Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of oral vt-1161 in patients with moderate - severe interdigital tinea pedis

Conditions: Tinea Pedis

Summary: the purpose of this study is to determine if the novel oral agent vt-1161 is safe and effective in treating patients with moderate - severe tinea pedis (also referred to as athletes foot). vt-1161 has been designed to inhibit cyp51, an enzyme essential for fungal growth. inhibition of cyp51 results in the accumulation of chemicals know to be toxic to the fungus. cyp51 is the molecular target of the class of drugs referred to as 'azole antifungals'. all currently approved azole drugs have poor selectivity for cyp51 and this results in many of the side effects associated with the azole antifungals. the safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. a safer antifungal drug would improve treatment options for infections seen in otherwise healthy individuals where significant side-effect risks are unacceptable.


Eligibility criteria:
key inclusion criteria: * healthy male and non-pregnant female patients ≥18 years and \<65 years * clinical diagnosis of tinea pedis * positive baseline koh * clinical signs and symptoms score of the target lesion is at least 6, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity) * patients must be able to swallow capsules intact * use acceptable birth control methods key exclusion criteria: * major organ system disease or clinical infection * poorly controlled diabetes mellitus * pregnant or lactating * confluent, diffuse moccasin-type tinea pedis * presence of onychomycosis involving a) more than 5 toe nails, b) any fingernail * recent use of topical corticosteroids, topical antibiotics, or topical antifungal therapy to the foot * recent use of systemic corticosteroids or antifungal therapy * known(hiv)infection * known significant hepatic, or hematologic impairment .requirement for treatment with concomitant antimicrobial or systemic antifungal therapy for any reason.
inhibition of food intake in response to oral glp-1 and peptide yy3-36

Conditions: Anti Obesity Agent

Summary: interaction of glp-1 and pyy3-36 in the inhibition of food intake in healthy subjects

pyy3-36 and glp-1 are two classical gastrointestinal peptides, which are released into the circulation during meals from l-cells of the distal gut; there is compelling evidence that each participates in the control of appetite regulating individual meal sizes in healthy subjects, but also in patients with obesity or diabetes type ii. the regulation of human eating habits is, however, highly complex and our understanding of appetite control is far from complete. in many areas our knowledge is rather rudimentary; little is known, to give an example, about the importance of individual signals and their interactions. from studies in animals and humans it is known that individual satiety signals can interact: contributions of glucagon and cck produced functionally synergistic inhibitions of feeding in rats, that is, simultaneous injection of the two peptides inhibited feeding significantly more than the sum of their individual effects. in contrast, we have been unable to show in healthy volunteers any interaction between glp-1 and cck33; the simultaneous infusion of cck33 and glp-1 resulted in an infra-additive reduction in meal size, which led us to suggest that the two peptides could even interact antagonistically. to further explore potential interactions between these two well-known satiety signals, we plan to investigate the effects of individual doses of pyy3-36 and glp-1, and their interaction in the control of food intake and satiety in healthy male subjects.

Eligibility criteria:
inclusion criteria: * healthy male subjects * no evidence of disease * no history of gastrointestinal or endocrine disorders exclusion criteria: * alcohol and drug abuse * history of gastrointestinal or endocrine disorders * female subjects

Keywords: appetite, energy consumption, gastrointestinal hormones
analysis of a training intervention for pulmonary embolism diagnosis in emergency department (apeed)

Conditions: Pulmonary Embolism

Summary: the purpose of this study is to analyze the clinical impact of an educational intervention on adherence to clinical practice guidelines in an emergency department (ed), by using a standardized training, for improving diagnostic sensibility and reducing unnecessary scans, adverse effects and stays in the ed.

