Kornimate/medical-research-clean huggingface dataset:
stool sample collection protocol for development of screening test for colorectal cancer and other digestive tract cancers

Conditions: Colorectal Neoplasms; Digestive System Diseases; Colonic Diseases; Colorectal Cancer

Summary: the primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.

this is a multi-site, prospective sample collection study. subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of crc and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy. one stool sample from approximately 300 subjects will be collected in this study. a blood sample will also be collected from subjects.

Eligibility criteria:
inclusion criteria: * subject is male or female, 40-90 years of age, inclusive. * subject has a diagnosis of crc, at any stage, confirmed with a tissue biopsy or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy. * subject understands the study procedures and is able to provided informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. exclusion criteria: * subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement). * individual has a condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Keywords: cancer colorectal cancer neoplasm colorectal neoplasm intestinal neoplasms gastrointestinal neoplasms digestive system neoplasms neoplasms by site neoplasms digestive system diseases gastrointestinal diseases colonic diseases intestinal diseases rectal diseases
importance of liver innervation for the osmopressor response in humans

Conditions: PHYSIOLOGICAL PHENOMENA

Summary: in patients with autonomic dysfunction water drinking elicits a pressor response mediated by sympathetic activation. if any, in healthy subjects there is only a slight increase in blood pressure. however, the sympathetic activation is observable by resting energy expenditure increases greater than 20%. the investigators believe that the response to water may be mediated through sympathetic activation elicited by osmosensitve spinal afferents in the liver. therefore, the investigators want to test water in liver transplant patients who have a denervated liver. kidney transplant patients serve as control subjects. the investigators hypothesize that the increase in norepinephrine after water drinking is blunted in liver transplant recipients.


Eligibility criteria:
inclusion criteria: * 3 to 24 month past liver or kidney transplantation * age 18 to 60 * written informed consent * ability to understand the oral and written information exclusion criteria: * pregnancy or lactation * transplantation of another organ * chronic heart or vascular disease * known alcohol or drug abuse * psychiatric diseases (e.g. chronic depression, schizophrenia, drug addiction)

Keywords: water drinking osmoreceptors autonomic failure syncope blood pressure liver transplant
assessment of pre hospital rescue intervention for seizure in pediatric patients

Conditions: Seizure

Summary: 1. evaluation of pre hospital rescue intervention of seizure management. 2. to investigate the type of rescue medication, efficacy, route of administration, side effects of this drug, frequency and indication of its use.

an epileptic seizure is a transient occurrence with signs or symptoms due to abnormal excessive and synchronous neuronal activity in the brain. there are many different types of seizures: current classification designates two large categories - partial or generalized. in a partial seizure, one area of the cortex is thought to be activated initially and may show simple symptoms such as a motor or sensory phenomena. partial seizures may rapidly secondarily generalize and spread to involve all cortical areas. generalized seizures result from diffuse cortical activation at seizure onset . seizure cluster provides an opportunity to administer prompt treatment. delays in the treatment of seizure emergencies are often associated with negative patient outcomes. seizure clusters become less responsive to treatment when they continue unabated over time . in addition to using anti epileptic medications, the treatment of seizures aims at correcting any identifiable causative process. care is needed to prevent any secondary brain injury, which may include advanced respiratory and cardiovascular support. monitoring is necessary to detect hypotension and hypoxia and steps taken to correct those conditions when recognized. common complications may include traumatic injuries such as tongue lacerations or scalp lacerations . convulsive status epileptic leads to brain damage on the cellular level and may itself be epileptogenic. transformed or subtle generalized convulsive status epileptic or non convulsive seizures detected by eeg monitoring in critically ill patients may also contribute to brain laceration .

Eligibility criteria:
inclusion criteria: * patient with recurrent attack of seizure and with prolonged seizure with prescribed treatment at home. * patients aged from 2 years to 18 years exclusion criteria: * first attack of seizure * condition mimic epilepsy

Keywords: seizure in pediatric patients
losartan for diffuse myocardial fibrosis in sickle cell disease

Conditions: Sickle Cell Disease; Diffuse Myocardial Fibrosis

Summary: this study is a pilot, phase ii, open-label study of the angiotensin ii receptor blocker, losartan, in patients with sickle cell disease (scd) 6 years or older for 12 months. the investigators will enroll 24 patients with scd over the course of 1 year with a goal to complete all study procedures in 2 years. the short-term goal is to obtain clinical pilot data regarding the safety and efficacy of losartan in stabilizing or decreasing extracellular volume fraction (ecv) after 12 months of therapy.


