Kornimate/medical-research-clean huggingface dataset:
hemodynamic changes after aortic aneurysm treatment with stent-graft

Conditions: Abdominal Aortic Aneurysm

Summary: to compare the aortic pulse profile before and after stent-graft implantation to prove that endovascular aaa repair using non-compliant stent-graft changes the aortic pulse profile.

this study will assess hemodynamic changes in aortas of patients after treatment of their abdominal aortic aneurysm (aaa) with an fda approved stent-graft (zenith). this study does not require any change in clinical protocol to the the way the aaa procedures are currently done. utilizing the catheters already employed in this procedure, intravascular blood pressure measurements will be documented at various times and at various anatomic levels prior to and after deployment of the stent-graft. as the compliant aortic aneurysm acts as a capacitor, expanding during systole and contracting during diastole, it is our hypothesis that endovascular aaa repair using a non-compliant stent-graft changes the aortic pulse profile.

Eligibility criteria:
inclusion criteria: * abdominal aortic aneurysm with planned treatment using zenith endovascular stent-graft

Keywords: abdominal aortic aneurysm zenith blood pressure
an observational study on fatigue in patients with rheumatoid arthritis treated with roactemra/actemra (tocilizumab)

Conditions: Rheumatoid Arthritis

Summary: this observational study will evaluate the presence and evolution of fatigue on treatment with roactemra/actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two dmards (one of them methotrexate) or to anti-tnf treatment. patients initiated on treatment with roactemra/actemra (8 mg/kg intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe active rheumatoid arthritis, defined as das28 \>/= 3.7 * inadequate clinical response to current treatment with \>/= 2 non-biologic dmards, 1 of them being methotrexate optimally administered for \>/= 3 months, or inadequate clinical response to anti-tnf therapy * eligible for roactemra/actemra treatment in daily clinical practice * absence of evolutive tuberculosis (tb) exclusion criteria: * hypersensitivity to tocilizumab or any of the excipients * active, severe infections * pregnant or lactating women * participation in any other interventional study * patients with major depression
exploring acne treatments through clinical research participation

Conditions: Acne

Summary: the purpose of this study is to understand the lived experiences of acne patients enrolled in a related clinical trial testing a particular treatment. the primary focus will be on tracking trial adherence and dropout rates to enhance future research and care approaches, especially for underserved groups.


Eligibility criteria:
inclusion criteria: * patients diagnosed with acne. * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination. exclusion criteria: * refusal of consent * women of childbearing potential without a negative pregnancy test; or women who are lactating. * any serious and/or unstable pre-existing medical disorders

Keywords: acne
the menstrual distress questionnaire (medi-q) reliability and validity of the turkish version

Conditions: Menstruation Disturbances

Summary: menstruation is a process in which metabolic and hormonal changes occur periodically every month to maintain reproductive functions in women. this cycle, which continues from menarche to menopause, repeats approximately every 28 days and lasts 3-7 days (1). the menstrual cycle is divided into three phases, the follicular phase, the ovulation phase, and the luteal phase, in which the levels of estrogen and progesterone hormones change (2,3). in this cycle, which is regulated by the hormones released from the pituitary, hypothalamus and ovary, changes occur not only in the genital organs, but also in the nervous system, cardiovascular system, respiratory system, musculoskeletal system and metabolic functions (4). responses to these changes, which cause physiological stress in the organism in women, are perceived in different degrees. the presence of recurrent abnormal bleeding or excessive pain may be a sign of various menstrual disorders (5). evaluation of menstrual problems that negatively affect women's mood, social and work life is clinically important (6,7). the scale, called menstrual distress questionnaire (medi-q), was developed by vannuccini et al. (2021), it is a tool that comprehensively evaluates menstrual problems (8). medi-q assesses the effects of menstrual symptoms on quality of life, recreational activities, work and social relationships. it consists of 25 items covering different areas of menstruation-related symptoms such as pain, discomfort, psychological and cognitive changes, and gastrointestinal disturbances. the level of distress caused by each symptom is assessed in the menstrual cycle phases, taking into account not only its impact on functionality and quality of life, but also its frequency. medi-q is a scale with good test-retest reliability and internal consistency (cronbach's = 0.85) (8,9). the scale provides a total score (medi-q total score) and three subscales that assess general menstrual distress. subscales; the number of distressing symptoms (ms) during menstruation, the mean level of distress related to menstrual symptoms (msd), and the menstrual specificity index (mesi) (8,9), which measures the proportion of symptoms at which distress exacerbates during the menstrual phase.


