Kornimate/medical-research-clean huggingface dataset:
exploration of genotype based personalized prescription of valproate sodium in anti-epileptic treatment

Conditions: Epilepsy; Adverse Effects

Summary: the purpose of this study is to investigate the relationship between the side effects of valproate sodium in the treatment of epilepsy in han chinese and the genetic polymorphisms of drug metabolizing enzymes and pharmacokinetics of valproate sodium.

valproate sodium is a widely applied agent in the treatment of epilepsy. although valproate sodium is effective in clinic, it is able to induce several side effects, including weight gain, thinned hair, loss of appetite, nausea, vomiting, hepatotoxicity, hematotoxicity, thrill, etc. however, the remarkable variability of the reactions to the drug -- the incidence of side effect or the outcome of the treatment -- has been observed among patients. valproate sodium is metabolized by some enzymes in the liver to transform it into several unreactive chemicals for excretion. among them there are two toxic metabolites catalyzed by the specific metabolic enzymes. this study is designed to explore the genetic variation among individuals in the key processes of the deactivation and elimination of valproate sodium in order to find out whether these genetic factors are associated to the side effects or efficacy. the further understanding into the factors concerning on the drug might imply possible solution to minimize the incidence of side effects in epileptic patients.

Eligibility criteria:
inclusion criteria: * the patients must have been diagnosed as epilepsy according to the international league against epilepsy (ilae) criteria published in 2001. * the patients must sign the informed consent. and for the patients who are under 18 years old, both the signatures of their legal guardians and that of the patients are required on the written informed consent. * the patients are receiving the regimen of 15-30mg/kg valproate sodium given as daily oral administration. exclusion criteria: * pregnant women, women in breast-feeding period and the women who refuse to take contraception measures during treatment. * patients with poor compliance. * patients who have blood transfusion during the therapy.

Keywords: epilepsy valproate sodium metabolic enzymes adverse effects systemic adverse effects
piroxicam premedication for postendodontic pain in non-vital mandibular molars

Conditions: Non-Vital Tooth

Summary: the aim of the study is to evaluate the effect of piroxicam (20mg) compared to placebo on post-endodontic pain of single-visit endodontic treatment of non-vital mandibular molars.

* patients will be clinically and radiographically examined and their eligibility will be assessed. eligible patients will be treated in one visit. * patients will be randomly assigned to one of 2 groups: experimental group (premedication with 20 mg of piroxicam) and the control group (premedication with placebo). each participant will receive a standard inferior alveolar nerve block injection. after endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication. * postendodontic pain intensity and incidence at the different pain categories (no, mild, moderate, severe) will be assessed 6, 12, 24, 48, 72 hours and 7 days postoperatively using a 0-10 numerical rate scale (nrs). analgesic intake throughout the 7 days will be recorded.

Eligibility criteria:
inclusion criteria: 1. patients aging between 18-50 years old 2. patients with mandibular molar with non-vital pulp. 3. systemically- healthy patients (asa i or ii). 4. patients who agree to attend for recall appointments and provide a written consent. exclusion criteria: 1. pregnant or lactating female patients. 2. patients allergic to piroxicam. 3. history of peptic ulceration. 4. periapical abscess, fistula. 5. non-restorable teeth. 6. moderate or severe marginal periodontitis i.e. pocket probe\>3mm.

Keywords: piroxicam postendodontic pain analgesic intake
a novel analgesia technique for acl reconstruction

Conditions: Anterior Cruciate Ligament Injury

Summary: a comparison of two anesthetic techniques-- the adductor canal block (acb) and the adductor canal block with infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (acb/ipack)-- in patients undergoing bone-tendon-bone (btb) anterior cruciate ligament (acl) reconstruction.


