Kornimate/medical-research-clean huggingface dataset:
the oncological safety and cosmetic outcome of areola sparing mastectomy : a single arm, prospective, cohort study

Conditions: Breast Neoplasms

Summary: to balance the oncological safety and cosmetic outcome is the basic principle of modern breast surgery. to preserve the nipple-areolar complex shows attractive cosmetic advantage but concerns regarding local recurrence make the oncological safety of nipple sparing mastectomy a controversial issue. since the involvement of areolar pigmented skin by cancer is rare compared to that of nipple, we designed the current study to investigate the oncological safety and cosmetic outcome of areola sparing mastectomy.

primary breast cancer originated from areolae is rare. we hypothesized that nipple and areola are two separate anatomy tissue and have different oncological impact on the treatment of breast cancer. areola sparing mastectomy (asm) is a innovative procedure that involves of removal of nipple and preservation of areola the pigmented skin of which would improve the cosmetic outcome of mastectomy and lead to a illusion of congenital crater nipple in some patients.

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive or in situ breast cancer. * ctis-2n0-1m0. * indicated for total mastectomy and desire immediate breast reconstruction. exclusion criteria: * ct3-4 or cn2-n3 breast cancer. * retraction of nipple or areola. * involvement of subcutaneous layer by cancer on ultrasound or mri.

Keywords: breast neoplasms mastectomy, subcutaneous areola
effect of tens for pain and function after total knee replacement

Conditions: Unilateral Primary Osteoarthritis of Knee; Primary Osteoarthritis of Knee Nos

Summary: our primary hypothesis is that tens decreases pain with movement by reducing hyperalgesia. minimizing the severe pain experienced during required activities in the immediate postoperative period will promote functional recovery and prevent the development of new chronic pain syndromes.


Eligibility criteria:
inclusion criteria: * primary osteoarthritis of the knee * speak english * unilateral total knee replacement exclusion criteria: * no ambulation, assisted or otherwise * use of tens by subject in past 5 yrs * current use of tens by someone else in subject's household * stroke or other condition which seriously impairs sensation in legs or ability to follow directions. * condition that precludes use of tens (pacemaker, allergy to nickel, etc.) * chronic pain (other than in surgical knee) that is currently being treated or is severe. (do not exclude for fibromyalgia).

Keywords: knee oa tens total knee replacement knee arthroplasty total unilateral knee replacement
an observational study investigating the safety and effectiveness of repaglinide in chinese patients

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is, under normal clinical practice conditions, to investigate the clinical safety and effectiveness in chinese patients with type 2 diabetes who have never received anti-diabetic treatment before.


Eligibility criteria:
inclusion criteria: * hba1c more than 6.5%, no anti-diabetes treatment accepted before entering the study exclusion criteria: * subjects who received any anti-diabetic treatment previously * known or suspected allergy to trial product(s) or related products. * subjects who previously enrolled in this study. * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
celecoxib in treating patients with relapsed prostate cancer following radiation therapy or radical prostatectomy

Conditions: Prostate Cancer

Summary: rationale: celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. purpose: phase ii trial to study the effectiveness of celecoxib in treating patients who have relapsed prostate cancer following radiation therapy or radical prostatectomy.

objectives: * determine the effect of celecoxib on prostate-specific antigen (psa) levels in patients with prostate cancer in biochemical relapse after prior definitive radiotherapy or radical prostatectomy. * compare the psa doubling times in patients treated with this drug vs historical controls. * compare the psa doubling times in patients treated with this drug vs pretreatment psa values. * determine the time to clinical recurrence in patients treated with this drug. outline: patients receive oral celecoxib twice daily. treatment continues for 5 years in the absence of disease progression. patients may continue treatment beyond 5 years at the discretion of the treating physician. projected accrual: a total of 100 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of clinically localized adenocarcinoma of the prostate * t1 or t2 disease * received prior primary treatment with definitive radiotherapy (at least 5,500 cgy) or radical prostatectomy * biochemical relapse within 5 years after prior primary therapy, defined as 1 of the following: * detectable and rising prostate-specific antigen (psa) after surgery (at least 2 values above the residual cancer detection limit of the assay) * psa at least 2 values above 1 ng/ml or at least 3 rising values at any level after radiotherapy * psa no greater than 10 ng/ml patient characteristics: age * not specified performance status * ecog 0-2 life expectancy * not specified hematopoietic * not specified hepatic * alt no greater than 2.5 times upper limit of normal renal * creatinine normal other * no allergy to cyclooxygenase-2 inhibitors, aspirin, nonsteroidal anti-inflammatory drugs, or sulfa drugs * no untreated peptic ulcer disease prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior chemotherapy endocrine therapy * more than 6 months since prior adjuvant or neoadjuvant hormonal therapy * duration of prior adjuvant or neoadjuvant hormonal therapy must have been no more than 6 months radiotherapy * see disease characteristics * prior salvage radiotherapy after prostatectomy allowed surgery * see disease characteristics

