Kornimate/medical-research-clean huggingface dataset:
implementing ctdna and circular dna in patients with localized pancreatic cancer

Conditions: Resectable Pancreatic Cancer

Summary: the goal of this clinical trial is to investigate if plasma ctdna and eccdna before resection for suspicion of pancreatic ductal adenocarcinoma (pdac) can predict early recurrence and overall survival, and to investigate if plasma ctdna combined with ct scan and endoscopic ultrasound surveillance increases the median overall survival compared with standard-of-care surveillance.

the aim of the circpac study is to evaluate if plasma ctdna from patients scheduled for surgical resection of pdac can identify patients who will benefit from surgery and if plasma ctdna can identify recurrence earlier and improve the survival and quality of life of the patients compared with standard-of-care surveillance. patients operated for pdac will be included in this danish multicenter study including an observational study (sub-study 1: 700 patients) and an interventional randomized trial (sub-study 2: 410 patients). in sub-study 1, patients will have blood samples drawn prior to surgery, 4 weeks after surgery, and 6 months after surgery. in sub-study 2, patients without recurrence 4 months after surgery, will be randomized in a 1:1 manor to an experimental arm (arm a) with ctdna guided surveillance, or to a control arm (b) with standard surveillance.

Eligibility criteria:
inclusion criteria: * sub-study 1: suspicion of pdac tumor stage i-iii, scheduled for pancreatic resection, with or without preoperative neoadjuvant chemotherapy. * sub-study 2: . * pdac tumor stage i-iii * has received intended curative resection (r0/r1) of pdac * no signs of local recurrence or metastatic disease at a ct scan 4 months after the operation exclusion criteria: * other cancers (excluding skin cancer other than melanoma) later than 3 years before inclusion * patients who are unlikely to comply with the protocol, inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the study
a comparison study with alendronate and raloxifene in postmenopausal women with osteoporosis (0217-189)

Conditions: Osteoporosis, Postmenopausal

Summary: the purpose of this study is to compare how well alendronate and raloxifene increase the bone density in women who have osteoporosis and have experienced menopause.


Eligibility criteria:
inclusion criteria: * patient is postmenopausal (or surgically menopausal) for at least 6 months * patient must be diagnosed with osteoporosis * patient has spinal anatomy suitable for dexa of the lumbar spine exclusion criteria: * patient is receiving or has received treatment prior to randomization which might influence bone turnover * patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss) * patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism
cardiometabolic syndrome response to therapeutic lifestyle changes

Conditions: Metabolic Syndrome; ASCVD; Lifestyle Risk Reduction

Summary: intensive lifestyle intervention has shown to be effective in high risk patient populations and has gathered support from leaders-as outlined in the 2015 consensus paper by the cardiometabolic health alliance. thus there has been a call to establish new care models that assist metabolic syndrome patients in reducing there risk. the investigators aim to evaluate the impact of a lifestyle intervention program on metabolic syndrome patients.


Eligibility criteria:
inclusion criteria: * metabolic syndrome patients meeting 3 of 5 criteria: 1. waist circumference (37 in) in white and aa men, (35 in) in asian men, and (31.5 in) in women; 2. triglycerides ≥150 mg/dl; 3. high-density lipoprotein cholesterol (hdl-c) \<40 mg/dl in men and \<50 mg/dl in women; 4. blood pressure ≥130/85 mm hg 5. fasting glucose ≥100 mg/d or hgba1c ≥ 5.71 (includes diabetics) * patients requiring secondary ascd prevention exclusion criteria: * patients with less than 5 year survival * patients with cancer undergoing therapy or on palliative treatment * patients with end stage heart failure

Keywords: cardiometabolic clinic
effect of magnesium sulphate on analgesia following knee arthroplasty

Conditions: Knee Arthroplasty, Total; Postoperative Pain

Summary: this study is designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block following total knee arthroplasty.

pain after knee arthroplasty is a serious concern. this study was designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block on analgesic requirements following total knee arthroplasty.

Eligibility criteria:
inclusion criteria: * scheduled for elective unilateral primary total knee arthroplasty exclusion criteria: * patient refusal to enroll in the study * patient refusal of neuraxial anesthesia * existence of contraindications for neuraxial anesthesia * known history of allergy to any of the study drugs

Keywords: total knee arthroplasty postoperative pain continuous femoral nerve block magnesium sulphate
effect of consuming a mixture of extracts and dha on the mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the objective of this trial is to evaluate the effect of the consumption of a mixture of extracts and dha on the mild cognitive impairment.

according to the world health organization, around 50 million people in the world have dementia, so developing new strategies to prevent cognitive impairment is an important aspect. certain plant extracts have properties related to the improvement of brain function. in addition, adequate levels of dha are essential for good cognitive functioning throughout the life cycle. therefore, the objective of this trial is to evaluate the effect of the consumption of a mixture of extracts and dha on the mild cognitive impairment.