Eligibility criteria:
inclusion criteria: * female gender * 18-35 years old * volunteer * native speaker turkish exclusion criteria: * pregnancy or breastfeeding * having a mental health problem
study to evaluate efficacy and safety of a double treatment plan using a combination of mebendazole and quinfamide for treating intestinal helminthiasis and amebiasis in the mexican population

Conditions: Helminthiasis; Amoebiasis

Summary: the purpose of this study is to assess the efficacy and safety of the combination of mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in mexican population.

this is a double-blind (neither investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), randomized (study medication assigned to participants by chance), prospective (study following patients forward in time) study. the total study duration for each participant will be approximately 48 days. the study will consist of 3 parts: screening phase (5 days) and double-blind treatment phase (from day 1 to 21, consists of phase-1 and phase-2) and follow-up phase (from day 21 to 43). participants will receive mebendazole (600 milligram \[mg\]) and quinfamide (200 mg) tablets orally once starting on day 1 and mebendazole 600 mg and quinfamide (200 mg) or placebo tablets orally once starting on day 21. efficacy will be primarily evaluated by percentage of participants with eradication of helminthic and/or protozoa. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * minors whose parents or tutor grant his/her informed consent in writing to participate in the study. adult participants that give their informed consent in writing to participate * participants having a copro-parasitoscopy test (scatology) (at least 1 with a series of 3) qualitative and quantitative and/or search of live amoeba, that comes out positive for one or more of the following parasites: ascaris lumbricoides, enterobius vermicularis, trichuris trichuria, taenia solium, necator americanus, ancylostoma duodenale and trophozoites of entamoeba histolytica * with at least two or more of the following symptoms: anorexia, nausea, vomit, abdominal pain, diarrhea, constipation, evacuations with mucus, evacuations with blood, gas discharge, weight loss and bruxism exclusion criteria: * participants with any known allergy to any of the drugs used in the investigation * female participant in reproductive age not using an adequate contraceptive method * pregnant or lactating participant * participant with any life-threatening condition (cancer, aids, etc.) * participant known to be a carrier of some illness that alters the metabolism or drug excretion (hepatic or renal illness) interfering with the absorption (malabsorption) or interferes with the evaluation of the participant during the study * participants that have taken any antiparasitic drug 14 days previous to his/her inclusion in this clinical investigation protocol * participants with diagnosis of extra-intestinal amoebiasis

Keywords: helminthiasis amoebiasis mebendazole quinfamide mexican population
functional neural connectivity at rest as a diagnostic tool for intolerance to heat

Conditions: Functional Neural Connectivity

Summary: functional neural connectivity at rest of 3 groups (heat tolerant, heat intolerant and healthy subjects) will be assessed using the anatomical and functional mri scans and compared.

20 healthy subjects that had already underwent heat tolerance test (htt) at the heller institute of medical research (sheba medical center) will be recruited and divided into 2 groups: heat tolerant and heat intolerant (according to the htt results). they will be asked to arrive to one experimental day at the imaging department in sheba medical center and undergo anatomical and functional mri scans. third group will consist of 10 existing brain scans (separated from personal details) of healthy males, at the same age range and who had never gone through heat injury. data will be analysed by fmri expert in order to compare the functional neural connectivity at rest between the three groups.

Eligibility criteria:
inclusion criteria: * generally healthy subjects * underwent heat injury in the past two months * underwent heat tolerance test at the heller institute of medical research exclusion criteria: * drug or alcohol use * history of neurological disorders, mental retardation or head injury * history or diagnosis of psychiatric disorders * claustrophobia
hepc micro-elimination on msm and tgw population.

Conditions: Hepatitis C; PrEP; Drugs of Abuse

Summary: this is an observational study, in which a single visit will be carried out, which includes a questionnaire on sexual habits and in which the possibility of carrying out a screening for hepatitis c will be offered. depending on the score obtained in the questionnaire, the screening will be carried out using a rapid serology test or viral load. during the first year, a score will be developed to classify the risk of positive results. this score will be used during phase 2 to offer users of the centres a targeted screening based on the pre-test score.


Eligibility criteria:
inclusion criteria: 1. all bcn checkpoint and bcn prep·point clients. 2. 18 years and older. 3. hiv uninfected or diagnosticated in the center in the last 7 days prior to the study inclusion. 4. men that have sex with men or transgender women. 5. signature of written consent form. 6. ability to comply with the requirements of the study protocol. exclusion criteria: 1. knowledge of hiv infection from more than 7 days 2. knowledge of active hcv infection

Keywords: msm tgw prep hepatitis c transmision micro-elimination
evaluation of the eareeg system for detection of hypoglycaemia-induced changes in the eeg in subjects with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the eareeg system is a novel non-invasive, unobstructed and discrete method for recording eeg in which the signal is recorded using dry-contact electrodes embedded on a customised ear piece. one intended medical indication of the eareeg system is the detection of hypoglycaemia-induced changes in the eeg in patients with type 1 diabetes. currently, no studies exist investigating the detection of hypoglycaemic episodes by use of ear electrodes. while a finger prick test accurately measures the blood glucose level, it does not provide continuous measurements, and hence it is unreliable as a hypoglycaemia alarm. recent studies have indicated that the use of continuous glucose monitoring (cgm) reduces the risk of severe hypoglycaemia. however, some find these devices troublesome to use and utilisation of cgm has remained limited to date. observational data show that only a small percentage of patients with type 1 diabetes are using cgm on an ongoing basis. thus, there is a medical need for a reliable hypoglycaemia detection device which is easy and convenient to use. this clinical study aims at investigating the feasibility of measuring hypoglycaemia induced changes in the eeg by use of the eareeg system.


