Kornimate/medical-research-clean huggingface dataset:
changes in dna after radiation therapy in patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in dna after radiation therapy and identify biomarkers related to cancer. purpose: this laboratory study is looking at changes in dna after radiation therapy in patients with prostate cancer.

objectives: primary * demonstrate the feasibility of acquiring specimens, both frozen and paraffin-embedded, to yield rna of adequate quality to perform dna microarray studies on markers of radiotherapy outcome in patients with intermediate-risk prostate cancer. secondary * compare the gene expression results from frozen tissue and paraffin-embedded tissue to see the correlation between the 2 methods in patients treated on the brachytherapy alone arm of protocol rtog-0232. * find genes that are expressed differentially before and after radiation therapy in patients treated on the brachytherapy plus external-beam radiation therapy arm of protocol rtog-0232. * find gene expression patterns in patients treated on either arm of protocol rtog-0232 who have significant associations with biochemically as well as clinically apparent local and distant failure. outline: this is a multicenter, pilot study. frozen and paraffin-embedded tissue samples are studied for biomarker/laboratory analysis. dna microarray analysis is performed on the samples to assess markers of radiotherapy outcome. projected accrual: a total of 156 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * histologically confirmed, locally confined adenocarcinoma of the prostate * zubrod performance 0-1 * clinical stages t1c - t2b, n0, m0 * combined gleason score 7 if prostate specific antigen (psa) \< 10, combined gleason score \< 7 if psa 10 - 20; psa must be ≤ 20 ng/ml, before hormone therapy, if given, and a prostate volume by transrectal ultrasound (trus) ≤ 60 cc. * american urological association (aua) score ≤ 15 (alpha blockers are allowed). * age ≥ 18 years old and must sign a study-specific informed consent form exclusion criteria: * no clinically or pathologically involved lymph nodes * no distant metastases or significant obstructive symptoms * no prior chemotherapy, pelvic radiation, transurethral prostatectomy (turp), cryosurgery, tuna, transurethral microwave thermotherapy (tumt) or radical surgery for carcinoma of the prostate is allowed. * no previous hormonal therapy beginning \ 6 months prior to registration is allowed. * no previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless the patient is disease free for ≥ 5 years. * no hip prosthesis or major medical or psychiatric illnesses are allowed. prior to study entry.

Keywords: stage iib prostate cancer stage iia prostate cancer adenocarcinoma of the prostate
effect of number of meals on metabolism after weight loss surgery

Conditions: Morbid Obesity

Summary: the purpose of this study is to determine the effect of meal size and texture on the levels of incretin hormone, glp-1, after gastric bypass surgery (gbp). patterns of food intake change after bariatric surgery and patients often eat multiple small low-calorie meals, a pattern that may affect blood glucose as well as incretin levels. whether the release of glp-1 after an oral challenge or a single liquid meal has any physiological relevance in 'real life' setting of multiple small meals diet is unclear.

the main goal is to study the effect of meal size and texture on incretin levels after gbp. patients will be studied before gbp (t0) and 12-15 months after gbp (t1). at t0 and t1, patients will come for 2 study days for 8 hours: on one study day, a single meal will be served, on the second study day, three small meals, with the order of the conditions randomly assigned. the total amount of calories (600 kcal) and the over all nutrient composition (55% cho, 15 % protein, 30% fat) will be equivalent between conditions. the meals will be either all solid or all liquid. patients enrolled in the study will be randomly assigned to solid or liquid test meals. recruitment and data gathering for this study were performed at st. luke's hospital in new york, ny. data analysis was performed at columbia university medical center in new york, ny.

