Kornimate/medical-research-clean huggingface dataset:
maximal use systemic exposure study of levulan kerastick (muse 2)

Conditions: Keratosis, Actinic

Summary: the purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ala) and protoporphyrin ix (ppix) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (ak) involving the upper extremities.


Eligibility criteria:
inclusion criteria: * at least 6 grade 1/2 aks on one upper extremity and * at least 12 grade 1/2 aks on the other upper extremity exclusion criteria: * pregnancy * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the treatment area * body mass index (bmi) \> 32.0 kg/m2 * skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * significant blood loss within 60 days or donated blood/plasma within 72 hours prior to visit 2 (baseline) * tested positive at screening for human immunodeficiency virus (hiv) or was known to be seropositive for hiv * a history of lead poisoning or a history of a significant exposure to lead * tested positive at screening for hepatitis b surface antigen, hepatitis c antibody or had a history of a positive result * positive drug screen at screening * screening safety labs are clinically significant in the opinion of the investigator * major surgery within 30 days prior to visit 2 (baseline) or plans to have surgery during the study * subject is immunosuppressed * currently enrolled in an investigational drug or device study * has received an investigational drug or been treated with an investigational device within 30 days prior to visit 2 (baseline) * known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol) * use of the following topical preparations on the extremities to be treated: * keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment * cryotherapy within 2 weeks of initiation of treatment * retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment * microdermabrasion, laser ablative treatments, ala-pdt, chemical peels, 5-fu, diclofenac, imiquimod or other topical treatments for ak within 8 weeks of initiation of treatment * use of systemic retinoid therapy within 6 months of initiation of treatment

Keywords: actinic keratosis
treatment of acute periprosthetic joint infection comparing single and planned double-debridement antibiotics and implant retention followed by chronic antibiotic suppression

Conditions: Periprosthetic Joint Infection

Summary: the purpose of this research is to evaluate two different standard of care surgeries in treating periprosthetic joint infection (pji) after total hip and knee arthroplasty. researchers are looking at differences in outcomes following single versus planned double debridement, antibiotics, and implant retention (dair) for acutely infected total hip arthroplasty (tha), and total knee arthroplasties (tkas).


Eligibility criteria:
inclusion criteria: * patients who speak english and are willing to sign the consent form * patients with acute early postoperative infection (symptoms ≤ 4 weeks from surgery; symptoms \< 4 weeks in duration) and acute hematogenous infection (greater than 4 weeks from surgery; symptoms \< 3 weeks in duration) of a primary total knee or total hip arthroplasty, defined as: * a sinus communicating with the prosthesis or * two positive cultures obtained from the prosthesis or * 4 of 5 criteria: elevated esr (\> 30mm/hr) and crp (\> 10mg/l); elevated synovial leukocyte count (\>3000 cells/μl) or change of ++ on; leukocyte esterase strip; elevated synovial neutrophil percentage (\> 80%); one positive culture; positive histological analysis of periprosthetic tissue (\> 5 neutrophils per high; power field in 5 high power fields x 400). * or patient with an acute infection diagnosed clinically by an orthopedic surgeon treated with dair exclusion criteria: * patients with a chronic pji, defined as: presentation of symptoms \> 4 weeks in duration. * revision surgery or previous two-stage reimplantation.

Keywords: total knee arthroplasty total hip arthroplasty
mindful waiting room

Conditions: Anxiety State; Depressive State; Pain; Nausea; Fatigue; Cancer

Summary: this will be a single-site, five-arm, parallel group randomized control trial involving patients seeking integrative healthcare. four different styles of 5-minute, audio-recoded mindfulness practices delivered in the clinic waiting room will be compared with a 5-minute audio-recording about integrative healthcare. a secondary sub-analysis will investigate the most effective mindfulness practice style for patients presenting at the clinic with elevated anxiety, depression, or pain.


Eligibility criteria:
inclusion criteria: * seeking treatment at the huntsman cancer institute's wellness center * adults 18+ * facility with the english language that is adequate to complete study procedures exclusion criteria: * cognitive impairment preventing completion of study procedures * an unstable illness judged by medical staff to interfere with study treatment
evaluation of predictors of aortic aneurysm growth and rupture

Conditions: Abdominal Aortic Aneurysm

Summary: the goal is to non-invasively study the metabolic processes within the aortic wall that are thought to explain progression to clinical manifestations of an aortic aneurysm. hypothesis is that the non-invasive imaging of abdominal aortic aneurysm (aaa) with contrast ultrasound, coupled with serum biomarker measurements will allow the identification of the vulnerable aortic wall and patients who are at risk of aaa growth or rupture.

