Kornimate/medical-research-clean huggingface dataset:
internet delivered cognitive behavior therapy based on intolerance of uncertainty

Conditions: Generalized Anxiety Disorder

Summary: the goal of this clinical is to pilot test an internet delivered cognitive behavior therapy (icbt) based on intolerance of uncertainty (one of several existing specific cognitive models for how worry works) in treating generalised anxiety disorder (gad). the main aims is to: * test the preliminary effect of the intervention in lowering symptoms of gad as measured by the self report scale gad-7 * test procedures for recruitment, assessment, treatment and follow up * test the acceptability of the intervention as measured by the client satisfaction questionnaire-8, dropout and adverse events participants will apply for treatment in an online system, be assessed via video by a licensed clinical psychologist and then receive a 10 week long icbt intervention based on the intolerance of uncertainty model. this is a pilot study for an upcoming randomized controlled trial.


Eligibility criteria:
inclusion criteria: * 18 years old or more. * diagnosis of gad based on clinical assessment. * at least 10 points on gad-7 at screening. * proficient in written swedish. * access to internet enabled device and swedish bankid for authentication * able to make sufficient time for the 10 week long treatment * consents to study exclusion criteria: * in need of treatment for other psychiatric diagnosis as priority (eg depression, psychosis) or high risk of suicide based on clinical assessment * ongoing risk use of alcohol or drugs * ongoing serious somatic of social disease/problem that is deemed to be to much of a hindrance for the completion of the treatment

Keywords: internet delivered treatment digital mental health services psychiatry cognitive behavior therapy intolerance of uncertainty
a real-world study to assess safety of ozurdex® (dexamethasone intravitreal implant) in adult participants with diabetic macular edema in china

Conditions: Diabetic Macular Edema

Summary: the dexamethasone intravitreal implant (ozurdex) delivers dexamethasone gradually to the retina over time. it is an approved drug for the treatment of diabetic macular edema (dme). this study will assess the long-term safety and effectiveness of ozurdex in adult participants with dme in the routine clinical setting in china. approximately 110 participants who are prescribed ozurdex by their physicians will be enrolled in multiple medical institutions in china where ozurdex is used for dme in routine clinical practice. participants will be followed for 24 months after the first administration of ozurdex according to the routine clinical practice of the prescribing centers. a subsequent 30-day follow-up after the last dose will be performed to obtain information on any new or ongoing safety events and concomitant medications. no additional burden for participants in this trial is expected.


Eligibility criteria:
inclusion criteria: - participant scheduled to receive at least one intravitreal ozurdex® injection for dme as per most current local approved label after its approval for dme in china. exclusion criteria: * concurrent participation in interventional clinical research that required treatment or use of an investigational agent. * participants for whom ozurdex® is contraindicated: * participants with known hypersensitivity to ozurdex® or any components of this product. * participants with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. * participants with late stage glaucoma that cannot be controlled with medication alone. * aphakia with ruptured posterior lens capsule. * eyes with anterior chamber intraocular lenses (aciol), iris- or scleral-fixated intraocular lenses, and ruptured posterior lens capsule.

Keywords: diabetic macular edema ozurdex
open label, multicenter, real world practice of durvalumab (imfinzi pms)

Conditions: Lung Cancer, Biliary Tract Cancer

Summary: the objectives of this study are to assess safety and efficacy of imfinzi (durvalumab) in a real world setting in patients treated with imfinzi under the approved indication in korea.

primary objective : to assess safety of imfinzi for patients treated with imfinzi under the approved indication in korea outcome measure: * safety (adverse event (ae), serious adverse events (sae), adverse drug reaction (adr), serious adverse drug reaction (sadr), adverse events of special interest (aesi), adverse events leading to discontinuation (dae), and adverse events leading to deaths (fatal ae)) * dose interruptions * duration of treatment * reason for treatment discontinuation secondary objective: to assess efficacy of imfinzi for patients treated with imfinzi under the approved indication in korea outcome measure: * progression free survival (pfs) * objective response rate (orr) * duration of response (dor)

