Kornimate/medical-research-clean huggingface dataset:
aluminium foil as an adjuvant to phototherapy for pathological unconjugated hyperbilirubinaemia in full term infants

Conditions: Neonatal Jaundice

Summary: prospective single center pilot randomized open label clinical trial, conducted at the neonatal care unit of mansoura university children's to assess the efficacy and safety of aluminum foil use in combination with phototherapy compared with phototherapy alone for pathological unconjugated hyperbilirubinaemia in full term newborn we enrolled 234 infants in the study who fulfilled the inclusion criteria and were randomly assigned to treatment groups, either conventional phototherapy with aluminum foil or conventional phototherapy alone.


Eligibility criteria:
inclusion criteria: * appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinaemia who are candidate for photo therapy according to american academy guidelines exclusion criteria: * preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections
incorporation of allomaxtm in breast reconstruction ver8-15-12

Conditions: Breast Cancer

Summary: the purpose of this study is to measure the level of allomax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction. the hypothesis is that the allomaxtm will have incorporation equivalent to adjacent breast capsule at the 3-4 month time point.


Eligibility criteria:
inclusion criteria: * adult patients (18 - 70 yrs) who require reconstructive breast surgery with allomaxtm implants and agree to participate will be included in this study. exclusion criteria: * patients who do not agree to be included in the study.

Keywords: breast reconstruction hydroxyproline concentration neoangiogenesis collagen deposition
efficacy and safety of shr-3167 and insulin glargine in type 2 diabetes subjects

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the efficacy and safety of shr-3167 compared with insulin glargine after treatment in insulin naïve subjects with type 2 diabetes treated with metformin alone or in combination with sglt2 subjects.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent. 2. diagnosed with type 2 diabetes mellitus ≥ 6 months prior to the day of screening. 3. a stable dose of metformin alone or in combination with a stable dose of a sglt2 inhibitor for 3 months prior to screening. 4. body mass index (bmi): 18.5\~35.0 kg/m2. 5. hba1c of 7.5%\~10.0% as assessed by the local laboratory. 6. insulin naïve. 7. female subjects and partners of male subjects who are of childbearing potential, have no fertility plan and agree to take highly effective contraceptive measures within 6 months after signing the informed consent form to the last dose, and have no plans to donate eggs/sperm; female subjects of childbearing potential have a negative pregnancy test during the screening period and are not lactating. exclusion criteria: 1. electrocardiogram (ecg) results show clinically significant abnormalities that may affect the safety of the subject. 2. poor blood pressure control at screening. 3. diagnosis or suspicion of type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (lada)，other special types of diabetes or secondary diabetes mellitus. 4. ≥1 episode of severe hypoglycemia or asymptomatic hypoglycemia within 6 months prior to screening, or recurrent hypoglycemic events within 1 month prior to screening. 5. history of diabetic ketoacidosis or hyperosmolar hyperglycemic state due to hyperglycemia within 6 months prior to screening. 6. presence of acute or chronic hepatitis, cirrhosis, or other serious liver disease other than non-alcoholic fatty liver disease. 7. those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening. 8. malignancy or history of malignancy within 5 years prior to screening. 9. received any diabetes mellitus or weight-loss medication outside the inclusion criteria within 3 months prior to screening. 10. participation in a clinical trial of any drug or medical device within 3 months prior to screening. 11. any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.
validation of a smartphone app for anemia screening among general population

Conditions: Anemia

Summary: the current standard for anemia screening, complete blood count, presents invasiveness, infrastructure requirements and high costs, leading to serious underestimation of anemia prevalence and insufficient care for anemia patients. here, the investigators established and validated an artificial intelligence system to achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae. this system has been integrated into a smartphone app to be further validated through hospital-based and population-based clinical trials.


Eligibility criteria:
inclusion criteria: * patients should be aware of the contents and signed for the informed consent. exclusion criteria: * patients who underwent ophthalmic or fingernail surgery in the past 30 days

Keywords: smartphone app artificial intelligence public health
pharmacokinetics and safety of tigecycline in the treatment of clostridium difficile associated diarrhea (cdad)

Conditions: Diarrhea; Clostridium Difficile

Summary: this is a prospective, non-comparative, interventional, observational pilot study of the safety and pharmacokinetics of intravenous (iv) tigecycline in conjunction with standard oral therapy in patients with known mild to severe confirmed clostridium difficile associated diarrhea (cdad).

the intervention is adding tigecycline (standard doses) to standard oral therapy for cdad. patients will then be observed for clinical outcomes and relapse of cdad.

