient with a bmi greather than or equal to28 kg/m\^2 with or without comorbidities) in the past month exclusion criteria: plwo 1. previous participation in this study. participation is defined as having given online consent in this study 2. currently pregnant 3. participates in intense fitness or body building programs 4. has had significant, unintentional weight loss (due to major injury, illness, etc) in the past 6 months 5. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation hcps 1. previous participation in this study. participation is defined as having given informed consent in this study. 2. unwillingness, inability, or language barriers precluding adequate understanding or cooperation
vancomycin treatment in recurrent psc in liver transplant patients

Conditions: Primary Sclerosing Cholangitis; Post- Orthotopic Liver Transplantation

Summary: the purpose of the study is to investigate the safety and efficacy of oral vancomycin in patients with recurrent primary sclerosing cholangitis (psc) after liver transplantation. the primary endpoint is looking at the effect of the drug on liver function tests, an important surrogate of psc disease activity at 12 weeks on treatment. secondary endpoints include a decrease in liver function tests at 1 year, changes in bilirubin and adverse events. effective treatment at the onset of psc recurrence may lead to decreases in disease progression, recurrent liver failure, and repeat liver transplantation.


Eligibility criteria:
inclusion criteria: 1. history of prior orthotopic liver transplant or liver and kidney transplant. 2. recurrent psc confirmed by clinical labs (ast/alt greater than 19 or alkp greater than normal), imaging (mrcp or ercp), and/or liver biopsy consistent with recurrent psc. 3. no clinical evidence of liver transplant rejection and stability of post-transplant immune suppression dosing for three months prior to enrollment in the study 4. no changes to therapy for inflammatory bowel disease for at least three months prior to enrollment (for patients with history of ibd) 5. patients on ursodiol must have been on a stable dose for two weeks prior to enrollment and dose must be stable for the remainder of the clinical trial. 6. all patients with inflammatory bowel disease must have had a colonoscopy within a year prior to enrollment 7. no antibiotics for 2 months before starting vancomycin 8. no probiotics for 1 month prior to starting vancomycin or during study period exclusion criteria 1. allergy to vancomycin 2. pre-existing advanced malignancies 3. pregnancy or lactation 4. inability to provide consent 5. findings suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis b or c infection, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, wilson's disease, or congenital biliary disease. 6. current biliary obstruction 7. active infection 8. involvement in any other investigational study

Keywords: vancomycin primary sclerosing cholangitis post-liver transplantation
oral health in bariatric patients

Conditions: Adiposity; Dental Diseases; Bariatric Surgery Candidate

Summary: as few is known about the oral health of bariatric patients, this study aimed to analyze the prevalence and severity of erosive tooth wear, dental caries and periodontal diseases of obese patients who underwent bariatric surgery in comparison to obese patients without bariatric procedures.

the prevalence of overweight and obesity is increasing since the 1980s. being associated with several risk factors such as hypertension, hyperinsulinemia and hyperlipidemia, obesity presents an immediate and long-term health risk for diabetes mellitus, heart diseases, osteoarthritis and certain forms of cancer. for the control of obesity several therapy options have been developed: beside conservative treatments including change of diet and lifestyle, bariatric surgery is considered as a promising option for patients with severe obesity (bmi ≥ 40 kg/m2). allowing impressive weight loss from 40 to 80% and effective reduction of comorbidities, bariatric surgery shows some negative/adverse effects as well, like kidney problems, hyperparathyroidism, anemia and metabolic bone diseases. for oral health, two facts are particularly important to consider: firstly, chronic regurgitation reaching the oral cavity is an important risk factor for erosive tooth wear which initially appear as smooth silky-shining glazed surfaces. further progress is often associated with hypersensitivities and aesthetic deficits. over time, often substantial loss can been observed, provoking hypersensitivities and aesthetic deficits. secondly, depending on the type of bariatric surgery, pronounced postoperative metabolic and nutritional changes can be observed which also might influence oral health. aim of this study is to analyze the prevalence and severity of erosive tooth wear, dental caries and periodontal diseases of obese patients who underwent bariatric surgery in comparison to obese patients without bariatric procedures.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * bmi ≥ 25 kg/m2 without or after bariatric surgery exclusion criteria: * refusal for participation * age \<18 years * bmi \<25 kg/m2

