Kornimate/medical-research-clean huggingface dataset:
evaluation of the impact of renal function on the pharmacokinetics of siklos ® (darh)

Conditions: Sickle Cell Disease; Renal Function Disorder

Summary: the use of hydroxyurea in sickle cell disease patients with glomerular hyperfiltration and renal failure requires a specific monitoring and dose adjustment in order to remain within the therapeutic interval while limiting the risk of toxicity or therapeutic failure. for this reason the investigators propose to compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * male or female. * sickle cell disease (ss or s-β0thal) confirmed by haemoglobin electrophoresis and genotyping by deoxyribonucleic acid (dna) analysis. * affiliation to a social security system. * having freely consented in writing after being informed of the objective, programme and potential risks incurred. these criteria will apply to the 3 groups of sickle cell disease patients according to the renal function stage defined by the glomerular filtration rate (gfr) estimated by the formula of the chronic kidney disease epidemiology (ckd epi) collaboration without ethnic criterion during the last 6 months before inclusion: * normal-renal function: 90 ≤ gfr ≤ 130 ml/min/1.73m2 in women or 140 ml/min/1.73m2 in men. * moderate renal failure: 30 ≤ gfr ≤ 60 ml/min/1.73m2. * glomerular renal hyperfiltration: gfr \> 130 ml/min/1.73m2 in women and gfr \> 140 ml/min/1.73m2 in men. * treated with hydroxyurea (siklos®) with a stable dosage for at least one week ± 2 days before inclusion in the study and dose administered in the morning at 9:00 ± 15 minutes. exclusion criteria: * refusal to consent. * patients that do not comply. * occurrence of vaso-occlusive crisis in the month prior to the inclusion in the study. * patients having had an exchange transfusion in the 15 days before inclusion in the study. * patients participating in another clinical trial or in the exclusion period of a previous clinical trial. * patients treated with a diuretic. * dialysis patient. * patients with an intercurrent disorder, especially inflammatory, that has not recovered for at least one month. * pregnant or breast-feeding women. * patients deprived of liberty or under legal protection. * patients who cannot understand the objective and the course of the study, incapable of giving their consent. * in the event of severe hepatic failure. * in the event of severe renal failure (creatinine clearance \< 30 ml/min). * patients who show toxic signs of bone marrow suppression.

Keywords: pharmacokinetics of hydroxyurea
the chinese registration study of driver ablation of persistent atrial fibrillation.

Conditions: Atrial Fibrillation, Persistent

Summary: this is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.

this is an open label, multi-center, randomized parallel control clinical trial. patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). postoperative atrial fibrillation recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 80 years old; 2. persistent af; 3. nonresponse or intolerance to ≥1 antiarrhythmic drug. - exclusion criteria: 1. with uncontrolled congestive heart failure; 2. having significant valvular disease and/or prosthetic heart valve(s); 3. with myocardial infarction or stroke within 6 months of screening; 4. with significant congenital heart disease; 5. ejection fraction was \<40% measured by echocardiography; 6. allergic to contrast media; 7. contraindication to anticoagulation medications; 8. severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (copd); 9. left atrial (la) thrombus measured by pre-procedure transesophageal echocardiography; 10. having any contraindication to right or left sided heart catheterization; 11. previous atrial fibrillation ablation; 12. presence of an implanted cardioverter-defibrillator; 13. any cardiac surgery within the past 2 months; 14. poor general health; 15. life expectancy less than 6 months.

Keywords: persistent atrial fibrillation driver ablation stepwise ablation
efficacy and safety of activase (ateplase) vs placebo in complicated pleural effusions (cpe)/empyemas

Conditions: Pleural Effusion Associated With Pulmonary Infection; Bacterial Pleural Effusion Other Than Tuberculosis

Summary: the purpose of this study is to document the efficacy and safety of intrapleural instillation of activase vs placebo in the management of complicated pleural effusions and empyemas

the current treatments available for complicated pleural effusions (cpe) include chest tube placement for drainage and iv antibiotics. if this fails and cpe occurs then in most patients thoracotomy is performed. patients that are not surgical candidates have image guided catheter placement performed, sometimes multiple times. the american college of chest physicians (accp) formed a cpe panel and published guidelines for treating cpe. percutaneous image-guided drainage is the most common approach for cpe. the panel recognizes the cumulative data that supports the use of fibrinolytics, vats, and thoracotomy. the cpe panel acknowledged the lack of randomized clinical trials to determine efficacy and safety of these modalities in cpe and strongly encourages the research to take place. fibrinolytic therapy is a relatively noninvasive, easy to use, and is relatively inexpensive. if successful, it will prevent sepsis and septic shock, decrease hospital stay, morbidity and mortality and prevent any surgical procedures. multiple doses of fibrinolytics have been used in cpe with no evidence of systemic anti-fibrinolytic activity. complications with these medications are also very uncommon and only isolated instances are reported. the benefit from successful pleural drainage using these agents will decrease morbidity, mortality, surgical procedures, and hospital stay.

