Kornimate/medical-research-clean huggingface dataset:
beneficial side effects of topiramate in obese patients undergoing total joint arthroplasty

Conditions: Weight Loss; Pain, Postoperative

Summary: the purpose of this study is to evaluate the effects of topiramate (tpm) in obese patients with respect to weight loss and pain after total joint replacement surgery

investigator hypothesize that low dose peri-operative topiramate is superior to gabapentin in reducing postoperative pain and opioid consumption after primary tja with a more favorable side effect profile that will facilitate patient optimization via pre- and postoperative weight loss.

Eligibility criteria:
inclusion criteria * patient will be eligible for the study if they are scheduled for a primary tka or tha with a bmi \>30 and \ 40 kg/m2 * patients refusing bariatric surgery or having had prior bariatric surgery exclusion criteria * patients will be ineligible to participate if they have any of the following: * known topiramate or gabapentin allergy * history of seizure disorder * chronic opiate use pre-operatively * history of nephrolithiasis * history of acute angle closure glaucoma * recurrent major depression * presence or history of suicidal behavior or ideation with intent to act * current substantial depressive symptoms (patient health questionnaire total score \>10), pregnancy * child-bearing potential and not on contraception * age \<18 years * major neurocognitive disorder * metabolic acidosis * incarcerated status * bilateral surgery
study of acalabrutinib and rituximab in untreated elderly and/or frail patients with dlbcl

Conditions: Diffuse Large B-Cell Lymphoma

Summary: the study will measure the safety, tolerability, and efficacy with acalabrutinib in combination with rituximab in treatment-naïve elderly and/or frail patients with diffuse large b-cell lymphoma (dlbcl), who are otherwise unsuitable for standard front line chemoimmunotherapy treatments.

treatment-naïve elderly and/or frail patients with dlbcl will be treated with acalabrutinib in combination with rituximab in a single arm. study details include the following: * the study duration will be up to 108 weeks for each patient, including up to 28 days for screening and 104 weeks of treatment and follow-up. * the treatment duration will be up to 8 cycles for rituximab and 28 cycles for acalabrutinib both beginning at cycle 1.

Eligibility criteria:
inclusion criteria: * ≥ 80 years of age at the time of screening, or * ≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy * histologically documented dlbcl * no prior treatment for dlbcl * stage ii, iii, or iv disease by the ann arbor classification . * eastern cooperative oncology group performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of the first dosing except when due to underlying lymphoma. * at least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography or magnetic resonance imaging and is suitable for accurate repeated measurements. * adequate organ and marrow function independent of growth factor or transfusion support within 1 week of screening. exclusion criteria: * any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active bleeding diseases), that would make the study undesirable for the patient or that would impact compliance with the protocol. * history of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results. * serologic status reflecting active hepatitis b or c infection. * serological positivity or known infection with hiv. * active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression. * any comorbidity or organ system impairment rated with a single cumulative illness rating scale-geriatric score (cirs-g) of 4 or a total cirs-g score of \> 17. * history of or ongoing confirmed progressive multifocal leukoencephalopathy. * known active significant infection. * history of stroke or intracranial haemorrhage within 6 months before the first dose of study drug. * history of bleeding diathesis (eg, haemophilia, von willebrand disease). * major surgical procedure within 30 days of first dose of study intervention or anticipated major surgery during the study timeframe. * requires or receiving anticoagulation with warfarin or equivalent vitamin k antagonists. * received a live virus vaccination within 28 days of the first dose of study drug.

Keywords: chemoimmunotherapy treatments treatment-naïve elderly patients
prevalence of lymphedema in valle del cauca, colombia.

Conditions: Unilateral Breast Cancer

Summary: this is an epidemiological cross-sectional study aiming to determine the prevalence of lymphedema and the incidence of risk factors in patients diagnosed with unilateral breast cancer in a cohort from 2008 to 2020 in a specialised oncology centre in valle del cauca, colombia.

context: breast cancer-associated lymphedema is considered one of the most frequent side effects of breast cancer therapy. (1,2) despite the abundant information available worldwide on epidemiology and risk factors, little is known about these data in colombia and latin america. objective: to determine the actual prevalence and incidence of risk factors for the development of lymphedema associated with breast cancer in a specialised oncology centre in valle del cauca, colombia. design, setting, and patients: between 2008 and 2020 a sample of 367 patients with a diagnosis of unilateral breast cancer was established, with which a descriptive study was carried out, in which a series of anthropometric measurements were taken of the upper limbs in order to obtain the volume of both arms and determine the prevalence of lymphedema using the formula of truncated volumes of the spanish society of lymphology, after which the medical records were reviewed in order to collect other data of interest. patients were excluded if they had bilateral breast cancer or direct trauma to the upper limb. interventions: a single intervention was carried out in which the patients were summoned for an interview and anthropometric measurements of the upper limbs, thus calculating the arm volume for a lymphedema primary diagnosis .

