Kornimate/medical-research-clean huggingface dataset:
a study to compare capsule and tablet forms of mdv3100 (enzalutamide) after administration of a single set dose under fasted conditions in healthy male subjects

Conditions: Healthy Subjects; Castration Resistant Prostate Cancer (CRPC); Relative Bioavailability; MDV3100

Summary: a study to evaluate the bioavailability (ba) of a single oral dose of mdv3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolerability of oral formulations. subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up to day 50. they return to the clinic for an end of study visit (esv) 7-10 days after the last pharmacokinetic (pk) sampling or after early withdrawal.


Eligibility criteria:
inclusion criteria: * the subject has a body mass index (bmi) range of 18.5 - 29.9 kg/m2, inclusive. the subject weighs at least 50 kg (screening). * male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 3 months after final study drug administration. * male subject must not donate sperm starting at screening and throughout the study period and for at least 3 months after final study drug administration. exclusion criteria: * known or suspected hypersensitivity to enzalutamide, or any components of the formulation used. * confirmed cyp2c8 poor metabolizer status based on genotyping analysis. * any history of seizure including a febrile seizure in childhood, loss of consciousness, transient ischemic attack, or any condition that may pre-dispose to seizure. * the subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check in. * use of grapefruit or marmalade in the week prior to admission to the clinical unit, as reported by the subject. * any significant blood loss, donated one unit (450 ml) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on day -1.

Keywords: phase i enzalutamide relative bioavailability of mdv3100 immediate release oral formulation xtandi
utility of postoperative bracing

Conditions: Postoperative Bracing for Spinal Deformity

Summary: the study is being done to assess if the use of bracing helps improve quality of life of patients that are undergoing a spinal fusion for deformity. if the participant agrees to be in this trial they will be randomly assigned (like the flip of a coin) to receive either brace treatment or non-brace treatment. regardless of what treatment group the participants are in, they will undergo surgery as planned. after surgery, patients in both groups will be treated per standard of care.


Eligibility criteria:
inclusion criteria: * the principal investigator's new or returning patients * adults 18 to 80 years of old * undergoing a spinal fusion procedure of greater than or equal to 5 levels for the purpose of correcting idiopathic spinal deformity exclusion criteria: * patients who are undergoing a spinal fusion for other reasons besides deformity * patients who are unable to provide consent or fill out survey questionnaires * patients who have brace-prohibitive body habitus * patients who are unable to obtain standing ap and lateral 3-foot standing scoliosis x-rays

Keywords: thoracolumbosacral (tlso) brace lumbosacral orthotic (lso) brace adult spinal deformity postoperative brace
screening and linkage to services for autism

Conditions: Autism Spectrum Disorders

Summary: the salsa (screening and linkage to services for autism) study will test whether patient navigation can help disadvantaged families obtain earlier diagnosis and treatment for their children who have had a positive screening test for autism spectrum disorder. half of the families will be offered help from an autism patient navigator. the other half will receive standard care.

despite its relatively high rate of occurrence, autism spectrum disorder (asd) is under-diagnosed and under-treated in young children, particularly in minority and disadvantaged populations. although screening for asd in the primary care setting is recommended as best practice, inadequate attention has been paid to addressing important obstacles to early recognition of asd, including barriers to referral after positive screening, completion of diagnostic evaluations, and receipt of treatment. patient navigation was originally developed to reduce health care disparities. the patient navigator guides patients with suspicious findings (e.g., a positive screening test) through and around barriers to care to ensure timely diagnosis and treatment. patient navigation has improved receipt of preventive care among low-income, minority children but has not been tested for improving early identification and treatment of autism spectrum disorders. the goal of this study is to test the effectiveness and feasibility of patient navigation to facilitate autism screening follow-up, diagnostic evaluation, and linkage to early intervention in a very young, disadvantaged, minority population. to increase patient navigation's potential for widespread application and public health impact, this study uses the reach, effectiveness, adoption, implementation and maintenance (re-aim) framework, a set of criteria for translating research into action, to guide planning and evaluation. the intervention's reach, effectiveness, adoption, implementation and maintenance over time will be examined.

