Kornimate/medical-research-clean huggingface dataset:
protocol to validate the performance of the lifekit® prevent colorectal neoplasia test for crc screening

Conditions: Colorectal Cancer; Colorectal Adenoma

Summary: the purpose of this study is to determine the sensitivity and specificity for lifekit prevent colorectal neoplasia test for colorectal cancer (crc) and for adenoma, including advanced adenoma.

subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. subjects will collect a stool sample that will be tested by the lifekit prevent colorectal neoplasia test at a central laboratory and that will be tested using a commercially available fit. after sample collection, subjects will undergo a screening colonoscopy per standard of care. investigators will be blinded to the results of the lifekit prevent colorectal neoplasia test during the study; the lifekit prevent colorectal neoplasia test and fit results will not be used for clinical management of subjects. personnel performing the colonoscopy and reports from the colonoscopy and personnel performing the histopathological review of the tissue and/or any reports will remain blinded to the results of the lifekit prevent colorectal neoplasia test results.

Eligibility criteria:
inclusion criteria: an individual must meet all of the criteria below to be eligible. 1. subject is ≥ 40 years of age at the time of enrollment. 2. subject presents for a screening colonoscopy per standard of care. 3. subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy. 4. subject is able and willing to sign informed consent. exclusion criteria: an individual meeting any of the below criteria is ineligible. 1. subject has a history of crc or advanced precancerous lesions. 2. subject has a diagnosis or medical history of any of the following conditions: * familial adenomatous polyposis (also referred to as "fap", including attenuated fap and gardner's syndrome) * hereditary non-polyposis crc syndrome (also referred to as "hnpcc" or "lynch syndrome") * other hereditary cancer syndromes, including but are not limited to, peutz-jeghers syndrome, myh-associated polyposis (map), turcot's (or crail's) syndrome, cowden's syndrome, juvenile polyposis, neurofibromatosis, or familial hyperplastic polyposis 3. subject has a diagnosis or personal history of inflammatory bowel disease (ibd), including chronic ulcerative colitis or crohn's disease. 4. subject has a diagnosis of cronkhite-canada syndrome. 5. subject has had a positive cologuard, fecal occult blood test or fit within the previous 2 years. 6. subject has undergone a colonoscopy within the previous 9 years. 7. subject has had overt rectal bleeding within the previous 30 days. 8. subject has any condition that in the opinion of the investigator should preclude participation in the study.
generic zoledronic acid versus original zoledronic acid in postmenopausal osteoporotic women

Conditions: Osteoporosis, Postmenopausal

Summary: this study compares the efficacy and safety of generic zoledronic acid (yigu®) and original zoledronic acid (aclasta®) in the treatment of postmenopausal osteoporotic women in china. four hundred and sixty-six subjects will be randomised (1:1ratio) to either yigu® 5mg iv or aclasta® 5mg iv treatment arms.

a single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis, and it significantly reduced the risk of vertebral fractures additionally. in this research, the efficacy and safety of generic zoledronic acid injection in the treatment of postmenopausal osteoporosis will be evaluated, using original drug as control drug. it will provide evidence for reasonable clinical administrations.

Eligibility criteria:
inclusion criteria: * postmenopausal women between the ages of 46 and 80（cessation of menses for 12 months for any reason） * subjects with osteoporosis diagnosed according to the world health organization (who) criteria：they had a bmd t-score of -2.5 or less at the spine or femoral neck；or they had low bone mass，defined as bmd t-score less than -1.0 and more than -2.5 at the spine or femoral neck，with the history of fragility fracture(fracture site included vertebra, hip,proximal humera, distal radius, distal ulna) * subjects signed informed consent voluntarily exclusion criteria: * any non-primary osteoporosis skeletal disease * subjects with abnormal hepatic function and renal function（alanine transaminase(alt) and aspartate transaminase(ast) are 2 times higher than the upper limits of normal(uln);plasma creatinine concentration and blood urea nitrogen are more than 1.5 uln or calculated creatinine clearance less than 60 ml/min） * subjects with serum calcium greater than 2.75 mmol/l (11.0 mg/dl) or less than 2.00 mmol/l (8.0 mg/dl) * subjects with severe heart disease, blood disease, mental diseases * subjects with cancer and other serious progressive disease * prior therapy with bisphosphonates within 12 months before trial entry, prior therapy with parathyroid hormone 1-34 or 1-84, estrogen, selective estrogen receptor modulators, strontium more than 2 weeks within 6 months, prior therapy with oral or intravenous glucocorticoid more than 3 months within 6 months * subject is hypersensitivity to experimental drugs, comparator drugs and their metabolites * subjects who participated in other drugs or medical devices clinical studies as subjects within 3 months before this study * subjects judged unfit for this study by investigators

Keywords: zoledronic acid yigu aclasta osteoporosis postmenopausal bmd fracture biochemical markers
to study the impact of cpap on gait parameters in osa patients

Conditions: Obstructive Sleep Apnea

Summary: to study the impact of cpap therapy on gait in patients with obstructive sleep apnea syndrome.

to study the impact of cpap therapy on gait velocity and temproral gait in patients with obstructive sleep apnea syndrome using the smtec system. patients will be assessed before and 8 weeks after cpap therapy.

