Kornimate/medical-research-clean huggingface dataset:
detecting recurrent prostate cancer with 11c-choline positron emission tomography

Conditions: Prostate Cancer; Recurrent Prostate Cancer

Summary: the purpose of this study is to use a new imaging drug called 11c-choline that is used with a pet/ct scan to see prostate cancer when it cannot be seen well on other scans, such as bone scans, ct or mri.


Eligibility criteria:
inclusion criteria: * patient must have biopsy-proven adenocarcinoma of the prostate initially treated with curative intent (surgery and radiation therapy are most common treatments but other treatments are also eligible). * biochemical recurrence defined as any of the following: 1. psa ≥ 0.2 ng/ml in at least two sequential tests for patients treated with surgery. 2. psa ≥ 0.2 ng/ml above the post therapy nadir for patients treated with radiation therapy, brachytherapy or cryotherapy. 3. psa ≥ 0.2 ng/ml above the most recent therapy nadir for patients who have received additional treatment in the recurrent setting * patient must have undergone standard-of-care restaging that does not clearly identify site(s) of active disease, or such prior studies must show equivocal findings for which further work-up is considered necessary to make clinical decision. standard staging examinations may include one or more of the following: ct or mri, bone imaging (either tc-99m bisphosphonate scintigraphy mdp or f-18 sodium fluoride pet), fdg pet, or in-111 capromab pendetide scintigraphy no older than 3 months of consent date. * age ≥ 18 years. * patient must be able to tolerate pet/ct imaging. * patient must be able to understand and willing to sign a written informed consent document. exclusion criteria: * patient must not have claustrophobia that would preclude pet/ct imaging or other contraindications to ct imaging.

Keywords: 11c-choline positron emission tomography 15-117
regenera implant in excised non-malignant breast lesions

Conditions: Benign Breast Disease

Summary: the purpose of this first-in-human pilot study is to evaluate the safety and performance of regenera breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom the tissue removed is replaced by regenera.

this is a pre-market, single center, interventional, open label, non-comparative, pilot first-in-human study on adult female patients with localized non-malignant breast lesion. this study will include an enrollment period of 12 months and 6 months study duration per patient. the primary objective of this study is to demonstrate the safety profile of a new breast implant (regenera) in excision or lumpectomy of non-malignant breast lesions. the secondary objectives of this study are: * to assess the safety of the implant procedure * to assess the feasibility of the implant procedure * to evaluate the performance of regenera breast implant: * in replacing the removed tissue * in potential interference with current diagnostic standard of care imaging procedures * on patient's quality of life and satisfaction * on investigator's satisfaction.

Eligibility criteria:
inclusion criteria: 1. female patients aged 20-85 years 2. patients eligible for excision or lumpectomy, as per current surgical guidelines 3. volume deficit compatible with an implant volume of 70 cc 4. adequate hematopoietic functions 5. good general health and mentally sound 6. confirmation of non-malignant lesion (b2 and b3) with no discordance between biopsy and radiological imaging 7. patients able and willing to give written informed consent form exclusion criteria: 1. pregnant or breastfeeding women or women who have nursed a child three months within enrolment in the study 2. non-malignant lesions (b2 and b3) with discordance between biopsy and radiological imaging 3. infection of the surgical site confirmed pre-operatively by clinical examination 4. acute or chronic severe renal insufficiency (creatinine values \< 180 μmol/l) 5. history of severe asthma or allergies (including to anaesthetics or contrast media) 6. autoimmune disease 7. subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or paget's disease 8. subject who are known to be carriers of bcra mutation 9. inability to undergo mri or allergy to contrast media 10. systemic infections in active phase 11. immunocompromised patients (hiv) 12. subjects who have participated in another study within the past 3 months 13. patients who received immunosuppressant therapy in the last 3 months 14. non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).