Eligibility criteria:
inclusion criteria: 1. 6 years old or older 2. diagnosis of hbss or sbeta0-thalassemia 3. ability to cooperate with and undergo cmr without sedation or anesthesia 4. ability to cooperate with and undergo echocardiogram without sedation or anesthesia 5. patients who are on a stable dose of sickle cell disease-modifying therapy: hydroxyurea, voxelotor, l-glutamine, or crizanlizumab, for 3 months prior to enrollment will be eligible. exclusion criteria: 1. current chronic transfusion therapy. patients who received a simple transfusion for an acute event will be eligible 3 months after completion of transfusion 2. scd genotypes other than specified in inclusion criteria 3. any contraindication to cmr such as metallic implants 4. inability to cooperate with cmr or echocardiography imaging 5. known congenital heart disease 6. estimated gfr ≤ to 30 ml/min/1.73 m2 by creatinine clearance 7. pregnant or lactating females or females of child-bearing potential who are unable to use a medically accepted form of contraception throughout the study 8. treatment with a renin-angiotensin pathway inhibitor during the 2 weeks prior to enrollment 9. hypersensitivity to angiotensin receptor ii blockers 10. hyperkalemia (k\>5.5 meq/l) on a non-hemolyzed sample despite low-potassium diet 11. hepatic dysfunction defined as serum alt \> 5x the upper normal limit for age 12. current lithium therapy 13. chronic daily use of nsaid 14. hiv infection.
study of trimebutine maleate (newbutin sr 300 mg tab)for treatment of post operative nausea and vomiting

Conditions: Nausea; Vomiting

Summary: this study will determine if giving trimebutine maleate (newbutin sr 300 mg tab)orally will be effective as a prophylactic anti-emetic drug for patients who underwent arthroscopic rotator cuff repair under general anesthesia.

the patients will be divided in two groups using a computer generated randomization software. the first will be the macperan group (controlled) and the other will be the newbutin group (variable). the controlled group will be treated with post-operative regimen in accordance with the standard protocol of the chungmu hospital, macperan(metoclopramide hydrochloride monohydrate 8.46 mg/2ml/a) thru iv twice in a day while the variable group will be given a single dose of newbutin sr 300 mg tab orally one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively. a clinical research coordinator will monitor the patient until 48 hours post-operative. first time frame will be from 0-2 hours once patient is transferred to the ward followed by 2 hours to 24 hours and 24-48 hours post ward transfer. all patients will be assessed using the simplified risk score of apfel et al. to determine who have the risk factors for ponv. the episodes of nausea and vomiting will be recorded taking note of its intensity and frequency on the said three time frames. nausea is defined as a subjectively unpleasant sensation associated with an awareness of the urge to vomit; vomiting is defined as the forceful expulsion of gastric contents through the mouth. as retching is similar to vomiting in all aspects, except for the expulsion of gastric contents, it was considered as vomiting. the efficacy of anti-emetic medication (newbutin 300 mg/tab) will be assessed by monitoring the frequency and severity of nausea, vomiting, and ponv (which was regarded as the primary outcome). the severity of nausea will be graded on a four-point scale, where 0= no nausea, 1= mild nausea, 2= moderate nausea, and 3= severe nausea.then the frequency will be assessed by monitoring how often the patient experienced these episodes (nausea and vomiting)during the said time frames.

Eligibility criteria:
inclusion criteria: * post arthroscopic cuff repair patient previously diagnosed with small to large rotator cuff tear thru mri exclusion criteria: * above 70 years old * massive rotator cuff tear

Keywords: post operative nausea and vomiting trimebutine maleate
a crossover study to assess the effects of vorinostat (mk0683, saha) in patients with advanced cancer (0683-070)(completed)

Conditions: Advanced Cancer Relapsed; Advanced Cancer Refractory

Summary: a 2-period, crossover study to assess the effects of mk0683 (vorinostat) on the qtc interval in patients with relapsed or refractory advanced cancer.

merck duration of treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached

Eligibility criteria:
inclusion criteria: * patient has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy or for which standard therapy does not exist * patient has life expectancy of greater than 3 months * patient is able to swallow capsules exclusion criteria: * patient has had chemotherapy, radiotherapy or biological therapy 2 weeks prior to taking study drug * patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent * patient has active cns metastases and/or carcinomatous meningitis * patient has primary central nervous system tumor * patient has a history of drug or alcohol abuse * patient has hepatitis b or c * patient is hiv positive * patient has active infection or has received intravenous antibiotics, antiviral or antifungal agents 2 weeks before taking study drug
wormwood in chronic progressive disorders with reduced appetite