Eligibility criteria:
inclusion criteria: * osa patients newly diagnosed exclusion criteria: * acute medical illness in the past months * neurological and psychiatric diseases * orthopaedic, rheumatologic or any sensory conditions affecting normal walking

Keywords: gait dual task
a clinical study of the safety and efficacy of a wearable device (cls uf) that delivers continuous administration of glucose to recirculated peritoneal dialysis fluid for the purpose of ultrafiltration in patients with congestive heart failure

Conditions: Heart Failure; Cardio-Renal Syndrome

Summary: a single-center, prospective, non-randomized, clinical and first-in-human study. each patient will be studied during a single treatment session of ten hours. the device will be connected to an existing, standard pd catheter that the patient will be using routinely prior to the study (i.e. a peritoneal dialysis catheter will not be specifically inserted for the study). the patient will be hospitalized for observation during the test day and during the night following the study session. ultrafiltration volume, dialysate glucose concentrations, blood glucose concentrations as well the patient's acceptability and tolerance of the wearable device will be evaluated.


Eligibility criteria:
inclusion criteria: * male or female patient, 18-80 years of age. * prevalent pd patients with chf with cardio-renal syndrome type ii, on stable ultrafiltration, for more than two months, treated with pd based uf according to german national guidelines. * therapy resistance of pharmacologic therapy: resistant hypervolemia with ascites, pleural fluid and pulmonary edema * recurrent hospitalization with cardiac decompensation, ≥ 2 occasions during the last six months * isolated failure of the right heart chamber * treatment based on night time apd therapy combined with a day time long dwell. * obtained written consent to participate in the study. exclusion criteria: * end stage renal disease requiring dialysis. * malignant disease. * on-going infection. * diabetes mellitus. * hiv and/or hepatitis positive. * pregnancy. * breastfeeding women. * participation in other clinical trials within one month before inclusion. * abdominal hernia. * cardiac diseases other than left ventricular heart failure, biventricular heart failure or isolated right heart chamber failure, with volume overload. * any immune deficiency.
a study to evaluate the effect of repeat oral doses of ym443 on cardiac repolarization in healthy adults

Conditions: Functional Dyspepsia

Summary: this study evaluates whether ym443 causes any changes in the electrocardiogram of healthy adults.

each subject participates in all four treatment periods separated by washout periods. in order to maintain the blind between arms, all subjects will receive the same number of tablets per day in each period of either active drug or placebo.

Eligibility criteria:
inclusion criteria: * healthy male or non pregnant, non lactating female * weighing at least 45 kg * body mass index (bmi) between 18 and 32 kg/m2 exclusion criteria: * the subject has evidence of any cardiac conduction abnormalities * the subject has a previous history of any medical or psychiatric condition that would preclude participation in the study * the subject has participated in another clinical trial in the last 30 days * the subject anticipates an inability to abstain from alcohol, or caffeine use, or from grapefruit and grapefruit juice from 48 hours prior to the administration of the first dose of ym443 on day 1 of period 1 and throughout the duration of the study * the subject has used tobacco-containing products and nicotine or nicotine-containing products within six months prior to screening * the subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week or has a history of substance abuse, drug addiction, or alcoholism within 2 years prior to screening * the subject has donated any whole blood or cellular blood component or has undergone significant loss of blood or has received transfusion of any blood or blood products within 56 days of day -1 of period 1 or has donated plasma within 7 days of day -1 of period 1

Keywords: qt interval cardiac repolarization cardiac conduction healthy subjects ym443 (z-338, acotiamide hydrochloride) evaluation of qt interval
oral carnosine for neuromuscular performance in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: low levels of tissue carnosine and mitochondrial dysfunction appears to accompany multiple sclerosis (ms), with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in ms, and perhaps win back neuromuscular function. however, several formulations of carnosine have shown limited applicability due to restraints in brain delivery or tissue performance. no human studies so far evaluated the impact of innovative carnosine formulation (karnozin extra) in ms. here, we will evaluate the impact of supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine metabolism, and health-related quality of life in a case series of patients with ms.

