Kornimate/medical-research-clean huggingface dataset:
comparison of the philips microdose tomosynthesis system to 2d digital mammography

Conditions: Breast Cancer

Summary: the primary objective of this study is to compare the safety and clinical performance of the philips microdose tomosynthesis system images and images from ffdm systems.

the study will be performed in two phases: image accrual and image reading. approximately 800 women who fulfill all inclusion and exclusion criteria will be enrolled in chronological order from up to 3 different us sites with one study investigator for each site. two cohorts of patients will be enrolled (i.e., biopsy and screening cohorts). paired sets of a standard 4-view exam will be collected both from philips tomosynthesis system (tomosynthesis and synthetic 2d images) and a fda-cleared ffdm system. all enrolled cases will be quality controlled for completeness of image and patient information. the reading portion of the study will include approximately 300 normal cases (including some cases determined to be normal after call back after screening mammography), 65 cancer cases, and 40 biopsy proven benign cases. the primary objective of the study is to compare the safety and clinical performance of the philips microdose tomosynthesis system (tomosynthesis and synthetic 2d) images to conventional 2d mammography images (ffdm).

Eligibility criteria:
inclusion criteria: * patient is female and at least 40 years of age * no contraindication for routine bilateral mammography screening cohort * patient presents for a routine screening mammogram biopsy cohort * patient is scheduled for a biopsy * patient has a screening detected abnormality exclusion criteria: * patient is pregnant or believes she may be pregnant; or, * patient is breast feeding; or * patient is unable or unwilling to give informed consent, including consent to reuse data for future research; or, * patient has breast implants; or * patient has previous surgical biopsy; or * patient has previous breast cancer; or * patient presented to screening with clinical symptoms (e.g. palpable lump, nipple discharge, nipple retraction, skin irritation or dimpling)

Keywords: mammography tomosynthesis
rheumatology clinical registry

Conditions: Rheumatoid Arthritis

Summary: the acr rheumatology clinical registry (rcr) is a tool developed to assist members in practice improvement, local population management, and efficient, successful participation in national quality programs. rcr integrates evidence-based quality measures aimed at improving care and drug safety for patients with rheumatoid arthritis, osteoarthritis, osteoporosis, gout and juvenile idiopathic arthritis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of rheumatoid arthritis exclusion criteria: * none
study of wound packing after superficial skin abscess drainage

Conditions: Abscess; Skin Diseases, Infectious; Boils; Furuncle; Carbuncle; Folliculitis; Cellulitis; Wounds

Summary: superficial skin and soft tissue abscess are frequently managed by opening them up with a procedure called "incision and drainage". it is routine practice in the united states to place packing material inside the abscess cavity after opening them up, in order to promote better wound healing and limit abscess recurrence. however, this practice has never been systematically studied or proven to decrease complications or improve healing. patients with wound packing usually return to the emergency room or practice setting for multiple "wound checks" and dressing/packing changes which lead to missed days from work or school and utilization of healthcare resources. this procedure can often be painful and may even require conscious sedation (and the risks entailed) especially in children. with rates of superficial skin and soft tissue abscesses on the rise, and emergency room resources being stretched, it is important to determine whether packing wounds is necessary or even advantageous to patients. this study is the first to systematically evaluate the efficacy of wound packing after superficial skin or soft tissue abscess incision and drainage in children. the investigators will be evaluating wound healing, complications, recurrence and pain associated with packing both short and long term. in addition, the investigators will also be evaluating the utility of bedside point-of-care ultrasound use in predicting the presence of pus inside the abscess cavity. this test may be useful to determine whether incision and drainage is necessary for an individual who has a skin infection that is suspicious for an abscess.


Eligibility criteria:
inclusion criteria: * age 1 - 24 years (i.e. any child seen in ped) * suspected abscess deemed to need incision \& drainage by attending physician or fellow * size of abscess is greater than or equal to 1cm * parent or patient consent, and child assent exclusion criteria: * location of abscess on face, perianal, or genitals * history of recurrent or chronic abscess * multiple abscesses requiring drainage at current visit * immunocompromised or unstable patient * hiv, transplant recipient, immune deficiency syndrome * immunosuppressive medications * wound already open/draining * previous participation in trial * patient will not be following up / managed by pes (e.g. surgical site)

Keywords: randomized clinical trial ultrasound prospective abscess packing incision and drainage superficial soft tissue infection
the intersectional viborg screening program: cost-(effectiveness) of screening for diabetes and cardiovascular diseases

Conditions: Aging; Aortic Aneurysm, Abdominal; Hypertension; Mass Screening; Peripheral Arterial Disease; Arrythmia; Diabetes; Carotid Atherosclerosis

