Kornimate/medical-research-clean huggingface dataset:
stopping antibiotics after 3 days for the treatment of high-risk febrile neutropenia

Conditions: Neutropenia, Febrile

Summary: the goal of this clinical trial is to compare a short course of antibiotics in patients in whom no bacterial infection is found with the current "golden standard": long-term antibiotic treatment in adult hematology patients who develop neutropenic fever. the main question it aims to answer is: whether the short-term treatment is equally safe for patients, hence the name 'safe study'. participants will be randomly assigned (randomized) to one of two treatment options once they develop neutropenic fever: short-term or long-term antibiotic treatment. an additional blood sample, urine sample and stool sample will be collected. researchers will compare the short-term and the long-term antibiotic treatment groups to see if the short treatment is equally safe as the long-term treatment group.


Eligibility criteria:
inclusion criteria: * voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures; * age older than 16 years; * intensive therapy is started within three days before randomization for one of the following haematological conditions: * remission induction chemotherapy for newly diagnosed acute myeloid leukemia (aml) or myelodysplastic syndrome (mds); or * re-induction chemotherapy for relapsed after haematological remission lasting for a minimum duration of 6 months; or * conditioning regimen to prepare for an allogeneic hct; or * conditioning regimen to prepare for an autologous hct. * expected longstanding (≥ 7 days) neutropenia (anc \< 0.5x10\^9/l); * expected length of hospital stay of at least 10 days. exclusion criteria: 1. clinically or microbiologically documented infection; 2. patient already receives broad spectrum antibiotic therapy; 3. any critical illness for which intensive care unit treatment is required; 4. sofa score ≥ 11; 5. longstanding neutropenia (\>21 days) prior inclusion; 6. previous enrolment in this study; 7. not able to provide written informed consent; 8. any disorder, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol; 9. any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the trial.

Keywords: neutropenia leukemia stem cell transplant complications infections
the effect of shared listening to personalized music on symptoms of behavioral disorders in the elderly with advanced dementia

Conditions: Dementia

Summary: this study is of great importance because it uses a method that has not been tested in the past. to date, various interventions have been examined that use music for patients with dementia. at the same time, no intervention was conducted that integrates an additional person who shares personalized music with the patient. if the combination of another person who shares the positive effect of the music with the patient is found to enhance the positive effect of the music, it can change the routine of work with dementia patients and may even reduce the use of tranquilizers among them. in many cases, it has been found that one of the biggest challenges for family members who treat patients with dementia is the lack of content in the sessions and as a result, the growing sense of alienation between the patient and his family. listening to music can be a significant tool in the hands of the family, the main caregiver, the medical staff, and any person who comes in contact with the patient, a tool that can strengthen the sense of connection and connection between them.


Eligibility criteria:
inclusion criteria: * hospitalized in the department of mental disorders at the mental health center in be'er sheva aged 18 and over. * patients who have been diagnosed with dementia for the issue. * patients whose guardian gave consent for the study. exclusion criteria: * hearing-impaired patients.

Keywords: music therapy
acoustic cough monitoring for the management of patients with known respiratory disease

Conditions: Cough; COPD; GERD; Asthma; Tuberculosis; Non-Tuberculous Mycobacterial Pneumonia; COVID-19 Pneumonia

Summary: this study pretends to evaluate the potential use of hyfe cough tracker (hyfe) to screen for, diagnose, and support the clinical management of patients with respiratory diseases, while enriching a dataset of disease-specific annotated coughs, for further refinement of similar systems.

this is an observational study that will take place in the two campuses of the clínica universidad de navarra, located in pamplona and madrid (spain). an artificial-intelligence system (ai) that detects and records explosive putative cough sounds and identifies human cough based on acoustic characteristics will be used to automatically monitor cough. potential participants either attending the outpatient clinic or hospitalised with a complaint of cough will be invited by their treating physician, or a member of the research team, and included in the study by part of the research team. a researcher will instruct participants on how to install and use hyfe cough tracker in their smartphones. participants will be monitored for 30 days (outpatients) or until discharged from the hospital (inpatients). participants will be asked to complete a daily, online, standardised 100 mm visual analogue scale (vas) to register changes in the subjective intensity of their cough, while using hyfe to objectively monitor changes in its frequency. in parallel, a dataset of annotated cough sounds will be constructed and retrospectively used to assess differences in acoustic patterns of cough, and to evaluate the performance of the system detecting them. a first subgroup of participants will be recruited outside the clinical setting and asked to provide a series of elicited sounds, including coughs, which will then be used to determine the system's performance accurately discriminating coughs from non-cough sounds, and compared to trained human listeners. a second subgroup of participants will be will be instructed to use hyfe, and the related hyfe air wearable device continuously for a period between 6 and 24 hours, while they record themselves using a mp3 recorder connected to a lapel microphone. this group will be used to evaluate the performance of hyfe and hyfe air in a real-life setting, with spontaneous coughs.