multiple sclerosis (ms) is a complex autoimmune disorder that affects millions of people around the world, negatively interfering with different aspects of health and everyday life. being the most frequently seen demyelinating disease, ms prevalence varies considerably, from high levels in north america and europe (\> 100/100,000 inhabitants) to low rates in eastern asia and sub-saharan africa (2/100,000 population). due to its rather high prevalence in developed countries, the development of effective and applicable strategies to prevent or manage ms becomes a must for the medical community. among other factors, it appears that low levels of tissue carnosine and mitochondrial dysfunction accompany ms, with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in ms, and perhaps win back neuromuscular function. however, several formulations of carnosine have shown limited applicability due to restraints in brain delivery or tissue performance thus pushing both industry and researchers to find bioavailable and effective formulation of carnosine. no human studies so far evaluated the impact of innovative carnosine formulation (karnozin extra) in ms. here, we will evaluate the impact of supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine metabolism, and health-related quality of life in a case series of patients with ms.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * body mass index 19 - 30 kg/m2 * free of major chronic diseases or acute disorders besides ms * fulfilled 2017 mcdonald criteria for the diagnosis of ms exclusion criteria: * pregnancy * psychiatric comorbidity * use of dietary supplements within 4 weeks before study commences * unwillingness to return for follow-up analysis * abnormal values for lab clinical chemistry (\> 2 sd) * immunotherapy for the past 6 months * treated with systemic corticosteroids during the 30 days before study commences
jugular venous oxygen saturation during therapeutic hypothermia after cardiac arrest

Conditions: Hypoxic Brain Injury; Hypothermia

Summary: the purpose of this study is to understand what happens to cerebral metabolism during therapeutic hypothermia for hypoxic brain injury following cardiac arrest.

latest international guidelines recommend the use of therapeutic hypothermia in patients who have had cardiac arrest and remain in coma after return of spontaneous circulation. this is recommended essentially to limit the cerebral injury caused by cardiac arrest and possibly amplified upon reperfusion. at times, although a spontaneous circulation has returned, cerebral oxygenation may remain inadequate due to inadequate perfusion pressure, and hypothermia, by reducing cardiac output and cerebral blood flow could actually aggravate this phenomenon. the rewarming period is thought to be at greatest risk of inadequate oxygenation for the increase in metabolic demand. with this study we aim to understand what happens to cerebral oxygenation and metabolism during therapeutic hypothermia for cardiac arrest through cerebrovenous oxygen saturation monitoring and in particular, to see whether through this type of monitoring we could recognize otherwise unnoticed periods of inadequate cerebral oxygenation.

Eligibility criteria:
inclusion criteria: * adult patients in coma after cardiac arrest undergoing therapeutic hypothermia exclusion criteria: * age \< 18 * pregnancy * traumatic brain injury * contraindications to cannulation as severe coagulopathy

Keywords: jugular venous oxygen saturation hypothermia
study of shr-a1811 in her2-expression advanced breast cancer with brain metastases

Conditions: Metastatic Breast Cancer

Summary: this study aimed to evaluate the use of shr-a1811 in her2-expression advanced breast cancer patients with brain metastases.


Eligibility criteria:
inclusion criteria: 1. females ≥18 yrs old; 2. pathologically confirmed her2-positive or her2-low advanced breast cancer; 3. at least one measurable intracranial lesion according to rano-bm criteria, which had not received local treatment; 4. without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment; 5. more than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. patients with her2-low disease must not have systemic treatment for brain metastases. 6. prior her2-target treatment, endocrine therapy and chemotherapy was allowed; 7. life expectancy is not less than 6 months. 8. adequate function of major organs. exclusion criteria: 1. leptomeningeal involvement; 2. cns complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases; 3. previous treatment with trastuzumab deruxtecan (ds-8201a) or any other antibody drug conjugate (adc) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor; 4. patients who had progressed on previous her2 tyrosine kinase inhibitor therapy were excluded from arm 2, and those who had progressed on previous bevacizumab therapy were excluded from arm 3; 5. no concurrent antitumor therapy for metastatic cancer other than the study treatment; 6. antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 2 weeks or endocrine therapy within 1 week prior to enrolment; 7. participated in other drug clinical trials within 4 weeks before admission; 8. history of clinically significant lung disease； 9. other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years. 10. according to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.). 11. any other conditions that researchers believe that patients are unsuitable for this study.
a study to evaluate the safety and immunogenicity of v710 in adults with kidney disease on hemodialysis (v710-005)(completed)

Conditions: Staphylococcus Aureus Infection

Summary: this is a study to evaluate the safety and immunogenicity of v710 with and without merck aluminum adjuvant (maa) in adult participants with end-stage kidney disease who are on hemodialysis.