Eligibility criteria:
inclusion criteria: * eligible for imfinzi treatment according to the approved label * provision of signed and dated written informed consent by the patient or legally acceptable representative exclusion criteria: * current participation in any interventional trial * other off-label indications according to the approved label
feasibility and efficacy study of conditioning regimen for allogeneic hematopoietic cell transplantation (hct) with fludarabine, busulfan, and total body irradiation (tbi)

Conditions: AML; MDS; ALL; CML; Lymphoma

Summary: the purpose of this study is to evaluate the os, rfs, and trm after hct with low-dose total body irradiation, fludarabine, and busulfan conditioning.

conventional allogeneic hematopoietic cell transplantation (hct) for patients with hematological malignancies involves conditioning with high doses of systemic chemo/radiation therapy such as cyclophosphamide (cy) plus 1200 or 1000 cgy total body irradiation (tbi; cy/tbi) or busulfan (bu) / cy (bucy). unfortunately, such regimens have been associated with significant toxicities, limiting their use to otherwise healthy, relatively young patients. recently, fludarabine plus 4 day dose of busulfan (flubu4) containing myeloablative regimen has been introduced successfully without increasing transplant-related mortality (trm). to improve transplant outcomes without increasing the risk of recurrence, russell et al introduced 400cgy of tbi with antithymocyte (atg, 4.5mg/kg) into flubu4 regimen with successful outcomes.

Eligibility criteria:
inclusion criteria: * at least 15 years old and not more than 65 years old. * ecog performance status 0-2. * patients with aml or mds with intermediate/unfavorable cytogenetics. * patients with all and cml ineligible for cy/tbi conditioning. * patients with nhl or hd eligible to myeloablative hct. * patients receiving unrelated bmt for aml, mds, all, cml, nhl or hd. * consent form signed and dated prior to study specific procedures. * subject able to comply with the scheduled follow-up and with the management of toxicities. exclusion criteria: -

Keywords: fludarabine busulfan total body irradiation conditioning regimen
determining the true incidence of atrial fibrillation before and after lung resection

Conditions: Lung Cancer; Atrial Fibrillation; Stroke

Summary: lung resections for pulmonary malignancies offer the best chance of survival for patients, but these procedures carry a significant burden of post-operative morbidity and mortality. patients are particularly at high risk for post-operative atrial fibrillation (a condition involving irregular heart rhythm). atrial fibrillation with symptoms can increase the risk of stroke - a blockage in a major blood vessel in the brain, which can potentially result in a disability or even death. the objective of this study is to establish the feasibility of using ambulatory heart rate monitoring to determine the total incidence of atrial fibrillation in the peri-operative period before and after anatomic lung resection for malignancies. the study will also investigate the correlation between atrial fibrillation and rates of stroke and other adverse events, as well as serve to identify the patients that are at a higher risk of developing atrial fibrillation.

novel literature suggests that atrial fibrillation that is asymptomatic may just be as problematic as atrial fibrillation that presents itself with symptoms. the objective of the study is to establish the feasibility of tracking the total incidence of atrial fibrillation in the peri-operative period, including both symptomatic and asymptomatic events, using an ambulatory heart monitor. additionally, the study aims to estimate the overall incidence of peri- and post-operative atrial fibrillation. these will be accomplished through usage of irhythm zio xt, a small pebble shaped device that will be adhered to the patient's chest for 14 days before and after surgery, to measure how often atrial fibrillation occurs.

Eligibility criteria:
inclusion criteria: * patients must be at least 18 years of age and competent to consent * patients must be diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy * patients must have one of: male gender, age greater than 65, hypertension, obesity, and recent tobacco use within the past year * patients must be booked for pneumonectomy, lobectomy or anatomical segmentectomy resection. exclusion criteria: * patients undergoing emergent lung resection * patients undergoing lung resection for non-oncologic indications (lung biopsy, bullectomy) * patients with an existing neurostimulator * patients with pre-existing cardiac disease, defined as: * patients with atrioventricular blockage of any degree or sick sinus syndrome; * patients with known previous atrial fibrillation or flutter lasting more than 1 month; * patients with any persistent diagnosed preoperative arrhythmia * patients with implanted external defibrillators or pacemakers * patients with known adhesive allergies * inability to comply with or understand ambulatory monitoring.

