Kornimate/medical-research-clean huggingface dataset:
long-term study of dsp-5423p in patients with schizophrenia

Conditions: Schizophrenia

Summary: the study evaluates the long term safety of dsp-5423p in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * patients who have schizophrenia diagnosed by dsm-5, diagnostic criteria * patients who are aged 18 years or older at informed consent * patient understands the objectives and procedures of the study and who provide written voluntarily consent to participate in the study, etc. exclusion criteria: * patients who fall under a contraindication listed in the lonasen® package insert * patients with parkinson disease, etc.
interferon-pegyle α2a efficiency and tolerance in myelofibrosis

Conditions: Myelofibrosis

Summary: patients who carried primary or secondary myelofibrosis from philadelphia negative mpns (pmf/smf) and who are treated or are about to be treated with pegylated-interferon (mostly α2a) are eligible to this prospective study. biological and clinical parameters will be collected from the beginning of the drug use until last news. a non-opposition consent form need to be signed before entering this study.

in all centres interested, patients who were diagnosed for pmf/smf can be treated with oral or sub-cutaneous drugs in order to reduce clinical symptoms and biological abnormalities belonging to these diseases. pegylated-interferon is one of the better weapons that can be used in these cases. these treatments are well known and used from many years in french hematological centres. the investigators to collect clinical and biological data from patients treated with pegylated-interferon α2a (the most use) in case of pmf/smf in order to assess efficacity and tolerance to this drug. the prescription of the product and the dose are under the responsibility of each practician. clinical data collected: disease and patients characteristics at the time of diagnosis and at the beginning of the drug use, spleen and liver size, presence of constitutive symptoms, transfusion needs. biological data collected: complete hemogram, cd34+ cells count, allele burden of jak2v617f and calreticulin clones if dna samples are collected. these data will be collected avery 3 months during the two first years and every 6 months after. the investigators also recorded adverse side effects if significative, the concomitant use of hematological drugs (cytoreductive treatments, ase...), modalities of prescription of the drugs and the reason for stopping the drug and etiology of death if happened.

Eligibility criteria:
inclusion criteria: * primary or secondary myelofibrosis * prescription of pegylated interferon α2a * age \> 18 years-old exclusion criteria: * other mpns treated with pegylated interferon α2a * patients treated for pmf or smf but without pegylated interferon

Keywords: myelofibrosis pegylated interferon
study to test efficacy of real-time reminders on apple watch to decrease late or missed meal boluses

Conditions: Diabetes Mellitus, Type 1

Summary: this will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the klue software for 6 weeks or to continue with their usual care for 6 weeks. subjects are eligible for enrollment if they are using a continuous glucose monitor (cgm) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. missing or late meal boluses will be assessed through their pump/pen and sensor downloads. this is a pilot study. there is no preliminary data to do a true power calculation. the primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. secondary outcome measures will be the number of missed meal boluses in each month of the study, change in hba1c levels (measured every 6 weeks), accuracy of the klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.


Eligibility criteria:
inclusion criteria: * age 18 and over * using an insulin pump for at least 3 months and currently using cgm or using an insulin pen with memory and currently using a cgm * willing to wear a cgm at least 70% of the time while in the study * willing to wear an apple watch on their dominant hand while awake * missing or late in giving at least four food boluses in the previous 2 weeks * understanding and willingness to follow the protocol and sign informed consent exclusion criteria: * pregnant or lactating women * a known medical condition that in the judgement of the investigator might interfere with the completion of the protocol note: adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment. * current treatment for a seizure disorder * inpatient psychiatric treatment in the past 6 months subject may participate in another trial if it is approved by the investigators of both trials.

