Kornimate/medical-research-clean huggingface dataset:
phase i/ii study of chemoprevention with egfr and cox-2 inhibitor

Conditions: Precancerous Conditions

Summary: evaluate effect on cells and patient response to study medications, assess side effects of these medications, and evaluate chemicals in cells that may tell how the drug works, before, and after receiving the study medications.

the purpose of this study is to evaluate the effect on cells and patient response to study medications, assess the side effects of these medications, and to evaluate chemicals in the cells that may tell how the drug works, before, and after receiving the study medications. approximately 61 patients will participate at emory winship cancer institute and emory crawford w. long hospital in atlanta, georgia.

Eligibility criteria:
inclusion criteria: * participants must have premalignant lesions. * lesion sites include oral cavity, oropharynx, and larynx. * must have at least a \>20 pack-year history of smoking. * must have a eastern cooperative oncology group (ecog)/zubrod performance status of 0-1. * participants must be 18 years of age or older. * no contraindications for laryngoscopy and biopsy. * adequate liver function. * must have hemoglobin and hematocrit levels at or above the lower limit of the normal range. * participants must have prothrombin time (pt)/partial thromboplastin time (ptt) levels at or above the lower limit of the normal range. * women of child-bearing potential must have a negative serum pregnancy test within 72 hours of receiving treatment. * must be able to swallow the oral dose of erlotinib and celecoxib. * participants must be disease free. * final eligibility will be determined by the health professionals conducting the trial. exclusion criteria: * participants with acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered. * history of previous malignancies unless the cancer was stage i or ii and rendered free of disease more than 1 year. * pregnant or breast feeding. * not practicing adequate contraception if the participants are of child bearing potential. * female patients who have a positive pregnancy test. * history or recent myocardial infarction. * hypertension not adequately controlled by medication. * documented history of coagulopathy. * documented history of congestive heart failure (chf) greater than new york heart association (nyha) grade ii. * participants who were taking cox-2 inhibitors or egfr tyrosine kinase inhibitors within 3 months of study entry. * documented history or interstitial lung disease. * known connective tissue disease. * history of nonsteroidal antiinflammatory drug (nsaid)-induced ulcers or those who are at risk for a gi ulcer. * participated in a clinical trial of an investigational drug within 12 months prior to enrollment. * final eligibility will be determined by the health professionals conducting the trial.

Keywords: skin lesions premalignant lesion
optimal dose of i.v oxycodone for postoperative pain

Conditions: Pain

Summary: postoperative pain control is required after major abdominal surgery, including laparoscopic colorectal surgery. intravenous oxycodone is widely used for postoperative acute pain control mainly in europe. the aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in korean.

oxycodone is known to be effective in pain control and has less sedative effect than morphine does. it has been described that distribution of cytochrome p450, which is associated with metabolism of oxycodone, differed between the races. proper dose of intravenous oxycodone after major abdominal surgery has not been well defined in korean. the purpose of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in korean based on pain score and side effects.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists class 1, 2 * expected surgical time between 2\~ 6hours * scheduled for laparoscopic colorectal surgery exclusion criteria: * severe dysfunction of liver, heart, kidney, or lung * cannot understand numeric rating scale of pain * known or suspected allergy to oxycodone * previous history of postoperative nausea or vomiting * medication of antidepressants * postoperative longterm * icu care or prolonged mechanical ventilatory support * chronic pain * drug abuser * hypersensitivity reaction to aspirin or nsaids * refuse to enroll

Keywords: acute pain postoperative surgery
iconquerms™ - a patient-powered research network for multiple sclerosis

Conditions: Multiple Sclerosis

Summary: iconquerms™ is a research initiative developed by and for people with multiple sclerosis (ms) to contribute their health data and ideas to advance and accelerate research into ms. iconquerms welcomes adults with ms and others interested in advancing ms research, children and teens with ms and their family members (via iconquerms kids \& teens) and ms caregivers (via iconquerms caregivers) to participate.

the purpose of this study is to create a multiple sclerosis patient-powered research network (ms-pprn) that includes at least 20,000 people with multiple sclerosis (ms) who contribute data on their health and other topics. survey data will be made available to research scientists who are studying ms and similar diseases. our goal is to use this data to answer questions that researchers and people with ms have regarding the disease, including its causes, treatments, and other topics. while the ms-pprn is focused on enrolling people with ms, people without ms are also welcome to participate in this research study. adults are invited to participate via iconquerms, while children and teens are invited to participate via iconquerms kids \& teens. adults who are ms caregivers may participate via the dedicated iconquerms caregivers site. this study will be conducted online via the iconquerms.org website. this is an ongoing study and will last for an indefinite period of time.