Eligibility criteria:
inclusion criteria: * men and women over 50 years of age at the time of the screening visit. * mild cognitive impairment according to multidomain criteria. * mini mental state examination (mmse) ≥21. * availability of an accompanying who is responsible for the patient taking the study product and attending visits. * patients and accompanying who agree to sign the informed consent before performing any study procedure and after they have been informed about the methods and limitations of the study. exclusion criteria: * inability to perform neurocognitive tests. * intake currently (or in the two weeks prior to the start the study) of nutraceuticals that may alter the results of the study: vitamin complexes, omega-3 supplements, omega-3 fortified foods, ginkgo supplements, or any other specific supplement for memory improvement. * consumption of anti-dementia drugs such as memantine or cholinesterase inhibitors (ice). * consumption of benzodiazepines in unstable doses. * severe psychiatric pathology. * allergy to any of the ingredients of the study product or placebo (lactose intolerance, intolerance to milk protein or allergy to any of the extracts used).

Keywords: dha plant extracts cognitive brain
breath gas measurement of propofol during anesthesia in patients with endourological procedures

Conditions: Urological Disease

Summary: propofol can be measured continuously in breath gas during anesthesia. this study compares propofol concentration in plasma and breath gas and processed electroencephalographic monitoring (bispectral index) under clinical conditions with patients and total intravenous anesthesia. target controlled infusion technique is used to deliver adequate propofol concentration in plasma.


Eligibility criteria:
inclusion criteria: • 18 years of age * written informed consent * ability and willingness to give written informed consent * american society of anesthesiologists (asa) risk score i-ii exclusion criteria: * denial of the patient * patients asa physical status iii- iv * pregnancy * volunteers with history of neurological disease or stroke * volunteers with a history of recreational drug abuse * volunteers with a history of alcohol abuse * known drug allergies * history of adverse events during general anesthesia * total intravenous anesthesia not practicable
angiotensin ii and chronic inflammation in persistent microvascular dysfunction following preeclampsia

Conditions: Preeclampsia

Summary: women who develop preeclampsia during pregnancy are more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. the reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. the purpose of this investigation is to 1) determine the mechanisms contributing to this lasting blood vessel damage and chronic inflammation, and to 2) identify factors (both physiological and pharmacological) that mitigate these negative effects in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.


Eligibility criteria:
inclusion criteria: * post-partum women who have delivered within two years and who have had a preeclamptic pregnancy diagnosed by their obstetrician before 34 weeks of gestation and confirmed according to the american college of obstetricians and gynecologists criteria for severe preeclampsia. \[this information will be self-reported by the subjects.\] * post-partum women who have delivered within two years and who have had a normal pregnancy. * 18 years and older. exclusion criteria: * skin diseases * current tobacco use * diagnosed or suspected hepatic or metabolic disease * statin or other cholesterol-lowering medication * history of hypertension prior to pregnancy * history of gestational diabetes * current pregnancy * allergy to aspirin or nsaids or known allergy to materials used during the experiment (e.g. latex) * renal disease, bleeding disorders and history of gastrointestinal bleeding. * known allergies to study drugs * taking blood thinners, aspirin or nsaids. * women who choose to breastfeed will not participate in any parts of the project that include salsalate.

Keywords: preeclampsia microvascular inflammation angiotensin ii
recurrent urinary tract infections and the microbiome

Conditions: Recurrent Urinary Tract Infection

Summary: the primary objective is to determine if polymerase chain reaction (pcr) (utip™) is more sensitive in identifying urinary tract infections (uti's) than standard urine cultures.


Eligibility criteria:
inclusion criteria: * 18 y/o-90 y/o * able to consent * female * group a only: recurrent uti (2 utis in 6 months) * group b only: no history of recurrent utis exclusion criteria: * pregnant * pelvic radiation * urinary retention (\>200 ml residual) * greater than stage 2 prolapse * renal calculi * immunosuppressed * neurologic disorder with significant bladder impairment * no current uti via dip stick
superselective adrenal arterial embolization for refractory hypertension: a proof-of-concept study

Conditions: Essential Hypertension

Summary: the subjects of this study were patients with essential refractory hypertension. the purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (saae) in patients with primary refractory hypertension and to explore the possibility of saae in patients with primary refractory hypertension.after the subject completes the saae, an 8-week follow-up will be conducted to assess the safety and effectiveness of the saae.

the subjects of this study were patients with essential refractory hypertension. the study design was a single-center, open-label, self-controlled, single-arm, prospective study. the purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (saae) in patients with primary refractory hypertension and to explore the possibility of saae in patients with primary refractory hypertension.after the subject completes the saae, an 8-week follow-up will be conducted to assess the safety and effectiveness of the saae.

