Kornimate/medical-research-clean huggingface dataset:
pediatric rehabilitation for children with cerebral palsy through pvt using ai to reduce spasticity

Conditions: Cerebral Palsy

Summary: the study foucs on pediatric rehabilitation for children with cerebral palsy through personalized vibration therapy powered by artificial intelligence.

innovative approach to reduce spasticity, improved motor function, quality of life. vibration therapy reduces spasticity by activating the body's natural stretch reflex, which in turn triggers muscular contractions. furthermore, it has been proposed that the primary ends of the muscle spindle ia afferent are stimulated by muscular vibration. this leads to the excitation of alpha motor neurons, subsequent contractions of motor units, ultimately producing a tonic muscle contraction. this study will modify vibration therapy by introducing artificial intelligence to rehabilitate the patients suffering from spastic cp.

Eligibility criteria:
inclusion criteria: * diagnosed spastic cp as per neurologist report, gmfcs level i-iii * ability to safely withstand intensity of vibrating device. * have no planned surgery within 5 months before/after entering the study exclusion criteria: * a bone fracture within 12 weeks of enrollment. * history of using anabolic agents, glucocorticoids (excluding inhaled), or growth hormone (regardless of dose) for at least 1 month, within the 3 months prior to enrollment. * history of botulinum toxin injection into the lower limb(s) within the 3 months before enrollment. * history of an illness or findings on physical examination that might prevent the child from completing the study (e.g., acute thrombosis, tendinitis).
exploration of anticoagulation program in cerebral aneurysm and arteriovenous malformations with hybrid operation 1

Conditions: Cerebral Aneurysm; Arteriovenous Malformations

Summary: in the stage of registration study, our purpose is to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation.

this study is divided into anticoagulation program in cerebral aneurysm with hybrid operation and anticoagulation program in cerebral arteriovenous malformations with hybrid operation two parts, and each part divide into two stage, on the stage of registration study. this study is a multi-center, single-blind, prospective cohort study. record the patient's intraoperative activated coagulation time changes in detail, to observe the effect of activated coagulation time maintenance level on hemorrhage event rate of intraoperative and postoperative 48 hours, purpose to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation. on the stage of randomized controlled study. this study is a multicenter, single-blind, prospective, randomized controlled study. patients is divided into intraoperative standard dose group of heparin sodium and low dose group of heparin sodium randomly. to observe the effect of different anticoagulation regimens on activated coagulation time safety coverage rate during surgery, and finally develop a scientific and effective intraoperative anticoagulant therapy program.

Eligibility criteria:
inclusion criteria: 1.all patients undergoing hybird surgery. exclusion criteria: 1. poor general condition , severe primary disease, surgical contraindications 2. patient or family refused surgery 3. fusiform aneurysm,traumatic aneurysm,infectious aneurysms 4. combined with other hemorrhagic cerebrovascular disease 5. combined with malignant brain tumor 6. perinatal, pregnancy 7. patients unwilling to participate in the trial

Keywords: cerebral aneurysm arteriovenous malformations hybrid operation anticoagulation
comparison of physical activity regimens as treatments for obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to compare the efficacy of two different physical activity regimens as complementary or alternative treatment options for the treatment of obstructive sleep apnea. a secondary purpose of the study is to examine the effects of these activity regimens on various health consequences of obstructive sleep apnea, including blood pressure, systemic inflammation, and daytime functioning.


Eligibility criteria:
inclusion criteria: * moderate-intensity obstructive sleep apnea (ahi \>= 15) * sedentary status exclusion criteria: * current treatment for obstructive sleep apnea (cpap, oral devices, etc.) * significant cardiovascular, pulmonary, or metabolic disease * uncontrolled hypertension * inability to exercise (e.g., musculoskeletal, neuromuscular, orthopedic problems)

Keywords: obstructive sleep apnea exercise training aerobic exercise resistance exercise
study in adults and adolescents with seasonal allergic rhinitis.

Conditions: Rhinitis, Allergic, Seasonal

Summary: compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. the focus of this study, seasonal allergic rhinitis (sar), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. commonly referred to as 'hay fever', it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.


Eligibility criteria:
inclusion criteria: * informed consent. * must be an outpatient. * females must be using appropriate contraception. * must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen. * must be able to comply with study procedures. * must be literate. exclusion criteria: * a significant concomitant medical condition. * use of corticosteroids or allergy or medications or tobacco. * clinically significant abnormal ecg. * laboratory abnormality. * positive pregnancy test. * allergy to any component of the investigational product.

