Kornimate/medical-research-clean huggingface dataset:
fecal microbiota transplantation for pancreatitis with infectious complications(fmtpic)

Conditions: Acute Pancreatitis; Fecal Microbiota Transplantation; Bacterial Translocation; Infectious Complications

Summary: infectious complications are responsible for most of deaths in acute pancreatitis.intestinal barrier dysfunction and increased intestinal permeability was associated with bacterial translocation which is believed to prompted these infections.the purpose of this clinical trail is to observe the potential capability of fmt in reduce the bacterial translocation and alleviate infectious complications by the reconstruction of a gut functional state.

investigators aims to restore the intestinal bacteria homeostasis through fmt by retention enema with fresh bacteria,thus minimizing bacterial translocation and alleviating infectious complications. the investigators will further examine the effect of fmt on the incidence of infectious complications，duration of clinical course and mortality.

Eligibility criteria:
inclusion criteria: 1. diagnosis of severe acute pancreatitis from the first affiliated hospital of nanchang university according to the classification of acute pancreatitis-2012: revision of the atlanta classification and definitions by international consensus 2. onset of pancreatitis more than 2 weeks 3. intestinal bacterium screening tips gut dysbacteriosis 4. patients with symptoms of infection, such as fever, abdominal pain or blood culture and pancreatic necrosis drainage culture positive patients. exclusion criteria: 1. sap complicated by gastrointestinal bleeding or intestinal fistula 2. pregnancy and lactation women 3. not signed the informed consent

Keywords: severe acute pancreatitis fecal microbiota transplantation bacterial translocation infectious complications
study to assess the efficacy and safety of oral potassium citrate on the prevention of nephrocalcinosis in extreme premature

Conditions: Nephrocalcinosis

Summary: study to assess the efficacy and safety of oral potassium citrate on the prevention of nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo controlled trial.


Eligibility criteria:
inclusion criteria: 1. premature infants of both sexes born at the hospital clinic of barcelona. 2. corrected gestational age below 32 weeks and lower birth weight 1500gr. 3. survivors at 7 days old. 4. clinically stable, in the opinion of the investigator, at the time of inclusion. 5. that, properly informed, parents and / or legal guardians give written consent to allow the participation of the infant in the study and submit to the tests and examinations that it entails exclusion criteria: 1. renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis. 2. chronic renal failure (serum creatinine\> 1.5 mg / dl or an increase of 0.3 mg / dl / day and / or oliguria defined as diuresis \<0.5 ml / kg / hour after the first day of life) 3. treatment with furosemide or dexamethasone 4. addison's disease. 5. persistent severe metabolic alkalosis. 6. impossibility of oral feeding.

Keywords: nephrocalcinosis extreme premature
glaucoma algorithm validation study in african population - the magic study

Conditions: Glaucoma; Diabetic Retinopathy

Summary: artificial intelligence (ai) algorithms require validation in a variety of populations to ensure widespread clinical applicability. in ophthalmology, ai algorithms are reaching maturity in diagnosis such as diabetic retinopathy and glaucoma. higher-at-risk subjects of african descent are nevertheless usually under-represented in training datasets and therefore unclear about representativity. a small scale validation study in consecutive patients in a large eyesore unit in mozambique will be performed to determine the diagnostic ability of these ai softwares in this population

artificial intelligence (ai) algorithm's are the next frontier in medical management, usually meant to improve diagnostic capabilities and to optimize the existing resources. they are particularly relevant in settings where there is a lack of specialised human resources such as physicians. ensuring these algorithms can be used in a wide population is therefore crucial to clinical implementation. validation studies in specific segments of populations are needed to ensure all patients are represented and the results are therefore reliable. higher-at-risk subjects of african descent are nevertheless usually under-represented in training datasets and therefore unclear about representativity. a pilot study for validation of an ai algorithm for glaucoma and diabetic retinopathy will be done for the mona g-risk® and diabetic retinopathy. consecutive patients from a large eye unit in mozambique's capital will be screened using these ai algorithms and validated using clinical standard as ground truth.

Eligibility criteria:
inclusion criteria: * subjects age above 18 years old presenting at the eye unit * willingness to sign an informed consent for the screening process exclusion criteria: * none * poor quality in screening image will be included in the intention to treat analysis, but excluded from the diagnostic comparator outcome. * patients with a known glaucoma diagnosis will not be excluded from the screening

Keywords: artificial intelligence validation screening
pre-study to evaluate ienfd induction in patients with taxane-induced cipn

Conditions: Peripheral Nervous System Diseases

Summary: this is a non-interventional study examining ienfd levels in patients with cipn after taxane chemotherapy and in age-matched healthy subjects.

this is a non-interventional study examining ienfd levels in patients with cipn after taxane chemotherapy and in age-matched healthy subjects. after the subjects sign the informed consent, the study physicians will judge the inclusion and exclusion criteria. subjects meeting the inclusion requirements will register at the study center according to the requirements of the study physicians, and skin samples will be collected by specialized researchers.

