Kornimate/medical-research-clean huggingface dataset:
study to evaluate the therapeutic action of tamsulosin and finasteride in symptomatic benign prostatic hyperplasia (bph) patients

Conditions: Prostatic Hyperplasia

Summary: study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic bph patients, two medications indicated in bph belonging to two different pharmacological classes, as evaluated from the point of view of patient's perception of his pathological condition and of the impact of the disease on general health and quality of life


Eligibility criteria:
inclusion criteria: * male out-patients aged 50-80 years * ipss \>= 13 at visit 1 * qmax: 4-15 ml/sec at visit 2 * residue urinary volume \> 400 ml as evaluated by ultrasonography * spi \>= 7 at visit 2 * prostate specific antigen (psa) value \< 3 ng/ml at visit 1, or of 3-10 ng/ml provided that prostate cancer is ruled out on the basis of the usual diagnostic procedures performed at each centre * written informed consent exclusion criteria: patients with known history or diagnosis at the time of the screening visit of the following conditions that could influence the end-points of the study: * urological disturbances * medical history of pelvic surgery; palpable bladder at the physical examination, or residue urinary volume \> 400 ml; known neurological bladder disorder, bladder neck stenosis, urethral stricture, bladder or prostatic cancer, bladder stone, severe diverticulum of the bladder, symptomatic urinary tract infection during the last month, or recurrent urinary tract infections (more than 2 during the last year); hematuria of unknown origin; diseases that may affect micturition (e.g. diabetes mellitus) * cardiovascular diseases - the following cardiovascular diseases if occurred in the last 6 months: * myocardial infarction * unstable angina * clinically significant ventricular arrhythmias * heart failure (nyha classes iii/iv) * orthostatic hypotension * cerebral stroke * neurological diseases * such as senile dementia, multiple sclerosis, parkinson's disease, psychiatric disturbances, if their severity could have prevented the correct performance of the trial * hepatic or renal insufficiency * (biochemistry values 15% outside normal laboratory ranges and regarded as clinically relevant by investigator) * clinically significant abnormalities in the results of hematologic and biochemical tests performed on blood samples drawn at the screening visit * patients who are taking or have been taking α-blockers for bph or for hypertension or phytotherapy for bph in the previous 6 weeks * patients who are taking or have been taking finasteride in the last 6 months * patients who require concomitant drugs which could influence the pharmacodynamic or pharmacokinetic properties of tamsulosin. in particular: alpha-blockers and mixed alpha-beta blockers, alpha- agonists, anti-cholinergics * patient who are or have been taking part in a clinical study in the previous 3 months * patients who have hypersensitivity or allergic reactions to previously prescribed alpha-blocker(s) or to finasteride * patients judged by the investigator to be inappropriate for inclusion in the study
incision and drainage versus needle aspiration in soft tissue abscesses

Conditions: Abscess; Cellulitis

Summary: the incidence of skin and soft tissue infections has increased dramatically over the last decade, in part due to increased prevalence of community-acquired methicillin-resistant staphylococcus aureus (ca-mrsa). incision and drainage (i\&d) is considered the primary intervention, however some clinicians prefer ultrasound guided needle aspiration (us asp). the investigators performed a randomized trial comparing us asp to i\&d for uncomplicated skin and soft tissue abscesses, with a subgroup analysis of patients with ca-mrsa.


Eligibility criteria:
inclusion criteria: * presenting to emergency department with skin abscess * abscess required surgical drainage * healthy appearing exclusion criteria: * pregnant * unable to give consent * abscess located in oral cavity * abscess located on genitalia * abscess located intra-gluteal at coccyx

Keywords: abscess infection ultrasound guidance incision and drainage needle aspiration skin ultrasound
efficacy of metronidazole versus metronidazole and rifampin in cdad treatment

Conditions: Clostridium Enterocolitis; Antibiotic-Associated Diarrhea; Pseudomembranous Colitis; Pseudomembranous Enterocolitis; Pseudomembranous Enteritis

Summary: what is the difference between the use of one drug (oral metronidazole) versus the use of this same drug combined with another drug (rifampin) in treatment of bacteria and infection-associated diarrhea in patients? this infection is an important cause of morbidity and mortality in both the community and hospitals, and the leading cause of hospital and chronic facility-acquired diarrhea. research is important for the treatment of this infection. patient care with use of two medication treatment regimens will be studied.

clostridium difficile infection contributes to both community and hospital acquired morbidity and mortality. metronidazole alone is usually considered the drug of choice, however, frequent relapses occur at a rate of 10-40%. the purpose of this study is to address the use of a combined drug regimen treatment (metronidazole and rifampin) for the treatment of cdad. these drugs used together have been successful. objectives are to determine the time (days) to resolution of symptoms in each treatment arm; to measure clinical relapse rates; and to assess adverse reactions related to treatment.