Keywords: bariatric surgery periodontitis caries erosive tooth wear gingivitis bmi oral health obesity
evaluation of the use of the atalante exoskeleton in patients presenting an hemiplegia due to cerebrovascular accident

Conditions: Stroke; Stroke, Acute; Stroke, Subacute; Chronic Stroke

Summary: the inspire study is interventional, european, prospective, open, multicentric, each patient being his/her own control. it is conducted to assess the safety and performance of the atalante exoskeleton system in patients presenting an hemiplegia due to cerebrovascular accident. the primary endpoint is defined by the reported adverse events. the study will include 40 patients and takes place in six rehabilitation centers (4 in france, 1 in luxembourg, 1 in belgium).


Eligibility criteria:
inclusion criteria: * patient with hemiplegia due to cerebrovascular accident, occurred two weeks ago or more, follow up in a rehabilitation center or in a hospital (inpatient or outpatient), * patient presenting a fac score of 0, 1, 2 or 3, * patient whose etiological evaluation of the stroke has been complete, * adult patient ≥18 years old, * patient able to read and write in at least one of the languages of the country and who have signed an informed consent form. exclusion criteria: * individuals with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. severe spasticity is defined by a score greater than 3 on the modified ashworth scale, * pregnant women * individuals with history of osteoporotic fracture and pathology or treatment causing secondary osteoporosis, * pressure ulcer of grade i or higher according to the national pressure ulcer advisory panel (npuap) international pressure ulcer classification system- european pressure ulcer advisory panel (epuap), in areas of contact with the atalante system, * severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician. * patient with a cardiac or respiratory contraindication to physical exertion, * patient with a score below 18 on the mini mental state test, * patient unable to deliver his/her consent, * patient under legal protection, * patient participating at the same time in another study, * patients with morphological contraindications to the use of the atalante exoskeleton.

Keywords: robotics rehabilitation physiotherapy powered exoskeleton walking exercises ambulation stroke acute stroke subacute stroke chronic stroke
effects of triphala and vsl#3 probiotic supplementation on stool microbiome profiles and inflammation

Conditions: Human Microbiome

Summary: normal aging can lead to loss of gut microbial biodiversity which is linked to inflammaging and immunosenescence or the loss of immunocompetence. probiotics, such as vsl#3®, and certain herbal supplements such as triphala are associated with restoration of gut community architecture, increased gut barrier function and decreased inflammation. the present project will examine the potential benefits of a synbiotic (which denotes a prebiotic plus probiotic, and in this study, is an herbal prebiotic plus probiotic) intervention (8 weeks of supplementation) on gut microbiome profiles assessed via stool, inflammatory blood markers, and questionnaires about gastrointestinal health and mood. in this exploratory study, the investigators will examine psychological and physical functioning at baseline and after 8 weeks of supplementation with synbiotic, triphala alone, or placebo.

primary aim: in healthy, cognitively intact elderly subjects, determine the effects of an 8-week synbiotic supplement intervention on the stool microbiome (pre- and post-intervention) as compared to triphala alone and placebo. secondary aim: in healthy elderly subjects, examine the effects of an 8-week synbiotic supplementation intervention on inflammatory blood markers compared to herb alone or placebo. exploratory aim 1: in healthy elderly subjects, examine the effects of an 8-week synbiotic intervention on gastrointestinal and psychological health via questionnaires compared to herb alone or placebo.

Eligibility criteria:
inclusion criteria: 1. cognitively intact; 2. able to give informed consent in english; 3. medical clearance by their doctor; 4. \> 60 years of age. exclusion criteria: 1. alzheimer's disease or other neurodegenerative disease such as parkinson's disease; 2. current use or use in the past 3 months of antimicrobial or steroidal drugs; 3. medical conditions affecting immune status (e.g., rheumatoid arthritis, heart failure, hepatitis c, hiv); 4. individuals diagnosed with diabetes mellitus 5. international travel in past 3 months. 6. previous known side effect or negative reaction to vsl#3 or triphala

Keywords: gastrointestinal system inflammatory biomarkers psychological health
carorite™ for skin health and signs of ageing

Conditions: Healthy Volunteer; Skin Condition; Ageing Signs

Summary: the goal of this study is to investigate the efficacy of carotenoids administered orally on skin health, skin condition and visible signs of ageing in healthy females aged 40-55 years old. researchers will compare the study product against placebo.