Conditions: Cancer

Summary: wormwood is approved herbal medicine for the treatment of reduced appetite in germany (registration no.: 1339.99.99). reduced appetite is observed in many chronic health disorders such as old age, immune disorders and cancer. trial aims at observing beneficial effects of wormwood supplementation in various chronic disorders associated with reduced appetite

supplementation with wormwood in chronic disorders associated with reduced appetite. examples: 1. cancer 2. autoimmune diseases such as crohns disease and iga nephropathy 3. old age 4. chronic stress and depression

Eligibility criteria:
inclusion criteria: * appetite and weight loss * chronic progressive disease exclusion criteria: * life expectancy less than 3 months

Keywords: crohn disease involuntary weight loss in cancer iga nephropathy depression with reduced appetite
study of xb010 in subjects with solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumors; Esophageal Squamous Cell Cancer; Head and Neck Squamous Cell Cancer; NSCLC (Non-small Cell Lung Cancer); Hormone-receptor-positive Breast Cancer; Triple Negative Breast Cancer (TNBC)

Summary: this is a fih study is to evaluate the safety, tolerability, pk, immunogenicity, and preliminary antitumor activity of xb010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.

this study consists of dose-escalation and cohort-expansion stages. the dose-escalation stage is designed to determine the maximum tolerated dose (mtd) and/or recommended dosage(s) for expansion (rde\[s\]) of xb010 as a single agent, and to evaluate xb010 monotherapy rde(s) in combination with pembrolizumab. the cohort-expansion stage is designed to explore the clinical activity and further characterize the safety and tolerability of xb010 as monotherapy in multiple tumor-specific cohorts.

Eligibility criteria:
* age 18 years or older on the day of consent. * eastern cooperative oncology group (ecog) performance status of 0-1. * adequate organ and marrow function. * cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent. * the cohort expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer). * capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital

Conditions: Type 2 Diabetes; Acute Coronary Event

Summary: background: in type 2 diabetes mellitus patients, an acute coronary event (ace) may result in a decreased quality of life and increased distress. according to the american diabetes association, transition from the acute care setting is a high-risk time for all patients, but tailored support specific to diabetes is scarce in that period. the investigators developed an intervention by a diabetes nurse to help diabetic patients reduce distress after their first ace. the intervention is based on bandura's social cognitive theory, leventhal's common sense model, and on results of focus groups which were conducted to define the needs and wishes of type 2 diabetes patients and their partners regarding professional support after an ace. the aim of this study is to evaluate the effectiveness of the intervention to reduce distress. the hypothesis is that patients who receive the intervention will have less diabetes related distress compared to the control group. methods/design: randomized controlled trial. patients will be recruited directly after discharge from hospital. a diabetes nurse will visit the patients in the intervention group (n = 100) within three weeks after discharge from hospital, two weeks later and two months later. the control group (n = 100) will receive a telephone consultation. the primary outcome is diabetes related distress, measured with the problem areas in diabetes questionnaire (paid). secondary outcomes are quality of life, anxiety, depression, hba1c, blood pressure and lipids. mediating variables are self-management, self-efficacy and illness representations. variables will be measured with questionnaires directly after discharge from hospital and five months later. biomedical variables will be obtained from the records from the primary care physician and the hospital. differences between groups in change over time will be analyzed according to the intention-to-treat principle. discussion: type 2 diabetes patients who experience a first ace need tailored support after discharge from the hospital. this trial will provide evidence of the effectiveness of a supportive intervention to reduce distress in these patients.

see citation design paper

Eligibility criteria:
inclusion criteria: * history of type 2 diabetes (\>1 year) * discharged from the hospital after a first acute coronary event defined as a myocardial infarction (mi), coronary artery bypass graft (cabg) procedure or percutaneous transluminal coronary angioplasty (ptca) * sufficient knowledge of the dutch language exclusion criteria: * a serious illness or condition which will prevent full participation * not able to fill in questionnaires

Keywords: type 2 diabetes acute coronary event (ace) distress self-efficacy quality of life depression primary care illness representations
an evaluation and factor analysis for maternal mental health

Conditions: Postpartum Depression

Summary: an evaluation and factor analysis for maternal mental health - the analytic study of the shin kong wu ho-su memorial hospital - objectives： 1. to construct a screening tool for domestic maternal mental health 2. to expect to find the screening timing for early assessment or intervention of domestic maternal mental health status. 3. to explore the impact of domestic maternal mental health factors.

