Kornimate/medical-research-clean huggingface dataset:
evaluation of modafinil vs placebo for treatment of anesthesia delayed emergence in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea; Delayed Emergence From Anesthesia

Summary: the purpose of this study is to determine whether modafinil use in patients with obstructive sleep apnea will improve postoperative delayed emergence after general anesthesia.

this is a randomized, double blind placebo controlled evaluation of modafinil versus placebo for the treatment of general anesthesia related delayed emergence in patients with the diagnosis of obstructive sleep apnea. 124 patients will be recruited and randomized on the day of surgery to receive 200mg modafinil or placebo. after randomization, patients will proceed to the operative suite for surgical procedure under general anesthesia. the primary outcome measured will be post-anesthesia care unit length of stay. secondary outcomes will include performance on a post-anesthesia recovery scale.

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. meets diagnostic criteria for obstructive sleep apnea 3. willing and able to comply with study procedures 4. willing and able to provide informed consent 5. if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) for one month after surgery and discontinuation of study medication (modafinil may reduce the effectiveness of steroidal contraception for one month after discontinuation) exclusion criteria: 1. have a medical condition that, in the study physician's judgment, may interfere with safe participation (active cardiac conditions such as angina, recent myocardial infarction w/in 6 months, severe renal or liver disease, unstable diabetes, or elevated liver enzymes greater than twice normal). 2. have a current neurological disorder (e.g. organic brain disease, dementia) or major psychiatric condition that would impair the collection of data (schizophrenia, bipolar illness). 3. currently on prescription medication that is known to interact with the study drug. (ethinylestradiol and triazolam). 4. have current dependence on cocaine, methamphetamine, alcohol or benzodiazepines (dsm-iv criteria). 5. have a history of severe valvular heart disease, severe left ventricular hypertrophy, cardiac arrhythmias, angina, cardiac syncope, or pre-syncope or myocardial infarction \<6 months. 6. have a history of uncontrolled or poorly controlled essential hypertension, or a heart rate greater than 70% of the maximum heart rate expected for their age (formula: 0.70(220 - age). 7. any condition, in the opinion of the principal investigators that would compromise patient safety. 8. a documented history of sensitivity to modafinil. 9. current modafinil use for daytime somnolence associated with obstructive sleep apnea.

Keywords: obstructive sleep apnea general anesthesia modafinil
evaluation of a novel optical microscope with a deep depth of field (deepdof) to provide histologic-quality images on cervical biopsies and loop electrosurgical excision procedure (leep) specimens at the point-of-care

Conditions: Cervical Cancer; HIV

Summary: all patients will be enrolled in mozambique and brazil. they will provide informed consent to use their cervical biopsy and/or leep specimens for imaging with deepdof prior to sending for standard of care processing and interpretation.

primary objectives: 1. evaluate the diagnostic performance of the deepdof digital histopathology platform compared with standard histopathology in cervical biopsies and/or leep specimens. 2. compare performance characteristics between wlwh and hiv-negative women. secondary objectives: 1. evaluate the ability of pathologists to provide a diagnostic evaluation of cervical biopsies and leep margins using digital deepdof images. 2. develop deepdof algorithms for automated diagnostic evaluation of cervical biopsies and leep margins.

Eligibility criteria:
inclusion criteria: 1. women aged 25 - 49 years 2. women undergoing cervical biopsy and/or leep 3. women who are not pregnant and with a negative pregnancy test (within 3 days of enrollment) 4. willing and capable of providing informed consent exclusion criteria: 1. women under 25 or over 49 years of age 2. women not undergoing cervical biopsy or leep 3. women who are pregnant

Keywords: hpv dna testing
myocardial work for prediction of left ventricular remodeling in patients with stemi

Conditions: ST-Segment Elevated Myocardial Infarction

Summary: the study intends to investigate the alteration of regional myocardial work in patients with acute anterior myocardial infarction underwent primary percutaneous coronary intervention (pci), and compare the distribution of regional myocardial work in patients with/without early remodeling at acute phase and 3-month follow-up.


Eligibility criteria:
inclusion criteria: * anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with st-segment elevation of at least 0.2 mv in two or more contiguous precordial leads) within 12 hours after onsets of symptom; * left anterior descending (lad) as culprit vessel, with timi 0-1 grade. exclusion criteria: * significant valvular disease; * cardiomyopathy; l * left bundle branch block; * atrial fibrillation; * previous myocardial infarction (mi); * history of cardiac surgery; * pacemaker implantation.

Keywords: st-segment elevated myocardial infarction myocardial work left ventricular remodeling
emp-activity: empagliflozin functional capacity

Conditions: Heart Failure

Summary: this is a multinational non-interventional study based on newly collected data to assess demographics, disease, and treatment pattern of patients with chronic heart failure (hf) in a two-cohort design: one cohort will receive first prescription of empagliflozin as routine therapy for hf, the other cohort will receive hf therapy with drugs with another mechanism of action. treatment of hf according to routine practice is determined by the physician independent of the participation of the patient in this non-interventional study.


