Kornimate/medical-research-clean huggingface dataset:
a longitudinal study in 1st degree relatives of parkinson's disease (pd) patients

Conditions: Parkinson's Disease

Summary: this is a longitudinal study in healthy 1st degree relatives of patients with parkinson's disease (pd) carriers of a genetic mutation in genes that are known to increase the risk for pd. the purpose of this study is to explore the association between genetic mutations in the known genes and early preclinical symptoms such as motor, sensory, autonomic, behavioral and cognitive functions.


Eligibility criteria:
inclusion criteria: * healthy 1st degree relatives of pd patients with known genotype that participated in an earlier genetic study at the sourasky medical center. exclusion criteria: * subjects with cognitive decline by the parameters defined in dsm- iv * subjects with psychiatric disorder * subjects unable to sign a consent form

Keywords: healthy 1st degree relatives of pd patients
a treatment study comparing two non-drug, self-help treatment of chronic insomnia.

Conditions: Insomnia

Summary: the purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia.

chronic primary insomnia is a highly prevalent condition, affecting up to 15% of the population. the condition is associated with daytime fatigue, lack of concentration, and decreased quality of life. most people with chronic primary insomnia go untreated, because of a desire to avoid medication or lack of access to quality non-drug treatments. therefore, an affordable, easy to use, and effective computer to help assess and treat insomnia symptoms could bring treatment to this population. comparison: we are comparing a new handheld computer that uses cognitive-behavioral treatment principles to a popular self-help manual for the treatment of primary insomnia symptoms.

Eligibility criteria:
inclusion criteria: * sleep less than 6.5 hours per night * at least 30 minutes of sleep onset latency or wakefulness after sleep onset * symptoms present for at least 6 months * must have insomnia symptoms at least 3 days per week exclusion criteria: * body mass index greater than 32 * presence of anxiety disorder * secondary forms of insomnia * presence of a substance use disorder * concurrent treatment for another mental disorder * history of other sleep disorders, including: apnea, restless legs, periodic limb movement disorder, or narcolepsy

Keywords: insomnia sleep
music therapy for pain modification in pediatric palliative care

Conditions: Neurological Impairment

Summary: the purpose of this within-subjects randomized controlled trial is to determine whether two music therapy interventions are efficacious in reducing pain symptoms, in order to improve the quality of care for children in pediatric hospice. the investigators hypothesize that both music therapy interventions, live guitar and vocal intervention and vibroacoustic intervention, will reduce behavioural pain scores and that behavioural pain scores will correlate with physiological outcome measures.

effective pain management in pediatric palliative care is a quality of life issue for patients, families and professionals. current research supports the use of music therapy to assist with pain management in pediatric medical settings. however, little research has been done to explore the use of music therapy for reducing pain in children with life-limiting neurological impairments or metabolic conditions. as the first known project to examine the effects of music therapy on pain symptoms with children who have life-limiting neurological impairments or metabolic disorders, this study will expand the evidence-base for practice with this population. it is imperative that an evidence base for music therapy in this area be established, so that the most effective interventions can be provided to these vulnerable children.

Eligibility criteria:
inclusion criteria: * children, ages 1-19, who have been diagnosed with life-limiting neurological impairments and metabolic conditions * cognitive functioning level of one year or less will be enrolled in the study * receiving respite or symptom management care at the time of admission to the canuck place children's hospice * guardians must be able to provide written consent in english; interpreters will be available if a guardian needs clarification on specific points. exclusion criteria: * children who are actively dying (i.e. admitted for end-of-life care or determined by physicians to require immediate end-of-life care) * any history of adverse responses to live or recorded music or to vibroacoustic stimulation * severe to profound hearing impairment will be excluded.

Keywords: music therapy infants children adolescents pediatric palliative care neurological impairment metabolic condition pain management
18f-dcfpyl pet/mri in regional nodal&distant metastases detection in intermediate &hr prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this research study is to see if patients' tumor can be identified by 18f-dcfpyl pet/mri scan. the radioactive study agent, 18fdcfpyl, combined with pet/mri scan may be able to identify smaller tumors than the standard of care contrast-enhanced ct or mri scan.

this is an expanded access study with a total of 100 participants with newly diagnosed intermediate or high-risk prostate cancer scheduled to undergo prostatectomy and lymph node dissection.