-study design： this project will be conducted at the shin kong memorial hospital for pregnant women or mothers within six months after birth, with the base of existing domestic and foreign screening tools for postpartum depression and the related scale modeled, and select respective women during different pregnant period and after birth as postpartum study, by longitudinal study and cross-sectional study of the advantages to be able to plan time for up to twelve months of data collection, able to undertake within-subjects comparison and the between-subjects comparison, to view depression during pregnancy , pregnancy depression, postpartum blues, postpartum depression, postpartum psychosis such as prevalence, risk factors or any other factors. to establish the screening tool and screening time for national early assessment of maternal mental health status of women in pregnancy and after birth. -effect： 1. expected to construct the applicable domestic early assessment screening or intervention time of maternal mental health status. 2. expected to develop different screening tools for a domestic early assessment of the maternal mental health status. 3. expected to identify the important factors of maternal depression to provide a reference for locking in a high risk group for early intervention. 4. the implementation of women's health policy on mental health care of pregnant women with specific feasible approach. 5. to provide mental health counseling, the implementation of the operation of the network of community resources to reduce maternal stress in coping to new life.

Eligibility criteria:
inclusion criteria: * the pregnant women or mothers within six months after birth exclusion criteria: * minor

Keywords: postpartum depression maternal mental health
influence of students behaviors on performance and quality of life on the osce

Conditions: Objective Structured Clinical Examination; Performance Anxiety

Summary: the students behave differentially before an exam. this study aims at determining the influence of all these behaviors on the perceived quality of life of students and their performance during their osce.

the students behave differentially before an exam. they can be discriminate, on their sleeping, coping, or physical activity behavior. they also show difference in the number of hours they study by weeks or if they use the services offer by their university. this study aims at determining the influence of all these behaviors on the perceived quality of life of students and their performance during their osce (a major exam).

Eligibility criteria:
inclusion criteria: * all volontary medical students of the third cycle that came for their exam during the sessions of december and may 2023 from the university of lyon (medecine est) exclusion criteria: * no exclusion criteria

Keywords: stress physical activity sedentarity sleep quality of life coping
ninds crc chronic migraine treatment trial

Conditions: Chronic Migraine

Summary: the purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo.

chronic migraine affects about 2 percent of all adults. currently there are no effective preventative treatments to deal with this disabling condition. three randomized, placebo-controlled trials found that topiramate was an effective, safe and generally well-tolerated drug for treating chronic migraine. as a result of these trials, topiramate is becoming the standard treatment among headache specialists. experts agree that treatment with combinations of preventive agents is required in the majority of individuals with chronic migraine for maximal headache relief. no randomized trials have assessed the value of frequently used combinations of preventive agents for chronic migraine. the goal of this trial is to determine if adding a second drug to topiramate treatment will further reduce the headache burden for people with this condition. in the study, 250 participants with chronic migraine will be randomized to two groups - treatment with topiramate and propranolol or topiramate and placebo. participants will be followed for six months.

Eligibility criteria:
inclusion criteria: * history of chronic migraine for at least 6 months * age ≥ 18 years and age of migraine onset 60 or younger * ekg performed in the last 12 months exclusion criteria: * prior neuro-imaging suggesting secondary structural causes of headache * beck depression inventory fastscreen score of 13 or greater or other severe psychiatric disorder * contraindication to or prior intolerance of topiramate or propranolol (no history of sinus bradycardia, heart block, heart failure, diabetes prone to hypoglycemia, asthma, kidney stones) * history of kidney failure or nephrolithiasis * a female who is currently pregnant or lactating or planning to become pregnant in the next year, or is of child-bearing potential and not practicing an acceptable form of birth control * currently requires butalbital or opioid drugs for acute headache treatment 10 or more days a month * failure of prior trials with at least 50 mg of topiramate combined with at least 80 mg of propranolol * use of other migraine preventive drugs (medications graded as groups 1, 2, 3, and 4 in the aan evidence-based guideline: valproate, divalproex sodium, gabapentin, amitriptyline, nortriptyline, protriptyline, beta-blocker, calcium channel blocker, cyproheptadine; and tizanidine) within the last two months or has received botulinum toxin injection in the past 3 months

Keywords: chronic migraine, migraine prevention, chronic headache