Kornimate/medical-research-clean huggingface dataset:
implementing a family caregiver checklist in primary care: a pilot study

Conditions: Caregiver Burnout

Summary: the goal of this project is to pilot test chec (collaborative healthcare encounters with caregivers) in primary care. chec is brief intervention with two components: 1) a checklist to identify the needs and concerns of unpaid/family caregivers who accompany older patients (aged 65+) to their primary care visits and 2) accompanying tip sheet for clinicians.


Eligibility criteria:
inclusion criteria: patients * age 65-89 * english speaking * women and men * of varying race/ethnicity * accompanied to primary care visits at the center on aging by a family caregiver (family caregiver also consents to participating in this study) * sufficient cognitive capacity to consent themselves or through a legal representative caregivers * age 21+ * english speaking * women and men * of varying race/ethnicity * accompany an older adult to his or her primary care visits at the center on aging (older adult also consents to participating in this study) * cognitively intact (on basis of a 6-item cognitive screen) clinicians * age 21+ * women and men * of varying race/ethnicity * treat patients at the center on aging exclusion criteria: * patients, caregivers, and clinicians that do not meet the inclusion criteria. * patients and caregivers who are deaf or have hearing impairments that limit their ability to answer telephone queries. * caregivers who are visually impaired and cannot see well enough to read large print and complete paper-based surveys. * patients and/or caregivers whose dyad counterpart does not consent to take part in the study (i.e., patients gives consent and their caregiver does not).

Keywords: caregiver older adult primary care screening
the application of m-charts and microperimetry for the assessment of visual function in patients after vitrectomy due to the full thickness macular hole.

Conditions: Macular Holes; Microperymetry; Vitrectomy; M-charts

Summary: to examine the relationship between morphological and functional results in eyes after vitrectomy due to the full thickness macular hole (ftmh).


Eligibility criteria:
inclusion criteria: the diagnosed full thickness macular hole and psuedophakia. exclusion criteria: macular pseudohole, non-full thickness macular hole, retinal detachment, other ocular comorbidities.

Keywords: macular hole microperymetry vitrectomy m-charts metamorphopsia
premod2 with near infrared spectroscopy sub-study

Conditions: Hypoxia, Brain; Premature Birth

Summary: early hemodynamic effects (within 3 hours of life) of delayed cord clamping compared to umbilical cord milking are still unknown. four sites experienced in the use of nirs and who have appropriate data collection equipment in the delivery room (alberta, ulm, cork and san diego) will obtain and report the physiological changes with ucm and dcc from birth until 24 hours of life. this data will yield the largest available sample of continuously recorded heart rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and administered fio2 to delineate the short term responses to two methods of placental transfusion. in our initial trial we demonstrated increased blood pressure from 3-15 hol with ucm compared to dcc in premature newborns \<32 weeks, but did not show any differences in cerebral oxygenation.

this substudy will include 400 infants \<28 weeks ga enrolled in the premod2 trial. once the newborn has been delivered, received the intervention (ucm or dcc), and been placed on the resuscitation bed a nirs sensor and a pulse oximeter will be placed within 60 seconds. while arterial saturation and heart rate data will be available to the clinical team, data from nirs will be blinded. data on all study infants will be recorded for at least the first 10 minutes in the delivery room, and then for 24 hours in the nicu. heart rate, oxygen saturations, and cerebral oxygenation, will be downloaded as per each site's practice for neonatal resuscitation.

Eligibility criteria:
inclusion criteria: * 23 weeks 0 days to 27 weeks 6 days. * enrolled in premod2 trial. exclusion criteria: * nirs device not available * research personnel not available

Keywords: near-infrared spectroscopy
incentives for influenza vaccination

Conditions: Influenza Vaccination

Summary: in this work, we are assessing the impact of messaging with or without a $50 financial incentive on influenza vaccination rates in a county health system. our main hypothesis is that a message with a $50 financial incentive will increase vaccination rates relative to a control/"treatment as usual" group. we further hypothesize that the financial incentive will increase vaccination rates relative to the message only arm.