Keywords: lumpectomy bio-absorbable
swog-9245 collecting and storing tissue samples from patients with relapsed or recurrent non-hodgkin lymphoma after treatment on a southwest oncology group clinical trial

Conditions: Lymphoma

Summary: rationale: collecting and storing samples of tissue from patients with non-hodgkin lymphoma to study in the laboratory may help the study of cancer in the future. purpose: this laboratory study is collecting and storing tissue samples from patients with relapsed or recurrent non-hodgkin lymphoma after treatment on a southwest oncology group (swog) clinical trial.

objectives: * acquire fresh snap-frozen lymphoma tissue from patients with relapsed or recurrent non-hodgkin lymphoma after treatment on a southwest oncology group (swog) clinical trial. * establish a standard set of procedures for routine acquisition, banking, and study of lymphoma tissues within the swog. * use repository tissue to establish clinical correlations via presently activated phenotyping studies and future projected molecular studies assessing specimen dna and rna status. * examine the biology of therapy failure in relationship to changes in pretreatment and post-treatment immunophenotypic data. outline: this is a multicenter study. tissues collected at biopsy are snap-frozen and archived for future molecular and genetic studies. projected accrual: not specified

Eligibility criteria:
disease characteristics: * diagnosis of relapsed or recurrent non-hodgkin lymphoma (nhl) * previously registered on 1 of the following swog clinical trials for previously untreated nhl: * swog-8410 * swog-8503 * swog-8508 * swog-8516 * swog-8736 * swog-8809 * swog-8907 * swog-8954 * swog-9125 * swog-9240 * swog-9320 * swog-9349 * swog-9432 * swog-9501 * swog-9703 * swog-s9704 * swog-9800 * tissue samples of relapsed or recurrent disease available patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult burkitt lymphoma recurrent adult grade iii lymphomatoid granulomatosis recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone b-cell lymphoma splenic marginal zone lymphoma waldenström macroglobulinemia adult nasal type extranodal nk/t-cell lymphoma recurrent childhood grade iii lymphomatoid granulomatosis recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma childhood burkitt lymphoma childhood nasal type extranodal nk/t-cell lymphoma
telemedicine on metabolic control in type 1 diabetes mellitus andalusian patients (platedian)

Conditions: Telemedicine

Summary: to assess the effect of a 6-month telemedicine program (diabetic) in patients with type 1 diabetes mellitus (dm1) and regular metabolic control (hba1c \<8%) in multi-dose insulin treatment (mdi) measured hba1c vs. conventional medical care.

the substitution of face-to-face visits for telematics visits has a similar effect on glycemic control (measured by hba1c) in patients with dm1 treated with multiple daily doses of insulin (mdi) and regular metabolic control (hba1c \<8 %). it even saves costs and consumption of health resources, and improves the quality of life and satisfaction of subjects with dm1 to evaluate the effect of a 6-month diabetic platform on telemedicine in patients with dm1 and regular metabolic control (hba1c \<8%) on mdi treatment in the following parameters: a) glycemic control: mean glycemia, number of mild hypoglycemia / week, number of severe hypoglycemia / 6 months, number of hyperglycemia greater than 250mg / dl / week, number of episodes of ketosis / 6 months, number of episodes of ketoacidosis / 6meses , number of hospital admissions due to glycemic decompensation / 6 months. b) glycemic variability: standard deviation, mean amplitude of glycemic excursions (mage). c) fear of hypoglycemia: scale fh-15. d) quality of life: diabetes quality of life questionnaire (dqol). e) stress: dds questionnaire. f) costs and consumption of health resources: -cost-effectiveness (hba1c)

Eligibility criteria:
inclusion criteria: * patients with dm1 over 2 years of evolution. * age ≥18 and \<65 years. * hba1c prior to inclusion of the study \<8% (the measure being valid in the month prior to inclusion in the study) * intensive insulin therapy with basal-bolus mdi. * patients living in andalusian * patients candidates for telemonitoring. * patients who have received written informed consent. exclusion criteria: * treatment with isci. * chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled). * pregnancy or pregnancy planning. * diabetes mellitus type 2. * severe psychological disturbances. * absence of collaboration (informed consent). * patients who are participating in other clinical studies.

Keywords: type 1 diabetes
ppi versus histamine antagnists as adjuvant to chemotherapy

Conditions: Lymphoma

Summary: the study is a comparative clinical and biochemical study evaluating the effect of proton pump i nhibitors versus histamine 2 receptor antagonists as an adjuvant with chemotherapy in patients with non-hodgkin lymphoma.

the study is a comparative clinical and biochemical study evaluating the effect of proton pump inhibitors versus histamine 2 receptor antagonists as an adjuvant with chemotherapy in patients with non-hodgkin lymphoma to compare the difference in efficacy.

