Kornimate/medical-research-clean huggingface dataset:
cenobamate in adults with focal-onset seizures

Conditions: Epilepsy; Focal-Onset Seizure; Neurological Disorder

Summary: the bless study contributes to filling this information gap by collecting data from the italian clinical practice and the compassionate use program, to better characterize the clinical profile of cenobamate describing its effectiveness, safety and tolerability in adult patients diagnosed with uncontrolled focal epilepsy despite the use of at least two antiepileptic medicinal products.

the main objective of the study is to describe the effectiveness of adjunctive cenobamate treatment in adult patients with uncontrolled focal epilepsy in italy, overall and according to age class, setting of cenobamate treatment, cenobamate final target daily dose prescribed, and number of concomitant anti seizure medications (asms). this will be assessed by intra-patient percent change and achievement of a ≥50% reduction in the seizure frequency from the pre-treatment baseline over a period of 52 weeks.

Eligibility criteria:
inclusion criteria: * age ≥18 years at the time of cenobamate treatment initiation * male or female patients * patients diagnosed with focal epilepsy uncontrolled despite a history of treatment with at least two antiepileptic medicinal products at the time of cenobamate treatment initiation in agreement with the summary of product characteristics (smpc) * patients who at enrolment had received at least 12 weeks (titration period up to the initial recommended target dose of 200 mg daily completed) but no more than 52 weeks of cenobamate as adjunctive treatment of focal-onset seizures with or without secondary generalization * patients with available retrospective data in medical charts and seizure diaries, including information about baseline seizure frequency prior to cenobamate treatment initiation * patients who gave written informed consent to take part into the study and personal data processing consent following local regulation. * patients who received adjunctive cenobamate for at least 12 weeks and discontinued permanently treatment before enrolment will also be included in the study- exclusion criteria: * patients diagnosed with familial short-qt syndrome * patients affected by hypersensitivity to the active substance cenobamate or to any of the excipients (e.g., lactose monohydrate) * patients with history of severe drug-induced hypersensitivity reaction, including (but not limited to) drug reaction with eosinophilia and systemic symptoms (dress), and stevens johnson syndrome * patients enrolled in a clinical trial in which treatments for epilepsy are managed through a study protocol * patient unable to read and write in italian language and to autonomously fill in questionnaires and scales * patients with a known pregnancy or who are breast-feeding from cenobamate treatment initiation till enrolment visit.

Keywords: cenobamate real-word epilepsy focal-onset seizure observational focal epilepsy uncontrolled
effect of low glycaemic index diet on blood glucose control in chinese type 2 diabetic patients

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to investigate the effect of low glycaemic diet on blood glucose control in chinese type 2 diabetic patients.

glycaemic index (gi) is the measurement of post-meal blood glucose rise cause by ingestion of carbohydrate. for the same amount of carbohydrate, food with lower gi value cause a lower post- meal rise in blood glucose concentration in both normal and diabetic patients. meta-analysis of randomized controlled trial has showed that low gi diet can achieve an additional reduction of a1c by 0.4% when compare with usual diabetic diet. furthermore, various diabetes associations have already endorsed the use of low gi diet in the management of diabetes. hong kong chinese obtain most of their carbohydrate intake through consumption of rice or rice related foods, which are considered as having high gi value. in addition, it has been demonstrated that asian have higher post-prandial rise in blood glucose than caucasian after consuming the same amount of carbohydrate. when the above two factors add together, we expect our local type 2 diabetic patients are suffering from significant post-prandial hyperglycaemia, which in turn translate into elevated 24-hour hyperglycaemia and a1c. however, nearly all studies about glycaemic index and diabetes are conducted in caucasian. it is unclear about the benefit in chinese patients with type 2 diabetes who are currently having diet with high gi value. we therefore hypothesized that low gi diet may improve blood glucose control in chinese type 2 diabetic patients. to test this hypothesis, we plan to conduct this randomized controlled trial about low gi diet in chinese diabetic patients.

Eligibility criteria:
inclusion criteria: 1. chinese type 2 diabetic patient. 2. already performing self monitoring blood glucose ( smbg ) with pre- and post-meal readings. 3. at least 50% of 2hr post-meal capillary blood glucose values are \> 9 mmol/l. 4. a1c between 7.0 to 8.0% within 2 weeks of randomization. 5. next follow-up is scheduled to at least 12 weeks or more if currently follow-up in tweh. 6. on stable dose of anti-diabetic drug in the preceding 10 weeks. 7. no change in anti-dm drug in the next 10 week. 8. at least 18 years old. 9. can read and understand consent form written in chinese. 10. can give informed consent. exclusion criteria: 1. unexplained hypoglycaemia in last 4 weeks. 2. using rapid onset insulin ( such as humalog, novorapid, actrapid hm, mixtard hm, novomix and humalog mix ). 3. using acarbose. 4. anaemia. 5. known thalassaemia. 6. suspected or confirmed iron deficiency. 7. on warfarin. 8. renal impairment with serum creatinine \> 150 umol/l 9. active medical illness, such as hepatitis, malignancy, infection, inflammatory arthritis, etc. 10. unable to follow low glycaemic index diet. 11. currently participate in other study. 12. mentally or cognitively disable. 13. pregnant or lactating women. 14. hospital authority or tweh staff.