Eligibility criteria:
inclusion criteria: * non pregnant adults (≥18 years old) with a diagnosis of mild to severe cdad (initial or recurrent) by positive c. difficile toxin assay along with clinical symptoms (watery stools, fever, abdominal pain). patients will receive a minimum of 3 days of tigecycline. exclusion criteria: * pregnant patients * allergy to tetracycline (or tigecycline) antibiotics or patients with life-threatening illness.
nurse anesthesist assessment of patient preoperative anxiety

Conditions: Anxiety; Anesthesia, General

Summary: preoperative anxiety is a major concern for patients who undergo surgery. to accurately identify anxious patient is therefore crucial to improve perioperative patient care. preoperative anxiety remain highly difficult to quantify in current practice. many patient fail to express their anxiety and the assessment of the level of anxiety is mainly based on heteroevaluation by caregivers. nurse anesthetists provide closed support to patient prior to the induction of anesthesia. the aim of the study is to assess whether nurse anesthetist accurately assess patient preoperative anxiety from arrival to the operating room to the induction of anesthesia.

evalanxi is a single-center prospective observational study. the main objective of the study is to assess whether the assessment of preoperative anxiety by nurse anesthetist (hetero-assessment) accurately estimate the level of anxiety reported by the patient from arrival to the operating room to the induction of anesthesia (self-assessment).

Eligibility criteria:
patient inclusion criteria: * age \> 18 years old * patients with asa 1, asa 2 ou asa 3 * patients undergoing planned surgery with general anesthesia patient exclusion criteria: * age \<18 * refusal, inability to oral consent * cardio-thoracic surgery or emergency surgery * patient with dementia, medically diagnosed psychiatric disorder, inability to answer questions nurse anesthetist inclusion criteria: * nurse anesthesis in charge of the corresponding patient nurse anesthetist exclusion criteria: * assessment of the preoperative anxiety of a previously included patient

Keywords: preoperative anxiety concordance self-assessment assessment of anxiety nurse anesthesist hetero-assessment of anxiety
incidence of intracranial hypertension during liver transplantation estimated by non-invasive ultrasound methods.

Conditions: Liver Transplantation

Summary: acute or chronic liver failure (fulminant hepatitis or advanced cirrhosis) disrupts brain physiology. beyond classical hepatic encephalopathy, intracranial hypertension may occur.during liver transplantation (lt) surgery, many factors can lead to cerebral assault. in addition, intracranial hypertension measured with invasive methods has been described in certain phases of lt, especially at the time of reperfusion. the invasive monitoring of the intracranial pressure is not used in these patients, due to a high risk of infection and bleeding. the non-invasive monitoring of intracranial pressure has been widely developed in recent years : transcranial doppler and recently ultrasound of the optic nerve sheath (onsd) allow an effective detection of intracranial hypertension.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years * patients who underwent orthotopic liver transplantation * patients who have received clear information and not opposed to participate in the study * patients affiliated to a social security scheme or similar * patients not undergoing a measure of legal protection exclusion criteria: * opposition to participation in the study * patients \< 18 years * pregnant women or breastfeeding * deprived of individual liberty * non-affiliated to a social security scheme * known ophthalmic pathology: untreated cataracts, glaucoma

Keywords: intracranial hypertension liver transplantation transcranial doppler optic nerve sheath diameter
a phase iv study to assess the impact of the change of antiretroviral treatment from dual therapy to triple therapy on inflammation in patients with hiv infection

Conditions: HIV Infections

Summary: 242 patients (121 patients in each of the two treatment arms) will be included with a confirmed diagnosis of hiv-1 infection and with a stable antiretroviral treatment during more than 48 weeks with dual therapy (dtg + 3tc)


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years * confirmed and documented diagnosis of hiv-1 infection * virological suppression of more than 48 weeks (confirmed with hiv rna \<50 copies / ml). the determination of the cv of a routine prior analysis of ≤ 12 weeks prior to signature of consent. * art in stable dual therapy (\> 48 weeks) with dtg + 3tc * signed informed consent * negative pregnancy test in urine or blood exclusion criteria: * inability to obtain written informed consent to participate in the study * pregnant or breastfeeding women or those who intend to become pregnant during the study period and do not undertake to use proven contraceptive methods. * any suspicion or confirmation of resistance to taf, 3tc, ftc, dtg or bic. in case of have a study of baseline resistance mutations prior to the start of art has to rule out resistance to investigational drugs. * patients with hypersensitivity to any excipient used with taf, ftc, dtg or bic * any chronic autoimmune or inflammatory disease * use of immunomodulatory or immunosuppressive agents, including steroids chronic treatment with aspirin, statins and other anti-inflammatory agents * any acute infection in the last 2 months * estimated glomerular filtration rate (tfge) \<30 mg / ml / m2 measured by any of the formulas available. the determination of the tfge of a previous routine analysis of ≤ 12 weeks prior to signing the consent is allowed * contraindication for the use of taf * clinical condition of the patient in rapid deterioration or the investigator considers that there is no reasonable hope that the patient will finish the study * simultaneous participation in another clinical trial or research study that requires the need of treatment with other drugs outside the study or interfere with the visits of the same. * any situation that, in the opinion of the investigator, may interfere with the patient's ability to meet the treatment schedule and protocol evaluations
post-operative complications and graft survival with conventional versus continuous glucose monitoring in patients with diabetes mellitus undergoing renal transplantation

