Kornimate/medical-research-clean huggingface dataset:
melatonin versus placebo in the lennox-gastaut syndrome: neurophysiological and neuropsychological effects

Conditions: Lennox-Gastaut Syndrome

Summary: lennox-gastaut syndrome is a severe epileptic encephalopathy of childhood. in that syndrome, various type of seizure occur, mainly tonic seizures, atonic seizures and atypical absences. the tonic seizure occur mostly at night. the hypothesis is that the melatonin could have a positive effect in that syndrome, by reducing the epileptic activity (assessed in the polysomnographic record by counting the number of interictal and ictal discharges) and stabilizing the structure of sleep. the study is double blind, randomised, cross-over designed.

the aim of the trial is to study the efficacity of melatonin in the lennox-gastaut syndrome, by assessing the reduction of the seizure/interictal discharges in polysomnography and assessing the sleep structure. after initial recruitment, the baseline visit includes a polysomnography. the patients will then be randomised in two groups: melatonin (1 cp containing melatonin 2 mg 1x/d 1h before sleep) vs placebo (1 cp 1x/d 1h before sleep). the treatment (melatonin or placebo) will be given for 1 month. after 1 month, the treatment will be stopped and another polysomnography will be recorded. the patients will take no treatment (wash-out period) for 15 days. the second treatment phase is cross-over: the group that had melatonin in the first phase will take placebo for one month, and the group that had placebo in the first treatment phase will take melatonin for one month. a last polysomnography will be recorded after the second treatment phase. the other medications (antiepileptic drugs) taken by the patients before the trial will not be modified.

Eligibility criteria:
inclusion criteria: * lennox-gastaut syndrome (based on ilae classification, 1989) * light mental retardation (qi 50-69) * french mother tongue * having someone helping the patient (parent and/or referent educator) * informed consent have been given by the patient / guardian * absence of concomitant evolutive affection or associated sleep pathologies * collaboration of the patient, ability to complete all aspects of the trial. exclusion criteria: * epileptic syndrome other than lennox-gastaut, other neurologic and/or psychiatric disease * moderate to severe mental retardation (qi \< 50) * psychiatric disease that could interfere with the diagnostic procedure * specific sleep disorder (anamnestic and diagnosed on the polygraphic record), for example: sleep apnea syndrome, narcolepsy, restless legs syndrome, periodic legs movements, etc...

Keywords: lennox-gastaut syndrome epileptic encephalopathy melatonin tonic seizures interictal discharges quality of sleep
influence of triathlon on the electrolyte balance

Conditions: Hyponatremia

Summary: aim of the study is examining the incidence of the occurrence of hyponatremia during a triathlon

studies in similar endurance sports (e.g. marathon) could already indicate a high incidence for the appearance of hyponatremia during competitions. the loss of sodium through sweating and the excessive fluid intake during the competitions is a primary risk factor for the development of hyponatremia. based on the known occurrence of hyponatremia in marathon runners, participants of the ironman european championship between the years 2005 and 2014 were screened for the occurrence of hyponatremia after finishing the race for safety reasons. subjects were approached at random in the athlete's garden and invited to participate. all participants were 18 years or older.

Eligibility criteria:
inclusion criteria: * finisher of a long-distance triathlon * \> 18 years * \< 60 years exclusion criteria: * not finished a long-distance triathlon * \< 18 years * \> 60 years

Keywords: ironman triathlon
a study for patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: a multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with type 2 diabetes mellitus (t2dm). patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. the primary objective of this study is to test the hypothesis that ly2428757 given to patients with t2dm inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin a1c (hba1c) from baseline to endpoint at 12 weeks as compared to placebo. trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus for at least 6 months prior to entering the trial. * treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening. * have a glycosylated fraction of hemoglobin a (hba1c) value of 7.0% - 10.0% at screening * women of child-bearing potential must test negative for pregnancy at screening and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study. * have a body mass index (bmi) between 25 and 40 kilograms per square meters kg/m\^2) at screening * stable weight during the 3 months prior to screening. exclusion criteria: * use any antidiabetic agent other than metformin during the 2 months prior to screening. * have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone bariatric surgery. * are currently taking prescription or over-the counter medications to promote weight loss. * have been previously diagnosed with pancreatitis * women who are breastfeeding. * have a history of myocardial infarction, unstable angina, coronary artery bypass graft (cabg), percutaneous coronary intervention, transient ischemic attack, stroke or decompensated congestive heart failure in the past 6 months. * have poorly controlled hypertension
lansoprazole intravenous 30 mg specified drug-use survey [hemostatic effect/rebleeding rate]

Conditions: Gastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions

Summary: the purpose of this survey is to evaluate the safety (i.e., frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (takepron intravenous 30 mg) to a large number of patients in daily medical practice.

this survey was designed to evaluate the safety (i.e., frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 mg (takepron intravenous 30 mg) to a large number of participants in daily medical practice. for adults, 30 mg of lansoprazole is typically mixed in physiological saline (jp) or 5% glucose solution for injection (jp) and administered twice daily by drip infusion or dissolved in 20 ml of physiological saline (jp) or 5% glucose solution for injection (jp) and administered twice daily by direct slow intravenous injection.