Eligibility criteria:
inclusion criteria: received taxane adjuvant chemotherapy for breast cancer for curative purposes and completed chemotherapy before entering the study; persistent peripheral neuropathy of the lower extremities; cipn severity: the presence of at least one of the following symptoms on both lower extremities in a gloved and sock glove pattern: pain or burning, numbness, or tingling. examination of the lower extremities showed needling loss of both legs; neurological symptoms occur after exposure to taxane and cannot be attributed to any other neurological disease; nrs rating ≥ 4. exclusion criteria: pregnant or lactating women. presence of any neuropathy other than cipn. according to the investigator's judgment, there are skin diseases in the affected skin area that may interfere with the evaluation of neuropathic pain symptoms, or diseases at the skin biopsy site that may affect the epidermal nerve morphology, or other factors. the presence of non-cipn pain may interfere with study evaluation and/or peripheral neuropathic pain self-assessment.
single-dose hybrid hyaluronic acid and sodium chondroitin with rehabilitation for sports adults with knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: : this observational case-control study aims to evaluate the efficacy of a single-dose intra-articular injection of a hybrid purified hyaluronic acid with high molecular weight and sodium chondroitin of biotechnological origin, combined with rehabilitation treatment, in sports adults with moderate to severe knee osteoarthritis. additionally, the study incorporates isokinetic testing to assess muscle strength and functional capacity. the primary objective is to determine whether this combined treatment improves pain relief, functional capacity, and overall quality of life compared to rehabilitation treatment alone. participants aged 18 to 50 years, diagnosed with knee osteoarthritis, will be recruited from clinics at the u.o.c. of recovery and functional rehabilitation at a.o.u.p. p. giaccone in palermo. participants will be divided into two groups: one receiving the hybrid hyaluronic acid and sodium chondroitin injection along with rehabilitation, and the other receiving only rehabilitation. the study will also utilize isokinetic testing to provide objective measurements of muscle strength and endurance.


Eligibility criteria:
inclusion criteria: * adults aged between 18 and 50 years. * radiologically confirmed diagnosis of knee osteoarthritis (kellgren-lawrence grade ≤3), present for at least 6 months. * persistent moderate to severe pain due to osteoarthritis, interfering with physical performance. * documented reduction in sports performance (use appropriate scales or tests to validate this). * lack of response to pharmacological or other conservative treatments. * willingness to provide written informed consent for participation. exclusion criteria: * coexisting rheumatic diseases. * history of intra-articular viscosupplementation in the target knee within the previous 6 months. * presence of significant venous or lymphatic stasis. * body mass index (bmi) ≥ 30 kg/m². * use of systemic or intra-articular corticosteroids in the target knee within the last 3 months. * chronic use of topical/systemic analgesics, nsaids, or narcotics. * history of alcohol or drug abuse. * allergy or hypersensitivity to hyaluronic acid or any of its components. * pregnant or breastfeeding women, or those not using adequate contraception.

Keywords: osteoarthritis knee hyaluronic acid sodium chondroitin rehabilitation sports adults isokinetic testing pain relief functional improvement
exogenous ketone esters for drug resistant epilepsy

Conditions: Drug Resistant Epilepsy

Summary: this study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy

epilepsy is a common neurological disorder among children with significant neurobiological, cognitive, psychological, and social consequences. seizures can usually be controlled by anti-seizure medications (asms) in up to two-thirds of children with epilepsy. however, this leaves a significant part of epileptic children whose seizures are not controlled by pharmacotherapy. currently, available alternatives for drug-resistant epilepsy (dre) include surgery, vagus nerve stimulation, and ketogenic diet (kd). kd has been classically used for treating children with dre. however, kd requires strict dietary restriction, which may not be applicable or acceptable for many patients, and is associated with several adverse effects, commonly including gastrointestinal (e.g., constipation, nausea, vomiting), cardiovascular (e.g., dyslipidemia), renal/genitourinary (e.g., renal calculi), and growth problems. exogenous ketone esters (eke) could be a more convenient and superior alternative to kd for children with dre.