Eligibility criteria:
inclusion criteria: * age \> 18 years, no gender restrictions; * primary refractory hypertension: taking three antihypertensive drugs, including a - diuretic, with an average office systolic blood pressure ≥150 mmhg measured three times; * duration of hypertension greater than 6 months; * standing plasma aldosterone and renin activity not below the lower limit of the unit's reference range; * signed informed consent form. exclusion criteria: * morning cortisol level \ 5.5 mmol/l; * type 1 diabetes, uncontrolled hyperthyroidism, malignant arrhythmias, malignant tumors, decompensated heart failure, severe liver dysfunction, severe hematological diseases, severe obstructive sleep apnea syndrome, history of myocardial infarction, syncope, cerebral hemorrhage, or cerebral infarction within the past 3 months; * pregnant women or those planning to conceive within the next year; * presence of other severe organic diseases that would make the patient unable to tolerate superselective adrenal arterial embolization; * adrenal mass with a diameter exceeding 2 cm; * severe allergy to contrast agents; * patients enrolled or planning to participate in other clinical studies that could impact the results of this study.

Keywords: essential hypertension superselective adrenal arterial embolization interventional therapy
effectiveness of childbirth preparation education

Conditions: Perception of Traumatic Birth; Perceived Stress

Summary: the act of birth, which is considered a natural event, is an act that the mother will remember with positive experiences in her life if it progresses normally. however, sometimes birth can be perceived as stressful and traumatic for women. stress during pregnancy is a problem that should be emphasized and managed due to its negative effects on the health of the mother and the baby. as the pregnancy progresses, the levels of stress hormones may increase. in addition, the thought of spontaneous birth exposes women to physical discomfort, stress and uncertainty during pregnancy. the perception of traumatic birth is an important concept that emerges as a result of the woman's mental birth scenario, the information she has acquired about birth, and every situation she experiences during the birth, and also affects the postpartum period. in studies conducted in turkey using the traumatic birth perception scale, it was determined that 23.6% and 26.9% of women experienced a high level of traumatic birth perception. nulliparity, negative feelings about birth, inadequate antenatal care, inadequate psychosocial support, risky pregnancies, and lack of information about birth are among the factors that may cause traumatic birth perception. physical and mental preparation for birth and information about pain management are considered to be the basic elements of prenatal education classes. there are study results indicating that birth preparation classes benefit women in many aspects such as self-sufficiency, reduced fear of birth, and positive pregnancy experience. no study results have been found in the literature examining the effect of birth preparation education on the perception of traumatic birth during pregnancy. based on this, this study was needed to examine the effect of pregnant women's participation in childbirth preparation training on their perceived stress level and perception of traumatic birth.


Eligibility criteria:
28-34th weeks of pregnancy agree to participate in the study be literate be able to speak and understand turkish

Keywords: childbirth childbirth preparation percieved stress perception of traumatic birth
long-term safety of lumacaftor/ivacaftor in participants with cystic fibrosis who are homozygous for f508del and 12 to <24 months of age at treatment initiation

Conditions: Cystic Fibrosis

Summary: this is a phase 3, multicenter, open-label and roll-over study in participants who are 12 to \<24 months of age at initiation of lumacaftor/ivacaftor (lum/iva) treatment.


Eligibility criteria:
key inclusion criteria: * participants from study vx16-809-122 part b (study 122) * completed the 24-week treatment period and the safety follow-up visit in study 122b * participants not from study 122 * subjects will be 1 to less than 2 years of age * homozygous for the f508del mutation (f/f) key exclusion criteria: * any clinically significant laboratory abnormalities that would interfere with the study assessments or pose an undue risk for the subject * solid organ or hematological transplantation other protocol defined inclusion/exclusion criteria may apply.
telemonitoring versus usual care