Eligibility criteria:
inclusion criteria: * females 40-55 years (inclusive) * generally healthy * bmi 18.5-29.9 kg/m2 (inclusive) * able to provide informed consent * agree not to change regular skincare routine * agree to not participate in another clinical trial while enrolled in this trial * agree to not significantly change current diet and/or exercise frequency or intensity during study period exclusion criteria: * regularly taking carotenoid containing medication/supplements within the previous 2 months * have a serious illness e.g. mood disorders such as clinical depression, anxiety disorder or bipolar disorder, neurological disorders such as ms, kidney disease, liver disease or heart conditions * have an unstable illness e.g. diabetes and thyroid gland dysfunction * current malignancy (excluding basal cell carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years * within the last 12-months received cosmetic surgery or procedures, including botox and other injectables, microdermabrasion and laser treatments on their face * within the last 12-months taken medications for acne or other skin conditions including topical retinoids (rein-a, retrieve) oral retinoids such as isotretinoin (roaccutane), benzoyl peroxide, aha's, serum, chemical peels. * active smokers, nicotine use or drug (prescription or illegal substances) abuse * chronic past and/or current alcohol use (\>14 alcoholic drinks week) * pregnant or lactating women * allergic to any of the ingredients in active or placebo formula * participants who are currently participating in any other clinical trial or who have participated in a clinical trial that may affect skin health during the past 1 month * any condition which in the opinion of the investigator makes the participant unsuitable for inclusion

Keywords: females skin health carotenoids
characterization of receptors in non-functioning pituitary macroadenomas

Conditions: Pituitary Tumor

Summary: characterization of receptors present in non-functioning pituitary macroadenomas by reverse transcriptase- polymerase chain reaction (rt-pcr) would assist with targeted medical therapy based on the information obtained by immunohistochemistry and rt-pcr.

the pituitary gland in the brain is the master hormonal gland and is surrounded by important nerves and blood vessels. the pituitary gland can develop various types of tumors, some which do not produce any hormones and are called non-functioning pituitary adenomas. these non-functioning tumors can grow and can cause compression of these important structures. the usual treatment of large non-functioning pituitary macroadenoma is surgery. as it is surrounded by neuro-vascular bundles, this makes complete removal of the tumor sometimes impossible and even dangerous. a large number of subjects will still have some residual tumor post-surgery. the risks of residual tumor are further growth with compression and compromise of the function of surrounding vital organs especially vision. if there is further growth of the tumor the options at present are repeat surgery or radiotherapy. repeat surgery involves all the risks associated with brain surgery and sometimes may not be possible if very close to vital organs, while radiotherapy will over a period of time lead to complete or partial deficiency of pituitary hormone function and has been associated with long term cognitive deficits. in addition radiotherapy has a lag time of 12-24 months prior to onset of action. however, pituitary tumors that do not actively secrete hormones may still harbour receptors to various hormones. the blockage of these receptors by various medications may enable us to stop the tumor from growing or recurring after surgery. this may open up a novel means of treatment of these non functioning tumors. so far there is very little information in the literature about the type of receptors present in these tumors. our study proposes to obtain a piece of the tissue removed during surgery and perform receptor characterization to help improve our knowledge in that area. also correlating the receptor status with the clinical, hormonal and radiological profile of the patients may help to develop improved treatment strategies in the future and help us to predict the possibility of tumor regrowth.