Eligibility criteria:
inclusion criteria: * patients with the following diseases for whom oral administration is not feasible: gastric ulcer, duodenal ulcer, acute stress gastritis, and acute gastric mucosal lesion (all of which should be accompanied by bleeding). exclusion criteria: -

Keywords: pharmacological therapy
phase iii multicenter double blind controlled trial of human immune globulin therapy in previously untreated patients with chronic inflammatory demyelinating neuropathy

Conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Summary: objectives: i. compare and evaluate the response to treatment with intravenous human immune globulin (ivig) or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy.

protocol outline: this is a double blind, randomized, controlled study. patients receive either intravenous human immune globulin (ivig) or placebo infused at a rate of 40 ml/hr, increasing every 30 min to a maximum of 100 ml/hr daily over 6 to 8 hours for 2 days. on day 2, infusions of ivig or placebo are delivered at the highest dose tolerated on day 1. on day 21, patients receive another ivig or placebo infusion. following day 42, patients may choose to continue infusions of ivig every 21 days for 2 doses. patients not receiving additional treatment are released from study. patients are evaluated on days 10, 21, and 43.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * chronic inflammatory demyelinating polyneuropathy (cidp) characterized by: progressive or relapsing disease or chronic stable course with elevated cerebrospinal fluid protein with normal cell counts acquired demyelination on electrophysiologic studies segmental demyelination on nerve histology --patient characteristics-- * not pregnant no significant medical disorders

Keywords: demyelinating neuropathy neurologic and psychiatric disorders rare disease
eus biliary drainage vs. ercp

Conditions: Biliary Obstruction

Summary: endoscopic ultrasound guided biliary drainage (eus-bd) is an evolving field that has grown in popularity in the management of malignant biliary obstruction. although endoscopic retrograde cholangio-pancreatography (ercp) with stent insertion has been the mainstay therapy throughout several decades, the transpapillary approach through tumor tissue is associated with significant risk for adverse events such as post-ercp pancreatitis and stent dysfunction from tumor tissue overgrowth and ingrowth. eus-bd, through the creation of a choledochoduodenostomy with a stent, has the potential advantage of avoiding the papilla and its associated complications while potentially improving stent patency with lower risks for tumor tissue ingrowth and/or overgrowth.


Eligibility criteria:
inclusion criteria: * radiological diagnosis (with or without pathological diagnosis) of borderline resectable, locally advanced, or unresectable malignant distal biliary obstruction at least 2 cm distal to the hilum. resectability based on tumor staging on axial imaging and surgeon evaluation. * elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (18.9 umol/l) * dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or us * confirmation of bile duct accessibility and size of at least 1.2 cm on endoscopic ultrasound * karnofsky index \> 30% * asa score \<iv * provision of informed consent exclusion criteria: * hilar obstruction (biliary obstruction \< 2 cm from the hilum) * uncorrectable coagulopathy and/or thrombocytopenia * age \< 18 * liver metastasis involving \> 30% of the liver volume * liver cirrhosis with portal hypertension or ascites * prior biliary sphincterotomy or stent placement * surgically altered anatomy * common bile duct measuring less than 1.2 cm will be excluded * patient with clinical and radiological evidence of gastric outlet obstruction

Keywords: eus ercp lumen apposing metal stent biliary drainage biliary obstruction pancreatic adenocarcinoma
tooth extraction in patients with atrial fibrillation in use of new oral anticoagulants

Conditions: Atrial Fibrillation; Periodontal Disease; Hemorrhage

Summary: the purpose of this study is to evaluate the safety of a protocol which does not suspend the new oral anticoagulants (dabigatran, rivaroxaban and apixaban) in front of dental extractions in patients with non-valvular atrial fibrillation.

the sample will be divided into three groups according to the pharmacokinetics of the oral anticoagulant: rivaroxaban 1x/day (group 1); dabigatran and apixabana 2x/day (group 2) and warfarin (control group). extraction of one to three teeth will be scheduled, in the valley of the new oral anticoagulants' concentration, considered the period of smallest haemorrhagic risk without suspension. in group 1 the surgery will be scheduled 14 hours after the last intake, in group 2 the surgery will be scheduled 8 hours after the last intake, while the control group will undergo the procedure with inr values between 2.0 and 3,0. hemostatic measures with tranexamic acid paste intra alveolar, suture and biological glue grf® (gelatin, resorcinol and formaldehyde) and post operative care will be associated. the patients will be contacted after the procedure to inform the presence or absence of late bleeding. the patient should return 24 hours later to evaluate the surgical site. this protocol is based on guidelines and scientific articles, pharmacokinetics and clinical experience of the authors.

