Kornimate/medical-research-clean huggingface dataset:
a prospective randomized postmarket clinical study of the transition stabilization system

Conditions: Acute Instabilities Thoracic, Lumbar and Sacral Spine; Chronic Instabilities Thoracic, Lumbar and Sacral Spine; Deformities of the Thoracic, Lumbar and Sacral Spine

Summary: this postmarket surveillance study is being conducted to evaluate the transition stabilization system as an adjunct to fusion in the treatment of acute or chronic instabilities or deformities of the thoracic, lumbar and sacral spine. the study will involve up to 360 subjects at no more than 20 sites, to be treated with the transition stabilization system. the data from this postmarket surveillance study will be provided to fda in accordance with the 522 order.


Eligibility criteria:
inclusion criteria: * any of the following acute or chronic instabilities or deformities of the thoracic, lumbar or sacral spine: * degenerative spondylolisthesis with objective evidence of neurologic impairment, * kyphosis, or * pseudoarthrosis (failed previous fusion) * age 18 or older at the time of consent * able to understand and sign informed consent form * psychosocially, mentally and physically able to comply with protocol * able to meet the proposed follow-up schedule at 6 mo, 12 mo, and 24 mo exclusion criteria: * prior fusion surgery or another spinal device implanted in the thoracic, lumbar or sacral spine * requires treatment of more than two vertebral levels * lytic spondylolisthesis at the index level(s) * clinically compromised vertebral bodies at the affected level(s) due to current or past trauma * sustained pathologic fractures of the spine or hip, including prior fracture or trauma to vertebral structures at any thoracic, lumbar, or sacral level * morbid obesity defined as a body mass index \> 40, or a weight more than 100 lbs over ideal body weight * pregnant or interested in becoming pregnant within the next 2 years * active systemic or local infection * known allergy to device materials titanium, polycarbonate (pcu), polyethylene terepthalate (pet), or hydroxyapatite (ha). * taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids, excluding routine nsaids) * systemic disease including aids, hiv, hepatitis c * has an active malignancy defined as a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years * neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, amyotrophic lateral sclerosis, etc. * participation in an investigational device or drug clinical trials within 30 days of surgery * acute mental illness or substance abuse * prisoners
using ultrasonography, shear wave elastography, strain imaging, and 3-d volume ultrasonography on cardiovascular disease

Conditions: Fibromuscular Dysplasia of Arteries; Segmental Arterial Mediolysis; Spontaneous Coronary Artery Dissection; Atherosclerosis of Artery

Summary: the researchers are trying to see whether contrast-enhanced ultrasonography, shear wave elastography, strain imaging, and 3-d volume ultrasonography improves arterial wall visualization and identifies arterial elastic properties among individuals with fibromuscular dysplasia (fmd), atherosclerosis, personal history of spontaneous coronary artery dissections (scad), or personal history of segmental arterial mediolysis (sam) that may be different compared to those without the aforementioned conditions.

aims, purpose, or objectives: 1. to describe whether contrast-enhanced ultrasonography, strain imaging, and 3-d volume ultrasonography are helpful to characterize affected arteries and improve the imaging of arterial wall among patients with fibromuscular dysplasia (fmd) and segmental arterial mediolysis (sam). 2. evaluate the arterial elastic properties of individuals with fmd and compare to normal individuals, those with atherosclerosis disease, those with personal history of spontaneous coronary artery dissections (scad), and/or personal history of segmental arterial mediolysis (sam) by elastography. 3. identification of vulnerable arterial elastic properties using contrast-enhanced ultrasonography, shear wave elastography, strain imaging, and 3-d volume ultrasonography to predict short-term and long-term outcomes among individuals with fmd, normal individuals, those with atherosclerosis disease, those with scad, and/or sam. 4. develop risk factor profiles and risk score systems of patients undergoing contrast-enhanced ultrasonography, shear wave elastography, strain imaging, and 3-d volume ultrasonography among individuals with fmd, those with atherosclerosis disease, those with personal history of scad, and/or personal history of sam.

