Kornimate/medical-research-clean huggingface dataset:
a study of tadalafil use with finasteride in men with enlarged prostates and urinary symptoms

Conditions: Benign Prostatic Hyperplasia; Enlarged Prostate

Summary: the purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of benign prostatic hyperplasia and demonstrable prostate enlargement.


Eligibility criteria:
inclusion criteria: * have not taken the following treatments within the indicated duration and agree not to use at any time during the study: * all other benign prostatic hyperplasia (bph) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication. * overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication. * erectile dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication. * finasteride or dutasteride use at any time. * have bladder outlet obstruction as defined by a urinary peak flow rate (qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (ml)/second before receiving study drug. * have prostate enlargement measured by ultrasound at screening. exclusion criteria: * have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer \[prostate-specific antigen (psa) greater than 10 nanograms/milliliter (ng/ml) at the start of study\]. * have had any of the following in the past 90 days: heart attack, also known as a myocardial infarction (mi); heart bypass surgery (called coronary artery bypass graft surgery); had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention). * have problems with kidneys, liver, or nervous system * have uncontrolled diabetes * have had a stroke or a significant injury to brain or spinal cord. * have scheduled or planned surgery during the course of the study.

Keywords: benign prostatic hyperplasia (bph) enlarged prostate
mebendazole as adjuvant treatment for colon cancer

Conditions: Colorectal Cancer

Summary: mebendazole treating colon cancer

mebendazole as adjuvant treatment for colon cancer

Eligibility criteria:
inclusion criteria: * colorectal cancer stage 4. exclusion criteria: * agranulocytosis * pregnancy * allergy to mebendazole.
influence of nep inhibition on vascular leak and inflammation (nepi-inflammation)

Conditions: Acute Respiratory Distress Syndrome

Summary: acute respiratory distress syndrome (ards) is a severe type of lung injury that affects 10% of patients admitted to intensive care units worldwide, with an unacceptably high mortality of up to 48% in those with the most severe form of the condition. it is a complex and poorly understood syndrome that results in progressive failure of the lungs. crucially, the inflamed lungs allow fluid to leak from the circulation into the airspace, so that patients' lungs fill with fluid - "drowning from the inside". as this condition progresses, the patient typically requires increasing amounts of oxygen and eventually, support from a ventilator. to date, there are no effective treatments for ards that can limit, stop or repair this process. this research study is aiming to look at a naturally occurring substance produced by blood vessels, c-type natriuretic peptide (cnp). the investigators have evidence suggesting that cnp plays a role in maintaining the barrier provided by blood vessels that stops fluid leaking out into tissues. this is based on various studies done on cnp by the investigators research group that have established its widespread role in maintaining cells that line blood vessels and play a vital role in lungs' barrier function: the endothelium. cnp is broken down in part by an enzyme called neutral endopeptidase and therefore, drugs that inhibit this enzyme would result in increased cnp concentration and activity. if cnp does in fact strengthen the lungs' endothelial barrier, then this class of drug may benefit patients with ards. the aim of this experimental medicine study is to assess the effect of using the licensed nep inhibitor racecadotril, in a well-established, safe model of inflammation-induced skin blisters in healthy human volunteers to determine primarily whether the fluid accumulation i.e. leak, in these blisters is reduced by treatment with this drug.


Eligibility criteria:
inclusion criteria: 1. healthy male and female volunteers 2. bmi of 18-40 kg/m2 3. aged 18-45 4. volunteers who are willing to sign the consent form exclusion criteria: 1. healthy subjects unwilling to consent 2. smokers 3. known sensitivity to racecadotril 4. history of any serious illnesses, including recent infections or trauma 5. a personal history of keloid scarring, or a family history of keloid scarring in a first degree relative with similar skin pigmentation 6. subjects taking systemic medication (other than the oral contraceptive pill) 7. subjects who are pregnant or any possibility that a subject may be pregnant, unless in the latter case a pregnancy test is performed with a negative result 8. women who are breastfeeding 9. subjects with recent or current antibiotic use 10. subjects with a history of skins conditions. 11. subjects with a history of allergic reaction to any topical application or history of angioedema 12. subjects with any history of a blood-borne infectious disease such hepatitis b or c virus, or hiv.

Keywords: ards endothelium cnp acute lung injury
parent-child early approaches to raising language skills (pearls) intervention

Conditions: Deafness, Bilateral

Summary: the purpose of this research study is to develop and evaluate a parent training program, which aims to improve language. the study is being conducted to see if teaching parents positive parenting techniques and behavior strategies will improve the rate of language development in children with cochlear implants when compared to standard speech therapy (e.g., auditory-verbal therapy).