Eligibility criteria:
inclusion criteria: 1. patient is older than 18-year-old 2. biopsy proven prostate adenocarcinoma 3. planned prostatectomy with lymph node dissection 4. intermediate to high-risk disease (as determined by elevated prostate-specific antigen (psa) \[psa\>10\], t-stage \[t2b or greater\], gleason score \[gleason score \> 6\] or other risk factors) 5. able to provide written consent 6. karnofsky performance status of ³50 (or eastern cooperative oncology group (ecog) /world health organization (who) equivalent) exclusion criteria: 1. neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (hifu) 2. androgen deprivation therapy or other neoadjuvant treatments prior to pet imaging surgery 3. metallic implants (contraindicated for mri)
a study to compare and measure the effects of insulin peglispro (ly2605541) and glargine on meal time insulin requirements

Conditions: Diabetes Mellitus, Type 1

Summary: this study will look into how a base dose of insulin peglispro and insulin glargine will affect the meal time dose and efficacy of insulin lispro in type 1 diabetics.


Eligibility criteria:
inclusion criteria: * have a stable (within 0.5 percent (%) from last measure) glycated hemoglobin (hba1c) \<9.0% * have a stable (within 30%) basal insulin dose of 0.2 to 1.0 units per kilogram per day (u/kg/day) and a total daily insulin dose (basal + prandial/bolus) \<1.5 units per kilogram (u/kg) * have c-peptide \<0.3 nanomoles per liter (nmol/l) * are able and willing to eat the protocol specified standard breakfast and other meals as required exclusion criteria: * have corrected qt interval (qtc) prolongation \>500 milliseconds (ms) or have any other abnormality in the 12 lead electrocardiogram (ecg) that, in the opinion of the investigator, increases the risks associated with participating in the study * have an abnormal blood pressure as determined by the investigator * have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from type 1 diabetes mellitus \[t1dm\]), hematological, or neurological disorders * have fasting triglycerides (tgs) \>400 milligrams per deciliter (mg/dl) (4.52 micromoles per liter \[mmol/l\]) * have used systemic corticosteroids within 4 weeks prior to randomization * currently receive insulin pump or insulin degludec * have poorly controlled diabetes or are known to have poor awareness of hypoglycemia * have history of gastroparesis or gastrointestinal malabsorption * require treatment with any drug other than insulin to treat diabetes * have a previous history of proliferative retinopathy
wbv on fascicle lenght and knee joint angle in cp

Conditions: Cerebral Palsy (CP)

Summary: this study investigates the effects of wbv on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy

to study the effect of wbv on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy

Eligibility criteria:
inclusion criteria: * ages varied from four to six years of both sex * hemiplegic cp children, were suffering from knee joint flexion deformity due to hamstring muscles tightness * level i and ii motor function, according to the growth motor function classification system (gmfc) expanded and revised * degree of spasticity ranged from 1 to 2 according to modified ashworth scale * all children received neuro-developmental techniques exclusion criteria: * other causes of knee flexion deformities * previous history of orthopedic surgery in knee joint * visual or auditory problems * seizures * sensory or perceptual deficits * any acute illness at the time of collection of data.

Keywords: cerebral palsy fascicle length hemiplegia range of motion whole body vibration
damage control surgery in the treatment of complicated diverticulitis

Conditions: Diverticulitis

Summary: to evaluate the use of damage control surgery by performing bowel resection and laparostomy in the treatment of hinchey iii or iv diverticulitis.

despite the progress in the resuscitation modalities of septic patients, hartmann procedure (hp) is still considered the safest treatment for generalized peritonitis as a consequence of a complicated acute diverticulitis (stages iii and iv of the hinchey's classification). almost the half of those patients do not have their stoma reversed because of its association with significant morbidity and mortality. to date, the use of resection with primary anastomosis (pa) is a matter of debate, as it is reported in the literature that it is substantially equivalent to hp in terms of morbidity and length of postoperative stay. for these reason, pa is often reserved for younger patients with few co-morbidities and a lesser degree of peritoneal contamination. in the last decade, damage control surgery has been emerging as a valid alternative to hp and ra in patients presenting a severe sepsis caused by purulent or fecal peritonitis in acute diverticulitis. initially described for the treatment of major abdominal injuries, indications for dcs have subsequently been extended to septic shock, abdominal compartment syndrome and impossibility to perform a primary closure. however, there is still no consensus about the use of dcs in perforated acute diverticulitis. the aim of this study was to describe "how-to-use" the damage control surgery in patients with purulent and fecal peritonitis following a severe acute diverticulitis and report the impact on patients' outcomes after the application of this technique in several italian centers of emergency surgery

Eligibility criteria:
inclusion criteria: * patients undergoing surgery for hinchey iii and iv stage scheduled for immediate hartmann's procedure and icu recovery exclusion criteria: * none

Keywords: diverticulitis damage control surgery
transvaginal ultrasound: preterm birth prevention in appalachia

