Kornimate/medical-research-clean huggingface dataset:
dosing and effectiveness study of sorafenib and rad001 in the treatment of patients with advanced kidney cancer

Conditions: Kidney Cancer

Summary: this study is being done in 2 parts. the first part is to determine the dose of rad001 that should be used in combination with sorafenib. the second part is using the above determined dose of rad001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer. participants will be asked to keep a pill diary.

the drugs used in this trial are called targeted drugs as they target specific activities that are carried out by cancer cells that make them grow and spread. sorafenib is an approved drug for the treatment of advanced kidney cancer. rad001 is an experimental drug that has been used in other research studies with other types of cancer. in this trial, the use of rad001 and sorafenib together for the treatment of kidney cancer is experimental. in the phase i portion of this study 13-16 patients will be treated with the same dose of sorafenib and different doses of rad001. the purpose is to see what is a safe dose of rad001 when combined with sorafenib in the treatment of kidney cancer. once this dose of rad001 is determined, about 65 more patients will be treated to see how effective this combination of drugs is against this kidney cancer. both of these drugs are taken by mouth. sorafenib will be taken twice a day. rad001 is taken by mouth weekly. patients will be able to continue treatment as long as their disease does not worsen or side effects become intolerable.

Eligibility criteria:
inclusion criteria: * clinically documented metastatic or unresectable locally recurrent clear cell renal carcinoma * previous removal of kidney except if the size of the tumor was less than 5 cm or there was extensive liver or bone metastasis * may have had no prior chemotherapy or up to 1 prior treatment regimen with immunotherapy or chemotherapy * performance status of 0-1 * measurable disease * adequate liver, renal, and bone marrow function * must be able to give written informed consent * women able to become pregnant must have a negative pregnancy test * must be 18 or over * must be able to swallow pills exclusion criteria: * prior treatment with sorafenib or m-tor inhibitors * history of acute mi within the last 6 months * active brain metastasis or patients with meningeal metastases * prior treatment for another cancer in the last 5 years * prior bleeding problems; coughing up or vomiting blood * non-healing wounds, ulcer, or long bone fracture * chronic use of systemic steroids or immunosuppressive agents * uncontrolled hypertension please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have. you can then decide if you wish to participate.
immune-cell membrane trafficking

Conditions: Severe Trauma

Summary: organ failure following trauma is a leading cause of morbidity and mortality. it appears that the development of organ failure is a direct result of an altered immune response. this altered response results in the production of circulating factors in the blood that causes direct injury to the injured patients' organs. the mechanism in which this altered immune response occurs is unknown. based on work we have performed in our laboratory, we believe that this response is initiated on the cell membrane of particular immune cells known as macrophages. although the cell membrane may appear uniform, it is not. the membrane is composed of specific segments that allow proteins to associate with each other forming receptors that are required for immune cell activation. these specific membrane components are composed of various lipids and cholesterol, and have been termed lipid rafts. based on our laboratory work it appears that these lipid rafts can be altered following injury. in particular both the lipid and protein content within these raft segments may be altered allowing immune cells to become active leading to the production of factors that directly injure normal cells and organs. thus, we plan to examine if these laboratory findings can be seen in patients suffering from trauma who develop clinical organ failure at harborview medical center. if this is accomplished, this data will lead to the development of both prognostic and therapeutic interventions for the optimal care of injured patient


Eligibility criteria:
inclusion criteria: * age 18 years or older, blunt or penetrating trauma and * one or more of the following: systolic blood pressure less than 90 mmhg at the scene or within one hour of arrival to the emergency department, 2) base deficit ≥ -6 within one hour of admission, 3) iss greater than 25, or 4) more than 6 units of blood transfused in the first 12 hours.- exclusion criteria:

Keywords: lipids proteins membrane lipid raft
vitamin d and its affect on growth rates and bone mineral density until age 5

