Kornimate/medical-research-clean huggingface dataset:
asparaginase activity monitoring (aam) in adult patients with acute lymphoblastic leukemia (all)

Conditions: Acute Lymphoblastic Leukemia

Summary: in order to understand how pharmacokinetics and immunological inactivation affect the therapeutic efficacy of asparaginase (asp), it is of help and advised in the frame of clinical font-line protocols to monitor the enzymatic activity by measuring the serum asp levels in the days following the administration of the drug.


Eligibility criteria:
inclusion criteria: * signed written informed consent according to ich/eu/gcp and national local laws * age 18 - 65 years * diagnosis of untreated ph- all entering treatment including peg-asp in induction and consolidation * ecog performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by pre-existing comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures exclusion criteria: * diagnosis of burkitt's leukemia * down's syndrome * adults with ph+ all * pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, nyha classes iii and iv) * severe liver disease with serum bilirubin \>3 mg/dl and/or alt \>3 x upper normal limit (unless attributable to all) * kidney function impairment with serum creatinine \>2 mg/dl (unless attributable to all) * severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan * presence of serious, active, uncontrolled infections * pre-existing hiv positive serology (i.e. already known before enrolment). if hiv positivity is detected after enrolment, the patient is put off study. * pregnancy * men and women should use effective contraception during treatment and for at least 6 months after asparaginase discontinuation. as a precautionary measure, breast-feeding should be discontinued during treatment with asparaginase and should not be restarted after discontinuation of asparaginase
mr-linac for head and neck sbrt

Conditions: Head and Neck Cancer

Summary: this study will evaluate the feasibility and safety of using mr-guided adaptive head and neck stereotactic radiotherapy (sbrt) at each fraction on the 1.5t mr-linac.

at the sunnybrook odette cancer centre (occ), stereotactic body radiation therapy (sbrt) (35- 50 gy in 5 fractions delivered 2x/week) has been employed in a subgroup of palliative head and neck cancer (hnc) patients, as part of an institutional protocol, when greater tumor response is desirable when compared to more palliative regimens. the mr-linac has been approved by health canada for radiation treatment. with superior soft tissue contrast and the possibility for daily plan adaptation, it allows for higher treatment precision delivery, improved target coverage and greater normal tissue sparing. as a first step, this study will evaluate the feasibility and safety of using the 1.5t mr-linac on patients with hnc who are treated with sbrt.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and older * karnofsky performance status score of ≥70 * biopsy-proven oligometastatic cancer to the hn * biopsy-proven primary hn cancer (either mucosal, nodal, skin) * patients deemed unsuitable by the treating radiation oncologist for radiation treatment with curative intent owing to advanced age, significant comorbidities, poor performance status, distant metastatic disease. * ≥ 1 site amenable to hn sbrt * capable of providing informed consent * required to complete any systemic therapy ≥ 10 days prior to planned start of hn sbrt, with no plans to initiate systemic therapy ≥10 days following completion of hn sbrt. exclusion criteria: * history of radiation within the projected treatment field * contraindications to mr imaging per institutional policy * patients with connective tissue disorders * history of severe claustrophobia * pregnant and or breastfeeding females * having an estimated glomerular filtration rate (gfr) \<40 ml/min/1.73m2

Keywords: adaptive radiotherapy
platelets in acute wounds: a pilot study (paws)

Conditions: Wounds

Summary: comparison of wound healing treatments; platelet gel vs. control

comparison of autologous platelet gel to a control treatment in acute wounds, specifically punch biopsy wounds. eight patients included in this pilot/feasibility study. wound healing evaluated over 6 months for wound closure and long term outcome.

Eligibility criteria:
inclusion criteria: healthy non-smokers, \>18 years of age, bmi\<30 - exclusion criteria: smokers, obese, keloid formers, bleeding disorders, medications -

Keywords: acute wounds wounds platelets platelet gel
anisakis blastocystis cryptosporidium fish serology

Conditions: Allergy to Fish; Allergy; Anisakis

Summary: anisakidae frequently infect fish species that are commonly eaten by humans. some of them are recognized as zoonotic diseases agents, and have a high impact on human health. infestation results from the ingestion of living larvae from contaminated fishes. it can be asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms. allergic manifestations are frequently encountered in gastric forms, but allergic symptoms can also occur in isolation, after ingestion of anisakidae antigens contained in raw or cooked fish, and may masquerade as fish allergy. in this study, we aim to characterize the relationship between anisakidae and/or fish sensitization and the presence of allergic manifestations in patients recruited in the general population and presenting fish allergy resulting from ingestion, cutaneous or respiratory contact. we will also determine the respective role of anisakidae or fish sensitization in patients with fish allergy. then, we will determine the prevalence of previous anisakidae infections among these patients and a matched control population. we will also compare the performances of serological tests (immunocap, immunoelectrophoresis and western blot) for the diagnosis of anisakidae allergy or infection. lastly, we will explore the relationship between domestic exposure to anisakidae or fish antigens and the occurrence of associated pathologies (anisakidae or fish allergy/sensitization; anisakidae infection).

