Kornimate/medical-research-clean huggingface dataset:
bioavailability of aliskiren and valsartan as a single tablet vs. the same doses of the two drugs given separately to healthy subjects.

Conditions: Healthy

Summary: this study will assess the bioavailability of aliskiren and valsartan as a single tablet compared to the same doses of the two drugs given as two separate tablets in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy subjects 18 to 45 years (inclusive) of age in good health as determined by past medical history, physical examination, vital signs assessments, electrocardiogram, and laboratory tests at screening and baseline.. * female subjects of child bearing potential must be using a double-barrier local contraception i.e. intra-uterine device plus condom, or spermicidal gel plus condom for at least 3 months prior to study start or postmenopausal females must have had no regular menstrual bleeding for at least 1 year prior to inclusion (menopause will be confirmed by a plasma fsh level of \>40 iu/l) or female subjects must have been surgically sterilized at least 6 months prior to screening with supportive clinical documentation. and all female subjects must have negative pregnancy results at screening and each baseline (regardless of reported reproductive status). * body mass index (bmi) must be 18 - 30 kg/m2 (inclusive) and subjects must weigh at least 50 kg. * vital signs should be within the following ranges: oral body temperature between 35.0-37.5 °c, systolic blood pressure, 90-140 mm hg, diastolic blood pressure, 50-90 mm hg, pulse rate, 40 - 90 beats per minute (bpm) exclusion criteria: * smokers (use of tobacco products within the previous 3 months). smokers will be defined who reports tobacco use or has a urine cotinine value of ≥ 300 ng/ml. * use of any prescription drugs within 4 weeks prior dosing, or over-the-counter (otc) medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. acetominophen is acceptable, with supportive clinical documentation.. * participation in any clinical investigation within a minimum of 4 weeks prior to dosing (or longer if local regulations apply). * significant illness within the 2 weeks prior to dosing. * lactating and breast feeding females. other protocol-defined inclusion/exclusion criteria may apply

Keywords: aliskiren , valsartan , bioavailability, hypertension healthy male and female subjects
could non-invasive biochemical, image or physiological index predict significant coronary arterial stenosis in symptomatic adults?

Conditions: Coronary Heart Disease

Summary: to validate the capability of non-invasive bio-image tests in prediction of significant coronary stenosis of symptomatic adults.

the main objective is to validate the capability of these non-invasive tests (ccs, hs-crp and abi) in prediction of significant coronary stenosis of symptomatic adults. the end-point will be the findings of coronary ct angiography. the investigators hope the results of our study could be applied on the interpretation of health examination and the advice of follow-up and therapy.

Eligibility criteria:
inclusion criteria: * subjects for a general health check-up protocol, which included cacs and ccta, and biochemical measurements (total cholesterol, total triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, high sensitivity c reactive protein) exclusion criteria: * anyone allergy to iodine contrast medium, unable cooperation for ct scanning, asymptomatic
turkish version of the hand20 questionnaire with carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: the questionnaire will be investigated by administering the hand-20 questionnaire and the boston carpal tunnel syndrome questionnaire to patients with carpal tunnel syndrome, one week apart.

questionnaires, which are used to express the perception of difficulty and hand functionality during daily living activities of individuals with carpal tunnel syndrome, and most importantly, which are easy to administer, should be preferred in order to plan a patient-specific treatment program with these results. self-administered questionnaires showing the physical dimension of recovery are effective and sensitive to change. hand20 is a short, easy-to-understand and visual questionnaire used to evaluate disorders caused by upper extremity pathologies, developed by suzuki et al. in 2010 and proven to be valid in upper extremity diseases by töre et al. in this questionnaire consisting of 20 questions, the answer to each question is graded between 0 and 10 (0: no restrictions, 10: impossible). the best score is 0, the worst score is 100. boston carpal tunnel syndrome questionnaire (bktsa) will be used to evaluate the functionality level and symptom severity of the patients. in this questionnaire, which consists of 2 parts: symptom severity and functional capacity, a separate average score will be calculated for each part by dividing the total score obtained by the number of questions. an increased score indicates decreased functional capacity and increased symptom severity.

