Kornimate/medical-research-clean huggingface dataset:
s9431: studying genes and immune response in tumor samples from patients with locally advanced or metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this laboratory study is assessing genes and immune response in tumor samples from patients with locally advanced or metastatic melanoma.

objectives: * characterize the frequency of non-random cytogenetic abnormalities in regional and distant melanoma metastases and explore their association with clinical outcome of patients with metastatic melanoma. * characterize the frequency of specific genetic alterations at either the dna, mrna, or protein level and explore the association of these abnormalities with clinical outcome in these patients. * characterize the host immunologic response to metastatic melanoma by determining whether the in vivo pattern of cytokine expression is consistent with specific subsets of t helper cells within melanoma deposits and to explore whether host immunologic response varies based on the site of metastatic disease and/or correlates with clinical outcome in these patients. * obtain peripheral blood, sera, and paraffin embedded tumor blocks from these patients. * correlate the most prevalent gene copy alteration observed in metastatic disease with the risk of progression in tissue samples from patients registered on swog-9035 (primary melanoma). outline: fresh and snap frozen tumor tissue samples are obtained from biopsy or surgical procedures in the coordinated study. specimens undergo mrna and dna analysis of tumor-related genes and cytokine gene expression. peripheral blood samples are obtained and processed for sera and mononuclear cell testing. tumor tissue samples embedded in paraffin or on unstained slides are also obtained. projected accrual: approximately 120 patients will be accrued for this study within 3-4 years.

Eligibility criteria:
disease characteristics: * diagnosis of stage iii or iv metastatic melanoma * concurrent enrollment on a swog-coordinated melanoma treatment study (within 56 days of registration on this study) or * previously enrolled on and eligible for at least 1 swog-coordinated melanoma study and scheduled to undergo biopsy/surgery for regional lymph node or disseminated metastatic disease or * concurrent enrollment on swog-9430 (fish analysis) patient characteristics: age * not specified performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * not previously enrolled on swog-9431

Keywords: stage iii melanoma stage iv melanoma recurrent melanoma
optimal stimulation programming for spinal peripheral neuromodulation

Conditions: Chronic Pain

Summary: to determine the best parameters with various leads to cover back and leg pain and provide best pain relief

prospective double-blinded trial of patients already implanted with scs to determine which programming model best controls their back and or leg pain. baseline visit is 2 weeks after implant. baseline study data is collected, program #1 is started. the visit @ week 4 collects nrs, changes to program #2. the visit @ week 6 collect nrs, and starts program #3. the visit @ week 8 collects nrs. subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. the visit @ week 20 collects nrs.

Eligibility criteria:
inclusion criteria: * spinal cord stimulator implant within last 3 weeks * nrs \> 6 * at least 22 years old * patients who agree not to add or increase their pain medications during the study exclusion criteria: * patients with prior spinal cord stimulators * pregnancy * infusion pump * history of substance abuse or dependency in last 6 months

Keywords: back pain neuromodulation spinal peripheral neuromodulation spinal cord stimulation postlaminectomy pain syndrome
monitoring asthma and copd in primary care

Conditions: Lung Diseases, Obstructive; Asthma

Summary: the purpose of this study is to determine the clinical effectiveness and cost-effectiveness of a written expert advice for gps on additional diagnostic, treatment, and referral of patients based on half-yearly monitoring routines for patients with copd or ashtma with a persistent obstruction in primary care based on a multicentre randomised nested clinical trial

in the netherlands, the majority of patients (60-80 %) with asthma or copd are treated in primary care, primarily by general practitioners (gps). in 1995 a regional diagnostic centre, etten-leur, the netherlands (also called shl: stichting huisartsen laboratorium) started a lung function monitoring service for patients with asthma and copd of gps in the region. the gp receives recommendations on treatment, additional diagnostics and referrals of the patient based on extensive anamnesis (i.e. dyspnoea, symptoms, smoking stage), measurement of lung function, and bmi. moreover,the general practitioners are supported by an asthma/copd nurse that visit the general practice half-yearly. main research question of this study: is a written expert advice for gps on additional diagnostic, treatment, and referral of patients based on half-yearly monitoring of patients with copd or asthma with a persistent airway obstruction with support of an ac nurse consultant related to less impaired health related quality of life (hrqol), less symptoms and better lung function of the patients compared to usual care? a multi-centre, single blinded (patient, lung function assistant, advisor, and research team are blinded), parallel group study is carried out to compare the monitoring intervention with usual care during 24 months. general practices were allocated by a minimisation procedure and all participating patients of a general practice were allocated to the same treatment group (nested design).