Keywords: seasonal allergic rhinitis intranasal corticosteroid
randomised placebo-controlled venlafaxine-referenced study of efficacy and safety of 5 and 10 mg of vortioxetine (lu aa21004) in acute treatment of major depressive disorder in adults

Conditions: Major Depressive Disorder

Summary: the purpose of this venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of vortioxetine in the acute treatment of major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * mde as primary diagnosis according to dsm-iv-tr criteria (classification code 296.xx) * current mde duration of at least 3 months and less than 12 months * the patient has a madrs total score \>=30 exclusion criteria: * any current psychiatric disorder other than mdd as defined in the dsm-iv tr * any substance disorder within the previous 6 months * female patients of childbearing potential who are not using effective contraception * use of any psychoactive medication 2 weeks prior to screening and during the study other protocol-defined inclusion and exclusion criteria may apply.

Keywords: major depressive disorder placebo-controlled active reference multicenter study randomised study acute treatment
long-term recurrence rates of atrial fibrillation following new-onset atrial fibrillation during icu admission

Conditions: Atrial Fibrillation

Summary: the primary objective of the study is to establish the one-year recurrence rates of atrial fibrillation (af) following new-onset atrial fibrillation during intensive care unit (icu) admission. the secondary objective is a composite of death from cardiovascular causes, stroke (either ischemic or hemorrhagic), or hospitalization with worsening of heart failure or recurrent af. the prevalence and recurrence rates of af will be divided into sub-groups based on primary icu admission diagnosis. all-cause mortality.

patients will be screened for atrial fibrillation during hospitalization in the intensive care unit and will be followed until discharge. once discharged home or to a rehabilitation center, they will be invited to a routine follow-up clinic at rmc cardiology institute 4-6 weeks after hospital discharge. during the clinic visit, patients will be recruited to the study follow-up plan. the follow-up plan will consist of 3 clinical visits at 4-6 weeks, 6-months and 1 -year after discharge. the follow-up program will include a comprehensive screening for symptomatic and asymptomatic atrial fibrillation events as following: patients will be provided with a home cellular-digital 12-lead ecg transmitter. they will be instructed to conduct routine weekly transmission in order to record asymptomatic events as well as to transmit at any time they suspect an event/feel symptoms (palpitations). home routine testing will be initiated and guided by a telephone call from a medical monitoring center. a blinded, independent, on-call medical professional team will analyze the received ecg. a 48-hour holter ecg will be performed at 6 months and 12 months after icu discharge clinical visits will include 12 leads ecg, physical examination, vital signs, symptoms evaluation for suspected af events, questioning for hospital admissions, or any other documented af event. patients will be asked to perform echocardiography as part of their clinical evaluation. for both the study and control group, documented af events will be managed according to physician discretion based on clinical practice and guidelines. long-term follow-up- 3 years- data regarding recurrent events of af, hospitalization due to thromboembolic events, and mortality will be evaluated by telephone call or by matching patient identification numbers with the israeli national population register.

Eligibility criteria:
inclusion criteria: * admitted to icu over 24 hours * diagnosed with new-onset atrial fibrillation * the patient survived the index hospitalization and was discharged home/ to a rehabilitation center. exclusion criteria: • previously documented atrial fibrillation

Keywords: atrial fibrillation intensive care unit
post-market clinical follow up for total knee arthroplasty system madison

Conditions: Knee Arthropathy

Summary: madison total knee prosthesis is intended to be used for total knee arthroplasty to reduce pain and restore joint mobility of the knee. clinical data for madison total knee prosthesis available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product. thus, in order to maintain compliance with the eu regulation (2017/745) related to medical devices and following iso 14/155:2020, serf has set up post-market clinical follow-up study (pmcf) to confirm safety and performance of total knee arthroplasty system madison. this study is designed to cover the expected 15-years follow-up, to retrieve data according to implant feature (posterior stabilized or ultra congruent) or fixation method and to gather data related to the revision of partial knee prosthesis. the primary objective of this study is to assess the clinical safety of madison total knee prostheses. the secondary objective is to evaluate the survival rates, the clinical performances and clinical benefits of madison total knee prosthesis.