Eligibility criteria:
inclusion criteria: * ages 18 and over * empaneled patients or non-empaneled patients with a primary care visit in past 18 months with valid insurance * due for an annual flu shot according to the electronic medical record * active phone number or email * do not have "do not contact" flag exclusion criteria: * under age 18 * received an annual flu shot based on medical record
outpatient and home pelvic floor training for stress urinary incontinence

Conditions: Urinary Incontinence, Stress

Summary: the objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. the hypothesis of this study is that home pelvic floor muscle training is as effective as outpatient pelvic floor muscle training for the treatment of stress urinary incontinence.

success with the pelvic floor muscle training (pfmt) is hampered by non-adherence, which is related to factors such as inability to contract the pelvic floor muscles and lack of motivation. thus under supervision by a physiotherapist (outpatient training), pfmt has the potential of improving adherence to training and has been demonstrated to be more effective when compared to unsupervised pfmt (home training). the objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. this is a randomized controlled trial and which will be conducted at the division of urogynecology and reconstructive pelvic surgery at the federal university of sao paulo, brazil. as a primary endpoint, the standardized volume test pad (250 ml) will be used. to assert that one of the groups (home pfmt or outpatient pfmt) is superior to the other, it will be necessary to find 38.5% more patients cured when the groups are compared. secondary outcome measures will be used, assessment of the pelvic floor muscles function, urinary symptoms, quality of life and subjective cure.

Eligibility criteria:
inclusion criteria: sui and mixed urinary incontinence with predominant symptoms of sui with ≥ 2 g of leakage measured by pad test exclusion criteria: younger than 18 years old chronic degenerative diseases pelvic organ prolapse greater than stage i by pop-q neurologic or psychiatric diseases inability to contract pfms previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries

Keywords: urinary incontinence, stress pelvic floor; exercise physical therapy modalities
effects of different modes of respiratory muscletraining on respiratory mechanics and nrd in patient with stable copd.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: chronic obstructive pulmonary disease (copd) is a chronic respiratory disease characterized by persistent airflow limitation. the patients are suffering dyspnea year by year, resulting in the decreased exercise tolerance and quality of life. patients with copd often have both inspiratory muscles and expiratory muscle dysfunction. respiratory muscle training was one of the widely used pulmonary rehabilitation method in copd patients. respiratory muscle training include inspiratory training ,expiratory training and concurrent inspiratory and expiratory muscle training . both of the training methods are effective. however, the effects of these different types of respiratory muscle training method on the respiratory physiology and neural respiratory drive of copd are still unclear. therefore, the purpose of this study was to investigate the different effects of these respiratory muscle training methods on respiratory mechanics and central drive in copd patients. besides,the effect of the different respiratory muscle training methods was compared between patients with and without respiratory muscle weakness.

the patients with copd will participate in a rehabilitation program including inspiratory muscle training, expiratory muscle training and concurrent inspiratory and expiratory muscle training. the outcome measures are the classic respiratory mechanics indicators and respiratory center drive.

Eligibility criteria:
inclusion criteria: * patients with pulmonary function test of forced expiratory volume at one second (fev1)/forced vital capacity(fvc) \< 70% after inhalation of bronchial dilation agent. patients in a clinically stable state. exclusion criteria: * patients were excluded if they had other respiratory diseases ,or evidence of pneumothorax or mediastinal emphysema and pacemaker installed. patients with acute cardiovascular event and severe cor pulmonale. patients with poor compliance. an other causes of diaphragmatic dysfunction

Keywords: chronic obstructive pulmonary disease inspiratory muscle training expiratory muscle training neural respiratory drive
adipose tissue gene expression profiles in women with polycystic ovary syndrome (pcos) versus controls

Conditions: Polycystic Ovary Syndrome

Summary: adipose tissue is a central organ in mediating metabolic health. there is some evidence that women with polycystic ovary syndrome (pcos) have a degree of adipose tissue dysfunction which may negatively affect their metabolic health. the aim of this study was to assess transcriptomic profiles of subcutaneous adipose tissue of women with pcos in comparison with a control population matched on the basis of age and body mass index (bmi). a secondary aim was to then relate these gene expression profiles to the biochemical environment.

adipose tissue is a central organ in mediating metabolic health. there is some evidence that women with polycystic ovary syndrome (pcos) have a degree of adipose tissue dysfunction which may negatively affect their metabolic health. the aim of this study was to assess transcriptomic profiles of subcutaneous adipose tissue of women with pcos in comparison with a control population matched on the basis of age and body mass index (bmi). a secondary aim was to then relate these gene expression profiles to the biochemical environment.

Eligibility criteria:
inclusion criteria: * had a positive diagnosis of pcos as defined according to the nih criteria as chronic oligomenorrhoea (\< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. clinical criteria included hirsutism with a ferriman-galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (dheas) greater than the laboratory reference range. * were between the ages of 18 and 40 exclusion criteria: * were under 18 years or greater than 40 years old, * were non-caucasian * were pregnant, lactating or trying to conceive * had a body mass index (bmi) \ 50kg/m2 * had a recent illness or any chronic illness likely to influence results * were taking hormonal contraception

Keywords: pcos
safety and feasibility of argatroban as anticoagulant in adults with ecmo

Conditions: Extracorporeal Membrane Oxygenation Complication; Anticoagulants and Bleeding Disorders

Summary: this prospective, randomized, controlled pilot trial aims to assess the safety and feasibility of argatroban as an alternative anticoagulant to unfractionated heparin in patients receiving extracorporeal membrane oxygenation.