Eligibility criteria:
inclusion criteria: * patients aged 25-60 years * patients diagnosed with carpal tunnel * patients who volunteered for treatment exclusion criteria: * patients who do not agree to volunteer * patients who have undergone surgery from the wrist region

Keywords: carpal tunnel syndrome
discontinuation of automated engagement support

Conditions: Chronic Kidney Disease

Summary: the chronic kidney disease engagement system is currently in place for 1700 adults receiving care from empire physicians medical group (epmg), an independent practice association located in palm desert, california. the system monitors routine clinical laboratory test results and send messages to patients and providers when action is indicated, such as when tests are overdue or results require extra clinical attention. this study will assess what happens to laboratory results, utilization of laboratory tests, and costs of care when ther system is discontinued.

the chronic kidney disease engagement system is currently in place for 1700 adults receiving care from empire physicians medical group (epmg), an independent practice association located in palm desert, california. the system monitors routine clinical laboratory test results and send messages to patients and providers when action is indicated, such as when tests are overdue or results require extra clinical attention. patients receive first class letters directing them to call their provider. providers receive fax or electronic messages directing them to reach out to the patient to arrange follow-up care. it has been used for over three years and appears to have improved adherence to chronic kidney disease (ckd) treatment guidelines by influencing both patient and provider actions. epmg wishes to restrict the service to those patients with advanced ckd and discontinue it for ckd stages 1-3. the investigators propose implementing this new policy in a randomized fashion with one half of the current early stage patients continuing to receive the service while the other half will no longer receive messages. the investigators will monitor laboratory results and health care utilization for both groups to determine what effect, if any, discontinuation has on quality of care. human subjects will either continue to receive letters from the service when their tests are overdue or require additional clinical attention, or will no longer receive the service. all subjects will continue to receive care from their providers. the main outcomes include the frequency of recommended tests for ckd, the level of those tests, and utilization of health care services as indicated by claims data provided by epmg. no additional data collection will occur beyond that which has been routinely done for clinical care. the study will continue for 36 months.

Eligibility criteria:
inclusion criteria: receiving services from patient engagement services at randomization. ckd stages 1, 2 or 3. under the care of empire physicians medical group of palm desert, california. exclusion criteria: patient refusal.
combined pet/ct imaging for the early detection of ocular melanoma metastasis compared to ct scanning alone

Conditions: Ocular Melanoma; Choroidal Melanoma; Uveal Melanoma

Summary: patients diagnosed with ocular melanoma consent to participate in the study. combined pet/ct scans of the whole body are performed at baseline, three months later, and six months after that for a total of three combined scans in the first year. subsequently, these combined scans will be performed at 6-monthly intervals for a total of two combined scans per year.


Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis of ocular melanoma (a pigmented malignant tumor) involving the choroid and/or ciliary body (the blood vessel layer in the back of the eye and/or the part of the eye behind the iris). 2. patients 18 years of age or older. 3. patients able to give informed consent. exclusion criteria: 1. patients who refuse to participate in the study. 2. patients who are unable to cooperate with or cannot undergo pet/ct scanning. 3. patients who will be moving out of the area of ucla during the ten years of this study.
behavior during experimentally induced pain

Conditions: Schizophrenia; Major Depression

Summary: numerous factors can influence the processing of pain message: the affective or emotional, the sensorial and the cognitive components. interindividual variations at the emotional and cognitive levels may interfere with the pain message and the consecutive behavior. some modifications in these components are observed in psychiatric troubles, but their influences on the behavior to pain have not been studied, although they have been studied in some populations characterized as non communicating, with obvious cognitive degradations (subject with dementia, older, newborns,...).in an other study in course, the past pain experience is explored in relation to results to experimental pain tests, emotional and anxious characteristics. this present pilot study aims at studying the infra-verbal behavioural signs during experimentally induced pain in subjects with schizophrenia, major depression, and controls.

the objective is to search for behavioral non verbal indicators of pain during experimentally induced pain (pressure application, ischemia induction). included subjects are subjected to experimental pain tests : pressure application (160 kpa) with an algometer to determine the pain with visual analogic scale (vas), and ischemia induction to determine the time needed to feel pain with an intensity equivalent to 3 with the vas. subjects are filmed during experimentation to identify the corporal mobility signs, facial expression signs and sonorous signs associated to pain stimulation. neurophysiological measures complete these observations : surface electromyogram, heart rate measure, blood pressure.

Eligibility criteria:
inclusion criteria: * subjects with psychiatric trouble : diagnosis of schizophrenia or major depression according to the dsm-iv-tr criteria. * control subjects : without known psychiatric history. * age between 18 and 60. exclusion criteria: * absence of consent, hospitalization under constraint, absence of health insurance. * inability to answer the questionnaires * pregnancy * antalgic or analgesic treatment * allergy to latex * non stabilized high blood pressure, bad blood coagulation, * peripheral neuropathy, nerve lesion, dermatosis at the superior extremities, muscular lesion or pathology at the upper member level * non treated alcohol dependence * illegal substance consumption in the past 48 hours * participation to an other biomedical study during the 2 weeks before inclusion, and until the pain tests, if this study can interfere with the realization of the objectives

Keywords: schizophrenia major depression pain behavior
a multi-surgery assessment of zynrelef (htx-011), amaze

Conditions: Analgesia

Summary: this is a phase 4, randomized, blinded, active-controlled, multicohort study to evaluate htx-011 compared with bupivacaine hcl in subjects undergoing abdominoplasty (cohort 2).


