Kornimate/medical-research-clean huggingface dataset:
influence of microfiltered-seawater supplementation and variable resistance training in blood pressure, oxidative stress, hepatic, and renal biomarkers in older women

Conditions: Blood Pressure; Oxidative Stress; Renal Disease; Hepatic Impairment

Summary: this study was conducted to investigate the effects of the intake of deep sea water prior to resistance training on blood pressure, oxidative stress and hepatic and renal variables in older women.

this study was a 32 weeks, double-blinded, randomized, placebo-controlled trial.

Eligibility criteria:
inclusion criteria: * (i) women aged ≥65years * (ii) able to climb 10 stairs without pause and walk 100m without a walker * (iii) score above 23 points in the mini-mental state examination * (iv) \<1h of physical activity per week throughout the six months before the study * (v) possess a medical certificate of aptitude to carry out physical activity exclusion criteria: participants who had suffered: * (i) any type of musculoskeletal, cardiovascular, hepatic, renal, pulmonary, neurological, or neuromuscular injury or disorder and/or * (ii) taking any type of drug/supplement that may alter the results of the study (e.g., vitamin c, vitamin e, estrogens, beta-blockers, calcitonin, steroid hormones, etc.) * (iii) changes in body weight of more than 10% in the year prior to the study * (iv) have a severe hearing or visual impairment * (v) participate in another research project (within the last six months) involving an exercise, dietetic and/or pharmaceutical intervention

Keywords: aged postmenopause bone mineral density muscle strength
safety and efficacy of imiquimod applied in dose-cycle for actinic keratoses

Conditions: Actinic Keratoses

Summary: it is believed that imiquimod 5% cream has the potential to be an effective treatment for actinic keratoses. the purpose of this study is to evaluate the duration of the effect of topical imiquimod 5% topical cream for the treatment of actinic keratoses.

this study will assess the safety and efficacy of imiquimod 5% cream applied to actinic keratoses on the head to reduce the size of lesions. the objective is to analyze the effect of dose cycling with respect to the complete clearance rate when imiquimod 5% cream is applied 3 times per week for 4 weeks in 1 or 2 cycles. the complete clearance rate is defined as the proportion of subjects with no clinically visible ak lesions in the treatment area at the end of cycle 1 or the end of cycle 2.

Eligibility criteria:
inclusion criteria: * at least 18 years of age. * have a total of 4 to 8 clinically typical, discrete, non-hyperkeratotic, non-hypertrophic ak lesions located within a contiguous 25 cm2 treatment area (balding scalp or face, but not both). * free of any significant findings (e.g. tattoos) in the potential application site area that may impair examination of treatment or surrounding area. * willing to eliminate tanning bed/sun parlor use for duration of study. exclusion criteria: * evidence of clinically significant, unstable cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease. * any dermatological disease and or condition in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination (e.g. rosacea, psoriasis, atopic dermatitis, eczema). * confirmed scc, bcc anywhere on the head. * share a household where there is a person participating in a concurrent clinical study of imiquimod or being treated with imiquimod 5% topical cream. * active chemical dependency or alcoholism, as assessed by investigator. * females who are pregnant, breast-feeding or considering becoming pregnant while on the study. * females with childbearing unwilling to practice an effective method of contraception, as defined by the investigator for the duration of the study as well as one month after completion. * received any treatment, products or procedures within the designated time period prior to the prestudy visit as listed on page 4 of the protocol (version 03 dd march 2003).

Keywords: actinic keratoses imiquimod pre-malignant squamous cell carcinoma immunosuppression
aspiration of residual gastric contents

Conditions: Infant, Premature; Nutrition, Enteral

Summary: the primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.

the participants in the study will be randomly assigned (like the flip of a coin) to either have the leftover food in their stomach removed before each feeding, or not have the leftover food removed before each feeding. in addition, when a blood drawn is performed as regular care an extra amount with be taken. a test to determine how much of the hormones gastrin and motilin are contained in the blood will be performed. stool samples will be collected. participation could last up to approximately 6 to 8 weeks of age.