Eligibility criteria:
inclusion criteria: * selection of patients: both genders, aged over 18 years, regardless of ethnicity, marital status, nationality, naturalness or profession, with non-valvular atrial fibrillation using dabigatran or rivaroxaban or apixaban or warfarin, under medical outpatient treatment or during the hospitalization period. * dentistry: patients with indications of exodontia of one to three permanent adjacent teeth erupted in the maxilla or mandible due to extensive dental caries or periodontal disease. exclusion criteria: * clinical: patients on concomitant use of antiplatelet agents or heparin, pregnant and lactating patients, with coagulation disorders, severe chronic renal insufficiency (crcl \<30), severe hepatopathies and proven to be allergic to lidocaine and / or epinephrine. * dentistry: odontophobic, edentulous, or healthy teeth; deciduous teeth and included teeth. * regarding the time of medication intake: regarding the time of medication intake patients taking rivaroxaban who routinely take the medication between 5:00 a.m. to 4:00 p.m. (unworkable schedule for surgery) that do not accept a change in the intake schedule suggested by the attending physician.

Keywords: dabigatran rivaroxaban apixaban warfarin tooth extraction
hemodialysis.-induced hypotension therapy for end stage kidney disease

Conditions: Hemodialysis Complication; Hypotension of Hemodialysis

Summary: bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. we and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced hypotension (dih) has not been evaluated. preliminary results from a pilot clinical trial showed that bradykinin b2 receptor blockade with icatibant prevents excessive blood pressure during hemodialysis. thus, in this study, we will test the overarching hypothesis that blockade plasma kallikrein with lanadelumab would ameliorate the reduction of blood pressure during hemodialysis in patients who are prone to dih. for this purpose, we will conduct a parallel arm, double-blind placebo-controlled trial, using lanadelumab to evaluate the occurrence of


Eligibility criteria:
inclusion criteria: * subjects age 18 to 85 years * on thrice-weekly hemodialysis for at least six months * clinically stable, adequately dialyzed (single-pool kt/v \> 1.2), with polysulphone membrane for at least three consecutive months before the study * subjects with pre-dialytic systolic blood pressure between 110 and 170 mmhg. * subjects with a reduction of systolic blood pressure during hemodialysis equal to or greater than 30 mmhg, with associated symptoms such as nausea, vomiting, muscle cramps, dizziness, or anxiety. * hypotensive episodes should occur four times or more in four weeks (12 hemodialysis sessions). exclusion criteria: * subjects with intradialytic hypotension that require the use of pharmacological intervention such as midodrine or vasopressin * subjects with pre-dialytic systolic blood pressure greater than 170 mmhg or diastolic blood pressure greater than 110 mmhg * history of myocardial infarction or cerebrovascular event within 3 months * history of serious hemorrhage (including cerebral hemorrhage) in the past 6 months * advanced liver disease * ejection fraction less than 30% * anticipated live donor kidney transplant * a history of poor adherence to hemodialysis or medical regimen * severe anemia (hemoglobin less than 8 g/dl) requiring blood transfusions * use of immunosuppressive drugs within one month before study enrollment * active connective tissue disease * history of acute infections disease within one month before study enrollment * inability to provide consent * pregnancy
a vasoconstriction study with leo 90100

Conditions: Psoriasis Vulgaris

Summary: the purpose of this study is to compare the pharmacodynamic activity of leo 90100 with dermovate® cream, dovobet® ointment, betamethasone dipropionate in leo90100 vehicle, synalar® ointment and leo 90100 vehicle using a human skin blanching test.


Eligibility criteria:
inclusion criteria: * following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out. * healthy male or female volunteers, 18 to 50 years old, both inclusive exclusion criteria: * female subjects who are pregnant or who are breast feeding. * abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type v and vi on the fitzpatrick scale)
impact of high dietary fiber on microbiome and vaccine responses

Conditions: Influenza

Summary: to learn if diet can enhance the microbes (such as bacteria and viruses) found in your gut and improve the body's immune response to the influenza (flu) vaccine.

primary objectives: --to determine the feasibility of two dietary intervention strategies focused on fiber-rich and prebiotic foods prior to seasonal influenza vaccination. feasibility is defined as ≥ 80% of subjects being compliant with the intervention. secondary objectives: * to evaluate the effects of each dietary intervention on the composition, diversity and function of the gut microbiome. * to assess the effects of each dietary intervention on response to influenza vaccination as measured by vaccine-specific immune response. * to assess the effects of each dietary intervention on systemic immunity. exploratory objectives: * to interrogate the overlap between the identified gut microbial and dietary patterns associated with vaccine response and those associated with excellent or poor responses to cancer immunotherapy (from our own published work and internal cohorts). * to identify components and determinants of the gut microbiome that could be modulated to enhance vaccine response. * to determine how modulation of the gut microbiome can be achieved through fiber and prebiotic-focused dietary changes.