Summary: this is an intersectional and interdisciplinary screening program in viborg municipality, including 67 years old citizens. this observational study will estimate the cost-effectiveness of a combined screening program for the following conditions: abdominal aortic aneurysm, peripheral arterial disease, carotid plaque, hypertension, arrhythmia, and type-2-diabetes. furthermore, the incidence of the outlined conditions will be described and so will the result of the intervention initiated (secondary medical prophylaxis, smoking cessation, introduction to nutritionally deficient diet etc.)

description of the cohort: all viborg municipality citizen are invited to the combined screening program around there 67th birthday. participants with positive screening results are offered following up consultations and prophylactic interventions are initiated (secondary medical prophylaxis, smoking cessation, introduction to nutritionally deficient diet etc.) 67 years-old citizens from the surrounding municipalities without the offer of the combined screening are used as a control group (1 case: 5 controls). there are no exclusion criteria. the screening examination includes: blood pressure in both arms, ankle brachial blood pressure index (abi), ultrasound for carotid plaque and abdominal aortic aneurysm, hba1c and pulmonary function test. furthermore, a questionnaire on lifestyle parameters, bmi, medical history, walking-related pain and self-rated quality of life (eq-5d). one year after the screening examination, the participants will receive a questionnaire in order to evaluate the effect from a participant perspective. the cost(-effectiveness) of the screening program will be estimated after 5 years based on prevalence of diseases, response rate, data extraction from nationwide registries and existing evidence of disease prevention.

Eligibility criteria:
inclusion criteria: all viborg municipality citizen are invited to the combined screening program around there 67th birthday. exclusion criteria: there are no exclusion criteria.

Keywords: mass screening cardiovascular disease diabetes
the physiotherapy and rehabilitation in calfan syndrome

Conditions: CALFAN Syndrome

Summary: calfan syndrome is a progressive neurodegenerative systemic disease. it is a rare and difficult disease to diagnose due to the complex symptoms that occur over the years to postpartum. the aim of this study is to investigate the effectiveness of the physiotherapy and rehabilitation program in a rare case with calfan syndrome.

13 years old, a female patient was diagnosed with calfan syndrome one year ago. only 11 patients have been identified in the literature. its phenotype is characterized by recurrent episodes of liver failure and hepatic fibrosis in early childhood. our patient had neurological symptoms that were gait disturbances, ataxia and tremor, as well as peripheral neuropathy and cognitive impairment. also, musculoskeletal problems such as scoliosis, hip dysplasia, osteoporosis, thoracic kyphosis, and increased lordosis were observed.

Eligibility criteria:
inclusion criteria: * calfan syndrome exclusion criteria: * any surgery in past six months

Keywords: ataxia rehabilitation disabilities
guided occupational therapist cognitive interventions in critically ill patients

Conditions: Delirium

Summary: title: guided occupational therapist (ot) cognitive interventions for critically ill patients short title: gotci methodology: randomized control trial study duration: 12-15 months study centre: single center - south health campus, icu, calgary, alberta, canada objectives: the aim for this study is to evaluate the effect of specific ot guided cognitive interventions on delirium in adult critically ill patients. number of subjects: 112 primary outcome: delirium prevalence and duration secondary outcomes: cognitive function, physical function, quality of life, icu length of stay, hospital length of stay and days of mechanical ventilation. inclusion criteria: adult critically ill patients admitted to south health campus icu, calgary, alberta type of intervention: ot guided cognitive intervention based on rass score dose: one on one therapeutic sessions with an ot. five days a week, monday to friday, between 0800-1600. there will be twice daily sessions for 20 minutes each. duration of administration: cognitive therapy to be initiated monday to friday, for the duration of participant icu admission. reference therapy: standard of care within the department of critical care medicine in calgary is delirium prevention strategies using the abcdef bundled approach. statistical methodology: descriptive statistics (mean, median, proportion) will be employed to describe the study population. the primary outcome of delirium prevalence will be explored using multivariable logistic regression, which will provide an estimate of the odds ratio and accompanying 95% confidence intervals. both per protocol and intent to treat analyses will be performed.


Eligibility criteria:
inclusion criteria: * adult medical/surgical critically ill patients admitted to the south health campus icu in calgary, alberta during designated 6-month study period. exclusion criteria as follows: 1. primary direct brain injury 2. prior diagnosis of dementia-related illness 3. prior diagnosis of developmental disability 4. pre-existing cognitive impairment 5. requiring palliative care 6. in icu for less than 48 hours 7. non-english speaking 8. severe communication disorders 9. non-critically ill plasma exchange therapy patients 10. severe hearing or visual impairment 11. icu to icu transfers 12. covid-19 positive patients
special drug use investigation for adoair diskus copd (salmeterol and fluticasone)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to investigate possible problems or questions in safety and effectiveness of salmeterol and fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic / emphysema). in this special drug use investigation, onset of pneumonia shall be handled as the priority investigation item.