aim#1: prospective contrast ultrasound (cus) imaging of patients with aaa to predict aaa growth and test gender differences in rate of growth and rupture. aim#2: serum biomarker testing of patient with aaa. cus findings will be correlated with serum biomarkers and aaa wall histology. prospective contrast ultrasound imaging of patients with aaa as part of a pilot feasibility study to predict aaa growth and test gender differences in rate of growth and rupture. cus findings will be correlated with serum biomarkers and aaa wall histology. potential significance: this study will evaluate the aaa wall and will be based on detecting areas of increased vasa vasorum density within the aneurysm wall and intraluminal thrombus, which indicate regional ischemia and inflammation of the aortic wall and propensity for weakening, enlargement or rupture. this novel evaluation of the aortic wall in patients with aaa will allow individualized treatment based on the biological potential for growth and rupture.

Eligibility criteria:
inclusion criteria: * diagnosis of aaa with confirmation of diagnosis of any size aneurysm with imaging. * 21 years of age or older * ability to give informed consent. exclusion criteria: * inability to provide an informed consent * known allergy to definity * unstable cardiopulmonary conditions * pregnancy
surpass impella 5.5 study

Conditions: Cardiogenic Shock; Acute Decompensated Heart Failure

Summary: a multi-center, prospective \& retrospective, observational single-arm study of the clinical outcomes up to one year collected from electronic health records of patients which have undergone standard of care implantation of impella 5.5, regardless of clinical situation or indication. all patients will be enrolled via an irb-approved waiver of informed consent and hipaa authorization. all patients who were supported retrospectively (prior to site irb approval) with impella 5.5 at the investigative site will be entered into the surpass registry and specified as the retrospective cohort.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * subject has previously undergone an impella 5.5 implant at a study site exclusion criteria: * patients not receiving impella 5.5

Keywords: impella impella 5.5 bridge to next therapy
evaluation of photodynamic therapy in pieces with presence of fistula.

Conditions: Periodontitis; Fistula

Summary: the goal of this clinical trial is to learn if adjuvant antimicrobial photodynamic therapy (apdt) can help in the treatment in patients with pieces with apical periodontitis and the presence of fistula, in terms of reducing symptoms, resolution of fistula and the clinical signs of inflammation at the oral mucose, as well as, evaluation radiographic parameters. participants will undergo conventional endodontic treatment at group i (n=15) and will undergo conventional endodontic treatment combined with antimicrobial photodynamic therapy at group ii(n=15).

the calculation of the sample size was conducted with the statistical software g-power 3.1 applying the chi-square homogeneity test. identical sample sizes were considered for the apdt group and the sham group. the percentage of type error was set at 5% and the statistical power at 80%, obtaining n = 30 considering 10% losses. the distribution of data within each group and the homogeneity of the variants will be verified for the choice of an analysis of variance or not. with this information the most proper statistical test will be conducted. the sample size calculation is based on the literature and a 5% significance level will be adopted

Eligibility criteria:
inclusion criteria: patients must have a single-rooted tooth with apical periodontitis and the presence of fistula. patients must be over 18 years of age. exclusion criteria: patients with comorbidities such as cancer, diabetes, coagulation diseases, and anemia; patients undergoing orthodontic treatment; patients with periodontal pockets deeper than 4 mm; patients taking antibiotics; pregnant or lactating patients; patients with parts that present the impossibility of performing absolute isolation.

Keywords: periodontitis fistula apdt methylene blue
investigation of desmoplastic squamous cell carcinoma

Conditions: Squamous Cell Carcinoma of the Skin

Summary: aim of the study is to verify wether it is possible to have a more sensitive diagnostic tool using pancytokeratin immunohistochemistry for desmoplastic squamous cell carcinoma compared to regular h\&e staining. the investigators therefore plan to include 73 participants with a confirmed diagnosis of desmoplastic squamous cell carcinoma and do regular follow up.


Eligibility criteria:
inclusion criteria: * desmoplastic squamous cell carcinoma (scc) of the skin exclusion criteria: * tumor recurrence * collision tumors * other skin malignancies * progeria * rothmund-thomson-syndrome * lacking of the capacity for informed consent

Keywords: squamous cell carcinoma dermatosurgery immunohistochemistry
remote monitoring of af recurrence using mhealth technology

Conditions: Long Standing Persistent Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common arrhythmia worldwide. it carries a significant health burden, conferring on sufferers a reduction in quality of life, risk of significant morbidities such as stroke and heart failure, and significant mortality. at present, diagnosis of af involves referral for conventional 12 lead electrocardiogram (ecg) recording, ambulatory ecg for fixed time period recording, or insertion of implantable loop recorders (ilr). these investigations are limited both by recording only at specific time points and failing to explore the interaction between heart rate and day-to-day physical activity. in recent years, the use of mobile health (mhealth) devices has emerged as a direct-to-consumer option for monitoring parameters such as heart rate and activity levels. from a clinical perspective they potentially offer a less invasive and cost-effective investigative approach, with remote monitoring solution to identify and possibly predict af. in this study, the investigators propose to recruit participants who have undergone an ablative procedure as part of a randomised clinical trial (loto in casa lspaf: nct04280042) and monitor for recurrence of af using mhealth technology by correlating with ilr data.