Keywords: diabetes mellitus chinese glycaemic index
aromatherapy for postoperative nausea and vomiting in children

Conditions: Postoperative Nausea and Vomiting

Summary: postoperative nausea and vomiting (ponv) is one of the most common postoperative complications of general anesthesia in pediatrics. pediatric rates of nausea and vomiting are approximately double those of adult patients. aromatherapy has recently been shown to reduce ponv in adults, but the effect in paediatric patients is unknown. the goal of this study is to determine the feasibility of a large-scale study in the paediatric population.

postoperative nausea and vomiting (ponv) is one of the most common postoperative complications of general anesthesia occurring after up to 40% of general anesthetics. ponv is an unpleasant experience and can result in secondary complications including wound dehiscence, electrolyte abnormalities and aspiration pneumonia. ponv often causes delayed stays in the postanesthesia care unit and delayed hospital discharge. the mechanism of ponv is poorly understood. given the multifactorial nature of nausea and vomiting, standard pharmacological therapy approaches the problem from various pathways. methods that include antihistaminic therapies such as dimenhydrinate (gravol), antiserotonergic medications such as ondansetron (zofran) and glucocorticoids (dexamethasone), have been used effectively in different surgical settings to address ponv. they do not work however, without occasional significant side effects such as urinary retention, blurred vision, increased infection rates, headaches and constipation. given that pharmacological interventions for ponv are not universally effective and have accompanying side effects, there has been recent interest in additional complementary interventions. aromatherapy has been used to treat nausea from motion sickness, pregnancy, cancer and pain. in postoperative adults, a recent large adequately powered randomized control trial found aromatherapy resulted in a significant risk reduction of nausea (0.37) when compared with saline. given the encouraging results of the first adequately powered adult study, the goal is to determine whether ponv is reduced by aromatherapy in the pediatric population. thus, the primary aim of this study is to determine if aromatherapy is more effective than placebo in the treatment of postoperative nausea in children as a complementary treatment to current postoperative practices. this research is important as it is the first study to assesses whether aromatherapy can be useful in postoperative nausea treatment for children. the implications of this study could mean an improvement in the health care experience of children who have nausea postoperation and potentially a reduction in rescue antinausea drug use in this population in the future.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) class i or ii * absence of neurodevelopment disorders * patient having elective day surgery exclusion criteria: * family or patient refusal * allergy or sensitivity to aromatherapy oils * inability to smell in the postoperative period

Keywords: aromatherapy
tadalafil for the treatment of raynaud's

Conditions: Raynaud

Summary: the investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary raynaud's phenomenon.

the primary goal of our study is to decrease the frequency, duration and severity of vasospastic attacks in patients with secondary raynaud's. the secondary goal is to document increased blood flow and lessened capillary dysfunction in these patients. both of these goals are to be achieved using a course of treatment with tadalafil.we anticipate a decrease in the frequency, duration and severity of raynaud's attacks. improved digital blood flow and digital blood pressures, and a decrease in digital capillary dysfunction.

Eligibility criteria:
inclusion criteria: * active raynaud's phenomenon * stable disease and medication requirements over the previous 2 months * subjects willing and able to participate in study assessments * ability to understand and sign informed consent * ages 18 to 65, both sexes * a diagnosis of diffuse or limited cutaneous sclerosis, mctd using the american college rheumatology criteria exclusion criteria: * uncontrolled htn, dm, unstable disease, angina or using oral nitrates * smoking, active alcoholism, drug abuse within 5 years * abnormal renal function * ulnar arterial occlusive disease as shown by a positive allen test * pregnant or breast feeding or considering preg. in next 4 months * past or present major psych. illness * allergy or sensitivity to tadalafil * subject unable to understand protocol or give informed consent * part. in another study trial within 30 days * taking sildenafil

Keywords: secondary raynaud's phenomenon
physical fitness and nutrition intake in bariatric surgery population

