Kornimate/medical-research-clean huggingface dataset:
24-hour ambulatory blood pressure monitoring in community pharmacies

Conditions: Hypertension

Summary: this study is designed to explore the feasibility of providing 24-hour ambulatory blood pressure monitoring in community pharmacies. the investigators hypothesize it will be feasible for community pharmacies to provide the service to assist medical providers in the diagnosing and management of high blood pressure. the investigators will also survey participants regarding their experience with the service as well as conduct interviews with participating pharmacists and medical providers to understand their views and opinions on the feasibility of the service.


Eligibility criteria:
inclusion criteria: * adults greater than or equal to 18 years of age suspected by their physician of having "white coat" or "masked" hypertension (htn), hypotension symptoms due to antihypertensive therapy, uncontrolled sustained htn, requiring additional confirmation of an initial diagnosis if htn, or resistant htn. exclusion criteria: * documented past medical history of persistent atrial fibrillation, on hemodialysis, pregnancy, or dementia.
combination of sar3419 and rituximab in relapsed/refractory diffuse large b-cell lymphoma

Conditions: Diffuse Large B-Cell Lymphoma

Summary: primary objective: participants achieving an objective response rate (cheson 2007) secondary objectives: * progression free survival * overall survival * response duration

* the screening period = up to 4 weeks prior to the first administration of combined therapy * the treatment period = 3 months of combined therapy. a safety follow-up of 42 to 49 days after the last dose of treatment is planned for all patients. * the follow-up period: patients who are not progressing at the end of study treatment will be followed until progression or initiation of another anti-lymphoma therapy. all patients will be followed for two years to evaluate survival.

Eligibility criteria:
inclusion criteria: * histological diagnosis of diffuse large b-cell lymphoma (dlbcl) * relapsed or refractory after at least one standard treatment including rituximab * cd19 and cd20 positive disease exclusion criteria: * no bi-dimensionally measurable lesion by ct scan (defined as presence of at least one tumor mass measuring \>1.5 x 1.5 cm) * the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a brief dental office intervention with tobacco quitline

Conditions: Smoking; Nicotine Dependence

Summary: the novel and exploratory nature of this intervention relates to the concept of incorporating patient-specific oral health information obtained during a dental hygiene visit into the tobacco quitline counseling. linking the patient-specific oral health information obtained during the dental hygiene visit to the tobacco quitline counseling will close the therapeutic loop for oral health professionals and make them a focal point for the tobacco use intervention without increasing clinical burden.

the overarching hypothesis of this line of research is: a brief office intervention with proactive tobacco quitline counseling incorporating patient-specific oral health information obtained during a dental hygiene visit (intervention) will increase prolonged abstinence rates from cigarette smoking compared to a brief office intervention alone (control) at 3 and 6 months.to test our overarching hypothesis in a phase iii clinical trial, we are first seeking r21 funding through the nidcr clinical pilot data grant (par-03-043) mechanism. this r21 funding will be used to refine the design of dental clinic staff training, study implementation, and data collection procedures, to optimize the design of the definitive trial, and to test and document recruitment and data collection mechanisms. the specific aims of this r21 proposal are: 1. to design and refine preconceived models of training format, study implementation, and intervention through focus groups with dentists and dental hygienists. 2. to define and refine study implementation, the referral process, recruitment, and data collection strategies and protocols through the sequential engagement of dental practices in active patient enrollment in a nonrandomized feasibility testing process. 3. to develop a working manual of procedures (mop) for a future phase iii clinical trial. the feasibility study will be conducted through private practice dental clinics surrounding the mayo clinic in rochester, mn. we are planning for a multicenter phase iii clinical trial involving private practice dental clinics in the communities surrounding rochester, mn, and indianapolis, in, in collaboration with the indiana university nicotine dependence program.

Eligibility criteria:
patients were eligible to participate if they were cigarette smokers, older than the age of 18 years, and presenting to the dentist for routine dental prophylaxis.
clinical investigation of the acrysof® iq panoptix™ iol

Conditions: Cataract

Summary: the purpose of this study is to evaluate the effectiveness and safety of the acrysof® iq panoptix™ intraocular lens (iol) model tfnt00 when implanted to replace the natural lens following cataract removal.

eligible subjects will attend a total of 10 visits over a 7-month period. subjects will complete a preoperative examination of both eyes (visit 0), followed by implantation of the iol at the operative visit for each eye (visit 00/00a), and up to 7 postoperative visits (each eye examined at day 1-2 (visit 1/1a), day 7-14 (visit 2/2a), and day 30-60 (visit 3/3a), with a binocular visit at day 120-180 (visit 4a) after the second implantation. the second implantation will occur within 30 days of the first.