Keywords: recurrent prostate cancer stage i prostate cancer stage ii prostate cancer adenocarcinoma of the prostate
home-based balance training using wii fit after stroke: a feasibility study

Conditions: Stroke

Summary: background: virtual gaming systems offer new possibilities for home-based exercises (hbe) in rehabilitation. pilot studies with stroke patients indicate that the application of nintendo wii® (wii) is practicable and can improve balance under clinical conditions. however, larger trials are necessary to verify these positive effects after discharge from the hospital. aim: this study aims to prepare and optimize a phase iii trial which compares the effects of two hbe programs for stroke patients. methods: a pilot study with randomized control design and repeated measures over three-months will be conducted. twenty elderly stroke patients will be randomly allocated to an experimental group (eg) and a control group (cg). all participants will receive an introduction to a hbe program by an individual mentoring over 6 weeks. during the following 6 weeks the participants perform the hbe on their own. the eg will perform a balance exercise program using the wii, the cg will perform a balance exercise program without technical support. recruiting potential, the participants' acceptance of the intervention and economic aspects will be examined. additionally, basic information about sensitivity of change and potential effect sizes regarding the proposed instruments to measure mobility are expected.


Eligibility criteria:
inclusion criteria: * cerebral infarction * place of residence: halle (saale) and immediate surroundings * television in household * independent ambulatory (functional ambulation classification \> 3) * self-selected walking speed \> 0,4 m/s exclusion criteria: * strong visual impairment despite visual aid * deafness / verbal communication is not possible * distinct mobility limitations due to comorbidity * body weight \>120kg * epilepsy * cardiac pacemaker * acute psychiatric, disease/dementia

Keywords: stroke balance exer-gaming home-based exercises wii postural balance nintendo balance board wii-fit home feasibility
self-induced cognitive trance for chronic pain management

Conditions: Chronic Pain

Summary: the need to find complementary approaches, based on a holistic perspective of the human being, takes on its full meaning in a political context that recommends efficient health programs. self-induced cognitive trance is one of these complementary approaches, which induce a non-ordinary state of consciousness. the aim of this work is to evaluate whether learning self-induced cognitive trance can improve the quality of life of people with chronic pain. participants will participate in two times two days workshop aiming at learning how to self-induce cognitive trance. pain, fatigue, anxiety, depression, attitudes towards pain, and quality of life will be assessed before and after each workshops. two follow-ups at 6 and 12 months afer the last workshop will be caried out were outomes will be assessed. furthmore, questionnaires related to the phenomenology of self-induced cognitive trance will be adeministrered. investigators also proceeded to interveiwes after the second workshop to gather qualitative information.


Eligibility criteria:
inclusion criteria: * french speacking * chronic pain * on stable pharmacological treatment over the last four months exclusion criteria: * psychiatric disorders, * drug addiction * alcoholism

Keywords: self-induced cognitive trance non-ordinary state of consciousness pain quality of life
n-acetyl cysteine in trichotillomania

Conditions: Trichotillomania

Summary: this is a 12-week, double-blind study of n-acetyl cysteine in the treatment of trichotillomania

the goal of the proposed study is to evaluate the efficacy and safety of n-acetyl cysteine (nac) in trichotillomania. forty subjects with dsm-iv trichotillomania will receive 12 weeks of double-blind nac or placebo. the hypothesis to be tested is that nac will be effective and well tolerated in patients with trichotillomania compared to placebo. the proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility criteria:
inclusion criteria: * men and women age 18-65; * current dsm-iv trichotillomania exclusion criteria: * unstable medical illness; * history of seizures; * myocardial infarction within 6 months; * current pregnancy or lactation, or inadequate contraception in women of childbearing potential; * any thoughts of suicide; * lifetime history of dsm-iv bipolar disorder type i, dementia, or schizophrenia or any other dsm-iv psychotic disorder; * previous treatment with n-acetyl cysteine; * treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline; * 9) diagnosis of asthma

Keywords: trichotillomania hair-pulling
registry of patients with hematologic disease and covid-19 in russia

Conditions: Coronavirus Infection and Hematologic Diseases

Summary: this is an observational prospective cohort study to evaluate the clinical course and outcomes of covid-19 and the underlying disease in patients with hematologic disease (malignant or non-malignant).

this is a web-based registry. after registration, physicians from hematology clinical centers and hospitals in russia will receive access to the web platform for clinical trial management to fill in the online data collection form in a de-identified manner. this form includes questions about general clinical history of hematologic disease, manifestation, treatment, and the course of covid-19, concomitant conditions, consequences on the hematologic disease, short-term and long-term outcomes. it will take approximately 10 min to answer the questions. patients will be followed for 30 days after covid-19 diagnosis and up to 6 months for hematologic disease outcomes and overall survival assessment.