Eligibility criteria:
inclusion criteria: * receives medical care at denver community health services (dchs) clinic * positive m-chat screening test (score 3 or higher) between ages 16 and 30 months at dchs * resident of city and county of denver exclusion criteria: * existing diagnosis of autism spectrum disorder * sibling of enrolled subject

Keywords: patient navigation health disparities coordination of services early intervention (education) health services accessibility patient advocacy
a study evaluating the efficacy and safety of sildenafil in patients with erectile dysfunction receiving hemodialysis

Conditions: Erectile Disfunction; Hemodialysis

Summary: the study was done to evaluate the efficacy, safety, and tolerability of orally administered sildenafil taken as needed about one hour before sexual activity after a 10-week period in male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.


Eligibility criteria:
inclusion criteria: * included patients had been in a stable relationship with a female partner for at least 6 months * a diagnosis of renal failure, with creatinine clearance ≤10 ml/min; been under hemodialysis for at least 6 months prior to the screening period, and a clinical diagnosis of erectile dysfunction (ed) as confirmed by international index of erectile function (iief-5) score of \<21 and defined as an "incapacity to obtain and/or maintain an erection sufficient for a satisfactory sexual performance". exclusion criteria: * patients in regular use of nitrates or nitric oxide donor drugs, or have received a prescription to use these substances in any formulation * patients with genital anatomic malformation that may significantly impair erection (e.g., serious penile fibrosis) * patients with other sexual disorders (e.g., hypoactive sexual desire) considered as a primary diagnosis, with a coexisting ed diagnosis, including patients receiving anti-androgenic therapy whose libido has not been preserved; patients receiving hormonal replacement therapy for at least 6 months, or whose dose has not been stabilized within the last 6 months before the study screening period * patients with diabetes mellitus presenting poor control of their diabetes and/or proliferate diabetes retinopathy.
prevention of leg cramps using compression stockings or magnesium supplements in the age group of 50 to 84

Conditions: Muscle Cramp; Stockings, Compression; Magnesium

Summary: leg cramps are painful sensations of tightening in the muscles of the legs, that are often associated with secondary insomnia. they are common especially at an older age. there is no evidence that any method of prevention of nocturnal leg cramps would be both safe and effective. there are no previous trials concerning cramp prevention by using compression stockings. the objective of this study is to assess in a prospective randomised controlled trial whether leg cramps can be prevented by daily use of knee-length compression stockings or magnesium supplements.

leg cramps are painful sensations of tightening in the muscles of the legs that commonly appear during the night and are often associated with secondary insomnia. they are common especially in older age. there is no evidence that any method of prevention of nocturnal leg cramps is both safe and effective. there are no previous trials concerning cramp prevention by using compression stockings. the objective of this study is to assess in a prospective randomised controlled trial whether leg cramps can be prevented by the daily use of knee-length compression stockings or magnesium supplements. methods the study will be set in finland, and 50-84-year-old volunteers will be recruited through google ads, the finnish health library and finnish primary health care centres. the participants must have a minimum of two episodes of leg cramps per week for the past four weeks to be included in the study. the participants (n = 225) will be allocated to three equal groups: the compression stocking arm, the magnesium supplement arm and the placebo arm. the participants will go through four weeks of follow-up without intervention, and then another four weeks of follow-up with the assigned intervention. the material for the study will be collected through electronic questionnaires. discussion this protocol describes a study that compares compression stockings, magnesium supplements and placebo for the prevention of leg cramps. the results of this study can significantly improve knowledge on the methods of preventing leg cramps.