Eligibility criteria:
inclusion criteria: * male or female adults (≥ 18 years) covered by french social security system * diagnosed with: * osteoarthritis (primary and secondary), * revision of a unicompartmental knee prosthesis. * patient requiring a surgery and implantation of a madison tka (total knee arthroplasty) * patient physically and mentally able to comply with protocol, meet the follow-up visits as deemed by the investigator and fill in quality of life questionnaire. * patient having signed a written informed consent exclusion criteria: * progressive, acute or chronic infection, local to the operative site or systemic that may affect the prosthetic joint, * any loss of musculature or serious lesions of muscles, nerves and/or blood vessels deficiency, putting the affected limb at risk, * lack of bone substance or inadequate bone quality on femoral or tibial surfaces, as it might compromise the stability of the prosthesis components, * skeletal immaturity, * pathologies that may compromise the functionality of the implant in any way (i.e. osteomyelitis, neuropathic joint), * parameters incompatible with satisfactory long-term results (i.e. age, weight, * neurological condition of the patient incompatible with the post-operative constraints associated with this type of intervention, * known allergy to one of the implant components. * severe obesity with or without comorbidities * pregnant or nursing women, * patients with a contraindication to radiography * patients deprived of their liberty or hospitalised without their consent * patients under legal protection (e.g. guardianship)

Keywords: total knee prosthesis
retrospective efficacy and safety study with elbasvir/grazoprevir in hcv-infected patients with chronic kidney disease

Conditions: Hepatitis C; Chronic Kidney Diseases

Summary: retrospective efficacy and safety study with elbasvir (ebr) 50 mg/grazoprevir (gzr) 100 mg in hepatitis c virus (hcv)-infected patients with chronic kidney disease (ckd) stage 4-5 during the french temporary authorization for use (atu) program: data from real-life

primary objective : retrospectively collect and describe the real life efficacy (svr 12)\* and safety data of ebr 50 mg/gzr 100 mg based therapy, 12 or 16 weeks dosed in hcv-infected patients with chronic kidney disease. these data are collected following french atu allocation.

Eligibility criteria:
inclusion criteria: * documented chronic (at least 6 months) hcv genotype1 (gt1) and genotype 4 (gt4) infection * mono infected by hcv or co-infected by hcv and hiv * have an hcv treatment status corresponding to one of the following: 1. treatment-naïve: naïve to all anti-hcv treatment 2. prior interferon or pegylated interferon + ribavirin treatment failure (null responders, partial responders, relapsers) 3. prior interferon (ifn) or pegylated (peg)-ifn + ribavirin + telaprevir or boceprevir or simeprevir treatment failures 4. prior sofosbuvir based therapy failures 5. pegylated interferon ribavirin intolerant * have ckd defined as: subjects with glomerular filtration rate (gfr) ≤30 ml/min who are non-dialysis dependent (ndd) or have been on hemodialysis (hd) for at least 3 months (including subjects awaiting kidney transplant and subjects with failed kidney transplants no longer on immunosuppressant therapy). exclusion criteria: * none
interaction between cocaine and quetiapine - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to assess the safety of intravenous (iv) cocaine in subjects taking quetiapine at 3 dosage levels.

a placebo-controlled, double-blind, inpatient assessment of interaction between intravenous cocaine and quetiapine (seroquel) in cocaine-experienced subjects. to assess the safety of iv cocaine in subjects taking quetiapine at 3 dosage levels.

Eligibility criteria:
inclusion criteria: includes but is not limited to: non-treatment seeking individuals. must meet dsm-iv criteria for cocaine abuse or dependence. must be able to verbalize understanding of consent and provide written informed consent and verbalize willingness to complete study procedures. site will provide further details. exclusion criteria: please contact site for further information
a study to assess the pharmacokinetics and safety of bimekizumab in children and adolescents with moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the purpose of the study is to assess the pk of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (hs)


Eligibility criteria:
inclusion criteria: * study participant must be 12 to \<18 years of age at the time of informed consent/assent, at tanner stage 2 or more, for the first 8 participants only, followed by also including participants ≥9 to \<18 years of age at tanner stage 2 or more. * study participant must have a diagnosis of hs for at least 6 months prior to the baseline visit. * study participant must have moderate to severe hs, defined as a total of ≥5 inflammatory lesions (ie, the sum of abscesses and inflammatory nodules), as assessed at both the screening and baseline visits. * study participant must have hs lesions present in at least 2 distinct anatomic areas, 1 of which must be at least hurley stage ii or iii, as assessed at both the screening and baseline visits. * study participant must have had a history of inadequate response to a course of a systemic antibiotic for treatment of hs * study participant must weigh ≥30kg at the screening visit. exclusion criteria: * study participant has a draining tunnel count of \>20 at either the screening or baseline visits. * study participant has experienced primary failure (no response within 12 weeks) to 1 or more il 17 biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) or primary failure to more than 1 biologic response modifier other than an il-17 biologic response modifier. * study participant has previously participated in this study or has received previous therapy with bimekizumab. * study participant has a history of ibd or symptoms suggestive of ibd. * history of active tuberculosis unless successfully treated, latent tb unless prophylactically treated * study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) * study participant has received drugs outside the specified timeframes relative to the baseline visit or receives prohibited concomitant treatments * study participant has the presence of active suicidal ideation, or positive suicide behavior, * study participant diagnosed with severe depression in the past 6 months prior to the screening visit. * study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study.