Eligibility criteria:
inclusion criteria: * 21 years of age or older at the time of informed consent or under 21 with parental consent and participant assent. exclusion criteria: * unwilling or unable to provide informed consent.

Keywords: multiple sclerosis ms
brain imaging of cognition inn schizophrenia and depression

Conditions: Schizophrenia / Schizoaffective Disorder; Depression / Major Depressive Disorder

Summary: schizophrenia and depression are among the most disabling disorders in all of medicine. cognitive deficits play a key role in patients' disability, affecting their capacity to contribute actively to society by sustaining employment or academic activity. moreover, cognitive difficulties tend to persist even after the stabilization of other clinical symptoms. verbal memory and emotion regulation are two important cognitive domains that are impaired in schizophrenia and depression and are associated with patients' functional outcomes. in this study, we are using brain imaging to investigate the brain mechanisms underlying these cognitive deficits in these populations.

this study uses functional magnetic resonance imaging (fmri) to help us better understand the cognitive problems that people who have schizophrenia, schizoaffective disorder, or depression experience. cognitive problems can encompass a variety of different domains such as with attention, thinking, memory, emotion, and emotional regulation. the study will involve three visits at the royal's institute of mental health research. each visit will last about 2.5 hours long. visits 1 and 2: we ask participants to fill out several questionnaires on a computer. we also ask participants to answer some questions about their current and past mental health. participants will also perform some tasks involving general thinking skills. visit 3: this is the scan visit where we use fmri, which is a technique that allows us to take a 3d picture of the brain using magnetic fields. it also allows us to estimate how active different regions of the brain are. during the fmri, participants will lay down in a narrow tube in the fmri scanner and hold still. throughout the experiment, participant will perform three short tasks in the scanner, where they will see words and pictures and press a button to answer some questions.

Eligibility criteria:
inclusion criteria: * age 18-65 years * current intelligence quotient (iq) \> 70 as measured by the wechsler abbreviated scale of intelligence (wasi) * the ability to read and speak fluent english * a diagnosis of schizophrenia, schizoaffective or major depression disorder * stable medication for more than one month exclusion criteria: * significant neurological or other medical disorders that may produce cognitive impairment * a recent history of substance abuse or dependence (within the past 3 months) * any magnetic resonance imaging (mri) contraindications (e.g. metallic head implant, history of seizure, pacemaker) * decisional incapacity requiring a guardian * taking medications that are rated as anticholinergic burden (acb) score 3 (severe) or taking benzodiazepines on a daily basis
correlation of the neck disability index (ndi) and voice handicap index (vhi) in neck pain patients and patients with voice disorders

Conditions: Neck Pain and/or a Voice Disorder

Summary: this study investigates in patients whose primary complaint is either neck pain and/or a voice disorder , if there are any correlations between subjective neck and voice symptoms according to neck disability index (ndi) and voice handicap index (vhi). ndi and vhi questionnaire results for voice disordered patients will be retrieved from the data base of the department of phoniatrics and speech pathology, university hospital zurich. neck pain patient questionnaire data will be retrieved from an ongoing study. the agreement between subjective neck handicap (ndi) and voice handicap (vhi) will be statistically analysed.


Eligibility criteria:
inclusion criteria: * 18 years old * primary diagnose of a functional disorder of the muscular structure in the neck area * primary diagnose of a functional or secondary structural voice disorder exclusion criteria: * systemic illness of the motion apparatus (i.e., polyarthritis rheumatica) * acute cancer * neurogenic voice and swallow disorder * intubation within the last 18 months * lack of german knowledge, (not able to fill out a questionnaire independently)

Keywords: neck pain, voice disorder
proactive study evaluation of the impact of a multidimensional geriatric intervention program

Conditions: Breast Cancer

Summary: proactive randomized study to evaluate the impact of a multidimensional geriatric intervention on treatment compliance, measured regularly by blood dosing of drug metabolites. patients in the intervention group will be proposed: * a regular geriatric follow up including an attentive screening of joint symptoms and functionality, * an adapted treatment of join pain, * weekly sessions of adapted physical activity (taï chi), * and a systematic correction of vitamin d deficits.