Eligibility criteria:
inclusion criteria * age 18 or older * any previously or currently diagnosed hematologic disease * laboratory confirmed or suspected (based on clinical symptoms and/or ct) covid-19 * known outcome of covid-19 in case of retrospective data input (protocol allows retrospective data input for patients who were prospectively followed in local centers) exclusion criteria • loss of follow-up within 30 days after covid-19 diagnosis

Keywords: covid-19 blood diseases leukemia lymphoma
a pilot study to evaluate the use of smart adherence technology to measure lumacaftor/ivacaftor adherence in cf subjects homozygous for the f508del cftr mutation

Conditions: Cystic Fibrosis

Summary: the study will evaluate the impact of smart adherence technology for monitoring on lumacaftor/ivacaftor (lum/iva) adherence rates among subjects 16 years of age and older with cystic fibrosis (cf) who are homozygous for the f508del cystic fibrosis transmembrane conductance regulator (cftr) mutation.


Eligibility criteria:
inclusion criteria: * subject (or his or her legally appointed and authorized representative) will sign and date an informed consent form (icf). * willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures. * confirmed diagnosis of cf and homozygous for the f508del-cftr mutation * forced expiratory volume in one second/forced vital capacity (fev1) ≥40% of predicted normal for age, sex, and height exclusion criteria: * presence of moderate or severe hepatic impairment (child-pugh class b or c) * subjects currently receiving invasive mechanical ventilation * known history of alcohol or drug abuse in the past year * clinically significant abnormal laboratory values during screening * pregnant or nursing females * female subjects and female partners of male subjects who plan to become pregnant during treatment period or within 90 days following the last dose of study drug * history of solid organ or hematological transplantation * ongoing or prior participation in an investigational drug study within 30 days of screening * current use of commercial lum/iva combination therapy
graded exposure in patients with painful diabetic neuropathy

Conditions: Painful Diabetic Neuropathy; Diabetic Neuropathies, Painful; Neuralgia, Diabetic

Summary: objective: to investigate the effects of a cognitive behavioural intervention targeting specific fears in patients with painful diabetic neuropathy, on physical activity and quality of life.

intervention: graded exposure in vivo (gexp) is a second-generation cognitive-behavioural intervention, and is characterized by systematic and repeated exposure to feared movements, activities and/or sensations in order to decrease fear and subsequently increase physical activity. main study parameters/endpoints: the purpose of this project is to develop and test a cognitive behavioural intervention targeting specific fears in patients with pdn, in order to increase physical activity and improve qol.

Eligibility criteria:
inclusion criteria: * patients with type ii diabetes mellitus, * aged \> 18 years who suffer from peripheral polyneuropathy. exclusion criteria: * patients with lower limb morbidities other than pdn such as peripheral arterial disease * severe osteoarthritis, any other neurological disease than pdn or any other disease that may cause pain in the feet and/or damage to the peripheral nervous system (e.g. ulcers).

Keywords: graded exposure quality of life physical activity anxiety
study of the safety, tolerability and pharmacokinetics of 1 mg/eye and 3 mg/eye pegaptanib sodium in patients with exudative age-related macular degeneration (amd)

Conditions: Age-Related Macular Degeneration

Summary: the objectives of this study are to characterize the safety, tolerability and pharmacokinetics of pegaptanib when given as 1 or 3mg/eye intravitreous injections every 6 weeks for 54 weeks in patients with subfoveal choroidal neovascularization (cnv) secondary to amd.


Eligibility criteria:
inclusion criteria: best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye. subfoveal cnv, secondary to amd, w/ a total lesion size \[including blood, scar/atrophy \& neovascularization\] of less than or equal to 12 disc areas, of which at least 50% must be active cnv. patients of either sex, aged greater than or equal to 50 years. exclusion criteria: previous subfoveal thermal laser therapy. any subfoveal scarring or atrophy \& no more than 25% of the total lesion size may be made up of scarring or atrophy. more than one prior pdt w/ visudyne is not permitted. pts may not have rec'd their 1st pdt w/in less than 8 wks or more than 13 wks prior to the bsl angiography/photography for the study.

