Kornimate/medical-research-clean huggingface dataset:
effect of a childcare resource on cervical cancer prevention

Conditions: Cervical Dysplasia

Summary: aim 1: determine the prevalence of unmet childcare needs among women with abnormal cervical cancer screening and establish the relevance of childcare as a social determinant of health in the context of cervical dysplasia. aim 2: conduct a pilot pragmatic patient-randomized control trial (rct) to evaluate the effectiveness of an intervention linking eligible patients to our childcare facility compared to standard of care on retention in care, defined as show-rate for the initial visit in the gynecology dysplasia clinic. the intervention will consist of 1) patient navigation to our childcare facility prior to the initial visit in the gynecology dysplasia clinic and 2) placement of an electronic medical record (emr) referral to our childcare facility. hypothesis: the study team hypothesizes that women receiving the intervention will have increased retention in care compared to women randomized to standard of care among women with abnormal cervical cancer screening referred to gynecology for diagnostic work-up. these two aims will demonstrate the significance of childcare as a social determinant of health in the cervical cancer screening and diagnostic continuum by assessing the burden of unmet childcare needs among women with cervical dysplasia and measuring the effect of health system-integrated childcare as an intervention for unmet childcare needs on retention in care and subsequent completion of diagnostic work-up among women with cervical dysplasia. this study will rigorously provide the first evidence illustrating the effect of health systems' investment in addressing unmet childcare needs on preventive care like cervical cancer screening. the findings of this proposed pilot study will be utilized to develop future large-scale studies with extramural funding, building a longitudinal program of research on addressing childcare as a social determinant of health in this and other similar clinical contexts (e.g., breast cancer screening and treatment).


Eligibility criteria:
inclusion criteria: * all women with abnormal cervical cancer screening referred to parkland gynecology dysplasia clinic as a new patient exclusion criteria: * pregnant women * patients \<18 years of age

Keywords: childcare social determinant of health patient navigation
adaptation in polyphenol bioavailability and bioactivity during long term exposure to polyphenol-rich foods

Conditions: Healthy

Summary: there are two primary objectives to be addressed in this study: to assess the differential response in bioavailability and metabolic pathways between lean and obese individuals exposed to acute, short term (14 day), and long-term (10-week) consumption of polyphenol-rich fruits (berries and apple), and beverages (tea); and to determine the differential systemic and gut anti-inflammatory response between obese and lean individuals exposed to polyphenol-rich fruits (berries and apple), and beverages (tea).


Eligibility criteria:
exclusion criteria: * younger than 25 years old or older than 75 years old * use of blood-thinning medications such as coumadin (warfarin), dicumarol (dicumarol), or miradon (anisindione) * presence of any gastrointestinal disease, metabolic disease, bariatric surgery, or malabsorption syndromes that may interfere with the study goals * have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study * type 2 diabetes requiring the use of oral antidiabetic agents or insulin * fasting triglycerides greater than 300 mg/dl * fasting glucose greater than 126 mg/dl * history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets) * use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity * active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months). * use of any tobacco products in past 3 months * unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study * known (self-reported) allergy or adverse reaction to study foods * unable or unwilling to give informed consent or communicate with study staff * self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (long-term participation in alcoholics anonymous is not an exclusion)

Keywords: pharmacokinetics polyphenol metabolites lean individuals obese individuals
mobile health app to reduce diabetes in latina women

Conditions: Gestational Diabetes

Summary: the proposed project sought to develop a culturally- and individually-tailored, plain-language spanish/english mobile phone intervention for latinas with prior gestational diabetes (gdm). the intervention is based on earlier in-person to online modification of the cdc-funded diabetes prevention program (dpp), for women with prior gdm led by co-investigator dr. ellen seely of brigham and women's hospital.

the specific aims of the study were as follows: primary aim 1: develop a culturally-tailored mobile phone intervention for latinas with prior gdm based on brigham \& women's hospital online dpp. primary aim 2: conduct a pilot trial of the intervention. primary aim 3:evaluate implementation feasibility.

