Kornimate/medical-research-clean huggingface dataset:
branch vein occlusion study

Conditions: Macular Degeneration; Neovascularization, Pathologic; Vitreous Hemorrhage

Summary: to determine whether scatter argon laser photocoagulation can prevent the development of neovascularization. to determine whether peripheral scatter argon laser photocoagulation can prevent vitreous hemorrhage. to determine whether macular argon laser photocoagulation can improve visual acuity in eyes with macular edema reducing vision to 20/40 or worse.

retinal branch vein occlusion (bvo) is the second most common retinal vascular disease after diabetic retinopathy. many treatments for this disorder were attempted before 1977, but none were proven to be effective. the only treatment that seemed at all promising in preventing visual loss from bvo was laser photocoagulation. approximately 500 patients were enrolled in the study. one-half were randomly assigned to treatment with argon laser photocoagulation; the other one-half remained untreated as controls. for bvo with or without neovascularization, scatter treatment of 100 to 400 laser burns was applied in the drainage area of the occluded vein site, avoiding the fovea and optic disc. individual laser burns were 200 to 500 microns in diameter with an exposure time of 0.1 to 0.2 seconds. for macular edema, burns of 50 to 100 microns in diameter with exposure time of 0.05 to 0.1 seconds were used. a fluorescein angiogram less than 1 month old had to have been available for each patient. treatment was performed under topical anesthesia using the argon laser to achieve a grid pattern over the area of capillary leakage identified by fluorescein in the macular region. photocoagulation was extended no closer to the fovea than the edge of the foveal avascular zone and did not extend peripherally beyond the major vascular arcade. the efficacy of treatment was judged on the basis of visual acuity measurements as well as assessment of the subsequent development of neovascularization and/or vitreous hemorrhage. patients were followed for at least 3 years.

Eligibility criteria:
patients with three types of diagnoses were accepted: 1. major bvo without neovascularization; 2. major bvo with neovascularization; 3. bvo with macular edema and reduced vision. all patients must have had onset of signs and/or symptoms of bvo less than 18 months before the initial visit, vision of 5/200 or better, and sufficient clarity of the ocular media to permit confirmation of the condition with fundus photography. other eligibility criteria apply to each of the three major groups as well as special cases such as the occurrence of bilateral disease.
a canadian open-label study to evaluate the safety and effectiveness of adalimumab when added to inadequate therapy for the treatment of psoriatic arthritis (psa) (acclaim)

Conditions: Psoriatic Arthritis

Summary: to further assess the safety and effectiveness of adalimumab 40mg in the treatment psa who have had an unsatisfactory response or intolerance to prior or ongoing dmards


Eligibility criteria:
inclusion criteria: * active psoriatic arthritis defined by \>= 3 tender or painful joints and \>= 3 swollen joints despite standard psoriatic arthritis therapy * has had an unsatisfactory response or intolerance to at least two prior or ongoing dmards (one of which has to be methotrexate) exclusion criteria: * has a history of cancer or other than certain skin or cervical cancers * has a history of, or current acute inflammatory joint disease of origin other than psa, e.g., systemic lupus erythematosus etc. * has other, unstable diseases, including congestive heart failure, inflammatory bowel disease, recent stroke, leg ulcers or other condition which would put the subject at risk * history of active tuberculosis, history of histoplasmosis or listeriosis * latent tb or risk factors for the activation of latent tb, e.g. previous exposure to tb, and has not initiated tb prophylaxis prior to the first adalimumab treatment
the effect of testosterone on mood and quality of life

Conditions: Gonadal Disorders; Depressive Disorder; Hypogonadism

Summary: we hypothesize that testosterone replacement will improve mood and quality of life in older men with low testosterone and mild depression. study subjects will receive either testosterone gel or a placebo (inactive) gel for 12 weeks. neither the subject or the investigator will know whether they are receiving placebo or testosterone gel. at the end of the initial 12 week period, all subjects will receive testosterone gel for 12 more weeks. mood and quality of life measures will be obtained at baseline, at the end of the double-blind phase and at the end of the extension phase (when all subjects receive testosterone.)

this is a randomized, double-blind, placebo-controlled trial of testosterone replacement in older men with age-associated hypogonadism and subsyndromal depression. men will receive either 7.5 gm/qd of testosterone gel or a placebo gel for 12 weeks. the double-blind phase will be followed by a 12 week open-label extension in which all subjects will receive 7.5 gm/qd of testosterone gel. procedures: depressive symptoms will be assessed with the hamilton depression rating scale (hdrs) and the scl-20, a 20-item self-report depression scale that has been shown to have high reliability and validity and to be sensitive to changes in depressive symptoms in outpatients in primary care settings. the short form (16 item) endicott quality of life enjoyment and satisfaction scale will be used to assess quality of life changes. the medical outcomes study short-form 36 (sf-36) will be used to assess changes in functional status. demographic information, medical history and current medications will be determined at baseline and follow up, via patient interview and chart review. overall medical morbidity will be ascertained with the cumulative illness rating scale. all outcome measures (scl-20, endicott quality of life scale, hdrs,sf-36) will be assessed at baseline, week 12 (end of the double-blind phase)and week 24 (end of the extension phase). blood draws will be done at baseline, week 12 and week 24. laboratory assays for testosterone leves at baseline, week 12 and week 24 will be performed at the same time to minimize interassay variability.