Keywords: klue meal bolus bolus reminder
clair -fo: clinical trial of ophthalmic insert mydriasert® versus reference treatment

Conditions: Retinal Anomalies; Premature Birth

Summary: pupillary dilation to perform a fundus in premature newborns and neonates is often difficult to obtain, because of the non mature iris sphincter. the fundus is essential to detect retinal anomalies (as retinopathy of prematurity or chorioretinal or disk anomalies). the aim of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two mydriatic treatments, with an optimal duration and a good tolerance of the drugs. the study will evaluate the mydriasis in premature newborns, neonates and infants justifying a mydriasis for a bilateral diagnosis fundus, using ophthalmic insert mydriasert® versus reference treatment (association of phenylephrine and tropicamide eyedrops). ophthalmic insert mydriasert® can control drug dispensation and decrease the number of nurse interventions to obtain mydriasis in patients.

the aim of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two mydriatic treatments, with an optimal duration and a good tolerance of the drugs. the study will evaluate the mydriasis in premature newborns, neonates and infants justifying a mydriasis for a bilateral diagnosis fundus, using ophthalmic insert mydriasert® versus reference treatment (association of phenylephrine and tropicamide eyedrops). ophthalmic insert mydriasert® can control drug dispensation and decrease the number of nurse interventions to obtain mydriasis in patients.

Eligibility criteria:
inclusion criteria: * premature newborns, neonates and infants of less 18 months-old indoor in the neonatology clinical department of robert debre hospital with cardiologic monitoring * presenting a risk of retinopathy of prematurity or fundus anomaly (chorioretinal and/or disk anomalies). * needing a bilateral fundus * parents, tutor or legal representing of the patient had been informed of objectives of the study and had given their written consent. * covered by french social security or cmu exclusion criteria: * neonates of less 1000g at inclusion * premature newborn of less 30 weeks of gestational age at inclusion * contra-indication to one of the evaluated drugs * any treatment that could provoke a dangerous drug interaction for the patient if associated with one of the drug of the study * anatomical predisposition to glaucoma, hypertension or any other contra-indication noted by the physician

Keywords: premature neonates infants children mydriasert® mydriasis fundus tropicamide phenylephrine clinical trial infant premature newborns bilateral diagnosis fundus
cross therapy registry - edema - us

Conditions: Edema Leg

Summary: the geko™ cross therapy registry - edema (gekotm ctr - edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months.

the geko™ device has a wide range of clinical applications including the post-operative management of edema. although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for edema management on patient outcomes during follow-up of up to twelve months. as the manufacturer of the device, firstkind limited has an obligation to collect safety and performance data to comply with current regulations (mdr eu 2017/745 annex xiv, part b). consequently, there is a need for an observational study to provide data to demonstrate patient benefit and regulatory compliance. the geko™ cross therapy registry - edema (gekotm ctr - edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months. this study forms part of the overall post-market clinical follow-up strategy for the device and post market surveillance (pms) to support device and performance.

Eligibility criteria:
inclusion criteria: * male or female aged ≥ 18 years and able to provide written informed consent. * intact healthy skin at the site of gekotm device application. * subjects receiving gekotm therapy as part of their standard care for edema reduction. exclusion criteria: * pregnancy or breast feeding. * use of any concurrent neuro-modulation device. * trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve. * no involuntary movement of the lower leg/foot at the maximum tolerable device setting. * bilateral lower limb surgical intervention. * unicondylar knee replacement surgical intervention.
28mm ceramic-on-ceramic total hip replacement study

Conditions: Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis; Post-traumatic Arthritis

Summary: this study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available ceramax™ ceramic on ceramic total hip system. this is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase. in phase one (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. in addition, harris hip evaluations, subjective evaluations and radiographs will be completed annually. in phase two (6 - 10 years), a subjective outcomes questionnaire and a sf-12 health survey will be mailed to subjects annually.

this is a prospective, non-randomized study of the 28mm ceramic on ceramic (coc) device. this study will follow each subject through 10 years postoperatively and will consist of: 1. a clinical follow-up phase and 2. a clinical outcomes phase. radiographic and clinical follow-up exams will take place at six-weeks, six-months and then annually through year 5 for each subject. for years 6 - 10, a communication will be sent to each subject in order to collect survivorship and general health information. this communication will ask whether the coc device is still in vivo and, if not, when the revision surgery took place, why, and which components were removed, if applicable. in addition, subjects will be asked to complete a sf-12 health survey at each 6 to 10-year follow-up interval. a self-addressed, stamped envelope will be provided to facilitate information return and privacy.