first, 51 patients with fish allergy will be recruited from the parasitology-mycology and immunology laboratories of lille university hospital databases (serology for anti-anisakis or anti-fish detection). then, clinical (characteristics of allergic manifestations) and epidemiological (domestic exposure to fish) data will be collected, and anti-fish or anti-anisakis antibodies will be detected using immunocap (ige), or immunocap, immunoelectrophoresis, western blot, respectively. similar serological tests will be performed for a control group of 51 matched subjects who will be recruited among lille university hospital workers.

Eligibility criteria:
inclusion criteria: allergic patients: * previous serological assessment for anti-anisakis or anti-fish antibodies detection (immunocap and/or immunoelectrophoresis) in lille university hospital center, and volume of serum conserved ≥500 µl * allergic manifestations after contact with fish (asthma, allergic rhinitis, conjunctivitis, chronic or acute urticaria, dermatitis/eczema, eosinophilic gastroenteritis, gingivostomatitis, angioedema, bronchospasm, anaphylaxis) control subjects: * serological assessment for infectious disease during a routine occupational health consultation in lille university hospital center * absence of fish allergy exclusion criteria: * pregnant or breast-feeding female * patient with no social insurance * patient unwilling to comply with the protocol * patient unable to understand the study and its objectives * patient under guardianship

Keywords: ige immunoelectrophoresis western blot immunocap
point in time of radiotherapy for patients with biochemical recurrent prostate carcinoma

Conditions: Prostate Cancer; Recurrence

Summary: psa-recurrence prostate carcinoma is associated with two general problems. 1. localisation of psa-recurrence is unconfident. in many cases it's not clear if a local, locoregional oder systemic relapse is available. 2. there is no standard therapy proved by randomised clinical trials. recommended radiotherapy starting with psa-value \< 0.5 ng/ml according to german s3 guidelines is based on retrospective data. these difficulties may lead to a therapy potentially not adapted to patients situation of disease.this study aims to randomised examine if an instant radiotherapy of prostate psa-recurrence (psa-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional imaging (psa value \>= 1 ng/ml) including pet/ct and bone scintigraphy for reliable information about tumor location and expansion is beneficial regarding therapy efficiency, quality of life and social economic aspects.


Eligibility criteria:
inclusion criteria: * postoperative, biochemical recurrent prostate carcinoma with psa value between 0.2 to 0.99 ng/ml * prior irradiation * comprehension of study protocol content and signed informed consent form * minimum age 18 years exclusion criteria: * primary therapy of prostate carcinoma * psa value \>= 1 ng/ml * diagnosed distant metastases before randomisation (osseous or systemic) * performed pet/ct before randomisation * malignant slave tumor * potent men that are not willing or are unable to apply consequent contraception * ongoing drug- and/or alcohol abuse * patients that are not willing or able to cooperate according to protocol * patients in care * patients that are not able to understand german language

Keywords: biochemical recurrence prostate carcinoma prostate cancer psa postoperative radiotherapy imaging diagnostic pet/ct social economic aspects quality of life
pilot study of imatinib mesylate to treat nephrogenic systemic fibrosis

Conditions: Nephrogenic Systemic Fibrosis

Summary: the purpose of this study is to determine the efficacy of imatinib mesylate in reducing cutaneous thickening and tethering in patients with nephrogenic systemic fibrosis (nsf). the study will also work to assess the safety and tolerability of imatinib mesylate in patients with chronic kidney disease and nsf.

nephrogenic systemic fibrosis (nsf) is a recently described, extremely debilitating and painful condition that affects individuals with renal failure. recent reports suggest an association between gadolinium exposure during magnetic resonance (mr) studies and the subsequent development of nsf in patients with chronic renal failure. nsf is characterized by rapidly progressive skin hardening, tethering and hyperpigmentation, predominantly on the extremities. visceral involvement is rare. skin biopsies of early nsf lesions demonstrate thickened collagen bundles, mucin deposition, angiogenesis and numerous dermal spindle cells that stain with antibodies to cluster of differentiation 34 (cd34) and procollagen. cutaneous changes of nsf are present in up to 13% of individuals receiving hemodialysis. among those patients with clinical evidence of nsf, the principle investigator of this protocol has recently reported that nsf is associated with increased early mortality at 24-months. there is no proven therapy for this devastating disorder. anecdotal reports have shown modest improvement in joint mobility and decreased skin thickening with extracorporeal photopheresis and pentoxyphylline. increased transforming growth factor (tgf)-beta1 messenger ribonucleic acid (mrna) on immunostaining has been observed in skin, fascia and striated muscle. imatinib mesylate, a tyrosine kinase inhibitor, prevents tgf-beta-induced stimulation of collagen and extracellular matrix protein synthesis as well as mrna expression by normal fibroblasts. this observation led the principal investigator to evaluate imatinib mesylate 400 milligrams (mg) orally (p.o.) daily for 1 year in two participants with nsf. the result was significant softening of previously hardened skin with increased mobility of skin that previously had been tethered to the underlying fascia. after one month of imatinib mesylate, one of the two participants had a 20 degree reduction of his knee flexion contractures.