Eligibility criteria:
inclusion criteria: * drug-resistant epilepsy * seizure frequency ≥ 7 per week exclusion criteria: * failure to obtain informed consent * recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications * severe disease conditions, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems * hypo-/hyperglycemia * metabolic acidosis * ketosis (βhb \> 2 mmol/l) * git disorders, including gastritis/peptic ulcer, diarrhea/constipation, and irritable bowel disease * malnutrition/obesity * limitations to oral feeding (e.g., severe gastroesophageal reflux) * inborn errors of metabolism * chromosomal disorders * surgically-remediable epilepsy * allergies or any other contraindication to ketone supplements * inapplicable recording of seizures * incompliance to anti-seizure medications and/or irregular follow-up * recent propofol therapy * intake of carbonic-anhydrase inhibitors

Keywords: drug resistant epilepsy exogenous ketone esters children
identification of optimal stimulation site for cervical dystonia symptoms: an exploratory study

Conditions: Cervical Dystonia; Spasmodic Torticollis

Summary: the overall objective of this application is to therapeutically target the dysfunctional premotor-motor interaction in dystonia-and to provide a focused treatment of specific anatomical networks in order to reduce side effects and to improve symptom control over conventional therapies.

we propose using repetitive transcranial magnetic stimulation (rtms) over distinct premotor areas in patients with cervical dystonia (cd) with the goal of improving symptoms and reducing unwanted side effects. the knowledge gained in this proposed research will identify a specific premotor area to be targeted with rtms that is expected to result in a novel intervention that could enhance or replace current treatments for cd. rtms could be included as an adjunct treatment to botulinum toxin that could sustain treatment effect and decrease the frequency of re-injection, potentially resulting in cost savings without a decrease in symptom control. in addition to medical cost reduction, improved quality of life could be expected with the successful development of therapies that extend dystonia symptom control. rtms has been fda-approved for the treatment of depression and our proposal uses an even lower stimulation rate, suggesting continued use within clearly safe parameters. successful completion of this research could lead to rapid adoption of this therapeutic modality. we will test the hypothesis that rtms of a distinct premotor site will provide more effective treatment of cd than non-specific activation of the entire premotor region. this will be done by performing a randomized, observer-blinded exploratory pilot study to determine the optimal site of rtms over various sites of the premotor and motor cortex to improve the symptoms of cervical dystonia. completion of this aim should lead to development of targeted tms therapy for cd.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic cervical dystonia * age 18 years or older * normal findings in the medical history, physical and neurological examination, except for dystonia * last treatment with botulinum toxin more than two months ago exclusion criteria: * history of seizure disorder * pregnancy- a pregnancy test will be performed for women of childbearing potential * history of any other neurological disorders or conditions requiring the use of anti-depressants that are known to increase seizure threshold, neuroleptic medication, anticholinergic drugs and muscle relaxants * history of neuroleptic medications/ prior use of neuroleptics

Keywords: cervical dystonia torticollis rtms
safety of the envpro hiv vaccine in healthy volunteers

Conditions: HIV Infections

Summary: the purpose of this study is to determine the safety of a new hiv vaccine. the vaccine in this study is mixed with a chemical called alum to improve the body's response to the vaccine. healthy adults who are not infected with hiv may participate in the study.

envpro is a recombinant, purified envelope protein vaccine with an aluminum hydroxide (alum) adjuvant. aluminum hydroxide is licensed as an adjuvant in other vaccines, such as the hepatitis b vaccine. this study will examine the safety and tolerability of envpro with alum adjuvant in healthy, hiv uninfected adults. all participants in this study will receive vaccine injections in the upper arm muscle. participants will receive a second vaccine injection eight weeks after the first injection. blood tests will be performed at study visits before the vaccine is given, during the eight weeks between injections, and at selected times for up to three years after the vaccine is given.

Eligibility criteria:
inclusion criteria: * hiv uninfected * normal medical history and physical exam * normal complete blood count * normal liver function * normal renal function * normal serum creatine phosphokinase (cpk) * availability for at least 1 year follow-up exclusion criteria: * history of immunosuppressive illness, chronic illness, or use of any immunosuppressive medications * medical or psychiatric condition or occupational responsibilities which preclude compliance with the study * live attenuated vaccines within 60 days of study entry * use of experimental agents within 30 days of study entry

Keywords: hiv preventive vaccine hiv seronegativity protein
digital flow enhancement in raynaud's phenomenon with an sgc (soluble guanylate cyclase) stimulator

Conditions: Raynaud Disease

Summary: patients with raynaud's phenomenon suffer from painful attacks triggered by stress or cold causing acute lowering of blood flow through the digits. in this trial the safety and efficacy as well as the effect of one dose of the sgc stimulator riociguat on digital blood flow will be measured during a cold exposure test in patients suffering from raynaud's phenomenon. measurements of two periods will be compared: in one period the patient will be given active drug and in the other period a placebo.