Eligibility criteria:
inclusion criteria: * age: 50 or older * total testosterone \<=280 ng/dl * subsyndromal depressive disorder: either dysthymia or minor depression (per dsm iv and dsm iv appendix) exclusion criteria: * psa \>=3.0 * klinefelter's syndrome * prostate or breast cancer * hospitalized in the past month * obstructive bph * current testosterone treatment * schizophrenia, bipolar disorder, dementia * treatment with antipsychotics or benzodiazepines * alcohol dependence or other substance dependence * suicidal or psychotic symptoms

Keywords: testosterone depression subsyndromal depression quality of life
muscle oxygenation and skin pigmentation

Conditions: Muscle Oxygenation; Skin Pigmentation

Summary: the investigators plan to enroll 500 consecutive subjects at a major trauma center for this study. for each patient, the body mass index (bmi), age, sex, diastolic pressure and mean arterial pressure (map) at time of measurements. additional information including diseases such as diabetes and vascular disorders will be recorded. social demographics including alcohol and tobacco use will be recorded. this is important as alcohol and tobacco use could also contribute to cardiovascular diseases. the skin pigmentation of each subject will be recorded. two different methods will be used for this measurement. each patient will be graded on a six point scale as described by young (young, 1997). additionally, each subject will have their skin measured using a reflectance colorimeter. the colorimeter, dermaspectrometer ii (cyberderm, broomall, pa) uses visible light to measure the amount of light reflected off the skin. by measuring the light reflectance, the skin pigmentation can be measure (clarys, 2000). muscle oxygenation will be measured using a continuous dual wavelength near infrared spectrometer. using the different absorption characteristics of deoxyhemoglobin and oxyhemoglobin, the concentration of oxyhemoglobin in the muscle at an approximate depth of 2.5 cm is determined. the invos cerebral oximeter (somanetics, troy, mi) will be used for all measurements.


Eligibility criteria:
inclusion criteria: * male or female between the ages of 18 and 75 years old * subjects that have no lower extremity injuries. * subject who are classified as being either light or dark skin pigmentation. * subjects willing to participate in the study. exclusion criteria: * patients with previous injury to either lower extremity * patients with previously diagnosed vascular disease or insufficiency * patients with pulmonary insufficiency or severe pulmonary injury * patients not willing to consent to participate

Keywords: compartment syndrome muscle oxygenation skin pigmentation
residual torsional deformity in pediatric genu varum after coronal plane deformity correction by 8 plate hemi epiphysiodesis.

Conditions: Paediatric Surgery

Summary: this study is to evaluate the residual torsional deformity in pediatric genu varum after coronal plane deformity correction by 8 plate hemi epiphysiodesis.

angular deformities around the knee in children is a common finding including genu valgum and genu varum. the genu valgum or varum may be idiopathic or arise from diverse etiologies, such as trauma, dysplasia, metabolic disease, inflammatory, endocrine, tumor, neoplastic, or developmental pathologies. surgical treatment options include osteotomies with either acute or gradual correction and temporary hemi epiphysiodesis (guided growth),the latter being less invasive and with significantly lower rate of major complications. guided growth by 8 plate hemi epiphysiodesis is commonly used to correct coronal plane deformity around the knee. since its introduction by stevens in 2007 many studies have demonstrated the efficacy, safety and advantages of tension band plating in the paediatric age group as an alternative to corrective osteotomy. genu varum deformities of the leg are often associated with internal tibial torsion. the 3 major causes of pediatric in-toeing are metatarsus adductus, internal tibial torsion, and femoral anteversion. ..yet, there is no enough available literature studies evaluating the amount of correction of torsional deformity after coronal plane deformity correction by 8 plate hemi epiphysiodesis. this is the question of this study and we are trying to answer it by measuring the residual torsional deformity after achieving full correction of coronal plane deformity by 8 plate hemi epiphysiodesis.