Eligibility criteria:
inclusion criteria: * the patient is categorised as asthmatic disease with persistent airway obstruction or copd in the monitoring system shl confirmed by the most recent lung function assessment (fev1/fvc \< 70% after bd and fev1 ≥ 50% pred after bd) or (fev1 \< 80% predicted after bd and ≥ 9% reversibility) * the patient is monitored by the ac service of the shl. * the gp of the patient is willing to participate in the trial. * written informed consent of participant exclusion criteria: * patients treated primary by a pulmonologist * patients currently participating in another respiratory intervention study * when the gp considers it detrimental to the patient to participate in the study * serious other non-pulmonary diseases (or disease-stages) that are presumed to lead to "lost to follow-up" because of the severity of the disease course (like diseases with low survival rate or mental deterioration) * serious other pulmonary diseases that effect bronchial symptoms and/or lung function, e.g. sarcoidosis, lung cancer, lung fibrosis * illiteracy

Keywords: copd asthma lung function monitoring primary care
exercise for stable myasthenia gravis

Conditions: Myasthenia Gravis

Summary: generalized fatigue in myasthenia gravis results in physical deconditioning that reduces fitness and increases risk of obesity, hypertension, elevated cholesterol and type 2 diabetes. this study will examine how active and fit are 30 individuals with chronic, generalized myasthenic subjects. this study will also determine whether a 3 month home exercise program with aerobic, resistive, and pulmonary training can improve physical activity, strength, fitness, lung function and reduce cardiovascular disease risk.

generalized fatigue in myasthenia gravis results in a sedentary lifestyle and profound physical deconditioning, leading to reduced fitness and increased risk of obesity, hypertension, dyslipidemia, and type 2 diabetes. this study will characterize the activity and fitness levels and cardiovascular disease risk profile in 30 chronic, generalized myasthenic subjects. hypotheses are that a) subjects with myasthenia gravis are physically inactive with reduced fitness level and high incidence of obesity and poor cardiovascular disease risk profile, and b) a 3 month multi-modal home exercise program that includes aerobic, resistive, and pulmonary training components will improve physical activity, strength, fitness, dyspnea, body composition and reduce cardiovascular disease risk. specific aims are to a) define the baseline physical activity and fitness levels and prevalence of insulin resistance and dyslipidemia in stable sedentary myasthenic subjects, b) determine whether a 3 month moderate intensity home exercise program is safe and feasible in deconditioned, stable myasthenic subjects and c) whether a 3 month comprehensive home exercise program can enhance fitness, strength, and lung function to improve physical activity and reduce cardiovascular disease risk.

Eligibility criteria:
inclusion criteria: * stable generalized myasthenia gravis * adults age 18-70 exclusion criteria: * already performing regular exercise * unstable angina * recent (\<3 month) myocardial infarction, stroke, hospitalization for major illness or major surgery * chronic pain or orthopedic condition restricting exercise * active cancer, excluding basal cell cancer * anemia (hct \<30) * pregnancy * myasthenia gravis exacerbation in past 3 months

Keywords: myasthenia gravis exercise fitness body composition physical activity pulmonary function balance
inter-rater reliability of the australian spasticity assessment scale (asas) in post-stroke spasticity

Conditions: Hemiplegia, Spastic

Summary: the reliability of the australian spasticity assessment scale (asas) has been reported to be not high enough in adult patients with acquired brain damage. the low number of patients and the heterogeneous study population have been reported as important limitations in the reliability study of this measure. therefore, the reliability of the asas needs to be confirmed in stroke patients with spasticity. this study aims to investigate the inter-rater reliability of the asas in a study population consisting of a larger and more homogeneous patient population (those with post-stroke spasticity).

spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex due to upper motor neuron lesion. the prevalence of post-stroke spasticity is between 17-40%. in the assessment of spasticity, although biomechanical and neurophysiological methods provide quantitative data, semi-quantitative methods are mostly used clinically. the most frequently used spasticity measures are the modified ashworth scale and the modified tardieu scale. however, these methods have significant disadvantages. therefore, the search for more reliable clinical measures continues. one of the newly developed clinical scales is called the australian spasticity assessment scale (asas). although asas has been reported to have a high level of reliability in children with cerebral palsy, the same has not been detected in adult patients with acquired brain damage. the low number of patients and the heterogeneous study population have been reported as two of the important limitations in the reliability study of this measure. in this study, researchers aim to investigate the inter-rater reliability of the asas in a study population consisting of a larger and more homogeneous patient population (those with post-stroke spasticity).