Eligibility criteria:
inclusion criteria: * subjects who were previously enrolled in the coc28 ide study, or * newly recruited individuals who are qualified based on the approved labeling of the device, and; * individuals who are willing and able to provide informed patient consent for participation in the study; * individuals who are willing and able to return for follow-up as specified by the study protocol; and * individuals who are willing and able to complete the hip outcomes questionnaire and sf-12 health survey as specified by the study protocol exclusion criteria: * in the opinion of the investigator, the individual does not qualify based upon approved labeling requirements.

Keywords: total hip replacement total hip arthroplasty hip joint replacement hip prosthesis replacement
donor lymphocyte infusion with azacitidine to prevent hematologic malignancy relapse after stem cell transplantation

Conditions: Acute Myelogenous Leukemia; Acute Lymphoid Leukemia; Juvenile Myelomonocytic Leukemia; Myelodysplastic Syndrome

Summary: the goal of this study is to determine whether post-transplant consolidation with azacitidine combined with donor lymphocyte infusion (dli) is a safe and effective approach for the prevention of relapse in pediatric and young adult patients with hematologic malignancies who have undergone hematopoietic stem cell transplantation (hsct).

this is a phase ii single-arm trial of azacitidine (iv or sc) in combination with escalating donor lymphocyte infusion (dli). patients will be enrolled on the study by day +28 +/- 7 post-transplant, prior to withdrawal of immunosuppression or administration of donor lymphocyte infusion (dli). they will have donor chimerism and minimal residual disease (mrd) testing from peripheral blood (pb) and bone marrow (bm) on day +28 ± 7. patients will be stratified according to risk categories (low, standard and high), defined by gvhd status, mixed versus full donor chimerism, and positive versus negative mrd results. depending on risk assessment, immunosuppression will be tapered according to standard or fast schedules, and patients (with the exception of low-risk all patients) will receive one cycle of low-dose azacitidine (40mg/m2 iv/sc daily x 4 days). after tapering immunosuppression, chimerism will be repeated and patients will receive up to 6 additional cycles of low-dose azacitidine, depending on risk assessment. for patients who meet criteria for high risk of relapse, azacitidine will be combined with escalating doses of dli for a maximum of 7 cycles in total. risk and safety assessments, including routine laboratory parameters, donor chimerism, minimal residual disease, and ghvd activity will be assessed following each cycle. chimerism and minimal residual disease testing will be repeated every cycle by peripheral blood (pb), and bone marrow (bm) will be tested every other cycle. patients will be followed by laboratory monitoring and physician evaluation prior to each cycle, and will be followed for two years post-transplant to study toxicity and gvhd outcomes.

Eligibility criteria:
inclusion criteria: * patients age 0 - 29.9 years undergoing allogeneic peripheral blood stem cell transplant * patients with acute myelogenous leukemia (aml) or acute lymphoblastic leukemia (all) * patients with juvenile myelomonocytic leukemia (jmml) * patients with myelodysplastic syndrome (mds) exclusion criteria: * patients who have had a prior transplant. * patients with fanconi anemia or other cancer-predisposition syndromes * patients with expected survival \<12 weeks * lansky score \<60%

Keywords: pediatric leukemia myelodysplastic syndrome azacitidine
impact of pre-operative web-based breast cancer information on the quality of patient decision-making

Conditions: Breast Cancer; Knowledge, Attitudes, Practice

Summary: this is a prospective randomized control trial to compare the impact of two different types of pre-operative web-based breast cancer information on the quality of patient decision making. patients are emailed web-based information prior to the surgical consultation. outcomes are assess at multiple time points: 1) prior to the surgical consultation, 2) immediately following the consultation.


Eligibility criteria:
1. \>18 years of age 2. newly diagnosed stage 0-3 breast cancer 3. english speaking 4. has an email address 5. no prior recent contact with the breast surgeon
smcv assessment on brain swelling in patients with sah from ruptured artery aneurysm

Conditions: Arterial Aneurysm

Summary: superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous dsa examinations

superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous dsa examinations.to explore the relationship between the structure of middle and superficial cerebral veins in cerebral angiography and cerebral edema after ischemia-reperfusion of anterior circulation with large core infarction.