Eligibility criteria:
inclusion criteria: * diagnosed with complicated pleural effusions * ability to provide written informed consent and comply with study assessments for the full duration of the study. * age \> 18 years exclusion criteria * current use of oral anticoagulants (e.g., warfarin sodium) with an international normalized ratio (inr) \>5- activated partial thromboplastin time (appt) \> 80, platelet count \< 100,000/mm3; * severe uncontrolled hypertension * recognized hypersensitivity to activase; or any component of its formulation; traumatic pleural effusion * pregnancy (positive pregnancy test) * in another study for this condition * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * participation in another simultaneous medical investigation * recent stroke * intracranial hemorrhage * arteriovenous malformation or aneurysm * intracranial neoplasm * acute myocardial infarction * acute pulmonary embolus

Keywords: parapneumonic pleural effusion empyema tpa (activase, alteplase)
efficacy and safety of pro-118 ophthalmic solution in allergic conjunctivitis

Conditions: Ocular Itching; Ocular Allergy; Seasonal Allergic Conjunctivitis; Perennial Allergic Conjunctivitis; Conjunctivitis, Allergic

Summary: the purpose of this study is to evaluate the efficacy and safety of four doses of pro-118 ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal (sac) and perennial (pac) allergic conjunctivitis.

a phase ii, double-masked, randomized, placebo-controlled, parallel-group and multicenter clinical trial, to evaluate and compared the clinical efficacy and safety of four doses of pro-118 ophthalmic solution ( pro-118 0.015% qd, pro-118 0.015% twice daily , pro-118 0.020% qd, pro-118 0.020% twice daily) for the treatment of seasonal (sac) and perennial (pac) allergic conjunctivitis.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of seasonal or perennial allergic conjunctivitis. * age ≥ 6 years old at screening visit. * male or female patients. applicable in patients ≥ 18 years old. * patient has signed the informed consent form (icf) prior to any screening procedures. applicable in patients with age ≤ 18 years old. * patients patients'parents or legal guardians signed an informed consent form (icf). * the patients also provided written assent. exclusion criteria: * presence of any form of allergic conjunctivitis other than seasonal or perennial allergic conjunctivitis (atopic keratoconjunctivitis, giant papillary conjunctivitis). * any other ophthalmic medication within seven days prior to randomization. * patient with one blind eye. * visual acuity of 20/40 in any eye. * patients with history of active stage of any other concomitant ocular disease. * contraindications or sensitivity to any component of the study treatments. * contact lens users. * ocular surgery within the past 3 months. * women who were not using an effective means of contraception or who were pregnant or nursing. * participation in any studies of investigational drugs within 90 days previous to the inclusion. discontinuation criteria: * patients could be discontinued before the completion of the study because of use of prohibited medications, adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.

Keywords: ocular allergy. seasonal allergic conjunctivitis perennial allergic conjunctivitis conjunctivitis, allergic ocular antihistamines.
the thiamine administration after cardiac surgery trial

Conditions: Lactate Blood Increase; Thiamine Deficiency

Summary: thiamine (vitamin b1) is essential for cell function and as a co-factor of the enzyme pyruvate dehydrogenase to initiate the krebs cycle and thus the aerobic metabolism of glucose. we hypothesize that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.

thiamine (vitamin b1) is essential for cell function and as a co-factor of the enzyme pyruvate dehydrogenase to initiate the krebs cycle and thus the aerobic metabolism of glucose. thiamine deficiency, can be caused by alcoholism or bariatric surgery and is associated with severe complications such as wernicke's encephalopathy or beri-beri syndrome. thiamine deficiency can also be the cause for an increase in lactate levels due to the transformation of pyruvate to lactate. an increase in lactate levels is associated with a worse prognostic. a decrease is, on the contrary, associated with an improved prognostic, during cpr and also after cardiac arrest. recently, studies have shown that thiamine deficiency is underdiagnosed in icu patients. on top of this, extra-corporeal circulation can worsen this deficiency. this could explain why certain on-pump cardiac surgery patients have increased lactate levels post-operatively, despite optimal blood pressure, cardiac output, diuresis, peripheral perfusion donnino et al have shown that in a sepsis context thiamine administration improved lactate clearance during the first 24 hours of icu admission and improved mortality rates at 28 days post-icu admission. therefore, the hypothesis of this study is that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.