Eligibility criteria:
inclusion criteria: morbidly obese individuals, bmi above 35 and less than 50 kg/m2 who chose gbp as treatment for their obesity * must be able to attend all study visits at st. luke's roosevelt hospital center in manhattan, new york city * individuals with or without type 2 diabetes mellitus are eligible exclusion criteria: * patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit. * patients with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome. * currently pregnant or nursing. * known cardiovascular disease. * patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection * any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study. * past history of severe food allergy * history of type 1 diabetes mellitus * individuals taking insulin, thiazolidinedione, exenatide, or dpp-iv inhibitors

Keywords: gastric bypass meal texture meal number glp-1 glucose
rct comparing ks versus ts for ovedenture

Conditions: Dental Implant; Dental Implant-Abutment Design; Edentulous Jaw

Summary: to evaluate the clinical and radiographic outcomes of ks implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on ts implants


Eligibility criteria:
inclusion criteria: * any edentulous patient (post-extractive sites must to be healed from at least 3 months), with sufficient bone height and width in the anterior mandible (between canines) to allow the placement of two implants of 3.5 mm diameter of at least 8.5 mm of length. * 18 years or older, and able to sign an informed consent. * smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). * in case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study. exclusion criteria: exclusion criteria * general contraindications to implant surgery. * patients irradiated in the head and neck area. * immunosuppressed or immunocompromised patients. * patients treated or under treatment with intravenous amino-bisphosphonates. * patients with untreated periodontitis. * patients with poor oral hygiene and motivation. * previous guided bone reconstruction at the intended implant sites. * uncontrolled diabetes. * pregnancy or nursing. * substance abuser. * psychiatric problems or unrealistic expectations. * lack of opposite occluding dentition in the area intended for implant placement. * patients with infection and or inflammation in the area intended for implant placement. * patients participating in other studies, if the present protocol cannot be properly adhered to. * patients referred only for implant placement and cannot be followed ant the treating centre. * patients unable to be followed for 5 years.

Keywords: dental implant overdenture implant-abutment connection
safety and efficacy of autologous adipose-derived stem cell transplantation in type 2 diabetics

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics.

diabetes mellitus is of large epidemic proportions worldwide. it is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. the purpose of this phase 1/phase 2 study is to determine whether the intavenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe to and can benefit the disease pathology of patients with type 2 diabetes mellitus (insulin resistance). patients will be observed over 12 months following the procedure, with a 2 week, 1 month and then tri monthly diagnostics and life style questionaires.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of type ii diabetes for at least 2 years * type 2 diabetics on oral hypoglycemic agents and/or insulin * fasting blood sugar of \>200mg% on at least two occasions * willing to keep a weekly diary and undergo observation for 12 months exclusion criteria: * presence of of previous and/or acute diabetic complications such as myocardial infarction, cva or nephropathy

Keywords: diabetes mellitus adipose-derived stem cells adipose stromal vascular fraction autologous hyperglycemia
safety of nintedanib in real world in china

Conditions: Pulmonary Fibrosis

Summary: the main objective of this study is to evaluate the incidence rates of adverse drug reactions (adrs) and fatal adverse events (aes) among idiopathic pulmonary fibrosis (ipf) patients in china who initiate nintedanib during the study period.


Eligibility criteria:
inclusion criteria: * patients who initiate nintedanib during the study period * patients who initiate pirfenidone during the study period * patients who use neither nintedanib nor pirfenidone * patients who were diagnosed with ipf according to the 2011 american thoracic society (ats)/european respiratory society (ers)/japanese respiratory society (jrs)/latin american thoracic society (alat) guidelines in the past 3 months before recruitment * patients who are 40 years old and above when enrolled * patients who are willing to participate in the study and sign the informed consent form
the efficacy and safety of mitizodone phosphate tablets in the treatment of patient with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: this is a phase 2 and 3 adaptive design study for mitizodone phosphate,to find out an optimal dose in phase 2 period and confirm the result an efficacy and safety in phase 3 period.dose-finding will be done after 8 weeks of double-blinded treatment in phase 2 period and will be assessed by both efficacy and safety from 3 dose groups of mitizodone phosphate.the dose be found in phase 2 period will be evaluated on efficacy and safety when compared with placebo in phase 3 period with a duration of 8 weeks treatment.the target subjects are patients with mdd.


