Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety and efficacy of the cytrellis micro-coring device for the treatment of moderate to severe facial wrinkles

Conditions: Wrinkle

Summary: study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles

up to 35 subjects who meet the inclusion/exclusion criteria will be treated. all subjects will be monitored for a period of 90 days post treatment. study results will be assessed with the following: * lemperle scale * investigator gais scale * subject satisfaction scale

Eligibility criteria:
inclusion criteria: * males and females 40-70 years of age * fitzpatrick skin type i to iv as judged by the investigator * cheek areas are at least a score of 3 using the lemperle wrinkle assessment scale as judged by the investigator * able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits. exclusion criteria: * lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated * history of keloid formation or hypertrophic scarring * history of trauma or surgery to the treatment areas in the past 6 months * scar present in the areas to be treated * silicone injections in the areas to be treated * injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, rf devices) * active smokers (0.5 pack/day) or having quit within 3 months prior to treatment * active, chronic, or recurrent infection * history of compromised immune system or currently being treated with immunosuppressive agents * history of sensitivity to analgesic agents, aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine * excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment * treatment with aspirin or other blood thinning agents within 14 days prior to treatment * history or presence of any clinically significant bleeding disorder * any issue that, at the discretion of the investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study * treatment with an investigational device or agent within 30 days before treatment or during the study period

Keywords: facial wrinkles skin laxity sagging skin
evaluation of an oxygen enhanced magnetic resonance imaging method on patients with chronic obstructive pulmonary disease during 8 weeks treatment with either symbicort turbuhaler or oxis turbuhaler

Conditions: COPD Method Evaluation; Chronic Obstructive Pulmonary Disease Method Evaluation

Summary: the main purpose of this study is to evaluate the sensitivity of a new oxygen enhanced magnetic resonance imaging (oe-mri) method in detecting changes in the lungs of patients with moderate to severe chronic obstructive pulmonary disease (copd) following treatment with either oxis turbuhaler or symbicort turbuhaler.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 40 years * male and female * clinical diagnosis of moderate to severe copd according gold guidelines * current or ex smoker with a smoking history equivalent to at least 20 cigarettes smoked per day for 10 years * a modified medical research council (mmrc) dyspnoea scale score of ≥2. * fev1/fvc \< 0.7 (post-bronchodilator) * fev1 \> 40 % pn and \< 70 % pn (post-bronchodilator) clinical study protocol local amendment affects uk: - fev1 \> 30 % pn and \< 80 % pn (post-bronchodilator) exclusion criteria: * current diagnosis of asthma according to gina guidelines * pregnancy, breast-feeding or planned pregnancy during the study. fertile women not using acceptable contraceptive measures as judged by the investigator * significant upper or lower respiratory tract infection not fully recovered in the 4 weeks prior to visit 1 * participation in or scheduled for an intensive copd rehabilitation program * claustrophobia, pacemaker, clips within the brain, previous brain or heart surgery, history of metal in the eye or other mri contraindication such as obesity or inability to stay in the supine position for 60 minutes

Keywords: oxygen enhanced magnetic resonance imaging chronic obstructive pulmonary disease method evaluation
argon plasma coagulation for barrett's esophagus

Conditions: Barretts Esophagus With Low Grade Dysplasia

Summary: background and study aims. to evaluate the impact of power setting and proton pump inhibitor (ppi) dose on the efficacy and safety of argon plasma coagulation (apc) of barrett's esophagus (be) with low-grade dysplasia (lgd). patients and methods. investigator initiated, single-center, parallel-group randomized controlled trial (rct) conducted in a tertiary referral center in poland. consecutive patients with be and lgd were randomly assigned to apc with power set at 90 watt (90w) or 60 watt (60w) followed by 120 mg or 40 mg omeprazole for six weeks. the primary outcome of the study was the rate of complete (endoscopic and histologic) ablation of be at six weeks. secondary outcomes included safety and long-term efficacy (at two years and at the end of a long-term follow-up of over 4 years.


Eligibility criteria:
inclusion criteria: * consecutive adult patients with low-grade dysplasia in flat barrett's mucosa referred for endoscopic treatment, * signed an informed consent to participate in the study. exclusion criteria: * high-grade dysplasia or adenocarcinoma, * visible lesions (nodules, ulcerations) in barrett's mucosa, * serious comorbidities and short life expectancy, * coagulopathy, * pregnancy or lactation, * psychiatric disorders.