Eligibility criteria:
inclusion criteria: * age \> 18 years * biopsy-proven nsf * ability to give consent exclusion criteria: * known sensitivity to imatinib mesylate or to any of its components * pregnant or lactating woman * bullous dermatologic disease * aspartate aminotransferase / alanine aminotransferase (ast/alt) \>3 x upper limit of normal * severe congestive heart failure \[new york heart association (nyha) class iii or iv\] * patients who have received gleevec in the past 12 months

Keywords: treatment chronic kidney disease fibrosing disorders imatinib mesylate
peds metabolic syndrome in psoriasis

Conditions: Psoriasis; Metabolic Syndrome

Summary: the objective of this study is to assess whether there is an increased risk of the metabolic syndrome in children with psoriasis compared to children without psoriasis.

adult patients with psoriasis, especially those who are young and with severe disease, have an increased prevalence of myocardial infarction and metabolic syndrome, and increased mortality. tumor necrosis factor (tnf) and other inflammatory cytokines are felt to play an important role not only in the pathogenesis of psoriasis and psoriatic arthritis, but in the pathogenesis of the metabolic syndrome and increased cardiovascular mortality and morbidity. however, the prevalence of metabolic syndrome and surrogate markers of increased cardiovascular risk, such as lower flow-mediated dilation (fmd) during reactive hyperemia, measured by high-resolution brachial artery ultrasound, lower hyperemia-induced, pulse wave amplitudes as measured by finger plethysmograph peripheral artery tonometry, and elevated blood crp levels, in children with psoriasis, are unknown. we will use the definition of metabolic syndrome described by de ferranti: participants are defined as having metabolic syndrome if they meet or exceed the criteria for 3 or more of the following 5 variables: 1) triglycerides ≥1.1 mmol/l; 2) hdl cholesterol \ 75th percentile for age and sex; and 5) systolic or diastolic blood pressure (mm hg) \>90th percentile for age, sex, and height. the following two noninvasive procedures will be used to assess additional cardiovascular risk: flow mediated dilation (fmd) and finger plethysmography peripheral artery tonometry (pat). these procedures have been used extensively to measure adults for clinical study purposes for many years. as a control group, we will compare children with psoriasis to age-, race-,and gender-matched children with warts.

Eligibility criteria:
inclusion criteria: * 10-17 year old children with either moderate to severe psoriasis or with warts * for psoriasis patients, body surface area covered must be 5% or more or must have had a documented history of 5% or more body surface area involvement * ability to understand and sign an age-appropriate consent form * parent or guardian over 18 years old able to understand and sign consent form exclusion criteria: * psoriasis or wart patient younger than 10 or 18 years or older * for psoriasis patients, body surface area covered less than 5% or have not had a documented history of 5% or more body surface area involvement * inability of child or adult parent/guardian to understand or sign consent * pregnant or lactating females.

Keywords: psoriasis metabolic syndrome cardiovascular risk
inhaled no for the treatment of covid-19 caused by sars-cov-2 (us trial)

Conditions: Corona Virus Infection; COVID-19; SARS-CoV 2; Nitric Oxide; Respiratory Disease; Pneumonia, Viral; Inhaled Nitric Oxide

Summary: the purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm nitric oxide given in addition to the standard of care of patients with covid-19 caused by sars-cov-2.

nitric oxide (no) is a small endogenously produced molecule recognized to play a critical role in the function of several body systems including the vasodilatation of smooth muscle, neurotransmission, regulation of wound healing and inhibition of pathogens. in-vitro studies have shown that no inhibits the replication cycle of the severe acute respiratory syndrome coronavirus (sars cov) in vitro. the suggested mechanisms of actions of no on sars are an effect on the fusion between the s protein and its cognate receptor, ace2, and reduction in viral rna production in the early steps of viral replication. the primary aim of this feasibility study is to investigate the safety of intermittent no, delivered via inhalation, in hospitalized patients with covid-19. the primary endpoint in the study will be time to deterioration of respiratory symptoms determined by escalation to either non-invasive ventilation (niv), high-flow nasal cannula (hfnc), or intubation.