Eligibility criteria:
inclusion criteria: * participants in loto in casa lspaf with implanted loop recorders (ilr) exclusion criteria: * participants in loto in casa lspaf who had their ilr explanted

Keywords: atrial fibrillation digital health artificial intelligence catheter ablation thoracoscopic surgical af ablation
immediate pressor response to oral salt

Conditions: High Blood Pressure

Summary: the goal of this study is to establish a diagnostic accuracy of an immediate pressor response to oral salt (ipros) to identify salt sensitivity of blood pressure (ssbp)

participants are given dietary salt and their bp is measured every 10 minutes for 2 hours. ipros is diagnosed with significant mean arterial pressure increase for ssbp, participants are put on high salt diet for a week and monitored and low salt week. the mean arterial pressure difference between high salt and low salt is used to diagnose ssbp

Eligibility criteria:
inclusion criteria: * participants will be included if they are males or females, aged 18-65 years. exclusion criteria: * kidney disease, cardiovascular disease
123i-mibg scintigraphy in patients being evaluated for neuroendocrine tumors

Conditions: Pheochromocytoma; Neuroblastoma; Paraganglioma; Medullary Thyroid Carcinoma; Carcinoid Tumors

Summary: the study is designed to study the safety and effectiveness of 123i-mibg as a diagnostic imaging agent in evaluating patients with known or suspected neuroendocrine tumors.


Eligibility criteria:
inclusion criteria: * subjects must have a clinical indication for 123i-mibg imaging to evaluate for the presence, extent, or status of neuroendocrine tumors; * subjects must be able and willing to comply with study procedures. exclusion criteria: * subjects with history of renal insufficiency (serum creatinine level \> 3.0 mg/dl \[265 µmol/l\]) and inability to be withdrawn from medications known to interfere with 123i-mibg uptake; * subjects unable to tolerate lying supine; * subjects pregnant or breastfeeding, unless the information to be gained outweighs the possible hazardous effects of 123i-mibg administration. where the assessment of the risk/benefit ration suggests the use of 123i-mibg in nursing mothers, the breastfeeding should be discontinued for at least 48 hours post-injection.
trichuris suis ova therapy for relapsing multiple sclerosis - a safety study

Conditions: Relapsing Multiple Sclerosis

Summary: the hypothesis of this study is that treatment with trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis.


Eligibility criteria:
inclusion criteria: * age between 19 and 55 years * relapsing course of multiple sclerosis (relapsing-remitting or secondary progressive ms with relapses * duration of the disease of at least 1 year * no disease modifying therapy or unchanged immunomodulatory therapy for the last 3 months * at least 2 documented relapses during the last 24 months with the last relapse within the last 12 months exclusion criteria: * pregnancy or period of breastfeeding or missing adequate contraceptive protection for female premenopausal patients * relapse in the last month prior enrolment * treatment with steroids in the last 30 days * previous treatment with mitoxantroneduring the last year * previous treatment with cyclophosphamide or other intensive immunosuppression, total irradiation * treatment with glatiramer acetate, azathioprine, ivig or any other immunosuppressive or immunomodulatory drug apart from interferon-beta in the 6 months prior to enrolment * cardiac insufficiency (nyha iii/iv), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (ccs iii or iv), malignant hypertension * diabetes mellitus and other autoimmune diseases * history of renal insufficiency * stay in tropical areas during the last 3 months * eosinophilia in the blood (\> 0,45 billion/l) * concurrent systemic infections

Keywords: multiple sclerosis safety mri immunological helminths trichuris suis
pilates exercises versus resistance exercises among geriatric population with sarcopenia

Conditions: Sarcopenia

Summary: the goal of this clinical trial is to compare the effectiveness of two exercises to improve physical functioning of older adults with sarcopenia. the primary aim of this rct is: to measure the influence of pilates exercises versus resistance training in elderly with sarcopenia. to introduce an affordable, effective and safe exercise care program, which prioritizes to make geriatric population independent. participants will be assessed for all outcome measures change at baseline and after 3 weeks following an exercise intervention. participants enrolled in pilates exercise group will receive total of 9 exercises and participants enrolled in resistance exercise group will receive total of 8 exercises.