Conditions: Vitamin D Deficiency

Summary: abstract background: vitamin d affects a wide variety of functions in the body including regulation of calcium, phosphorus, and bone metabolism. israeli studies have documented a high prevalence of vitamin d deficiency in israeli infants in general, which was more severe in infants from ultra-orthodox jewish families. modest dress requirements in this population drastically reduce sun exposure, known to encourage production of vitamin d. countless research has analyzed preterm as well as term neonates born to mothers with vitamin d deficiency, with regard to weight, height, and bone mineral density at birth. however, there is a paucity of information about healthy infants' vitamin d levels and its' correlation to these parameters during the first few years of life. objectives: the purpose of the proposed study is to measure and correlate levels of 25(oh)d and bone mineral density towards the end of the first year of life with growth rates and bone mineral density in the same children at the ages of 2, 3 and 5 years. patients and methods: the study will be performed in the ultra-orthodox jewish community of beitar illit. 25(oh)d levels will be taken between 9-12 months of age (when routine blood tests are normally drawn for these infants) and bone mineral density will be measured using quantitative ultrasound. infants will be divided into 2 groups: those with those with normal 25(oh)d levels (\>15ng/ml), and those with 25(oh)d deficiency (\<15ng/ml). group 1- normal levels will receive no intervention. infants with 25(oh)d below 15ng/ml will be randomly assigned into one of two groups; group 2-those receiving continued vitamin d supplementation of 800 international units(iu) (4gtt/d) for one year, or group 3- those receiving the placebo. height, weight, and head circumference growth curves will be recorded every two months until 2 years of age. quantitative ultrasound, growth charts and blood tests including 25(oh)d, serum calcium and phosphate levels, parathyroid hormone (pth), and alkaline phosphatase, taken at approximately 9-12 months will be repeated at 2 years of age. at that time children from group 1 (no supplementation) will be divided into three: group 1a- normal 25(oh)d levels will continue with no intervention, group 1b \<15ng/ml will begin receiving vitamin d 4gtt/d, group 1c \<15ng/ml will receive a placebo until age three. groups 2 and 3 will continue their previous treatment until age three. all aforementioned tests will be repeated at age 3, when treatment will stop, and the same tests will be repeated at age 5.


Eligibility criteria:
inclusion criteria: infants between 9-12 months old in tipat chalav and kupat holim clalit in beitar illit undergoing a blood draw for cbc at one year of age. exclusion criteria: parents that refuse to participate in this study, infants with any diagnosed chronic disease, and preterm infants less than 34 weeks.

Keywords: vitamin d bone densitometry vitamin d supplementation growth
a study to identify and characterize lal-d patients in high-risk populations

Conditions: Lysosomal Acid Lipase Deficiency

Summary: the objective of this study is to determine the frequency of lysosomal acid lipase deficiency (lal d) by lysosomal acid lipase (lal) enzyme activity assay in patients who are considered to be at risk.


Eligibility criteria:
inclusion criteria: 1. non-obese\*\* patients with elevated low-density lipoprotein (ldl) 2. non-obese\*\* patients with low high-density lipoprotein (hdl) 3. non-obese\*\* patients with unexplained and persistently elevated liver transaminases, 4. non-obese\*\* patients with hepatomegaly 5. patients with cryptogenic cirrhosis 6. patients with biopsy-proven microvesicular or mixed micro/macrovesicular steatosis without a known etiology 7. patients with presumed familial hypercholesterolemia (fh) in which genetic analysis was performed for the genes encoding the low-density lipoprotein receptor (ldlr), apo-b and pcsk9 genes and no disease-causing mutations were identified 8. patients with presumed fh with unclear family history 9. patients with autosomal recessive hypercholesterolemia (other than homozygous fh) 10. patients with autosomal recessive low hdl of unknown etiology also, patient must meet the following: * patient or patient's parent or legal guardian (if applicable) consents to participate in the study and provides informed consent prior to any study procedures being performed. if the patient is of minor age; he/she is willing to provide assent where required per local regulations, and if deemed able to do so. * patient is willing and able to comply with protocol requirements. * patients who do not fall into one of the aforementioned categories (cohorts) but are considered highly suspicious for lal d should be tested to rule out the disorder outside of the study at the discretion of the investigator. exclusion criteria: * active viral hepatitis; * other confirmed genetic liver diseases (e.g., wilson's disease, hemochromatosis, alpha 1-antitrypsin).

