Kornimate/medical-research-clean huggingface dataset:
study of obeticholic acid（oca） combination with ursodeoxycholic acid (udca) in patients with primay biliary cirrhosis (pbc)

Conditions: Primary Biliary Cirrhosis

Summary: obecholic acid is a modified bile acid and farnesoid x receptor (fxr) agonist. fxr is a key regulator of bile acid synthesis and transport. bile acids are used by the body to help with digestion. conventional therapy with obecholic acid will improve liver function of patients with pbc.


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 to 75 years. 2. meet at least 2 of the following 3 pbc diagnoses: 1. patients had elevated alkaline phosphatase for at least 3 months before enrolment. 2. ama positive (titer ≥1:40), or if ama negative, pbc specific antibodies (anti- gp210 and/or anti-sp100 and/or ama-m2) are required. 3. liver biopsy suggested pbc 48 weeks before enrollment. 3. alp \> 1.67× uln before enrollment. 4. taking udca with stable dose for at least 3 months before enrollment. exclusion criteria: 1. merging with other virus infected. 2. with other existing liver disease or a history of liver disease. 3. with clinical complications of pbc or clinically significant hepatic decompensation. 4. child-pugh grade b or c. 5. creatinine (cr) ≥ 1.5×uln and serum creatinine clearance rate \< 60ml/min; \[calculation formula: cr:(140-age)×weight(kg) /0.818 × scr (μmol/l)，female cr=cr × 0.85\]. 6. alt or ast\>5×uln;tbil \> 2×uln. 7. patients with a history of severe pruritus 2 months before enrollment. 8. the presence of clinically relevant arrhythmias or associated history that may affect survival during the study period. 9. with diseases that may cause nonhepatic alp increases (e.g., paget's disease) or which may diminish life expectancy to \< 2 years.
study of alxn1210 in complement inhibitor treatment-naïve adult and adolescent participants with atypical hemolytic uremic syndrome (ahus)

Conditions: Atypical Hemolytic Uremic Syndrome (aHUS)

Summary: the purpose of the study is to assess the safety and efficacy of ravulizumab to control disease activity in adolescent and adult participants with ahus who had not previously used a complement inhibitor.


Eligibility criteria:
inclusion criteria: 1. male or female ≥ 12 years of age and weighing ≥ 40 kg at the time of consent. 2. evidence of thrombotic microangiopathy, including low platelet count, hemolysis (breaking of red blood cells inside of blood vessels), and decreased kidney function. 3. documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study drug. participants who received a meningococcal vaccine less than 2 weeks before initiating ravulizumab treatment must have received treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. participants who had not been vaccinated prior to initiating ravulizumab treatment should have received prophylactic antibiotics prior to and for at least 2 weeks after meningococcal vaccination. participants \< 18 years of age must have been vaccinated against haemophilus influenzae type b and streptococcus pneumoniae according to national and local vaccination schedule guidelines. 4. female participants of childbearing potential and male participants with female partners of childbearing potential had to use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab. exclusion criteria: 1. a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 deficiency (activity \< 5%). 2. shiga toxin-related hemolytic uremic syndrome. 3. positive direct coombs test. 4. pregnancy or breastfeeding. 5. identified drug exposure-related hemolytic uremic syndrome (hus). 6. bone marrow transplant/hematopoietic stem cell transplant within last 6 months prior to start of screening. 7. hus related to known genetic defects of cobalamin c metabolism. 8. systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome. 9. chronic dialysis (defined as dialysis on a regular basis as renal replacement therapy for end-stage kidney disease).
nitrous oxide for lumbar puncture

Conditions: Pain; Anxiety

Summary: lumbar puncture (lp) is a frequent exam that can cause pain and anxiety. in a pilot single-center study, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety (moisset et al., eur j neurol 2017). the goal of this multi-center trial is to confirm these results in a larger and more heterogeneous group of patients having a lp.

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 only been investigated in a single-centre study. 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 lumbar puncture * at least 18 * no previous use of nitrous oxide exclusion criteria: * contra-indication to nitrous oxide use * body mass index\>35 * mini mental state examination \<24/30 * temperature \>38°c * confusion * patient unable to communicate verbaly

Keywords: spinal puncture pain anxiety nitrous oxyde
aida2000 - risk-adapted therapy for patients with acute promyelocytic leukemia

Conditions: Leukemia, Promyelocytic, Acute

Summary: in aida 2000 therapy of acute promyelocytic leukemia (apl) is given in a risk-adapted manner. risk factors are age and white-blood-cell (wbc)-count at diagnosis. induction therapy is done with atra and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone in age adapted dosages. patients with an high wbc were additionally treated with cytarabine. finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and atra is performed.

in aida 2000 therapy of acute promyelocytic leukemia (apl) is given in a risk-adapted manner. risk factors are age and white-blood-cell (wbc)-count at diagnosis. induction therapy is done with atra and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone in age adapted dosages. patients with an high wbc were additionally treated with cytarabine. finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and atra is performed.