Eligibility criteria:
inclusion criteria: for a subject to be eligible, all inclusion criteria must be answered "yes": 1. informed consent obtained before any study related activities1 2. age 18-70 years 3. patients with type 1 diabetes (duration ≥ 5 years) exclusion criteria: for a subject to be eligible, all exclusion criteria must be answered "no": 1. severe cardiac disease 1. history of myocardial infarction 2. cardiac arrhythmia 2. previous stroke or cerebral haemorrhage and any other structural cerebral disease 3. uraemia defined as s-creatinine ≥ 3 times upper reference value, 4. liver disease defined as s-alat ≥ 3 times upper reference interval 5. epilepsy 6. use of antiepileptic drugs for any purposes 7. use of the following drugs: chemotherapeutic drugs of any kind, methotrexate, third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine) 8. known or suspected abuse of alcohol defined as estimated consumption beyond that, which is recommended by the dha1 or any other neuro-active substances 9. use of hearing aid or cochlear implants2 10. allergic contact dermatitis caused by metals or generally prone to skin irritation 11. narrow or malformed ear canals 12. patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation 13. pregnancy
pharmacokinetics of caspofungin (cancidas ®) given intravenously as therapy to patients with an invasive fungal infection in the intensive care unit - a search for co-variates

Conditions: Invasive Fungal Infection

Summary: the pharmacokinetics of caspofungin are expected to be different in icu patients compared to non-icu patients. the investigators will determine caspofungin concentrations in 20 icu patients, who will get caspofungin as standard care. full pk curves will be taken on day 3 and a limited pk curve on day 7, trough levels will be taken daily.

the pharmacokinetics of caspofungin are expected to be different in icu patients compared to non-icu patients and healthy volunteers due to underlying disease(s). therefore, extrapolation of data from healthy volunteers and non-icu patients is not possible. to be able to include 20 patients within the study duration, a multi-centre approach is necessary. patients will receive standard care, as stated in the spc or according to local protocols. blood sampling for pk analysis will be retrieved through a central venous catheter. approximately 60ml will be drawn in total for this study. patients will be monitored daily during the treatment period for adverse events of the study drug. although steady state of caspofungin will be achieved after approximately 14 days of treatment, full pk curves will be taken on day 3. as probably not all patients included will be treated with caspofungin for 14 days, taking full pk curves on day 14 is considered not feasible. these two moments of pk analysis will enable the determination steady state and enable the determination of intra-individual variability.

Eligibility criteria:
inclusion criteria: * patient is admitted to an icu * subject is at least 18 and not older than 65 years of age on the day of the first dosing * subject has been treated with caspofungin for a maximum of two days before enrolment in this trial * is managed with a central venous catheter exclusion criteria: * is known to be hypersensitive to echinocandin antifungal agents * documented history of sensitivity to medicinal products or excipients similar to those found in the caspofungin preparation * positive hiv test or hepatitis b or c test * history of qt time prolongation * history of or current abuse of drugs, alcohol or solvents * has previously participated in this trial

Keywords: caspofungin pharmacokinetics invasive fungal infection candidiasis aspergillosis intensive care
knee aspiration and high definition mri for acl injury

Conditions: ACL Injury

Summary: the aim of this pilot study is to understand the biological changes that occur within the knee joint following injury to the anterior cruciate ligament (acl). this will be achieved through aspiration and analysis of the haemarthrosis which fills the knee following injury. the study will look at inflammatory and healing responses using dna, rna and protein analysis. this, combined with high resolution imaging of the knee and surrounding soft tissue structures, may enable a more patient specific approach to treatment of acl injury.


Eligibility criteria:
inclusion criteria: * diagnosis of acl injury confirmed by mri * all participants must have the capacity to provide informed consent to participate * participants must be able to comply with required study visit exclusion criteria: * participants outside of the specified age range * participants who do not have the mental capacity to make informed decisions * participants who have meniscal pathology or other injuries requiring urgent surgery
fast food photo study 2

Conditions: Obesity

Summary: participants will be exposed to a hypothetical fast food menu, asked to place a hypothetical lunch order, and will then be exposed to a second menu with several changes made to the menu. participants will be asked to identify as many changes as possible on this second menu, and then complete a survey about their eating tendencies and demographics.

the menu with changes will feature changes to both calories and prices, allowing for measures of whether participants notice such changes and the order in which changes are noticed.