Eligibility criteria:
inclusion criteria: * age ≥ 70 years old * non metastatic breast cancer, with or without node metastases * hormone receptor (hr) positive breast cancer patients * women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery or radiotherapy * introduce an hormonal therapy during 5 years * life expectancy \> 6 months (at the discretion of the investigator) * covered by a health system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research * patient must be available for follow-up * having given written informed consent prior to any procedure related to the study exclusion criteria: * no other primary malignant tumor \< 5-years old except cured in situ cancer of the cervix, in situ urothelial cancer, or basocellular cancer * patient with an experimental treatment in the 30 days prior to the enrollment * evidence of metastatic disease * not under any administrative or legal supervision

Keywords: oncogeriatrics adjuvant endocrine therapy compliance elderly taï chi physical training
disease management and educational intervention outcomes in high-risk diabetics

Conditions: Diabetes Mellitus Self Management Education; Hyperglycemic Control; High Risk Diabetes

Summary: social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. studies have demonstrated improved glycemic control with nurse case-management or educational care models. however, none have controlled for their independent contributions, intervened with advanced practice nurses (apn), or targeted highest risk individuals.

background: social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. studies have demonstrated improved glycemic control with nurse case-management or educational care models. however, none have controlled for their independent contributions, intervened with advanced practice nurses (apn), or targeted highest risk individuals. objectives: the objective of this project is to examine whether interventions of diabetes self-management education programs with or without apn case managers improve outcomes and are cost effective. methods: patients were randomly assigned to one of four groups: 1) disease-management and diabetes education; 2) disease-management alone; 3) diabetes education alone; and 4) routine care. veterans receiving primary care in visn-5 and meeting high-risk criteria (hba1c � 9.0%) were screened for inclusion. patient outcome measures were collected at baseline, three months and twelve months. these included: quality of life (qol), hgbalc levels, and incidence of diabetes-related hospitalizations/er visits. in addition, patient-level intervention costs, health care use and costs were examined. anova comparisons were used to test hypotheses. status: recruitment is over and final analyses are underway.

Eligibility criteria:
inclusion criteria: type 2 diabetes hba1c. 9.0%, consistent diabetes tx over last 3 months. exclusion criteria: homelessness-not able to be consistently contacted; dementia, planned movement from area; unstable angina, myocardial infarction in past 3 months; stroke; two or more seizures in last 3 months; document alcoholism or drug abuse; pregnant or planning to become pregnant in next 12 months; severe immunodeficiency or cirrhosis of the liver; type 1 diabetes; blind individuals; psychosis; pancreatitis with secondary diabetes; renal disease.
prospective and comparative analysis of arthroscopic and open surgery for hallux rigidus

Conditions: Hallux Rigidus

Summary: comparison between arthroscopic and open surgery for hallux rigidus.


Eligibility criteria:
inclusion criteria: * hallux rigidus exclusion criteria: -
group music therapy for acquired brain injury

Conditions: Acquired Brain Injury

Summary: the study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (abi). to achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. the protocol will be tested in a pilot sample to improve adaptation to the disease and promote integration with the usual health measures of patients with abi. implementing a group treatment programme based on music therapy applied to patients with abi.


Eligibility criteria:
inclusion criteria: * patient with acquired brain damage who has been admitted to the hospital for at least one week. the patient has experienced a sudden brain injury resulting in physical, psychological, cognitive, behavioural or sensory deficits that have reduced their previous functional capacity and quality of life. the patient is clinically stable enough to undergo rehabilitation and had a good functional situation prior to the episode (barthel index \> 60). * be over 18 years of age. * the participant or their relatives have signed the informed consent form. * they have completed the group music therapy intervention session, as well as the pre-test and post-test evaluations. exclusion criteria: * failure to obtain informed consent * the barthel index score is below 60, indicating functional dependency.

Keywords: music therapy-based treatment psychological intervention discomfort acquired brain injury
18f-ambf3-tate pet/ct for imaging net patients

Conditions: Neuroendocrine Tumors

Summary: neuroendocrine tumours (nets) are generally slow growing, but some can be aggressive and resistant to treatment. compared to healthy cells, the surface of these tumor cells has a greater number of special molecules called somatostatin receptors (sstr). somatostatin receptor scintigraphy and conventional imaging are used to detect nets. this study proposes 18f-ambf3-tate positron emission tomography/computed tomography (pet/ct) is superior to current imaging techniques. the goal is to evaluate the biodistribution and safety of 18f-ambf3-tate pet/ct for neuroendocrine tumour imaging.