Eligibility criteria:
inclusion criteria: * minimum of two leg cramps per week in the past four weeks. * age from 50 to 84 years. exclusion criteria: * peripheral artery disease (confirmed or suspected). * peripheral artery bypass surgery. * grave peripheral neuropathy or any sensory disorder. * allergy to the material of the compression stockings. * grave renal failure (gfr under 30 ml/min). * the use of a magnesium carbonate product (e.g. rennie® or berocca®). * cardiac failure with pulmonary oedema or massive lower limb swelling. * lower limb soft tissue problems, including skin transplant, thinned skin, varicose ulcer, necrosis and any infection. * lower limb deformity or atypical shape or size that could prevent the usage of compression stockings. * continuous usage of compression stockings for any other reason than leg cramps.
a clinical study to evaluate the safety and effectiveness of an investigational product called ct gel

Conditions: Acne Vulgaris; Acne

Summary: the purpose of this study is to demonstrate the safety and effectiveness of ct gel in subjects with acne vulgaris. the hypothesis is that ct gel is superior to clindamycin gel, tretinoin gel and vehicle gel for the treatment of acne vulgaris.

ct gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

Eligibility criteria:
inclusion criteria: * male or female 12 years of age or older in good general health * investigator's static global assessment (isga) score of 2 or greater at baseline exclusion criteria: * any nodulo-cystic lesions at baseline * pregnancy or breast feeding * history or presence of regional enteritis or inflammatory bowel disease or similar symptoms. * treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start. * use of topical anti-acne medications within the past 2 weeks. * use of topical or systemic antibiotics on the face within the past 2 weeks. * use of topical or systemic corticosteroids within the past 2 weeks. * use of systemic retinoids within the past 3 months. * use of astringents, toners and skin cleansers for less than 2 weeks prior to the start of the study. * concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids. * concomitant use of mega-doses of certain vitamins, such as vitamin d (\>2000iu qd) vitamin b12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital. * facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study. * concomitant use of tanning booths or sunbathing. * known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, retinoids or excipients of the study product * a significant medical history of or are currently immunocompromised * current drug or alcohol abuse. (drug screening not required.) * use of any investigational therapy within 4 weeks of enrollment. * any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Keywords: acne vulgaris acne
evaluation of a medical food for chronic wounds

Conditions: Foot Ulcer, Diabetic

Summary: the study objective is to compare outcomes in subjects with a diabetic foot ulcer after 16 weeks of consuming a medical food versus a calorically similar control drink.


Eligibility criteria:
inclusion criteria: * non-pregnant * diabetic * neuropathic foot ulcer * abi\> 0.7 exclusion criteria: * uncontrolled dm * collagen vascular disease or autoimmune disease * wound infection; recent therapies with steroids * growth factor or bioengineered tissue * radiation therapy * treatment with antibiotics within 1 week, charcot's arthropathy of the foot * active malignancy * renal function impairment * liver failure * planned surgery * myocardial infarction within 3 months * malnutrition * substance abuse * taking conflicting oral nutritional supplements
sorafenib vs tace in hcc patients with portal vein invasion

Conditions: Hepatocellular Carcinoma

Summary: the investigators are going to compare the therapeutic effect of sorafenib and transarterial chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein invasion.

tace is an established therapy for patients with unresectable hepatocellular carcinoma (hcc) and has been shown to significantly improve survival in these patients compared to no treatment. moreover, tace can be performed safely and may improve the overall survival of patients with hcc and major branch of portal vein invasion. sorafenib, already approved for hcc, could lead to significantly improvement in tumor control and survival in patients with advanced stage hcc. so far there are no head to head comparison reports about the efficacy of sorafenib and tace. here the investigators evaluate the efficacy of sorafenib and tace in advanced hcc with major branch of portal vein invasion.

Eligibility criteria:
inclusion criteria: 1. 80 \> age \>= 18 years. 2. child-pugh class a (class b could be included when childs score is 7). 3. hepatocellular carcinoma with major branch of portal vein invasion on dynamic ct or mri * not only newly diagnosed treatment-naive patients, * but also hcc patients previously treated with other therapies in case of development of major branch of portal vein invasion 4. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: * white blood cell counts (wbc) \>= 2,000 /μl, absolute neutrophil count (anc) \> 1,200/μl * hemoglobin \>= 8.0 g/dl * platelet count \> 50,000/μl * serum creatinine \< 1.7 mg/dl * total bilirubin =\< 3.0 mg/dl * prothrombin time (pt)-international normalized ratio (inr) =\< 2.3 or prothrombin time (pt)-sec =\< 6 sec 5. eastern cooperative oncology group (ecog) performance status of 0-2. exclusion criteria: 1. child-pugh score \>= 8. 2. age \ = 80 years. 3. ecog performance status \>= 3. 4. recipient of living donor or deceased donor liver transplantation 5. patients unable to understand the contents of informed consent or refuse to sign the informed consent. 6. patients with evidence of uncontrolled or severe medical conditions requiring treatment.
effect of ultrasound combined with microbubbles on blood perfusion in invasive breast cancer

