Kornimate/medical-research-clean huggingface dataset:
pilot efficacy and safety study of aqx-1125 in atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of aqx-1125 compared to placebo on change from baseline in total lesion symptom score in subjects with mild to moderate atopic dermatitis

one of the causative factors for the inflammatory response observed in ad is the release of chemokines and other chemoattractant factors followed by recruitment of inflammatory cell subtypes (10). il-16, a langerhans cells (lc)-derived chemoattractant cytokine for cd4+ cells, rantes, monocyte chemotactic protein (mcp-4) and eotaxin are overexpressed in epidermal keratinocytes from ad subjects and may contribute to the chemotaxis of eosinophils, macrophages and th2-lymphocytes (11). since the activation of ship1 by aqx-1125 results in the inhibition of inflammatory cell chemotaxis and reduction of pro-inflammatory cytokine synthesis, this study hypothesized that aqx-1125 would improve ad.

Eligibility criteria:
inclusion criteria: 1. male or female aged from 18 to 65 years old 2. confirmed clinical diagnosis of active atopic dermatitis (ad) according to the hanifin and rajka criteria 3. at least a 6 months history of atopic dermatitis. 4. body surface area (bsa) covered with atopic dermatitis of 1% or more 5. mild or moderate atopic dermatitis (iga score of 2 or 3). 6. tlss of 5 or more at day 0. 7. subject must use a non-medicated emollient daily for at least (≥) 7 days prior to day 0 and should continue using that same emollient, at the same frequency, throughout the study. exclusion criteria: 1. female subject who is pregnant or breast-feeding 2. unstable or clinically infected atopic dermatitis

Keywords: atopic dermatitis eczema ad aqx-1125 ship1
efficacy and safety study of pregabalin in the treatment of pain on walking in patients with diabetic peripheral neuropathy (dpn)

Conditions: Diabetic Peripheral Neuropathy

Summary: the intent of this study is to treat subjects with painful diabetic peripheral neuropathy (dpn) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing dpn pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.


Eligibility criteria:
inclusion criteria: * men or women who are at least 18 years old. * diagnosis of painful diabetic peripheral neuropathy. * pain on walking. exclusion criteria: * inability to walk 50 feet on a flat surface. * pain on walking due to conditions other than diabetic peripheral neuropathy.

Keywords: diabetic peripheral neuropathy pain on walking pregabalin
ultrasound-guided blood sampling drawing for microbiological analysis in the critically ill

Conditions: Sepsis; Septic Shock; Infections; Diagnosis

Summary: this study will test the feasibility of ultrasound-guided sterile blood sampling for critically ill patients with suspected sepsis requiring blood culture. the aim of the study is to evaluate the feasibility and safety of the use of ultrasound for blood cultures in a population of patients which can present difficult venous access and requiring more than one venipuncture attempt in general clinical practice


Eligibility criteria:
inclusion criteria: * adult patients (18 year-old) * admitted to intensive care unit * suspected sepsis requiring blood cultrure exclusion criteria: * pregnancy * infections requiring respiratory isolation * burns or skin disease involving arms and/or more than 60% of body surface
cultures in picu patients compared to healthy children

Conditions: Ventilator Associated Pneumonia; Pneumonia, Bacterial

Summary: this study is being done to determine if the bacteria found in your mouth (oral flora bacteria) in children admitted to the intensive care unit who need to be on a breathing machine is different from the oral flora in healthy children undergoing anesthesia for their dental caries. children in the intensive care unit with a breathing tube are at a higher risk for getting a lung infection due to the bacteria in the mouth slipping into their lungs past the breathing tube over several days. this means that bacteria are found in the child's lung when this is normally not the case. if the bacteria in the mouth have changed from normal then they may get a pneumonia.

the oral cavity has natural flora of microbiology that may be associated with the development of dental decay. another possible problem arising from this flora is the migration of the bacteria into the trachea causing pulmonary infections such as trachietis or pneumonia. the risk of developing a pulmonary infection appears to be increased in patients who have been intubated for a period of time (days) such as those patients ventilated in the intensive care unit (icu). it has also been shown that in patients in the icu the nature of the oral flora changes over time to include bacteria that are more commonly associated with the nosocomial pneumonia, ventilator associated pneumonia. we have previous demonstrated in a small pilot study (cyirb2779) that the changes in the oral flora in children intubated in the icu was similar to those bacteria grown from tracheal cultures ordered by the intensivist. patients intubated in the icu maybe at risk of decreased salivary flow, sedated and unable to clear secretions and are reliant on the bedside nurse to maintain adequate oral hygiene. most icu's have guidelines and policies to ensure that oral hygiene is appropriately cared for. they are also at risk for changes in the oral flora due to concomitant broad-spectrum antibiotic use that is common in the initial 48 hours after admission with respiratory failure. the second are of interest is to determine whether children who are very sick and require intubation and ventilation support have different bugs growing in their mouth that may predispose them to future infection whilst in the icu.