Eligibility criteria:
inclusion criteria: * inpatients + outpatients diagnosed with cdad based on shea definition \[laboratory confirmation for presence of c.difficile toxin using enzyme immunoassay and no other etiology for diarrhea + presence of 1 or more of the following: diarrhea (6 watery stool over 36 hours or 3 unformed stools in 24 hours for at least 2days), pseudomembranes at endoscopy\]. exclusion criteria: * age \< 14 yr * known hypersensitivity to metronidazole, rifampin * receiving medication(s) with potential significant drug interaction with rifampin * active liver disease as indicated by alt \> 200 u/l * adynamic ileus * toxic megacolon * pregnancy

Keywords: antibiotic associated diarrhea c. difficile metronidazole rifampin
proton radiation therapy registry

Conditions: Cancer, Therapy-Related

Summary: the johns hopkins proton therapy center is establishing a registry to capture the full 3d radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. the goal is to have all patients treated at the proton center to be included in the registry to enable future comparisons of treatment outcomes to assist in understanding which patients can benefit from the use of protons.

proton based radiation therapy has considerable dosimetric advantages over the standard photon based radiation therapy, with a significantly higher cost. the clinical advantages, however, may not be realized for all patient populations, even with the improved dose distributions. establishing the clinical efficacy of proton therapy requires years of experience treating patients. the goal is to accelerate the knowledge gain through the use of the registry that allows for detailed information to be captured and is inclusive of every patient treated.

Eligibility criteria:
inclusion criteria: * all patients treated at the proton center. exclusion criteria: * any other than what is supplied in the inclusion criteria

Keywords: proton therapy
open label randomized clinical study to promote a healthy lifestyle in medical students

Conditions: Healthy; Obesity; Nutrition, Healthy; Vitamin D Deficiency

Summary: the main medical and social purpose of the project "it's trendy to be healthy!" is the promotion of healthy lifestyles and healthy eating among student youth. the relevance of this project is beyond doubt, as the who called obesity a non-communicable epidemic, and according to research by the jane schiller university of germany (germany), as mentioned above, ukraine topped the list of the countries with high mortality due to malnutrition


Eligibility criteria:
inclusion criteria: * medical students aged between 18-25 years; * presence of presence of vitamin d deficiency or insuficiency (serum total vit d3 level less than ); * signed informed consent. exclusion criteria: * regular intake of probiotics, prebiotics, antibiotics, anticonvulsants, calcium and vit. d supplements for 3 months prior the inclusion; * previously diagnosed allergy to gut microbiota-based therapy; gastrointestinal disorders including food allergy, gluten-sensitive enteropathy, ulcerative colitis; * suffering from any psychiatric illness; presence of diabetes mellitus, chronic cardiovascular or respiratory disease, an active malignant tumor or chronic infections; participation in another clinical trial; * pregnancy or lactation; * any condition thought to be associated with poor compliance (e.g., alcoholism or drug addiction) or any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results.

Keywords: gut microbiota vitamin d personalized nutrition lifestyle in students synbiotic depression
biliary or digestive protection by room air interposition for thermal ablation of central hepatic tumors

Conditions: Radiology, Interventional; Liver Neoplasm; Carcinoma, Hepatocellular (RENI); Neoplasm Metastasis; Ablation Techniques; Radiofrequency Ablation; Microwaves

Summary: this study aims to analyse retrospectively the feasibility, the safety, and the efficiency, of biliary or digestive protection with room air interposition for thermal ablation of central liver tumors with high iatrogenic risk. thermal ablation is a mini-invasive and curative treatement of liver tumors. however, it requires to be carefull about surrunding organs, such as digestive structures or central biliary tree, which can be injured if not insulated. the technique of gas interposition to protect adjacent gut is already known and validated with carbonic gas. nevertheless, resorption of this gas is very fast, making its use tricky to keep a correct insulation during the whole thermal ablation process. room air interposition is easy to use and can offer a slow resorption speed. furthermore no datas are available concerning the use of room air whatever the organ protected, and the protection of central biliary tree whatever the gas used.