Conditions: Obesity

Summary: the purpose of this research study is to determine how bariatric surgery affects physical activity and nutrient intake. this research study is being done because the investigators want to determine better recommendations to provide to bariatric surgery patients.

this is a two-pronged study. the first phase is a cross-sectional study design meaning each participant will only be tested once. the investigators wish to test patients from each of the groups listed below to determine cr fitness, activity level, and nutrient intake. the investigators wish to determine if any improvements from bariatric surgery can be maintained over a 2-year period following surgery. if this is the case, our next project will be to track the patients recruited at their new visit longitudinally at all of the five time points listed below. 1. new visit with gi nutrition 2. 1 month prior to bariatric surgery (at the time of the patient's initial visit with the surgeon (6-7 months after their new visit)) 3. 6 months after bariatric surgery 4. 12 months after bariatric surgery 5. 24 months after bariatric surgery

Eligibility criteria:
inclusion criteria: * competent patients enrolled in the pre- or post-operative bariatric surgery program at the center for nutrition and weight management at gmc, danville, pa. * ability to perform a 6 minute walk test. * aged 18 through 70. * willingness to receive dietary recall phone calls and accessibility to a telephone. exclusion criteria: * patients with severe lung disease requiring oxygen therapy. * pulmonary embolus or pulmonary infarction. * patients with cardiopulmonary disease (e.g., prior myocardial infarction, coronary artery bypass, or vascular stent). * unstable angina. * uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise. * patients with any health reason that limits walking. * patients with a temporary injury that limits walking. * patients who use a wheelchair, other assistive device for walking, or have difficulty ambulating during activities of daily living. * patients predetermined to be illiterate or incompetent. * patients who are currently pregnant or have been pregnant at any time since bariatric surgery. * tobacco use. * patients with electronic defibrillators or other embedded electronic medical devices. * acute systemic infection, accompanied by fever, body aches, or swollen lymph glands * patients who have undergone revisional bariatric surgery.

Keywords: obesity bariatric surgery physical activity nutrition weight loss
an algorithm driven sepsis prediction biomarker

Conditions: Sepsis; Septic Shock; Severe Sepsis

Summary: a sepsis early warning predictive algorithm, insight, has been developed and validated on a large, diverse patient cohort. in this prospective study, the ability of insight to predict severe sepsis patients is investigated. specifically, insight is compared with a well established severe sepsis detector in the ucsf electronic health record (ehr).


Eligibility criteria:
inclusion criteria: * all adult patients admitted to the participating units will be eligible. exclusion criteria: * all patients younger than 18 years of age will be excluded.

Keywords: insight dascena
li-fraumeni & tp53 (lift up): understanding and progress

Conditions: Li-Fraumeni Syndrome; TP53 Gene Mutation; Hereditary Cancer Syndrome; Clonal Hematopoiesis; Mosaicism

Summary: the purpose of this research study is to learn more about variants in the tp53 gene both associated with li-fraumeni syndrome (lfs), a hereditary cancer risk condition, and tp53 variants found in the blood for other reasons (e.g. ace/chip and mosaicism).

this research study looks to enroll as many people with lfs or tp53 gene variants as possible in order to: * better estimate cancer risks in individuals with tp53 variants or lfs, which is a rare condition. * learn the range of cancer risks linked to tp53 variants to help individuals and families to improve our ability to counsel patients and families about cancer risks more accurately. * improve opportunities for cancer prevention, early detection, and treatment. * learn more about the meaning of tp53 variants in the blood that are not inherited (e.g. ace/chip and mosaicism). study procedures will include: * collecting information from the participant's medical record and short questionnaires. * collecting blood, saliva, eyebrow hair and tumor tissue samples (optional). * sharing study information with family members (optional). it is expected that about 1500 people will take part in this research study. participants will be in this study until it closes or the participant withdraws consent. the national cancer institute is providing funding for part of this study and is considered a study sponsor. they will require that some of the genetic information be made available to the research community without personal identifying information.

Eligibility criteria:
inclusion criteria: * individuals with a tp53 pathogenic or likely pathogenic variant identified in blood or saliva, * individuals with variants of uncertain significance in tp53 may be eligible at the pi's discretion, * blood relatives of individuals with a tp53 variant, who may be presumed obligate carriers or healthy controls, * individuals who meet classic or chompret lfs criteria whether or not they have a tp53 gene variant, * individuals may enroll their deceased relatives in the study. * individuals with a known tp53 variant that is not lfs, but rather ace, chip, or mosaicism. * individuals participating in other lfs studies can still enroll in lift up. investigators may be collaborators. exclusion criteria: * individuals who decline to sign consent * individuals who are unable to give consent or assent and are without a designated healthcare proxy