Eligibility criteria:
inclusion criteria: * dlbcl lymphoma subtype --no comorbid disease exclusion criteria: * pregnancy * peptic ulcer * severe cardiac disease * osteoporosis
safety and efficacy of atherectomy on vascular functions

Conditions: Peripheral Arterial Disease; Claudication, Intermittent

Summary: interventional strategies aim to restore tissue perfusion. however, despite the simple reopening of a narrowed artery they affect endothelial function, perpetuating dysfunctional vascular homeostasis. pta and atherectomy might alter the endothelial function but the mechanisms are incompletely understood. the primary goal of atherectomy is vessel preparation and improving compliance, which could aid in preserving vessel functions. aim of this study is to determine safety, efficacy, patency and vessel functions in the femoropopliteal artery following atherectomy and dcb.


Eligibility criteria:
inclusion criteria: * peripheral artery disease, lesions in the sfa and popliteal artery. * clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by rutherford 2, 3, or 4 * planed peripheral intervention tasc a-d * subject must be between 18 and 85 years old * female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation * vessel diameter ≥3.0 mm and ≤7.0 mm * willing to comply with the specified follow-up evaluation * written informed consent prior to any study procedures exclusion criteria: * thrombolysis within 72 hours prior to the index procedure * aneurysm in the femoral artery or popliteal artery * concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy * unstable angina pectoris at the time of the enrollment * recent myocardial infarction or stroke \< 30 days prior to the index procedure * life expectancy less than 12 months * septicemia at the time of enrollment * known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb * known or suspected allergies or contraindications to aspirin, clopidogrel or heparin presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
comparison of intraocular lens power calculation methods after corneal laser refractive surgery in axial and refractive ammertropia

Conditions: Cataract; Refractive Errors

Summary: the study aims at determining the best biometry calculation formula to be used in iol calculation of cataract patients how previously underwent laser refractive correction surgery

patients undergoing laser refractive surgery will will be investigated in means of pentacam testing and iol master biometry both preoperative and 6 weeks postoperative to determine which iol calculation formula is the nearest and most accurate to preoperative records in different refractive sittings.

Eligibility criteria:
inclusion criteria: * all patient undergoing laser refractive surgery exclusion criteria: * previous ophthalmic surgery * previous trauma * ocular pathology other than refractive error

Keywords: lasik intraocular lens biometry iol master
manipulating tobacco constituents in male menthol smokers

Conditions: Nicotine Dependence

Summary: this study examines the potential effect of reducing nicotine content or menthol or both in men. it will also examine whether there are gender differences in manipulating tobacco flavors and nicotine concentrations in cigarettes on smoking behavior.

the fda has the regulatory authority to reduce, but not eliminate, nicotine from cigarettes. the tobacco products scientific advisory committee has noted, among other things, that removal of menthol cigarettes from the marketplace would benefit the public health. a parent study (nct02048852) examines the potential impact of these two regulatory actions alone and in combination in female menthol smokers. this supplemental study will recruit an additional group of male menthol smokers, which will examine whether there are gender differences in manipulating flavors and nicotine concentrations in cigarettes on smoking behavior. the approach to add the opposite sex allows findings of sex/gender to be incorporated in the design and development of new technologies (i.e., modified cigarettes). emerging research shows that women may be more responsive to the non-nicotine sensory aspects of smoking such as menthol flavor, whereas men may smoke primarily for nicotine intake. consequently, this study expects to observe gender differences in response to manipulating flavors and nicotine content in cigarettes.

Eligibility criteria:
inclusion criteria: 1. smoking at least 5 menthol cigarettes daily for the last year; 2. able to speak, read and understand english; 3. male age 18 -45 years of age; 4. stable residence; 5. not intending to quit smoking within the next 6 weeks. exclusion criteria: 1. unstable psychiatric disorder (psychiatric symptoms reported that cause current significant impairment in functioning or judgment such that the person's ability to come consistently for study appointments or render a decision regarding informed consent is in question.); 2. substance use which exceeds any of the following: marijuana use 3x/week, consuming 21 drinks/week or illicit drug use 1x/week; 3. history of cardiovascular disease; 4. current blood clot in arms or legs; 5. blood pressure \>160/100; 6. unstable medical problems which may include but are not limited to immune system disorders, severe respiratory diseases, kidney or liver diseases, thyroid problems, substance abuse or dependence that would limit patients ability to follow experimental protocol 7. serious quit attempts in the last 3 months; 8. regular use (e.g., greater than weekly) of tobacco products other than cigarettes; 9. currently using nicotine replacement or other tobacco cessation products

Keywords: menthol nicotine reduced nicotine smoking cigarette cigarettes men smoking smoking research nicotine dependence
vaginal vault suspension during benign hysterectomy. a questionnaire and register-based study.