a total sample of 70 of geriatric population with sarcopenia will be collected from dow university hospital ojha. non-probability purposive sampling technique will be used. participants will be screened and referred from medicine, family medicine and neurology opd to physiotherapy opd. outcome measure assessment will be performed in all patients at two time points: baseline and follow up at the end of last session. outcome measures include short physical performance battery assessment tool (sppb). strength and gait are first evaluated by the ability to perform the tasks of getting up and sitting on a chair five consecutive times and performing the walking speed test (3 meters), time up and go test, sit and reach test, and 2-minute step test as a measure of physical functioning. after complete assessment at baseline all participants will be randomized to different treatment groups using 70 opaque sealed envelopes containing notes written with "new treatment" or "standard treatment" on (n= 35 of each). the envelops will be scrambled before each participant allow to draw an envelope and thus find out in which group they will be allocated. treatment will be provided to both groups. group 1 will be provided with pilates exercises and group 2 will be provided with resistance exercises. both groups will perform generalized warm up for up to 10 minutes at the beginning and 10 minutes of relaxation exercises at the end of treatment session.

Eligibility criteria:
inclusion criteria: * referred and screened patients with sarcopenia from medicine, family medicine and neurology opd at dow university hospital ojha campus, karachi. * patients from 60 to 70 years of age * both male and female. * patients who consent to participate exclusion criteria: * being bedridden * implanted pacemaker * recent history of any fracture * patients with cognitive \& neurological impairment * already enrolled in any exercise intervention program * known case of patients with malignancy * patients on steroids

Keywords: sarcopenia resistance training exercise movement techniques
internet-based treatment for chronic insomnia

Conditions: Insomnia; Insomnia Disorder

Summary: study objectives. despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. this study evaluates the impact of a 6-week, online treatment for insomnia. design this is a randomized controlled trial with online treatment and waiting list control conditions. participants participants are adults in manitoba canada with chronic insomnia. setting participants receive online treatment from their homes. intervention. online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. measurement and results. the impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.


Eligibility criteria:
inclusion criteria: * access to high speed internet, insomnia duration \> 6 months and occurring at least 4 nights per week, sleep-onset latency \> 30 minutes and/or time awake at night \> 30 minutes, and/or early morning awakening \> 30 minutes before desired time, at least one type of daytime impairment. exclusion criteria: * shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake \> 14 drinks/week for males, \> 12 drinks per week for females, current or past behavioral treatment for insomnia

Keywords: insomnia online systems
the longitudinal ovarian reserve study

Conditions: Effects of Chemotherapy

Summary: postmenarchal female cancer patients scheduled to undergo cancer therapy may enroll in this study to assess changes in existing and novel surrogate measures of fertility potential before, during and after chemotherapy. measures of fertility potential to be tested include ultrasound imaging for antral follicle counts and ovarian volumes, endocrine evaluation, and assessment of oxidative stress.

eligible women are asked to complete a structured interview, questionnaires, a monthly menstrual diary, a brief physical examination, a blood test, and an abdominal or pelvic ultrasound at baseline and at 3 month intervals following start of chemotherapy through 6 months post end of treatment. within subject changes in continuous variables (hormones, urinary isoprostane levels, ovarian volume, afc) will be compared using paired t-tests (nonparametric tests as appropriate). non-gaussian-distributed variables will be logarithmically transformed prior to analysis. in general, changes from baseline to every 3 month assessment will be compared individually as well as changes from baseline to post treatment. in addition, regression models for repeated measures will be used to describe the pattern of change in these outcomes over time. additional models will be constructed to adjust for potential confounding variables including age, chemotherapy type, dose and duration of treatment, radiation treatment, gonadotropin releasing hormone agonist use, and hormone use. finally, regression models will be used to evaluate the association between changes in urinary isoprostane levels over the study with changes in endocrine measures.

Eligibility criteria:
inclusion criteria: * females with the diagnosis of cancer schedules to be treated with chemotherapy and or radiation therapy. * age between 15-45 years. * post-menarchal. * presence of a uterus and both ovaries. * ability and willingness to comply with study protocol. * have given written informed concent (or assent with parental consent in minors), prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn byt he patient at any time without prejudice to their future medical care. exclusion criteria: * current pregnancy. * lactation within the previous 3 months. * any medical condition other than cancer, with in the judgment of the investigator is known to be associated with premature ovarian failure (such as turner's syndrome or fragile x) or ovulatory dysfunction (such as thyroid disease, adrenal dysfunction, cushing's syndrome, hyperprolactinemia, and polycystic ovarian syndrome).

Keywords: reproductive hormones cancer survivors endocrine function antral follicle counts female infertility due to diminished ovarian reserve perimenopause premature menopause