Kornimate/medical-research-clean huggingface dataset:
a study of health care use and costs in participants with early stage alzheimer's disease (ad)

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Summary: the purpose of this study is to learn about health care use, costs, and clinical outcomes over time for amyloid positive participants with early stages of ad in the united states. this study is for research purposes only, and is not intended to treat any medical condition. no study therapy(ies) for ad will be administered.


Eligibility criteria:
inclusion criteria: * presents within normal course of outpatient care for whom the physician deems to meet clinical criteria for mci due to ad or mild ad dementia. * fully informed written consent of the participant (or his/her legal representative). * study partner who has frequent contact with the participant is willing to accompany the participant at the study observations. * fully informed written consent of the study partner; this person must be willing to serve as study partner for at least 6 months of the year. * able to communicate in english and/or us spanish. * able to provide evidence of amyloid testing. * has an mini-mental state examination (mmse) score of 20 or greater. exclusion criteria: * are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study at baseline. * are investigator site personnel directly affiliated with this study and/or their immediate families. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * lack of evidence of amyloid positivity through pre-study test. note: after baseline assessment, participants with amyloid negativity identified as part of the study will not continue in post-baseline assessments. * are lilly employees or are employees of any third-party organization (tpo) involved in study who require exclusion of their employees.
non-interventional study prevent

Conditions: Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) Patients

Summary: this is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including "go" / "no go" decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in russia.

this is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including "go" / "no go" decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in russia. no additional procedures besides those already used in the routine clinical practice will be applied to the patients. treatment assignment will be done according to the current practice. it is planned to enrol 200 subjects in up to 30 sites in russian federation. the average number of patients per site is planned as 6 - 10; there are no restrictions on minimum and maximum number of subjects per site in this study.

Eligibility criteria:
inclusion criteria: 1. the voluntarily given informed consent, confirmed by the informed consent form, properly signed by both the subject and the investigator. 2. locally advanced stage of pca (stage t3-t4, nx-n0, m0: prostate adenocarcinoma with extracapsular invasion (t3a) or invasion to the seminal vesicles (t3b), invasion to adjacent structures (t4) but without lymphatic invasion (n0) nor metastasis (m0)) 3. prostatectomy or radiotherapy completed within 3 months prior to the study enrolment 4. high (t3a or gleason score = 8-10 or pca \>20 ng/ml) and very high (t3b-t4) risk of recurrence 5. histologically confirmed diagnosis of prostate adenocarcinoma exclusion criteria: 1. patients participating in clinical trials 2. any medical condition which on the opinion of the investigator may interfere with the patient's participation in the study, e.g. severe non-malignant concomitant disease which can affect life expectancy 3. evidence of metastatic disease on imaging studies

Keywords: prostate adenocarcinoma, locally advanced prostate cancer with high and very high risk of recurrence, adjuvant endocrine treatment, prostate specific antigen
independent walking speed and crossing a city street

Conditions: Balance Problems; Cerebral Palsy

Summary: the purpose of this study is to determine if selected sequence training using the balance master, added to established physical therapy treatment programs, will increase gait velocity of ambulatory children receiving inpatient or outpatient rehabilitation in relation to their ability to cross an intersection within the confines of community traffic signal (\>120 cm/sec).

the ability to adequately perform functional tasks at a level that allows independent community living is key to measuring the success of any physical therapy program. the essential tasks needed to allow independent community living have been well documented in the elderly population. however, these tasks have not been delineated in the pediatric population. the investigators aim to determine if selected sequence training using the balance master, added to established physical therapy treatment programs, will increase gait velocity of ambulatory children receiving in-or outpatient rehabilitation in relation to their ability to cross an intersection within the confines of community traffic signal (\>120 cm/sec). one essential task that is necessary in the urban environment is to have the ability to cross a street within the time constraint of a traffic signal. walking speed becomes increasingly important for those living in urban settings, as the ability to cross the street safely is fundamental for achieving independence. one of the major criticisms of clinic/lab-based measures of gait speed is that relative performance may not be representative of independence within the community. participants aged 5 to 21 years, will be recruited from the patient population at blythedale children's hospital for a six week trial. children will be assigned to one of two random groups: one weekly balance master sequence training group (in addition to their regularly scheduled therapy sessions) and a group that continue regularly scheduled therapy sessions alone. gait velocity will be measured by "walk across" functional assessment using balance master long force plate.