Eligibility criteria:
inclusion criteria: * 1.a man or a woman with major depressive disorder(mdd) as the primary diagnosis according to the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria (classification code 296.22、296.23、296.32、296.33) * 2.has a montgomery åsberg depression rating scale (madrs) total score of 26 or greater at screening and baseline visits. * 3.has a clinical global impression - severity of illness (cgi-s) score of 4 or greater at screening and baseline visits. exclusion criteria: * 1.has major depressive disorder with psychotic features according to the dsm-5. * 2.current or history of: bipolar disorder、schizophrenia、anixety disorder、insomnia、any substance abuse or dependence and other psychiatry disorder as defined in the dsm-5. * 3.current or history of a clinically significant neurological disorder (including epilepsy、alzheimer disease, parkinson disease, multiple sclerosis, huntington disease). * 4. has serious body disease such as neurological disorders、cardiacvascular disorders、hepatic disorders、 renal disorders, blood system disorders and endocrine disorders. * 5. current or history of cancer( except basal cell of the skin and preinvasive carcinoma of cervix uteri). * 6. current or history of angle-closure glaucoma. * 7. has made a suicide behavior in the previous 1 year ，or has a score greater than or equal to 4 on item 10 (suicidal thoughts) of madrs . * 8.has taken fluoxetine within 4 weeks prior to initial dosing. * 9. has taken other antidepressive medications or antipsychotic medications within 2 weeks prior to initial dosing. * 10.has psychotherap at screening and/or baseline visits. * 11.has had physiotherapy within 3 months prior to initial dosing. * 12.has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal. * 13.has an alanine aminotransferase, aspartate aminotransferase level greater than 2 times the upper limits of normal；or total bilirubin， direct bilirubin，creatinine level greater than 1.5 times the upper limits of normal；or a thyroid stimulating hormone value outside the normal range. * 14.has an abnormal electrocardiogram confirmed as clinically significant by the investigator. * 15.has a history of severe allergies.
insulin resistance in hcv infection

Conditions: Insulin Resistance

Summary: the study hypothesis is that the means by which hcv induces glucose intolerance is through impairment of b-cell function and compensatory hyperinsulinemia in predisposed latinos with insulin resistance and that hcv eradication improves these abnormalities. it is also hypothesized that moderate alcohol consumption impact insulin sensitivity and secretion with latinos with or without hcv infection.

the study hypothesis is that the means by which hcv induces glucose intolerance is through impairment of b-cell function and compensatory hyperinsulinemia in predisposed latinos with insulin resistance and that hcv eradication improves these abnormalities. this study addresses changes in the metabolic parameters over time. in addition, it is hypothesized that moderate alcohol consumption impacts insulin resistance and secretion and 30 patients with or without hcv who drink alcohol moderately will have discontinuation of alcohol use for 6 weeks and have metabolic testing before and after alcohol discontinuation.

Eligibility criteria:
inclusion criteria for hcv participants: * male or female patients between 18 and 60 years of age * body mass index (bmi) \> 20 kg/m2 * serologic evidence of hepatitis c infection by anti-hcv antibody * detectable plasma hcv-rna * compensated liver disease with the following minimum biochemical parameters: prothrombin time \< 2 seconds prolonged compared to control and bilirubin \< 3 mg/dl * willingness to provide informed consent inclusion criteria for healthy latino volunteers (without hcv infection): -same inclusion criteria as above except no evidence of hcv infection (anti-hcv antibody negative) inclusion criteria for participation in 6-week alcohol abstinence follow-up testing: -latinos who are moderate1 alcohol drinkers (1niaaa definition: female: no more than 3 drinks on any day \& no more than 7 drinks per week; male: no more than 4 drinks on any day and no more than 14 drinks per week). steady-state plasma glucose \< 180 mg/dl exclusion criteria: * hepatitis b or hiv infection * subjects with liver disease other than that caused by hcv * known history of diabetes, or fasting plasma glucose concentration \>126 mg/dl * known history of cirrhosis of the liver, as well as individuals with decompensated liver disease such as those with ascites, variceal bleeding, and encephalopathy * known history of pancreatitis * prior or current treatment for hcv * heavy alcohol use (\>80 g/d) * subjects of lipid lowering agents, steroid/ anabolic therapy * significant medical illness that would interfere with the completion of the study exclusion criteria for healthy (non hcv) latino volunteers: -same as above, including subjects with hcv infection