Eligibility criteria:
inclusion criteria: * patients suffering from raynaud's phenomenon diagnosed at least ≥1 year before beginning of the study of the following origin: * idiopathic (primary) * limited cutaneous scleroderma associated * diffuse cutaneous scleroderma associated * mixed connective tissue disease associated exclusion criteria: * patients taking medication interfering with the digital flow measurement such as calcium channel blockers (ccb), phosphodiesterase 5 (pde5) inhibitors, endothelin receptor antagonists (era), nitrates * smokers * systolic blood pressure (sbp) below 105mmhg at rest

Keywords: digital ischemia raynaud's phenomenon
evaluation of the use of a remote monitoring and follow-up option for patients with chronic obstructive pulmonary disease (boreal)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate the ability of the bora care remote monitoring solution to detect early acute exacerbations of chronic obstructive pulmonary disease (copd).

worldwide, copd has been increasing for 20 years with nearly 300 million patients, i.e. 4 to 10% of the adult population (7.5% in france). according to the who, it is now the fourth leading cause of death in the world. acute exacerbations of copd (worsening of symptoms requiring an increase in treatment) represent frequent events in the course of the disease and the consequences are significant for the patient in terms of vital prognosis, deterioration of respiratory function, impact on quality life and for the health system in terms of cost. missed diagnosis and delayed treatment are associated with impaired outcomes. the prevention and early treatment of acute exacerbations of copd therefore have a major role in the management of copd patients and could be facilitated by telemonitoring tools. the purpose of the present study is to validate the interest of remote monitoring of various parameters (cardio-respiratory, environmental, symptom questionnaires) to predict and detect early the occurrence of acute exacerbations of copd.

Eligibility criteria:
inclusion criteria: * patient with copd defined according to the splf recommendations, whose level of lung function in a stable state is known (measurement less than 12 months old) * patient with at least one of the following criteria : * hospitalized for a copd exacerbation at the time of enrolment in the study, and having had at least one other exacerbation in the last 12 months * followed-up and part of the active file of the site, having had at least 2 exacerbations during the last 12 months, including one with hospitalization * copd patient with at least 2 exacerbations in the last 12 months, including one with hospitalization * patient having given written informed consent to participate in the study * patient affiliated to the french social security system exclusion criteria * vulnerable patient (minor, protected adult, prisoner) * patient unable to use the boraband tool and without access to a caregiver * presence of a comorbidity considered unstable or very severe by the investigator * patient already participating in another interventional research study

Keywords: copd acute exacerbation prevention early detection
wearable monitor in patients with syncope

Conditions: Syncope, Vasovagal

Summary: the main purpose of this study is to assess the reliability of a new patient's self-administered wearable watch-type bp monitor in detecting episodes of hypotensive (pre)syncope. secondary aim regards the estimation of feasibility of this tool.

background while ecg monitoring is a reliable and established method that allows to document bradycardia in a substantial proportion of patients affected by cardioinhibitory reflex syncope, the documentation of a transient hypotension is only seldom achieved in patients affected by hypotensive syncope. conventional ambulatory blood pressure (bp) monitoring (abpm) has important limitations due to the short period of monitoring (usually 24-48 hours) and the intermittent nature of bp measurements (usually every 15-20 min). the main purpose of this study is to assess the reliability of a new patient's self-administered wearable watch-type bp monitor in detecting episodes of hypotensive (pre)syncope. secondary aim regards the estimation of feasibility of this tool. method the study is a prospective intrapatient comparison during tilt testing between bp measured by mean of a wearable watch-type bp monitor (omron heartguide 6410t, omron healthcare, kyoto, japan) and by mean of the standard methods for continuous finger bp monitoring (finometer®, finapres medical systems, enchede, the netherlands, and task force® monitor, cnsystem, graz, austria), based on the photoplethysmographic volume clamp method . study design bp values observed during tilt testing baseline and at the time of impeding syncope will be measured by mean of the heartguide device and will be compared with the standard of reference of bp. bp will be recorded at rest at baseline, shortly after upright in tilting position (at stabilization), at the time of occurrence of impeding syncope (presyncope) or, alternatively at the time of maximum hypotensive effect, if syncope will not occur, and finally in the recovery period at the end of the test after returning in supine position.

Eligibility criteria:
inclusion criteria: * consecutive patients, * \>18 years of age, referred for tilt testing because affected by suspected reflex syncope exclusion criteria: * arrhythmias or the inability of heartguide to measure bp supine at rest.

Keywords: syncope tilt testing blood pressure monitoring