Eligibility criteria:
inclusion criteria: * 18 or older, * agrees to consent form exclusion criteria: * n/a

Keywords: fast food literacy
analgesic effect of non invasive stimulation : transcranial direct current stimulation of opercular-insular cortex

Conditions: Neuropathic Pain

Summary: the aim of this study is to evaluate, versus placebo, the analgesic efficacy of the opercular-insular cortex stimulation with transcranial direct current stimulation (tdcs), in both healthy subjects and chronic neuropathic pain patients. in healthy subjects analgesia by tdcs will be assessed using both laser stimuli and cold pressor test. in patients the assessment regards their chronic pain (ratings for ongoing, evoked and paroxysmal pain, sleep and fatigue). opercular-insular stimulation is obtained via a combined 6-electrode montage and by bi-vestibular stimulation (since vestibular pathways reach the posterior insular cortex). in patients, three separate conditions (two active and one sham) will be tested in randomised order. in healthy subjects, two other conditions are added to control for attention and distraction confounders.


Eligibility criteria:
inclusion criteria: * healthy subjects aged from 18 to 70 years, male or female, with social security protection, fully informed and having given their written consent. * patients aged from 18 to 80 years, male or female, with social security protection , fully informed and having given their written consent. * pharmacoresistant neuropathic pain during at least one year, * without any change of the pharmacological treatment since at least one month exclusion criteria: in healthy subjects only: * history of chronic pain * analgesic medication within 24h before stimulation for patients only: new analgesic treatment within 1 month before consent for both: * drug addiction, headache, epilepsy * ferromagnetic intracranial device * implanted stimulator * recent neurosurgery and open wound of the scalp. * absence of contraceptive method for women of childbearing age

Keywords: drug resistance neuropathic pain opercular-insular cortex transcranial direct current stimulation
hypoglycemia at initiation of pump therapy in children with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to determine if patients have more hypoglycemic episodes the first 3 days following pump start compared to their usual number of hypoglycemias with our actual pump initiation protocol.


Eligibility criteria:
inclusion criteria: * patients with type 1 diabetes with follow-up at the chu sainte-justine * patient about to start insulin pump therapy at the chu sainte-justine * last hba1c between 7.2 and 9.7% * informed and signed consent exclusion criteria: * type 1 diabetes diagnosed less than 1 year ago with total daily dose of insulin \< 0.5u/kg/day * home of the patient at more than 50km of the chu sainte-justine * refusal to consent

Keywords: hypoglycemias insulin pump children
efficacy of sens-111 in patients suffering from acute unilateral vestibulopathy

Conditions: Acute Unilateral Vestibulopathy (AUV)

Summary: a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose-regimens of orally administered sens-111 (100mg and 200mg) given during 4 days in patients suffering from acute unilateral vestibulopathy (auv)


Eligibility criteria:
inclusion criteria includes, but is not limited to: \* subject has a diagnosis of definite acute unilateral vestibulopathy exclusion criteria includes, but is not limited to: * acute continuous vertigo lasting more than 72 hours prior to randomization * history of acute or chronic vestibular diseases * history of prior acute central vestibular lesion * acute or chronic disease of middle ear

Keywords: acute unilateral vestibulopathy, auv
blessing or curse? combined vitamin therapy in non viral septic shock.

Conditions: Septic Shock

Summary: introduction: septic shock leads to high morbidity and mortality in critically ill patients. several lower-case scientific studies have supported the synergistic positive effect of vitamin c, thiamine, and hydrocortisone on sepsis-induced organ dysfunction. aim: our aim was to investigate the effect of vitamin complex on organ failure, laboratory parameters, respiratory and antibiotic treatment, intensive care time, and mortality in septic shock patients. material and methods: in our retrospective and prospective analysis, we collected parameters from 43 (23 vitamin-treated, 20 control) septic shock patients. patients treated with vitamin, they received vitamin c (4x1500 mg), thiamine (2x200 mg) for three days (2). in other respects, and for hydrocortisone (200 mg / 24h), both groups of patients received treatment according to the european sepsis recommendation. spss (v-21) data were used for data collection, kolmogorov-smirnov, wilcoxon, mann-whitney u tests were used for statistical analysis. ethical license: 7849-pte 2019.


Eligibility criteria:
inclusion criteria: * septic shock * intensive care unit administration exclusion criteria: * under age 18 * above age 80 * moribund patients * pregnant patients * active kidney stone * inability to obtain consent * viral or mixed sepsis * missed dose of vitamin c/ thiamin or hydrocortisone * physician refused * vitamin c / thiamine/ hydrocortisone for other indications

Keywords: sepsis vitamin-c thiamine septic shock