Eligibility criteria:
inclusion criteria: * chronic stroke (\> 6 months) * fist stroke * increased tone according to the modified ashworth scale in at least one of the elbow, wrist, and ankle * stability of spasticity for the last 3 months exclusion criteria: * increased tone due to causes other than stroke (traumatic brain injury, spinal cord injury, multiple sclerosis, motor neuron disease, etc.) * acute or subacute stroke (≤6 months) * recurrent stroke attacks * presence of contracture and/or moderate to severe pain in the joints to be assessed (elbow, wrist, and ankle) * botulinum toxin injection in the last three months * history of neurolysis for spasticity (alcohol or phenol) * history of surgery for spasticity * initiation of a new drug for spasticity, or a change in drug dose

Keywords: hemiplegia spasticity upper limb
comparison of mobile-bearing and fixed-bearing all-polyethylene tibia total knee designs

Conditions: Osteoarthritis, Knee

Summary: this study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/ap) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (rp) design for total knee arthroplasty. comparing these two designs will afford the investigators information in the following areas: 1. does a rp design offer improvement in range of motion over a ap design? 2. does a rp design have improved wear characteristics over a nonmodular ap design? 3. is there a clear clinical advantage to the rp design that justifies its increased cost? answering these questions will allow surgeons to use rp designs appropriately in different demand populations. this study was designed to address the questions of whether an rp design offers improvement in rom, knee society scores, western ontario and mcmaster universities index of osteoarthritis (womac) scores, selected medical outcomes short-form health survey short form-36 (sf-36) scores or radiographic measures, over an apt design. the investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. a secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival.


Eligibility criteria:
inclusion criteria: * generally accepted clinical and radiographic criteria for primary total knee arthroplasty exclusion criteria: * substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator * patients whose mental function precluded them from responding to our standard questionnaires

Keywords: knee arthritis total knee arthroplasty total knee replacement mobile bearing design all-polyethylene tibia
efficacy and safety of inhaled bronchodilator in non-cf bronchiectasis with airflow limitation

Conditions: Bronchiectasis Adult

Summary: airflow limitation is common exist in idiopathic bronchiectasis patients. however, there are few evidence on the treatment of bronchodilator in bronchiectasis with airflow limitation. the efficacy and safety of dual bronchodilator in idiopathic bronchiectasis with airflow limitation are still unclear. thus, the investigators conduct a multicenter, open-label randomized controlled trial to investigate the efficacy and safety of dual bronchodilator in idiopathic bronchiectasis with airflow limitation.

airflow limitation is common exist in idiopathic bronchiectasis patients. our previous studies showed that fev1\<50% is one of the major risk factors for poor prognosis and high incidence of acute exacerbation in patients with bronchiectasis. however, there are few evidence on the treatment of bronchodilator in bronchiectasis with airflow limitation, and there is no recommendation in bronchiectasis guidelines. moreover, because of the high risk of infection and bacterial colonization in bronchiectasis, there is still unclear whether inhaled corticosteroids or bronchodilators affect the parameters of bronchiectasis. thus, there is urgent need to optimize the treatment of bronchiectasis with airflow limitation.

Eligibility criteria:
inclusion criteria: * idiopathic bronchiectasis with fev1/fvc \< 70% exclusion criteria: * with asthma * α-1 antitrypsin deficiency * turculosis * lung cancer * sarcoidosis * idiopathic pulmonary fibrosis * primary pulmonary hypertension * uncontrolled sleep apnea * bronchiectasis accepted long-term low dose macrolides * pulmonary surgery within 6 months * lower respiratory tract infections require antibiotic treatment in 6 weeks * upper respiratory tract infection did not recover for at least 7 days * with glaucoma or severe prostate hyperplasia that can not use indacaterol * patients allergic to experimental drugs * women pregnant, breast-feeding or who planned a pregnancy during the study
the effect of incentive spirometry added to routine physiotherapy program on hemodynamic responses and hospital stay in patients with copd exacerbation