Keywords: insulin resistance
testosterone for peripheral vascular disease

Conditions: Hypogonadism; Peripheral Vascular Disease; Type 2 Diabetes

Summary: there is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.

testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). peripheral vascular disease is also caused by atherosclerosis. we hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes mellitus. 2. serum testosterone 12 nmol/l or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism. 3. peripheral vascular disease as defined by * previous diagnosis by a specialist vascular surgeon or * abpi less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene). 4. agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study. 5. ability to give written informed consent after verbal and written explanation in the english language. 6. ability to comply with all study requirements. exclusion criteria: 1. current or previous breast cancer. 2. current or previous prostate cancer. 3. raised prostate specific antigen (psa) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion. 4. severe symptoms of benign prostatic hypertrophy ('prostatism') 5. treatment with testosterone in the 3 months prior to the trial. 6. investigational drug treatment in the 3 months prior to the trial.

Keywords: testosterone hypogonadism diabetes pvd rct
nevus doctor clinical decision support for gps

Conditions: Melanoma (Skin); Non-melanoma Skin Cancer; Actinic Keratoses

Summary: the study investigates if a computer-based clinical decision support tool for skin cancer may improve the diagnostic accuracy of general practitioners (gps). the aim of the program is to help gps increase their diagnostic accuracy, in particular regarding the selection of suspicious skin lesions that need biopsy or referral to specialist health care for further assessment. half of the physicians in the trial will have the clinical decision support tool available during consultations, while the other half has no such tool available. we hypothesize that general practitioners using the clinical decision support tool will have a higher number of correct classifications of skin lesions compared to doctors without the tool.

general practitioners (gps) examine patients who attend a primary health care center. in the intervention group the computer-based clinical decision support tool "nevus doctor" in a first step assists doctors in the process of selecting skin lesions that are suggestive of cancer. in the next step a given skin lesion is photographed using a dermatoscope attached to the lens of the camera. the dermatoscopic image is then processed by the computer program "nevus doctor" and a preliminary result is presented. finally the gp reviews the result and assesses the clinical significance of the output by using guidelines presented by "nevus doctor". the patient is subsequently referred to a dermatologist and a complete skin examination is performed. the assessment of the dermatologist serves as the gold standard.

Eligibility criteria:
inclusion criteria: * patients concerned about one or several skin lesion(s) * patients with any other condition if doctor has observed a skin lesion suspicious for skin cancer (incl. actinic keratosis) exclusion criteria: * patients not able to give consent
clinical trial to evaluate the efficacy and safety of the transarterial supraselective embolization of the prostate to treat the urinary symptoms.

Conditions: Transurethral Resection of Prostate; Artery Embolization; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Summary: the purpose of this study is to determine whether the transarterial supraselective embolization (tse) is a technique as effective as transurethral resection of the prostate (turp) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (bph).


Eligibility criteria:
inclusion criteria: * diagnosis of benign prostatic hyperplasia with moderate or severe obstructive lower urinary tract symptoms * refractory to medical treatment for at least 6 months * qmax (maximum urinary flow) less than 10 ml/second exclusion criteria: * patients not candidates for transurethral resection of the prostate (turp) * advanced atherosclerosis and tortuosity of the iliac arteries * no visualization of the prostatic artery ct angiography study * urethral stenosis, detrusor failure or neurogenic bladder * glomerular filtration \< 30 ml/min * presence of malignant tumor * history of allergy to iodinated contrast * patients with any other medical or social condition, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
efficacy and tolerability study of two dose regimens of ctp-543 in adults with alopecia areata

Conditions: Alopecia Areata

Summary: this study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of ctp-543, in adult patients with chronic, moderate to severe alopecia areata.


Eligibility criteria:
inclusion criteria: * definitive diagnosis of alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of screening. total disease duration greater than 10 years is permitted. * at least 50% scalp hair loss, as defined by a severity of alopecia tool (salt) score ≥50, at screening and baseline. * clinical lab results within the normal range exclusion criteria: * active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp. * treatment with systemic immunosuppressive medications or biologics. * vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study