Kornimate/medical-research-clean huggingface dataset:
clinical study of the easytrak 3 spiral fixation coronary venous bipolar pace/sense lead

Conditions: Congestive Heart Failure

Summary: the purpose of this clinical investigation was to assess the safety and effectiveness of the easytrak 3 lead

this clinical study was a prospective, multi-center, clinical evaluation to document safety and effectiveness of the easytrak 3 lead in humans. patients implanted with the easytrak 3 lead were followed through pre-discharge, 1-month, 3-month and 6-month follow-ups

Eligibility criteria:
inclusion criteria: * moderate to severe heart failure (nyha class iii/iv) including left ventricular dysfunction (ef \ = 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy. * creatinine \< 2.5 mg/dl obtained no more than two weeks prior to enrollment. * age 18 or above, or of legal age to give informed consent specific to state and national law. * willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol. exclusion criteria: * a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate. * previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement. * pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads). * requiring dialysis. * a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment. * hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis). * a documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months. * enrolled in any concurrent study, without prior guidant written approval, that may confound the results of this study. * have a mechanical tricuspid heart valve.

Keywords: artificial cardiac pacemaker implanted electrodes
feasibility of a team approach for discussing prognosis and treatment goals in breast cancer

Conditions: Advanced Breast Cancer; Stage 4 Breast Cancer; Recurrent Breast Cancer

Summary: this research study will examine how patients with advanced breast cancer and their oncology team communicate and plan ongoing care.the purpose of this study is to find out more about care planning during advanced breast cancer. the study will see if certain aspects of communication make a difference in how patients understand their illness.

the new communication practice (t-pat) is a team approach for discussing prognosis and treatment goals. t-pat is specifically designed to a) increase understanding of the prognosis and treatment goal, b) decrease illness uncertainty, and c) help the patient preserve hope for the future.this dedicated clinical visit features a structured discussion of prognosis, treatment goals and options, and end of life concerns. the planned team discussion will include information contributions for the treating medical oncologist, an oncology nurse and social worker who currently work together to provide breast cancer care. primary objectives: 1. assess the feasibility of implementing the t-pat prognosis discussion intervention. 2. compare the effects of t-pat vs. usual care on pertinent patient reported outcomes including: a) understanding of the prognosis and treatment goal, b) illness uncertainty, and c) hope. * first, a survey will be administered to patients in the waiting room before the next office visit. this should take 15-20 minutes. * the second part involves participating in a scheduled appointment that will be audio-recorded and focus on sharing information about the patient's illness. patients will be randomized to either participate in an appointment featuring new communication practices (t-pat)or a regular care appointment. * the third part involves a 20 minute survey, after the appointment, with a member of the study staff. this will take place over the telephone one or two days after the appointment. * the fourth part is completion of a written reflection on the patients participation in the study, which will be returned in a pre-addressed, stamped envelope. generally, this should take about 15 minutes.

Eligibility criteria:
inclusion criteria: * women newly or currently diagnosed with stage 4 or recurrent breast cancer * patients of dr. paula silverman at seidman cancer center * ambulatory * able to understand and participate in a discussion about their disease progression exclusion criteria: * hospitalized * unable to speak english * unable to attend an office visit * ecog performance score of \>3

Keywords: breast cancer patient-doctor communication supportive care
predictive factors for the development of osteonecrosis after the treatment of the developmental dislocated hip

Conditions: Predictors of Osteonecrosis of the Femoral Head After Treatment of the Dislocated Hip

Summary: several risk factors for the development of osteonecrosis of the femoral head following treatment of developmental dislocated hip have been reported. the need for further research with a large-enough sample size including statistical adjustment of confounders was demanded. the purpose of the present study was to find reliable predictors of osteonecrosis in patients managed for developmental dislocation of the hip and to evaluate if delayed treatment increased the risk of residual acetabular dysplasia requiring secondary surgeries.


Eligibility criteria:
inclusion criteria: * follow-up \> 3 years exclusion criteria: * teratological hip dislocation * neuromuscular disease * previous open reduction at another medical institution
reduction ratio and clearance during hemodialysis with mco-filter compared to hdf with standard high-flux filter

Conditions: Chronic Kidney Failure; Uremia; Dialysis

Summary: the medium cut-off dialysis (mco) membrane has been developed to improve middle molecule removal compared to standard high-flux dialysis filters. the major aim of this study is to compare the reduction ratio of middle molecules, during a single hemodialysis session with mco-filter, compared to hemodiafiltration (hdf) with standard high-flux filter. secondary aims are to compare the reduction ratio of small and large molecules between the treatments.