Keywords: lal d cesd nash nafld wilson's niemann pick familial hypercholesterolemia
cross-sectional evaluation of the subjective performance and satisfaction with ponto sound processors

Conditions: Hearing Loss; Hearing Loss, Conductive; Hearing Loss, Unilateral

Summary: the study is a non-interventional, observational, cross-sectional, study on users of ponto sound processors. the purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with oticon medical's sound processors fitted with the genie medical fitting software.

the study is a non-interventional, observational, cross-sectional, study on users of ponto sound processors. the purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with oticon medical's sound processors fitted with the genie medical fitting software. subjects fitted with one or two ponto sound processors will be invited to participate in an online survey. the survey contains questions about the subjectively experienced performance and satisfaction of the device. the survey can be filled out on computer, tablet or mobile phone and should take the participants about 10 minutes to fill out.

Eligibility criteria:
inclusion criteria: online consent form filled out has been fitted with at least one ponto sound processor exclusion criteria: no exclusion criteria
comparison of circumferential pulmonary vein isolation alone versus linear ablation in addition to circumferential pulmonary vein isolation for catheter ablation in persistent atrial fibrillation: prospective randomized controlled trial

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for persistent atrial fibrillation. after randomization, investigators will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation and anterior linear ablation in the other group. investigators will compare clinical recurrence rate, complication rate, and procedure time, etc.


Eligibility criteria:
inclusion criteria: * patients with persistent atrial fibrillation (20\~80 years) * la diameter \<55mm * patients possible to anticoagulation and anti arrhythmic drug exclusion criteria: * structural cardiac disease * contraindication to brain perfusion ct * catheter ablation history for af, * cardiac surgery for af * active internal bleeding * impossible to anticoagulation or antiarrhythmic drug * valvular af (ma\> gii, mechanical valve, mitral valve replacement) * patients with severe medical disease * expected survival \< 1year * severe alcoholics, drug addiction
detection and characterization of pulmonary disease by transthoracic doppler (ttd)

Conditions: Lung Disease, Chronic Obstructive; Lung Disease, Interstitial

Summary: the study seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound doppler signals obtained from lung tissue. a standard ultrasound device in a doppler mode is placed on the chest wall and the unique software the investigators have developed analyzes the signals reflected from within the lung. on the basis of of pilot studies performed previously the investigators expect to receive different signals from different diseases that will enable diagnosis of different lung diseases.


Eligibility criteria:
inclusion criteria: * able and willing to provide informed consent * age 18 years or older * clinic and hospital records including additional background medical data such as results of echocardiograms, cardiac catheterization pathology reports etc., available and accessible. * evaluation by a physician who determines that a high resolution computed tomography (hrct) of the thorax and pulmonary function tests, including spirometry, lung volumes and diffusion capacity, are indicated as part of the standard clinical care. * if full lung function tests are normal imaging with a regular chest x-ray is sufficient. * study population - subjects will be grouped based on the following criteria after obtaining pulmonary function tests and hrct of the thorax - 1. copd based on clinical assessment and spirometry showing airflow limitation i.e., (fev1/fvc \< 0.70). 2. interstitial lung disease (ild) diagnosed by hrct. 3. control subjects presenting with pulmonary complaints evaluated by full pfts (spirometry, lung volume and dlco) and a chest x-ray and/or hrct , all found to be within normal limits, . exclusion criteria: * primary or metastatic lung cancer. * acute pneumonia. * concomitant or previous diagnosis of bronchial asthma. * patients with severe chest wall deformity * decompensated heart failure or volume overload. * significant right-sided pleural effusion.

Keywords: chronic obstructive lung disease; interstitial lung disease; ultrasound doppler; lung disease diagnosis;
user study of an investigational blood glucose monitoring system

Conditions: Diabetes

Summary: this clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes * 18 years of age and older * able to speak, read, and understand english * willing to complete all study procedures exclusion criteria: * previously participated in a study using this investigational system * working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors * pregnancy * hemophilia or any other bleeding disorder * working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company * a condition which, in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
a study to evaluate the efficacy and safety of topical administration of fmx101 in the treatment of moderate-to-severe acne vulgaris

Conditions: Acne Vulgaris

Summary: a randomized, double-blind, vehicle-controlled study to evaluate the efficacy and safety of topical administration of fmx101 for 12 weeks in the treatment of moderate-to-severe acne vulgaris (study fx2017-22)

this is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of fmx101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. qualified subjects will be randomized to receive 1 of the following 2 treatments: * fmx101 4% minocycline foam * vehicle foam