Conditions: Preterm Birth

Summary: preterm birth is the number one cause of infant morbidity and mortality worldwide and represents an important health disparity in the united states, particularly across the state of kentucky. the best biomarker for the prediction of preterm birth is transvaginal ultrasound (tvu). this study will attempt to identify and rectify provider and patient related barriers to tvu screening implementation.

preterm birth is the number one cause of infant morbidity and mortality worldwide and represents an important health disparity in the united states, and especially across the state of kentucky. the best biomarker for the prediction of preterm birth is transvaginal ultrasound (tvu) measurement of cervical length. however, several unique provider and patient related barriers for implementation of this screening limit the widespread uptake of this evidence based practice in appalachian ky. the investigators propose to adopt a dissemination and implementation science approach using the consolidated framework for implementation research (cfir) as the guiding framework for identification of key areas of knowledge deficits as well as attitudes, practices and perceived barriers among prenatal care providers and patients in eastern ky towards tvu cervical length screening using a mixed - methods design. this will be utilized to develop a multifaceted implementation strategy best suited for addressing and overcoming barriers identified by the target population in eastern ky. the investigators anticipate that such an implementation strategy will likely include an educational component targeting obstetric care providers and patients in addition to hands-on tvu cervical length evaluation as well as telemedicine support and surveillance. three community based sites (hazard, morehead and ashland, ky) will be recruited for implementation of this multi-component pilot program focused on community engagement and outreach targeting obstetric providers and their patients. at the end of the pilot implementation phase, acceptability of the study intervention and feasibility of implementation will be evaluated along with a preliminary assessment of effectiveness of implementation.

Eligibility criteria:
inclusion criteria: participant * female sex * prior history of preterm birth (for initial set of interviews), no preterm birth history required for intervention feedback * current pregnant status exclusion criteria: participant * male sex inclusion criteria: provider * certified as obstetric/gynecologic provider

Keywords: transvaginal ultrasound telemedicine
evaluating the safety of de-escalated head and neck irradiation in hpv positive oropharynx cancer in non-smokers/minimal smokers

Conditions: Oropharyngeal Cancer

Summary: a prospective, observational study evaluating the durability of local/regional control of previously published de-escalated radiotherapy protocols for patients with p16 positive oropharynx cancers who have minimal nicotine exposure who are not current uses (\< 10 pack year smoking history; \< 10 year history of any nicotine product \[electronic cigarette, chewing tobacco\]). quality of life measures will also be collected.

this is a prospective, single-site, observational study in head and neck cancer participants. the purpose of this study is to provide a systematic platform to analyze, interpret, and track radiation dose de-escalation therapy and associated participant outcomes from treatments identified by these results. participants will be asked to complete quality of life questionnaires at regular time points before, during, and after treatment.

Eligibility criteria:
inclusion criteria: * age \> 18 years * histologic confirmation of tumor of the oropharynx * radiation therapy (de-escalated head and neck irradiation) decision has been made * human papilloma virus (hpv) associated cancer as determined by positive p16 immunohistochemistry * hpv positivity is defined by p16 ihc staining of \> 70% of tumor cells (strong and diffuse nuclear and cytoplasmic staining) * for cases that are indeterminate or if p16 testing cannot be accurately performed, hpv positivity can be confirmed by high-risk hpv dna testing which covers the following hpv subtypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 * \< 10 pack year smoking history or \< 10 year nicotine use history * no current tobacco/nicotine use (including electronic cigarettes and chewing tobacco) * t1-t3, n0-n2 (ajcc8) requiring definitive therapy greater than surgery alone * ability to provide informed written consent * willingness to return to sanford cancer center for follow-up * life expectancy \> 12 weeks * ecog performance status \< 3 (appendix b) * adequate organ function for chemotherapy and radiotherapy exclusion criteria: * any of the following because the inclusion criteria require delivery of radiotherapy and chemotherapy which is known to be genotoxic, and is associated with mutagenic and teratogenic effects: pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception. * prior head and neck radiotherapy * any factor precluding safe delivery of chemotherapy

Keywords: oropharynx head and neck cancer
quality of life in patients with rectal cancer receiving total mesorectal excision with or without stoma

Conditions: Rectal Cancer

Summary: the goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (tme) and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer.

in most cases it is recommended that patients after low anterior resection with tme and neoadjuvant chemoradiotherapy for rectal cancer need a temporarily diverting stoma. recent evidence suggests that this is not always necessary. the decision for or against a stoma is made by the surgeon in charge and is based on an algorithm of risk factors for anastomotic leakage. many patients receive an adjuvant chemotherapy postoperative. this may influence the quality of life e.a. due to mucositis and urge incontinency or the stoma itself.the objective of this pilot study is to establish the basis for a randomized controlled trial. the long-term goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with tme and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer. all patients scheduled for low anterior resection of the rectum for rectal carcinoma will be invited to participate and prospectively enrolled into the study.