Eligibility criteria:
inclusion criteria: * ability to ambulate independently at least 25 feet with or without assistance device and/or orthoses. * receiving physical therapy services that include ambulation training. exclusion criteria: * diagnosis of a progressive disorder. * inability to follow directions. * uncorrected vision impairment. * require additional physical assistance to ascend a ramp and over force plate. * refusal to participate.

Keywords: gait balance street-crossing
fecal calprotectin for prediction of esophageal varices in cirrhotic patients

Conditions: Esophageal Varices

Summary: the goal of this cross-sectional observational study is to evaluate the accuracy of fecal calprotectin versus non-invasive scores in assessing the presence and grading of esophageal varices in egyptian patients. researchers will compare fecal calprotectin levels in cirrhotic patients with and without esophageal varices (evs) and healthy subjects. researchers will also evaluate the performance of fecal calprotectin, ast to platelet ratio index (apri) score, fibrosis-4 (fib-4) score, albumin-bilirubin (albi) score, platelet-albumin-bilirubin (palbi) score, and platelet-spleen diameter ratio (psr) for predicting esophageal varices. participants will undergo history-taking, clinical examination, laboratory investigations, fecal calprotectin, abdominal ultrasonography, and upper endoscopy. endoscopic grading of esophageal varices will be done using paquet's classification. the apri, fib-4, albi, palbi, and psr scores will be calculated. the performance of fecal calprotectin for predicting evs will be compared versus other non-invasive scores.


Eligibility criteria:
inclusion criteria: * age ≥18 years * liver cirrhosis exclusion criteria: * patients aged \< 18 years. * inflammatory bowel disease. * infectious gastroenteritis. * malignancy. * patients on proton pump inhibitors or nsaid. * patients with spontaneous bacterial peritonitis. * patients with hepatic encephalopathy. * unwilling to participate in our study.

Keywords: fecal calprotectin esophageal varices liver cirrhosis
study of patients hospitalized in specialized cognitive-behavioral unit (ucc)

Conditions: Behavior Disorders

Summary: the purpose of the study is to assess the mortality of patient discharged from the specialized cognitive-behavioral unit (ucc) of toulon.

the purpose of specialized cognitive-behavioral unit is to take care of patients demented, valid and with disruptive behavior disorders. the hypothesis is that analyzing the healthcare of these discharged patients might provide a view of the benefices of these units. the study will be explained to the eligible subjects if they are able to understand it, or to their trusted person, primary caregiver or legal representative. medical information will be collected during and after the hospitalization in the specialized cognitive-behavioral unit. the investigator will call the medical staff and the primary caregiver at 3, 6, and 12 months after the patient's discharge, in order to collect study data.

Eligibility criteria:
inclusion criteria: * inpatient at the ucc of toulon exclusion criteria: * patient already included in the study ( a patient cannot be included twice during the study) * non-affiliated to a social security regimen * objection of the patient, the trusted person, the legal representative, the relative or the member of the family (depending on the overall condition of the patient)

Keywords: ucc mortality alzheimer's disease longitudinal study
restoration of cutaneous sensorum in patients with diabetic peripheral neuropathy (dpn) via metanx®

Conditions: Diabetic Peripheral Neuropathy

Summary: the purpose of this research study is to determine if metanx improves sensory neuropathy in persons with type 2 diabetes. metanx is a medical food available with a prescription from a physician. it consists of l-methylfolate, pyridoxal 5'-phosphate, and methylcobalamin, which are the active forms of folate, vitamin b6, and vitamin b12, respectively. subjects will be assigned to receive metanx for 12 months. baseline quantitative sensory testing will be done before the patient receives metanx. additional quantitative sensory testing will be done at 6 and 12 months to evaluate.


Eligibility criteria:
inclusion criteria: * consecutive diabetic patients entering the office (private practice) * subjective symptoms of numbness, burning, paresthesia, etc. * failed monofilament of at least two points on each foot * abnormal pssd study * willing to participate in protocols or study * taking one metanx tablet bid for 2 weeks then one metanx tablet daily * keep scheduled appointments for follow up studies * report any other medical interventions, studies, or medication changes * report any problems of medical or psycho-social matters to investigators * hgba1c not monitored or specific value required for participation exclusion criteria: * history of back problems (surgery or ecsi) or other large fiber neuropathies * history of chemotherapy * history of chemical exposure