Eligibility criteria:
inclusion criteria: for participants in the main study group * outpatient or inpatients at the clinical universidad de navarra with a complaint of cough. * the patient or his/her legal representative, have given consent to participate in the study. for participants in the sub-study groups: * being 18 years or older. * providing consent for the sub-study exclusion criteria: * inability to accept the privacy policy and terms of use of hyfe. * lack of access to a wi-fi network at the site of residence (for the main study group). * unwillingness to regularly use the cough-surveillance system throughout the monitoring period
randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy and safety of fb102 in adult with celiac disease

Conditions: Celiac Disease

Summary: this study is a randomized, double-blind, placebo controlled clinical study to assess the efficacy, safety, pharmacokinetics (pk) and pharmacodynamics (pd) of fb102 in adult participants with well controlled (on a strict gfd) ced following an oral gluten challenge.


Eligibility criteria:
inclusion criteria: 1. men and women aged 18 to 70 years at screening. 2. has documented diagnosis of ced confirmed by intestinal biopsy and positive celiac serology at least 12 months prior to screening (intestinal biopsy and serology do not have to be performed concurrently). 3. body mass index (bmi) between 16.0 and 40.0 kg/m2, inclusive. 4. self-reported to be on a gfd for at least 12 months prior to screening and must be willing to remain on a gfd for the duration of study participation, with the exception of the oral gluten challenge administered as a study procedure. prior acute and resolved accidental exposures are not exclusionary. exclusion criteria: 1. uncontrolled ced and/or active signs/symptoms of ced, in the opinion of the investigator. 2. history of or current neuropsychiatric manifestations specifically related to gluten exposure including ataxia, seizures, severe peripheral neuropathy, cognitive impairment, and depression.
study to investigate the efficacy and safety of regimens containing brii-179, brii-835, and peg-ifnα treating chronic hepatitis b virus (hbv) infection (enrich)

Conditions: For Treatment of Chronic Hepatitis B Virus Infection

Summary: this study will evaluate the efficacy and safety of the regimens containing brii-179, brii-835, and peg-ifnα in adult participants with chronic hepatitis b virus (hbv) infection receiving nucleos(t)ide reverse transcriptase inhibitors (nrtis) as background therapy.


Eligibility criteria:
inclusion criteria: * 1. male or female aged 18-60 years. * 2. body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * 3. chronic hbv infection for ≥ 6 months. * 4. on nrti therapy for ≥ 6 months. exclusion criteria: * 1. any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation. * 2. significant liver fibrosis or cirrhosis. * 3. history or evidence of drug or alcohol abuse. * 4. history of intolerance to sc or im injection. * 5. history of chronic liver disease from any cause other than chronic hbv infection. * 6. history of hepatic decompensation. * 7. contraindications to the use of peg-ifnα.
bariatric embolization before sleeve gastrectomy for super obese patients

Conditions: Sleeve Gastrectomy; Morbid Obesity; Bariatric Surgery

Summary: in patients with severe obesity, bariatric surgery provides consistent and long-term weight loss. bmi ≥50kg / m2 is an independent factor of increased morbidity / mortality in bariatric surgery compared with patients weighing less than 50 kg / m2 (1.2% and 0.8%) mainly due to technical difficulties. preoperative weight loss reduces this morbidity / mortality. recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss. the purpose of this study was to evaluate the safety and effectiveness of the association bariatric embolization before sleeve gastrectomy in super obese patients.


Eligibility criteria:
inclusion criteria: * willing, able and mentally competent to provide written informed consent. * body mass index (bmi) \>50kg/m². * 3 risk factors (de maria et al) among: hypertension, male gender, age\>45, risk of pulmonary embolism * vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist amenable to bariatric embolization, as assessed on 3d ct angiography. * adequate hematological, hepatic and renal function as follows: hematological neutrophils \> 1.5 x 109/l platelets \> 100 x 109/l inr \ 60ml/min.1.73m2 * aged 18 years or older. * patient who is going to be operated by sleeve gastrectomy exclusion criteria: * prior history of gastric pancreatic, hepatic, and/or splenic surgery * prior radiation to the upper abdomen * prior embolization to the stomach, spleen or liver * portal venous hypertension * prior or current history of peptic ulcer disease * significant risk factors for peptic ulcer disease including daily nsaid use and smoking. * active h. pylori infection * weight greater than 240 kg * known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of \< 60 milliliters per minute * major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease. pregnancy * asa class 4 or 5 (very high risk surgical candidates: class 4= incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study will be excluded from participation. this exclusion criterion exists because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects. * history of inflammatory bowel disease * cirrhosis * known history of allergy to iodinated contrast media * contraindications to use embosphere (ex:known allergy to gelatin ..)