Keywords: barretts esophagus dysplasia argon plasma coagulation endoscopic treatment
zoster vaccine response in the frail elderly

Conditions: Immune System Diseases

Summary: this study is being done to evaluate the zoster vaccine response in the nursing home elderly (80 years or older). as the immune system ages, the response to vaccines is not always as strong as in younger people. previous zoster vaccine studies have excluded nursing home residents so the vaccine effect in this population is not known. furthermore, the immune and genetic reasons as to why the vaccine works well in some people but not in others are also unknown. the goal of this study is to evaluate why some immune systems respond well to the vaccine and why others do not.

deleterious changes in immunity that occur with aging are known as immunosenescence. such changes, particularly in adaptive immunity, may lead to an impaired vaccine response in the elderly. characterizing the immune determinants and the genetic basis for vaccine response in the frail elderly is a practical approach to better our understanding of immunosenescence. data on genetic determinants to immunization are sparse, furthermore, to the best of our knowledge, none exist in the elderly. in this pilot study, we propose studying the immune response to the herpes zoster vaccine and the underlying genetic determinants of the immune response in elderly residents of nursing homes. the three specific aims of this study are to generate data in order to 1) assess the t-cell response to the varicella-zoster virus (vzv) vaccine in the frail elderly; 2) assess whether immune (t-cell) phenotypes are associated with a response; 3) test the association between immune response genotype sets and t-cell response. we hypothesize that response to the vzv vaccine in elderly nonambulatory nursing home residents is a function of characteristic t-cell immune phenotypes prior to vaccination and that there are immune genetic polymorphisms associated with the response. this study will allow us to generate preliminary data and establish feasibility in order to address these questions fully in a larger population in a subsequent grant application.

Eligibility criteria:
inclusion criteria: * nursing home resident * greater than or equal to 80 years old * non-ambulatory exclusion criteria: * less than 80 years old * ambulatory * taking immunosuppressive medication * history of primary or acquired immuno-deficiency states including leukemia, other malignant neoplasms affecting the bone marrow or lymphatic system, and aids * active untreated tuberculosis * previous receipt of varicella vaccine * residents expected to expire within 30 days, in the opinion of the most responsible physician * residents planning to move nursing homes within the year * temporary residents

Keywords: varicella-zoster virus vaccine t-cell genes frail elderly immunosenescence immune and genetic correlates of response to zoster vaccine in the elderly
a study of sklb1028 in subjects with relapsed/refractory acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: patients will receive oral sklb1028 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia with flt3 mutations.

it is open-label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of orally administered sklb1028 as a single agent given daily for 28 days. cohorts of 3 patients receive sklb1028 until dose limiting toxicity is noted (dlt). at that point cohorts will expand to 6 patients until mtd is determined. patients not experiencing dlt or significant disease progression could continue receiving sklb1028 up to 1 year.

Eligibility criteria:
inclusion criteria: * written informed consent must be provided. * males and females age ≥ 18 years; * histopathologically documented primary or secondary aml, as defined by who criteria, confirmed by pathology review at treating institution, meeting at least one of the following: 1. refractory to at least 1 cycle of induction chemotherapy, or 2. relapsed after at least 1 cycle of induction chemotherapy, or 3. patient is not, according to the clinical judgment of the principal investigator, a candidate for induction chemotherapy due to age, comorbidity, or other factors; * eastern cooperative oncology group (ecog) performance status of 0-3; * in the absence of rapidly progressing disease, the interval from prior treatment to time of sklb1028 administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents; * serum creatinine ≤1.5 × uln; * total serum bilirubin ≤ 1.5 × uln unless considered due to gilbert's syndrome or leukemic organ involvement; * serum ast or alt ≤ 3.0 × uln unless considered due to leukemic organ involvement; * females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study; exclusion criteria: * histologic diagnosis of acute promyelocytic leukemia; * clinically active central nervous system leukemia; * persistent clinically significant toxicity from prior chemotherapy that is grade 2 or higher; * bone marrow transplant within 100 days prior to study; * active, uncontrolled infection; * major surgery within 4 weeks prior to study; * radiation therapy within 4 weeks prior to study; * left ventricular ejection fraction ≤1 × uln,or﹤50%. clinically significant ecg qtc prolongation (male: \>450ms, female: \>470ms).significant cardiac disease. * human immunodeficiency virus positivity; * active hepatitis b or c or other active liver disease; * women who are pregnant, lactating; * medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the principal investigator, could jeopardize patient safety or interfere with the objectives of the study.

Keywords: aml
comparison between laying open and sinus excision of pilonidal sinus - a randomized study

Conditions: Pilonidal Sinus

Summary: a pilonidal sinus is a cyst or abscess near or on the natal cleft of the buttocks that often contains hair and skin debris. the condition is common and requires surgery to be cured. several surgical procedures are described in literature. the most common surgical procedure in sweden is excision of the sinus followed by suturing the subcutaneous tissue and skin. this method, however, has some problems regarding healing and recidives. therefore this study is comparing the standard excision procedure to another surgical procedure, laying open. healing frequency is the main variable, but postoperative pain, sick leave time and patient satisfaction is also measured.