Conditions: Health Care Quality; Health Care Access

Summary: background: older adults with multiple chronic illnesses are at risk for worsening functional and medical status with ensuing hospitalization. one goal of medical care is to prevent this decline. one method that may help slow this functional and medical decline is home telemonitoring. specific aim: to determine the effectiveness of home telemonitoring compared to usual care in reducing combined outcomes of hospitalization and emergency room visits in an at risk population over 60 years of age. materials and methods: this will be a randomized trial of 200 patients into one of two interventions. home telemonitoring involves the use of a computer device at home which records biometric and symptom data from patients. this information is monitored by mid level providers associated with the primary care medical practice. usual care involves patients who make appointments with their providers as problems arise and utilize ongoing support like a 24 hours nurse line. the study participants are adults over 60 years of age within the highest 10% on elderly risk assessment (era) scores. patients will have initial evaluations of gait, quality of life (sf12), kokmen test of mental status, and phq 9. patients will be followed for 1 year for primary outcomes of hospitalizations and emergency room visits. secondary analysis will include quality of life, compliance with the device and attitudes about telemonitoring. sample size is based upon an 80% power to detect a 36% difference between the groups. the primary analysis will involve cox proportional time to event analysis comparing both interventions for telemonitoring or usual care. secondary analysis will use t-test comparisons for continuous variables (quality of life, attitudes) and chi square for proportional analysis.


Eligibility criteria:
inclusion: 1. at least 60 years of age; 2. have an elder risk assessment (era) index score of 16 or greater; 3. are able to participate fully in all aspects of the study; 4. have been provided with, understand, and have signed the informed consent; exclusion: 1. patients who are currently residing in a nursing home 2. patients with a clinical diagnosis of dementia 3. patients with a score of ≤29 on the kokmen short test of mental status 4. patients for whom we cannot obtain informed consent. 5. patient under the age of 60 will also be excluded from participating. 6. patients who have not granted universal research authorization to use medical records. 7. patients will also be excluded if the subject would not be able to use the interventional machine

Keywords: telemonitoring usual care elderly hospitalization emergency room visits
the life and care of colorectal cancer patients after 65 years and their family

Conditions: Colorectal Cancer

Summary: given a context where patients autonomy respect is important, it is necessary to pay a sustained attention to the patients care and life experiences, as well as the families and relatives of patients with colorectal cancer or patients in remission of colorectal cancer. thanks to families and relatives data, it will allow to improve the analyses carried out by the "societal cancer observatory" in 2016.


Eligibility criteria:
inclusion criteria: the patients will be: * over the age of 65 and under 80 * with a colorectal cancer operated between 65 and 80 years with a documented histological diagnosis, dating from 2 to 5 years. * be able to provide informed consent and appoint a caregiver who would be willing to participate in the study. the spouse and / or children and / or parents will be eligible: if he is at least 18 years old, if he can be considered a caregiver of the index patient for whom a diagnosis of crc has been made. exclusion criteria: * patients with a diagnosis of colorectal cancer before the age of 65 or after the age of 80 from 2 to 5 years old. near a deceased patient or under 18 years old.
predict tooth wear

Conditions: Prediction of Tooth Wear

Summary: tooth wear, resulting from gradual loss of dental hard tissue due to mechanical and chemical factors, impacts tooth structure, texture, and function. it affects quality of life, with varying prevalence (26.9% to 90.0%), and is traditionally detected visually during check-ups, often at advanced stages. monitoring alterations in tooth shape via intraoral scanners aids early detection, but restoration remains challenging. prevention through early detection is vital, as patients may not fully comprehend tooth structure loss until visible. recently, statistical shape analysis (ssa) used to learn the tooth anatomy and define a reference shape (biogeneric tooth) using. however, assuring landmark consistency is challenging mostly due to biases of the operator. recently, a robust method called meg-isoquad offered automated, isotopological remeshing. combining this with ssa holds promise for diagnostic and simulation purposes. this study aims to assess the reliability of a remeshing-ssa approach for altered and intact premolar analysis and compare machine learning algorithms for simulating the shape of the initially intact tooth or future altered one. the clinical perspective of the current work offers possibilities to: * prevent future tooth wear by detecting it at an early stage; and communicate better to the patient by presenting him/her potential future altered teeth * simulate the adapted reconstruction for the altered tooth by simulating the initially intact one


Eligibility criteria:
inclusion criteria: * teeth avulsed presenting a tooth wear index between 0 and 3 * mature incisor, canine, premolar or molars (1st and 2nd only) exclusion criteria: * teeth avulsed presenting a tooth wear index over 3 (or presenting an oral rehabilitation representative of a similar wear) * immature teeth or teeth without root edification * wisdom teeth
effect of nigella sativa on nonalcoholic steatohepatitis and steatosis

Conditions: Nonalcoholic Steatohepatitis; Liver Steatosis

Summary: the investigators hypothesize that nigella sativa will have an effect on nonalcoholic steatohepatitis and liver steatosis by enhancing lipophagy in the liver tissue.


Eligibility criteria:
inclusion criteria: * patients suffering from steatohepatitis * patients suffering from liver steatosis exclusion criteria: * patients suffering from viral hepatitis * patients with hiv infection * patients suffering from wilsons disease