Keywords: dpn
nilotinib with radiation for high risk chordoma

Conditions: Chordoma

Summary: the study drug, nilotinib, is believed to slow down tumor growth by regulating a gene involved in cellular growth of chordoma cells. during this research study, subjects will also receive radiation therapy which is considered a standard treatment for advanced chordomas. it is hoped by adding nilotinib, the benefits of radiation therapy can be enhanced without adding significant toxicities. the purpose of this research study is to determine the safety of nilotinib when used in combination with radiation therapy, and the highest dose of nilotinib that can be given safely with radiation therapy.

nilotinib will be taken orally daily in two cycles of 28 days each. two weeks after taking nilotinib, subjects will begin radiation therapy. radiation therapy will continue every weekday until day 56 of the study. if it is determined that the subject's tumor cannot be removed by surgery, an additional 3 weeks of radiation therapy will be applied after day 56 of the study. during study visits subjects will have physical exams, routine blood tests, urine and blood clotting tests, and ekgs. subjects will also have tumor assessment by chest ct and mri or ct of the tumor at screening, on approximately day 56 of the study, then every 6 months for one year and then annually thereafter if ther is no disease progression.

Eligibility criteria:
inclusion criteria: * histologically confirmed chordoma * considered to have high risk disease * measurable disease * life expectancy \> 3 months * adequate organ function * able to swallow oral capsules exclusion criteria: * previous treatment with any other tyrosine kinase inhibitor * previous treatment with radiotherapy to the primary or recurrent chordomas * impaired cardiac function * currently receiving treatment with strong cyp3a4 inhibitors * requires anticoagulation with coumadin * impaired gi function or gi disease that may significantly alter the absorption of study drug * acute or chronic pancreatic disease * known cytopathologically confirmed cns infiltration * another primary malignant disease which requires systemic treatment * acute or chronic liver disease or severe renal disease considered unrelated to the cancer * history of significant congenital or acquired bleeding disorder unrelated to cancer * major surgery within 4 weeks prior to day 1 of the study or who have not recovered from prior surgery * treatment with other investigational agents within 30 days of day 1 * history of non-compliance to medical regimens * pregnant or breast-feeding

Keywords: high risk chordoma
amyloid plaque and tangle imaging in aging and dementia

Conditions: Memory Disorders; Alzheimer's Disease

Summary: amyloid senile plaques (sps) and neurofibrillary tangles (nfts) are neuropathological hallmarks of alzheimer's disease (ad) that also accumulate in key brain regions in association with normal aging. this project will expand an established program in early detection and prevention of ad designed (1) to identify presymptomatic persons most likely to benefit from early intervention and (2) to provide an objective, noninvasive means to monitor therapeutic trials.

a total of 165 volunteers will be recruited for this 2-year study. participants will receive a baseline clinical and imaging evaluation and one follow-up evaluation two years later. these evaluations will include clinical and neuropsychological assessments, structural mri and/or pet scans. additional scans and scanning procedures will be performed on a subset of participants and participant visits, including serotonin density levels.

Eligibility criteria:
inclusion criteria: * agreement to participate in a clinical and brain imaging study * age 30 years or older * no significant cerebrovascular disease - modified ischemic score of ≤ 4 * for volunteers with mci or dementia, there must be a family member or potential caregiver available * adequate visual and auditory acuity to allow neuropsychological testing * screening laboratory tests and ecg without significant abnormalities that might interfere with the study. exclusion criteria: * evidence of neurologic or other physical illness that could produce cognitive deterioration; in addition to a physical and neurological examination, volunteers will be screened for parkinson's disease * history of myocardial infarction within the previous year or unstable cardiac disease * uncontrolled hypertension (systolic bp\>170 or diastolic bp\>100), history of significant liver disease, clinically significant pulmonary disease, diabetes, or cancer * major psychiatric disorders, such as bipolar disorder or schizophrenia * because medications can affect cognitive functioning, volunteers needing medicines that could influence psychometric test results will be excluded; use of any of the following drugs will also exclude volunteers: centrally active beta-blockers, narcotics, clonidine, anti-parkinsonian medications, benzodiazepines, systemic corticosteroids, and medications with significant cholinergic or anticholinergic effects, anti-convulsants, or warfarin * current diagnosis or history of alcoholism or drug dependence * evidence of untreated depression as determined by a ham-d (hamilton, 1960) score of ≥ 12 (17-item version) or untreated anxiety by a score of ≥ 8 on the hamilton anxiety scale (ham-a; hamilton, 1959) * use of any investigational drugs within the previous month or longer, depending on drug half-life * contraindication for mri scan (e.g., metal in body, claustrophobia)