Eligibility criteria:
inclusion criteria: * diagnosis of fibromuscular dysplasia (fmd), and/or segmental arterial mediolysis (sam), and/or spontaneous coronary artery dissection (scad), and those with atherosclerosis, and normal individuals. * adult male and non-pregnant female patient 18-100 years of age. * patients who are able and willing to sign the informed consent will be enrolled. exclusion criteria: * missing records to determine whether or not they have fibromuscular dysplasia (fmd), and/or segmental arterial mediolysis (sam), and/or spontaneous coronary artery dissection (scad), and those with atherosclerosis, and normal individuals. * patients who do not accept to participate in research studies. * prior contraindication to contrast agent. * women who are breastfeeding or pregnant * patients less than 18 yo

Keywords: ultrasound 3d ultrasonography contrast-enhanced ultrasound shear wave elastography
adjuvant vaccination after conization for the treatment for cervical dysplasia

Conditions: Cervical Intraepithelial Neoplasia

Summary: hpv vaccination has emerged as a strategy to reduce the risk of recurrence oafter excisional treatment. however, only few data are aviable. in this trial the investigators aim to assess the role of hpv vaccination in women traeted for hpv-related lesions

patients treated for hpv-related disease are counseled about the potential protective role of hpv vaccination. the investigators will monitor the risk of hpv recurrence in pateints who choce to have vaccination and who did not.

Eligibility criteria:
inclusion criteria: * treatment of hpv-related disease exclusion criteria: * previous hpv vaccination

Keywords: hpv
zenith® dissection clinical trial

Conditions: Aortic Dissection

Summary: the zenith® dissection clinical trial is a clinical trial approved by us fda to study the safety and effectiveness of the zenith® dissection endovascular system in the treatment of acute, complicate type b aortic dissection.


Eligibility criteria:
exclusion criteria: 1. age \< 18 years; 2. other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the clinical investigation plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years); 3. pregnant, breast-feeding, or planning on becoming pregnant within 60 months; 4. unwilling or unable to comply with the follow-up schedule; 5. inability or refusal to give informed consent; 6. simultaneously participating in another investigative device or drug study. (the patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.); 7. additional medical restrictions as specified in the clinical investigation plan; or 8. additional anatomical restrictions as specified in the clinical investigation plan.

Keywords: aorta thoracic aortic dissection rupture type b debakey type iii endovascular
amo's tecnis™ multifocal intraocular lenses (tecnis mf), alcon's restor multifocal iol

Conditions: Cataract

Summary: the purpose of this study is to compare the visual outcomes with bilateral implantation of tecnis mf and restor iols six months post cataract surgery.

the purpose of this study is to compare the visual outcomes with bilateral implantation of tecnis mf and restor iols six months post cataract surgery.

Eligibility criteria:
inclusion criteria: * age 18 or greater * bilateral condition (cataracts or presbyopia) for which phacoemulsification and posterior iol implantation has been planned for both eyes * visual potential of 20/25 or better in each eye after cataract removal and iol implantation * clear intraocular media other than cataract * normal oct of the macula * no evidence of keratoconus or significant irregular astigmatism on preoperative topography * no evidence of epithelial basement membrane dystrophy on slit lamp exam * availability, willingness, and sufficient cognitive awareness to comply with examination procedures exclusion criteria: * use of systemic or ocular medications that may affect vision * uncontrolled systemic or ocular disease * history of ocular trauma * history of intraocular, extraocular muscle, or corneal surgery (including laser vision correction) * amblyopia or strabismus * known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) * diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/25 or worse * subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy) * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) * contact lens usage within 2 months for pmma contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses

Keywords: visual outcomes with bilateral implantation of tecnis mf and restor iols six months post cataract surgery
using addiction comprehensive health enhancement support system (achess) in an alcoholic liver disease population

Conditions: Liver Diseases, Alcoholic

Summary: this is a pilot study examining whether an evidence-based recovery support smartphone application, the addiction comprehensive health enhancement support system (a-chess), can decrease alcohol recidivism in a previously unstudied group of patients with alcoholic liver disease (ald).

a-chess is a smartphone application developed by the university of wisconsin-madison based on self-determination theory, with a previous randomized clinical trial showing that use of the app resulted in significantly fewer risky drinking days in patients leaving treatment for alcohol-use disorders. the application is downloaded to the participant's smartphone, and provides ongoing access to peer support and educational materials, monitoring of the risk of relapse, and delivery of reminders and encouragements to the patient. the application also has a survey platform to assess and reassess the participants' most recent alcohol consumption, quality of life, and experience using the application. we anticipate that use of the a-chess app will result in decreased drinking and improved abstinence, identifying a potential intervention to offer patients with ald to improve their mortality, liver disease, and likelihood of liver transplant candidacy status.