the hospital de la santa creu i sant pau emergency department (ed) implemented a training program between may and june 2015 to improve compliance and adherence to recommended clinical practice and optimize the diagnosis and management of patients with suspected pulmonary embolism (pe). the training program was standardized, systematic and continuous, with subsequent reinforcement to ensure implementation. this paper aims to evaluate the clinical impact of the training intervention. the establishment of training measures to improve adherence to guidelines implies clinical practice improvement and benefits patients and health system. moreover, it is a simple and inexpensive intervention, and can be easily reproduced in other ed. all adult patients (\<18 y) with suspected pulmonary embolism attended at emergency department will be included. retrospective information from two different periods (before and after the training intervention) will be collected. first period: 1/1/2012 - 31/12/2012 and second period: 01.06.2015 - 30/11/2015, pre and post intervention. objectives a. primary: 1. analyze adherence to guidelines for the evaluation of suspected pe in the ed. 2. determine the clinical impact of training intervention (change in adherence to guidelines after training measures among staff in emergency department) 3. implementation and consolidation of a systematic, standardized, continuous training intervention for improving processes and results. b.- secondary 1. analyze pe cases (presentation, clinical features, treatment, clinical evolution) 2. analyze the clinical differences in three subgroups of patients with pe: young patients (\<50 years), elderly patients (\<65 years) and cancer 3. analyze the value of d-dimmer corrected by age in diagnostic algorithms 4. analyze the results of a new algorithm (epc + dimmer corrected age) in the elderly population group (\<65 years).

Eligibility criteria:
inclusion criteria: * are included * those patients who underwent a d-dimmer for suspected pe * all those who underwent the diagnosis of pe at discharge * those who died from ep. exclusion criteria: * are excluded: * all patients who underwent d-dimmer test with a different diagnosis of ep and those who had a chronic ep

Keywords: pulmonary embolism adherence to practice guidelines age-adjusted d-dimer clinical prediction rules elderly patients
venous thromboembolism in pregnant and puerperal women in denmark 1995-2005

Conditions: Venous Thromboembolism

Summary: the purpose of this study is to describe the incidence of thromboembolic events in relation to pregnancy and when in pregnancy and the puerperal period.

venous thromboembolism (vte) still causes maternal death in the western world. the purpose of this study is to estimate the relative and absolute risk of vte at different gestational ages in pregnant women compared to non-pregnant women. all danish women 15 to 49 years old in the period january 1995 through december 2005, free of previous vte and current use of oral contraceptives are included.non-pregnant women are controls.

Eligibility criteria:
inclusion criteria: * danish woman at 15 to 49 years old in the period january 1995 through december 2005. * free of previous vte and current use of oral contraceptives. exclusion criteria: * previous vte or current use of oral contraceptives.

Keywords: thromboembolic event
efficacy and safety assessment of niacinamide cosmetic preparation: a randomized controlled trial

Conditions: Skin Hyperpigmentation; Dry Skin; Eczema

Summary: niacinamide in lower concentrations has been recognized as a cosmetic ingredient with hydrating properties. therefore, aim was to test the efficacy and safety of niacinamide cosmetic preparation in a randomized, controlled trial.

skin hydration (as use of hydrating cosmetic ingredients) is one of the most interventions for healthy skin and skin barrier function. therefore, cosmetic ingredients used for this purpose should be examined for their efficacy.

Eligibility criteria:
inclusion criteria: * healthy volunteers who gave written informed consent exclusion criteria: * skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior to the inclusion and during the trial, non-adherence to the trial protocol, exposure to artificial uv radiation, pregnancy and lactation
a randomized controlled double blinding study of intradermal acupuncture treatment on obesity

Conditions: Obesity

Summary: the purpose of this study is to determine whether intradermal acupuncture is effective and safe in the treatment of obesity.

recently the studies of auricular acupuncture or common acupuncture on obesity have been conducted. saam acupuncture, the korean unique acupuncture, is famous with its high efficacy but not established by the scientific way yet. thus, we tried a double-blind study on the effect of sa-am acupuncture on obesity using intradermal acupuncture.