Eligibility criteria:
inclusion criteria: icu group: * intubated within 12 hours * asa 1 or 2 (asa - american society anestehesiology preopoerative status) * age 2 to 8 or group: * asa 1 or 2 * elective dental surgery requiring intubation * age 2 to 8 exclusion criteria: icu group: * trauma patients * postoperative patients * children under 2 or over 8 or group: * received antibiotics within the last week * received prednisone within the last 2 weeks * viral respiratory infective process within the last 2 weeks

Keywords: icu or pneumonia picu pediatric pcr
mepolizumab in the treatment of patients with severe uncontrolled crswnp: a multicentric real life observational study

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: chronic rhinosinusitis with nasal polyposis (crswnp) is a complex chronic inflammatory disease of the nasosinusal mucosa that has a significant negative impact on patients' quality of life. in crswnp, chronic inflammation is primarily driven by type 2 pro-inflammatory interleukins (ils )such as il-5, il-4, and il-13 along- side high levels of eosinophils in the surrounding tissue. mepolizumab is a targeted, humanized anti-il-5 antibody that prevents il-5 from binding to its receptor on eosinophils and selectively inhibits eosinophilic inflammation. so far, randomized clinical trials have assessed efficacy and safety of mepolizumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series. herewith, we present a multicenter, observational, prospective/retrospective nationwide real-life study with the aim to confirm the effectiveness and the safety of mepolizumab over the first year of treatment in a real life setting. the primary objective of this study is to evaluate the reduction of dimension of nasal polyps and the improvement of quality of life in the patient measured through symptomatologic questionnaires. the secondary objective is to evaluate improvements in terms of smell dysfunction, comorbidities, biomarkers (nasal cytology and blood eosinophilia), need of surgery or systemic steroids.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age who can sign a written informed consent confirmed clinical / radiological diagnosis of chronic rhinosinusitis with diffuse naso-sinusal polyposis by nasal endoscopy and/or massive facial ct scan without contrast medium carried out within 6 months prior to the start of therapy; * blood eosinophils \>150 * severe disease stage, defined by nasal polyp score (nps) ≥ 5 or nasal obstruction symptom visual analogue scale (vas) score of \>5 and/or sinonasal outcome tests-22 (snot-22) ≥ 50); * inadequate symptom control with intranasal local corticosteroid therapy; * failure of previous medical treatments (at least 2 cycles in the last year of systemic corticosteroid) and failure of previous surgical treatment through nasal endoscopic surgery (fess), with no clinical benefit or postoperative complications. exclusion criteria: * age \<18 years; * patients undergoing immunosuppressive therapies; * patients undergoing radio/chemotherapy treatments for cancer in the 12 months before the start of therapy; * patients on concomitant long-term corticosteroid therapy for chronic autoimmune disorders.
a study to reduce the reflux after a sleeve gastrectomy in obese patients

Conditions: Gastroesophageal Reflux; Obesity

Summary: this is a monocentric randomized controlled prospective study. a total of 122 patients will be recruited and randomized 1: 1 in the experimental group - laparoscopic sleeve gastrectomy and diaphragmatic pillar closure - or in the control group - laparoscopic sleeve gastrectomy. at 6 months post surgery a gastroscopy, an oesophageal manometry and a ph-study will be perform to detect de novo gastroesophageal reflux disease and hiatal hernia appearance.


Eligibility criteria:
inclusion criteria: * age between 18-65 years * patient with bmi between 35 and 50 kg/m2 for whom laparoscopic sleeve gastrectomy indication was made * patients with no preoperative gastroesophageal reflux disease symptoms * hill 2-3 or 4 (with hh \<2 cm) hypogastric valve diagnosed preoperatively exclusion criteria: * gastroesophageal reflux disease with daily symptoms or daily use of proton pump inhibitors drugs or daily use of anti-h2 drugs * hiatal hernia \>2cm and/or esophagitis and/or barrett metaplasia * previous bariatric and/or gastric surgery * normal gastroesophageal valve (hill 1) * motility disorders of the esophagus (documented on manometry) * ph-study positive for gastro-oesophageal reflux disease (demeester score \>14.1) * contraindications to gastroscopy or manometry or ph-study * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * patient not legally competent * pregnancy
evaluate the efficacy of anti-jak1 inhibitors as treatment for patients with aicardi-goutières syndrome

Conditions: Aicardi-Goutières Syndrome (AGS)