Eligibility criteria:
inclusion criteria: * has american society of anesthesiologists (asa) physical status of i, ii, or iii. * is scheduled to undergo abdominoplasty. exclusion criteria: * is undergoing a revision surgery. * has a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to bupivacaine (or other local anesthetics), nsaids, acetaminophen, oxycodone, morphine, or hydromorphone. * history of severe allergic reaction to aspirin or other nsaids, or known history of severe gastrointestinal adverse reactions associated with nsaid use. * has taken meloxicam within 10 days prior to the scheduled surgery, or any nsaid within 24 hours prior to the scheduled surgery, with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection. * opioid use for most days within the last 3 months prior to screening in the opinion of the investigator. * has been administered immediate-release bupivacaine hcl within 5 days prior to the scheduled surgery, or a modified-release bupivacaine product within 14 days prior to the scheduled surgery. * has initiated treatment with any of the following medications within 1 month prior to study drug administration: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 inhibitors. * has been administered systemic steroids within 5 half-lives or 10 days prior to the scheduled surgery (whichever is longer). * has a known or suspected history of drug abuse, a positive drug screen (except for cannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5 years. * suspected or confirmed active coronavirus disease 2019 (covid-19) infection. * had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * has undergone 3 or more surgeries within 12 months, other than for diagnostic procedures (eg, colonoscopy). * has a body mass index (bmi) \>40 kg/m2. * had undergone prior abdominoplasty or major abdominal wall surgery.

Keywords: postoperative pain abdominoplasty multimodal analgesia
imaging features for the risks for recurrence after stereotactic radiosurgery in brain metastasis

Conditions: Brain Metastases; Radiosurgery

Summary: this trial uses multi-parametric magnetic resonance imaging (mri) to develop and validate imaging risk score to predict radiation necrosis in participants with brain metastasis treated with radiation therapy. diagnostic procedures, such as multi-parametric magnetic resonance imaging (mri), may improve the ability to diagnose radiation necrosis early and help establish treatment strategies.

primary objective: i. to develop an imaging risk score for recurrence after stereotactic radiosurgery (srs) in brain metastasis using multiparametric mri. ii. to validate the imaging risk score in retrospective external validation and prospective internal validation test set. secondary objective: i. to predict radiation necrosis using imaging risk score. outline: participants undergo multi-parametric mri including 3d pre- and contrast-enhanced t1 weighted image, t2 weighted image, diffusion-weighted image, dynamic susceptibility contrast mri, and arterial spin labeling image before receiving srs, and every 3 months after srs.

Eligibility criteria:
inclusion criteria: 1. patients who underwent stereotactic radiosurgery (srs, gamma-knife radiosurgery or cyberknife radiosurgery) for brain metastases 2. patients with lesions eligible for srs : * one to ten newly diagnosed brain metastases * patients without acute neurological symptom 3. patients with a karnofsky performance status score of 70 or higher 4. patients who underwent brain mri within 1 month of enrollment 5. patients with measurable enhancing lesions on mri. 6. patients who have available reference standard (second-look surgery for recurrence) or available follow up imaging for clinic-radiologic reference standard. 7. a longest diameter \> 1.5 cm for tumor habitat analysis. exclusion criteria: 1. patients who have undergone prior brain surgery, srs, or whole-brain radiation therapy. 2. patients who are diagnosed with leukemia, lymphoma, germ-cell tumor, small-cell lung cancer, leptomeningeal disease, or unknown primary tumor. 3. patients with age \< 18 years. 4. patients without baseline mri. 5. patients with nonmeasurable enhancing lesions on mri : all other lesions, including lesions with longest dimension \< 10 mm, lesions with borders that cannot be reproducibly measured, dural metastases, bony skull metastases, and leptomeningeal disease.