each subject will have a pet/ct scan using 18f-ambf3-tate. the 18f-ambf3-tate radioactive tracer is manufactured for this study under a clinical trial application filed with health canada. after providing informed written consent subjects will complete a medical history questionnaire. monitoring of adverse events there will be short-term evaluation of adverse events by comparison of vital signs before and after administration of 18f-ambf3-tate . eighteen to seventy-two hours after 18f-ambf3-tate administration the participant will return to the imaging department to perform a follow up safety assessment and routine blood draw. the study coordinator will ask the participant if they have experienced any adverse events during that time period and complete the adverse event questionnaire. follow-up assessments the following information will be collected up to 12 months following the pet/ct scans: initiation of a new treatment, laboratory results and pathology reports, results of imaging studies, final clinical diagnosis by physician and relevant clinical notes. the study is expected to take up to 1 year for accrual.

Eligibility criteria:
inclusion criteria: all subjects: * participants with newly diagnosed or documented neuroendocrine tumours (net), with at least one measurable lesion based on ct, mr or at least one visualised lesion on pet/ct imaging (either from an 18f-fdg, 18f-fdopa or 68ga-dotatoc/dotatate scan) or scintigraphy (with 111in-pentetreotide imaging). * ecog performance status of 2 or less. exclusion criteria: * pregnancy * medically unstable (eg. acute illness, unstable vital signs) * unable to lie supine for the duration of imaging * unable to provide written consent * exceeds safe weight limit of the pet/ct bed (204.5 kg) or unable to fit through the pet/ct bore (diameter 70 cm) * patients with widespread liver metastases occupying more than 50% of the liver volume will not be eligible to participate in this study as this would preclude assessment of normal liver activity for dosimetry purposes. * patients with baseline alt or ast higher than 5× uln or 250 u/l. * patients with elevated baseline levels of total bilirubin (higher than 1.2× uln, or 1.3 mg/dl, (with exception of gilbert's syndrome), with inr \>1.2, or platelet count below the lower limit of normal (typically \<150 000/μl. * patients with elevated alkaline phosphatase (alp), equal to or higher than 2× uln or 250 u/l, unless the alp elevation is not from a hepatic origin.
trial of magnesium sulfate tocolysis versus nifedipine tocolysis in women with preterm labor

Conditions: Premature Birth; Premature Labor

Summary: primary hypothesis: acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 6/7 weeks' gestation.

primary objective: to compare the efficacy of oral nifedipine versus iv magnesium sulfate on the rate of preterm delivery at \<37 weeks in women with preterm labor between 24 and 32 6/7 weeks gestation. secondary objective: 1. to compare maternal side effects between the two tocolytic agents 2. to compare neonatal morbidities between the two study groups.

Eligibility criteria:
inclusion criteria: * women in preterm labor between 24 to 32 6/7 weeks' gestation with intact membranes with an age range of 15 to 50 years old. exclusion criteria: * cervical dilatation of ≥ 6 cm * maternal contraindication to tocolysis * known fetal anomalies * suspected chorioamnionitis * nonreassuring fetal heart tracing * vaginal bleeding due to placenta previa or abruptio placenta * preterm premature rupture of membranes * prolapsed membranes * human immunodeficiency virus positive * multiple gestation * patients on procardia within 24 hours of po intake * magnesium sulfate tocolysis prior to randomization * patient refusal

Keywords: premature labor premature birth magnesium sulfate nifedipine
a clinical study of safety and p2y12 receptor inhibition effects of ticagrelor and clopidogrel in vietnamese patient

Conditions: Coronary Heart Disease

Summary: study in vietnamese patients with coronary heart disease to investigate safety and p2y12 receptor inhibition effects of ticagrelor and clopidogrel

safety and p2y12 receptor inhibition effects of ticagrelor and clopidogrel in vietnamese patients with coronary heart disease: a randomized, open label, crossover study

Eligibility criteria:
inclusion criteria: * male or female vietnamese patients (as confirmed by the principal investigator) aged \>18 years with suitable veins for cannulations or repeated venipunctures and stable coronary heart disease * stable use of aspirin 75 to 100 mg daily for at least the preceding 2 weeks and which will be continued throughout the study period * have a body mass index (bmi) between 18 and 30 kg/m2 inclusive * women must have a negative urine pregnancy test at visit 1 exclusion criteria: * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study * unstable angina or any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of ip * patients who had acute coronary syndrome or stent placed within 12 months of screening * planned arterial revascularization * current use of adp receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole or cilostazol

Keywords: coronary heart disease