Eligibility criteria:
inclusion criteria: * unilateral breast cancer, cancer diagnosis between 2008-2020 in the oncology institution colombia exclusion criteria: * moving to a different institution for attention (other than hemato-oncólogos sa), unwillingness to become volunteer and death, bilateral breast cancer, congenital disease or trauma in the upper limb.

Keywords: lymphedema breast cancer prevalence risk factors epidemiology
helmet ventilation during self-paced walking test

Conditions: COPD

Summary: the aim of this study is to investigate the use helmet ventilation (hv) in walking test and analysis of effect patients with copd.

chronic obstructive pulmonary disease (copd) is characterized by persistent airflow limitation with chronic inflammation of the respiratory system. symptoms of copd may contribute to activity restriction, deconditioning and exercise intolerance. non-invasive positive pressure ventilation (nippv) has been shown to improve exercise intolerance and health-related quality of life in patients with severe copd. helmet ventilation (hv) is a new option for nippv to alternative to nasal or face mask. a study which published on jama demonstrated the feasibility and benefits of hv. the aim of this study is to investigate the use helmet ventilation (hv) in walking test and analysis of effect patients with copd.

Eligibility criteria:
inclusion criteria: * patents with copd who confirm by pulmonary function test exclusion criteria: * copd ae within 3 months * diagnosed neuromuscular disease * unable to perform 6-mwt
eyeshot (employed antithrombotic therapies in patients with acute coronary syndromes hospitalized in italian coronary care units)

Conditions: Acute Coronary Syndromes

Summary: this register will evaluate the use of different antithrombotic therapies, combinations of different drugs routinely used during any stage of hospital admission, with their timing, dosage and mode of administration, in patients with a diagnosis of acute coronary syndrome in the italian coronary care unit during a study period of three weeks


Eligibility criteria:
inclusion criteria: * all consecutive patients discharged with a diagnosis of acute coronary syndrome ( non st elevation or st elevation) undergoing myocardial revascularization or conservative treatment , admitted to the coronary care unit during the observation period established. * age ≥ 18 years * signed informed consent exclusion criteria: * patients enrolled in clinical trials of intervention * diagnosis of acute coronary syndrome caused by confounding comorbidities (eg . trauma or surgery after non- cardiac ) * patients already enrolled in eyeshot from another center.

Keywords: acute coronary syndromes intensive care unit
adjuvant treatment of pulmonary embolism with drotrecogin alfa (activated): phase ii exploratory study

Conditions: Submassive Pulmonary Embolism

Summary: an exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation study comparing a standard therapy for submassive pulmonary embolism (enoxaparin sodium) to a combined therapy of drotrecogin alfa (activated) plus enoxaparin sodium.


Eligibility criteria:
patients with symptoms of acute pulmonary embolism (pe), without an indication for fibrinolytic therapy but with echocardiographic evidence of right ventricular dysfunction (submassive pe) within 48 hours of onset of symptoms inclusion criteria: * clinical symptoms of pulmonary embolism for less than 48 hours exclusion criteria: * patients with symptoms of pulmonary embolism for more than 48 hours
spirituality, religiosity, and immune functioning

Conditions: Cancer; Depression; Dying Process

Summary: the purpose of this study is to determine whether religiosity and spirituality are related to immune functioning, as measured by interleukin-6 blood plasma level, among terminally ill cancer patients.


Eligibility criteria:
inclusion criteria: * inpatient at calvary hospital * diagnosis of terminal cancer * score of 20 or above on mini-mental state exam exclusion criteria: * presence of a psychiatric disorder that would preclude the production of meaningful data

Keywords: spirituality religiosity immune functioning psychoneuroimmunology cytokines cancer death depression
mr-guided laser interstitial thermal therapy in treating patients with prostate cancer

Conditions: Stage I Prostate Cancer; Stage II Prostate Carcinoma

Summary: this phase ii trial studies how well magnetic resonance (mr)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer

primary objectives: i. to evaluate the oncologic efficacy of laster interstitial thermal therapy (litt) with primary endpoint of undetectable cancer on magnetic resonance imaging (mri)-guided biopsy of treatment zone at 3 months following treatment. secondary objectives: i. to evaluate oncologic efficacy at 12 months following treatment based on biopsy of the treatment zone. ii. to determine treatment-related safety and toxicity. iii. to longitudinally assess urinary and sexual function in the year following treatment. outline: patients undergo mr-guided litt. after completion of study treatment, patients are followed up at 1, 3, and 12 months.