Keywords: imaging habitat recurrence prediction radiation necrosis
macular hole reopening

Conditions: Vitrectomy

Summary: the purpose of this investigation was to determine the incidence and the factors that cause a reopening of a macular hole (mh) after a surgical closure.

a reopening of a macular hole (mh) is a well-known complication of successfully closed mhs. recently, internal limiting membrane (ilm) peeling has become widely used as an adjunctive procedure during mh surgery. the incidence of a reopening of a mh is 0 to 8.6% in eyes in which the ilm was peeled off, and 2 to 16% in which the ilm was not peeled off. part of the variation in the percentages of reopening was the length of the follow-up period; eyes with longer follow-up periods have higher incidences of reopening.

Eligibility criteria:
inclusion criteria: * patients who underwent vitrectomy with or without internal limiting membrane (ilm) peeling for an idiopathic full-thickness macular hole exclusion criteria: * eyes with previous vitreous surgery, cystoid macular edema from any cause, and traumatically-induced mh were excluded.

Keywords: vitrectomy macular hole ilm peeling
intralesional versus intramuscular methotrexate for non-melanoma skin cancers

Conditions: Non-melanoma Skin Cancers

Summary: to compare the effectiveness and safety of intralesional vs. systemic mtx in nmsc management

intralesional methotrexate (mtx) could to be promising conservative alternative for non-melanoma skin cancer (nmsc). systemic mtx was attempted as adjuvant for locally-advanced nmsc.

Eligibility criteria:
inclusion criteria: • adult patients of both sexes with histologically-confirmed primary or recurrent non- metastatic nmscs of different types (bcc,scc, and/or ka), sites, number, sizes and duration were included in the study. exclusion criteria: • hypersensitivity reactions to methotrexate, liver or kidney disease, immunosuppressive conditions, hiv, hbv, and hcv infection, hematological abnormalities and metastasis. pregnant or lactating women, females in their child-bearing period not using or refusing contraceptive methods, and those who had any other form of nmsc management in the month preceding enrollment.

Keywords: non-melanoma skin cancer intralesional methotrexate systemic methotrexate intramuscular methotrexate keratoacanthoma basal cell carcinoma squamous cell carcinoma
the power of touch. non-invasive c-tactile stimulation for chronic osteoarthritis pain

Conditions: Chronic Pain

Summary: osteoarthritis (oa) is a degenerative disease with a prevalence of up to 30% among adults over 45 years old. moreover, elderly people over 60 years are more prone to develop a chronification of pain symptomatology. chronic pain in oa enormously restricts patients' ability to perform their daily activities, eliciting psychological distress and mood alterations, and producing massive socioeconomic consequences. for these reasons, any non-invasive drug-free treatment that decreases chronic pain in oa requires serious evaluation. this study aims to investigate the effectiveness of noninvasive interoceptive stimulation (affective touch) in treating chronic pain associated with osteoarthritis (oa). this study aims to investigate the effectiveness of noninvasive interoceptive stimulation (affective touch) in treating chronic pain associated with osteoarthritis (oa).

the current study aims to assess the long-term analgesic efficacy of interoceptive tactile stimulation in patients suffering from chronic moderate-to-severe osteoarthritis (oa) pain. the study will be a randomized, double-blind, sham-controlled crossover trial involving 60 oa patients with moderate-to-severe chronic pain. patients will be randomly assigned to the treatment or control group and received interoceptive (affective touch) or control stimulation two days a week for 12 weeks. patient will then undergo to a 4-week washout period, after that they will be assigned to the crossover treatment for another 12 weeks. the study will measure changes in pain and physical function, heart rate variability, as well as inflammatory and anti-inflammatory cytokines and medication intake, assessed at baseline, and at the end of each crossover phase. follow-up measures will be assessed 4 weeks after the end of each crossover phase. intermediate outcomes for pain and physical function, heart rate variability and medication intake will also be assessed after 4 and 8 weeks.

Eligibility criteria:
inclusion criteria: * osteoarthritis patients * age 45-90 * diagnosis of oa acr criteria * moderate-to-severe oa chronic pain. exclusion criteria: * other joint diseases * trauma, or pain condition * fibromyalgia * bmi\>39 kg/m2.
open label safety and efficacy study of levetiracetam in korean patients with epilepsy

Conditions: Epilepsy, Partial

Summary: a korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy. similarity with a similar study conducted in caucasian epileptic subjects will be assessed.


Eligibility criteria:
inclusion criteria: * subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized. * subjects must present between 3 and 42 partial seizures over the three months prior to protocol visit 1. * use of one (1), but no more than two (2) concomitant marketed aeds at the time of trial entry. exclusion criteria: * subjects on felbamate with less than 18 months exposure. * subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months. * presence of known pseudoseizures within the last year. * presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors. * uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Keywords: epilepsy partial onset seizures keppra levetiracetam