Eligibility criteria:
inclusion criteria: * written informed consent prior to study participation * male and female patients ≥ 18 years at visit 1 * patients must be contractually capable and mentally able to understand and follow the instructions of the study personnel * patients with diagnosis of chronic heart failure nyha class 2-4 * treatment-naïve for sglt2i at visit 1 * women of childbearing potential must take appropriate precautions against getting pregnant according to approval of chosen hf drug(s) exclusion criteria: * missing physician's diagnosis of chronic heart failure * patients hospitalized at visit 1 * life expectancy ≤ 12 months according to physician's assessment * lack of informed consent * pregnant or lactating females * participation in a parallel interventional clinical trial * chosen treatment with another sglt2i drug than empagliflozin * having been enrolled into the non-empagliflozin-arm of this non-interventional study * current or prior treatment with sglt2i at visit 1 * patients with contraindications according to current summary of product characteristics (smpc) * patients with dependency or relationship to the treating physician
tyveco: surveillance protocol

Conditions: Typhoid Fever; Intestinal Perforation

Summary: in kisantu health zone, approximate population 200,000, fever surveillance will be implemented in 8 health centers and 1 tertiary hospital. individuals presenting to one of these study facilities with acute fever or history of fever or individuals presenting with suspicion of intestinal perforation irrespective of fever status, will be considered for enrollment. following consent, blood samples (between 2.5 ml for children and 22 ml for adults) will be collected from eligible subjects and demographic and clinical information will be recorded in study forms at the time of enrollment at study health centers and hospitals. peritoneal fluid and ileal tissue samples will be collected from surgical patients where possible. biological specimens will be used for various testing, including microbiological culture of blood, tissue and peritoneal fluid for confirmation of bacterial growth, malaria diagnostics (microscopy and rapid testing), and storage of tissue samples for pathological investigation, and biobanking. hospitalized patients will be followed-up to track clinical outcomes for the duration of hospitalization.


Eligibility criteria:
inclusion criteria: at health center: 1. patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°c tympanic or 37.5 °c axillary or 2. patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation at hospital: 1. suspicion of intestinal perforation/peritonitis due to typhoid fever requiring surgery for patients living in and outside the catchment area (even in the absence of laboratory confirmation) or 2. patients living in the catchment area of the hospital with invasive salmonellosis confirmed through blood-culture surveillance embedded in routine patient cares exclusion criteria: * individuals who do not provide informed consent
the use of a fda cleared, drug-free, breathing system for anxiety and panic disorders in children and teens

Conditions: Anxiety; Panic Disorder

Summary: this study will test the efficiency of the freespira breathing system in youth.

the freespira breathing system (fbs; www.freespira.com) developed by palo alto health sciences, inc, is a portable home device , and has been employed in breathing biofeedback in adults with panic disorder (pd). the fbs has now received fda clearance for the treatment of pd adults and is currently commercially available and more than 150 therapist have provided the service nationally. however, fbs has not yet been tested for efficacy in a pediatric populations. due to its portability, fbs may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for cognitive behavioral therapy (cbt) or lower acceptability for long-term medication use for adolescent pd. in this pilot intervention study, the efficacy of the fbs system in youth will be tested. in children adolescents, pd itself is less common than in adults, but when present, pd is commonly associated with and/or preceded by other anxiety conditions, including generalized anxiety disorder (gad), social phobia (sop) and separation anxiety (sad). thus, in children and adolescents, the breathing biofeedback intervention for panic, should include other anxiety disorders.

Eligibility criteria:
inclusion criteria: * scared score ≥ 25 + prior clinical diagnosis of an anxiety disorder * participants must be 9-17 years of age * if on psychotropic medication(s), participant must be on a stable dose for at least one month prior to study enrollment exclusion criteria: * anxiety has occurred exclusively during a major depressive episode, psychiatric illness, dementia, intellectual disability, or brain disease * currently enrolled in another device or drug study or less than 30 days has elapsed since participation in such a study * currently undergoing breathing biofeedback elsewhere * demonstrate evidence of severe suicidal ideation or psychosis * there is an active condition of asthma

Keywords: obsessive compulsive disorder (ocd) anxiety pediatrics
association of capecitabine pharmacokinetics and toxicity with aging

Conditions: Breast Cancer; Colorectal Cancer

Summary: this is a multi-centre prospective non-interventional study designed to evaluate the effects of patient age on the pharmacokinetics of capecitabine and its metabolites 5'dfcr, 5'dfur, and 5-fu. in addition, the study will assess the correlation between the pharmacokinetic parameters calculated and cytidine deaminase, biomarkers of aging, clinical frailty, treatment outcome, and toxicity. to be enrolled, patients must have breast or colorectal cancer and be eligible to receive capecitabine monotherapy in accordance with its approved clinical usage in the uk. treatment will be administered according to nice guidelines as well as the clinical judgement of the prescribing physician. one hundred patients (50 breast cancer patients, 50 colorectal cancer patients) who are about to start treatment with capecitabine monotherapy will be recruited to the study and undergo study procedures within the first week of treatment.