Keywords: amd macugen pharmacokinetics age-related macular degeneration pk
effects of transcranial direct current stimulation (tdcs) in drug-resistant partial epilepsy

Conditions: Epilepsy

Summary: drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life expectancy itself. only a minority of patients may benefit from a curative epilepsy surgery. neurostimulation, which can be an effective add-on treatment, is currently mainly represented by vagus nervus stimulation. transcranial direct current stimulation, a non -invasive technique already used in other areas of neurology, may be efficient on some partial epilepsies, in particular through the individual configuration of stimulation, made possible by recent technological advances. main goal : to study the effect of transcranial electrical stimulation on the frequency of seizures in patients with drug-resistant partial epilepsy. hypothesis : reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured tdcs session: responders in real tdcs vs placebo stimulation.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 15 years; * patients with drug-partial resistant epilepsy with the following characteristics: * disabling epilepsy despite an optimized pharmacological treatment. * an average of one seizure a day or more during the week preceding the inclusion * focal epilepsy in which epileptogenic zone is documented by paraclinical examinations consistent with clinical data * existence of measurable eeg markers of epilepsy * anti-epileptic drug treatment unmodified during the 2 weeks preceding the inclusion no change to treatment planned during the study. * signed informed consent. exclusion criteria: * patients under 15 years; * patients in which a standard quality eeg recording is not possible * patients with ictal bradycardia or ictal syncope ; * patients with heart disease which may result in heart arrhythmia ; * incapacitated patients (curatorship, guardianship), patients deprived of liberty. * pregnant or lactating women * vagus nervus stimulation is not an exclusion criteria

Keywords: transcranial direct current stimulation
correlation of biomarkers with the presence and severity of coronary artery disease

Conditions: Coronary Artery Disease

Summary: the development of coronary artery disease is multifactorial. peripheral blood biomarkers paly an important role in the prediction of coronary artery disease. however, the identification of those biomarkers and their correlation with the presence and severity of coronary artery disease are unclear. the present study aims to identify the differentially expressed biomarkers from peripheral blood between normal population and patients with different disease burden confirmed by coronary angiography, and to analyze the correlation of those biomarkers with the severity of coronary artery disease. finally, the prediction of biomarkers for clinical events.

this study includes three parts: 1. part 1 (pilot analysis): 30 normal people and 30 patients with at least one epicardial coronary artery disease confirmed by angiography will be included. 10 ml peripheral blood from arterial sheath (just before angiography) will be collected in each subject. proteomics analyses are performed in order to obtain the differentially expressed proteins (coded by proteins 1-x. 2. part 2 (training group): differentially expressed proteins 1-x are measured and compared between patients with diameter stenosis \<70% (n=100) vs. with diameter stenosis ≥ 70%(n=100), respectively. finally, proteins 1-y from proteins 1-x will be identified. subgroups stratified by single-, double-, and triple-vessel disease will be performed. 3. part 3 (validation group): the difference in blood concentration of proteins 1-y between patients with different disease burden will be further analyzed: patients with diameter stenosis \<70% (n=200) vs. diameter stenosis ≥70% (n=200), respectively. subgroups stratified by single-, double-, and triple-vessel disease will be performed.

Eligibility criteria:
inclusion criteria: * for pilot study, both health and patients with at least one epicardial coronary artery disease are included * for both training group and validation group, patients must have at least one epicardial coronary artery disease * left ventricular ejection fraction \> 30% * stable or unstable angina * myocardial infarction older than 1 month * no active inflammation * no scheduled non-cardiac surgery within 12 months * egfr \> 30 ml/min/m2 * patients agree to participate in this study exclusion criteria: * severe liver dysfunction * blood platelet count \<100 x 109/l * cancer * on dialysis * pulmonary hypertension (defined as mean pulmonary arterial pressure \> 25 mmhg and pulmonary vessel resistance \> 3.0 woods unit)

Keywords: biomarkers, coronary artery disease, disease burden, clinical events
oral nutritional supplementation in hospital patients

Conditions: Malnutrition

Summary: the study objective is to evaluate the benefits of oral nutritional supplementation (ons) plus dietary counseling (dc) in newly admitted hospital subjects with moderate or severe malnutrition.

approximately 212 subjects (men and women) from multiple institutions in india will participate in this study. eligible subjects will be randomized into 2 treatment groups. * dietary counseling only (n=106) * dietary counseling + ons (n=106)

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * recently admitted into hospital ≤36 hrs. * identified as having "moderate malnutrition" or "severe malnutrition". * anticipated length of hospital stay of at least 3 days. * life expectancy of ≥ 12 weeks * able to consume foods and beverages orally. * willing to abstain from nutritional supplements throughout the study period unless provided be study. exclusion criteria: * alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, dysphagia, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances. * diabetes, burn injury covering greater than or equal to 15% of the body, advanced renal or hepatic disease, active malignancy. * ascites, pleural effusion, severe edema or dehydration. * severe edema. * medications/ supplements/substances that could profoundly modulate metabolism or weight * active tuberculosis, acute hepatitis b or c, or hiv.