Conditions: Invasive Breast Cancer; Cavitation; Perfusion

Summary: blood perfusion insufficiency and hypoxia are the main causes of drug resistance to chemotherapy in breast cancer. increasing blood perfusion can improve drug delivery. the cavitation effect of ultrasound-stimulated microbubbles (usmbs) is known to enhance tumor blood perfusion, so we conducted a prospective human study to investigate the effects of usmbs on hemoperfusion in invasive breast cancer (ibc).

patients with ibc were selected from the breast surgery department of our hospital. to induce an enhanced perfusion effect, ibc tumors were treated with sonovue® microbubbles (mbs) stimulated by ultrasound, with a mechanical index (mi) of 0.2-0.3; 1 ml of sonovue® mbs were injected at 3.5-min intervals three times for a usmb treatment lasting 10 min. the contrast-enhanced ultrasound (ceus) parameters peak intensity (pi), area under the curve (auc), and perfusion area were used to evaluate the changes in blood perfusion.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of invasive breast cancer * patients scheduled to undergo surgical resection * maximum lesion diameter \< 4 cm * age over 18 years exclusion criteria: * patients with allergies to sonovue® * patients with severe cardiopulmonary insufficiency, * patients who had already received neoadjuvant chemotherapy * pregnant women * individuals with mental illness * patients who refused to participate in the study

Keywords: contrast-enhanced ultrasound ultrasound combined with microbubbles invasive ductal carcinoma of breast
aorta calcium scoring

Conditions: Cardiovascular Diseases

Summary: calcium scoring of the coronary arteries is use as a predictor of coronary stenosis. the aim of this study is to measure the calcium scoring of the abdominal aorta using an helicoidal fast scan and to correlate this measurement with classical cardiovascular risk factors and newer parameters reflecting vascular rigidity, like pulse velocity measurement.


Eligibility criteria:
inclusion criteria : * patients with at least one cardiovascular risk factor * ambulatory or hospitalized patients exclusion criteria : * significant cardiovascular complications

Keywords: calcium scoring/aorta/ cardiovascular risk factor/scann patients with at least one cardiovascular risk factor
classification of periodontitis revisited: a cluster analysis

Conditions: Periodontitis

Summary: this study aims to identify phenotypic groups of patients with periodontitis by applying a cluster analysis.

this is a retrospective cross-sectional study based on a prospectively maintained database of consecutive patients attending the departement of periodontology at the rothschild hospital. a cluster analysis will help to distinguish clinical and microbiological profils of periodontal patients.

Eligibility criteria:
inclusion criteria: * patients with periodontitis either aggressive or chronic exclusion criteria: * patients who had received periodontal therapies or antimicrobial therapy within the 6 months preceding the examination

Keywords: periodontitis classification cluster analysis
a study on bioequivalence of cabergoline tablets in human body

Conditions: Hyperprolactinemia

Summary: the purpose of this study is to evaluate the bioequivalence of the test formulation and reference formulation of cabergoline tablets in healthy chinese subjects under fasting and postprandial conditions.


Eligibility criteria:
inclusion criteria: * healthy subjects aged 18-45 years (including boundary values), male or female; * body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg; * normal results of physical examination, vital signs, laboratory tests, 12 lead-ecg, chest x-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above. exclusion criteria: * received camergoline treatment within the past six months; those who have a history of allergy to carergoline or any drug component; those who have had a history of allergy to two or more drugs, foods, etc. * those who currently have the following clinically significant diseases, including but not limited to peripheral vascular lesions, orthostatic hypotension, valvular heart disease, fibrous lesions, severe peptic ulcers and other diseases, or have a previous history of related diseases; or those with other related diseases of the respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, mental and nervous system, otorhinolaryngology, etc., which have been judged by researchers as having clinical significance;