Eligibility criteria:
inclusion criteria: * adult patients scheduled for elective cardiac surgery with extra-corporeal circulation in the chu de charleroi between november 2020 and december 2021. written informed consent will be obtained from each patient/ family member participating in the study. exclusion criteria: * patients already supplemented with vitamins * patients with an allergy to thiamine * patients who are priorly treated with linezolide, antiretrovirals and/or metformin treatment within 48 hours preoperatively * patients with mitochondrial disorders * patients with child pugh c cirrhosis * patients with a history of epilepsy with tonic-clonic movements postoperatively. * pregnant patients
role of intrauterine insemination in patients with endometriosis i-ii

Conditions: Endometriosis I-II

Summary: intrauterine insemination (iui) is an art that provides good results in selected patients, improving their reproductive prognosis. endometriosis i y ii, according to asrm classification, remains an indication to perform iui. this indication is on continuous debate, considering that different studies have shown controversial results about it, due to the poor reproductive outcomes in this group of patients


Eligibility criteria:
inclusion criteria:\ 6, basal fsh \< 10mui/ml, bmi\<30, infertility time \<4 years, absence of uterine malformations, endometrial polyps or myomas, absence of known thrombofilia, normal kayotype, \< 3 previous iui cycles, no male severe factor associated - exclusion criteria: * \> 38 years old
prevact : preventive reversal of vitamine k antagonist in minor craniocerebral trauma

Conditions: Coagulation; Intravascular; Craniocerebral Trauma; Haemorrhage

Summary: the occurence of a minor craniocerebral trauma in patients receiving vitamine k antagonist treatment leads to a high risk of bleeding. current guidelines recommend to perform a ct scan, and, in case of intracranial bleeding, to reverse anticoagulation with concomitant administration of prothrombin complex concentrates (pccs) and vitamin k. however, even if a reversion is performed, the prognostic of post-traumatic intracranial bleeding remain bad. the investigators hypothesize that, for patients admitted in an emergency department after a minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion with pccs can lead to a significant reduction of intracranial haemorrhage and can also improve the neurological prognostic of patients versus the current strategy. prevact will test this hypothesis, in an open label, randomized, multicentre, clinical trial involving 400 patients.


Eligibility criteria:
inclusion criteria: * admission in an emergency departement for a recent and isolated minor head trauma with at least one of the following characteristic : a period of alteration in the level of consciousness, a period of loss of consciousness (\< 30 min), a posttraumatic amnesia, persistant posttraumatic headache, repeated vomitting (at least 2 episodes) or any other neurological sign such a convulsion or a localised neurological sign, wound of the scalp or the face testifying of the importance of the cranial trauma... * subject receiving anticoagulant treatment with anti-vitamin k for the treatment of atrial fibrillation (af) * initial ed glasgow coma scale (gcs) score of ≥13 * achievable follow up * informed consent form signed by the patient or if he/she isn't able an emergency inclusion can be realised. exclusion criteria: * delay between the minor head trauma and the possible preventive pcc's administration \> 6h * subject receiving anticoagulant treatment other than anti vitamin k (heparin, fondaparinux, dabigatran, rivaroxaban, apixaban...) * subject receiving anticoagulant treatment for other reason than a af * subject on antiplatelet treatment (except the use of low dose of aspirin (≤ 100 mg/day) * delocalised biology inr in capillary blood \< 1.5 if it's available (only in departement where this analyse is a usual practice) * haemorrhage or suspected haemorrhage other than intracranial which could led to a reversion of the anticoagulation * head trauma associated with one or further potential haemorrhagic traumatic lesions * subject who reject the use of products derived from human blood * women who are pregnant * subject with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study * subject without social security registered
potential molecular predictors of response to novel therapies in metastatic pancreatic neuroendocrine tumors

Conditions: Pancreatic Neuroendocrine Cancer

Summary: sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic neuroendocrine tumors (nets). in addition, some traditional chemotherapies are often used to treat pancreatic nets. traditional chemotherapy is also known as "cytotoxic therapy" and works by killing cells that are actively dividing. there have been no studies to compare the different types of treatment. since the patient is eligible for treatment with either sunitinib, everolimus or traditional chemotherapy it can help us identify factors that may help future patients benefit from these therapies.


Eligibility criteria:
inclusion criteria: * histopathologic evidence of well differentiated pancreatic net * evidence of measurable disease by recist 1.1. both patients with synchronous disease and those with prior resected primary cancers will be eligible. * patient ≥18 years of age on the day of signing informed consent. * planned initiation of active therapy with everolimus ,sunitinib or traditional cytotoxic chemotherapy. patients can be included in this study, regardless of prior therapy, but cannot undergo concurrent therapy, such as hepatic artery embolization * available archival tissue with adequate ffpe tissue for analysis verified by a pathologist (in cases of biopsies less than 2 cm and/or less than 70% tumor content 10 slides will be required for adequate dna preparation. for larger biopsies and any resections, 5 slides are sufficient for dna extraction). exclusion criteria: * patient has a history of a second active malignancy with evidence of metastases. patients with a history of resected prior malignancy are allowed. * patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.