Keywords: bimekizumab hs hidradenitis suppurativa
extension study to evaluate safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of abbv-951 in adult participants with parkinson's disease

Conditions: Parkinson's Disease (PD)

Summary: parkinson's disease (pd) is a neurological condition, which affects the brain. pd gets worse over time, but how quickly it progresses varies a lot from person to person. some symptoms of pd are tremors, stiffness, and slowness of movement. the purpose of this study is to continue testing whether abbv-951 is safe, effective, and tolerable in participants with parkinson's disease after completion of the parent study m15-741. abbv-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (ldp/cdp) given as infusion under the skin for the treatment of parkinson's disease. participants who have successfully completed m15-741 study will immediately enter this study's treatment period to continue receiving abbv-951. adult participants with advanced pd will be enrolled. approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide. participants will receive continuous subcutaneous infusion (csci) of abbv-951 for 24 hours daily during the primary treatment period and during the optional extended treatment period. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.


Eligibility criteria:
inclusion criteria: * participants who have parkinson's disease and who have successfully completed the parent study m15-741. * participants willing and able to comply with procedures required in the protocol. exclusion criteria: - participants, if judged by the investigator to be unsuitable candidates to continue to receive abbv-951 for any reason.

Keywords: parkinson's disease (pd) abbv-951 levodopa/carbidopa (ld/cd) levodopa phosphate/carbidopa phosphate (ldp/cdp)
efficiency and tolerance of hazelnut oral immunotherapy protocol in hazelnut allergic children

Conditions: Allergy, Nut; Pediatric ALL

Summary: prevalence of food allergy in the world has been inscreasing in recent years. among nut allergy, hazelnut allergy is the most widespread in europe and particularly in france. the current treatment for hazelnut allergy is based on eviction and wearing of an emergency kit with adrenaline auto-injector pens, to be used in the event of severe anaphylactic reaction. oral immunotherapy (oit) is a treatment that is now increasingly being offered as an alternatice to eviction. there are few published data concerning hazelnut oit in europe, where its consumption is nevertheless very high. the main objective of our study is to evaluate the clinical efficacy of the hazelnut oit protocol, implemented since 2015 in the pneumology and allergology-paediatric department of the mother and child hospital in bron, in hazelnut allergic children under 18 years old. the secondary objectives will be to evaluate the biological efficacy and clinical tolerance of the protocol. the study is retrospective and observational, and is based on the collection of medical data from patient records.


Eligibility criteria:
inclusion criteria: * aged under eighteen years old * hazelnut allergy (clinically and biologically) * under iot hazelnut protocol in pneumo/allergology-paediatric departement of the mother and child hospital in bron exclusion criteria: * lack of consent to be included in the study (by their parents) * age \> 18 years old

Keywords: hazelnut oral immunotherapy children protocol efficiency tolerance
beta-cell function after near-normalisation of blood glucose

Conditions: Type 2 Diabetes

Summary: the incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. the aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to gip and glp-1 in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * age 18-70 years * type 2 diabetes diagnosed after 30 years of age * bmi \> 25 exclusion criteria: * severe complications to diabetes * abnormal liver and kidney function * haemoglobin below the lower limit * macroalbuminuria * systemic disease * pregnancy
a study to evaluate the efficacy and safety of dexycu® for the treatment of ocular pain associated with cataract surgery

Conditions: Cataract

Summary: a study to evaluate the efficacy and safety of dexycu® for the treatment of ocular pain associated with cataract surgery

a phase 3, prospective, randomized, double-masked, placebo-controlled, parallel-design, multicenter study to evaluate the efficacy and safety of dexycu® for the treatment of ocular pain associated with cataract surgery

Eligibility criteria:
inclusion criteria: * male or female subjects at least 40 years of age scheduled for cataract surgery * best corrected visual acuity (bcva) of 20/30-20/200 in the study eye * must be considered by the investigator to have visual (va) acuity potential greater than 20/30 in the study eye. exclusion criteria: * use of any corticosteroids within 7 days prior to day 0 * injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days * score greater than "0" on the ocular pain assessment in the study eye at screening.