Summary: aicardi-goutières syndrome (ags) is a hereditary multisystem autoinflammatory disorder that predominantly affects the central nervous system. it is characterized by severe neurological disability and chronic inflammation caused by the persistent overproduction of type i interferon. to date, nine causative genes of ags have been identified, each of which can lead to classic ags presentations, atypical forms, or other manifestations that do not meet the formal diagnostic criteria for ags and are referred to as "ags-related interferonopathies." janus kinase 1 (jak1) inhibitors, including baricitinib and ruxolitinib, offer a promising therapeutic strategy for aicardi-goutières syndrome (ags) by directly targeting the central pathogenic pathway of the disease. patients treated with jak1 inhibitors for ags have shown significant improvement in systemic symptoms, though the effect on neurological symptoms and brain imaging remains unclear. the aim of this project is to retrospectively analyze the efficacy, particularly on neurological symptoms and brain imaging, and the safety of jak1 inhibitor treatment in ags patients treated at italian tertiary centers. data will be collected before starting the therapy and during follow-up at 6, 12, 18, and 24 months, where available. preliminary data collection was carried out through a survey conducted by the ags italy group to assess the number of patients treated with jak1 inhibitors. clinical, brain imaging, genetic, and laboratory data routinely recorded in nine different italian centers as part of the standard clinical care of these patients will be retrospectively collected and analyzed. in the second phase of the study, brain mri data from ags patients treated with jak1 inhibitors will be compared to untreated ags patients matched for age and genotype, in order to evaluate the potential therapeutic efficacy of jak1 inhibitors on brain imaging compared to the natural clinical progression of the disease. through the analysis of the italian experience, this study could lay the groundwork for drafting a potential consensus on the use of jak1 inhibitors for the treatment of ags patients.


Eligibility criteria:
inclusion criteria: * patients aged 0 to 25 years * patients who have been genetically diagnosed with aicardi-goutières syndrome (ags) or ags-related interferonopathies for case cohort-patients treated with janus kinase 1/2 (jak1/2) inhibitors, such as baricitinib or ruxolitinib exclusion criteria: * patients over the age of 25 years * patients who have not been genetically diagnosed with aicardi-goutières syndrome (ags) or ags-related interferonopathies.

Keywords: anti-jak1/2 ruxolitinib baricitinib ags-related interferonopathies
endometrial biopsy as diagnostic method for endometriosis and endometrioma

Conditions: Women in the Reproductive Age Group; Undergoing Laparoscopy for Pelvic Pain and/or Infertility; Not Currently Receiving Hormonal Treatment for at Least 3 Months Prior to Laparoscopy.

Summary: our aim was to evaluate the efficacy of examining endometrial biopsy specimens for nerve fibers as a diagnostic test for endometriosis and endometrioma in a double-blind comparison with diagnostic laparoscopy.


Eligibility criteria:
inclusion criteria: * women in the reproductive age group undergoing laparoscopy for pelvic pain and/or infertility, and not currently receiving hormonal treatment for at least 3 months prior to laparoscopy will be included in the study
burden of herpes zoster and post-herpetic neuralgia among people ≥ 50 years old in france

Conditions: Herpes Zoster

Summary: the purpose of this study is to assess the burden of herpes zoster (hz) and post-herpetic neuralgia (phn) among people ≥ 50 years old in france, in terms of healthcare resources used, medical direct and indirect costs, as well as pain severity and impact on quality of life.

* an observational, prospective cohort study of patients ≥ 50 years old with a herpes zoster (hz) diagnosis, carried out by a national random sample of community first line practitioners concerned by hz diagnosis: general practitioners, dermatologists and ophthalmologists. * all patients ≥ 50 years old with a hz diagnosis (as the primary diagnoses and without history of previous hz) during approximately 6 months inclusion period will be included in the hz cohort, until total study target is achieved. * all patients of the hz cohort presenting a post-herpetic neuralgia (phn) 3 months after onset of the hz rash onset will be included secondarily in the phn cohort * patients of the hz cohort will be followed-up for 3 months (i.e. 1 and 3 months after hz rash onset) and patients of the phn cohort will be followed-up for additional 6 months (i.e., 6 and 9 months after hz rash onset) using phone interviews with a nurse. * 250 cases of hz and 40 cases of phn are expected, with the hypothesis of 16% of phn 3 months after hz rash onset.