Keywords: bariatric embolization sleeve gastrectomy super obese left gastric artery morbid obesity bariatric surgery
occupational cataracts and lens opacities in interventional cardiology : the o'cloc study

Conditions: Cataracts; Lens Opacities

Summary: the purpose of this study is to test the existence of an increased risk of cataracts among interventional cardiologists as compared to cardiologists not exposed to x-rays.

this cross-sectional study includes cardiologists aged \> 40 years: a group of interventional cardiologists (coronary interventionists and electrophysiologists) and a group of unexposed workers (including cardiologists). individual information, including risk factors of cataracts (age, diabetes, myopia, etc. ...), are collected during a telephone interview. for the exposed group, a specific section of the questionnaire is focused on the occupational history, the description of the procedures (type, frequency, radiation protection tool) and will be used for the classification into "comparable exposure level" groups according to estimates of cumulative dose. for all participants, eye examinations are performed to specifically detect cataracts even in the early stages (lens opacities, locs iii according to the international standard classification).

Eligibility criteria:
inclusion criteria: * aged at least 40 yrs old * for interventional cardiologists: cumulated number of procedures \> 2000 exclusion criteria: * previous history of medical radiation exposure for radiotherapy or brain scans * for non-interventional cardiologists: occupational history of interventional cardiologist

Keywords: radiation cataracts lens opacities x-rays interventional cardiologists electrophysiologists
a clinical efficacy and safety study of ohb-607 in preventing bronchopulmonary dysplasia in extremely premature infants

Conditions: Bronchopulmonary Dysplasia; Chronic Lung Disease of Prematurity; Intraventricular Hemorrhage; Retinopathy of Prematurity (ROP)

Summary: the purpose of this study is to determine if an investigational drug can prevent bronchopulmonary dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.


Eligibility criteria:
inclusion criteria: 1. written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. the informed consent and any assents for underage parents must be approved by the irb/iec (in accordance with local regulations). 2. written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. the informed consent and any assents for underage birth mothers must be approved by the irb/iec (in accordance with local regulations). 3. subjects must be between 23 weeks +0 days and 27 weeks +6 days ga, inclusive. exclusion criteria: 1. detectable major (or severe) congenital malformation identified before randomization. 2. known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion. 3. hypoglycemia at baseline (blood glucose less than (\<) 45 milligrams per deciliter \[mg/dl\] or 2.5 milli moles per liter \[mmol/l\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism. 4. clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion. 5. any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results. 6. current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis). 7. the participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator. 8. birth mother with active covid-19 infection at birth or a history of severe covid-19 infection (requiring intensive care hospitalization) during pregnancy.
a prospective study of surgical treatment strategies for goal b type basilar invagination

Conditions: Basilar Invagination; Prospective Study; Surgical Outcome

Summary: the etiology of goal b type basilar invagination (bi) is still not clear, and it may be related to platybasia and short slope. there is no unified standard surgical strategy for goal b type bi, and different surgical strategies have a great influence on the surgical results of patients. the purpose of our prospective study in china is to (1) further clarify the etiology of goal b type bi, and (2) improve the surgical outcome in these patients.


Eligibility criteria:
inclusion criteria: * goal b type basilar invagination (bi) exclusion criteria: * preoperative diagnosis was confirmed as not goal b type basilar invagination (bi) * the patient was not physically fit for surgery.
study on recurrence monitoring of hepatocellular carcinoma with 5-hydroxymethylcytosine test

Conditions: Hepatocellular Carcinoma

Summary: in this study, investigators aim to find out how plasma 5hmc level changes in hepatocellular carcinoma patients after liver resection, and determine whether 5hmc can be used as a biomarker for hcc recurrence monitoring.