Keywords: atrial fibrillation symptomatic atrial fibrillation asymptomatic atrial fibrillation lung resection ambulatory cardiac monitor
biological phosphocalcic metabolism and coronary artery calcifications

Conditions: Cardiovascular Disease

Summary: study a sample of patients in primary prevention, moderate cardiovascular risk (n = 83 patients), with normal, non-diabetic renal function. the investigators quantify the phophocalcic intake and excretion, realizing a food examination and a urine collection of 24 particular. the investigators will measure plasma levels of fgf23 serum calcium, phosphatemia, the investigators will calculate the tubular reabsorption of phosphate. the investigators will conduct a quantitative assessment of coronary calcification by a non-injected ct scan, measuring semi automated way agatston calcium score. there will be an analysis of collinearity. an adjustment will be made for confounding variables in a generalized linear regression model.


Eligibility criteria:
inclusion criteria: * hospitalization for a cardiovascular check in the detection centre and the atherosclerosis prevention (chu rangueil toulouse) * in primary prevention of coronary heart disease * introducing an intermediate cardiovascular risk according to the european score equation, that is to say, a risk of cardiovascular death at 10 years greater than or equal to 1% and less than 5% * signed the informed consent, exclusion criteria: * chronic renal failure patients with an estimated gfr less than 60 ml / min / 1.73m2, due to alterations in phosphate metabolism, * patients receiving glucose-lowering therapy, * patients with a fasting blood glucose greater capillary or equal to 1.10 g / l, confirmed by a plasma glucose greater than or equal to 1.10g / l. * the diuretic therapy patients (due to a change in urinary electrolytes) * hiv-positive patients for hiv, antiretroviral (due to a change in urinary electrolytes) * pregnant women, * patients under judicial protection, guardianship or trusteeship.
kidney histopathology after covid-19 and sars-cov-2 vaccination

Conditions: Covid19; Vaccination Reaction

Summary: the study aims to summarize kidney histopathological findings in patients with coronavirus disease 2019 (covid-19) and post-severe acute respiratory syndrome-coronavirus-type 2 (sars-cov-2) vaccination.

the sars-cov-2 pandemic has had substantial global morbidity and mortality. while covid-19 is most commonly characterized as a respiratory illness, extrapulmonary manifestations are a prominent part its clinical spectrum. kidney disease is a common finding in covid-19, and has also been rarely described after sars-cov-2 vaccination. the main objective of this study is to summarize kidney histopathological findings in patients with covid-19 and post-sars-cov-2 vaccination, in whom native kidney biopsy was performed and samples were obtained by the nephropathology section, institute of pathology, university medical center hamburg-eppendorf, hamburg, germany.

Eligibility criteria:
inclusion criteria: * being diagnosed with covid-19 when kidney biopsy was performed * history of recent homologous or heterogenous vaccine regimen comprising either vector-based vaccines or messenger ribonucleic acid-based vaccines exclusion criteria: * patient refuses participation
twice daily altabax application for the treatment of uncomplicated soft tissue infection

Conditions: Impetigo; Folliculitis; Secondarily Infected Eczema; Minor Soft Tissue Infections

Summary: the purpose of this study is to document the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with bacterial infections, including impetigo, folliculitis, and minor soft tissue infections including secondarily infected eczema presumed to be caused by methicillin resistant staph aureus. male and female patients ages 9 months to 98 years will be recruited from a university based dermatology clinic. upon enrollment, wound cultures will be collected, and then subjects will apply topical retapamulin twice daily for five days. the primary endpoint will be resolution of methicillin-resistant staphylococcus aureus (mrsa) infection based on clinical presentation and physical exam, as well as bacteriological efficacy based on culture results. it is anticipated that approximately 75 patients will be enrolled, with expectation that approximately 50 of these patients will have mrsa infections.