Eligibility criteria:
inclusion criteria: * born at 32 weeks of less of gestational age * birth weight \</= to 1250 grams * receiving some enteral feedings by 72 hours of age * receiving parenteral feedings by 24 hours of age exclusion criteria: * congenital or chromosomal abnormalities * complex congenital heart diseases and congenital anatomic gastrointestinal abnormalities

Keywords: premature infant nutrition enteral
the feasibility of florbetapir quantitation

Conditions: Alzheimers Disease

Summary: the overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir f 18 scan interpretation. the hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir f 18 scan interpretation.


Eligibility criteria:
inclusion criteria: * readers have undergone amyvid reader training * readers have minimal experience with quantitation of amyloid pet scans exclusion criteria: * readers have previously been trained to quantitate amyloid pet scans
drug interaction between daclatasvir/asunaprevir/bms-791325 and rosuvastatin

Conditions: Hepatitis C

Summary: the primary purpose is to assess the effect of daclatasvir (dcv)/asunaprevir (asv)/bms-791325 combination therapy on the exposure of rosuvastatin.

ind number: 79,599/101,943 primary purpose: other - phase 1 clinical pharmacology drug interaction study in healthy subjects

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy subjects with no clinically significant deviations from normal in medical history, physical exam findings, 12 lead ecg measurements and clinical laboratory tests * females must be of non-childbearing potential exclusion criteria: * women of childbearing potential * any significant acute or chronic medical condition * inability to tolerate oral medications * inability to be venipunctured and/or tolerate venous access * abnormal liver function tests * current or recent (within 3 months of dosing) gastrointestinal disease
evaluate safety and efficacy of aegr-733 and atorvastatin vs atorvastatin monotherapy in hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: evaluate the efficacy of combination therapy aegr-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. the primary efficacy parameter is percent change in ldl-c after 8 weeks of therapy.

following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, or aegr-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by aegr-733 5 mg + atorvastatin 20 mg for 4 additional weeks. during the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/\< 1 drink per day.

Eligibility criteria:
inclusion criteria: * m/f 18-70 * 0-1 risk factor, mean ldl-c -/\> 160 and -/\< 250 mg/dl (visit 2 \& 3) * 2+ risk factors, mean ldl-c -/\> 130 \& -/\< 250 mg/dl (visit 2 \& 3) * fasting mean tgs -/\< 400 mg/dl * understanding and compliance of protocol * sign consent exclusion criteria: * females pregnant, lactating, or cbp who have not been using acceptable contraceptive methods over previous 3 months * uncontrolled hypertension \>180/95 at screening * hx of chronic renal insufficiency (serum creatinine \> 2.5 mg/dl) * hx of liver disease or transaminases \> 1.5 x uln * positive for hepatitis b or c * major surgery within past 3 mos * cardiac insufficiency defined as functional class ii-class iv * hx of malignancy within previous 5 years * participation in another investigational drug study within past 6 wks * serious or unstable medical or psychological condition * regular alcohol use \> 1 drink per day * regular consumers of grapefruit juice or medications known to be metabolized by cyp 3a4 * use of other lipid-lowering meds (washout permitted) * acute cvd * diabetes mellitus * fasting glucose \>110 mg/dl * bmi -/\> 40 kg/m2 * significant gastrointestinal symptoms such as ibs * use of fish oils, niacin, herbal wt. loss products (washout permitted)

Keywords: hyperlipidemia
efficacy and safety of cyclosporine microemulsion in diabetic adult stable liver transplant recipients

Conditions: Liver Transplant

Summary: the purpose of this study is to determine whether the switch from tacrolimus to cyclosporine microemulsion benefits post-transplant diabetes management (in terms of glycogenic control and insulin dosage) in stable liver transplant recipients.