Eligibility criteria:
inclusion criteria: * 1) histologic or cytologic diagnosis of breast cancer or colorectal cancer. patients should have disease that is suitable for capecitabine monotherapy as defined by the nice guidelines. 2) patients must be within the first week of their first cycle of capecitabine treatment. 3) estimated life expectancy of greater than 3 months. 4) eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. 5) total serum bilirubin less than or equal to 25 micromol/l. 6) serum aspartate aminotransferase (ast) and alanine aminotransferase (alt) levels less than 2.5 times the upper limit of the normal range. 7) serum albumin level greater than 32 g/l. 8) creatinine clearance greater than or equal to 30 ml/minute. 9) blood haemoglobin level of greater than 9 g/dl, with transfusion allowed. 10) absolute neutrophil count greater than 2.5 x 109/l. 11) platelet count greater than 100 x 109/l. 12) 18 years of age or older. 13) written informed consent. exclusion criteria: 1. pregnancy or breast feeding. 2. known hiv, hepatitis b, or hepatitis c infection. 3. known gilbert syndrome. 4. uncontrolled diabetes (hba1c greater than 7.5%). 5. any condition or disease that might affect oral absorption of medications, including: 1. crohn's disease 2. ulcerative colitis 3. major gastric or small bowel resection -

Keywords: capecitabine pharmacokinetics ageing frailty breast cancer colorectal cancer
project viva: a longitudinal study of health for the next generation

Conditions: Pediatric Obesity

Summary: project viva is a prospective cohort study of maternal and child health, following over 2,000 mother-child pairs from the mother's pregnancy into the child's adolescence.

in 1999-2002 the project viva team recruited 2,670 pregnant women during their first trimester of pregnancy from eight obstetric (ob) offices of a multi-site group practice in eastern massachusetts. 2,128 of the women had a live birth and approximately 1,600 mother-child pairs are still involved in the study. project viva collects data annually from multiple sources, including questionnaires, interviews, medical records, examinations, and biospecimen samples. project viva intends to follow participants as long as there is grant funding and interest from the participants. some of the most beneficial health findings come from long-term follow-up.

Eligibility criteria:
inclusion criteria: * less than 22 weeks pregnant at the time of enrollment * receive prenatal care at one of the selected practices * plan on delivering at one of two study hospitals * be able to answer questionnaires in english. exclusion criteria: * multiple gestation * plans to move away before delivery * plans to terminate the pregnancy

Keywords: pregnancy obesity diet maternal/child health asthma/allergy air pollution epigenetics cognition/behavior
a study comparing two magnetic resonance imaging (mri) contrast agents in mri of the brain

Conditions: Brain Pathology

Summary: this study aims at a direct comparison between multihance and a validated comparator like omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of mulihance for this indication


Eligibility criteria:
inclusion criteria: * 18 yrs of age or older; provide written informed consent; scheduled to undergo mri; willing to undergo 2 mri exams within 14 days exclusion criteria: * known allergy to one or more ingredients in the test agents; severe chf (class iv); suffered stroke one year ago; pregnancy or lactating females; contraindications to mri; severe claustrophobia; scheduled to receive surgery prior to or between the two mri exams, or steroids or radiosurgery between the two mri exams
fresh lime alone for smoking cessation

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to determine whether fresh lime alone is effective for smoking cessation.

smoking is the major preventable cause of chronic medical diseases and death worldwide. significant efforts led by world health organization (who) and several countries have been made to help current smokers to quit, particularly in the developing countries, where their smoking rates continued to rise. clinical practice guidelines were therefore developed to guide all healthcare personnel in those countries to provide treatment for smokers. however, despite that, only a small number of smokers were able to quit successfully. a large number of smokers who are poor and heavily addicted to nicotine remain and have no access to any effective smoking cessation aids. although there are several effective medications available for smoking cessation nowadays, the high price of them completely keeps poor smokers away from using them. alternative and cheaper smoking cessation aids are therefore necessary. during the past decade, certain herbal remedies have been introduced in smoking cessation in thailand. one of them that have been used widely without any supporting evidence is the fresh lime (citrus aurantifolia), the well-known native citrus to southeast asia. it is anecdotally claimed to be effective and safe in smoking cessation. the present study was designed to determine the efficacy and safety of fresh lime as a smoking cessation aid compared with those of nicotine gum.