Eligibility criteria:
inclusion criteria: * must use salmeterol and fluticasone for the first time exclusion criteria: * patients with hypersensitivity to salmeterol and fluticasone * patients with infection which salmeterol and fluticasone is not effective * patients with deep mycosis
a psychoeducation intervention for caregivers of patients with bipolar disorder

Conditions: Bipolar Disorder Family Members

Summary: bipolar disorder is a debilitating chronic illness characterized by periods of elation and depression. since deinstitutionalization of the mentally ill over 40 years ago, families have become major caregivers for patients with bipolar disorder . this illness imposes a substantial and chronic burden on family caregivers despite their persistent stress and burden, these caregivers have been largely ignored. interventions to help them have been very limited. one comprehensive intervention was developed and implemented by miklowitz (2008) and has shown to be effective in reducing caregiver depression and improving health outcomes. however, this intervention and is highly complex, long, and was given on an individual basis, significantly raising the cost of the program. one core component of the miklowitz (2008) intervention is psychoeducation, which provides the fundamental support and information needed to caregivers on an individual basis. in this pilot study, the intervention group will receive 7 weekly psychoeducation sessions. after completion of these sessions in the intervention group, the wait list control group will receive the same weekly sessions. in this study, the investigators plan to test the feasibility and potential efficacy of this specific psychoeducation intervention implemented in a group setting. the investigators will also examine the effects of this psychosocial intervention on biological mechanisms (cortisol and inflammatory biomarkers) and health outcomes. the specific aims are to: 1. test the feasibility of implementing a 7-week group psychoeducation program for family caregivers of patients with bipolar disorder by assessing recruitment and retention rates, attendance, satisfaction with the program, and data and sample collection rate. 2. explore the effect of the intervention on caregiver outcomes (depression, burden, health status, mental wellbeing, cortisol, interleukin (il)-1 and il-6 levels. the intervention will be delivered by at the university of texas health science center at houston center of excellence for mood disorders (cemd) and at the university of texas health science center at houston school of nursing. forty family caregivers of patients with bipolar disorder will be recruited into the study.


Eligibility criteria:
inclusion criteria: * primary family caregiver of a patient with bipolar disorder who is age 16 or older; * live within a 70 mile radius of the center for excellence in mood disorders (in the texas medical center) exclusion criteria: * unstable major medical illness; * health condition that may impact biomarker levels, e.g. is taking corticosteroids or anti-inflammatory drugs; * unable to read, write, or speak english
association between testosterone levels and copd severity

Conditions: Chronic Obstructive Pulmonary Disease; Hypogonadism

Summary: the aims of the study are estimate the association between the severity of copd and free testosterone level and the prevalence of hypogonadism in adult men with stable copd


Eligibility criteria:
inclusion criteria: * adults men ≥ 45 years * copd defined according to clinical diagnosis and spirometry american thoracic society ( ats) criteria * stable copd without recent acute exacerbation (less than 2 weeks) exclusion criteria: * refusal to participate or informed consent process * those who are under treatment with testosterone replacement or anti-androgens * comorbidities: cirrhosis, alcoholism, cryptorchidism, panhypopituitarism, pituitary adenoma. * orchiectomy * systemic glucocorticoids (equivalent dose ≥ 4 mg of prednisone in the last 3 weeks). * relative and absolute contraindications for spirometry.

Keywords: hypogonadism chronic obstructive pulmonary disease severity of illness index testosterone
laser therapy in the treatment of post thoracotomy pain; a pilot study

Conditions: Laser Therapy; Post Thoracotomy Pain

Summary: the purpose of this study is to demonstrate the safety of the avicennatm class iv laser for application over the skin of human subjects. in addition, we seek to measure the effectiveness and utility of this class 4 laser therapy in the treatment of post-thoracotomy pain syndrome.

this study was terminated prior to enrollment and closed.

Eligibility criteria:
inclusion criteria: * men and women age 25-65 years old with chest wall pain after lung surgery lasting more than 2 months after surgery. * subjects shall have failed conservative treatment which may include rest, physical therapy, braces, and over the counter anti-inflammatory medications. all those enrolled will be native english speakers and have at least a high school degree exclusion criteria: * subjects will be excluded if they are pregnant (which will be confirmed by a urine pregnancy test if they are of childbearing age) * have previous history of other pain syndromes or psychiatric disorders. * we will exclude the morbidly obese (bmi \>30) because the laser may not be able to penetrate deep enough through adipose tissue. in addition, subjects who have had previous back surgery, or are on antidepressants for the treatment of depression in the preceding 6 weeks will be excluded as these may represent potential confounding factors.