Eligibility criteria:
inclusion criteria: * diagnosed with end stage kidney disease and is on hemodialysis * female patients who are able to have children must have a negative urine pregnancy tests exclusion criteria: * developed a serious infection within the past 12 months; allergy to the components of the vaccine * has been vaccinated with a live virus within the past 30 days or are scheduled to be vaccinated with a live virus in the next 60 days * received v710 vaccine before
northwell health visits: a family connects pilot implementation at northwell health

Conditions: Unspecified Child Maltreatment, Suspected; Unspecified Child Maltreatment, Confirmed; Postpartum Depression

Summary: northwell health visits (nhv) is a three year pilot replication of the evidence-based model, family connects, which is a brief universal nurse practitioner home visiting program for new mothers and their infants. we seek to compare outcomes among mothers and infants enrolled in the nhv enhanced intervention arm, those enrolled in the nhv screening-only arm, and those in the control arm. nhv will follow a three- armed randomized control trial design.

northwell health visits (nhv) is based on family connects (formerly durham connects), which is a short-term, universal, inexpensive postnatal nurse home visiting program designed to provide brief parenting intervention and to connect families with community resources based on individualized assessments of family needs. the intervention was found to reduce the number of infant emergency medical care episodes and rates of anxiety in mothers, as well as increase community connection, positive parenting behaviors, participation in higher quality out-of-home child care when implemented in durham, so we are looking to replicate these outcomes. we are adapting the model to serve the local population that is served by northwell health - katz women's hospital at long island jewish (lij) medical center, to see if increasing services in and around discharge is more useful for mothers and infants, and improves outcomes for infants. the focus is of early intervention (education and support by nurse practitioner), and connection to community agencies, in order to: reduce healthcare costs, decrease the rate of mothers and infants potentially preventable emergency room visits (ppvs), adhere to well-baby care and mother's postpartum care schedules, improve family functioning, strengthen family partnerships and well-being, reduce necessary reports to child protective services, improve mental and physical health outcomes of mothers and infants within the first six months of life.

Eligibility criteria:
inclusion criteria: * infant born at katz women's hospital at long island jewish (lij) medical center * mother age 18 years or older * mother who has delivered a single live born normal infant, vaginally or by cesarean section * mother primary language spoken is english exclusion criteria: * loss of pregnancy * fetal demise * no health insurance * infant in neonatal intensive care unit

Keywords: postpartum nurse home visitation infant emergency medical care presentations mother emergency medical care presentations parent-child relationship quality family connections to community resources child development and milestone achievement maternal mental health child abuse child neglect child well-care compliance mother well-care compliance
mrd test in common risk stage ii colorectal cancer

Conditions: Stage II Colorectal Cancer

Summary: patients with colorectal cancer who were confirmed as stage ii general risk type in the postoperative pathological report began to be enrolled. observe the sensitivity of the detection of micro-mrd before operation and the postoperative positive rate of this type of patients.

this observation part is about the patients with general risk stage ii colorectal cancer who have received r0 resection after screening by nanofiltration criteria. twenty milliliters of venous blood samples were reserved before surgery, and tumor tissue samples were reserved within 30 minutes in vitro during surgery. after the pathological diagnosis of the patients after surgery, they began to be enrolled. to observe the sensitivity of mrd detection in preoperative diagnosis of patients with general risk stage ii colorectal cancer, and to study its positive rate one month and three months after operation.

Eligibility criteria:
inclusion criteria: * age 18-75; * pathologically confirmed rectal adenocarcinoma; * pathological differentiation is highly or moderately differentiated; * the pathological stage was pt3n0, that is, invasion of the proper muscular layer of the intestinal wall without lymph node metastasis; * no new adjuvant treatment before operation * there was no vascular infiltration and nerve infiltration in postoperative pathology; * no preoperative intestinal obstruction or tumor site perforation; * no postoperative pathological margin was positive or unknown; * the distance between the pathological cutting edge and the tumor was more than 1 cm; * invasion of mesentery of intestinal wall ≤ 2mm; * more than 12 lymph nodes were submitted for examination; * nonlocal recurrence and distant metastasis; * no multiple primary carcinoma of colon and rectum; * physical condition score ps ≤ 2 points; * patients and their families can understand and are willing to participate in this study and provide written informed consent. exclusion criteria: * multiple intestinal carcinomatosis * previous history of malignant tumor, * there are concurrent malignant tumors in the whole body except for colorectal cancer * colorectal cancer with preoperative anti-tumor treatment * pregnant or lactating women * there are serious complications during or after operation, affecting the prognosis * hepatitis b or hepatitis c antibody positive * hiv antibody positive * other diseases considered by the research doctor to affect the prognosis and survival * other conditions that the research doctor believes are not consistent with this study.