Eligibility criteria:
inclusion criteria: * patients undergoing btb acl reconstruction with participating surgeon * age 13 or greater * planned use of regional anesthesia * ability to follow study protocol * english speaking (secondary outcomes include questionnaires validated in english only) exclusion criteria: * hepatic or renal insufficiency * younger than 13 years old * patients undergoing general anesthesia * allergy or intolerance to one of the study medications * bmi \> 40 * diabetes * american society of anesthesiology (asa) score iv * chronic gabapentin/pregabalin use (regular use for longer than 3 months) * chronic opioid use (taking opioids for longer than 3 months, or daily morphine equivalent of \>5mg/day for one month) * non-english speaking
laser trial. laparoscopic elective sigmoid resection following diverticulitis - a multicenter, prospective, randomized clinical trial

Conditions: Diverticulum; Colon, Sigmoid

Summary: the purpose of this study is to find out whether elective sigmoid resection will improve quality of life compared to conservative treatment with lifestyle guidance and fiber supplement in patients with a recurrent or complicated diverticulitis.


Eligibility criteria:
inclusion criteria: * recurrent left colon diverticulitis (minimum 3 within 2 years, at least 1 confirmed with ct) or * earlier complicated left colon diverticulitis or * prolonged (over 3 months) pain or disturbance in bowel habits after a ct-confirmed left colon diverticulitis exclusion criteria: * multimorbidity that prevents elective surgery * contraindication to laparoscopy * colonic stricture * fistula (e.g. colocutaneous, colovaginal, colovesical) * active malignancy * earlier resection of sigmoid colon or rectum * acute diverticulitis that has not settled * colonoscopy/sigmoidoscopy/virtual colonoscopy not performed within 2 years * age \ 75 years * pregnancy * inability to answer health surveys (e.g. dementia, psychiatric condition)
a bioequivalence study of two different peg-rhgh preparations.

Conditions: Pediatric Growth Hormone Deficiency (PGHD)

Summary: the purpose of this study is to investigate whether peg-rhgh with new preparation is bioequivalent to peg-rhgh with present preparation.


Eligibility criteria:
inclusion criteria: * healthy male aged ≥18 years old and≤45 years old; * the body mass index (bmi): 19-26 kg/m2 (inclusive), and body weight ≥50 kg; * normal results of physical examination, vital signs, laboratory tests, 12 lead-ecg, chest x-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above. exclusion criteria: * subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing; * subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or other diseases deemed unsuitable for participation in the trials by the investigators; * subjects with severe infection, severe trauma, or major surgery prior to screening; * subjects who have received blood transfusions, had blood donors, or lost blood before screening; * subjects who have positive results of human immunodeficiency virus antibodies (hiv-ab), or hepatitis b surface antigen (hbsag), or hepatitis c virus antibodies (hcv-ab), or syphilis specific antibodies (tppa); * subjects who have participated in clinical trials for medication or medical device prior to screening;etc.
effect of genetic and epigenetic factors on the clinical response and toxicity to doxorubicin among egyptian breast cancer patients

Conditions: Breast Cancer

Summary: recent advances in technologies, such as microarray and high-throughput sequencing, represented a deeper understanding of molecular biology, especially noncoding rna (ncrna). it was found that there are only \<2 % of the total genome sequence as protein-coding genes while at least 98 % of the genome are transcribed into ncrna. in the past, non-protein-coding rnas were known as "transcription noise," but now it is obvious that ncrnas play a crucial regulatory role in cell differentiation and organism growth and metabolism.


Eligibility criteria:
inclusion criteria: * metastatic and localized breast cancer patients treated with doxorubicin among chemotherapeutic protocol. * measurable disease. * age of 18 years to 80 years. * the women of childbearing age must use an effective contraception for the duration of the study. exclusion criteria: * breast cancer patients who had undergone radiotherapy or chemotherapy. * pregnant and lactating females. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to chemotherapeutic agents used. * any other medical or psychiatric condition or severe or chronic laboratory abnormality making the inclusion of the patient in the study inappropriate in the opinion of the investigator.