Eligibility criteria:
inclusion criteria: * latina women * ages 19-45 * with prior gestational diabetes by carpenter and coustan criteria * within the past 5 year validated by medical record review * own an android or ios smartphone. exclusion criteria: * diagnosis of pre-pregnancy diabetes(type 1,2, or secondary diabetes) * underlying disease that might interfere with participation in study (e.g.,significant gastrointestinal conditions) * taking certain medications (e.g., glucocorticoids) * pregnancy/undergoing infertility treatment.
dtm (tm) spinal cord stimulation (scs) study

Conditions: Chronic Pain

Summary: prospective, multi-center, open-label, post-market study to evaluate the efficacy and energy use of a low energy dtm™ (dtm-le) scs therapy for pain relief.

this post market study will measure the following: * visual analog scale * programming parameters

Eligibility criteria:
inclusion criteria: * 18 years of age or older * willing and able to provide signed and dated informed consent * capable of comprehending and consenting in english * candidate per labeling for an scs system as an aid in the management of chronic, intractable pain of the trunk and/or limbs * has moderate to severe back and leg pain * stable pain medications for back and leg pain for at least 28 days prior to enrollment * willing and able to comply with all study procedures and visits * willing and able to not increase their pain medications through the 3-month visit * able to differentiate between pain associated with the indication for scs implant and other types of pain exclusion criteria: * previously trialed or implanted with a stimulator or intrathecal drug delivery system * expected to be inaccessible for follow-up * current diagnosis of moderate to severe central lumbar spinal stenosis with symptomatic neurogenic claudication * currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results * if female, is pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study * has untreated major psychiatric comorbidity * serious drug-related behavioral issues * unable to achieve supine or prone position * classified as vulnerable or requires a legally authorized representative (lar)
temporary spinal cord stimulation to prevennt atrial fibrillation after cardiac surgery

Conditions: Coronary Artery Disease; Atrial Fibrillation

Summary: to compare of atrial arrhythmia incidence in patients with coronary artery disease and atrial fibrillation history, undergoing either coronary artery bypass grafting plus temporary spinal cord stimulation or coronary artery bypass grafting alone

the study includes 60 patients. patients are randomized into 2 groups: coronary artery bypass grafting plus b-blocker treatment (according to guidelines; group i) and coronary artery bypass grafting plus b-blocker treatment (according to guidelines) plus temporary spinal cord stimulation (group 2). temporary spinal cord stimulation is performed for 3 days before surgery and 7 days after coronary artery bypass grafting. continuous ecg during intensive care unit stay, daily ecg and 24-h holter monitor recordings at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit until 30 days after coronary artery bypass grafting. rhythm status and clinical outcome assessment at 12 month follow up

Eligibility criteria:
inclusion criteria: * age 18-80 years; * indications for coronary artery bypass grafting according to guidelines; * pre-operative history of paroxysmal atrial fibrillation; * absent of contraindications for spinal cord stimulation; * signed inform consent. exclusion criteria: * previous heart surgery or atrial fibrillation ablation procedure; * emergency coronary artery bypass grafting; * left ventricle ejection fraction \<35%; * unstable angina or heart failure; * persistent atrial fibrillation or atrial fibrillation at the time of screening; * planned maze procedure or pulmonary vein isolation; * use of class i or iii antiarrhythmic drugs within 5 elimination half-lives of the drug; * need for concomitant valve surgery; * inability to control the device for spinal cord stimulation; * coagulopathy, immunosuppression, or other condition associated with an unacceptable surgical risk for spinal cord stimulation; * need for therapeutic diathermy in the area of leads placement; * need for pacemaker/icd/crt-d implantation; * unwillingness to participate.

Keywords: atrial fibrillation spinal cord stimulatoin coronary artery bypass grafting
risk assessment of peritoneal dialysis failure based on catheter tip location.

Conditions: Renal Failure

Summary: the location of the catheter tip in radiographic planes 1 and 2, is a protection factor for the mechanical performance of peritoneal dialysis. instead radiographic planes 3 and 4 are risk factors.

radiolucency of the peritoneal dialysis catheter, allow to classify the location of the tip into 4 radiographic planes. plane 1: below the zone of a line on the head of the femur. plane 2: is the area above the plane 1 and below a line connecting the two iliac spines. plane 3: is the area that is above the plane 2 and below a line connecting the upper edge of the two iliac crests. plane 4: is the area located above the plane 3.