Eligibility criteria:
inclusion criteria: * ongoing hdf treatment * crp \<30 * no acute myocardial infarction within 3 months. exclusion criteria: * not able to understand the study information.

Keywords: dialysis mco middle molecules high retention onset medium cut-off
a study to assess adverse events and effectiveness of gel stent (xen63) implantation using ab interno and ab externo approaches in adult participants with glaucoma

Conditions: Primary Open Angle Glaucoma

Summary: glaucoma is the second most common cause of blindness in the world, second only to cataracts. this study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab externo (outside the eye) approach. adverse events and intraocular pressure will be assessed. xen63 is an investigational device for the treatment of intraocular pressure (iop) in patients with glaucoma when both medical and conventional surgical treatments have failed (for us approval) and when medical treatments have failed (for outside us \[ous\] approval). participants will be placed in one of two groups called study arms. one group will receive the xen63 gel stent ab interno (inside the eye) and the other group will receive the xen63 gel stent ab externo (outside the eye). approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in select countries in north america and europe. participants will receive xen63 implanted using either the ab interno approach or the ab externo approach on day 1 and will be followed for 12 months. participants will attend regular visits during the study at a hospital or clinic. the safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.


Eligibility criteria:
inclusion criteria: * diagnosis of glaucoma in the study eye (se) (meeting criterion a or b) 1. that meets the following refractory glaucoma criteria of eyes diagnosed with glaucoma uncontrolled by maximal medical therapy (four or more classes of intraocular pressure (iop)-lowering medications, or fewer in cases where it has been documented that certain medication classes cannot be tolerated or are contraindicated), and failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, tube shunt) 2. uncontrolled by medical therapy (to meet out-of-us \[ous\] requirements) with participants who only have glaucoma uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion b (and not a) will be enrolled in each cohort. exclusion criteria: * history of angle-closure glaucoma where the angle has not been surgically opened in the se. * history of secondary open-angle glaucoma (e.g., neovascular, pigmentary, pseudoexfoliative, uveitic, angle recession/traumatic glaucoma, etc.) in the se. * active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) in the se.

Keywords: primary open angle glaucoma agn-9003
atg5 as a serum marker of autophagy in psoriatic patient

Conditions: Psoriasis Vulgaris; Autophagy

Summary: it will be of interest to know the atg 5 as a serum marker of autophagy in serum of psoriasis vulgairs patients and explore its relationship with psoriasis severity.


Eligibility criteria:
inclusion criteria: psoriasis vulgaris of both sex, age 18-55 years exclusion criteria: i. patients with other types of psoriasis ii. pregnant or lactating women iii. patients with hepatic or renal diseases iv. patients receive any systemic treatment in last 3 months

Keywords: serum marker atg5
effect of exercise in head and neck cancer patients

Conditions: Head and Neck Cancer

Summary: head and neck cancers (hnc) are malignancies originating from the mucosa in the oral cavity, nasopharynx, oropharynx, hypopharynx and larynx. unfortunately, the majority of patients with hnc have locally advanced disease at diagnosis and should, therefore, be treated with chemoradiotherapy (crt) or with radical surgery followed by adjuvant (c)rt. treatment of hncs with (c)rt frequently results in serious and persistent impairments in physical and psychosocial functioning. in order to prevent worsening of a person's functioning at diagnoses and limit the physical impact of the treatments for hnc, a comprehensive supervised exercise program (csep) is needed early during treatment. there is a need to improve integration of exercise programs into hnc care with aim to help head and neck cancer patients regain physical, mental and social functioning. currently, no program is available adapted to the specific needs of head and neck cancer patients, in particular during cancer treatment. the primary scientific objective is to examine the effectiveness of a comprehensive supervised exercise program, in addition to usual care, on health-related quality of life (primary outcome parameters) during treatment of head and neck cancer, compared to usual care only, up to 1 year after diagnosis. secondary objectives entail gathering information on the effectiveness of the csep, in addition to usual care on secondary outcome parameter such as physical and mental functioning, activity level and participation level; to determine the feasibility of such csep (defined as at least 50% of eligible patients enrolling in the study and completing at least 50% of the planned intervention sessions) and possible barriers and facilitators for participating in a csep during head and neck cancer treatment.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years * diagnosed with primary malignant tumour head and neck region (oral cavity, nasal cavity and paranasal sinuses, pharynx, larynx, salivary glands, thyroid) * ecog performance score 0-1 * planned for curative (chemo)radiotherapy * able to complete baseline assessments prior to start of radiotherapy. * physically and mentally capable of taking part in an exercise program and motivated to engage in a supervised exercise program. exclusion criteria: * patients \< 18 years * ecog ≥ 2 * patient with hnc, treated with palliative intent * evidence of distant metastases

Keywords: exercise program
estimated blood loss: novel model for estimating surgical blood loss.