Eligibility criteria:
inclusion criteria: * bmi\>25, regular menstruation, volunteer exclusion criteria: * symptomatic obesity, acupuncture treatment within 3 months, \>120kg, pregnancy or breast-feeding, hemophilia, dementia, mental illness, arrhythmia, liver cirrhosis, renal failure, pace maker, diabete mellitus, tuberculosis, steroid taker,
11ß-hsd1 and metabolic syndrome

Conditions: Metabolic Syndrome; Impaired Glucose Tolerance

Summary: the purpose of this study is to determine whether the insulin sensitizing effects of rosiglitazone were accompanied by changes in 11ß-hsd1 expression and activity in different tissues. furthermore the metabolic and hormonal effects of ppar gamma stimulation by rosiglitazone will be analysed in several tissues.

the ppargamma agonist rosiglitazone (r) increases insulin sensitivity, which is comparable to the effects of a reduction in 11ß-hydroxysteroid dehydrogenase type 1 (11β-hsd1) activity in animal models. we therefore aimed to investigate whether rosiglitazone-induced insulin sensitivity is associated with changes in 11β-hsd1 activity in different tissues in subjects suffering from impaired glucose tolerance. furthermore the metabolic and hormonal effects of ppar gamma stimulation by rosiglitazone will be analysed in those tissue samples.

Eligibility criteria:
inclusion criteria: * impaired glucose tolerance exclusion criteria: * treatment with insulin * orally taken antidiabetic medication, glucocorticoids or vitamin k-antagonists * heart failure * impaired hepatic or renal function * anaemia * disturbed coagulation * any other endocrine disorder

Keywords: 11ß-hydroxysteroid dehydrogenase rosiglitazone insulin sensitivity impaired glucose tolerance
walk with ease program for patients with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the effects of "walk with ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. participants will receive a copy of the "walk with ease" workbook. the book provides guidance about walking safety as well as how to start, build-up, and maintain a walking program. participants will complete questionnaires assessing their symptoms before and after completing the six-week program.

the purpose of this study is to evaluate the effects of "walk with ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. participants will receive a copy of the "walk with ease" workbook, a publication of the arthritis foundation. participants will complete self-reported outcomes questionnaires prior to beginning the program and six weeks later at completion of the program. the questionnaires will include visual analog scales for pain, stiffness, and fatigue as well as a facit-fatigue form. participants will also complete a satisfaction survey at the end of the program.

Eligibility criteria:
inclusion criteria: * physician diagnosis of systemic lupus erythematosus * age \>/= 18 exclusion criteria: * age \<18 * engagement in \>150 minutes of moderate-intensity activity at baseline * systemic lupus erythematosus disease activity index (sledai) score \>8 * pregnancy

Keywords: systemic lupus erythematosus exercise
a study to assess safety and efficacy of venetoclax in combination with gilteritinib in participants with relapsed/refractory acute myeloid leukemia

Conditions: Acute Myeloid Leukemia (AML)

Summary: a dose-escalation study evaluating the safety, tolerability, pharmacokinetics (pk) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (r/r) acute myeloid leukemia (aml) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.


Eligibility criteria:
inclusion criteria: * should have an established, confirmed diagnosis of acute myeloid leukemia (aml) by world health organization (2016). * should have failed at least 1 line of prior therapy (defined as failure to respond to therapy, and/or progression during or after therapy). * should have an eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. * should have adequate hematologic, kidney and liver function as described in the protocol. * for participants enrolling into the expansion cohort only: a documented fms-like tyrosine kinase (flt3) mutation in bone marrow or peripheral blood, as described in the protocol. exclusion criteria: * has a diagnosis of acute promyelocytic leukemia (apl) or bcr-abl-positive leukemia. * has a history of other malignancies within 2 years prior to study entry, with exceptions as described in the protocol. * has active central nervous system leukemia. * has a history of chronic new york heart association (nyha) class iv heart failure. * has a corrected qt interval of \> 450 ms. * has a chronic respiratory disease that requires continuous oxygen use.