Eligibility criteria:
inclusion criteria: * alcoholic liver disease * followed or seen at new york presbyterian hospital / weill cornell medical center * english speaking * access to a smartphone exclusion criteria: * unable to consent * primary language other than english * no access to a smartphone
long-term radial artery occlusion in coronary diagnosis and intervention via distal radial approach (condition)

Conditions: Coronary Artery Disease; Distal Radial Artery; Radial Artery Occlusion

Summary: randomized-controlled trial to comparison of the long-term radial artery occlusion in coronary diagnosis and intervention via distal vs conventional radial approach

coronary diagnosis and intervention via distal radial artery is prevalent worldwide. this study aims to explore the long-term radial artery occlusion after coronary diagnosis and intervention via distal radial artery at 3 months after procedure using portable high-frequent ultrasound. the secondary endpoints include the success rate of puncture, time of puncture, duration of hemostasis, radial artery trauma, etc.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * palpable unilateral distal radial and radial artery exclusion criteria: * age ≥ 90years; * height≥ 185cm; * cardiogenic shock; * contraindications to puncture at the puncture site; * inability to obtain written informed consent * previous right radial or distal artery intervention

Keywords: coronary artery disease distal radial artery conventional radial artery radial artery occlusion
team-based technology-enabled integrated patient/caregiver-focused dementia study

Conditions: Dementia

Summary: dementia patients experience memory and other cognitive function deterioration leading to loss of independent function. care required for dementia is multifactorial, spanning cognitive, behavioral, emotional, and physical symptoms, and complicates aspects of daily living. this places tremendous strain on caregivers who, in turn, experience their own increased physical and mental health needs. the current care model focuses primarily on patient pharmacological management but misses the mark on caregiver focus and collaboration. building on systematic reviews and existing evidence gaps in information and support for patient/caregiver dyads, dealing with behavioral symptoms, referrals to available community resources, and multidisciplinary team care with improved coordination and communication17, the study investigators propose a patient- and caregiver-targeted integrated dementia practice unit (idpu) model of care. idpu integrates disconnected care under a centralized specialty team, providing monitoring, education, individualized support, and proactive, ongoing collaboration and coaching using technology and home/virtual visits for maximal impact. days alive at home (daah) best captures quality of life (qol) for the index dementia patient, from the perspective of both the healthcare system and the caregiver, and degree of support for the caregiver and is often an outcome in assessing health delivery. the study investigators hypothesize idpu will increase daah and improve patient-level (behavioral; depressive symptoms; chronic disease management) and caregiver-level (strain, depressive symptoms, social support) outcomes relative to an educational+ model, merging a standard care design with additional education support for patients/caregivers and their primary care providers (pcp). this study seeks to (a) improve and establish idpu feasibility of the in the feasibility phase, (b) determine if idpu is more effective than education+ in increasing daah and patient- and caregiver-level outcomes, and (c) determine if benefits of idpu are more or less pronounced in vulnerable subgroups in the full-scale study.


Eligibility criteria:
inclusion criteria include: * alzheimer's disease or vascular dementia diagnosis provided by a study investigator * 2 or 3 on the clinical dementia rating scale at time of enrollment * mini mental status examination score of \>10 or \<25 administered at the time of enrollment * willingness and ability to provide patient or surrogate consent, and since caregiver cooperation will be an integral part of this study, an ability to provide caregiver consent to participate exclusion criteria include: * individuals with mild cognitive impairment * institutionalized individuals (extended care facility, nursing home, group home, or similar institutional setting) * individuals who in the opinion of the investigator cannot be enrolled or followed due to geographic or other constraints
examining the role of improved nsaid management in treating dysmenorrhea and bladder pain

Conditions: Dysmenorrhea; Pain

Summary: the goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea will improve pain report from baseline. in addition, we will determine whether cross-organ influences from the uterus on bladder pain sensitivity change from baseline after reduced menstrual pain experience over six months. finally, a battery of quantitative sensory tests and eeg measures of sensory sensitivity will be used to evaluate mechanisms associated with improvements in menstrual and bladder pain.

endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokine concentrations producing moderate to severe pelvic pain in more than 20% of reproductive-age women. one out of every five of those women in turn will experience chronic pelvic pain (cpp) which may be in part due to cross-organ neural sensitization. in this study we will establish whether prophylactic and adequate dosages of naproxen are capable of reducing menstrual pain more than \*\*\* use.