Eligibility criteria:
inclusion criteria: * enrollment within 24 hours of hospital admission of patients diagnosed with covid-19 * patients with oxygen saturation less than 93 % on room air * shortness of breath, with symptom onset within the previous 8 days. * female subjects of childbearing potential should take adequate measures to avoid pregnancy * signed informed consent by the subject exclusion criteria: * patients who are treated with or require high flow nasal cannula, cpap, intubation, mechanical ventilation, or tracheostomy * diagnosis of acute respiratory distress syndrome * subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction or myocardial damage, severe pulmonary hypertension and/or unstable hypertension * patients receiving drugs that have contraindications with no. * breastfeeding or pregnancy as evidenced by a positive pregnancy test. * patients with active pulmonary malignancy or lung transplant * patients with a history of frequent epistaxis or significant hemoptysis

Keywords: covid-19 coronavirus inhaled nitric oxide ino sars-coronavirus virus
methionine and cysteine restriction in humans

Conditions: Overweight

Summary: the aim of this study is to examine the effect of methionine and cysteine restriction on energy and macronutrient metabolism in overweight human subjects

the sulfur-containing amino acid methionine and its downstream metabolite cysteine has been associated with fat mass in animal studies and human observational studies. some of the proposed mechanisms include an association with lipogenesis, insulin sensitivity and disrupted energy metabolism. the overall aim of this project is to evaluate the effects of a diet low in methionine and cysteine on markers of lipids, amino acids, glucose and other biomarkers related to energy metabolism, including transcriptomic and protein expression data from adipose tissue and lymphocytes. overweight and obese but otherwise healthy volunteers will be randomized to receive a diet either low, moderate or high in methionine and cysteine concentrations for 1 week. this is a pilot study that may be considered an extension of nct02647970. in addition to the primary and secondary outcomes we will evaluate the feasibility of the intervention and procedures.

Eligibility criteria:
inclusion criteria: * body mass index of 25-35 kg/m2 exclusion criteria: * high physical activity * smoking * drugs * chronic disease * pregnancy or breastfeeding

Keywords: methionine cysteine energy metabolism sulfur amino acids
pregnancy tracking pilot

Conditions: Gestational Weight Gain

Summary: this pilot study will examine perceptions about daily weighing for pregnant women with overweight or obesity by testing the feasibility, acceptability, and preliminary efficacy of daily weighing for reducing excess gestational weight gain (gwg) within the context of a low intensity, digital-health based intervention delivered remotely with electronic feedback to participants.


Eligibility criteria:
inclusion criteria: * women ages 18-34 * first pregnancy and at 13-20 weeks' gestation * low-risk uncomplicated pregnancy * overweight or obese at the time they became pregnant * willing to receive emails. exclusion criteria: * individuals who are not pregnant * not willing to receive emails * pregnant women expecting more than a single birth, * outside the window of 13-20 weeks' gestation * high-risk or complicated pregnancy for which participation would be contraindicated * advanced maternal age according to obstetric guidelines (i.e., age 35 or older) * diabetes * history of eating disorders * pre-pregnancy weight less than 25 kg/m2or greater than 36 kg/m2 (either not overweight or with extreme obesity)

Keywords: pregnancy digital health daily weighing
a comparison of the resection rate for hot and cold snare polypectomy of colorectal polyps (10-15 mm)

Conditions: Adenomatous Polyps

Summary: colorectal cancer (crc) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. adenomatous polyps of the colon are possible precursor lesions for crc. screening for crc has been shown effective in preventing crc and related deaths, especially colonoscopy and resection of adenomatous polyps. currently, for intermediate sized polyps 5 - 19 mm hot snare polypectomy (hsp) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. on the other hand, cold snare polypectomy (csp) has grown popularity. absence of electrocautery makes it technically easier and most important reduces adverse events. csp is recommended as the preferred technique for polyps \<5 mm by the european society of gastrointestinal endoscopy (esge) guidelines. in literature, there is one multicenter trial from japan recommending csp for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen. in this randomized controlled trial, the investigators want to compare the complete resection rates of small and intermediate sized colorectal polyps 10-15 mm with csp and hsp.


Eligibility criteria:
inclusion criteria: * indication for colonoscopy * at least 1 adenomatous polyp 10-15 mm * provided written informed consent exclusion criteria: * american society of anaesthesiologists class iv or higher * florid inflammatory bowel disease * emergency indication for colonoscopy * haemorrhagic diathesis * continued dual antiplatelet therapy * continued anticoagulant therapy