Eligibility criteria:
inclusion criteria: * for hz cohort * patient with a first visit for a diagnosis of hz and who attend the clinic within two week of the hz start of symptoms, * without history of previous hz, * ≥ 50 years old, * who agree to participate and signed informed consent, * able to understand the study, to complete self-administered questionnaires and to answer phone interviews. * for phn cohort * all patients of the hz cohort presenting phn 3 months after onset of the hz rash onset will be included in the phn cohort. phn will be defined as the presence of hz-associated severe pains: ≥ 3 of the zbpi item "worst pain". exclusion criteria: * none

Keywords: france post-herpetic neuralgia herpes zoster economic burden of disease
patient perspectives in mantle cell lymphoma clinical research

Conditions: Mantle Cell Lymphoma

Summary: clinical studies with a distinct emphasis on mantle cell lymphoma play a pivotal role in evaluating the safety and effectiveness of novel treatments for this disease. these trials are instrumental in ascertaining whether new medications surpass conventional therapies, providing substantial evidence to endorse their broad utilization. this particular study stands out as it centers on the firsthand experiences of individuals battling mantle cell lymphoma who are actively engaged in a clinical trial featuring medicinal interventions. the primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this patient group.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of mantle cell lymphoma * no serious medical or psychiatric illness likely to interfere with participation in this clinical study. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * concurrent participation in another therapeutic clinical trial. * subject has an uncontrolled infection * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Keywords: mantle cell lymphoma
aggressive incidents in medical settings study

Conditions: Aggression

Summary: the purpose of this study is to identify the incidence rate and characteristics of aggressive behavior perpetrated by patients and visitors in inpatient medical units and to understand the role of missed care events, professional quality of life and self-efficacy in relationship to aggressive events.

this prospective cohort study will examine the incidence of and outcomes associated with patient and visitor aggressive behavior towards nursing staff practicing on medical inpatient units. staff on each unit will be informed about the aims study and all eligible nursing staff will be invited to participate in the study. after completing the informed consent nursing staff will be asked to complete the baseline demographic form and survey on professional quality of life. for the data collection phase of the study consented participants will be educated on use of the aim log and provided with scenarios to practice aim log use. consented staff will carry event counters and use the aim log for all shifts worked over the next 2 weeks.

Eligibility criteria:
inclusion criteria: * all registered nurses and assistive nursing personnel, including patient care associates (pcas) , patient care technicians (pcts), clinical technicians (cts), * primary employment on the study unit, * minimum of 24 hours per week of employment on study unit. exclusion criteria: * any registered nurse or assistive nursing personnel working less than 24 hours per week, * whose primary employment is on a unit not involved in the study or float-pool / centralized resource staff who do not have a primary employment unit, * any nursing staff member still on orientation or working with an orientee.
study of the interactions between dientamoba fragilis and the gut microbiota

Conditions: Diarrhea

Summary: d.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. the study aim to determine if the carriage of the intestinal parasite d.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms.


Eligibility criteria:
inclusion criteria for symptomatic group: * male/female aged at least of 18 years * subject with abdominal pain, diarrhea, bloating * no other known intestinal disease inclusion criteria for asymptomatic group: * male/female aged at least of 18 years * no known intestinal disease exclusion criteria of symptomatic and asymptomatic groups: * chronic intestinal diseases such as ibd, ibs ... * intake of antibiotic or probiotic within the 2 last months * subject in exclusion period * subject unable to understand information for a free consent to the study * subject in safeguarding justice or guardianship
the relationship between phonological awareness skills and home environment literacy in cochlear implant users

Conditions: Cochlear Implants; Child Language; Literacy; Phonological (Speech) Disorder

Summary: the aim was to examine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant.

this study was designed to determine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant.to collect data from the parents, "demographic questionary" which is prepared by the researchers, "early literacy home environment scale (elhes)" (karaahmetoğlu \& turan, 2017), and "family literacy scale" (kılıç, doğan \& özden, 2017) were used in the study. to collect data from the children with cochlear implant users, "the turkish early language development test (tedi̇l) " (topbaş \& güven, 2013), and "the early childhood phonological sensitivity scale (pasecp)" (sarı \& acar, 2013) were used in the study. this study was carried out with follow-up patients in the audiology, language and speech disorders clinic of xxx university - medical faculty, department of otorhinolaryngology. the study was performed with the approval of ethics committee, and written informed consent was obtained from all patient families (138955/ july 2021). there are 23 cochlear implant users and, 23 their family. children ranging in age from 5 to 7 who also have 5-6 years old language skills without any neurological problems were included in the study. spss 25.0 (ibm) was used program for statistical analysis. the differences of the numerical measurements used in the research according to the binary demographic categories were analyzed with the mann whitney u test, and the analysis of the differences according to the multiple categories was analyzed with the kruskal wallis h test. the significance level (α=0.05) was used.

Eligibility criteria:
inclusion criteria: * language skills were between 60 and 72 months; not enrolled in primary school; regular use of unilateral or bilateral cochlear implants;regular training in an auditory rehabilitation center exclusion criteria: * the study excluded individuals who did not meet the inclusion criteria for the control and study groups.

Keywords: cochlear implant home environment early literacy phonological awareness pediatri