Eligibility criteria:
inclusion criteria : * patients with single malignant primary or secondary liver tumor * thermal ablation area located within 1 centimeter from central biliary tree or gut * thermal insulation using room air interposition * follow-up of at least 2 months
perioperative multimodal analgesia protocol for supratentorial craniotomy

Conditions: Postoperative Pain; Analgesia; Supratentorial Brain Tumor

Summary: supratentorial craniotomy is one of the most common neurosurgical procedures, with severe perioperative pain. inadequate perioperative pain relief has been associated with increased blood pressure and intracranial pressure, favoring bleeding and cerebral cerebral hypoperfusion. the ideal analgesia for neurosurgery requires complete pain relief, eliminates the side effects of opioid drugs and no influence for neurological function. previous studies have proposed a multimodal analgesic strategy, combining analgesics and local anaesthesia, it is expected to achieve the above benefits.

the trial has been designed to analyze the efficacy of local analgesic techniques and dexmedetomidine in the treatment of postoperative acute pain in craniotomy. this randomized clinical trial aims to enroll 2000 patients, which will be randomized to one of 4 groups.

Eligibility criteria:
inclusion criteria: * aged from 18 to 65 years * american society of anesthesiologists physical status i to iii * scheduled to undergo elective supratentorial tumor resection exclusion criteria: * incision-area skin infection * a history of previous craniotomy * allergy to study medications * a history of preoperative change in consciousness or cognitive function * severe hepatic or renal dysfunction * severe bradycardia (heart rate\<40 beats/min) * sick sinus syndrome or second- to-third degree atrioventricular block

Keywords: multimodal analgesia postoperative acute pain
prognostic value of ctc in hnscc patients

Conditions: Recurrence; Metastasis; Death

Summary: we hypothesized that the number of circulating tumor cells (ctcs) and molecular markers on ctcs could be a prognostic factor or predictive factor to patients with head neck cancer.

1. histologically or cytopathologically proven head and neck squamous cell carcinoma (hnscc) 2. disease status: locally advanced or recurrent/metastasized at initial presentation 3. age \>=20 years old 4. could understand and signed the informed consents of this study 5. enrolled patients were classified into three distinct subgroups: 1. patients underwent curative surgery followed by adjuvant chemoradiotherapy (crt) because of some pathologic features such as positive margin, pathologic n2, and extracapsular spread (ecs) of involved lymph nodes indicating early relapse according to recommendation from national comprehensive cancer network(nccn) guidelines; 2. patients with advanced disease directly underwent definitive concurrent chemoradiotherapy(ccrt); 3. patients were to have palliative chemotherapy for existence of distant metastasis or poor general condition for definitive ccrt. 6. blood samples were collected within 7 days before the first dose of chemotherapy.

Eligibility criteria:
inclusion criteria: * histologically or cytopathologically proven head and neck squamous cell carcinoma age ≥ 20 years. measurable or evaluable disease according to response evaluation criteria in solid tumors(recist) criteria. ability to sign informed consent. exclusion criteria: * prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers. inability to comply with study and/or follow-up procedures.

Keywords: circulating tumor cells head and neck cancer squamous cell carcinoma survival prognosis
conventional platelet-rich plasma versus concentrated bone marrow stem cell injections for osteoarthritis of the knee

Conditions: Osteo Arthritis Knee

Summary: previous clinical trials have demonstrated the human body's own healing and regenerative cells can relieve the pain of arthritis. bone marrow contains stem cells which can change into cells of various different tissue types, while platelet rich plasma contains growth factors. both techniques have been shown to relieve pain and with this study the investigators wish to compare the two treatments.

participants will be randomized into two groups. concentrated bone marrow aspirate (bmac) or platelet-rich plasma (prp). bmac subjects will have bone marrow aspirated from the subjects iliac crests and the cellular rich portion will be concentrated and subsequently injected into the subjects' symptomatic knee. bmac patients will also have a venous whole blood drawn from the antecubital vein to simulate a prp procedure. prp subjects will have the same venous blood draw from the antecubital vein with subsequent platelet concentration. the resulting prp will be injected into the symptomatic knee. prp subjects will also undergo a bone marrow aspiration from the iliac crest to simulate the bmac procedure. follow-up at 1 week, 6 weeks, 6 months, and 12 months after injection, with repeat radiographs at 12 months.

Eligibility criteria:
inclusion criteria: * subjects must have bilateral oa and pain in one knee. * osteoarthritis may be primary or secondary. knees must have kellgren-lawrence grades 1-3. * subjects must have previously tried 6 weeks of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory, or injection therapy. * patients must be able to provide written informed consent after the nature of the study is fully explained. exclusion criteria: * patients with abnormal hematology, serum chemistry, or screening laboratory results. * patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit. * patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry. * patients receiving injections to the treated knee within 3 months prior to study entry. * patients who are pregnant or currently breast-feeding. * patients with systemic, rheumatic, or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, charcot's knee joint, villonodular synovitis, and synovial chondromatosis. * patients with ongoing known infectious disease. * patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, or cancer. * patients participating in a study of an experimental drug or medical device within 30 days of study entry.