Keywords: cancer acute myeloid leukemia (aml) relapsed or refractory aml pharmacokinetics venetoclax gilteritinib
incidence and risk factors of ocular complications among patients with homocystinuria

Conditions: Complications

Summary: background: cysteine beta-synthase (cbs) deficiency, often known as classic homocystinuria (hcu), is an uncommon inborn mistake in methionine metabolism. developmental delay, intellectual incapacity, skeletal and vascular symptoms, and ocular abnormalities are possible main clinical characteristics. objective: this study sought to describe the ocular anomalies that king fahad armed forces hospital, jeddah, saudi arabia, hcu patients presented with between 2018 and 2022.

this retrospective research included 6 hcu patients. demographic and clinical characteristics of patients as age, gender, comorbidities were collected. relevant clinical and ophthalmic assessments, like visual acuity, fundus examination findings, complications and type of surgery were also reported

Eligibility criteria:
inclusion criteria: * all patients from all age groups who were diagnosed with homocystinuria between 2018 and 2022 were included, regardless of whether the diagnosis was made biochemically (by exhibiting hyperhomocysteinaemia and hypermethioninaemia) or genetically (by discovering biallelic pathogenic mutations in the cbs gene) exclusion criteria: * patients with incomplete investigations for various reasons

Keywords: ocular complications high myopia saudi arabia classic homocystinuria ectopia lentis
renal mechanism of action/splay vs. tmg

Conditions: Diabetes, NOS

Summary: the purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * male and female subjects * age 18 to 65 years * bmi 18 to 35 kg/m2 * healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin * no evidence of impaired renal function exclusion criteria: * unwilling or unable to use an acceptable method of birth control * subjects with type 1 diabetes mellitus, heart disease, hepatic c or b * exposure to insulin * use of exclusionary concomitant medications * evidence of significant kidney disease or any other significant medical or psychiatric disorder
radiofrequency nucleoplasty vs percutaneous nucleotomy vs decompression catheter in lumbar disc herniation

Conditions: Herniated Disc

Summary: the purpose of this study is to learn which of three minimally invasive procedures is the most effective for treatment of contained lumbar disc herniation.

contained herniation of the lumbar intervertebral disc is a frequent cause of leg and back pain. over the last decade, there is a tendency to shift from surgical treatment of the intervertebral disc including laminectomy/discectomy to an excess of nonoperative management. three techniques introduced recently are used as minimally invasive treatments for decompression of contained herniation of the nucleus pulposus. nucleoplasty uses coblation® radiofrequency vaporization of nuclear tissue to decompress the intervertebral disc. catheter disc decompression uses heat from a resistive coil positioned in the area of disc herniation while dekompressor® uses volume reduction to decrease an intradiscal pressure. this is a comparison study which investigates if intervertebral electrothermal disc decompression produces better pain relief measured on vas scale, improvement in functional capacity, return to work and opioid use, than nucleoplasty or percutaneous disc decompression (dekompressor) of the lumbar intervertebral disc in a prospective randomized controlled study. patients will be randomized into four treatment groups in equal numbers. the first group will be treated using nucleoplasty, the second will receive dekompressor® lumbar disc decompression, the third will receive thermal treatment using decompression catheter (achutherm tm) and the forth will be the control group. the control group will be treated conservatively using medications including gabapentin, a breakthrough opioid (oxycodone 5 mg 1-2 tablets q 4-6 hours as needed), nsaid, epidural steroid injections and physical therapy. patients will be followed and assessed at one, three, six, nine and twelve months following the procedure using vas scores, oswestry and sf-36 short form questionnaires, opioid use and return to work evaluation.

Eligibility criteria:
inclusion criteria: * history of concordant radicular leg pain unresponsive to conservative treatment for longer than 3 months * leg pain must be greater than back pain * contained disc herniation as evidenced by mri * no evidence of psychological issues by exam or history exclusion criteria: * a score of greater than 10 on beck depression inventory (bdi) * patients with pending workers compensation claim or litigation * pregnancy * tumor * systemic infection or localized infection at the anticipated entry needle site * traumatic spinal fracture * history of coagulopathy * unexplained bleeding * progressive neurological deficits * history of opioid abuse or patients currently on long acting opioids * patients presenting with moderate or severe lumbar central or lateral canal stenosis, free disc fragments or degenerative disc disease as described on mri