Eligibility criteria:
- inclusion criteria: skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral) - exclusion criteria: 1. skeletal maturity. 2. epiphyseal dysplasia. 3. metabolic and neurologic disorders. 4. previous trauma. 5. patients younger than 2.5 years and older than 12 years old
feasibility and success trial of remote patient monitoring in heart failure

Conditions: Congestive Heart Failure

Summary: previous research has investigated the use of remote patient monitoring in various clinical contexts, however there has not been a clinical trial examining use of the vitalcare platform for ambulatory management of heart failure. this trial will serve as a pilot study examining the feasibility of use of the vitalcare platform for ambulatory heart failure management and examine the effect of remote patient monitoring on patient engagement. to the investigators' knowledge, this will be the first study examining the effect of remote patient monitoring with the vitalcare platform on heart failure clinical outcomes, such as hospitalization for heart failure exacerbations and emergency room visits for heart failure.

the next step in determining the role of remote patient monitoring in the management of patients with heart failure is to better understand which patients are most likely to benefit from a more intensive outpatient management or simply conservative management. the subject population is patients with mild hfref or hfpef who are prone to readmission. this patient population does not have implanted devices to supply objective data to evaluate patient's volume status and therefore can be challenging to manage on an outpatient basis. by providing regular data on weight, blood pressure, pulse oximetry, electrocardiogram and heart/lung sounds that is reviewed on a monthly basis, this may allow a clinician greater insight into their patient's clinical status and allow for a more accurate and timely intervention to prevent clinical deterioration. furthermore, this should enhance patient engagement with their own health as well as with their healthcare provider. this study would significantly add to the current knowledge of management of heart failure in an ambulatory patient population without implanted devices.

Eligibility criteria:
inclusion criteria: * a clinical diagnosis of heart failure * new york heart association class ii or iii congestive hf symptoms * admission to hospital within 12 months for symptomatic heart failure. * own a smartphone or tablet or comfortable with using one * english as primary language * able to provide informed consent exclusion criteria: * left ventricular ejection fraction \< 35% * implanted cardiac device (permanent pacemaker (ppm), implantable cardioverter defibrillator (icd), chronic resynchronization therapy (crt), implantable loop recorder (ilr)) * cardiomems * left ventricular assist device (lvad) * nyha class i or iv congestive hf symptoms * listed for cardiac transplant * pregnant at time enrollment * end-stage renal disease
evaluation research of a national accreditation and improvement programme for general practice

Conditions: Cardiovascular Disease

Summary: objective: this study aims to determine the effectiveness and efficiency of a national accreditation and improvement programme for general practice, focusing on patients with established cardiovascular diseases. design: cluster randomised trial with a block design. all practices start with the accreditation procedure.intervention group practices are requested to focus their improvement plans in the first year on cardiovascular disease. control group practices are requested to focus their improvement plans in the first year on other domains. measurements at baseline are based on the standard audit in the accreditation procedure. follow-up measurements are done 12 months after approval of improvement plans. participants: primary care physicians in the netherlands. interventions to be implemented: improvement plans concerning cardiovascular risk management, as described by recently updated national multidisciplinary evidence-based nhg / cbo guidelines, considering patients with established cardiovascular diseases. implementation strategy: the national programme for accreditation and improvement of general practice. this procedure consists of a package of activities, including audit, feedback, improvement plans, and follow-up. outcome measures: primary outcomes are percentages of patients with cvd who have acceptable systolic blood pressure and cholesterol levels (quantified according to the indicators in the accreditation)and who use aspirin or alternatives. secondary measures include clinical and organisational indicators of quality of cardiovascular care, such as percentages of patients with cardiovascular disease whose risk factors were assessed and who received specific medication. economic evaluation: incremental cost effectiveness ratio's are determined of the implementation strategy compared to no implementation. the analysis will take a societal perspective and a time horizon of the observed period as well as a hypothetical 10 years period (using modelling). uncertainty related to the estimations is examined with sensitivity analyses and bootstrapping. the long term economic evaluation is based on markov modelling.


Eligibility criteria:
inclusion criteria: * patients with established cardiovascular diseases (myocard infarct, angina pectoris, cerebrovascular accident, transient ischaemic attack, peripheral vascular disease, aneurysma aortae) exclusion criteria: -

Keywords: accreditation cardiovascular disease primary care
target muscle re-innervation and regenerative peripheral nerve interfaces alone and in combination for the treatment of residual and phantom limb pain in cancer patients who have received an amputation

Conditions: Amputation

Summary: this clinical trial evaluates two surgical techniques (targeted muscle re-innervation \[tmr\] and regenerative peripheral nerve interfaces \[rpni\]) alone and in combination for the alleviation of chronic residual limb and phantom limb pain in cancer patients who have had an amputation. chronic residual limb pain and phantom limb pain are debilitating outcomes of traumatic and oncologic amputation. emerging microsurgical treatments for post-amputation pain are very promising. tmr and rpni are both approved surgical techniques that involve connecting cut nerves to parts of the muscle as a way to heal and protect the nerves. this trial evaluates these techniques alone and in combination for the treatment of residual and phantom limb pain in cancer patients who have received an amputation.