Eligibility criteria:
inclusion criteria: * minimum age 18 years * vv- or va-ecmo therapy * minimum of 24h planned ecmo-therapy exclusion criteria: * history of heparin-induced thrombocytopenia (hit) * high risk of bleeding, contraindication for anticoagulation (eg. active gi-bleeding, intracerebral bleeding; platelet count \<50g/l, congenital bleeding disorder) * pregnancy * severe liver disease (sofa score liver domain 4 points = bilirubin \>12mg/dl) * postoperative admission * strong lupus anticoagulant or acquired intrinsic clotting factor deficiency at admission (aptt \>50 sec without anticoagulation).
goalsetting in patients with chronic pain: a european survey

Conditions: Chronic Pain

Summary: the aim of this survey is to get insight in the individual goals of chronic pain patients according to the icf framework.


Eligibility criteria:
inclusion criteria: * patients who are suffering from chronic pain exclusion criteria: * healthy participants or patients with acute pain
efficacy and safety of melatonin and clonazepam for irbd

Conditions: REM Sleep Behavior Disorder

Summary: this study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic rem sleep behavior disorder.

this study is open-label parallel trial with 4 weeks treatment with slow-release melatonin (circadin) or with clonazepam (rivotril). polysomnography, symptom diary and questionnaire (clinical global impression, rbdq-hk, psqi, ess, sss, isi, bdi-ii) will be performed before and after 4 weeks of each medications.

Eligibility criteria:
inclusion criteria: * rem sleep behavior disorder (icsd-3 criteria) exclusion criteria: * neurological disorder including epilepsy or stroke * history of psychiatric illness * neurodegenerative disease including dementia or parkinsonism. * medication affecting sleep within 1 month * intake of melatonin or clonazepam within 1 week. * unable to complete questionnaires

Keywords: clonazepam melatonin treatment rem sleep behavior disorder
safety and efficacy of trastuzumab as part of breast cancer treatment regimen

Conditions: Breast Cancer

Summary: this is a prospective, phase iv, multi-center, single arm, open-label, interventional study to evaluate the safety of trastuzumab for the treatment of human epidermal growth factor receptor 2 protein (her2)-positive node positive or high risk node negative breast cancer participants with regimen consisting of doxorubicin and cyclophosphamide followed by either paclitaxel or docetaxel (ac-th regimen) or a regimen consisting of docetaxel and carboplatin (tch regimen) in indian population.


Eligibility criteria:
inclusion criteria: * histologically confirmed early invasive her2 positive, node positive or high risk node negative breast cancer with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage i to iiia that is eligible for adjuvant treatment with trastuzumab * eastern cooperative oncology group (ecog) performance status 0 to 2 * her2 over expression/amplification defined as either immunohistochemistry (ihc)3+, or ihc2+ and fluorescence in situ hybridization (fish) positive as determined in a central laboratory * at time of starting trastuzumab therapy, lvef measured by echocardiography * screening lvef greater than or equal to (\>/=) 55 percent (%) * adequate bone marrow, renal, and hepatic function * agreement to use an adequate, non-hormonal means of contraception by women of childbearing potential exclusion criteria: * any contraindication to trastuzumab * previous adjuvant breast cancer treatment with an approved or investigational anti-her2 agent * history of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for at least 5 years * past history of ductal carcinoma in situ and/or lobular carcinoma that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops * locally advanced (stage iiib and iiic) and metastatic disease (stage iv) * clinically relevant cardiovascular disorder or disease * uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy * history of severe allergic or immunological reactions, example difficult to control asthma * pregnant or lactating women
is meniscal volume critical to post-meniscectomy symptoms?

Conditions: Meniscal Tear

Summary: with this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain.