Eligibility criteria:
inclusion criteria: * able to comprehend and sign a statement of informed consent; * willing and able to complete all required postoperative visits; * cataracts in both eyes with planned cataract removal by phacoemulsification; * calculated lens power within the available range; * potential postoperative best corrected distance visual acuity (bcdva) of 0.5 decimal or better in both eyes; * able to undergo second eye surgery within 30 days of the first eye surgery. exclusion criteria: * significant irregular corneal aberration as demonstrated by corneal topography; * inflammation or edema (swelling) of the cornea affecting post-operative visual acuity; * degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses; * previous refractive surgery; * diabetic retinopathy * other eye conditions as specified in the protocol * pregnant.

Keywords: trifocal iol
effect of a nursing teaching protocol on mastitis prognosis: quasi-experimental research design

Conditions: Mastitis

Summary: aim: evaluate the effect of a nursing teaching protocol on mastitis prognosis. research design: quasi-experimental research design was utilized. a convenient sample of sixty adult female patients diagnosed with mastitis, patients divided equally into two groups(study and control) thirty for each.

the study was conducted in the breast unit in general surgery department at main assiut university hospital. a convenient sample of sixty adult female patients diagnosed with mastitis, their ages range from 20 to 65years old. patients divided equally into two groups; thirty for each. both groups had been assessed at base line using the following tools: tool (i): an interview questionnaire sheet tool (ii):mastitis self-care practices tool (iii): numeric pain rating scale tool (iv): mastitis prognosis sheet the control group exposed to routine care and study group received mastitis teaching protocol. after three weeks; both groups had been reassessed by the same tools. data analysis had been performed by using the statistical package for the social sciences (spss) categorical variables described by number and percent (n, %). continuous variables described by mean and standard deviation (mean, sd). chi-square test and fisher exact test used to compare between categorical variables .t-test and pearson's chi-square used to appear the association between patients' knowledge, practice, and mastitis prognosis before implementation of nursing teaching protocol and three weeks post.

Eligibility criteria:
exclusion criteria: 1. mental health problems 2. visual or hearing problems 3. uncooperative
high spinal anesthesia and the incidence of delirium after cardiac surgery

Conditions: Post-Operative Confusion

Summary: this is a feasibility study to determine if enough patients undergoing elective or urgent cardiac surgery, can be enrolled in a study where patients are randomized to receive high spinal anesthesia as an adjunct to general anesthesia for their cardiac surgery. the primary clinical outcome will be the incidence of post-operative delirium.

intervention patients will be randomized to either general anesthesia (ga) or hsa + ga. 1. spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg). 2. standard intraoperative monitors will include ecg, pulse oximetry, end-tidal co2 and anesthetic gas measurement, quantitative eeg monitoring (bis monitor), arterial line, central venous pressure line and any other monitor as clinically indicated. 3. conduct of the general anesthetic will not be protocolized. it will be a pragmatic study. the attending anesthesiologist will attempt to have a bis score of 20- 40 during the operation. 4. intraoperative physiological data (mean blood pressure, end-tidal anesthetic gas concentrations, bis score) will be recorded and downloaded to a laptop computer using the trend face solo acquisition system for subsequent analysis. 5. the routine postoperative care map for the postoperative cardiac intensive care unit (iccs) will be followed. 6. all patients will be assessed by the study investigator for presence/absence of delirium on postoperative days 1,2 \& 3, as well as routine nursing assessment by the delirium assessment tool cam-icu, routinely done by nursing staff. chart reviews will be conducted to confirm any additional incidence of delirium. 7. all patients will be contacted at one and three months after surgery and asked to complete a ten-minute survey (postop qor-15 questionnaire) assessing their quality of recovery.

Eligibility criteria:
inclusion criteria: * adult (\>18 years old) patients * undergoing elective or urgent cardiac surgical procedures with cardiopulmonary bypass exclusion criteria: * contraindications to spinal anesthesia such as active anticoagulation, clopidogrel within 7 days of surgery, ticagrelor within 3 days of surgery and all other contraindications to lumbar puncture * pre-existing psychiatric diagnoses such as schizophrenia or manic-depressive disorder * complex aortic surgery (\> hemi-arch repair, descending thoracic surgery) * difficult airway requiring an awake intubation * bmi \> 50

Keywords: cardiac surgery delirium spinal anesthesia
study of postoperative 3d-crt/imrt in hepatocellular carcinoma

Conditions: Hepatocellular Cancer

Summary: hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some patients can not receive radical resection. such patients have high risk of recurrence. tumor resection and postoperative radiation is an option for such patients to achieve radical treatment and radiation may reduce local recurrence.

patients with risk factors of recurrence receive postoperative radiotherapy using intensive modulated radiation therapy (imrt) or three-dimensional conformal radiation therapy (3dcrt). the clinical target volume includes tumor bed. the dose will be 50-60gy/25-30f. overall survival, local-recurrence free survival, disease free survival and toxicity need be observed.