Keywords: platelet rich plasma bone marrow stem cell
increasing exercise adherence after percutaneous coronary intervention with the fitbit charge hr device

Conditions: Acute Coronary Syndrome

Summary: design: single center, prospective, randomized study that will compare activity levels in patients who complete cardiac rehabilitation after clinically indicated percutaneous coronary intervention with and without use of the wrist-worn fitbit charge hr device and mobile platform application. primary endpoint: the average number of steps taken per day will serve as the main marker of daily physical activity. control: patients who do not receive the device (fitbit charge hr). secondary endpoints: (1) change in daily energy expenditure (2) change in number of activity and sedentary bouts (3) change in sleep efficiency (4) change in weekly time of moderate/vigorous physical activity (5) change in quality of life (6) change in indicators of depression (7) change in medication adherence(8) change in hdl and ldl cholesterol (9) change in bmi and waist circumference (10) change in resting heart rate and blood pressure (11) change in exercise stress test performance (timeframe for all: baseline - 12 weeks)


Eligibility criteria:
inclusion criteria: * age 18 years or greater * willing and able to give informed consent * successful, clinically-indicated pci with no plan for staged procedure * clinically stable and able to exercise * access to smartphone (apple or android platform) * completed 10 weeks of cr and is expected to graduate program. exclusion criteria: * plan for pci or other major surgical procedure, which would limit exercise capability, within the 14 weeks following study enrollment. * home oxygen requirement * amputation, peripheral arterial disease, other musculoskeletal or neurological disease affecting mobility * end-stage renal disease * ongoing unstable angina or ccs iv angina * nyha iv heart failure * terminal illness * dementia * fall risk (inability to hold semi-tandem stance for 10 seconds) * pregnant women and prisoners * any other criteria that in the opinion of the investigator would preclude patient participation in the study and/or impact exercise capability.

Keywords: percutaneous transluminal coronary intervention cardiac rehabilitation fitbit charge hr
confidence registry

Conditions: Breast Abnormality Diagnosis

Summary: this registry has been designed to obtain real-life, post-market data on the use of the imagio breast imaging system. this registry is sponsored by seno medical instruments, inc., the manufacturer of the device.

this is a prospective, controlled, multi-center, observational international registry designed to evaluate the imagio breast imaging system. the registry will be conducted at up to 12 international centers. investigators will use imagio us (ius) and/or imagio oa/us imaging per standard of care, anddata will be collected accordingly. additional imaging and biopsy/surgery will be conducted per standard of care to reach a final diagnosis.

Eligibility criteria:
inclusion criteria - subjects must meet all the following criteria to be included in the registry: 1. have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities, 2. are females 18 years of age or older at the time of consent, 3. have been referred for a breast us and are subject to treatment with the imagio breast imaging system. exclusion criteria - aligned with the contraindications on the use of the device, subjects who meet any of the following criteria will be excluded from the registry: 1. are pregnant. 2. have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast. 3. are experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline. 4. are currently undergoing phototherapy. 5. have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus). 6. are undergoing treatment for a photosensitive disease and is experiencing photosensitivity. 7. have previously participated in this registry, 8. are currently enrolled in another investigational study or registry that would directly interfere with the current registry.
acetabular fracture reduction assessment

Conditions: Acetabular Fracture

Summary: it is widely accepted in the literature that quality of acetabular fracture reduction is one of the most important factor for the outcome. to obtain best results, anatomical reduction has to be obtained. intra-operative radiographic assessment depends mainly on plain x-ray. plain x-ray alone is not enough for post-operative assessment as it depends mainly on reduction of the dome with concentricity of the hip.

it is widely accepted in the literature that quality of acetabular fracture reduction is one of the most important factor for the outcome. to obtain best results, anatomical reduction has to be obtained. intra-operative radiographic assessment depends mainly on plain x-ray. plain x-ray alone is not enough for post-operative assessment as it depends mainly on reduction of the dome with concentricity of the hip. complex fractures with multi-fragmentary fracture pattern, impacted fragments (marginal or roof), fractures with osteo-chondral loss and associated head of femur injuries, pose problems with reduction assessment using both plain x-ray and ct due to lack of clear standardized way of assessment. matta criteria has been used widely in the literature for assessment, however it lacks some important criteria which directly related to the functional outcome. few papers in the literature address this problem and reporting some ways for assessment but with lack of testing and reproducibility. since there is in our level 1 trauma center a lot of cases of acetabular fractures that is admitted yearly to our center purpose of our study is to use those methods for our cases in order to test their validity and reproducibility

Eligibility criteria:
inclusion criteria: * isolated displaced acetabular fractures * skeletally mature patients exclusion criteria: * skeletally immature