Eligibility criteria:
inclusion criteria: * male or female patients from 9 months of age up to 98 years of age. * clinical diagnosis of impetigo, folliculitis, or minor soft tissue infection including secondarily infected eczema presumed to be caused by staphylococcus aureus. * the patient, and if applicable the parent or guardian, is able to give informed consent * females of child bearing potential have a negative urine pregnancy test. * patient, and if applicable parent or guardian, are willing to and capable of complying with the study protocol. exclusion criteria: * subject who has used a topical antibacterial medication to the area being treated within the last 48 hours. * subject who has been enrolled in a clinical trial within the last 30 days. * subject with signs of systemic infection (such as fever), or with evidence of abscess or cellulitis at the site to be treated. * subject has a bacterial skin infection which would not be appropriately treated by a topical antibiotic in the opinion of the investigator * subjects who have taken oral antibiotics within the last 7 days. * subjects with known sensitivity to the study medication. * the subject is pregnant or breastfeeding

Keywords: eczema atopic dermatitis infection impetigo folliculitis
neurofibromatosis type 1 (nf1) and tibial dysplasia

Conditions: Neurofibromatosis Type 1; Tibial Dysplasia

Summary: the study is a multicenter four-year outcome study of the natural history of tibial dysplasia in patients with nf1 and selected patients without nf1. we will obtain information on the natural history, burden, functional and health status, health-related quality of life, and surgical interventions/outcomes of tibial dysplasia. the project will also establish a core facility (nocf) for tissue samples for future studies.

the three specific aims of this study are: * specific aim 1 - to assess health status and health - related quality of life (hrql) in 50 children and adolescents with nf1 and tibial dysplasia and in nf1 controls. we hypothesize that children and adolescents with nf1 and tibial dysplasia will experience an additional burden of morbidity due to tibial dysplasia and a downward trajectory of health status and hrql over time. * specific aim 2 - to assess the long term outcome of current treatment in 100 adult patients diagnosed with nf1 and tibial dysplasia in childhood. we hypothesize that better quality of life and function, in adults with nf1 and tibial dysplasia, are associated with amputation in childhood compared to multiple surgical procedures, the lack of fibular involvement, and fracture later in childhood. we also hypothesize that individuals with nf1 and tibial dysplasia have a higher risk of other bony dysplasias but are at no higher risk of fracture in other bones. * specific aim 3 - to assess the natural history and short-term response to therapy in a cohort of at least 60 children with nf1 and tibial dysplasia and at least 60 children with tibial dysplasia presumably without nf1 prospectively diagnosed during the course of the four-year study period. we hypothesize that nf1 patients with earlier presentation, crawford class ii a-c, male gender, and the lack of bracing prior to age two are more likely to fracture. we also postulate that individuals with and without nf1 have a similar outcome and response to treatment. the results of this project will provide a rational basis for future clinical and therapeutic trials.

Eligibility criteria:
inclusion criteria: * aim 1: * group 1, nf1 with tibial dysplasia, ages: 3-18 * group 2 (control), nf1 without tibial dysplasia, ages 3-18 * aim 2: nf1 with tibial dysplasia, 19+ * aim 3: tibial dysplasia with or without nf1, ages: birth to 18 * tissue procurement, any participant undergoing surgery at the tibial site for routine standard of care exclusion criteria: * patients without a diagnosis of nf1 or tibial dysplasia

Keywords: neurofibromatosis (nf1) tibial dysplasia (td)
effectiveness of manual physical therapy to improve endocrine levels in women

Conditions: FSH Hypersecretion; Endocrine System Diseases; Infertility

Summary: this study will examine the impact of manual physical therapy on endocrine function in women diagnosed as being infertile due to elevated follicle stimulating hormone (fsh) levels (10 miu/ml or higher) on days 2-5 of their menstrual cycle. it is hypothesized that the manual physical therapy will decrease fsh levels.