Keywords: doxorubcin breast cancer cardiotoxicity gene polymorphism
efficacy of administration of somatostatin in the prevention of post-endoscopic retrograde cholangiopancreatography (ercp) pancreatitis

Conditions: Acute Pancreatitis

Summary: acute pancreatitis is the most frequent (5-10%) and severe complication after endoscopic retrograde cholangiopancreatography (ercp), that could require of surgical intervention and lead to death. a double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ercp procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ercp pancreatitis. patients submitted to ercp will be randomized in two groups of treatment, one will receive somatostatin and another placebo. the main aim of this study will be the incidence of acute post-ercp pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ercp pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. the study will include 510 patients submitted to an ercp during a period of 3 years.

a double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ercp procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ercp pancreatitis. patients submitted to ercp will be randomized in two groups of treatment, one will receive somatostatin and another placebo. the main aim of this study will be the incidence of acute post-ercp pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ercp pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. the study will include 510 patients submitted to an ercp during a period of 3 years.

Eligibility criteria:
inclusion criteria: 1. patients undergoing therapeutic endoscopic retrograde cholangiopancreatography (ercp). exclusion criteria: 1. pregnancy or history of allergy to somatostatin. 2. acute myocardial infarction within 3 months of the procedure. 3. acute pancreatitis in patients undergoing early ercp in the acute phase of the disease. 4. previous sphincterotomy. 5. chronic pancreatitis.

Keywords: acute pancreatits
nutrition education to promote calcium intake among 30-65 year-old women in vietnam

Conditions: Osteoporosis

Summary: osteoporosis is an important public health problem in vietnam, with one in ten vietnamese women suffering from it. there is enough evidence demonstrating that low calcium intake is one of the risk factors for osteoporosis among asian women in general and vietnamese women in specific. it is reported that the intake of calcium among vietnamese women is under 400 mg/day, which is less than the daily recommendation of 1,000 mg/day by the vietnam national institute of nutrition, even though calcium-rich foods are largely available in vietnam. therefore, the purpose of this study is to promote dietary calcium intake among vietnamese women aged 30-65 years through implementing a nutrition education intervention.

vietnamese women aged 30-65 years without medical problems that could interfere with the calcium consumption, such as kidney stone, kidney and liver diseases. the women will be excluded if they are blinded, deaf, or have general learning disability. outcomes of the study are dietary calcium intake, calcium knowledge, and osteoporosis health belief. a quantitative questionnaire is being used to collect these data.

Eligibility criteria:
inclusion criteria: * women aged 30 to 65 years exclusion criteria: * have medical conditions that can interfere with calcium intake, such as physician-diagnosed kidney stone, kidney and liver diseases, etc. * blind, deaf, and have general learning disability

Keywords: nutrition education nutrition intervention calcium intake calcium-rich foods
impact of 50% nitrous oxide inhalation on pain and anxiety induced by lumbar puncture: a double-blind randomized controlled trial

Conditions: Lumbar Puncture

Summary: this study is designed to evaluate the analgesic effect of nitrous oxide (n2o) on the pain induced during lumbar puncture.

nitrous oxide (n2o) has analgesic and anxiolytic properties that are known for more than a century. nonetheless, it's use during lumbar puncture in adults has never been investigated properly. thus, this study is designed to evaluate the analgesic effect of n2o on the pain induced during lumbar puncture. patients with scheduled lumbar puncture realized for diagnosis purposes will be randomized in 2 groups. one group will inhale n2o for the 5 minutes before the puncture and during the rest of the procedure. the second group will inhale compressed air during the same period of time. neither the investigator realizing the lumbar puncture, nor the patient will know which type of gaz they are inhaling (double-blinding). the maximal pain level that occurred during the procedure will be evaluated on a numerical rating scale (nrs). nrs will also be used to evaluate the maximal anxiety induced by the procedure.

