Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and long-term prognosis of imatinib in patients newly diagnosed with chronic myelogenous leukemia (chronic phase)

Conditions: Chronic Myelogenous Leukemia in Chronic Phase

Summary: this study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase cml.


Eligibility criteria:
inclusion criteria: * diagnosed as chronic myelogenous leukemia in chronic phase * previously untreated with interferon-alpha * performance status is normal or capable of only limited self-care exclusion criteria: * patients who are pregnant or possibly pregnant * significant hepatic diseases * chronic myelogenous leukemia in advanced phase other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic myelogenous leukemia imatinib cml
effect of maxillary third molar extraction vs. non-extraction on distalization of first molars in a group of adolescent patients

Conditions: Class II Malocclusion

Summary: there is a scarcity in literature regarding the influence of maxillary third molar on distalization . this study aimed to compare the influence of unerupted maxillary third molars and their extraction on the bilateral distalization of upper first molars using the infra-zygomatic gear distalizer

maxillary molar distalization is one of the non-extraction modalities for treating class ii malocclusion. when distalizing maxillary molars in adults, it is not a problem to extract fully erupted third molars, and it may even be suggested that the extraction site may accommodate distalization. on the contrary, adolescents usually have unerupted third molars with partially formed roots, rendering the surgical extraction more difficult and traumatic. the necessity of surgically extracting upper third molar buds before distalization remains questionable. therefore, this study was conducted to three-dimensionally assess the impact of maxillary third molar presence on distalizing maxillary molars in adolescent patients having class ii malocclusion.

Eligibility criteria:
inclusion criteria: * adolescent patients aged 16-19 years * skeletal class i * bilateral class ii molar relationship. defined by at least an end-to-end molar relationship. * normal vertical growth pattern. * full permanent dentition with unerupted upper third molars. exclusion criteria: * skeletal class ii or class iii relationship. * past orthodontic treatment. * poor oral hygiene. * increased vertical dimension.

Keywords: infra-zygomatic mini-implant distalization infra-zygomatic crest digital models molar tipping
surgimend mesh at the hiatus

Conditions: Hiatal Hernia

Summary: prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary hiatal hernia repair using surgimend biological mesh. up to 15, with a target of 10, subjects are planned to be enrolled at one site. all subjects will receive the surgimend mesh during surgery. data collected will be compared to historical data. subjects will complete a pre-operative visit. after surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone qol survey and will have an upper gi series at 6 months.


Eligibility criteria:
inclusion criteria: * diagnosis of type 3 or 4 hiatal hernia (8) * subject is able to give informed consent * adults at least 18 years of age exclusion criteria: * currently pregnant * prior hiatal hernia repair * prior gastric surgery * prior foregut surgery * known esophageal dysfunction or dysmotility * cirrhosis or ascites * known malignancy * known allergy to biologic mesh * known allergy to barium or other contrast material used in ugi * religious objection to animal implant * cognitive impairment * prisoners
targeting leukemic stem cell expressing the il-1rap protein in chronic myelogenous leukemia (cml)

Conditions: Chronic Myeloid Leukemia

Summary: the tyrosine kinase inhibitor therapy (itks) is the first-line treatment of chronic myelogenous leukemia (cml). its effectiveness in controlling the progression of the disease is such that it is possible today to consider stopping treatment in patients with deep molecular response (\> rm4.0). only in about 50% of cases, patients relapse. it has been shown in these patients that hematopoietic stem cells (hscs) are persistant, quiescent and insensitive to itks. these cells are probably at the origin of relapse. it is therefore necessary to develop complementary therapies to cure the disease and consider discontinuation itks the development of anti-tumor immunotherapy approach using genetically modified t cells to express a chimeric antigen receptor (car) and specifically targeting cml csh + could address this issue. the membrane expression of the il-1-rap protein could be an interesting target.