Conditions: COPD Exacerbation

Summary: copd; it is a common, preventable and treatable disease that is associated with increased chronic inflammatory responses in the airways and lungs against harmful gases and particles, and that it manages progressive airflow. the definition of exacerbation is defined as an acute onset with a change in where daily differences in the main symptoms occur and which may occur with the presence of drugs. the number of exacerbations in the course of the disease is between 1-3 years on average. routine physiotherapy treatment in copd exacerbation is expected to increase lung volume and effective removal of airway secretions. the concept of physiotherapy programs is vibration, thoracic expression exercise, positive expiratory pressure therapy and gait programs. an incentive spirometer is a simple, inexpensive device to adjust lung tissue re-expansion by increasing lung volumes and diaphragmatic mobility, providing maximal inspiration with termination control without a resistive loading. in copd patients, the use of incentive spirometry is to increase alveolar ventilation and oxygenation in lifestyle. there are a limited number of studies in the literature regarding the results of the use of incentive spirometry in copd patients. the results of postoperative results of incentive spirometry in copd patients were tried and established on pulmonary complications, diseases, postoperative dyspnea perception and lifestyle. the importance of the investigator's research; this is the first study to evaluate hemodynamic responses and hospitalization plans of incentive spirometer and routine physiotherapy program in copd exacerbations.


Eligibility criteria:
inclusion criteria: * being diagnosed with copd exacerbation * hemodynamically stable * to be conscious and voluntarily agree to participate in the study exclusion criteria: * existence of neurological, cardiovascular and musculoskeletal problems to prevent exercise * having chronic respiratory disease other than copd

Keywords: copd incentive spirometry length of stay hemodynamic responses
a study to establish the feasibility of biolen for the local delivery of bicalutamide in patients with prostate cancer

Conditions: Prostate Adenocarcinoma; Lower Urinary Tract Symptoms

Summary: biolen, a novel implant, is intended to deliver an anti-androgen locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. the objectives of the study are to assess whether the biolen is safe.

this prospective, multi-center, single-arm feasibility study is planned to assess the safety and patient tolerance of biolen for the localized delivery of bicalutamide into the prostate in patients presenting for treatment of prostate cancer. study participants will have placement of the drug eluting biolen and be followed through scheduled radical prostatectomy.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate. * study participant qualified and planning for radical prostatectomy. * at least 1 prostate lesion measurable by mri \> 0.5 cm within one month of screening. * psa \> 3 ng/ml within 3 months of screening. * gleason score 3+4 or higher. * study participant must be willing to undergo post-treatment imaging by mri. * ecog performance status 0 or 1. exclusion criteria: * prior radiotherapy or surgery for prostate cancer. * prior or ongoing hormonal therapy for prostate cancer. * prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive bph procedure. * study participant unwilling or unable to undergo mri, including patients with contra-indications to mri, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc. * metallic hip implant or any other metallic implant or device that distorts the quality of prostatic mr images. * use of 5 alpha reductase inhibitors (e.g. finasteride or dutasteride) within 3 months of screening or total use within the last two years prior to screening of \> 3 months. * presence of any metastatic disease. * prostate volume more than 80 cc at prior mri imaging. * i-pss score \>20. * history of prostate infection.
early versus routine caffeine administration in extremely preterm neonates

Conditions: Caffeine

Summary: premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. however, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. there are risks to having a breathing tube, so it would be beneficial to avoid it if possible. if caffeine is given earlier, it may decrease the need for a breathing tube. some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.

this goal of this observational study is to compare the respiratory and acute hemodynamic effects of caffeine administered in the first 2 hours versus 12 hours of life in infants \<29 weeks gestation. our primary hypothesis is that caffeine administered in the first two hours of life can prevent the need for endotracheal intubation in the first 12 hours of life.. these evaluations are critical in determining both the safety and efficacy of early caffeine therapy.

Eligibility criteria:
inclusion criteria: * any infant delivered at sharp mary birch hospital between 23 and 28 6/7 weeks; gestation exclusion criteria: * any infant with a major congenital anomaly including airway anomalies, congenital diaphragmatic hernia, or hydrops * any infant with a known or a discovered major cardiac defect other than a patent ductus arterious (pda), patent foramen ovale (pfo), or small ventricular septal defect (vsd) * inability to place a peripheral iv after two attempts. severe apnea or bradycardia in the first 60 minutes of life requiring emergent endotracheal intubation.

Keywords: caffeine intubation hemodynamic