Conditions: Blood Loss, Surgical; Blood Loss; Blood Loss, Postoperative

Summary: estimated blood loss is an important parameter recognized as a standard practice in anesthesiology and others medical specialties, with relevant clinical and research applications. currently is no model capable of accurately estimate blood loss. the purpose of this study is to evaluate the accuracy of a novel model.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective urologic laparoscopy surgery. exclusion criteria: * patient with suspected or confirmed heart failure, severe hypertension, hepatic cirrhosis, chronic kidney disease on dialysis, coagulopathy, as well as patient receiving diuretics, anticoagulant or antiplatelet agents. * cases in which surgical gauzes were used, including conversion to open surgical technique. - patients who have received transfusions of rbcs during the perioperative period. * patients who have showed postoperative bleeding, defined by an amount greater than 50 ml in surgical drains, or any other type of blood loss.
study of the vascularity of uterine septum using three dimensional power doppler ultrasound

Conditions: Septum; Uterus

Summary: this study aims to assess the relation between the vascularity of uterine septum and obstetric performance with transvaginal 3d power doppler ultrasound

research hypothesis: in women with uterine septum vascularity of the septum may affect obstetric performance. research question: in women with uterine septum does vascularity of the septum affect obstetric outcome?

Eligibility criteria:
inclusion criteria: * patients with septate uterus diagnosed by office hysteroscopy exclusion criteria: * women with previous uterine scar. * women with suspected or confirmed pregnancy. * women with active pelvic infection or old one. * women with abnormal uterine bleeding. * fibroids, adenomyosis or ovarian swelling.
a study to evaluate the efficacy and safety of experimental drugs abt- 493/abt-530 in adults with chronic hepatitis c virus genotype 1-6 infection and human immunodeficiency virus -1 coinfection (expedition-2)

Conditions: Hepatitis C Virus Infection; Human Immunodeficiency Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis and Non-cirrhotics

Summary: the purpose of this study is to assess the efficacy and safety of abt-493/abt-530 in adults with chronic hepatitis c virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.


Eligibility criteria:
inclusion criteria: 1. male or female, at least 18 years of age at time of screening. 2. screening laboratory result indicating hepatitis c virus (hcv) genotype (gt)1-, 2-, 3-, 4-, 5-, or 6-infection. 3. subject has positive anti-hcv antibody (ab) and plasma hcv ribonucleic acid (rna) viral load greater than or equal to 1000 iu/ml at screening visit. 4. subjects must be hcv treatment-naïve (i.e., subject has never received a single dose of any approved or investigational anti-hcv medication) or hcv treatment-experienced (subject who has failed prior ifn or pegylated-interferon \[pegifn\] with or without ribavirin \[rbv\], or sofosbuvir \[sof\] plus rbv with or without pegifn). gt3 subjects must be hcv treatment-naïve. previous hcv treatment must have been completed greater than or equal to 2 months prior to screening. 5. subjects naïve to antiretroviral treatment (art) must have cd4+ count greater than or equal to 500 cells/mm\^3 (or cd4+ % greater than or equal to 29%) at screening; or subjects on a stable art regimen must have * cd4+ count greater than or equal to 200 cells/mm\^3 (or cd4+ % greater than or equal to 14%) at screening; and * plasma hiv-1 rna below lower limit of quantification (lloq) at screening and at least once during the 12 months prior to screening. exclusion criteria: 1. recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. 2. positive test result at screening for hepatitis b surface antigen (hbsag). 3. positive human immunodeficiency virus, type 2 (hiv-2) ab at screening. 4. receipt of any other investigational or commercially available direct acting anti-hcv agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir). 5. consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive abt-493/abt-530.