Eligibility criteria:
inclusion criteria: * age 18-70 years; * hunt-hess grade iv-v on admission; single aneurysm in the anterior circulation; interventional embolization of aneurysm is the first choice, and preoperative ventricular puncture drainage and intracranial pressure probe placement. exclusion criteria: * hunt-hess grade i-iii on admission; * patients with blood bubble-like aneurysm or accompanying intracranial hematoma who are not suitable for interventional embolization; those who directly choose craniotomy and clipping; * poor general condition or combined with pregnancy , malignant tumors, etc.

Keywords: brain swelling,subarachnoid hemorrhage,artery aneurysmal
18-month study of long-term efficacy & safety of safinamide as add-on therapy in patients with mid-late stage pd

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.


Eligibility criteria:
inclusion criteria: * the patient completed 24 weeks of treatment in study 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at weeks 12 and 24, as part of the retrieved dropout (rdo) population. * the patient was compliant with taking study medication in study 016. * the patient is willing to participate in the study and signed an approved informed consent form. exclusion criteria: * the patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study. * the patient has shown clinically significant deterioration during participation in study 016, and has reached hoehn and yahr stage v. * the patient discontinued study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at weeks 12 and 24.

Keywords: parkinson's disease pd levodopa patients with idiopathic parkinson's disease with motor fluctuations,
selective criteria and a modified technique of applying "uragpi" technique for more proximal degree of hypospadias

Conditions: Hypospadias

Summary: hypospadias is a condition in which the location of the urethral meatus is on the ventral aspect of the penis. hypospadias is the most common congenital anomaly of urogenital organs in boys, with an incidence of approximately 1 in 250 newborns. recently, case selection has been advised to avoid possible complications and limitations \[1\]. the meatal advancement and glanuloplasty (magpi) procedure was first described in 1981 for the repair of distal hypospadias. an excellent surgical result requires careful case selection, avoiding cases with thin or rigid ventral para-meatal skin or a meatus too proximal or too wide. the glans wrap to support the advanced ventral urethral wall requires a solid tissue approximation in two layers to prevent regression of the meatus. meatal stenosis can be avoided by assuring an adequate dorsal heineke- mikulicz tissue rearrangement and making an incision from within the urethral meatus well distally into the urethral groove. . the overall success rate with the magpi procedure suggests that it should continue to be used in the repair of distal hypospadias \[2\]. the advantage of urethral advancement, glanuloplasty, and preputioplasty \&quot; uragpi\&quot; versus magpi is that a) applicability to almost any type of distal hypospadias regardless of the severity of glanular ventriflexion. b) normal appearance of the penis. c) good functional results.


Eligibility criteria:
inclusion criteria: * all patient with hypospadias from 1 to 12 years with penile selection according to wang yn et. al exclusion criteria: * circumcised patients * sever degrees of chordae * previous surgical repair * meatal stenosis
cefiderocol pk in patients on ecmo

Conditions: Sepsis

Summary: extracorporeal membrane oxygenation (ecmo) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. it is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. there is a need to understand how ecmo circuits affect the pharmacokinetics and disposition of drugs. this study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, cefiderocol, in critically ill patient receiving ecmo.

this is a prospective, open-label, phase 1b, pharmacokinetic study of cefiderocol in 8 critically ill patients receiving ecmo support at hartford hospital. informed consent will be collected from all study participants, legal authorized representative, or their next of kin in order to participate. this is not a treatment study; all participants will receive other antibiotics as necessary to treat any current infection.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * on support with veno-venous- or veno-arterial-ecmo exclusion criteria: * females who are pregnant or breast-feeding * history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication) * receiving cefiderocol to treat documented or suspected infection within 72 hours of screening, or expected to receive cefiderocol during the study intervention phase * severe renal dysfunction defined as a crcl \< 15 ml/min (as calculated by the cockcroft gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis * a hemoglobin less than 7.2 gm/dl at baseline * acute liver injury, defined as aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 5 times the upper limit of normal, or ast or alt \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal * any rapidly progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator) * any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data.

Keywords: pharmacokinetics cephalosporins