Eligibility criteria:
inclusion criteria: * age older than 18, * low anterior resection and tme due to rectum carcinoma after standardized neoadjuvant combined chemo- and radiotherapy and receiving adjuvant postoperative chemotherapy, * german speaking patient who is capable to fill in the questionnaire, * signed informed consent exclusion criteria: * age younger than 18, * preoperative stoma, * not german speaking * inability to fill in the questionnaire, * no standardized chemo- and radiotherapy
optimal protein dose per meal during weight loss in perspective to maintaining muscle mass

Conditions: Protein Metabolism

Summary: the primary aim of the trial is to determine the optimal dose of protein per meal in relation to enhancing muscle protein synthesis and thereby in perspective counteract muscle loss during weight loss. in addition, we aim to determine whether the response to protein intake is reduced in women on hypocaloric diet compared to in women on an energy-balanced diet.

aim of this project is to determine the optimal protein dose (high quality milk protein) per meal in relation to enhancing muscle protein synthesis and thereby counteract muscle loss during weight loss. the hypothesis is that the optimum dose of protein for women on a hypocaloric diet will be greater than when women eat an energy sufficient diet, and also higher than the optimal dose previously determined in weight stable men. methods: forty women (\~ 50 years) will be randomized to four groups. following a five day hypocaloric diet (three groups) or an energy balanced diet (one group). the women will report to the laboratory to ingest one of three different protein doses. the muscle protein response to the different doses of protein will be determined by the muscle protein fractional synthetic rates using tracer kinetics.

Eligibility criteria:
inclusion criteria: * healthy * postmenopausal women exclusion criteria: * smoking * metabolic and/or chronic diseases

Keywords: hypocaloric diet dietary protein
understanding and discouraging overuse of potentially harmful screening tests

Conditions: Preventive Screening; Prostate Cancer; Osteoporosis; Colorectal Cancer

Summary: most prevention efforts focus on promoting services (e.g. vaccination, screening tests). while some of these services have clear net benefit, many instead have possible or clear net harm. currently, three quarters of services graded by the u.s. preventive services task force (uspstf) have possible or clear net harm (c, i, and d services). many of these services are delivered in healthcare settings at higher rates than what might be expected based on their potential for harm. this leads to adverse outcomes, excess costs, and missed opportunities to deliver more quality care. an important issue in delivering prevention messages is how to shift toward a focus on the appropriateness of prevention: encouraging services with clear net benefit and either discouraging or reducing demand for services with possible or clear net harm. unfortunately, little is known about what drives overuse of potentially harmful screening services or how to make harms relevant to patients. this randomized controlled trial (rct) of 775 patients at 4 primary care practices aims to 1) assess factors associated with intent to receive possibly or clearly harmful screening services and 2) determine whether and how patients' plans to get screened change with various presentations of information about harms (e.g. qualitative, quantitative, narrative, framed). the investigators will focus on three types of screening services: osteoporosis screening (previous c recommendation and now no recommendation for women \< 65 years old with no fracture risk factors), prostate-specific antigen (psa) screening (d recommendation for all men, regardless of age), and colorectal cancer (crc) screening (c for ages 76-85).


Eligibility criteria:
inclusion criteria: * women between ages 50 to 85 * men between ages 50 to 85 * eligible for exemplar service of interest (see below for specifics of inclusion/exclusion for specific services) exclusion criteria: * current treatment of psychosis * history of alcohol or substance abuse within the last 2 years * dementia or other severe cognitive dysfunction * serious medical illnesses with a life expectancy of less than 2 years (e.g., metastatic cancer) * inability to speak and understand english * blindness * presentation for an acute medical visit * no telephone number osteoporosis screening (women aged 50-64) exclusion criteria: * a personal history of osteoporosis * a personal history of moderate or severe osteopenia * bmi (body mass index) \< 18.5 * personal history of non-traumatic fracture * family history of hip fracture * current smoking * current use of prednisone (\>30 consecutive days) * alcohol use of 3 or more drinks/day. prostate cancer screening (men aged 50-69) exclusion criteria: * a prior history of prostate cancer colorectal cancer screening (men and women aged 76-85) exclusion criteria: * prior history of colorectal cancer * adenomatous colon polyps \> 6mm (or 2 or more \< 6mm) * symptoms referable to colorectal cancer