Eligibility criteria:
inclusion criteria: 1. children who are severely to profoundly deaf and a cochlear implant candidate, 2. children who are 12 to 48 months, 3. english or spanish as primary language spoken at home, 4. families educating their children in spoken language, 5. children who pass the cognitive screening, scoring 75 or above on the screening measure exclusion criteria: 1. parents who do not consent to being videotaped, 2. children with moderate to severe developmental delays (as assessed using the battelle developmental inventory (bdi-2) 2nd edition for children ages 0 to 24 months or the leiter international performance scale-revised), 3. children with significant syndromes (e.g., charge, autism, cerebral palsy) or severe brain abnormalities, 4. families who do not receive their auditory-verbal therapy from university of miami (um). further, children who have already completed the bdi-2 within the past year as part of their early steps (florida early intervention) program will not have it re-administered.

Keywords: cochlear implants language development parenting intervention maternal sensitivity facilitative language techniques
effect of physiological ischemic training on patients with atherosclerosis

Conditions: Atherosclerosis

Summary: to study whether the resistance training with blood flow obstruction in patients in early atherosclerosis period can produce a beneficial effect on preventing atherosclerosis.


Eligibility criteria:
inclusion criteria: 1. ldl \> 3.11mmol/l and less than 5.63mmol/l; 2. no serious heart, blood vessel and other related diseases; 3. there were no skeletal and muscular diseases affecting sports training; 4. no regular exercise in the past half year (no more than 2 times a week, no more than 30 minutes each time); 5. smoking less than 1 pack / year, no history of drinking. exclusion criteria: 1. haven't other serious heart and vascular diseases other than hyperlipidemia and / or bones and muscles that affect sports training diseases; 2. pregnant women and people with disabilities; 3. other circumstances determined by the researcher not suitable for the study.

Keywords: resistance training
automated breast radiation therapy using an mr-guided process

Conditions: Breast Cancer

Summary: in the proposed research study, we are investigating the feasibility of integrating automated planning tools to mr images acquired using a novel mr-guided linac, for on-line adaptive radiation treatment. however, these on-line automation tools require further technical refinement and clinical validation. the goal of this research proposal is to develop an on-line mr-guided radiation therapy process for adapting breast imrt treatment. such an approach will provide early stage breast cancer patients timely access to high-quality adaptive treatments without exposure to additional ionizing radiation.


Eligibility criteria:
inclusion criteria: * patients who will receive standard two-field tangential whole breast radiation therapy with dose prescription of 4240 cgy in 16 fractions, 5000 cgy in 25 fractions or 4000 cgy in 16 fractions. * female patients with any stage of breast cancer. * patients with prior treatment such as surgery or chemotherapy for any type of cancer. * able to provide a written informed consent. * ≥ 18 years of age. exclusion criteria: * patients who will not receive 4240 cgy in 16 fractions, 5000 cgy in 25 fractions, or 4000 cgy in 16 fractions * males. * patients who received partial breast radiation and not the standard dose. * patients who are unable to provide informed consent. * \< 18 years of age.

Keywords: breast rt breast radiation therapy
wp01 - normothermic liver preservation

Conditions: Liver Transplantation

Summary: a multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.


Eligibility criteria:
inclusion criteria: * subject is 18 years of age or greater * subject is registered as an active recipient on the united network for organ sharing (unos) waiting list for liver transplantation * subject, or legally authorized representative, is able and willing to give informed consent and hipaa authorization * subject is able and willing to comply with all study requirements exclusion criteria: * subject requiring all of the following at the time of transplantation: oxygen therapy, inotropic support, renal replacement therapy * subject has acute/fulminant liver failure * subject undergoing simultaneous transplantation of more than one organ * subject is pregnant or nursing * concurrent enrollment in another clinical trial. subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (no test device or test drug used) are allowed to participate.
safety and efficacy of bgs649 in obese, hypogonadotropic hypogonadal men

Conditions: Obese Hypogonadotropic Hypogonadism

Summary: this study is designed as a 2-part study, with part 1 being open-label to best determine the appropriate dose levels to use in part 2, which has a randomized, double-blind, placebo controlled design. the study aims to assess the safety and tolerability of bgs649, and determine whether or not bgs649 is able to normalize testosterone levels and improve insulin sensitivity in obese, hypogonadotropic hypogonadal (ohh) men


Eligibility criteria:
inclusion criteria: * males who meet the criteria of obese, hypogonadotropic hypogonadism defined as: * patients with a body mass index (bmi) ≥ 30 kg/m2 * patients with a morning serum total testosterone level \< 300 ng/dl on at least two separate occasions during the screening and/or baseline periods. * patients with inappropriately low gonadotropins at screening given the low testosterone: * luteinizing hormone (lh) ≤ uln * follicle stimulating hormone (fsh) ≤ uln * estradiol within or above the normal range (defined as ≥ lln of the approved assay) * normal hypothalamic/pituitary function, including: * prolactin: within the normal range * thyroid stimulating hormone (tsh): within the normal range * ferritin: within the normal range * patients agree to use a barrier method of contraception (e.g., condom), for the duration of the study and for at least 3 months following their study completion visit to prevent bgs649 exposure to their partners. exclusion criteria: * patients with hypogonadism, not related to obesity or as a result of other underlying issues * patients with significant major organ class illness (e.g. kidney or liver disease). * other protocol-defined inclusion/exclusion criteria may apply