Eligibility criteria:
inclusion criteria: * written informed consent provided * 18\~75 years old * patients with histopathological proved hepatocellular carcinoma received hepatectomy and had at least one risk factor of recurrence * without any lymph node or distant metastasis (any t n0m0) * liver function: child-pugh a or b * performance status: karnofsky (kps)≥70 or world health organization(who) score 0,1 * life expectation\>6 months * no dysfunction of major organs * no prior radiotherapy * negative for human immunodeficiency virus syndrome (hiv) * considerable to computed tomography(ct) simulation and 3d-crt or imrt exclusion criteria: * malignant tumors of other sits * combining severe diseases, such as acute myocardial infarction(ami), arrhythmias, infection * surgery performed in other hospitals without details * pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (hcg)

Keywords: hepatocellular carcinoma postoperative radiotherapy
study of the efficacy of adjunctive lithium treatment for the treatment of psychotic mania

Conditions: Bipolar I Disorder

Summary: the proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial comparing two treatment strategies in adolescents with mania and prominent psychotic features. one group will receive a second generation antipsychotic (sga) and placebo and the other will receive a sga and lithium. the primary double-blind phase of the study will last 8 weeks, followed by a 24-week extension-phase.


Eligibility criteria:
inclusion criteria: * males and females, 12-18 years old, inpatients or outpatients * meet dsm-iv criteria for bipolar i disorder - manic or mixed episode * psychotic symptoms present exclusion criteria: * current serious homicidal/suicidal ideation * prior non-response or intolerance to an adequate trial of lithium * prior non-response or intolerance to adequate trials of both aripiprazole and risperidone * any unstable medical condition or medical contraindication to treatment with lithium, aripiprazole or risperidone * inability or unwillingness to discontinue concomitant medication that interferes with the pharmacokinetics of either lithium, aripiprazole, or risperidone * seizure disorder * pregnant or, if sexually active, not using birth control, such as oral contraceptives, two barrier methods, long-acting depot preparations or an intra-uterine device * full scale iq less than 70 * meets criteria for a dsm-iv diagnosis of substance-induced mood disorder or mood disorder due to a general medical condition.
an open-label, randomized pilot study comparing the safety of a single dose of tnx-1300 to usual care (uc) alone for the treatment of signs and symptoms of acute cocaine intoxication in male emergency department (ed) subjects

Conditions: Cocaine Intoxication

Summary: an open-label, randomized pilot study comparing the safety of a single dose of tnx-1300 to usual care (uc) alone for the treatment of signs and symptoms of acute cocaine intoxication in male emergency department (ed) subjects


Eligibility criteria:
inclusion criteria: 1. subject is male (sex assigned at birth). 2. subject is 18-50 years of age. 3. subject has the capacity to provide voluntary written informed consent. 4. at screening, subject presents with a sis total score of ≥6 and a score \>1 on at least 1 of the 3 cardiovascular items (hr, systolic and diastolic bp). 5. at screening, subject presents with cardiac symptoms not present prior to cocaine intoxication, with or without behavioral symptoms. 6. subject has a positive urine drug screen test at screening to confirm cocaine use and detect polysubstance abuse (subject may test positive for cannabinoids or opiates). 7. subject is a suitable candidate for investigational treatment based on the opinion of the investigator. exclusion criteria: 1. subject who has been admitted to the ed involuntarily. 2. subject who participated in this clinical study previously. 3. subject received naloxone (narcan) within 3 hours prior to informed consent. 4. subject tests positive for 3,4-methylenedioxymethamphetamine (mdma) or amphetamine at screening. 5. subject has a prior or current clinically significant untreated cardiac condition. untreated hypertension may be allowed if not considered severe or life threatening. 6. subject incurred or is likely to incur a myocardial infarction or other life-threatening severe event or has acute ecg changes indicative of acute coronary syndrome according to investigator judgment. 7. subject has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of clinical outcome parameters. 8. subject requires physical restraints due to physiological and/or behavioral symptoms. 9. participation in another investigational drug study (current or within 30 days of screening).
ultrasound-guided botulinum toxin injection on cricopharyngeal muscle dysfunction