Eligibility criteria:
inclusion criteria: * at least 4 months post-transplant * patients in treatment with tacrolimus * post-transplant diabetes treated with insulin for at least one month exclusion criteria * known hypersensitivity to cyclosporine microemulsion * investigational drug within 60 days before baseline or during the study * patients who cannot comply with the study requirements other protocol-defined exclusion criteria applied

Keywords: adults post transplant diabetes
infections and colonization with the third group of enterobacteriaceae in the intensive care unit

Conditions: Critically Ill; Enterobacteriaceae Infections; Antibiotic Resistant Infection

Summary: there is a lack of data whether colonization and infection with enterobacteriaceae of the third group (eb3) affect the outcomes for icu patients. this study evaluated the effects of eb3 colonization and infection on icu mortality, icu length of stay (los) and broad-spectrum antibiotic exposure. we focused on the sub type enterobacter regarding its a priori higher risk of resistance.


Eligibility criteria:
inclusion criteria: * adults critically ill patients admitted to the the participating icus during the study period * with colonization and/or infection with a third group enterobacteriacea * and with a lenght of stay \> 24h exclusion criteria: * minors patients * lenght of stay \< 24h

Keywords: third group enterobacteriaceae infection colonization resistance ampc cephalosporinase
effect of rfviia on peri-operative blood loss in patients undergoing major burn

Conditions: Burns

Summary: the purpose of the study is to see if a medication (recombinant coagulation factor viia or novoseven), normally used to stop bleeding in persons with a bleeding disorder, will lower the amount of blood lost during burn surgery.

to identify the clinical use for factor viia in the operating room to reduce blood loss and blood transfusion , determine the recombinant factor viia (rfviia) pharmacokinetics in burned patients, determine if ffviia should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal to 20 percent of the total body surface area, determine the efficacy of the drug in burned patients undergoing excision of burn wounds.

Eligibility criteria:
inclusion criteria: * male or female * burn wounds * 18-65 years of age * scheduled excision of burn wound of at least 20 percent tbsa exclusion criteria: * age greater than 65 years * history of blood coagulation disorders * taking anti-coagulation medication * contraindication for heparin therapy * pregnant or nursing females * unstable angina * mi within the last 6 months * recent of diagnosis of dvt, stroke within the last 6 months * renal failure requiring dialysis or creatinine clearance less than 25 ml/min * religious prohibition to blood transfusion * have received rfviia during current hospitalization * previous enrollment in this study

Keywords: burns
comparison of two types of pain relief after cesarean delivery

Conditions: Cesarean Section

Summary: women undergoing elective cesarean delivery, performed under a standard spinal anesthesia, will be randomized to undergo either tap block or incisional infiltration with local anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen, nefopam and ketoprofen. short acting oral morphine will be given as a rescue treatment in case of severe pain.


Eligibility criteria:
inclusion criteria: * scheduled cesarean section performed under spinal anesthesia * asa i or ii * height above 1,55 m * singleton pregnancy exclusion criteria: * contre indication to a drug used in the study (levobupivacaine, ketoprofen, nefopam)

Keywords: cesarean section continuous wound infiltration transversus abdominis plane block
effect of extended-release oxymorphone taken with or without food on cognitive functioning

Conditions: Chronic Pain

Summary: the purpose of the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher cmax, impacts cognitive functioning, using cambridge neuropsychological test automated battery (cantab) tests, to a greater extent than when taking under conditions of fasting.

oxymorphone 40 mg er affects cognitive performance similarly within 3 hours post dose, whether given on an empty stomach or after a high-fat meal, suggesting that the altered pharmacokinetics, fed versus fasting and as described above, is not relevant for the medication's impact on cognition. hence, the direction for oxymorphone er to be dosed at least 1 hour before or 2 hours after eating, at least from a cognitive perspective, may be without merit.

Eligibility criteria:
inclusion criteria: 1. man or woman, 18-65 years of age, inclusive 2. able to provide informed consent and comply with all study procedures 3. women of childbearing potential with a negative urine pregnancy test at screening and on adequate contraception 4. chronic, non-malignant, painful condition, treated with long-acting opioid (methadone, oxycontin®, ms (morphine sulfate) contin®, kadian®, avinza®, fentanyl®, opana® er) 5. opioid treatment for at least 3 months prior to screening at a minimum dose of 90 mg of morphine equivalents per day or 50 mcg of the fentanyl transdermal patch 6. dose of opioid treatment stable for at least 1 week prior to screening and expected to be stable from screening through end of second testing 7. weight at screening 100-300 pounds, inclusive exclusion criteria: 1. pregnant or breastfeeding 2. gastrointestinal disorder or s/p gastrointestinal surgery impacting absorption of study medication (delayed gastric emptying, partial or complete gastrectomy) 3. alcohol or substance abuse within 2 years of screening 4. consumption of alcohol within 24 hours of a screening or testing visit 5. consumption of xanthine-containing beverages (coffee, tea, coke) on the morning of a screening or testing visit 6. impaired kidney or liver function (transaminase levels more than 3 times elevated; estimated creatinine clearance less than 50 ml/min) 7. epworth sleepiness scale (ess) score 16 or higher at screening 8. medically concerning hypertension (≥ 160/100) or unstable cardiovascular illness 9. any clinically significant illness that would interfere with study participation or put the subject at risk 10. exposure to investigational medication within 30 days of screening

Keywords: opioid tolerant chronic pain
a study of syha1807 in subjects with extensive-stage small cell lung cancer

Conditions: Extensive-Stage Small Cell Lung Cancer

Summary: this is a phase i, open-label, multi-center, non-randomized, 2-part first time inhuman (ftih) study for syha1807. part 1 is a dose escalation phase to determine the recommended phase 2 dose (rp2d) for syha1807 based on the safety, tolerability and pharmacokinetics (pk) profiles observed after oral administration of syha1807. the dose escalation study will be performed according to the 3+3 design. once rp2d is identified, an expansion cohort (part 2) of up to 12\~40 subjects will be enrolled to further evaluate the clinical activity and tolerability of syha1807 in subjects with extensive-stage small cell lung cancer (sclc).


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of advanced sclc; * ecog(eastern cooperative oncology group) performance status of 0 or 1; * measurable disease according to recist v1.1; * recovered from all toxicities associated with previous treatments; * life expectancy ≥ 3 months; * adequate organ function; * use of reliable contraceptive methods; * signed informed consent from the patient; exclusion criteria: * patients with primary malignant tumor other than small cell lung cancer; * identified central nervous system metastasis (such as brain metastasis or meningeal metastasis); * uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; * inadequate washout period for previous anti-tumor therapy; * previous treatment with any lsd1(lysine specific demethylase 1) inhibitor; * unable to swallow oral medications; * history of serious systemic diseases; * history of serious autoimmune diseases； * hiv positive; * pregnant or lactating women.
isometric handgrip home training to lower blood pressure in hypertensive older adults

Conditions: Hypertension

Summary: this study evaluates the effect of 20 weeks of isometric handgrip (ihg) home training in adults aged 50 years or more. half of the participants will serve as a control group and will only receive hypertension-guidelines on lifestyle changes.

hypertension markedly increases the risk of cardiovascular diseases and overall mortality. lifestyle modifications such as increased levels of physical activity are recommended as the ﬁrst line of anti-hypertensive treatment. a recent systematic review showed that isometric handgrip (ihg) training was superior to traditional endurance and strength training in lowering resting systolic blood pressure (sbp). the average length of previous ihg training studies is approximately 7.5 weeks with the longest being 10 weeks. therefore, presently it is unknown if it is possible to further lower blood pressure levels beyond the 10 week mark. recently, the investigators developed a novel method for monitoring handgrip intensity using a standard nintendo wii board (wii). the primary aim of this study is to explore the effects of 20-weeks ihg home training facilitated by a wii in hypertensive older adults (+50 years of age) in lowering sbp compared to usual care. secondary aims are to explore if/when a leveling off effect on sbp will occur during the 20-week intervention period in the training group and to explore adherence and potential harms related to the ihg home training. methods: based on previous evidence, the investigators calculated that 50 hypertensive older adults (+50 years of age) is needed to achieve a power of 80% or more. participants will be randomly assigned to either an intervention group (ihg home training + hypertension-guidelines on lifestyle changes) or to a control group (hypertension-guidelines on lifestyle changes). participants in the intervention group will perform ihg home training (30% of maximum grip strength for a total of 8 min per day per hand) three times a week for 20-weeks.

Eligibility criteria:
inclusion criteria: 1. age +50 years old 2. un-medicated (anti-hypertensive medicine) with resting sbp between 135-179 mmhg or hypertensive patient medicated with no change in treatment for ≥ 4 months with resting sbp between 135-179 mmhg exclusion criteria: 1. manifest cardiovascular disease (cerebrovascular disease, heart failure, chronic kidney disease, peripheral vascular disease, and advanced retinopathy (fundus hypertonus iii-iv)). 2. diabetes (any type) 3. more than three blood pressure regulating agents 4. physical limitation preventing ihg training (e.g. missing an arm or musculoskeletal disorders). 5. arthritis in the hand or carpal tunnel 6. sbp ≥ 180 mmhg (will be advised to see a doctor)

Keywords: isometric handgrip training home training older adults hypertension
navaset: nava level titration using comfort scales

Conditions: Acute Respiratory Failure

Summary: determining the optimal neurally adjusted ventilatory assist (nava) level remains challenging, and several methods have been suggested. however none of them seems easily utilisable. thus the investigators propose to test a way of nava level titration according to ventilator comfort.

physiological comparison of different levels of ventilator assistance during neurally adjusted ventilatory assist (nava) to evaluate the effect of these on tidal volume, inspiratoy activity, comfort scales. we propose to evaluate the ability to guide the titration according the patient's comfort scale. the intensity of the breathing sensations will be evaluated using the labeled visual analog scale (banzett scale).

Eligibility criteria:
inclusion criteria: * age \> 18 years * hospitalized in intensive care unit for an acute respiratory failure * intubated or tracheotomized and mechanically ventilated * rass score: 0;-2 * weaning period exclusion criteria: * hemodynamic instability * absence of consent * contraindication of nasogastric catheter insertion

Keywords: mechanical ventilation acute respiratory failure weaning pressure support ventilation neurally adjusted ventilatory assist
role of myo-inositol and d-chiro inositol on the ovaric and metabolic functions

Conditions: PCOS

Summary: polycystic ovary syndrome (pcos) is one of the most common endocrine disorders in women of reproductive age and is characterized by menstrual abnormalities, clinical or biochemical hyperandrogenism, multiple abnormal cysts and enlarge ovaries. women affected by pcos often suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk of developing several metabolic disorders. inositol is a six-carbon polyol which has been characterized as an insulin sensitizer: it exists as nine different isomers and among them myo-inositol and d-chiroinositol are the most represented and studied in physiology and physiopathology. in particular, myo-inositol (mi) and d-chiro inositol (dci) glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels. the aim of this randomized study is to evaluate the metabolic and ovaric effects of a six-month supplementation of myo-inositol and d-chiro-inositol on young women with pcos and hyperinsulemia.


Eligibility criteria:
inclusion criteria: * pcos * women aged between 14-40 years * bmi \> 28 * hyperinsulinemia exclusion criteria: * pre-existing secondary endocrine and metabolic disorders * pre-existing secondary adrenal disorders * pharmacologic treatment in the last 3 months before entering the study * pregnancy

Keywords: pcos metabolic disorders ovarian functionality myo-inositol d-chiro-inositol
internet walking program and pedometer in chronic obstructive pulmonary disease

Conditions: COPD; Internet Access

Summary: higher levels of physical activity are associated with better functional status, fewer hospital admissions, and lower mortality. the investigators studied the feasibility and safety of a novel program that combines a pedometer with a website to increase walking. this is a pilot study.


Eligibility criteria:
inclusion criteria: * copd * able to ambulate * internet access exclusion criteria: * current pulmonary rehab