Eligibility criteria:
inclusion criteria: * acute promyelocytic leukemia confirmed by detection of t(15;17) and/or pml/rara * no contraindication for chemotherapy * written informed consent exclusion criteria: - severe comorbidities

Keywords: acute promyelocytic leukemia risk adapted therapy
irt in infants with intestinal perforation

Conditions: Intestinal Perforation; Necrotizing Enterocolitis

Summary: this study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk. analysis of perforation rates of all infants in the three largest participating sites shows that the majority of infants with perforation will do so prior to day of life 21. this study will target the group of infants at highest risk for ip, those with birth weight less than 1000 grams, within the time frame most likely to capture the perforation. hypothesis: an irt value exists that can adequately differentiate premature infants with and without intestinal perforation in the first 3 weeks of life.

at least 300 infants age 1-16 days will be enrolled. irt values will be obtained daily through day of life 21, if the infant is already having labs drawn that day. the primary outcomes will be intestinal perforation and/or death on or before day of life 21. each patient will be followed until death or discharge. discharge will be defined as the release of the infant to home. infants who are transferred to another nicu may be followed if the receiving nicu is one of the investigational sites. transfer includes the release of the infant to outside units or other units within the same hospital. the purpose of this follow up is to obtain serial irt values through day of life 21.

Eligibility criteria:
inclusion criteria: * informed consent * birth weight less than 1000 grams * admitted to investigative site within first 16 days of life. exclusion criteria: * evidence of intestinal perforation in utero * suspected or confirmed custic fibrosis * abdominal wall defect or intestinal atresia * concomitant medical condition that may create an unacceptable risk.

Keywords: immunoreactive trypsinogen nectrotizing enterocolitis premature infants serial irt
multicenter study of tetanus patients in fujian province of china

Conditions: Tetanus

Summary: background: tetanus is a life-threatening disease in developing countries, and accompanied by a high mortality rate. china is the world's largest developing country, and fujian province is a typical coastal province in china with a relatively developed economy. therefore, the purpose of this study was to investigate the epidemiology, incidence and management of tetanus in fujian province and to understand the current treatment and prognosis of tetanus patients in china. methods: this was a retrospective multicenter observational study of patients who presented with a clinical diagnosis of tetanus at 5 general hospitals in fujian. data was analyzed using computer software system.


Eligibility criteria:
inclusion criteria: * this study included all patients of all age groups and both sexes who presented with a clinical diagnosis of tetanus. exclusion criteria: * none.

Keywords: neonatal tetanus tetanus immunization program drug-induced tetanus antitoxin critical care medicine artificial airway
laparoscopic versus open left hemihepatectomy for liver benign lesions

Conditions: Benign Lesions in Left Liver

Summary: the purpose of this study is to investigate the influence of the laparoscopic and open left hemihepatectomy on acute surgical trauma and stress response.


Eligibility criteria:
inclusion criteria: * patient with benign lesions who requires left hemihepatectomy * child-pugh classification of a to b * american society of anesthesiologists (asa) grading of i to iii * a body mass index of between 18 and 35 * willingness to participate in the study * able to understand the nature of the study and what will be required of them exclusion criteria: * pregnant or lactating women * unwillingness to participate * child-pugh classification of c * asa grading of iv to v * with condition of acute inflammatory,fever or diabetes mellitus * with autoimmune disease or immunodeficiency * taking drugs that affect the immune system
pd-1 antibody expressing car-t cells for egfr family member positive advanced solid tumor (lung, liver and stomach)

Conditions: PD-1 Antibody; CAR-T Cells; Advanced Solid Tumor

Summary: objectives: to evaluate the safety and effectiveness of cell therapy using herincar-pd1 cells to treat relapsed or refractory cancer. eligibility: individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.

a total of 20 patients may be enrolled over a period of 1-2 years.