Keywords: mri ct 12-058
midostaurin in indolent systemic mastocytosis

Conditions: Indolent Systemic Mastocytosis

Summary: rationale: patients with indolent or smoldering systemic mastocytosis can have severe disabling symptoms. almost all patients have fatigue, a compromised quality of life, hampering normal functioning. because this form of mastocytosis is not considered life-threatening, mast cell eradication has never been applied and patients receive only symptomatic therapy with histamine blockers. midostaurin, a c-kit inhibitor has shown activity regarding symptom control and decrease of malignant mast cells in patients with aggressive systemic mastocytosis (asm) or mast cell leukemia

objective: primary: to study in a pilot phase ii trial the efficacy of midostaurin administered at an oral dose of 100 mg twice daily in patients with indolent or smoldering systemic mastocytosis on mediator symptom reduction, documented by the mastocytosis symptom assessment questionnaire, measured at 3 months. secondary: 1. to study whether symptom improvement persists at 6 months, and whether midostaurin can reduce mast cell infiltration in the skin and bone marrow, documented by decrease of serum tryptase, decrease of urticaria pigmentosa and decrease of bone marrow mast cells. 2. to assess safety and tolerability of midostaurin in the above mentioned settings study design: single arm, open label pilot phase ii study. study population: adult patients (n=20) with histologically documented systemic mastocytosis, indolent or smoldering subtype, with severe symptoms, not controlled by histamine 1 and 2 blockers. intervention: treatment with midostaurin, twice daily 100 mg orally for 6 months continuously.

Eligibility criteria:
inclusion criteria: * patients with indolent systemic mastocytosis (ism) or smouldering systemic mastocytosis (ssm) according to the who criteria * presence of the d816v c-kit mutation * serum tryptase \> 20 mg/l * serious mediator-related symptoms that cannot be controlled by h1 and h2 blocking drugs. symptoms will be scored by an adapted msaf (mastocytosis symptom assessment form) with at least: * a pre-study score of 4 or more on 3 non-related items, * or a pre-study score of 5 or more on 2 non-related items. * one item from the scoring list can be replaced by flushes 7 or more per week or anaphylactic attacks 1 or more per week. * age \>18 years * willingness to apply optimal contraceptive measures (double barrier method, both men and women) for women below the age of 55, men at all ages; for both: if sexually active. * written informed consent exclusion criteria: * aggressive systemic mastocytosis, mast cell leukemia, or asm with or without accompanying non-clonal related non-mast cell disorder (sm-anhmd). * any known other present malignancy, non-melanoma skin cancers excluded * history of malignancy within the last 5 years, non-melanoma skin cancers excluded * any serious comorbidity interfering with therapy compliance and follow-up compliance * pregnancy * patients not willing or who are not able to comply with contraceptive measures

Keywords: mastocytosis ism ssm
follow-up safety and efficacy evaluation on subjects who completed phase i clinical trial

Conditions: Knee Osteoarthritis

Summary: this is a follow-up study to investigate the long-term safety and explore efficacy of smup-ia-01, for the treatment of knee osteoarthritis. subjects who participated in and completed the initial stage of the phase i trial (nct04037345 ) will be followed-up until 60 months.

the subjects will be followed up at 6-month, 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of smup-ia-01.

Eligibility criteria:
inclusion criteria: 1. subject who completed the safety and explore efficacy evaluations in smup-ia-01 phase i clinical trial. 2. subjects who have been treated with either smup-ia-01 at least 6 months ago. 3. subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial. exclusion criteria: 1. subjects who were not enrolled in phase 1 clinical trial of smup-ia-01 for assessing safety and explore efficacy. 2. other subjects, excluding those listed above, who were deemed unsuitable by the pi

Keywords: human umbilical cord blood derived mesenchymal stem cells knee osteoarthritis
phase3 study of amrubicin with cisplatin versus etoposide-cisplatin for extensive disease small cell lung cancer

Conditions: Lung Cancer

Summary: this study drug(amrubicin)is believed to work by stopping the tumor cell in your body from growing. the purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer the subject, who is randomized to ap group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.


Eligibility criteria:
inclusion criteria: * histologically/cytologically proven small cell lung cancer * extensive disease * no prior chemotherapy regimen * age 18 years or older * ecog performance status of 0-1 exclusion criteria: * brain metastasis requiring treatment * treatment (surgical or radiotherapy)of primary tumor * interstitial pneumonia or pulmonary fibrosis * abnormal cardiac function or myocardial infraction within 6 months before study enrollment

Keywords: extensive disease-small cell lung cancer