Eligibility criteria:
inclusion criteria: * patients coming in the neurology department for a scheduled lumbar puncture * 18 to 60 years. * no previous use of nitrous oxide exclusion criteria: * contra-indication to nitrous oxide use * body mass index\>35 * mini mental state examination \<26/30 * temperature \>38°c * confusion * patient unable to communicate verbaly

Keywords: lumbar puncture adults nitrous oxide procedural pain procedural anxiety
trial of the impact of sibeprenlimab on immunoglobulin a nephropathy kidney tissue

Conditions: IgA Nephropathy

Summary: this is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin a nephropathy (igan) and demonstrate potential changes in response to sibeprenlimab.


Eligibility criteria:
inclusion criteria: 1. participants must be at least 16 years of age or older at the time of signing the informed consent/assent. 2. source-verified kidney biopsy confirmed diagnosis of igan. 3. participant has estimated glomerular filtration rate (egfr) \> 45 ml/min/1.73 m2 using serum creatinine (chronic kidney disease-epidemiology collaboration \[ckd epi\] creatinine egfr 2021 equation for those 18 years and older; chronic kidney disease in children under age 25 \[ckid u25\] egfr equation for those younger than 18 years) exclusion criteria: 1. participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab. 2. participant has coexisting chronic kidney disease, other than igan. 3. participant has a serum igg value \<600 mg/dl at screening. 4. participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note: topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed). 5. participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmhg or diastolic blood pressure \> 90 mmhg). 6. participants who would be likely to require prohibited concomitant therapy during the trial.
comparison of nevirapine and efavirenz for the treatment of hiv-tb co-infected patients (anrs 12146 carinemo)

Conditions: Tuberculosis; Aids; Hiv Infections

Summary: the purpose of this study is to determine whether the use of nevirapine in hiv patients already treated against tuberculosis by rifampicin is as efficient and as well tolerated as efavirenz.

anti retroviral therapy (art) reduces tuberculosis (tb) incidence in hiv-infected patients and reduces mortality among tb patients with deep immune suppression. the fixed drug combination (fdc) nevirapine (nvp)-lamivudine-stavudine is the first line art available for low-income countries. rifampicin (rmp), due to its liver induction effect, reduces significantly nvp plasma concentration, raising concerns regarding the risk of resistance and subsequent treatment failure. therefore, in co-infected patients, who recommends delaying art or using efavirenz (efv)-based art. although efv is also reduced at lower level, longitudinal studies report good efficacy and safety when given concomitantly with rmp. in low-income countries, poor access to efv, contradiction during pregnancy and absence of fdc containing efv lead to difficulties in hiv-tb treatment. despite 2 limited retrospective studies and a non-randomised prospective study, which report good virological response at 6 months in co-infected patients receiving nvp and rmp co-administration, existing data are too limited to change the recommendation. the aim of the study is to compare, in terms of therapeutic efficacy and clinical safety, the nevirapine-based haart to the standard efavirenz-based haart, in hiv/tb co-infected patients receiving a rifampicin-based tb treatment. the study will evaluate one year after tb treatment initiation, whether the haart efficacy (virological outcome, death or lost of follow-up) induced by nvp-based haart is non-inferior to those induced by efv based haart, in patients receiving concomitantly haart and rmp-based tb treatment.

Eligibility criteria:
inclusion criteria: * person hiv infected * aged of 18 years or more * signed informed consent * new case of tuberculosis: patient who never received tb treatment or for less than 1 month * patients receiving rifampicin based tb regimen since 4 to 6 weeks * cd4 cell count \< 250 cell/mm3 in the 4 weeks following the tb diagnosis * naïve of haart * for women of childbearing age, to have a negative plasmatic test for pregnancy and to accept to take a contraception or declare no wish of pregnancy in the coming year. exclusion criteria: * to have a positive plasmatic test for pregnancy * karnofsky score \<60% * alat \> 4n (hepatitis grade 3 or 4) * ongoing psychiatric pathology * refuse to participate in the study amendment : * bilirubin \> grade 3 * any grade 4 clinical sign or biological result at time of inclusion