Eligibility criteria:
inclusion criteria: 1. age 18\~65 years old, male or female; 2. life expectancy≥6 months; 3. ecog score: 0-3; 4. advanced solid tumor (lung cancer, gastric cancer, liver cancer) were diagnosed by pathological or clinical physicians; 5. enough venous channel, no other contraindications to the separation and collection of white blood cells; 6. immunohistochemistry and rt-pcr technology will be used to determine the positive egfr family (including egfr, her2, her4) and igfr1 protein. at least one protein expressed in immunohistochemical tumor tissue should be no less than grade 2 or 2+ scores. the levels of protein are defined as follows: (according to cell staining) : grade 0: without staining; grade 1: 1-25%; grade 2: 26-50% and grade 3: 51-100%; (according to the intensity): negative; 1+; 2+ and 3+; 7. laboratory examination: white blood cell≥3 x 10\*9/l, blood platelet count≥60 x 10\*/l, hemoglobin≥85g/l; lymphocyte count≥15%, total bilirubin≤100 mol/l; alt and ast less than five times of the normal level; serum creatinine less than 1.5 times of the normal level； 8. signed informed consent； 9. women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion. exclusion criteria: 1. expected overall survival \< 6 months; 2. patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> class ii, nyha), or myocardial infarction within 6 months. 3. abnormal lung function: fev (forced expiratory volume) \< 30% prediction, dlco (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90%; 4. other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc; 5. unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Keywords: pd-1 antibody car-t cells egfr family advanced solid tumor
a block-and-replace therapy with osilodrostat and concomitant glucocorticoid replacement

Conditions: Endogenous Cushing Syndrome; Adrenal Insufficiency; Hypercortisolism

Summary: the major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach). the investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.

phase 1 (titration): participants will provide written informed consent and receive the first dose of osilodrostat (1-2 mg) in the evening. the following morning, participants will add treatment with at least a physiologic replacement dose of methylprednisolone (4-6 mg/d based on body size in not more than 2 divided doses) and concurrently continue 1-2 mg bid of osilodrostat. frequent communication is maintained with each participant, at least twice weekly for the first 3 months and weekly thereafter until target osilodrostat dose is reached. study personnel will ask targeted questions related to the primary endpoint with parameters to notify the study physicians for early signs of adrenal insufficiency. participants are instructed to double their methylprednisolone dose for intercurrent illness and for symptoms of cortisol deficiency or withdrawal that do not resolve with pausing osilodrostat dosing. every 4-12 weeks, an am cortisol, as well as a research sample for steroid profiling (including 11oha4), is obtained prior to the first doses of methylprednisolone and osilodrostat. the osilodrostat dose is up-titrated as necessary to achieve an am cortisol goal of \<5 µg/dl. once the am cortisol is at goal, a late-night saliva cortisol (lnsc) and 24 h urine free cortisol (ufc) is obtained per standard of care. osilodrostat titration is continued if necessary until the ufc is also at goal of \<10 µg/24h. once the am cortisol and ufc are at goals (\<5 µg/dl and \<10 µg/24h, respectively), the primary endpoint measures are completed, and the participant enters phase 2. phase 2 (maintenance): once the participant reaches what the investigator considers the maintenance doses of osilodrostat and methylprednisolone, participants are followed for a total of 48 weeks from the first osilodrostat dose before being considered at the end of study. the am serum cortisol, ufc, and lnsc are repeated at the end of the 48-week period and as clinically indicated throughout phase 2, generally every 3-6 months.

Eligibility criteria:
inclusion criteria: * endogenous cushing syndrome, either following surgery or not candidates for surgery * under consideration to receive osilodrostat as part of their clinical care * able to provide informed consent. exclusion criteria: * treatment with other investigational drugs within 30 days or five half-lives (whichever is longer). * a history of hypersensitivity to osilodrostat or therapies of a similar chemical class.

Keywords: osilodrostat glucocorticoid methylprednisolone medrol
rabeprazole extended-release 50 mg versus esomeprazole 40 mg for healing and symptomatic relief of moderate to severe erosive gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: the purpose of this study is to determine the safety and efficacy of rabeprazole extended release (er) 50 mg versus esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (gerd).

this is a multicenter, randomized, double-blind, double-dummy, parallel-group study. subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, rabeprazole er 50 mg or esomeprazole 40 mg for the treatment of moderate to severe erosive gerd.

Eligibility criteria:
key inclusion criteria: 1. male or female, ages 18 to 75 years. 2. history of gerd symptoms for at least 3 months immediately before screening. 3. heartburn for at least 2 days a week for at least 1 month before screening. 4. esophageal erosions of los angeles (la) grades c or d based on egd taken within 14 days prior to enrollment. 5. subjects who are h. pylori negative based on a screening test. 6. females should be either of non-childbearing potential or of childbearing potential. females of childbearing potential must have negative pregnancy tests prior to randomization. female subjects of childbearing potential must agree to use medically acceptable methods of contraception. 7. subjects must be able to read, write, and understand the language of the symptom diary. key exclusion criteria: 1. current or a history of esophageal motility disorders. 2. current or a history of barrett's esophagus. current esophageal strictures or esophagitis (known or suspected to be due to etiology other than gerd such as infection or medications). 3. current or a history of zollinger-ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer. 4. current or a history of cancer, with the exception of fully excised skin basal cell carcinoma. 5. inflammatory bowel disease. 6. unstable diabetes mellitus. 7. history of esophageal, gastric and duodenal surgery except simple suturing of an ulcer. 8. subjects who require daily use of nonsteroidal anti-inflammatory drugs (nsaids), oral steroids (-\>;= 20 mg/day prednisone or equivalent), or aspirin (-\>; 325 mg/day).