this study will investigate the effect of manual physical therapy on the endocrine levels of women by comparison of pre- and post- treatment hormone levels (fsh, lh and estradiol). secondary measures include assessment of pain and sexual function via questionnaires. hormones will be measured at prescribed time points: * baseline: 30-60 days before treatment * pre-treatment: 7-30 days before treatment * post treatment 1: 10-30 days post treatment * post treatment 2: 30-60 days post treatment pain and sexual function questionnaires will be completed: * baseline: 30-60 days before treatment * pre-treatment: 7-30 days before treatment * post treatment 1: 30 days post treatment * post treatment 2: 60 days post treatment

Eligibility criteria:
inclusion criteria: * diagnosed as infertile * fsh greater than 10miu/ml on days 2-5 of menstrual cycle * regular menstrual cycle * residing in the us, accessible to a labcorp testing facility exclusion criteria: * active infection including hiv or inflammation * cancer within the past 5 years * currently pregnant * hemophilia, abnormal bleeding or clotting disorder * immune system disorder * abnormal ovarian cyst or endometrioma * bmi of 35 or greater * any other condition in which deep manual physical therapy is contraindicated * currently taking any fertility medications or planning to take any fertility related medications during the course of the study. this includes all ovarian stimulating medications, artificial hormones and birth control medications. * participation in any assisted reproductive technique (such as ivf) other than intra-uterine insemination during the course of the study.

Keywords: infertility elevated fsh alternative treatment clear passage approach clear passage physical therapy
mindfulness interventions to improve health activation, coping, and stress among childhood cancer survivors

Conditions: Leukemia; Lymphoma; Childhood Cancer

Summary: this study will explore feasibility and acceptability of using a daily mobile mindfulness app to cope with stress. in addition, feasibility of digital health data collection procedures including wrist-worn devices and ecological momentary assessments will be examined. primary objectives * determine the feasibility and acceptability of completing the 30-day mobile mindfulness program * evaluate the feasibility of digital health data collection procedures to detect autonomic nervous system (ans) activation associated with stress (e.g., electrodermal activity, pulse rate variability, skin temperature) via wearable devices and self-reported ecological momentary assessments (ema) among adult survivors of childhood cancer in the sjlife cohort * generate preliminary data to estimate the effect size and power needed for an extramurally funded randomized controlled trials (rct) examining the impact of daily mindfulness mediation on biomarkers of ans activation, coping, health behaviors, and cardiometabolic outcomes in a cohort of survivors of childhood cancer.

prior to engaging in the intervention participants will complete baseline assessments of stress and coping. participants will then engage in a daily mindfulness practice via the headspace mobile application. the basic application program includes daily 10-minute sessions in guided mindfulness meditation that include mindful breathing, body awareness, emotion and thought recognition, and attentional control. during the first and fourth week of the intervention, participants will complete emas assessing mood, current activity, and intervention engagement. participants will also wear a wrist-worn device to assess biomarkers of stress. at the completion of the intervention participants will complete follow-up assessments related to intervention and data collection procedures feasibility and acceptability as well as coping behaviors and stress.

Eligibility criteria:
inclusion criteria: * research participant is at least 18 years old at enrollment * research participant is followed by st. jude children's research hospital (sjcrh) * research participant has a diagnosis history of leukemia or lymphoma * research participant takes part in the st. jude lifetime cohort study (sjlife) * research participant has elevated psychological stress scores of 6 or greater on most recent sjlife questionnaire * participant can speak and read english exclusion criteria: * research participant currently engages in mindful stress-reduction practices \>2x per week (e.g., tai chi, meditation) * research participant takes psychiatric medications or medications that impact cardiac functioning, beta-blockers, alpha-blockers * research participant wears a pacemaker * research participant has a diagnosis of a congenital heart disease * research participant has no access to a smartphone * research participant has elevated pain interference scores (t≥70)