Eligibility criteria:
inclusion criteria: * patients for whom there is a strong suspicion of cml diagnosed as part of routine activity. * written informed consent exclusion criteria: * patient with atypical cml * patient with a non smp cml * patients previously treated with interferon * patient enrolled in another study therapy or within the exclusion period thereof * pregnant or breast-feeding women * patient under guardianship, curator or under the protection of justice.
to assess ear blood flow during dialysis

Conditions: Kidney Failure

Summary: this is a prospective observational pilot study of patients under the care of the royal free hospital with chronic kidney disease who have been established on regular thrice weekly haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the ear during haemodialysis.

10 patients, attending for thrice weekly outpatient haemodiafiltration shall be studied during a dialysis session using a ce marked commercially available digital otoscope capable of recording digital videos of the tympanic membrane and ear canal. patients will receive standard clinical care and monitoring of their dialysis session, which includes recording of blood pressure and changes in haematocrit and volume status during dialysis and noting patient symptoms.

Eligibility criteria:
inclusion criteria: * patients age 18 years and older up to 80 years * under the care of the royal free hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration. * able to provide written informed consent obtained exclusion criteria: * patients unable to provide written informed consent * patients using hearing aids * patients who have had previous middle ear surgery * patients not fulfilling inclusion criteria

Keywords: haemodialysis hypotension
study of the relationship between dose-concentration-effect of delta-9-tetrahydrocannabinol (thc) and the ability to drive in chronic or occasional cannabis users

Conditions: Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users

Summary: study of the effects of smoked cannabis consumption on performance on a driving simulator and reaction time. the study aims to explore the relationship between concentrations of cannabis in the blood, driving performance and reaction time.

this study will examine: * the relationship between thc blood levels and driving performance measured on a york driving simulator * the relationship between thc blood levels and reaction times as measured on the psychomotor vigilance test (pvt) * the pharmacokinetics of thc in occasional and chronic cannabis consumers * determine the minimum blood concentration level of thc and 11-oh-thc, below which no effect of cannabis is observed * determine whether the polymorphism of cyp2c9 (\* 3) is associated with the auc, cmax, and higher thc t1/2 * determine if the polymorphism of cyp2c9 (\* 3) is associated with different pharmacodynamic effects at a given thc level on performance measured by driving simulation

Eligibility criteria:
inclusion criteria: * healthy volunteer of male gender from 18 to 25 years * normal medical examination * driving license owner * bmi between 18.5 and 25 * moderate tobacco consumption * moderate consumption of coffee, tea, cola (≤ 225mg caffeine per day) * cannabis user for at least 1 year * occasional (1-2 joints per week) or chronic (1-2 joints per day) cannabis consumers * availability during the study * signed consent exclusion criteria: * participation in another clinical study * having taken any psychotropic medication in the past one month * having taken any narcotic (alcohol, psychotropic drugs, other narcotics) other than thc in the past 3 days (negative urinary test at inclusion) * alcohol blood level positive at inclusion * excessive alcohol consumption (audit score \> 7) * dependence, present or past, to any psychotropic product (alcohol, psychoactive drugs, other narcotic) * depression * sleep disorders * any psychiatric history, including psychosis * deprived of their liberty by judicial or administrative decision * lack of medical insurance * professional use of motorized vehicles

Keywords: delta-9-tetrahydrocannabinol, volunteers, cannabis users
electrolytes in chronic kidney disease patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: study of serum calcium and phosphorus level in chronic kidney disease patients and its relation to occurrence of acute coronary syndrome in them.

prospective study to : 1. find the relation between electrolytes disturbance and renal diseases 2. the effect of electrolyte abnormalities on atherosclerosis 3. prevalence of acute coronary syndrome in patients with chronic kidney disease

Eligibility criteria:
inclusion criteria: * 1-the ckd patients with or without dialysis who admitted to coronary care unit with chest pain consistent with acs with any of following features : a- electrocardiogram (ecg) changes: * st elevation. * st depression. * t wave inversion. * recent left bundle branch block. b- troponin t elevation. 2-the ckd patient with or without dialysis with no previous history of acs. exclusion criteria: 1. patients who were diagnosed with primary hyperparathyroidism. 2. acute kidney injury (aki) which is defined as any of the following:(kdigo2012) * increase in s.cr by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48hours; or * increase in s.cr to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days;or * urine volume \<0.5 ml/kg/h for 6 hours
squid liquid embolic agent for the embolization of abdominopelvic arterial bleeding syndrome (squidperi study)

Conditions: Arterial Bleed; Abdominal; Embolism Arterial; Pelvic Bleeding

Summary: abdominopelvic bleeding can occur due to numerous causes including for the vast majority, trauma, surgery complications and tumors. interventional radiologists often exclude arterial acute hemorrhage using cyanoacrylate or a liquid embolic agent, but few prospective results have been published to assess their efficacy and safety. the historic and most studied liquid embolic agent to date is onyx. results in the treatment of acute peripheral non-neurologic hemorrhage have been detailed in a meta-analysis published in 2015. this systematic review found 19 articles presenting 131 patient cases and 150 lesions treated with onyx from 2005 to august 2014. there were 11 case series and 8 case reports but no prospective trial. the most common presenting symptoms were of gastrointestinal (gi) origin (n = 51). rebleeding of the baseline lesion occurred in 7/131 patients. no deaths resulting from complications of the embolic procedure were reported. one patient died of persistent hemoptysis after treatment with onyx. no deaths were directly attributable to the use of onyx. during a peripheral embolization procedure with available embolic agents other than squidperi, residual feedings or collateral vessels became gradually less visible to the operator due to the high radiopacity of the liquid. it was therefore essential to develop an embolization system with lower radiopacity, or with radiopacity that decreases over time. additionally, depending on the angioarchitecture and flow characteristics, it is important to have an embolic agent with various viscosities. squidperi is a liquid embolic agent with various viscosities and radiopacities. it is indicated for the embolization of lesions in the peripheral vasculature but its use is poorly reported as of today. the purpose of this prospective non interventional multicenter study is to evaluate the safety and efficacy of squidperi for the treatment of abdominopelvic arterial acute bleeding or imminent risk of bleeding.


Eligibility criteria:
inclusion criteria: * patient presenting with an arterial abdominopelvic bleeding or imminent risk of bleeding, including visceral, muscular or gi territories, requiring embolization, along with angiographic abnormalities * patient for whom the use of squidperi had been decided for an embolization * patient or authorized representative dully informed and having no objection to the clinical data collection and medical file access * patient \> 18 years exclusion criteria: * patient with severe live failure * patient participating in another interventional study * vulnerable patients including pregnant women * patient not eligible for treatment with liquid embolic agent * patients presenting contra-indications to squidperi as describes in the informations for use (ifu)
maternal serum amyloid a levels in pregnancies complicated with preterm labour.

Conditions: Preterm Labor

Summary: the aim of the current study is to assess the accuracy of maternal serum amyloid a for prediction of preterm labor in women with threatened preterm labor.


Eligibility criteria:
inclusion criteria: * pregnant women, age 18 - 35. * gestational age: 28 - 36+6 weeks. * singleton pregnancy. * no past history of any medical disorder and with no other medical complications during pregnancy * nonsmoker. * diagnosis of preterm labor is based on the american college of obstetricians and gynecologists guidelines criteria of preterm delivery: 1. gestational age: 28 - 36+6 weeks 2. presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes) 3. cervical dilation ≥ 4 cm 4. cervical effacement ≥ 80%. exclusion criteria: * of any patient with the following risk factors for preterm labor: * over distended uterus . * hemorrhage * uterine anomalies
a study to evaluate glucose and insulin response to nutralin

Conditions: Diabetes

Summary: the purpose of this study is to evaluate how an investigational food product affects a healthy person's blood sugar and insulin levels.

the investigational food product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs using the product. the hypothesis for this study is that healthy human subjects will have an increase in insulin levels after consuming the investigational food product.

Eligibility criteria:
inclusion criteria: * men and women who are at least 18 years of age * non-diabetic exclusion criteria: * diabetes * women who are pregnant, breastfeeding or planning to become pregnant * current and active liver or kidney disease * any food allergies * celiac disease

Keywords: diabetes, insulin, blood sugar
neoadjuvant immunochemotherapy for locally advanced cervical cancer: a prospective, single-arm, phase ii clinical trial

Conditions: Cervical Cancers

Summary: this is a prospective, single-arm, phase ii clinical trial designed to evaluate the efficacy and safety of paclitaxel and carboplatin combined with pd-1/pd-l1 immune checkpoint inhibitors in the treatment of locally advanced cervical cancer. using single-cell rna sequencing (scrna-seq), the study aims to investigate the molecular mechanisms underlying differential treatment responses and optimize personalized therapeutic strategies. eligibility criteria: patients with locally advanced cervical cancer (figo stages ib3 to iib) and a primary tumor diameter \>4 cm will be enrolled. all patients must have histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma, an ecog performance status of 0-1, and no prior treatment. outcome measures: * primary endpoint: objective response rate (orr), assessing tumor regression. * secondary endpoints:overall survival (os), progression-free survival (pfs), and incidence of treatment-related adverse events (graded by ctcae criteria). * exploratory endpoint:\*\* impact of treatment on the tumor microenvironment and gene expression profiles. study intervention: all patients will receive three cycles of paclitaxel and carboplatin chemotherapy combined with pd-1/pd-l1 inhibitor therapy, followed by open radical hysterectomy and pelvic lymphadenectomy. postoperative adjuvant therapy (chemotherapy, chemoradiation, or maintenance immunotherapy) will be determined based on pathological assessment. tumor tissue samples will be collected during treatment for single-cell sequencing analysis. sample size: the study plans to enroll at least 34 eligible patients. based on treatment response, patients will be categorized into high-response and low-response groups, with a minimum of 5 cases per group selected for scrna-seq to ensure robust molecular mechanism analysis. the sample size calculation assumes a historical orr of 65% and a target orr of 85%.


Eligibility criteria:
inclusion criteria: * patients with locally advanced cervical cancer (figo stages ib3 to iib) and a primary tumor diameter \>4 cm will be enrolled. * all patients must have histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma. * ecog performance status of 0-1. * no prior treatment. exclusion criteria: * patients with a history of other malignant tumors in the past. * patients whose clinical data or treatment information is incomplete. * patients with severe comorbidities or those who cannot complete follow-up.
a study to investigate the efficacy, safety and tolerability of remibrutinib versus placebo in adult patients with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: a study to evaluate the efficacy, safety and tolerability of remibrutinib versus placebo in adult patients with generalized myasthenia gravis who are on stable, standard-of-care (soc) treatment.

this study is a randomized, double-blind, placebo-controlled, multicenter, phase iii study, to evaluate the efficacy, safety and tolerability of remibrutinib in gmg patients who are on stable soc treatment. approximately 180 eligible participants will be randomized in a ratio of 1:1, to receive either remibrutinib or matching placebo. the study consists of a core part (6-months double-blind treatment) and an extension part (up to 60-month open-label treatment).

Eligibility criteria:
inclusion criteria: * adult patients with gmg (age 18-75 years) * confirmed diagnosis of myasthenia gravis foundation of america (mgfa) class ii-iv gmg at screening and likely not in need of a respirator for the duration of the study, as judged by the investigator * documented evidence of positive serologic testing for achr+ antibody or musk+ antibody at screening, or seronegative for both achr and musk antibodies at screening * baseline mg-adl score ≥ 6 with ≥ 50% of the total score due to non ocular symptoms * participants who have been on a stable dose of standard-of-care treatment as specified in the protocol * able to safely swallow the study medication according to investigator clinical judgement based on a bedside swallowing test or another formal swallowing test in line with local practice, both at screening and baseline exclusion criteria: * prior to baseline have been treated with intravenous immunoglobulins or plasma exchange (ivig/plex) in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti-fcrn therapies in the past 3 months, or had a thymectomy in the past 6 months or a planned thymectomy during the trial period * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment other protocol-defined inclusion/exclusion criteria may apply.

Keywords: myasthenia gravis gmg generalized myasthenia gravis lou064 remibrutinib placebo-controlled double-blind phase iii
levobupivacaine vs levobupivacaine + dexmedetomidine infiltration for post-tonsillectomy analgesia and laryngospasm in pediatric patients

Conditions: Post-tonsillectomy Analgesia; Levobupivacaine

Summary: tonsillectomy is one of the most common surgical performed procedures in children. adenotonsillectomy surgery in pediatrics is commonly managed as an ambulatory surgery. this may be attributed to the use of the electro-dissection surgical technique that decreases the incidence of immediate postoperative hemorrhage. however, the use of the electro-cautery technique increases postoperative inflammation. postoperative throat pain is a very important and significant problem because it can lead to decreased oral intake and dehydration with subsequent serious complications of dehydration.

the idea behind the use of local anesthetic agents in the peri-operative period is not only related to its ability to block peripheral nociceptor transmission after tissue damage but also in preventing sensitization of the central nervous system. levobupivacaine is new, long-acting bupivacaine, amide-type local anesthetic and is thought to be less cardio and neurotoxic. however, few studies showed that local infiltration of levobupivacaine reduces the intensity of postoperative pain. dexmedetomidine is a highly selective α2-adrenoceptor agonist recently introduced to anesthesia practice producing dose-dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites), without respiratory depression. dexmedetomidine is being used off-label as an adjunctive agent in pediatric patients for sedation and analgesia; in the critical care unit, during non-invasive ( magnetic resonance imaging) and invasive procedures ( cardiac catheterization and endoscopy). it may also decrease opioid usage and anesthesia requirements as seen from adult data prevent emergence delirium and postanesthesia shivering.

Eligibility criteria:
inclusion criteria: * weight: 10-40 kg * american society of anesthesiologists asa physical status: i-ii. * operation: elective tonsillectomy (±adenoidectomy) in the otorhinolaryngology department, assuit university hospitals due to recurrent or chronic tonsillitis with or without adenoidectomy (using the surgical retraction and bipolar diathermy if indicated). exclusion criteria: * patients having known hypersensitivity to dexmedetomidine or levobupivacaine. * patients with the following conditions: obstructive sleep apnea syndrome (whether confirmed by a polysomnography test or not), previous peritonsillar abscess formation and those with swallowing disorders.
ozone application before fissure sealants

Conditions: Caries,Dental

Summary: decay is a multifactorial infective degenerative disease of hard dental tissues, caused by streptococcus mutans and lactobacillus forming the bacterial biofilm of teeth surfaces. decays generally evolve in fissures and pits of secondary molars. pits and fissure sealants prevent decays if performed in two years from eruption. ozone has bactericidal effect and remineralizing capacity on enamel. the aim of this study is to assess the effectiveness of ozone application before sealants in increasing their duration in time.


Eligibility criteria:
inclusion criteria: * first or second secondary molars to be sealed * possibility to isolate with rubber dam both the teeth involved * no clear signs of pigmentations * good general health exclusion criteria: * latex allergy * epilepsy or other severe neurological pathologies * psychiatric disease * excessive sensibility to electrical current * severe asthma * enamel disorders, such as amelogenesis imperfect, white spots, fluorosis or molar incisors hypomineralization

Keywords: ozone pits and fissures sealants prevention