Eligibility criteria:
inclusion criteria: * clinical characteristics: * stage t1c or t2a * prostate-specific antigen (psa) \< 15 ng/ml or psa density (psa divided by prostate volume in cubic centimeters) \< 0.15 ng/ml\^3 * no evidence of metastatic disease based on national comprehensive cancer network (nccn) guidelines: * bone scan if psa \> 20 ng/ml and clinical stage t1c * bone scan if psa \> 10 ng/ml and clinical stage t2 * biopsy requirements: * gleason score 7 or less * 25% or fewer biopsies with cancer * at least 12 biopsy cores of the prostate * within 12 months of treatment * imaging requirements: * up to 2 visible magnetic resonance (mr) lesion(s) concordant with sextant of biopsy-detected cancer(s) * mri within 6 months of treatment * karnofsky performance status of at least 70 * general health is suitable to undergo the planned minimally invasive procedures * risks, benefits, and alternatives discussed with informed consent given exclusion criteria: * previous treatment of prostate cancer with luteinizing hormone releasing hormone (lhrh) agonist/antagonist, chemotherapy, surgery, or radiation * presence of 3 or more visible lesions on mri * high suspicion of seminal vesicle invasion or lymph node metastases on mri * unable to tolerate mri (medical device, foreign body, claustrophobia, body habitus, or other) * renal insufficiency with estimated glomerular filtration rate (egfr) \< 30 ml/min/body surface area (bsa) based on modification in diet renal disease equation; inability to safely receive gadolinium contrast for mri * history of prior pelvic surgery with surgical clips remaining in situ (e.g., bladder, bowel, internal pelvic organs) that compromise mri image quality * other serious illnesses involving the cardiac, respiratory, central nervous system (cns), or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study
cloudcare in the treatment of type 1 diabetes in pediatrics

Conditions: Type1diabetes; Pediatric ALL

Summary: this prospective cohort study aims to estimate the effect of the cloudcare application in daily practice on treatment satisfaction and emotional burden for pediatric patients and their parents/caregivers, patients' glycemic control (glucometrics), healthcare professional satisfaction, and the impact on costs. a total of 600 pediatric patients (1-15 years) with type 1 diabetes will be enrolled into the study.

this is a multi center prospective cohort study in europe with pre- and post-measurements in type 1 diabetes with 12 months follow-up. this study will only include pediatric patients for which cloudcare is part of their (new) standard care of type 1 diabetes. participants will be enrolled in several hospitals/healthcare organisations in europe. participant's data will be retrieved from their medical records and from uploaded data of their medical devices used for their type 1 diabetes treatment. the study will consist of two periods. a 3 months' retrospective period in which data will be retrieved from patients' dossier followed by a 12 months' prospective period after introduction of cloudcare as part of patients' standard care by the treating physician. the 3 months' retrospective period is the control period for the prospective period.

Eligibility criteria:
inclusion criteria: * parents/caregivers and, depending on local laws and regulations, also the patient are willing to sign the study informed consent form prior to any data collection for this study * clinical diagnosis, based on investigator assessment, of type 1 diabetes and using insulin with or without metformin for at least 6 months. * age between 1 and 15 years old. * use of multiple daily injections of insulin (mdi, with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion (csii) with flash or continuous glucose monitoring (fgm/cgm), but without cloudcare for at least three months. * receiving cloudcare as part of their standard care for at least 6 months. exclusion criteria: * patients with type 1 diabetes on glucose lowering treatments other than insulin with or without metformin. * any known factor, condition, or disease that might interfere with study conduct or interpretation of the results, as deemed by the investigator.
accuracy comparison: optoelectronic motion capture and markerless system

Conditions: Children, Adult; Motor Disorders

Summary: the purpose of this study was to assess the openpose reliability to measure kinematics and spatiotemporal gait parameters and to evaluate the minimum technical requirements. this analysis used video and optoelectronic motion capture simultaneously recorded. we assessed more of 20 subject with different motor gait impairments

marker-based optical motion tracking is the gold standard in gait analysis, but today, markerless solutions are growing rapidly. treatment of physical impairments could improve if supported with reliable motion capture. moreover, the use of markerless technology offers numerous advantages for working with pediatric populations under various conditions. in this paper, we assess the openpose reliability to measure kinematics and spatiotemporal gait parameters and to evaluate the minimum technical requirements., in a population of children with and without gait impairments. validating markerless methods can open the way for new motion capture techniques and enhance the accessibility of kinematic measurements and improve the treatment of physical impairments.