Keywords: functional magnetic resonance imaging positron emission tomography beta-amyloid tau
olmesartan alone or in combination with hydrochlorothiazide in subjects with mild to moderate essential hypertension

Conditions: Essential Hypertension

Summary: efficacy, tolerability and safety of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension


Eligibility criteria:
inclusion criteria: * subject has mild to moderate hypertension exclusion criteria: * history of secondary hypertension
an efficacy, safety, and tolerability study of vrdn-003 in participants with chronic thyroid eye disease (ted)

Conditions: Thyroid Eye Disease

Summary: this is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, vrdn-003, in participants with chronic thyroid eye disease (ted).

this is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with chronic ted. the key objectives of this study are to determine if vrdn-003 is efficacious, safe and tolerable when administered as subcutaneous/sc injections every 4 weeks or every 8 weeks compared to placebo in participants with chronic ted. participants who do not have a meaningful response at week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of vrdn-003.

Eligibility criteria:
key inclusion criteria: * must have moderate to severe chronic ted, with any cas (0-7) on the 7-item scale, and with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening * must agree to use highly effective contraception as specified in the protocol * female ted participants must have a negative serum pregnancy test at screening key exclusion criteria: * must not have received prior treatment with another anti-igf-1r therapy * must not have received systemic corticosteroids or steroid eye drops for any condition, including ted, or selenium within 2 weeks prior to first dose. * must not have received other immunosuppressive drugs for any condition, including ted, or any other therapy for ted within 12 weeks prior to first dose * must not have received an investigational agent for any condition, including ted, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose * must not have received radioactive iodine (rai) treatment within 8 weeks prior to first dose * must not have had previous orbital irradiation or decompression surgery for ted to the study eye's orbit * must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results * must not have abnormal hearing test before first dose. must also not have a history of ear conditions considered significant by study doctor * must not have a history of inflammatory bowel disease * female ted participants must not be pregnant or breastfeeding note: there are additional eligibility criteria for participants who do not have a meaningful response at week 24 (irrespective of initial treatment arm) who may receive additional injections of vrdn-003. these are described in the protocol.

Keywords: ted thyroid eye disease graves thyroid-associated ophthalmopathy dysthyroid ophthalmopathy graves eye disease graves orbitopathy myopathic ophthalmopathy edematous ophthalmopathy infiltrative ophthalmopathy
investigating stat3 as a driver of pathology in periodontitis

Conditions: Periodontitis

Summary: periodontitis is a prevalent inflammatory condition that destroys tooth-supporting structures. this condition is associated with pro-inflammatory mediators that utilize stat3 as an activator of specific genes related to inflammation and tissue destruction. stat3 has not been studied in the context of periodontitis in humans. we propose that stat3 is associated with periodontitis. this knowledge might help to further our understanding of periodontitis pathology


Eligibility criteria:
inclusion criteria: * 18-year-old, in good general health, and had no significant medical history. * no history of diabetes or other diseases different than periodontitis. exclusion criteria: * pregnancy and lactation * use of antibiotics, immunosuppressive agents, or probiotics within 3 months.

Keywords: periodontitis, stat3
pk/pd properties and safety of remazolam besylate for injection in icu patients with impaired renal function

Conditions: Mechanically Ventilated Patients

Summary: pharmacokinetic/pharmacodynamic profiles of remazolam besylate were compared in patients with impaired and normal renal function in the icu, and safety was assessed by recording hemodynamic parameters and adverse events.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥18 and ≤ 30 kg/m2 * being intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a ventilator for at least 6 hours * requirement for light to moderate sedation (a richmond agitation-sedation scale score of -2 to 1) patients with impaired renal function were defined as having a glomerular filtration rate of 30 to 89 ml/min/1.73m2. patients with normal renal function were defined as having a glomerular filtration rate of 90 to 120 ml/min/1.73m2 exclusion criteria: * refusal to be included * allergy or unsuitability to any composition of study drugs or remifentanil * living expectancy less than 48 hours * myasthenia gravis * status asthmaticus * abdominal compartment syndrome * serious hepatic dysfunction (ctp 10-15); * chronic kidney disease with glomerular filtration rate (gfr) \< 29 ml/ min/1.73m2 * mean blood pressure less than 65 mm hg or the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain mean blood pressure ≥ 65 mm hg * possible requirement for surgery or bedside tracheostomy in 24 hours * possible requirement for renal replacement therapy in 24 hours * acute severe neurological disorder and any other condition interfering with sedation assessment * abuse of controlled substances or alcohol * pregnancy or lactation