Eligibility criteria:
inclusion criteria: 1. adults, both males and females age 18 years old or more 2. pituitary tumor more than 10 mm in diameter diagnosed by mri 3. no clinical or laboratory evidence of pituitary hormone oversecretion (non-functioning pituitary macroadenoma) exclusion criteria: 1. subjects with pituitary tumors less than 10 mm in diameter 2. subjects with clinical or laboratory evidence of hormone oversecretion 3. presence of dementia

Keywords: non-functioning pituitary adenoma rtpcr hormonal receptors
adolescents bariatric surgery cohort survey

Conditions: Bariatric Surgery Candidate; Obesity, Morbid; Obesity, Adolescent

Summary: obesity affects 3%-4% of the pediatric population and leads to cardiac mortality during adult life. bariatric surgery is the best treatment for weight loss and preventing obesity associated comorbidities in adults, but its applications and safety are yet to be defined for adolescents.

since 2008, in france, certain university hospitals have been eligible to perform bariatric surgery for adolescents. it was therfore possible to define its feasibility, potential complications and specific indications. this led to recommandations published by health authorities (has) in 2016. however, it seems imperative to continue monitoring these patients in order to improve their management, especially as the use of these surgical techniques becomes increasingly widespread. the angers university hospital is one of the leading hospitals when it comes bariatric surgery for adolescents through its use of gastric bands. the aim of this protocol is to update data on how effective this surgery is on weight loss and obesity-associated comorbidities, and to monitor medical, psychological and surgical complications associated with this treatment.

Eligibility criteria:
inclusion criteria: * patients aged 14-20 years of age and asking for bariatric surgery * bmi \>= 40 kg.m-2 or \>= 35 kg.m-2 with major obesity-related comorbidities (hypertension, diabetes, sleep apnea, etc...) exclusion criteria: * an unstable psychiatric disorder * bariatric surgery anesthesic contraindications * having not completed a minimum of six months of the pre operative program * lack of consent from the patient or the patient's relatives.

Keywords: gastric banding complications weight loss
dexamedtomidine in control of intracranial pressure in preeclampsia

Conditions: Intracranial Pressure Control in Pre-eclampsia

Summary: the present study is designed to evaluate the differences in the effect of mg sulphate alone and dexmedetomidine as an adjuvant to mg sulphate on intracranial pressure when administered intravenously in cases of pre-eclampsia

preeclampsia remains one of the leading causes of maternal morbidity and mortality in pregnant women. preeclampsia occurs in 7% to 8% of pregnancies. preeclampsia is a multisystem progressive disorder characterized by the new onset of hypertension and proteinuria or the new onset of hypertension and significant end-organ dysfunction with or without proteinuria after 20 weeks of gestation or postpartum. preeclampsia is a potentially severe disease associated with maternal complications. cerebral oedema is predominantly vasogenic and may be related to failure of cerebral autoregulation with subsequent hyperperfusion, blood brain barrier disruption, and endothelial cell dysfunction. the optic nerve with its dural sheath cover is considered a window to central nervous system. the subarachnoid space surrounds the optic nerve and communicates freely with the cerebral subarachnoid space. changes in the optic nerve sheath diameter (onsd) mirror the changes in the icp as increases in the onsd correlates with increase in the icp. magnesium sulphate (mgso4) is a drug that is routinely used in the treatment of preeclampsia and prevention of eclamptic fits. currently, several mechanisms have been proposed by researchers to explain the neuroprotective effect of mgso4 .dexmedetomidine is a potent alpha-2 adrenergic receptor agonist. dexmedetomidine-induced stimulation of postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow.

Eligibility criteria:
inclusion criteria: female patients aged 25-43 and the gestational age above 34 weeks, with diagnostic preeclampsia (hypertension and proteinuria) occurring after the 20th week of gestation and cesarian section is indicated with systolic blood pressure above 160 and diastolic blood pressure above 100.albumin in urine ++ or +++. no cardiac, hepatic,renal nor neurological problems. exclusion criteria: 1. age: younger than 25 or older than 43. 2. pregnant females with mild preeclampsia. 3. patients with cerebro-vascular diseases, glaucoma, hepatic failure, renal failure . 4. patient who got their mgso4 medication before the first reading of optic nerve sheath diameter onsd were also excluded. 5. history of allergy to dexamedotomidine. -