Eligibility criteria:
inclusion criteria: 1. has facial acne vulgaris with: 1. 20 to 50 inflammatory lesions (papules, pustules, and nodules) 2. 25 to 100 non-inflammatory lesions (open and closed comedones) 3. no more than 2 nodules on the face 4. iga score of moderate (3) to severe (4) 2. willing to use only the supplied non-medicated cleanser (cetaphil gentle skin cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study. exclusion criteria: 1. acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations. 2. sunburn on the face.
hemodynamic instability index: the impact to care with a new predictive indicator

Conditions: Shock; Hemodynamic Instability

Summary: philips has developed a new algorithm, called hemodynamic instability rules based advisor (hirba 2.0) system, for the prediction of hemodynamic instability in critically ill patients, who were not previously known to be at risk. this algorithm provides with the numerical index - hemodynamic instability index (hii) and its trend which are calculated from existing real time data derived from patient's current hospital stay such as heart rate and blood pressure, labs, and admission - discharge- transfer (adt) data to help healthcare providers obtain information about patient's status and make clinical decisions. the aim of the study is to determine if the patient clinical information, displayed in the form of hii, can prompt possible patient hemodynamic status change and trigger earlier clinical care team response. we hypothesize that this real-time information on hemodynamic instability and earlier clinical decision making will lead to reduced length of stay (los) and icu mortality relative to standard care practice. study will also identify if the use of the philips new algorithm called hemodynamic instability rules based advisor (hirba 2.0) can improve outcomes for patients admitted to the intensive care units (icus). during this study, upon patient admission to the icu clinical data collection will begin. data that will be pulled during the study includes: vital signs, medications, reason for admission to the icu, treatments that patient may receive. research subjects will not be asked to do anything as far as specific activities expected to be accomplished during study participation. subjects will be involved in the study only during their stay in icu. hii information will be visible to clinicians, taking care of this patient only during his/ her stay in the study unit. study team will collect patient information and have the ability to view the hii for subjects. once patient leaves the icu the study team will collect information on the remainder of patient's hospital course including date of hospital discharge. all collected data will be then fully de-identified and released to philips for analysis.


Eligibility criteria:
inclusion criteria: * all patients admitted to the study unit will be invited to participate in the study. * study subject has to stay in study unit for at least 12 hours. exclusion criteria: * patients who were discharged from study unit earlier then 12 hours after admission. * patients who are or become dependent on extracorporeal membrane oxygenation (ecmo) support.

Keywords: hemodynamics medical informatics
complementary medicine approaches to tmd pain management

Conditions: Temporomandibular Joint Disorders

Summary: this study will determine whether selected complementary approaches to temporomandibular joint (tmj) pain management-acupuncture are as effective as usual care.

temporomandibular disorders are characterized by pain and tenderness in the muscles of mastication and/or the (tmj), limitations of jaw opening often accompanied by deviations in mandibular path, and clicking, popping or grating tmj sounds. this study will compare the effectiveness of the complementary therapies chiropractic therapy and bodywork therapy to the standard of care for tmj pain. if these complementary interventions are shown to be effective, the goal is to design and implement a phase iii clinical trial to further evaluate the health consequences and cost of these therapies. participants will be evaluated at baseline, and 6 and 12 months post-intervention. clinical examinations, saliva samples to assess salivary cortisol levels, and a series of questionnaires to assess pain and grade of dysfunctional pain, psychological functioning, and other physical symptoms will be used to assess outcomes. the investigators will passively monitor health care utilization within kpnw using clinical, research, and administrative databases.

Eligibility criteria:
inclusion criteria: * psychologically functional tmd patients
nasal irritation study: individual factors in nasal irritant sensitivity

Conditions: Rhinitis, Allergic, Nonseasonal

Summary: this study seeks to document differences in nasal irritant sensitivity within the population. the investigators are interested in knowing whether age, gender, and allergy status (nasal allergies) predict nasal irritant sensitivity. this is important in understanding symptom reporting patterns in air pollution situations (particularly in so-called "problem buildings"), as well as in understanding the reflex mechanism of a response of the nose to irritants (e.g., nasal congestion).


Eligibility criteria:
inclusion criteria: * non-smokers * 18-69 years of age * with or without allergic rhinitis (hay fever) * in good general health and with no prior history of asthma

Keywords: rhinitis irritation trigeminal