Keywords: contained lumbar herniated disc nucleoplasty percutaneous decompression dekompressor intervertebral electrothermal disc decompression idet
preoperative planning with psma-pet in melanoma surgery trial

Conditions: Malignant Melanoma

Summary: this is a non-randomised, single-centre phase 2 study, investigating whether the diagnostic biomarker, prostate-specific membrane antigen (psma), can detect melanoma metastases using psma pet/ ct.

the proposed 'preoperative planning psma-pet in melanoma surgery (pppims)' trial is a phase 2 study, investigating the ability of psma as a biomarker to accurately detect melanoma metastases in patients with palpable lymphadenopathy and oligometastatic melanoma. if proven to have diagnostic utility, it may allow more precise 3d lymphatic mapping and identification of tumour in intricate anatomical areas, resulting in more accurate surgical planning. a more precise delineation of nodal disease and metastasis will result in a more accurate and lesser surgical dissection, and consequent reduction in morbidity. the psma-pet-ct will be compared with the standard-of-care imaging, fdg-pet-ct to evaluate utility of this approach. it is of note that fdg-pet ct has a high background fdg uptake normally seen in the brain and liver, and psma could potentially be a more favourable tracer if there is less background uptake.

Eligibility criteria:
inclusion criteria: * males ≥18 years of age * biopsy proven first and recurrent metastatic melanoma with palpable nodal disease who have undergone a staging fdg pet-ct scan as part of routine clinical care and are scheduled for surgery for resection of the primary site exclusion criteria: * patients unable to give voluntary written informed consent to participate in this study * patients not willing to complete all the study assessments * patients who are females * patients who are taking androgen deprivation therapy (adt) and other therapies targeting the androgen pathway, such as androgen receptor antagonists. * patients who have or have previously been diagnosed with prostate cancer * patients who have had lu-177 psma therapy or barium studies within a period of 10 days prior to undergoing psma pet-ct scanning * patients not fluent in english
unraveling the role of extracellular vesicles-driven senescence in myeloproliferative neoplasms

Conditions: Essential Thrombocythemia (ET); Myelofibrosis (MF); Polycythemia Vera (PV)

Summary: in this study the aim is to investigate the pathogenetic role of extracellular vesicles and senescence in myeloproliferative neoplasms. in particular, the goal of this project is to identify possible ev-based biomarkers of senescence according to gender, which are disease-specific, biology-related, and predictive of short-term outcome in terms of event-free survival and to define personalized targets for new therapeutic approaches.

this is a 3-year multi-centre prospective in vitro study. 120 patients with mpn (et (n=45), pv (n=45), and mf (n=30)) will be enrolled for a period of 22 months. follow-up: 12 months. patients (et=group a; pv=group b; mf=group c) will be enrolled at the complex operative unit of haematology-irccs azienda ospedaliero-universitaria di bologna and at the haematology centres of reggio emilia, brescia, meldola, and ravenna. peripheral blood samples from patients with et, pv, and mf (group a-c; 40 ml) and/or bone marrow samples from patients with et and pv (group a, b; 5 ml) will be collected at diagnosis as part of normal clinical practice. the samples will be analysed at the complex operative unit of haematology-irccs azienda ospedaliero-universitaria di bologna in collaboration with the istituto romagnolo per lo studio dei tumori 'dino amadori' - irst irccs (analysis of ev size and concentration) and with the university of perugia (analysis of ev lipid cargo). the data analysis will be carried out in collaboration with the department of physics and astronomy of the university of bologna.

Eligibility criteria:
inclusion criteria for patients: * age ≥ 18 years. * patients with who2017-defined diagnosis of myeloproliferative neoplasms. * patients at first diagnosis. * informed consent signed. exclusion criteria for patients: - patients with concomitant second neoplasia inclusion criteria for healthy donors: * age ≥ 18 years. * informed consent signed. exclusion criteria for healthy donors: - healthy donors with neoplasia.