Conditions: Postoperative Pelvic Organ Prolapse; Benign Hysterectomy; Suspension

Summary: female pelvic organ prolapse (pop) is characterized by lack of vaginal support which enables pelvic organs to bulge into the vaginal walls and sometimes protrude through the genital hiatus. pop is more frequent among women who had their uterus removed. we would like to investigate whether suspension of the top of the vagina during remowal of the uterus prevents subsequent pop. the purpose of the phd project is therefore to describe validity, terminology, and operative performance of used suspension methods during benign hysterectomy in denmark. further, to investigate these suspension methods' possible association with pain, life quality, sexuality, pessary use, and pop .

in 2012 the investigators introduced codes of suspension methods to the danish hysterectomy and hysteroscopy database's registration chart. consequently, validity of these codes needs to be ensured to enable their use in further research. thereafter, the prevalence of danish gynecologists' use of the different suspension methods will be investigated. a questionnaire will elucidate a possible relation between the suspension methods and pain, life quality and sexuality. through a register based study in the national patient register the association between suspension methods and post hysterectomy pop and possible confounding will be investigated.

Eligibility criteria:
inclusion criteria: * alive women two years after hysterectomy * benign hysterectomy * willingness to participate (in the questionnaire) exclusion criteria: * death * emigration * secret address

Keywords: suspension, benign hysterectomy, post operative prolapse
evaluation of effective lens position with a uniplanar bi-aspheric iol

Conditions: Cataract

Summary: the primary goal of this study is to determine the effective lens position (elp) - or location an intraocular lens (iol) "sits" in the eye - of the softec hd iol. a secondary study goal is to determine if measures of the eye taken prior to surgery can reliably predict postoperative elp.

the primary objective of this study is to determine the effective lens position (elp) of the study lens, and to report the stability of elp post-operatively. additionally, correlations of elp to predicted postoperative lens position, capsular bag metrics, preoperative biometry and age will be statistically analyzed for determination of elp prediction via one, or a combination of preoperative variables.

Eligibility criteria:
inclusion criteria: * \>=40 years of age, of any race and either gender * operable, age related cataract grade 3+ or lower in the study eye * able to achieve best corrected visual acuity (bcva) 20/30 snellen or better postoperatively in the study eye * ≤1.0 diopter (d) of corneal astigmatism preoperatively in the study eye * able to achieve a dilated pupil \>6.0 millimeter (mm) in the study eye * able to adequately visualize the lens equatorial diameter on ultrasound biomicroscopy (ubm) unit (preoperatively) * desire implantation of a monofocal lenses targeted at emmetropia in the study eye * in good general and ocular health * able to competently complete testing * willing and able to attend study visits * willing and able to understand and sign an informed consent exclusion criteria: * previous intraocular surgery or laser treatment * severe dry eye * uncontrolled iop or glaucoma * retinal or macular pathology (i.e. macular degeneration, proliferative diabetic retinopathy, etc.) * history of retinal detachment * microphthalmia * chronic severe uveitis * corneal decompensation * irregular astigmatism * history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) * clinically significant corneal endothelial dystrophy (e.g., fuchs' dystrophy) * pseudoexfoliation syndrome * iris atrophy * pupil abnormalities (e.g., corectopia) * aniseikonia * amblyopia * an acute or chronic disease or illness that may confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness) * pregnant, lactating, or planning to become pregnant during the course of the trial * participation in another clinical trial within 30 days of study start

Keywords: cataract biaspheric intraocular lens uniplanar intraocular lens effective lens position
effects of simeox on static hyperinflation in patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study will investigate the effects on the simeox technology on static hyperinflation in patients with chronic obstructive pulmonary disease (copd).

this is a crossover study assessing the short-term effects of simeox and pep device on static hyperinflation in patients with copd. patients will perform lung function tests (to assess the residual volume and functional residual capacity) before, after and 30 minutes after a 20-min long session of simeox or pep (depending of randomization).

Eligibility criteria:
inclusion criteria: * patients with chronic obstructive pulmonary disease, * forced expiratory volume in 1s (fev1) \<80% of predicted value, * stable condition (no pulmonary exacerbation for more than 28 days). exclusion criteria: * routine use of one of the two treatments - simeox and/or pep, * inability to understand or carry out the instructions, * severe cardiac comorbidity, neuromuscular disease, * severe scoliosis, * patient with a pacemaker.