Eligibility criteria:
inclusion criteria: * pilonidal sinus eligible for surgery * age \> 18 years * swedish speaking exclusion criteria: * active signs of infection prohibiting primary sewing of the wound
cumulative live birth rates in patients with repeated implantation failure (rif) undergoing preimplantation genetic screening (pgs )

Conditions: Infertility; Preimplantation Genetic Screening

Summary: this is a single centre retrospective study in repeated implantation failure patients: \< 39 years old, at least 4 d3 good quality embryos or 2 good quality blastocysts transferred without implantation, absence of known causes of implantation failures (uterine malformation, thrombophilia, severe male factor, uncontrolled thyroid disfunction, autoimmune disease). patients scheduled for pgs underwent one or more stimulation cycles (oocyte or blastocyst banking) in order to maximize chances of embryo transfer. pgs cycles are analyzed globally. aditionally, pgs cycles with a single stimulation cycle are analyzed in comparison to standard ivf cycles.


Eligibility criteria:
inclusion criteria: * women \< 39 years * repeated implantation failure: at least 4 day 3 good quality embryos or 2 good quality blastocysts transferred without implantation exclusion criteria: * partner with severe male factor, or abnormal sperm fluorescence in situ hybridization (fish) analysis * presence of uni or bilateral hydrosalpinx, uterine malformation, thrombophilia, uncontrolled thyroid disfunction or autoimmune disease
the impact of different skin suture methods in episiotomy repair on healing and pain

Conditions: Labor; Prolonged, Second Stage; Episiotomy Wound

Summary: episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. this study aimed to compare various skin closure techniques in episiotomy repair.


Eligibility criteria:
inclusion criteria: * primiparous * age between 18 to 45 * given birth in our labor ward exclusion criteria: * multiparous * having deep vaginal lacerations * having abnormalities in fetus * rheumatologic diseases * postpartum bleeding * shoulder dystocia * operative delivery * using antithrombotic or anticoagulant medications

Keywords: labor vaginal birth episiotomy suturing
safety and efficacy of omission of sentinel node biopsy in patients with estrogen-positive breast cancer over age 65

Conditions: Breast Cancer

Summary: this study will examine the outcomes of lumpectomy, surgery to remove a tumor, without sentinel node biopsy (snb) for women at least 65 years of age with clinically node-negative breast cancer. clinically node-negative means that during a physical exam your doctor cannot feel or see that any lymph nodes near the breast area are swollen and there is also no imaging evidence, such as from a mammogram, of nodal involvement.

the primary objective of the study is to determine whether omission of sentinel node biopsy in patients who meet eligibility criteria results in an acceptable regional recurrence rate over a 6-year period. a regional recurrence is defined as any recurrence in the ipsilateral axillary nodes, supraclavicular nodes or internal mammary nodes. eligible patients will undergo standard of care lumpectomy without sentinel node biopsy followed by radiation and hormonal therapy or have already undergone the procedure prior to enrollment in the study. she may also receive chemotherapy as determined by her treating physician. a physical examination of the affected breast and regional lymph nodes will be conducted every six months for the first two years of follow up and then yearly for the last 3 years of follow up. imaging of the affected breast will occur every 12 months after surgery per standard of care.

Eligibility criteria:
inclusion criteria: * female age 65 and older * staging: 1. patients enrolled prior to surgery: diagnosis of clinical t1-2n0, er+, her2-negative, invasive breast cancer as determined by treating physician. dcis or lcis may be present with invasive cancer. 2. patients enrolled after surgery: pt1-2nx, or pt1-2n0, er+, her2-negative, invasive breast cancer. dcis or lcis may be present with invasive cancer. * plan to undergo lumpectomy within 3 months of study registration, or underwent lumpectomy within 60 days of study registration (without sentinel node biopsy) * patients in whom lymph nodes are palpable and not suspicious who are found to be nodal tumor-free by nodal core needle biopsy are permitted, but those with biopsy-proven nodal metastases are excluded exclusion criteria: * patients with diagnosis of ductal or lobular carcinoma in situ * patients with diagnosis of inflammatory breast cancer * patients who have undergone neoadjuvant chemotherapy for current primary breast cancer (past treatments for other cancers are acceptable) * patients planning to have mastectomy or had a mastectomy of the ipsilateral breast * prior history of ipsilateral (invasive or dcis) breast cancer * diagnosis of clinical t3 or t4 breast cancer

Keywords: clinical t1-2n0 er+ invasive breast cancer estrogen-positive
comparative trial evaluating safety and immunogenicity of an adjuvanted and a conventional influenza vaccine in elderly subjects (> 60 years)

Conditions: Influenza

Summary: clinical trial in two parts: part 1: phase i, open-label, single-center study to evaluate the safety of an adjuvanted influenza vaccine when administered to elderly subjects. part 2: a phase iii, randomized, controlled, observer-blind, single-center study to evaluate the immunogenicity and safety of an adjuvanted and a conventional influenza vaccine when administered to elderly subjects.