Eligibility criteria:
inclusion criteria: * patients with functional class k-digo 5d, initiating peritoneal dialysis program, with recent positioning of less than 2 weeks of dialysis catheter placement exclusion criteria: * patients with agenesis of pelvic bones that prevent divisions radiographic

Keywords: tip catheter peritoneal dialysis risk factot mecanical function
low-dose temozolomide for 2 weeks on brain tumor enzyme in patients with gliomas (p04602 am1) (completed)

Conditions: Glioma

Summary: the main purpose of this study is to assess the effect of a two-week pre-surgery treatment with low-dose temozolomide (tmz) on brain tumor methylguanine-dna (deoxyribonucleic acid) methyltransferase (mgmt) activity in patients with gliomas.


Eligibility criteria:
inclusion criteria: * presence of a brain tumor with high probability of being a glioma as detected by magnetic resonance imaging (mri). these would include newly diagnosed tumors or potentially recurrent gliomas. * no prior treatment for the tumor including chemotherapy or radiotherapy. * amenable to surgery for biopsy or resection of the brain tumor. surgically confirmed diagnosis of glioma (glioblastoma multiforme \[gbm\], anaplastic astrocytoma \[aa\], anaplastic oligodendroglioma \[ao\], anaplastic oligoastrocytoma \[aoa\], astrocytoma \[a\] or oligodendroglioma \[o\]) will be required for patients to be maintained in the study. those not fulfilling this requirement will be discontinued and will be replaced. * use of medically approved contraception in fertile males and females. * women with childbearing potential must have a negative urine or serum pregnancy test (urinary excretion or serum level of beta-human chorionic gonadotropin \[bhcg\]) within 72 hours of randomization. * karnofsky performance status score \>= 70%. * signed informed consent form exclusion criteria: * prior chemotherapy. * prior radiotherapy at the tumor site. * history of non-compliance to other therapies. * inadequate haematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to study inclusion): * absolute neutrophil count ≤1.5 x 10\^9/l; * platelets ≤100 x 10\^9/l; * haemoglobin \<90 g/l; * serum creatinine ≥1.5 times upper limit of laboratory normal; * total serum bilirubin ≥1.5 times upper limit of laboratory normal (uln); * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 2.0 uln; * alkaline phosphatase of \> 2.5 uln. * known human immunodeficiency virus \[hiv\] infection. * known chronic hepatitis b or hepatitis c infection. * any other serious medical condition according to the medical judgment of the physician prior to inclusion in the study. * any medical condition, which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction).
prevention of new onset af after tavi (paf-tavi trial)

Conditions: Atrial Fibrillation New Onset

Summary: new onset atrial fibrillation (noaf) is a relatively frequent complication after transcatheter aortic valve implantation (tavi). this complication has been related with worse short and long-term outcomes, including higher stroke, mortality, readmission and bleeding rates. the aim of this study is to evaluate the effectiveness of amiodarone in the prevention of the noaf after tavi. the study is a multicenter, randomized double-blinded trial including 120 patients without prior af that will undergo tavi in a scheduled basis. patients will be randomized to be treated with amiodarone orally from 6 days before to 6 days after the tavi procedure versus placebo. all the patients will be monitored with a 60-day holter to evaluate noaf incidence. the main objective is noaf incidence after tavi at 30-day. secondary endpoints are the incidence of noaf, stroke, bleeding and all-cause and cardiovascular mortality in both groups at 60-day. results of this study can contribute to optimize tavi results in a short and long term, potentially improving the survival and quality of life in this group of frail patients with comorbidities, which makes them vulnerable to noaf, stroke, bleeding, heart failure and readmission.


Eligibility criteria:
inclusion criteria: * men and women over 18 years old. women of childbearing age must commit to the use of contraceptive methods of assured efficacy. * patients that will undergo tavi due to aortic stenosis. * sinus rhythm showed by an ecg during 72 hours previous to the inclusion in the study. exclusion criteria: * pregnancy or lactation. women of childbearing age who do not have a negative pregnancy test. * paroxysmal persistent or persistent af (documented record in electrocardiogram or ecg holter) * congestive heart failure with functional class nyha iv despite optimal medical treatment. * sustained hypotension (tas \< 80mmhg) * severe mitral stenosis or regurgitation * treatment with antiarrhythmic drugs (amiodarone included) 3 months before the procedure, treatment with beta-blockers or dihydropyrimidine calcium channel blockers are not considered an exclusion criteria. * sinus bradycardia (\ 240 mseg or second or third degree av block. * qt interval longer than 480 msec in an ekg performed in 72 hours before the inclusion, without a permanent pacemaker. * clinical hypo- or hyperthyroidism, clinical or subclinical autoimmune thyroid disease, or multinodular goiter. * allergy or adverse reaction known or suspected to the amiodarone. * denial of the patient or inability to give informed consent. * hypersensitivity to iodo * concomitant drugs that, in association with amiodarone, can induce torsades de pointes
incorporating patient-reported outcomes into shared decision making with patients with osteoarthritis of the hip or knee