Conditions: Cricopharyngeal Achalasia

Summary: ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. the combination with a balloon for fixation further enhances the precision of the injection. in this study, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.

the patient's long-term inadequate food intake leads to malnutrition, decreased quality of life, and impacts the prognosis of the disease. currently, both domestically and internationally, treatment options for cricopharyngeal muscle dysfunction include balloon dilation technique, surgical incision, and botulinum toxin injection. passive dilation with a balloon can easily cause mucosal edema and damage. cricopharyngeal myotomy surgery often presents complications such as local infection, excessive bleeding, and local nerve damage. botulinum toxin can alleviate muscle spasms and has been widely used in the treatment of hypertonic disorders \[3\]. common injection localization methods include ultrasound, electromyography, and endoscopy. ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. combining it with balloon fixation further enhances the precision of the injection. in this study, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.

Eligibility criteria:
inclusion criteria: * videofluoroscopic swallowing study (vfss) confirming incomplete/opening dysfunction of the cricopharyngeal muscle; * no significant improvement in swallowing function after standardized rehabilitation treatment for more than 2 weeks (unchanged or decreased fois); * presence of swallowing initiation, with vfss showing that the upward movement of the hyoid bone during swallowing is greater than half the height of the c3 vertebral body; * stable vital signs, alert consciousness, and cooperation with treatment; exclusion criteria: * patients with severe cognitive impairments, psychiatric disorders, and severe cardiopulmonary diseases; * abnormalities in the pharynx and larynx structures; * patients with malignant tumors; * patients with infections or wounds at the injection site; * patients allergic to botulinum toxin; patients with bleeding tendencies or coagulation disorders.
acarbose and secondary prevention after coronary stenting

Conditions: Glucose Metabolism Disorders; Coronary Artery Disease

Summary: the purpose of this study is to determine whether the intervention for newly diagnosed abnormal glucose tolerance after coronary stenting will improve the long-term clinical outcome.

recent studies have demonstrated that newly diagnosed abnormal glucose tolerance (agt; diabetes mellitus and impaired glucose tolerance) are common among the patients with ischemic heart disease. several large cohort studies indicate that people with prediabetic conditions, such as impaired glucose tolerance, have a raised risk of future cardiovascular disease. intervention with acarbose can prevent myocardial infarction and cardiovascular disease in type 2 diabetic and igt patients. however, the effect of acarbose to secondary prevention of myocardial infarction or cardiovascular events in patients with newly diagnosed agt after coronary stenting remains unclear. the purpose of the present study is to determine whether the intervention to such abnormalities after coronary stenting will improve the long-term clinical outcome. this is a opened, randomized study to compare acarbose versus a standard lifestyle modification. patients will have a 1:1 chance of receiving acarbose versus the standard lifestyle modification. there is some research evidence that suggests acarbose may improve clinical outcome in patients with type 2 diabetes and in igt patients.

Eligibility criteria:
inclusion criteria: * within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome. * abnormal glucose tolerance according to a 75 g oral glucose tolerance test (ogtt). * hba1c is less than 6.5%. * age is between 20 and 75 years (at time of consent). * patients who can give informed consent themselves in writing. exclusion criteria: * patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, cushing syndrome, prader-willi syndrome, etc. * patients with planned angioplasty. * patients with uncontrollable congestive heart failure. * less than 6 months since last episode of cerebral infarction. * patients who have received medication for diabetes mellitus before. * ast (got) exceeding 100 iu/l or alt (gpt) exceeding 100 iu/l. * creatinine exceeding 2 mg/dl. * patients with a history of ileus or less than 6 months since celiotomy. * pregnant women or those who plan to become pregnant, or are in the lactation period. * habitual drinker (more than 100 ml/day of alcohol). * patients with a history of gastrectomy. * patients for whom it is impossible to follow up for 5 years. * any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.

Keywords: abnormal glucose tolerance coronary artery disease diabetes mellitus clinical outcome
ras mutation testing in the circulating blood of patients with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this study will evaluate the concordance of ras mutation detection between the results obtained from circulating tumor dna and those obtained with the "standard" method (testing from tumor tissue).


Eligibility criteria:
inclusion criteria: * pathologically confirmed metachronous or synchronous metastatic colorectal cancer * no prior chemotherapy with the exception of adjuvant chemotherapy completed ≥ 6 months prior to enrollment * signed written informed consent obtained prior to any study specific screening procedures * patients willing to provide a blood sample for translational research exclusion criteria: * no tumor block available * previous malignancy in the last 5 years * medical, sociological, psychological or legal conditions that would not permit the patient to sign informed consent

Keywords: ras mutation dna colorectal cancer