1. background and rationale it is known that a partial meniscectomy of the knee is a risk factor to the development of early osteoarthritis with complaints of pain. 2. trial objectives and design 2.1 trial objectives with this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain. 2.2 primary endpoints how much volume can be resected peroperatively without developing postoperative pain. 2.3 secondary endpoints a possible correlation between the resected volume and the severity of the pain. 3. selection and withdrawal of subjects 3.1 inclusion criteria * all patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative mri's. * age between 14 and 50 years old * women of child bearing age can be included: the study has no effect on their methods of contraception. 3.2 exclusion criteria * a history of a tibia plateau fracture or severe deformity of the knee * rupture of the acl/pcl/collateral ligaments of the knee * focal cartilage defects of the knee

Eligibility criteria:
inclusion criteria: * all patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative mri's. * age between 14 and 60 years old * women of child bearing age can be included: the study has no effect on their methods of contraception. exclusion criteria: * a history of a tibia plateau fracture or severe deformity of the knee * rupture of the acl/pcl/collateral ligaments of the knee * focal cartilage defects of the knee

Keywords: meniscectomy volume pain
ctdna and organ preservation/pathologic cr in rectal cancer

Conditions: Rectal Cancer; Non Metastatic Rectal Cancer

Summary: this prospective observational, non-therapeutic study for patients with t3, t4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy. this research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor dna (genetic material) ctdna will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care c2i genomics, a biotechnology company, and the spier foundation are supporting this research study by providing funding for the study.

the research study procedures include screening for eligibility and the collection of data and biospecimens. non-operative management is offered as part of routine clinical care. it is expected that up to 60 participants will be enrolled, with the goal that 55 participants will take part in this research study . participants enrolled on the study will remain on study for up to 60 months.

Eligibility criteria:
inclusion criteria: * participants with t3, t4, or node-positive non-metastatic rectal cancer. * participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy. * participants must be 18 years of age or older. * ecog 0-2. * participants must be eligible for at least 3 months of folfox, folfirinox/folfoxiri, or capox * participants must be eligible for long course chemoradiation to 40-54 gy. * participants must be able to understand and willing to sign a written informed consent document. exclusion criteria: * participants must not have any other organ cancer evident at the time of enrollment. * participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate. * participants must not be actively or planning to be pregnant or breastfeeding

Keywords: rectal cancer non metastatic rectal cancer
effects of oral cancer treatments on upper esophageal opening during swallowing

Conditions: Cancer of Head and Neck

Summary: the purpose of this study is to investigate post-operative and post-radiation upper esophageal sphincter opening measures in oral cancer patients, compare measures to age- and gender-matched healthy adults, and determine relationships with patient swallowing outcomes and quality of life.


Eligibility criteria:
inclusion criteria: * oral cancer that includes tongue or floor of mouth clinical stage t1 or higher * may have disease that extends to base of tongue or other site as long as floor of mouth or tongue are involved * adults at least 18 years of age exclusion criteria: * oral cancer of the lip, cheek, palate or other site not impacting tongue or floor of mouth musculature * history of floor of mouth, tongue base, pharyngeal or laryngeal surgical resection * history of radiation treatment to the head and neck * history of dysphagia prior to onset of oral cancer symptoms * allergy to lidocaine, barium, adhesive tape or apple flavoring * woman of childbearing years who are pregnant

Keywords: quality of life swallowing outcomes oral cancer
low-potassium content vegetables in chronic kidney disease

Conditions: the Recommended Target of Daily Vegetables Intake; Risk of Hyperkalemia

Summary: prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (ckd). however, compared with the normal population, patients with ckd are more likely to consume less vegetables and fruits. thus, the investigators aim to evaluate whether proving low-potassium content vegetables to this population are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.

prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (ckd). however, compared with the normal population, patients with ckd are more likely to consume less vegetables and fruits. according to the suggestions from 2018 ministry of health and welfare in taiwan, vegetables intake are at least 3 to 5 servings daily based on the daily energy requirement. in our own data, the average daily vegetables intake was only 2.1 servings among patients with ckd stages 3 to 5 not yet on dialysis. therefore, the investigators aim to evaluate whether proving low-potassium content vegetables to patients with ckd stages 3 to 5 not yet on dialysis are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.

Eligibility criteria:
inclusion criteria: * ckd stage 3b\~5, not yet on dialysis * age ≥20 years * stable doses of medications for 4 weeks * serum potassium level: ≥3.5 and \< 5.5 mmol/l exclusion criteria: * anticipated to receive dialysis within 3 month * major gastrointestinal diseases (inflammatory bowel disease, celiac disease) or intestinal resection * patients with infection, malignancy, heart failure, liver cirrhosis or impaired cognitive or mental disorders * patients who are just hospitalized due to an acute cardiovascular events or infection 3 months prior to the start of study * patients with kidney transplants * patients who receive immunosuppressant * pregnant women or patients who are planning to become pregnant

Keywords: chronic kidney disease vegetables hyperkalemia