hepatocellular carcinoma (hcc) is the most common primary liver cancer and the third leading cause of cancer-related death worldwide. liver resection is a common treatment for hcc. however, even after successful surgical resection, most patients suffered from recurrence or progression of the tumor. because clinical staging systems cannot precisely predict the outcome of patients with hcc, it's of great interest to search biomarkers for hcc. among them, alpha-fetoprotein (afp) is the most well-studied. however, the applicability of afp for hcc after surgical resection of tumor is still uncertain. the discovery of cell-free dna (cfdna) originating from different tissues in the circulating blood has revolutionary potential for the clinic. liquid biopsy-based biomarkers and detection tools offer substantial advantages over existing diagnostic and prognostic methods, including being minimally invasive. they thus have a cost-efficient potential to promote higher patient compliance and clinical convenience to enable dynamic monitoring. 5-hydroxymethylcytosine (5hmc) is the intermediate of active demethylation from 5-methylcytosine. 5hmc not only marks active demethylation but also serves as a relatively stable dna mark that plays distinct epigenetic roles. recent genome-wide sequencing maps of 5hmc in various mammalian cells and tissues support its role as a marker for gene expression. previous studies have established 5hmc-seal technology for 5hmc profiling in cfdna and showed that the differentially enriched 5hmc regions in cfdna are excellent markers for solid tumors. in this study, investigators aim to find out how plasma 5hmc profile changes in hepatocellular carcinoma patients after liver resection, and determine whether 5hmc can be used as a biomarker for hcc recurrence monitoring.

Eligibility criteria:
inclusion criteria: 1. patients who received liver resection within 3 months; 2. hepatocellular carcinoma confirmed pathologically; 3. serum alpha-fetoprotein level lower than 20ng/ml before hepatectomy. exclusion criteria: 1. patients with macroscopic tumor remnants; 2. patients with other diseases which may affect the observation mentioned here; 3. patients with medical history of other malignant tumors; 4. pregnant or nursing women.

Keywords: recurrence monitoring 5-hydroxymethylcytosine liquid biopsy cell-free dna
to assess the efficacy of early introduction of a combination of low dose vasopressin analogue in addition to noradrenaline as a vasopressor in patients of cirrhosis with septic shock

Conditions: Cirrhosis With Septic Shock

Summary: the consecutive patients admitted to intensive care unit of hepatology department of ilbs and full filling all the eligibility criteria will be enrolled in 1:1 ration by the process of randomization.- the study is an open level study. the investigators will strictly follow the randomization table to give therapy as per the intervention arm. * intervention:-the therapeutic intervention is vasopressor i.e. noradrenaline alone and terlipressin along with noradrenaline to maintain the map \>65mm hg. * intervention arm * arm (a) - noradrenaline * arm (b) - noradrenaline + low dose terlipressin


Eligibility criteria:
inclusion criteria: * 18-70 yr * cirrhosis with septic shock not responding to fluid resuscitation within 2 hrs. exclusion criteria: * ecg (electrocardiography)changes at presentation which exclude the use of vasopressin analouges * cardiac dysfunction ( valvular heart disease, coronary artery disease) * acute mesenteric ischemia (confirmed or suspected) or vasospastic diathesis (e.g. reynaud's syndrome or related diseases). * pregnancy * acute gi bleed * no consent
evaluation of dermafill dressing for donor sites

Conditions: Burns

Summary: the purpose of the study is to compare one type of dressing against the current standard dressing that is used to cover the unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned. hypothesis: the mean healing time for wounds treated with the dermafill dressing will be less than the mean healing time for wounds treated with xeroform dressing.

at the time of the procedure, donor sites that are symmetrical in size and shape will be selected. the donor sites will be harvested. once the grafts have been harvested, the wounds will be randomized for treatment using either the dermafill dressing or xeroform. the wound dressings will then be observed at least once a day beginning post op day 2/48hours after surgery until healed, which is defined as 90% or more of the wound surface is confluently re-epithelized.

Eligibility criteria:
inclusion criteria: * 18 years or older; male or female. * burn wounds less than 30% of total body surface area (tbsa) with no systemic abnormalities * burns do not involve the harvesting area * burn wounds require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas * scheduled excision and grafting procedure is the first such operation for subject during this hospitalization * subject agrees to participate in follow-up evaluations exclusion criteria: * critical illnesses requiring ventilator support, systemic infection or hemodynamic instability * major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder) * subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). the use of anticoagulants does not include deep venous thrombosis (dvt) prophylaxis. * cellulitis or other infection of potential donor site * previously harvested donor site * subjects with greater than 30% tbsa burns * pregnancy

Keywords: burns donor site care dermafill dressing