Eligibility criteria:
inclusion criteria: * age over 4 years; * ability to walk independently without walking aids and/or orthoses. exclusion criteria: * inability to walk independently and safely for short distances without walking aids and/or orthoses.

Keywords: kinematic markerless openpose
acute effects of inhaled treprostinil in fontan patients

Conditions: Congenital Heart Disease

Summary: in this pilot study investigators propose to explore the effects of a locally delivered inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood flow, venous pressure response and vascular function in stable fontan patients. investigators will also assess the effects of resting and acute rises in exercise induced systemic venous pressure on liver stiffness and will also assess whether treprostinil will attenuate the acute stiffness increase that investigators expect to see. this will be a prospective, randomized, double-blinded placebo controlled, crossover trial. following recruitment and informed consent, each participant will undergo three study visits, including baseline testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and visit 3) at cchmc. twenty-six patients will be enrolled in this study.


Eligibility criteria:
inclusion criteria: 1. patients age 18 years and older 2. single ventricle patients status post fontan procedure exclusion criteria: 1. clinically unstable: these are patients who are experiencing new cardiovascular symptoms such as worsening shortness of breath, new onset arrhythmia, uncontrolled heart failure, or evidence of clinically significant cirrhosis or renal failure. 2. evidence of fontan pathway or intra cardiac obstruction as identified on prior clinically indicated imaging studies (echocardiography and mri); 3. evidence of left or right systemic ventricular systolic dysfunction with an ejection fraction of \<40% on either echocardiogram or mri from previously documented clinical data; 4. presence of uncontrolled arrhythmias; 5. unable to perform exercise testing for any reason or if deemed by the pi or designee that exercise testing would not be in the best interest of the participant 6. currently pregnant and/or breastfeeding 7. patient unable to provide informed consent 8. bmi \> 30 mg/m2

Keywords: congenital heart disease
gi symptoms in infants fed goat milk-based infant formula

Conditions: Stool Assessment; Skin Rash; Urticaria; Regurgitation; Respiratory Ilness; Crying Time in Colicky Infants; Bloating; DIARRHEA, INFANTILE; Constipation

Summary: a cross-sectional observational survey was conducted in brazil, mexico, russia, and the netherlands by recruiting parents/legal guardians through social media. gastrointestinal symptoms after introduction of goat milk-based infant formula (gmf) were questioned using the validated cow's milk-related symptom score (comiss®; scoring 0-33), lower scores indicate fewer symptoms. occurrence of crying, gassiness, eczema, respiratory symptoms and stool consistency were asked retrospectively before and ≥14 days after introduction of gmf.

a cross-sectional observational online anonymous survey on gi symptoms in infants aged 0-24 months fed gmf has been developed and conducted in brazil, mexico, russia, and the netherlands. the gmf of interest was commercially available kabrita® stage 1 or 2 (ausnutria, b.v., the netherlands). participants who had purchased kabrita® were asked to complete a voluntary survey regarding their experience and observation on their infant's gi complaints. no inclusion criteria were set at the time point of sending out the survey. the survey consisted of 30 questions and was online from june 2021 until november 2022. the survey and associated data collection do not meet the criteria for human subject research and therefore approval by an institutional and/or licensing committee is not needed, and participant consent is not required. participation in the survey was anonymized and completely voluntary.

Eligibility criteria:
inclusion criteria: * infants aged 0-24 months * fed at least once with goat milk-based infants formula exclusion criteria: * infants aged \>24 months * taking medication for functional gi disorders

Keywords: gastrointestinal symptoms comiss consumer survey goat milk-based infant formula
immunogenicity, safety and tolerability of two doses of a pre-pandemic influenza vaccine in participants aged 6 months to 17 years

Conditions: Prophylaxis of Avian Influenza

Summary: evaluate the immune response and reactogenicity of h5n1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination


Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * receipt of seasonal influenza vaccine for season 2007/2008 * receipt of another vaccine within 3 weeks before and after each vaccination * previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant mf59 or a similar adjuvant * children who are in the local recommendation for influenza vaccination due to underlying diseases

Keywords: bird flu seasonal influenza vaccine influenza vaccine prepandemic vaccine virus strain with the potential to cause pandemic toddlers children adolescents