Eligibility criteria:
inclusion criteria: 1. md anderson employees with existing mrns 2. body mass index (bmi) 18.5-40 kg/m2 3. age 18 or older 4. intends to receive the seasonal influenza vaccine at md anderson through employee health (starting fall of 2022) 5. willing to adhere to the provided dietary interventions 6. willing to provide blood and stool specimens, complete diet questionnaires and logs, and pick up food on-site within the study schedule 7. english-speaking 8. has easy access to a scale at home, work, or in their community exclusion criteria: 1. contraindication to the recommended annual influenza vaccine 2. medical contraindications to the intervention diet 3. major dietary restrictions (including vegetarian or vegan diets) or food allergies 4. unable or unwilling to undergo study procedures 5. has diabetes mellitus requiring medical treatment 6. has inflammatory bowel disease 7. has a history of bariatric surgery 8. has a history of major gastrointestinal surgery (not including appendectomy or cholecystectomy) 9. antibiotic use within 30 days of study initiation or planned antibiotic treatment during study course 10. habitual consumption of a high fiber diet 11. use of a supplement containing fiber/prebiotics/probiotics within 30 days of study initiation 12. women who are pregnant, planning to become pregnant, or who are lactating may not be included in this study

Keywords: microbiome flu fiber vaccination
effects of tourniquet applied during total knee replacement surgery on patient hemodynamics and blood table

Conditions: Primary Gonarthrosis

Summary: this study was planned to investigate the physiopathology of bradycardia and hypotension that occur in some patients with total knee arthroplasty (tka) between the ages of 65 and 90 years when the tourniquet, which is routinely used in patients with total knee arthroplasty (tka), is opened at the end of the operation and to determine the physiopathology of these effects of the tourniquet and how these effects can be prevented.

this study was planned to investigate the effects of lower extremity tourniquets routinely used in tdp surgeries on hemodynamics, spo2, etco2 and blood tables in male and female patients aged 65-90 years. in the patients included in the study, measurements from the monitor will be recorded and preop and postop hemogram, complete biochemistry, coagulation arterial blood gases will be recorded from each patient's file and the values before and after the tourniquet will be compared. new randomized prospective studies will be proposed by determining the physiopathological changes (reperfusion syndrome) that occur after opening the tourniquet in patients and evaluating how these changes can be prevented

Eligibility criteria:
inclusion criteria: * asa score: 1-3 * primary gonarthrosis exclusion criteria: * asa score 4 and above * the diagnosis of secondary gonarthrosis * concomitant rheumatological disorders * concomitant peripheral vascular disease * concomitant malignant disease * presence of organ failure * having active infection * use of immunosuppressive drugs * having addiction to cigarettes, alcohol or drugs * use of anticoagulation medicine * presence of metabolic disease * presence of renal disease * presence of familial hemophagocytic syndrome * being unwilling to participate the study
epicardial adipose tissue thickness and the related factors in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the aim of this study was to assess the eatt and the related factors in patients with as and to compare the results with that of the healthy controls'

the aim of this study was to investigate the epicardial adipose tissue thickness (eatt) and the related factors in patients with ankylosing spondylitis (as) and to compare the results with those of the healthy controls. this cross-sectional study comprised thirty patients diagnosed with as based on the modified new york criteria. the control group consisted of 31 healthy volunteers. demographic characteristics were recorded. eatt was measured via transthoracic echocardiography. bath ankylosing spondylitis disease activity index (basdai), bath ankylosing spondylitis functional index (basfi), bath ankylosing spondylitis metrology index (basmi), ankylosing spondylitis disease activity score (asdas), ankylosing spondylitis quality of life (asqol), international physical activity questionnaire short form (ipaq-short form) were used. functional capacity assessment was conducted using the six-minute walk test (6mwt).

Eligibility criteria:
inclusion criteria: * disease duration \>1 year, * being ≥18 years * as diagnosis according to modified new york criteria exclusion criteria: * being illiterate, * \>65 years, * history of ischemic heart disease, * cerebrovascular disease, * hypertension, * chronic kidney failure, * endocrinopathies like diabetes mellitus, * hypothyroidism, * cushing syndrome and primary hyperlipidemia.

Keywords: ankylosing spondylitis atherosclerosis epicardial adipose tissue thickness