Keywords: li-fraumeni syndrome tp53 gene mutation (variant) hereditary cancer syndrome clonal hematopoiesis mosaicism
nivolumab and oral cyclophosphamide for r/r aml and high risk mds

Conditions: Acute Myeloid Leukemia; Higher Risk Myelodysplastic Syndrome

Summary: this is a phase ii trial of nivolumab and low dose cyclophosphamide (ctx) when given in combination to patients with relapsed/refractory acute myeloid leukemia (aml) and higher-risk myelodysplastic syndrome (mds) who are not eligible for or decline hematopoietic stem cell transplant. it includes a randomized pilot sub-study during stage 1.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * meets one of the following disease criteria: * primary (de novo) aml or higher-risk mds with induction failure: no cr after 2 or more induction attempts with high dose chemotherapy or hypomethylating agents or other agents; no cr after 1 induction attempt and not eligible for a 2nd induction.. higher risk mds defined as risk score \> 4.5 based on the revised ipss criteria. * secondary aml (from antecedent hematologic malignancy or treatment-related): not in cr after 1 or more cycles of chemotherapy. * relapsed aml: blasts ≥5% in bone marrow or peripheral blood after prior attainment of cr; relapse at any time but currently ≥100 days following allogeneic hct. * relapsed mds: morphologic evidence of relapse or increase in blasts ≥5% in bone marrow or peripheral blood after prior attainment of hematologic improvement; or partial or complete response ; relapse at any time but currently ≥100 days following allogeneic hct.. * ecog performance status ≤ 2 - refer to appendix ii * adequate organ function within 14 days of study registration defined as: * absolute lymphocyte count: ≥ 500 cells/mm3 * hepatic: total bilirubin ≤ 3 x upper limit of institutional normal (uln); alt and ast ≤ 5 x uln * renal: serum creatinine ≤ 2 mg/dl * pulmonary: no oxygen requirement on room air or requiring ≤ 2l supplemental o2 * sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and continuing (23 weeks for females, 31 weeks for males) after the last dose of nivolumab * voluntary written consent exclusion criteria: * pregnant or breastfeeding -the agents used in this study fall under pregnancy category d - drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days of study drug administration. * prior allogeneic hematopoietic stem cell transplantation within previous 100 days (note patients with a prior allohsct receive nivolumab at the reduced dose of 1 mg/kg) * signs or symptoms of active graft versus host disease * active pneumonitis or uncontrolled infection * received chemotherapy drugs within previous 2 weeks * estimated life expectancy \<28 days in the opinion of the enrolling investigator

Keywords: aml mds
morphological abnormalities of the olfactory bulb on mri and olfactometry in anosmic versus normosmic covid-19 patients

Conditions: Olfaction Disorders; COVID-19

Summary: olfactory and gustatory disorders are prevalent symptoms in european covid-19 patients. this study aimed to detect these disturbances among positive covid-19 patients (symptom not initially highlighted by the patient and not sought by caregivers) in order to allow early management of olfactory and gustatory dysfunction.

several medical teams have recently shown that disturbances of smell and taste are common and can be a precursor and even an isolated sign of covid-19 involvement. preliminary results suggest the presence of clinical mri abnormalities, particularly in the olfactory bulbs in anosmic patients with covid-19. anosmia and taste disturbance are early warning signs that could be important in improving the detection and diagnosis of covid-19, and also in monitoring disease. in addition, disturbances in smell and taste could be an aid in establishing the prognosis of the clinical course of the viral disease. the question of olfactory recovery is also fundamental. to date, we do not know the possibilities of recovery from covid-19 post viral anosmia. ent exams, olfactometry and mri are proposed to study these phenomena.

Eligibility criteria:
inclusion criteria: * patient aged 18 or over * patient with or without a sense of smell diagnosed with a positive covid-19 pcr test by nasopharyngeal swab in one of the investigation centers * patient who has already undergone cerebral mri and olfactometry, as part of their routine care, within 3 days of being diagnosed with covid-19+ or who agrees to undergo cerebral mri and olfactometry within 3 days of being diagnosed with covid-19+. * patient who signed a consent form * patient being affiliated to a health insurance plan exclusion criteria: * history of chronic rhino-sinusitis with or without polyp (s) * history of major craniofacial trauma that led to loss of smell * history of chronic sense of smell * diagnosis of parkinson's disease or alzheimer's disease * refusal to perform the 3 mris * refusal to participate in the study * pregnant, parturient or lactating woman * patient with contraindications to performing mri * patient not speaking or understanding french * patient deprived of liberty or under guardianship

Keywords: anosmia smell disorder covid-19 mri