Conditions: Osteo Arthritis Knee

Summary: osteoarthritis (oa) of the knee constitutes a major public health problem. treatment options for knee oa range from lifestyle changes to pharmacological management to total knee replacement surgery. as a "preference-sensitive" condition, management of oa of the knee is ideally suited for shared decision making (sdm), taking into consideration benefits, risks, and patients' health status, values, and goals. patient-reported outcomes (pros) reflect health status from the patient's perspective. for knee oa, relevant pros include pain and other symptoms, functional status and limitations, and overall health. prior research indicates that patients with higher baseline physical function and/or poor baseline mental health do not benefit as much from total knee replacement. still, due to logistical challenges, costs, and disruptions in workflow, pros have not yet achieved their full potential in clinical care. musculoskeletal providers at dell medical school and ut health austin currently collect general and condition-specific pros from every patient seen in their musculoskeletal institute. pros are collected via an electronic interface and results are pulled into the athena electronic health record (ehr). given the promise of combining pro data with clinical and demographic data, musculoskeletal providers at ut health austin have begun utilizing an innovative electronic pro-based predictive analytic tool at the point of care to guide sdm in patients with knee oa. this project plans to evaluate the clinical effectiveness and impact of the pro-guided predictive analytic sdm tool and process in a randomized controlled trial in austin. outcomes will include decision quality, as reported by patients; treatment decision (surgical vs. non-surgical); and decisional conflict and regret. our project contributes to ahrq's strategy to use health it to improve quality and outcomes by evaluating a tool and process for the use of pro data at the point of care. the model being tested puts patients at the center of their care by enabling them to participate in informed decision making by using their personal health data, preferences, and prognostic models. knowledge gained will be critical to scaling and spreading use of this pro-guided sdm tool among patients with knee oa nationally.


Eligibility criteria:
inclusion criteria: * new patients * presumptive diagnosis of knee oa * aged 45 to 89 * k-l joint oa severity grade 3 to 4 (moderate to severe) * koos jr score 0-85 * able to consent exclusion criteria: * prior total knee replacement (tkr) * prior consultation with orthopaedic surgeons for tkr * prior experience with joint insights * trauma condition or psoriatic/rheumatoid arthritis * non-english or non-spanish speakers * bmi \ 46
determinants of metabolic control in children with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: a good metabolic control of type 1 diabetes mellitus (t1dm) is crucial to avoid long-term complications associated with the disease. although recent evidences suggest that a good metabolic control of t1dm is partly independent of management intensity and could be anticipated since onset, factors that influence glycated haemoglobin (hba1c) patterns remain poorly understood and are likely to be genetic. while significant progress has been made in understanding of the genetic contribution to t1dm onset, very few studies have evaluated the role of genetic factors on t1dm metabolic control. this study aims to create a comprehensive database of genetic and phenotypic data in a cohort of children and young adults with t1dm and to evaluate genetic and environmental factors that might predict trajectories in glycemic control


Eligibility criteria:
inclusion criteria cases: * age between 6 and 21 years; * patients suffering from type 1 diabetes controls: * age between 6 and 21 years; * patients for whom a venous sampling is planned exclusion criteria cases: * patients for whom it is not possible to collect information on the clinical history, starting from the onset of diabetes * patients with other types of diabetes mellitus (type 2, monogenic diabetes, diabetes related to cystic fibrosis...) * patients incapable of expressing valid informed consent or whose parents are incapable of expressing valid informed consent. controls: * subjects with type 1 and 2 diabetes * obese subjects and those with a family history of diabetes and obesity or other metabolic disorders * subjects with hba1c \>6% * patients incapable of expressing valid informed consent or whose parents are incapable of expressing valid informed consent.

Keywords: type 1 diabetes metabolic control