Keywords: drug interactions treatment naive
a study that uses data from routine eye examinations of patients participating in studies fidelio-dkd and figaro-dkd to explore whether finerenone can delay the progression of a diabetes complication that affects the eyes (diabetic retinopathy, dr)

Conditions: Diabetic Retinopathy

Summary: diabetic retinopathy (dr) is a diabetes complication caused by damage to the small blood vessels inside the retina at the back of the eye. diabetic retinopathy may cause mild vision problems or eventually blindness. diabetes is a condition that makes your blood sugar levels higher than they should be. in the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy (npdr)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina. this damage results in small outpouchings of the vessel lumens leading to rupture. at the same time the blood vessels can leak and making the retina swell and can cause so called macula edema. in these early stages of dr current treatment to reduce the risk of this eye complication is focused on controlling blood sugar levels and blood pressure. participants in this study have npdr, type 2 diabetes (t2d) and chronic kidney disease (ckd), a condition in which the kidneys become damaged and do not work as they should. these participants are already taking part in one of the phase 3 studies (fidelio-dkd and figaro-dkd). they study the effect of finerenone on delaying kidney disease progression and reducing the risk of events that may cause damage to the heart and blood vessels to learn more about the effect of finerenone on diabetic retinopathy, data from routine eye examinations performed during the two phase 3 studies will be collected and analyzed. all male and female participants included in this study are at least 18 years.


Eligibility criteria:
inclusion criteria: * signed informed consent to participate in definedr * included in fidelio-dkd or figaro-dkd, and with dr as medical history * documented npdr in at least one eye, as documented by ophthalmological records within 6 months prior to baseline in fidelio-dkd or figaro-dkd, and up to one month after baseline in fidelio-dkd or figaro-dkd * an ophthalmological assessment available 6 month before or maximum 1 month after the baseline examination in fidelio-dkd or figaro-dkd, and at least one additional assessment afterwards. exclusion criteria: * participants with pdr, macular edema or anterior segment complications present at baseline in fidelio-dkd or figaro-dkd in at least one eye. * participants with any documentation of prior or planned retinal laser treatment, intravitreal injection or vitrectomy at baseline in fidelio-dkd or figaro-dkd in at least one eye. * participants with any other retinal disease documented at baseline in fidelio-dkd or figaro-dkd in at least one eye that would likely interfere with the study objectives (e.g. neovascular age-related macular degeneration or retinal vein occlusion).
study effect of via-2291 on vascular inflammation

Conditions: Coronary Artery Disease

Summary: this is a dose ranging study to compare the effect of via-2291 vs. placebo on various inflammatory biomarkers in patients with recent acute coronary events

this is a phase ii, randomized, double-blind, placebo-controlled study of the effect of via-2291 on atherosclerotic vascular inflammation

Eligibility criteria:
inclusion criteria: * female patients are to be of non-childbearing potential * patient has suffered an st elevation myocardial infarction (mi), non-st elevation mi, or unstable angina 21 days (±3 days) prior to study randomization * patient has documented coronary artery disease exclusion criteria: * renal insufficiency defined as creatinine \>1.5 x upper limit of normal (uln) * cirrhosis, recent hepatitis, alt \>1.5 x uln or alt \> 1 x uln and at least one other liver function test * uncontrolled diabetes mellitus within 1 month prior to study screening * congestive heart failure (chf) defined by the new york heart association as functional class iii or iv * previous coronary artery bypass graft (cabg) surgery * planned additional cardiac intervention * recurrence of st elevation mi, non-st elevation mi, or unstable angina less than 18 days prior to randomization * current atrial fibrillation, atrial flutter, or frequent premature ventricular contractions * acetaminophen use in any form in the 7 days before enrollment