Keywords: obese obesity hypogonadism hypogonadotropic hyperestrogenemic testosterone hypogonadal
sarcopenia and cirrhosis

Conditions: Cirrhosis

Summary: the study investigates the effect of aminoacid infusion on proteinturnover in muscle from cirrhosis subjects, compared to healthy controls. the hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation that follows cirrhosis.


Eligibility criteria:
inclusion criteria: * male subjects * diagnosis of cirrhosis, child-pugh a, b, c. exclusion criteria: * acute illness within 3 weeks * ascites collections within 10 days * heart-, kidney, pulmonary disease. cancer. type 1 diabetes. * active alkoholdrinking
vitamin d and t-regulatory cells in coronary artery disease

Conditions: Coronary Artery Disease; Cardiovascular Disease

Summary: the purpose of this study is to evaluate the effect of vitamin d supplementation on cardiovascular disease and certain cells (t-regulatory cells) in the body that play a role in plaque formation in arteries. this study will determine the levels of vitamin d and t-regulatory cells in subjects with coronary artery disease and if vitamin d supplementation will affect future events such as heart attach and stroke.


Eligibility criteria:
inclusion criteria: * between the ages of 30 and 80 years * have a history of medically treated coronary artery disease exclusion criteria: * history of smoking in the past 2 years * history of diabetes mellitus

Keywords: cad vitamin d cvd
exercise interventions, running biomechanics and injury in novice runners

Conditions: Running; Leg Injuries

Summary: the purpose of this study is to understand the effects of muscle strengthening and balance exercise interventions on muscle strength, running mechanics and postural control in novice recreational runners. participants will be assessed before and after they engage in an 8-week exercise intervention program.


Eligibility criteria:
inclusion criteria: * novice recreational runners * less than one year of running experience * run at least twice a week for a total weekly distance between 5 and 15 km as your main form of physical activity * 18-50 years of age exclusion criteria: * neurological abnormalities or lower extremity injury or pain within three months of enrollment. * no extensive history with balance training or isolated ankle strengthening within the last year.

Keywords: biomechanics ankle strength postural control running mechanics
passive body heating, sleep and fibromyalgia

Conditions: Fibromyalgia

Summary: objectives: to assess the effect of passive body heating on the sleep pattern of patients with fibromyalgia. methods: six menopausal women diagnosed with fibromyalgia according to criteria determined by the american college of rheumatology were included. all women underwent passive immersion in a warm bath at 36±1 °c, for 15 sessions of 30 minutes each over 3 weeks. their sleep pattern was assessed by polysomnography at the following conditions: pre-intervention (baseline), on the first day of intervention (acute), on the last day of intervention (chronic) and 3 weeks after the end of interventions (follow-up). core body temperature was evaluated by a thermistor pill at the above-mentioned conditions. the impact on fibromyalgia was assessed through of a specific questionnaire called fibromyalgia impact questionnaire.

patients were attended at the psychobiology and exercise studies centre 5 times a week for 3 weeks between 6:00pm and 8:00pm for passive body-heating interventions for 30 min each session. the patients were accompanied by a researcher to a therapeutic water bath (barritz hydrotherapy appliance, germany) and were comfortably positioned in a supine position with their necks supported by an inflatable floating pillow to keep the body relaxed and safe during the intervention. the room temperature at the laboratory was maintained at 23±1 ºc, and the water temperature was 36±1ºc.

Eligibility criteria:
inclusion criteria: * fibromyalgia diagnostic * women * post menopausal * sedentary exclusion criteria: * other diagnosis of chronic illnesses

Keywords: fibromyalgia hydrotherapy sleep pain body temperature
evaluation of accuracy and precision of a new arterial blood gas analysis system blood in comparison with the reference standard

Conditions: Hypoxia; Hypercapnia; Anaemia

Summary: evaluate the precision and accuracy of the proxima 3® system by obtaining quantitative clinical data at various time points. compare the methods associated with obtaining blood gas results using the proxima 3® system device versus a conventional abg analyse. the aim of the investigator is to evaluate the precision and accuracy of the proxima 3® abg system parameters (ph, pco2 po2, hematocrit and potassium) in clinical practices with rapid changing context.