Keywords: hcv genotype 3 non-cirrhotic hcv genotype 1 hcv genotype 6 human immunodeficiency virus (hiv) infection hcv genotype 5 hcv treatment naive hcv genotype 4 hcv treatment experienced hcv genotype 2 hepatitis c virus (hcv) infection compensated cirrhosis
reliability and reproducibility of automated angular measurement in strabismus

Conditions: Strabismus

Summary: angular measurement of deviation is an essential element in the clinical evaluation of strabic patients. it is performed by orthoptic methods. however, studies show that the same patient presents a great variability of his angular measurement between 2 consultations, and between 2 observers. automated angle measurement is a recent concept that aims to overcome the defects of subjective angle measurement by alternate occlusion test and prismatic bar. improvements made by these devices would provide reliable, objective and reproducible measurements of the angle of deviation by increasing the accuracy of strabal angle assessment, improving decision making and surgical follow-up, decreasing inter-examiner variability and variability over time, and facilitating data comparison to improve scientific publication possibilities. the gazelab® device is a video-oculograph combined with a laser projection system and an infrared camera. it allows an objective angular evaluation, in non-dissociating physiological conditions, possible even in the absence of binocular vision and allows an analysis of the deviation in all positions. there is extremely little data in the literature on automated measuring devices. the gazelab tool is still little known in the strabology discipline and seems to have a number of advantages over other devices. the interest of this examination towards this pathology led the ophthalmology department to use it in the current practice, and since recently it is an act nomenclaturé.

the objective of this work is to evaluate the reliability and reproducibility of the automated angular measurement by the gazelab® (es12/13127) apparatus, compared to the standard gold which is the angular measurement by alternate occlusion test and prismatic bar, in horizontal strabisms (converging and diverging). indeed in our daily practice the 2 examinations are carried out. to compare with the standard gold which denotes a strong inter-observer variability, the investigator will compare the results of the gazelab to the alternate occlusion by prism bar (standard gold) 2 times with 2 trained examiners

Eligibility criteria:
inclusion criteria: * patients over 18 years of age * strabic convergent or divergent patients or patients requiring an oculomotor check-up in their follow-up consultation * patient giving oral consent to this study exclusion criteria: * patient with medical follow-up impossible, * impossibility to install gazelab equipment for anatomical reasons of the head (craniostenosis...) * no ocular fixation. * major without freedom under guardianship or trusteeship

Keywords: angle measurement automated strabismus
prognostic value of tumor deposits for patients with papillary thyroid carcinoma

Conditions: Exploring the Prognostic Value of Tumor Deposits PTC Patients

Summary: tumor deposits (td), nodules in the peritumoral adipose tissue with no architectural residue of lymph node, which is a definition often being confusing to the extranodal extension (ene), have been described in several malignancies and linked to a worse prognosis. in gastric cancer and colon cancer, td and ene should be distinguished and collected separately in 8th ajcc manual. however, in thyroid cancer, td as a collection variable was absence in both the 8th ajcc manual and the 2015 ata guideline. this is a study that revealed the presence of td by reviewing a large number of papillary thyroid carcinoma (ptc) specimens and explored its prognostic value by constructing a nomogram to accurately predict disease-free survival in ptc patients.


Eligibility criteria:
inclusion criteria: (1) patients with histopathologically confirmed ptc and sections stored in the pathology department; (2) patients underwent lobectomy or total thyroidectomy and central lymph node dissection with or without lateral neck dissection; (3) patients cooperated to provide follow-up information after surgery. exclusion criteria: (1) patients with previous history of neck irradiation or other systematic cancers; (2) patients died of unrelated diseases.

Keywords: tumor deposits, extranodal extension, papillary thyroid carcinoma, lymph node metastasis, prognosis.
comparing the safety and efficacy in the use of hormonal therapy on endometriosis patients after conservative surgery

Conditions: Endometriosis Ovary

Summary: the goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery. the main question\[s\] it aims to answer are: 1. health-related quality of life (hrqol) 2. vas score 3. beta estradiol 4. tnf alpha 5. adnexal mass recurrence participants will be randomized into 4 groups, each group will receive: 1. leuprolide acetate injection/month 2. dienogest 2 mg/day 3. coc (mycrogynon)/day 4. dmpa injection 150mg/month researcher will compare the efficacy and safety in the assigned group.

1. beta estradiol level is measured in the serum, before and after treatment 2. tnf alpha is measured in the serum, before and after treatment 3. evaluation of hrqol using the endometriosis health profile-30 (ehp-30) 4. vas score will be recorded before and after treatment 5. adnexal massa recurrence evaluation using usg

Eligibility criteria:
inclusion criteria: patient post surgical removal of endometriosis cyst willing to participate exclusion criteria: 1. use of any hormonal therapy for endometriosis within the previous 16 weeks. 2. history of severe adverse drug reactions or hypersensitivity to steroid hormones. 3. failure of previous treatment with coc, dmpa used in this study. 4. there are contraindications to the use of leuprolide acetate, coc, dmpa or dienogest, such as a history or complications of thrombosis/embolism, stroke, diabetes mellitus, liver cirrhosis or other liver function disorders, breast, ovarian and endometrial malignancies. 5. smoker.