Conditions: Diabetes Mellitus

Summary: this will be a prospective, randomized, single-blinded controlled trial in which the investigators evaluate post-operative serum glucose control using conventional point-of-care glucose monitoring in the morning and before meals (standard of care) versus continuous glucose monitoring using the medtronic guardian™ sensor 3 continuous glucose monitor. the investigators will compare the average daily glucose level in the post-operative period (through post-operative day five) between the two arms in patients with diabetic nephropathy immediately post-renal transplant. this will serve as a pilot study to in order to power a main study.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 18 years or older 4. undergoing first-time renal transplantation 5. have a pre-existing diagnosis of type 2 diabetes mellitus exclusion criteria: 1. age less than 18 years 2. use of insulin pump at time of transplant 3. insulin infusion requirement during hospitalization 4. pregnancy or lactation 5. known allergic reaction to guardian™ sensor 3 or adhesives 6. history of hypoglycemia unawareness
diagnosis of congenital cmv infection in neonates who failed newborn hearing screening

Conditions: Congenital Cytomegalovirus Infection

Summary: universal hearing screening at birth by use of otoacoustic emission (oae) is now offered in most maternities in france to detect symptomatic hearing impairment at birth but screening of ccmv infection is not coupled with this screening. in this study, the feasibility of achieving before one month of age the diagnosis of congenital cmv diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.

congenital cytomegalovirus (ccmv) is the most frequent congenital infection in france. around 90% of ccmv infected infants are asymptomatic at birth, of whom 7 to 20% develop sensorineural hearing loss (snhl). ccmv explains at least 10% of all hearing loss cases in young children. early antiviral treatment (implemented before 1 month of age) with ganciclovir or valganciclovir can improve hearing outcome. in the absence of universal screening, ccmv remains largely undetected because most infected neonates are asymptomatic or have non-specific symptoms. when symptoms become apparent or develop, it may be too late for confirmation that the infection is of congenital origin becausediagnosis of congenital infection is based on the detection of cmv in samples collected within 2 to 3 weeks after birth. the presence of cmv in samples collected after this time may represent postnatal infection which does not carry the risk of hearing loss or neurodevelopmental sequelae. universal hearing screening at birth by use of otoacoustic emission (oae) is now offered in most maternities in france to detect symptomatic hearing impairment at birth but screening of ccmv infection is not coupled with this screening. in this study, the feasibility of achieving before one month of age the diagnosis of congenital cmv diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.

Eligibility criteria:
inclusion criteria: * all newborns who have failed universal newborn screening exclusion criteria: * neonates whose mothers would object to the use of their child's medical data

Keywords: congenital cytomegalovirus infection newborn universal hearing screening
study with a topical gel to treat common warts in adults

Conditions: Warts

Summary: the primary purpose of this study is to evaluate the effectiveness in adults of four different strengths of resiquimod gel applied to common wart(s) five times a week for four weeks. a second purpose is to evaluate the safety of the drug.


Eligibility criteria:
inclusion criteria: * diagnosis of common warts * two forms of birth control exclusion criteria: * pregnant or breast feeding * other types of warts, ie. plantar * currently participating in another clinical study * chronic viral hepatitis b or c

Keywords: warts adults common warts resiquimod
a study of epacadostat and nivolumab in combination with immune therapies in participants with advanced or metastatic malignancies (echo-208)

Conditions: Solid Tumors

Summary: the purpose of this study is to determine the safety, tolerability, and efficacy of epacadostat when given in combination with nivolumab and ipilimumab, and in combination with nivolumab and lirilumab, in participant with advanced or metastatic malignancies.