in this study the investigator will test the applicability of the proxima 3® abg system in a heterogeneous patient population consisting of patients scheduled for hybrid atrial fibrillation surgery, patients scheduled for heart valve surgery, complex cardiac surgery with deep cooling, spine surgery or patients with expected major blood loss. the investigator will compare the abg values obtained with the traditional abg measurement system of the hospital. the availability of a disposable patient-dedicated blood gas analyser allows rapid, frequent measurement of blood gases in theatre without the loss of theatre staff. as well as facilitating measurement in the unstable patient, this approach opens up the possibility for more frequent measurement to identify patient deterioration before a crisis occurs. the conventional laboratory abg method uses sensor technology for ph, pco2, po2, sodium, potassium, calcium, glucose and lactate levels. it measures hemoglobin concentration via spectrophotometry methodology at a set wavelength of 467-672 nm. the blood gas laboratory uses abl90 flex (radiometer®). the optical system is based on a 138-wavelength spectrophotometer with a measuring range of 467-672 nm. the spectrophotometer is connected via an optical fiber to a combined hemolyzer and measuring chamber.

Eligibility criteria:
inclusion criteria: * male and female patients ≥18 years old * patients who have (or will have) an arterial line, which was (will be) inserted for clinical - need, will be considered for inclusion in this study * patients who give informed consent (or their personal/nominated consultee) to participate in the study * patients who are likely to have an arterial line for at least 6 hours. exclusion criteria: * patients contraindicated for an arterial line * refusal of consent by a patient * not for use with patients with uncorrected hyperphosphataemia, hypocalcaemia or hypercalcaemia. * the patient is considered to be unsuitable for the study by the investigator

Keywords: arterial blood gas
a multicenter evaluation of methods to reduce hyperemia associated with bimatoprost therapy for glaucoma or ocular hypertension

Conditions: Glaucoma

Summary: evaluate the incidence of hyperemia in patients using bimatoprost and to determine if simple interventions reduce its incidence and to assess the value of detailed instruction in increasing patient compliance and willingness to continue bimatoprost therapy, despite the occurrence of hyperemia.


Eligibility criteria:
inclusion criteria: * · male or female \> 18 years of age * no prior use of bimatoprost * diagnosis of open-angle glaucoma or ocular hypertension * ability to provide informed consent and likely to complete all study visits exclusion criteria: * · known contraindication to bimatoprost * uncontrolled systemic disease * active ocular disease other than glaucoma or ocular hypertension * required use of ocular medications other than the study medications during the study (intermittent use of artificial tear solutions will be permitted) * history of intraocular surgery within the last 3 months
safety of haemophilus influenza type b vaccine when administered to korean children

Conditions: Haemophilus Influenzae Type B Infection

Summary: this is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to korean children according to the product insert.


Eligibility criteria:
inclusion criteria: * male and female children 2 months to 5 years of age scheduled to receive vaccination exclusion criteria: * contraindications to vaxem™hib korean prescribing information

Keywords: haemophilus influenza type b children korea vaccine prevention of haemophilus influenza type b
chess caregivers study: web-based support for informal caregivers in cancer

Conditions: Breast Cancer; Prostate Cancer

Summary: web-based support for informal caregivers in cancer brief summary (including hypothesis): informal caregivers need information, skills and emotional support to address physical, spiritual, and emotional needs associated with chronic illnesses including late stage cancer. unfortunately, current conditions force clinicians to reduce their interaction time with patients and informal caregivers. complimentary methods must be developed to provide needed information and support to caregivers. the proposed research will measure and explain the impact of two computer-based support systems that meet caregiver needs and facilitate information exchange with clinicians. the system, chess (comprehensive health enhancement support system) is a non-commercial computer system that provides patients with disease specific information, emotional support and skill building tools. in the expanded form to be tested in this study, chess with caregiver support (cgchess) will also provide the caregiver with more information, support and skills training related to palliative care. cgchess will be further enhanced to communicate essential patient and caregiver information to clinicians prior to a scheduled clinic visit and when patient symptoms exceed a threshold. the investigators' primary hypothesis is that cgchess + clinician report (cr) will reduce caregiver burden more than cgchess because of the additional support caregivers and patients receive from clinicians who have access to the chess clinician report. secondary analyses will study the mechanisms of the chess effect. specifically the investigators anticipate that the chess effect on caregivers will be mediated by the chess effect on interaction patterns with clinicians, satisfaction with clinical visits and by the chess effect on four patient outcomes (quality of life, negative affect, average severity of nine common late-stage cancers).


Eligibility criteria:
inclusion criteria: * metastatic breast or prostate cancer patients and their primary caregivers exclusion criteria: * cannot be homeless
efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes failing on oads

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in north america. the aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on oads (oral anti-diabetic drugs).


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus for at least 12 months * hba1c between 7.5-14.5% (inclusive) at screening * insulin naïve * an antidiabetic regimen that has been stable for at least 3 months prior to screening * an antidiabetic regimen that includes a minimum of 2 oads exclusion criteria: * use of any insulin preparations within the past 6 months * active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening