Kornimate/medical-research-clean huggingface dataset:
the nexus™ compassionate use data collection study

Conditions: Aortic Arch Aneurysm

Summary: a multicenter, observational data collection study to evaluate the safety and performance of the nexus™ aortic arch stent graft system in patients that were implanted with the device as part of compassionate use procedures.

the purpose of the study is to collect and analyze data that is recorded as standard of care for patients that were implanted with the nexus device as part of compassionate use procedures.the data will be used to obtain additional information on the safety and performance of the nexus™ aortic arch stent graft system in patients affected by pathologies involving the aortic arch. data will be collected at each time point of patient's follow up conducted according to the standard of care in each site.

Eligibility criteria:
inclusion criteria: * patients for whom the nexus implantation was initiated as part of a compassionate use procedure. * a signed and dated informed consent document is available that authorizes to collect the patient's personal data following implantation of the nexus systems and throughout the follow ups visits up to 5 years following implantation. exclusion criteria: -there are no exclusions. data will be collected for all implanted population as described in the inclusion section above
study comparing two ventilation modes nava (neurally adjusted ventilatory assist) mode and spontaneous breathing with inspiratory pressure support (ips) mode in consecutive patients hospitalized for acute respiratory failure requiring mechanical ventilation with endotracheal tube.

Conditions: Acute Respiratory Failure

Summary: this is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous nava mode and spontaneous breathing with ips mode (the latter is considered as the reference ventilatory mode) in patients admitted to the icu for acute respiratory failure and ventilated with an endotracheal tube. nava mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.


Eligibility criteria:
inclusion criteria: * patient ventilated with endotracheal tube for more than 24 hours * return for at least 30 minutes to spontaneous ventilation allowing ips with a level of pressure support \<30 cm h2o; * level of sedation =\< 4 on the ramsay scale in the absence of medical decision to increase the level of sedation; * fraction of inspired oxygen (fio 2) =\< 50% with a positive end-expiratory pressure (peep) =\< 8 cm h2o; * absence of administration of high-dose vasopressor therapy defined by: 1. norepinephrine \> 0.3 mcg / kg / min; 2. dopamine \> 10 mcg / kg / min; * estimated duration of mechanical ventilation \> 48h00 exclusion criteria: * contraindication to the implementation of the nava endotracheal tube, ie any contraindication to the implementation of a gastric tube or to the repositioning of a tube already in place: 1. recent gastrointestinal suture ; 2. esophageal varices rupture with gastrointestinal bleeding within 4 days prior to inclusion; * therapeutic limitation or active treatment discontinuation; * pregnant women; * minors; * protected adults; * patient already included in the study;
rituximab and fludarabine followed by campath-1h in chronic lymphocytic leukemia or small lymphocytic lymphoma

Conditions: Non-Hodgkins Lymphoma

Summary: in this multicenter trial, we will investigate the use of fludarabine plus rituximab, followed by campath-1h, in previously untreated patients with cll/sll. patients who are elderly, or who are considered unlikely to tolerate this combination therapy well, will receive single agent rituximab followed by campath-1h.

upon determination of eligibility, all patients will receive: fludarabine + rituximab + campath-1h patients who are judged by the investigator not to be candidates for fludarabine due to advanced age, marginal performance status or coexistent medical conditions will receive rituximab alone followed by campath-1h.

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * histologically proven b-cell cll/sll * positive staining for cd20 antigen * no systemic chemotherapy. * measurable or evaluable disease * able to perform activities of daily living with minimal assistance * age \> 18 years * life expectancy \> 12 weeks * adequate liver and kidney function * must be accessible for treatment and follow-up * must give written informed consent prior to entering this study. exclusion criteria: you cannot participate in this study if any of the following apply to you: * female pregnant or lactating * unstabilized active infection on the basis of neutropenia * history of previous severe opportunistic infections * serious underlying medical conditions * central nervous system involvement * history of other neoplasms, either active or treated within five years please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
corneal crosslinking in keratoconus and corneal ectasia

Conditions: Progressive Keratoconus; Corneal Ectasia

Summary: prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (cxl) using riboflavin and uva light in eyes progressive keratoconus or corneal ectasia.

after epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.then the uva light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.

Eligibility criteria:
inclusion criteria: * diagnosis of keratoconus with documented progression over the previous 12 months. * diagnosis of corneal ectasia * must be able to complete all study visits. exclusion criteria: * prior corneal surgery in keratoconus group * corneal scarring * pregnancy

Keywords: keratoconus ectasia cross-linking riboflavin uva light cornea
a clinical trial to evaluate the safety and efficacy of single-use fibrous ring sutures for the suture of fibrous ring incision after nucleus pulposus removal

Conditions: Intervertebral Disc Disorder

Summary: the objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. participants used single-use annular sutures to close the annular fibers. the success rate of suture, reduction value of annulus, proportion of annulus reduction, intraoperative blood loss, suture time, vas pain score (low back, bilateral lower extremities), oswestry index (odi index), and short were evaluated the effectiveness evaluation results of form-12 health survey (sf-12 score), treatment success rate, device defects, product operation satisfaction, and safety evaluation results of recurrence rate, adverse events, and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, gender unlimited; 2. meet the diagnosis of lumbar disc herniation (refer to the guidelines for diagnosis and treatment of lumbar disc herniation), and expect to undergo single-level disc nucleus pulposus extraction; 3. the history of lumbar disc herniation is more than 6 weeks, and systematic conservative treatment is ineffective； 4. odi index ≥20 points; 5. in the vas score of bilateral lower limbs, at least one side was ≥4 points; 6. the score of the three evaluation indicators according to the modified pfirrmann grade, age and disc height is no more than 7 points (see annex 1 for the criteria); 7. voluntarily participate and sign informed consent; 8. be able to communicate well with research doctors, have good compliance, and can follow the requirements of clinical research. exclusion criteria: 1. laboratory examination (blood routine examination, blood biochemistry, coagulation function and blood pregnancy, etc.), imaging examination (mri) and vital signs examination have abnormal results with clinical significance, and the researchers believe that they are not suitable for inclusion; 2. active local or systemic infection; 3. patients with lumbar tumors and/or spinal malformations; 4. imaging showed calcification of the posterior longitudinal ligament; 5. a history of serious diseases of important organs (such as cardiovascular system, liver, lung, kidney and nervous system); 6. there are autoimmune diseases or abnormal coagulation function; 7. previous or planned surgical procedures to fuse or stabilize the lumbar spine during the trial; 8. intraoperative exploration of the location of the annulus fibriatus could not satisfy the requirement that the needle entry point was more than 2mm away from the margin of the annulus fibriatus; 9. pregnant or lactating women, or those who have a pregnancy plan during the trial period; 10. those who are participating in other clinical trials at the same time; 11. other situations that the researcher considers inappropriate to participate in this study.
comparison of a new formulation of insulin glargine with lantus in patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: primary objective: * to compare the efficacy of a new formulation of insulin glargine and lantus (overall, regardless the injection time) in terms of change of hba1c from baseline to endpoint (scheduled month 6) in participants with type 1 diabetes mellitus secondary objective: * to compare hoe901-u300 and lantus when given in the morning or in the evening in terms of: * change of hba1c from baseline to endpoint (scheduled month 6) * change from baseline to endpoint (month 6) in fasting plasma glucose (fpg), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with type 1 diabetes mellitus (t1dm) * reaching target hba1c values and controlled plasma glucose (all and reaching target without hypoglycemia) * frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative) * safety and tolerability of hoe901-u300 including development of anti-insulin antibody (aias) during the 12-month study period

the maximum study duration was up to approximately 54 weeks per participants: * up to 2-week screening period * 6-month open-label comparative efficacy and safety treatment period * 6-month open-label comparative safety extension period * 48-hour post-treatment safety follow-up period

Eligibility criteria:
inclusion criteria: * adult participants with type 1 diabetes mellitus exclusion criteria: * hba1c less than (\ ) 10% (86 mmol/mol) at screening * less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit * participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit * participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit * use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months * not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening; * severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit * unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
measuring blood pressure in pregnancy using mercury and automated device

Conditions: Hypertension; Pregnancy; Pre Eclampsia

Summary: the aim of the pram study was to determine whether women diagnosed with hypertension in pregnancy, using the traditional mercury device, have the same pregnancy outcomes when blood pressure is measured by either an automated device or a mercury device throughout the pregnancy.


Eligibility criteria:
inclusion criteria: * women with a diagnosis of hypertension in pregnancy exclusion criteria: * non-pregnant and normotensive pregnancy women

Keywords: pregnancy hypertension mercury sphygmomanometry blood pressure automated blood pressure pre eclampsia hypertension in pregnancy
retrospective study of covid-19 on reproductive function

Conditions: COVID-19

Summary: this multi-center, retrospective cohort study aimed to determine which factors are associated with ongoing pregnancy rates in infertile patients received art treatments during the current outbreak of covid-19 infection.couples who underwent ivf-et/icsi-et/fet due to infertility in the department of reproductive medicine from 2022-11-23 to 2023-01-07 were included. patients who were infected with coronavirus were observation groups; the infection status and clinical outcome were tracked. patients who were not infected with coronavirus were control groups.

in this multi-center, retrospective cohort study, we included patients who underwent ivf-et/icsi-et/fet due to infertility in the department of reproductive medicine from 2022-11-23 to 2023-01-07. patients who were infected with coronavirus were observation groups; the infection status and clinical outcome were tracked. patients who were not infected with coronavirus were control groups. we compared different parameters between two groups. the primary outcome was ongoing pregnancy rate. basic information about patients' menstruation, sexual desire, and sexual function were collected from medical record system. other information about patients' vaccination status, symptoms related to viral infection were collected by telephone follow ups. susceptibility indicators to covid-19 infection including fasting blood glucose, insulin, blood lipids, alpha-function, renin-angiotensinase, i-aldosterone were obtained . reproductive function indices amh, inhb, sex hormones, follicle retrieval rate, gn days, total gn, endometrial thickness, the incidence of ohss, semen quality, oocyte maturation rate, fertilization rate, qualified embryo rate, blastocyst formation rate, and other laboratory indices of both men and women were also collected . assisted pregnancy outcome: clinical pregnancy rate, embryo implantation rate, early abortion rate, ongoing pregnancy rate, and other clinical indicators were analyzed to determine whether there is deference in clinical outcomes between two groups.

Eligibility criteria:
inclusion criteria: * diagnosed with infertility * patients with ivf-et/icsi-et/fet from 2022/11/23 to 2023/01/07 exclusion criteria: * patients with contraindications to pregnancy or assisted reproductive technology

Keywords: covid-19 reproductive function sustained pregnancy rate
rudra registry (real-world clinical registry for patients with recurrent pericarditis)

Conditions: Pericarditis

Summary: а multicenter, non-interventional real world clinical registry of patients with recurrent pericarditis. the main goal of the registry is to epidemiologically assess the pattern, clinical outcomes, and approaches to therapy in patients with recurrent pericarditis.

а multicenter, non-interventional real world clinical registry of patients with recurrent pericarditis. the main goal of the registry is to epidemiologically assess the pattern, clinical outcomes, and approaches to therapy in patients with recurrent pericarditis. this goal can best be achieved through a registry of real clinical practice. epidemiologic assessment of the structure will be possible due to the retrospective part of the registry and will give an idea of the etiology of rp in the russian federation, as well as allow to identify a subpopulation of patients with idiopathic recurrent pericarditis and study it in more detail. the prospective branch involves three-year dynamic follow-up of patients with already diagnosed and newly diagnosed irp. based on the data obtained during the retro- and prospective parts of the registry, it will be possible to evaluate clinical outcomes and approaches to therapy in patients with recurrent pericarditis, which may become valuable material for assessing the real clinical situation in the russian federation, as well as deepen knowledge on the diagnosis and management of this cohort of patients.

Eligibility criteria:
inclusion criteria: 1. men or women 18 years of age or older at the time of data recording or pericarditis debut; 2. presence of one of the following conditions: * a specialist-confirmed diagnosis of recurrent pericarditis without an established etiology at the time of inclusion in the study (suspected "idiopathic recurrent pericarditis"); * a specialist-confirmed diagnosis of "idiopathic recurrent pericarditis". exclusion criteria: 1. age below 18 years at the time of inclusion in the registry or debut of pericarditis; 2. specialist-confirmed secondary genesis of rp (infectious, autoimmune, neoplastic, metabolic, traumatic, iatrogenic, etc.); 2. manifestations and complications of myocarditis, various diseases of thoracic organs, systemic diseases, cardiac surgery, radiation therapy, tuberculosis, etc.); 3. lack of possibility of screening examination and dynamic follow-up; 4. organ/tissue transplantation less than 5 years prior to study inclusion or debut of pericarditis; 5. oncologic disease less than 3 years prior to study inclusion or pericarditis debut; 6. chemotherapy with anthracycline-type drugs at the time of pericarditis debut; 7. administration of amphetamine-type drugs at the time of pericarditis debut; 8. cardiac/pericardial surgery in the last 6 months prior to study inclusion or pericarditis debut; 9. myocardial infarction in the last 3 months prior to study inclusion or debut of pericarditis; 10. traumatic chest injury in the last 3 months prior to study inclusion or pericarditis debut; 11. absence of an informed consent form signed by the patient for participation in the study
a study comparing the efficacy and safety of orally administered ibuprofen and placebo in delayed onset muscle soreness

Conditions: Delayed Onset Muscle Soreness

Summary: the hypotheses to be tested are: efficacy: ibuprofen will be more effective than the placebo in relieving muscle pain/soreness over 48 hour post-dosing with study medication. safety: there will be no or minimal increased incidence of adverse events (aes) with ibuprofen versus and both will be well tolerated.


Eligibility criteria:
inclusion criteria: * are male or female, 18-55 years of age * are a sexually active female of childbearing potential willing to use a medically acceptable form of birth control throughout the study and for 30 days following the end of study participation * have a history of experiencing muscle soreness after moderately strenuous exercise * are in good general health, with a bmi less than or equal to 30, and able to perform the exercise regimen * are able to read, comprehend, and sign the informed consent form * develop muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the nrs (numerical rating scale) and at least "moderate" on the categorical scale exclusion criteria: * regularly works out or exercises the upper extremities with weights or gym equipment during the past 6 months * works in an occupation that requires regular heavy lifting or involvement of the upper extremities (eg: mover, construction workers) * allergy or intolerance to any non-steroidal anti-inflammatory drug (nsaid), aspirin or acetaminophen * the presence of any medical condition (eg: history of bleeding ulcers or current peptic ulcer disease) that would preclude the subject from safely participating in the study' * any form of arthritis that requires prescription or over-the-counter (otc)treatment pregnant or lactating female * current habituation or history of chronic use of analgesic or drugs or severe chronic pain problems that do not respond to otc medication and/or requires a prescription analgesic * currently on chronic nsaid therapy for any reason * current or recent history of drug or alcohol abuse * has taken an analgesic medication within 5 half lives of performing the exercise regimen during the run-in period or completing the baseline assessment * has donated blood within the past 30 days * is unable to swallow whole or large tablets or capsules * is unable/unwilling to remain at the study center for the 6 hour inpatient observation period. * participation in an investigational study within the past 30 days of screening * prior participation in this trial * site employee or close relative of a site employee directly involved in the conduct or the study or is an employee or close relative of the study doctor.

Keywords: delayed onset muscle soreness doms
anomalies of nocturnal gaz exchanges in patients with down syndrome

Conditions: Down Syndrome

Summary: recently, retrospective studies have shown that down syndrome children have a higher co2 (carbone dioxide) sleep pressure than the general pediatric population. this increase does not seem to be always related to sleep apnea. the investigators wish to confirm these results prospectively. the investigators hypothesize that this alveolar hypoventilation may be due to ventilatory control disorders caused by dysautonomia, but also to a decrease in the strength of the respiratory muscles within the framework of the global muscular hypotonia described in children with down syndrome. .

47 down syndrome patients age from 4 to 16 will be included. they will perform a medical visit at j0, then a measurement of gaz nocturnal exchanges at home within 1 month

Eligibility criteria:
inclusion criteria: * down syndrome patient without mosaicism * age 4 to 16 years * predominant french language in the living environment exclusion criteria: * oas diagnostic focused on an earlier polysomnography * methylphenidate treatment started before inclusion

Keywords: sleep apnoa down syndrome children osa
safety of rad001 in combination with cisplatin and etoposide in lung cancer patients

Conditions: Small-Cell Lung Cancer

Summary: this study aims to establish a tolerable dose level and regimen of rad001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (sclc) who have not previously been treated with systemic chemotherapy.


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed diagnosis of extensive disease small-cell lung cancer (ed sclc) * age ≥ 18 years * who performance status grade ≤ 1 (ie. ability to perform normal daily functions) * adequate bone marrow, liver and renal function exclusion criteria: * chronic steroid treatment * prior treatment with chemotherapy for advanced lung cancer * prior treatment with mtor inhibitors * active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions * symptomatic or uncontrolled brain metastases * other cancers within the past 5 years * pregnant or breastfeeding women other protocol-defined inclusion/exclusion criteria may apply.

Keywords: small-cell lung cancer sclc advanced lung cancer rad rad001 chemotherapy cisplatin etoposide