Eligibility criteria:
inclusion criteria: * during phase 1, participant with locally advanced or metastatic solid tumors with disease progression on or after treatment with available therapies, or who are intolerant to treatment, or who refuse standard treatment. * during phase 2, participant with advanced cancer who have received at least one prior therapy or are treatment naive, depending on the specified tumor type. * presence of measurable disease per recist v1.1. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * expected survival of ≥ 12 weeks. exclusion criteria: * laboratory and medical history parameters not within the protocol-defined range. * receipt of anticancer medications or investigational drugs within protocol-defined time frames. * previous radiotherapy within 7 days of cycle 1 day 1. * known active central nervous system metastases and/or carcinomatous meningitis. * prior treatment with any immune checkpoint inhibitor and/or an ido inhibitor. * active infection requiring systemic therapy. * any active or inactive autoimmune disease or syndrome

Keywords: epacadostat nivolumab ipilimumab lirilumab solid tumor melanoma non-small cell lung cancer (nsclc) squamous cell carcinoma of the head and neck (scchn) ido inhibitor
short-term effects kinesiology tape on sitting postural control in moderate and severe cerebral palsy

Conditions: Cerebral Palsy; Kinesiology Taping; Postural Control

Summary: to analyze the short-term effect of kinesiology taping on sitting postural control in moderate and severe cerebral palsy


Eligibility criteria:
inclusion criteria: * age between 4 and 14 years * diagnosis of motor and cognitive disability * have prescribed physiotherapy treatment at school * acquisition of autonomous sitting * sign the consent informed exclusion criteria: * presentation of an allergic reaction to tape * presentation of wounds in the area of application of the tape * having received botulinum toxin treatment in the last 6 months
effect of cgm with predictive alarm on hypoglycemia in young patients with t1d.

Conditions: Type 1 Diabetes

Summary: the use of continuous glucose monitoring (cgm) is becoming the new standard in glycometabolic control in patients with type 1 diabetes mellitus (t1dm) even in subjects in multiple daily insulin injections (mdi). compared to self-monitoring of blood glucose (smbg), the cgm systems allow continuous monitoring of the glycemic trends contributing to modify the therapeutic habits of adult and pediatric patients with t1dm and allowing to better managing of critical situations such as hypoglycemia. recently, the accuracy and reliability performance of the latest generation of cgms using predictive alarm for hypoglycaemia and hyperglycemia has been compared to other commercially available cgm systems, showing good levels of concordance. the use of this new technology, through the continuous monitoring of the pre-and post-prandial glucose levels and the evaluation of the glycemic trends, could influence the therapeutic habits of patients and could substantially contribute to modifying insulin therapy. furthermore, the presence of the predictive alarm technology for hypoglycemia could lead to reduce the number of hypoglycemic episodes and to modify the way these hypoglycemic episodes are managed; moreover, the use of this technology could improve the time spent in the target glycemic range \[time in range (tir), 70-180 mg/dl\] with possible improvement also in glycemic variability control.


Eligibility criteria:
inclusion criteria: * t1dm for at least 12 months \[assessed by positivity of at least one of the antibodies against islet cells (ica), insulin (iaa), glutamate dehydroxylase (gada), islet antigen 2 (ia2a), or zinc transporter 8 antibodies (znt8)\]; * mdi therapy from at least 6 months with basal-bolus treatment (long acting insulin analog plus rapid acting insulin analogue); * hba1c \< 9.0% * normal weight (bmi \<85th percentile for age and gender); * no other chronic diseases (thyroiditis, celiac disease, etc) or eating behavior disorders (dca); * signed informed consent from parents or legal guardians and patients (\<18 y). exclusion criteria: * t1dm for less than 12 months; * csii therapy * previous usage of cgm with predictive alarm for hypoglycemia or hyperglycemia * mdi therapy from less than 6 months * use of regular insulin instead of rapid acting insulin analogue; * other chronic diseases (thyroiditis, celiac disease, etc.) or eating behavior disorders (dca).
cenobamate in the intensive care unit

Conditions: Epilepsy; Neurologic Disorder

Summary: the cenobite study will be conducted as a multi-center trial involving x leading centers from the critical care eeg monitoring consortium (ccemrc). a total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. each site will obtain its own approval from their institutional review board. data will be shared through the mgb redcap; raw eeg files will be shared through the mgb dropbox and analyzed at the bwh. monitoring for the development of drug reaction with eosinophilia and systemic symptoms (dress) syndrome, a potential adverse reaction, will be a key aspect of the study. regular assessments, including regiscar scoring (a validated scoring system for dreess5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as dress syndrome.


Eligibility criteria:
inclusion criteria: * age 18-70. * undergoing eeg monitoring. * acute frequent seizures (\>1/hour) or status epilepticus (\>5 min of consecutive seizures, or seizure burden \>20% within past 1 hour). * adjunctive conventional antiseizure medication indicated. exclusion criteria: * history of medication-related rash. * on medication or device affecting enteral absorption (e.g., phenobarbital, pentobarbital). * counterindication to cenobamate as described in the prescribing information.

Keywords: icu