Eligibility criteria:
inclusion criteria: * reproductive-age women (age 18-45) with dysmenorrhea * average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least one day during menses or during withdrawal uterine bleeding from cyclic ocs without painkillers * menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament * indication the participant has attempted to resolve pain by medical means (including nsaids and/or ocps) exclusion criteria: * presence of active pelvic or abdominal malignancies (primary or metastatic) * absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding) * active genitourinary infection in the last four weeks * unable to read or comprehend the informed consent in english * unwilling to complete study procedures * presence of hypertension or risk for developing hypertension * unwillingness to take naproxen and/or placebo * contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function) * formal urological diagnosis such as overactive bladder or bladder pain syndrome.

Keywords: cross-organ sensitivity bladder pain nsaid visceral pain
response of pulmonary functions to deep breathing exercise in twin pregnancy

Conditions: Pregnancy Related

Summary: this study is to investigate the response of pulmonary function to deep breathing exercise in twin pregnancy

physiological changes during pregnancy impose numerous changes on the respiratory system that can affect the health of both mother and foetus. regarding the importance of the normal breathing in the health of mother and foetus. many investigators have studied pulmonary function tests during normal pregnancy, most of them found a significant decrease in pulmonary function test parameters during all pregnancy trimesters. others showed that the pfts parameters are normal in the first trimester but there was significant decrease in them in the second and third trimesters, or in the third trimester only. study design: randomized control trial sixty twin pregnant women during the third trimester i (27th weeks gestation),aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. they will be assigned into two equal groups; control group and study group ( study group only will make deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary function test will be applied for both groups at 27th week gestation and at 36th weeks gestation.

Eligibility criteria:
inclusion criteria: * all pregnant women will be in 27th week gestation * they will be recruited from soaad kafafy university hospital * their age between 25-35 years old * their bmi ≥30kg/m2 exclusion criteria: * pregnant women with any pulmonary disorders before pregnancy * women suffering from any physical or mental disorders. * pregnant women with gestational diabetes * pregnant women with gestational hypertension * pregnant women with asthma
colorectal cancer screening intervention trial

Conditions: Colorectal Cancer; Colorectal Cancer Screening

Summary: colorectal cancer is the second deadliest among cancers and disproportionately affects african americans. the colorectal cancer screening intervention trial(ccsit) project has as its goal to test three interventions designed to increase screening rates among medically underserved african americans in the metropolitan atlanta area. it is designed to increase awareness of modifiable risk factors and promote the benefits of screening as a means of early detection of colorectal cancer. mportance of being screened for colorectal cancer,african americans continue to be disproportionately affected by this disease. the colorectal cancer screening

despite increased awareness of the importance of being screened for colorectal cancer, african americans continue to be disproportionately affected by this disease. the colorectal cancer screening intervention trial (ccsit) is designed to test and expand a public health intervention that combines social marketing and community-coalition building efforts. the purpose of this study is to 1) evaluate the effects of three different approaches on knowledge, attitudes and beliefs (kabs) about colorectal cancer; 2) to examine the effects of three different approaches to adherence to screening guidelines and 3) to evaluate the independent role of setting on screening practices. participants age 50 and over are recruited from churches, clinics and senior sites which allows us to examine the impact of setting on participant recruitment and changes to kab. pre and post questionnaires are administered to determine the knowledge attitudes and behaviors (kab) related to screening and to measure psychosocial parameters (self-esteem, perceived stress and social support). these persons are randomized into one of four groups, the control group and three intervention arms: (1) one-on-one counseling sessions, (2) small group educational sessions and (3) financial incentives interventions where out of pocket cost for screening is reimbursed. the counseling and educational interventions incorporate the health belief model and social learning theory.

Eligibility criteria:
inclusion criteria: * african american * previously not screened for colorectal cancer according to acs guidelines * reside in fulton,,gwinett,cobb,clayton and dekalb counties * 50 years of age or older exclusion criteria: * non-african american * less than 50 years of age * previously screened consistent with acs guideline

Keywords: african americans colorectal cancer screening colorectal cancer colorectal cancer and african americans cancer disparities