primary objective: determine the relative effectiveness of three surgical techniques, tmr, rpni, and tmr with rpni, on chronic and phantom limb pain in the oncologic amputee using the validated numerical rating scale (nrs) and patient-reported outcomes measurement information system (promis) behavior, intensity, interference, and global health forms. secondary objectives: i. to estimate the rate and total quantity of any pain medication use among oncology amputees who received one of the three surgical techniques. ii. to estimate the rate of prosthetic use among oncologic amputees. iii. to compare nrs and promis among three surgical techniques to calculate the effect size and project the sample size which will be used to plan a multi-institutional study. outline: patients are randomized to 1 of 3 arms. arm 1: patients undergo tmr procedure. arm 2: patients undergo rpni procedure. arm 3: patients undergo tmr in combination with rpni. after completion of study procedure, patients are followed up at 3, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons * patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue * patients able to complete informed consent exclusion criteria: * patients under 18 years of age * patients unable to give consent * patients receiving an amputation for non-oncologic purposes * patients with amputations performed for immediate palliation (life expectancy less than 3 months), as this technique takes a minimum of 3-6 months for effect * patients with multiple limb amputations * patients receiving nerve management in a delayed fashion (patients who have previously received an amputation and present with neuroma)
cafeteria-based study of weight gain prevention

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to investigate two cafeteria-based methods of weight gain prevention in overweight men and women.

background: obesity is a risk factor for a number of adverse medical and psychosocial outcomes. solving the obesity problem will require a much greater emphasis on prevention. treatment research indicates that interventions focusing directly on the food environment (structured meals and control of food stimuli) have considerable promise for weight control. prevention research has found little support for trying to modify characteristics (e.g., knowledge, beliefs, skills) of individuals, perhaps because this approach does little to modify the food environment. the research will be implemented in a workplace cafeteria where employees eat year-round and where the nutritional composition of the food can be modified. the study was initiated in response to a request for applications issued in october, 2001 on "environmental approaches to the prevention of obesity". the request for applications was jointly issued by the national institute of diabetes and digestive and kidney diseases, the national institute of environmental health sciences, the national center for minority health and health disparities, the office of behavioral and social sciences research, and the national heart, lung, and blood institute. design narrative: the influence of two promising interventions on food intake, weight change, and related outcomes will be investigated. the first intervention consists of a training program aimed at reducing the energy density of participants' diets inside and outside of the cafeteria. the second intervention consists of financial incentives to encourage the consumption of cafeteria foods lower in energy density. participants will be 195 caucasian and african-american men and women between the ages of 21 and 65. they will have a bmi of 23-35 and will have characteristics associated with an increased risk of weight gain. selection and intake of lunch foods will be measured with digital photography and cashiers' computerized records of food purchases. cafeteria patrons will be randomly assigned to 1) a measurement-only condition; 2) an intervention designed to teach participants how to reduce the energy density of their diets; or 3) the reduced energy density intervention plus financial incentives for choosing cafeteria foods low in energy density. the potential moderating influence of individual differences characteristics on outcome will also be evaluated. outcome measures will be administered repeatedly during the intervention and at 9- and 18-month follow-ups. the assessments will include measures of anthropomorphic and blood lipid variables, nutritional intake (both in and out of the cafeteria), physical activity, overeating, eating self-efficacy, and weight-related quality of life.

Eligibility criteria:
no eligibility criteria
management with fear of cancer in women undergoing colposcopy: randomized controlled study

Conditions: Cancer Fear; Cervical Cancer

Summary: cervical cancer is the fourth most common cancer in women worldwide. due to advances in early diagnosis and treatment, the number of survivors of cancer has increased over the past 50 years. therefore, the current standard of care for the detection of cervical neoplasm, a papanicolaou smear and then a colposcopic biopsy, requires a high degree of diagnostic accuracy. in particular, the fear of developing cancer after cancer screening tests is becoming an increasingly significant problem, with an impact on psychosocial health in individuals. for people who are afraid of cancer, meditation and awareness training can make it easier for emotions to self-regulate in times of distress and pain. this study aim to conducted to determine the impact of the awareness-based initiation program on cancer fear and level of awareness in women undergoing colonoscopy.


Eligibility criteria:
inclusion criteria: * colposcopy procedure due to hsil, lsil, asc-h or hpv on cervical cytology * volunteering to participate in the 6-session mindfulness-based coping programme knowing what a colposcopy procedure means, exclusion criteria: * interference with verbal communication, * being diagnosed with major depressive disorder or psychiatric disorder, * having participated in mbsr training or meditating before * lack of skills to use smart phones and computers * learning biopsy results during the programme

Keywords: fear of cancer mbsr nursing awareness cervical cancer