Eligibility criteria:
inclusion criteria: * subjects 60 years of age or older, mentally competent, willing and able to give the written informed consent prior to study entry exclusion criteria: * any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (copd) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure. * hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine. * history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine. * known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).

Keywords: influenza, elderly, vaccine
recurrence score-guiding chemotherapy in non-pcr hr positive her2 negative breast cancer after neoadjuvant therapy

Conditions: Breast Cancer

Summary: the luminal subtype of breast cancer means hormone receptor positive, human epidermal growth factor receptor 2 negative (hr+her2-), which counted 60%-70% of breast cancer but achieve low pathologic complete response (pcr) rate (7.5%-15%) in neoadjuvant chemotherapy. it is controversial whether additional chemotherapy after surgery is necessary for those non-pcr hr+her2- patients. multiple gene is a mature diagnose tool for recurrence score in adjuvant treatment strategy. this study is to investigating the value of multi gene detection tool based recurrence score for guiding additional chemotherapy after surgery in hr+her2- non-pcr breast cancer.

this study is designed as stratified cluster randomized, parallel-control research. the hr+her2- breast cancer patients after neoadjuvant chemotherapy (including anthracyclines and taxane, at least 6 cycles) assessed non-pcr are recruited, receiving multiple gene test before neoadjuvant treatment and after surgery. after enrollment, the patients were stratified according to multiple gene test based recurrence risk level (high risk or low risk) and then randomized into two groups respectively in each cluster: receiving additional chemotherapy (capecitabine) group or negative control group. the primary endpoint is 2-year disease free survival. the second endpoint is 5-year disease free survival (dfs), 2-year overall survival (os), 5-year os, safety of additional chemotherapy. the exploratory endpoint is the variety of multiple gene test based recurrence risk after neoadjuvant chemotherapy in non-pcr patients.

Eligibility criteria:
inclusion criteria: 1. invasive breast cancer at the first diagnosed 2. clinical stage ct1-4cn0-3m0 (ajcc 8th), receiving neoadjuvant chemotherapy at least 6 cycles 3. neoadjuvant chemotherapy regimen should include anthracyclines and taxane 4. primary tumor hr+(er+ or pr+) and her2 negative before neoadjuvant chemotherapy 5. pathological evaluation non-pcr after neoadjuvant chemotherapy (residual invasive cancer in primary tumor) exclusion criteria: 1. metastasis, recurrent breast cancer or receiving other treatment before neoadjuvant chemotherapy 2. pregnant breast cancer 3. ihc or fish test of primary tumor confirmed her2 positive at anytime 4. complete fewer than 6 cycles chemotherapy before surgery 5. deficiency of surgery after neoadjuvant 6. contraindication of chemotherapy or surgery

Keywords: breast cancer neoadjuvant multiple gene detection
al-sense 1-step - determination of product specificity

Conditions: PREMATURE RUPTURE OF MEMBRANES

Summary: clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard procedure, using pooling test and/or sterile speculum examination and /or ph test, and amnisure, n-dia, inc. (immunoassay for diagnosis of ruptured fetal membranes (rom)). amniotic fluid leak test, using the al- sense 1-step device, will be considered positive in case of presence of a blue or green or grey stain on a yellow background of the al-sense 1-step, as observed by the patient and the clinician (positive/negative).

pregnant women arriving at the hospital and reporting unidentified wetness (undetermined whether they sense amniotic fluid leakage or urinary incontinence) will receive a single al-sense 1-step to use up to 12 hours or until they notice any wetness. the clinician will explain the proper use and handling of the al-sense 1-step and how to read the result. in each case, the subject and the clinician/midwife (non bias to the hospital standard procedure results) will be required to read and record any occurrence of color change of the al-sense 1-step immediately after removing the test to mark if it changes color to blue or to green or to grey on the designated form. the non bias physician, who is not aware to the al-sense 1-step result (other than the clinician/midwife who records the al-sense 1-step results) will perform a diagnosis tests for amniotic fluid leak detection, according to the hospital standard procedure. the investigator will compare the al-sense 1-step results reading of the patient to the clinical diagnosis.

Eligibility criteria:
inclusion criteria: 1. age 18 years or greater. 2. subject who will sign the informed consent form. 3. subject who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether she sense amniotic fluid leakage or urinary incontinence). exclusion criteria: 1. subjects that have had sexual relations within the last 12 hours. 2. subject is unable or unwilling to cooperate with study procedures. 3. subject is currently participating in another clinical study

Keywords: prom