Keywords: gerd erosive gerd erosive esophagitis
provide pre-approval single-patient expanded access (compassionate use) of vyd222 for patients with symptomatic covid-19 refractory to other treatments

Conditions: COVID-19

Summary: provide pre-approval single-patient expanded access (compassionate use) of vyd222 for patients with symptomatic covid-19 refractory to other treatments.


Eligibility criteria:
safety and efficacy of a sore throat lozenge dorithricin in patients with acute pharyngitis

Conditions: Pharyngitis

Summary: the aim of this multi-center, randomized, double-blind, placebo-controlled trial is to compare the efficacy and safety of dorithricin® lozenge - a triple combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3 days to matched placebo lozenges in the treatment of acute pharyngitis in adults.

in this randomized, double-blind, placebo-controlled trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (pain intensity on the 11-point sore throat pain intensity scale nrs ≥7 and ≥50 mm on the subjective 0-100 mm visual analogue) are assigned to dorithricin® or matching placebo lozenge treatment. efficacy was assessed at the investigating center for 2 hrs after first dosing, and 3 days later (visit 2). the primary efficacy end-point is the percentage of total responders assessed at visit 2, i.e. complete resolution of throat pain and difficulty in swallowing at approx. 72 hrs after first application of treatment, safety and local tolerability are also assessed.

Eligibility criteria:
inclusion criteria: * male and female outpatients aged ≥18 years * signed informed consent form * clinically diagnosed acute pharyngitis (tpa ≥5) * recent onset of symptoms (≤24 hours) * pain intensity of ≥8 on an 11-point nrs * difficulty in swallowing (100-mm vas ≥50 mm) exclusion criteria: * patients with strong suspicion of streptococcus a infection (mcisaac score ≥3) * positive rapid streptococcus a test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat * purulent tonsillitis * the use of systemic/local antibiotics in the throat area within 7 days prior to screening and during the study * the use of any systemic analgesics/local analgesics in the throat area (e.g. non-steroidal drugs, \[acetylsalicylic acid \>100 mg\], paracetamol) within 36 hours prior to screening and during the study * the use of local anaesthetics for treatment of sore throat within 2 days prior to screening and during the study * the use of any systemic anti-inflammatory drug/local anti-inflammatory drug in the throat area (e.g. glucocorticoids) within 4 weeks prior to screening and during the study * the use of any other 'sore throat medication' (e.g., lozenges, drops, sprays) or other 'cold medication' that could have interfered with the results of the study within 7 days prior to screening and during the study

Keywords: dorithricin tyrothricin benzalkonium chloride benzocaine placebo-controlled pharyngitis sore throat throat pain difficulty swallowing complete responder lozenge non-streptococcal infections
risk factors for the occurrence of post intensive care syndrome (pics)

Conditions: Post Intensive Care Syndrome

Summary: monocentric, observational, descriptive riph3 study with prospective data collection.

a consultation in the form of a teleconsultation with video conference is proposed to all adult patients who have stayed more than 24 hours in the rangueil intensive care unit. this consultation is scheduled and will take place approximately three months after the end of the stay in the intensive care unit. during this consultation, signs will be sought through questioning to detect or even diagnose the presence of a pics. we will also look for elements that will allow us to characterize people with chip. if a pics was detected during the consultation, the summary letter sent to the attending physician informs him/her of 1. the presence of a chip in his patient 2. the nature of this chip (chip with a purely psychological component, chip with a psychological and physical component, etc.) in this same summary letter, the attending physician will be offered a list of specialists practicing at the chu who are likely to take charge of the patient's chip.

Eligibility criteria:
inclusion criteria: * adult patient * hospitalized in the intensive care unit of rangueil of the toulouse university hospital * length of stay in intensive care equal or superior to 24 hours * affiliated to a social security system * having expressed no objection to participate in the study exclusion criteria: * minor patient * no consent to the study * patient not capable of expressing his "non opposition" to the study * patient under guardianship, curatorship or safeguard of justice