Eligibility criteria:
inclusion criteria: * age over 18 * smoked regularly at least one year prior to study entry * had the desire to quit smoking * signed informed consent exclusion criteria: * having current dental problems * active peptic ulcer disease * psychiatric disorders * citrus allergy * pregnancy * use of illicit drugs * participation in another clinical trial and/or using any first-line smoking cessation aids within the past 30 days

Keywords: fresh lime nicotine gum smoking cessation craving
pd frontline (part of rapsodi gd) remote assessment of people with parkinson's

Conditions: Parkinson Disease

Summary: pd frontline (part of rapsodi gd) is an online study observational study with the goal of bringing people with parkinson's to the frontline of research by getting them trial ready. to do this, participants are offered genetic sequencing for the gba and lrrk2 gene with an at-home saliva collection kit.

pd frontline is an online one-time questionnaire based study with the purpose of identifying potential candidates for gene targeted trials and observational studies. once the questionnaire is completed, the participant is sent a saliva collection kit in the post to provide a sample for genetic testing. the genes tested for are gba1, the most common risk factor gene for parkinson's, and lrrk2. once tested, the participant is informed of their results and kept up-to-date with any studies or trials for which they may be eligible.

Eligibility criteria:
inclusion criteria: * formal diagnosis of parkinson disease exclusion criteria: * confirmation that the individual carries a gba variant (gba positive). these individuals will be referred to sister-study, rapsodi. * history of parkinsonism (progressive supranuclear palsy, multiple system atrophy, traumatic, manganese toxicity, postencephalitic, vascular pd; drug induced pd; corticobasal degeneration) * individuals with another neurological disorder including: dementia, movement disorders, and motor neurone disease. * individuals on drugs known to be associated with parkinsonism, including neuroleptic agents (amisulpride, chlorpromazine hydrochloride, flupenthixol, fluphenazine hydrochloride, haloperidol, methotrimeprazine, levomepromazine, olanzapine, oxypertine, pericyazine, perphenazine, pimozide, pipotiazine, prochlorperazine, promazine hydrochloride, reserpine, risperidone, sulpiride, thioridazine, trifluoperazine, zuclopenthixol acetate, zotepine), plus bupropion, , lithium, methyldopa, metoclopramide and sodium valproate).
the heidelberg engineering bi us evaluation study

Conditions: Normal Eyes; Eye Abnormalities

Summary: evaluation of defined parameters measured in pathological and non-pathological eyes with the heidelberg bi

the primary objectives of this study are to assess the feasibility to acquire acceptable images and to assess repeatability

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. able and willing to undergo the test procedures, sign informed consent, and follow instructions at least one of the following: 3. eyes with normal anterior segment 4. eyes with cataract 5. eyes without a crystalline lens 6. eyes with corneal abnormality 7. eyes with anterior segment pathology exclusion criteria: 1. subjects unable to read or write 2. active infection or inflammation in one or both eyes 3. insufficient tear film or corneal reflex 4. physical inability to be properly positioned at the study devices or eye exam equipment 5. inability to fixate 6. rigid contact lens wear during past 2 weeks 7. soft lenses, in the study eye, if worn, should be removed at least one hour prior to the measurements \*note: eyes with risk for acute angle closure glaucoma are excluded from the dilated portion of the study
prelude:study to investigate the prevention of relapse in lymphoma using daily enzastaurin

Conditions: Non Hodgkin Lymphoma

Summary: this clinical research study is to investigate the prevention of relapse in patients with diffuse large b cell lymphoma (dlbcl) using enzastaurin daily. this is a randomised trial which compares enzastaurin to placebo (dummy treatment), the chance of receiving enzastaurin is 2 to 1.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of diffuse large b cell lymphoma * recently completed r-chop therapy and achieved remission * international prognostic index (ipi) score 3,4,5 * at least 18 years of age * agree to study follow-up schedule exclusion criteria: * have received therapy other than r-chop for lymphoma * serious medical condition such as infection,second cancer,heart disease * received radiation to more than one lesion * unable to swallow tablets
swebcg 91:a rt. breast conserving surgery with or without radiotherapy for breast cancer patients

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Summary: the main goal of the trial was to analyse the value of radiotherapy after breast conserving surgery for patients with breast cancer, and to find groups of patients where the treatment could be omitted.

the trial recruited patients between 1991-1996, and the primary outcome in terms of recurrences has been updated through the years since then. tumour material has been collected in order to study prognostic and predictive factors for breast cancer patients that are treated today. late side effects of the treatment are studied.

Eligibility criteria:
inclusion criteria: * female * not over the age of 75 years * operated because of stage 1-2 invasive adenocarcinoma of the breast * radical excision of the tumour exclusion criteria: * earlier cancer except cancer in situ of the cervix or skin * distant metastases

Keywords: breast cancer radiotherapy