Keywords: laser therapy post thoracotomy pain avicennatm laser
incidence and clinical progression of asymptomatic picc-related thrombosis in solid cancer patients

Conditions: Catheter Related Complication

Summary: in this prospective cohort study, the investigators evaluated the incidence of superficial vein thrombosis, deep vein thrombosis, and fibroblastic sleeve formation in solid cancer patients undergoing chemotherapy. the study aimed to shed light on the clinical progression of venous thrombosis in cancer patients with central venous catheters, with a particular focus on certain cancer types associated with a higher risk of venous thromboembolism (vte). the investigators believe that such findings hold significant clinical relevance as a substantial portion of the study population was affected by pancreatic cancer, a cancer type known to carry a high risk of thrombotic events. this research adds valuable insights into understanding asymptomatic picc-related thrombosis in this specific subgroup of cancer patients, which can aid in developing effective management strategies for venous access in this challenging population. the study employed an ultrasound-guided approach for follow-up at 30 and 90 days after catheter insertion, enabling us to detect and treat asymptomatic picc-vte in a timely manner. identifying independent risk factors for catheter-related thrombosis, including age and cancer type, has further enhanced the clinical applicability of our findings.

managing venous access in cancer patients is challenging, and peripherally inserted central catheter-ports (picc-ports) have emerged as a promising option for safety and efficacy. however, understanding the clinical progression of venous thrombosis in cancer patients with central venous catheters remains limited, especially in certain cancer types associated with a higher risk of venous thromboembolism (vte). in this prospective cohort study of solid cancer patients receiving chemotherapy, the investigators will evaluate the incidence of superficial vein thrombosis, deep vein thrombosis, and fibroblastic sleeve formation through ultrasound follow-up at 30 and 90 days after catheter insertion. the investigators will analyze clinical factors associated with picc-related vte (picc-vte) and compare incidence rates between picc-ports and traditional piccs. ultrasound follow-up is valuable for detecting asymptomatic picc-vte, enabling timely and effective initiation of therapy, especially in elderly patients and those with high-risk thrombotic cancers.

Eligibility criteria:
inclusion criteria: * patients with: 1. a documented active malignancy; 2. picc or port placement for systemic chemotherapy; exclusion criteria: * patients with: 1. a communication disorder; 2. contraindications to anticoagulation therapy; 3. hematopathy; 4. expected survival of less than one month; 5. were lost to follow-up.

Keywords: catheter-related thrombosis peripherally inserted central catheter-ports cancer associated thrombosis upper extremities vein thrombosis
comparison of vibratory perineal stimulus with transvaginal electrical stimulation

Conditions: Urinary Incontinence

Summary: aim: to compare the effects of vibratory perineal stimulus with transvaginal electrical stimulation to the pelvic floor muscles functionality in women with urinary incontinence and who are unable to voluntarily contract their pelvic floor muscles. study design: randomized controlled trial

* the purpose of this study is to find out the effect of vibratory perineal stimulus compared to transvaginal electrical stimulation on the functionality of pelvic floor muscles in women with urinary incontinence who are unable to perform voluntary contraction of this musculature. * study design: randomized controlled trial * search location: the data will collected at the ambulatory of urogynecology and obstetrics of porto alegre clinical hospital (hcpa), where the activities of pelvic physiotherapy are performed.and in the clinical research center of the same hospital. * inclusion criteria: women with urinary incontinence with zero or one strength degree of pelvic floor muscle contraction by the modified oxford scale. * main outcome: improvement the functionality of pelvic floor muscles * secondary outcome: improvement of urinary loss * first protocol: patients will be referred by the medical team and will undergo physiotherapeutic evaluation to collect personal data, check the symptoms of urinary incontinence, apply a quality of life questionnaire and measure pelvic floor muscles strength. if patient has zero or one degree of pelvic floor muscle strength, will be referred to the second phase. * second protocol: patients will be randomized into two groups - vibratory stimulus group or electrical stimulation group. both will follow a 6-week treatment protocol with intervention once a week. both are intravaginal devices applied for 20 minutes, with on cycle of 8 seconds and off cycle of 16 seconds. * final protocol: patients will repeat the initial evaluation.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of urinary incontinence; * to be unable to perform a voluntarily contraction of pelvic floor muscles; * understand the instruments used in the research; exclusion criteria: * allergy to latex; * individual or group pelvic floor muscle training in the last 6 months.