Kornimate/medical-research-clean huggingface dataset:
long term outcomes of lumbar epidural steroid injections for spinal stenosis

Conditions: Lumbar Spinal Stenosis

Summary: spinal stenosis is one of the most common causes of low back pain among older adults and can result in significant disability. despite this, it still isn't known which treatments are most effective or what outcomes are most important to these older adults. through a patient centered outcomes research institute (pcori) contract, the investigators are building on the existing infrastructure of an ahrq-funded (arra choice award) comparative effectiveness research (cer) trial of epidural steroid injections (esi) for spinal stenosis (the less trial) to address several critical research questions. the proposed study will answer the following key questions. do decision aids tailored to older adults with spinal stenosis change patient decision-making regarding subsequent treatments? do patients respond differently at subsequent outcome assessments time-points after receiving tailored decision aids that contain their own individual outcome data from prior treatments? the investigators hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.

less trial participants will be randomized to receive the individualized outcome report before the 18-month interview or after the 24-month follow up. both groups will be asked to rank outcome domains of most importance to them, to answer questions regarding their beliefs about receiving future treatments for spinal stenosis and to complete the standard self-reported outcomes questionnaire. in addition, we will ask the study participants whether the information presented in the individualized report was helpful in deciding their future epidural injection treatments as well as if the content of the reports was easy to understand. at 24 months, we will repeat the interview and the outcomes assessment. we will again compare the groups in terms of their responses to determine if there are lasting differences in how patients who received the individualized reports make decisions regarding future treatments and respond to the self-reported outcomes questions. in addition, we will compare healthcare utilization between the two groups from 18 months to 24 months to determine if providing the individualized outcomes reports changed treatment utilization (i.e., do people who receive the report undergo fewer subsequent injections or other treatments for pain?). we hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.

Eligibility criteria:
inclusion criteria: patients already enrolled in the less trial will be eligible for participation in the lesser trial exclusion criteria: none
evaluation of safe use of securidrap® selfia®

Conditions: Disorientation; Cognitive Impairment; Behavior Disorders

Summary: interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 french establishments in order to assess the safety of the sécuridrap® selfia® bedding by mesasuring all the adverse events likend to its use. following the withdrawal from the market of the first version of the securidrap® selfia®, this clinical investigation is being carried out at the request and on the recommandation of the asnm in order to assess the safety of the second version of the securidrap® selfia® coating.

the proposed study is a prospective, multicenter, interventional and non-comparative research. this clinical investigation is carried out in real life in accordance with the usual care for all patient with a prescription for securidrap® selfia® and who meet the eligibility criteria, in nursing homes and public and private hospitals based in france. this interventional clinical investigation with minimal risks and constraints aims to confirm the safety of use of securidrap® selfia® in healthcare establishment. the patient will be followed for 15 nigths, during witch an independent assessor will ensure that the conditions of use os the securidrap® selfia® sleeping bag are respected.

Eligibility criteria:
inclusion criteria: * patient at least 18 years old * patient having a medical prescription for sécuridrap® selfia® * patient in phase or state of disorientation * patient with nocturnal behavior disordre * patient with major cognitive impairment * patient at risk of falling into bed * patient subject to guardianship or curatorship * patient beneficiary or affiliated to a social security scheme * patient who has given their participation agreement aand informed consent exclusion criteria: * patient and/or guardianship or curatorship refusing to agree to participate in the clinical investigation * patient in psychiatry * patient with severe agitation * patient who will be agitated once installed in the sécuridrap® selfia® * patient with intolerance to the medical device * patient able to extract himself from sécuridrap® selfia® * patient able to unlock the bed rails by himself * patient without social coverage or not benefiting from it through a third party * patient minor, pregnant woman, persons deprived of their liberty * patient who participating or having participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion

Keywords: disorientation nocturnal behavioral disorders major cognitive impairment
study of ptg-300 in non-transfusion dependent and transfusion-dependent beta-thalassemia subjects with chronic anemia

Conditions: β-thalassemia; Ineffective Erythropoiesis; Chronic Anemia

Summary: this is a phase 2 open-label, single-arm design study with dose escalation by subject cohort . the study is designed to monitor the ptg-300 safety profile, to obtain preliminary evidence of efficacy of ptg-300 for the treatment in β-thalassemia.

this is a phase 2 open-label, single-arm design study with dose escalation by subject cohort and with the potential for individual titration (dose increase or decrease) within each cohort. the study is designed to monitor the ptg-300 safety profile, to obtain preliminary evidence of efficacy of ptg-300 for the treatment of chronic anemia in β-thalassemia and to evaluate the appropriate dosing regimen for ptg-300 in the target population

Eligibility criteria:
main inclusion criteria: 1. male and female subjects aged 18 to 65 years, inclusive (cohorts 1-4b). 2. male and female subjects aged 12-\<18 years, with a minimum weight of 30 kg (cohorts 5 and 6). 3. documented diagnosis of β-thalassemia with no other hgb abnormality. inclusion criteria applicable only for ntd β-thalassemia subjects: 1. mean hgb \< 10.0 g/dl of two measurements (one performed 7-28 days prior to dosing and the other performed within 7 days prior to dosing). 2. requirement of \< 6 units rbc transfusion in a 24 week period with the last transfusion at least 8 weeks before screening. inclusion criteria applicable only for td β-thalassemia subjects: 1. transfusion requirement of at least 6 units of rbc in the 24 weeks prior to screening with no transfusion free period \> 45 days. 2. last rbc transfusion 5-10 days prior to dosing. main exclusion criteria: 1. subjects with sickle cell disease, hgb h, hb bart's hydrops foetalis or hemoglobin s 2. infection requiring hospitalization or iv antimicrobial therapy, or opportunistic infection within 6 months of dosing, any infection requiring antimicrobial therapy within 2 weeks of dosing; history of infection with human immunodeficiency virus (hiv). 3. subject has a concurrent clinically significant, unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic or other medical disorder that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject by their participation in the study. 4. known primary or secondary immunodeficiency. 5. history within 6 months of screening of any of the following: myocardial infarction, unstable angina, transient ischemic attack, decompensated heart failure requiring hospitalization, congestive heart failure (new york heart association class 3 or 4), uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension (resting systolic blood pressure \[bp\] \> 160mmhg or resting diastolic bp \> 100mmhg on more than one occasion) or uncontrolled diabetes (hgb a1c \> 9% or \> one episode of severe hypoglycemia). 6. pregnant or lactating females.

Keywords: chronic anemia β-thalassemia
comparison of co-op and gdt on occupational performance and functional status in the cp

Conditions: Cerebral Palsy; Occupational Problems; Cognitive Orientation; Goals

Summary: this study was designed as a three-armed, single-blinded, randomized, controlled trial to examine the effectiveness of co-op and gdt interventions on occupational performance and functional status in children with cp compared with their usual care.

cerebral palsy (cp) is a group of neurological disorders that affect movement, muscle tone, and posture, causing activity limitations that originated in the developing fetal or infant brain that are attributed to non-progressive disorders. symptoms such as spasticity and contracture in cp cause a decrease in functional skill level with limitations in daily living activities such as learning a new skill or self-dressing and handwriting. in this disease, the simultaneous presence of sensory, cognitive, perceptual, and behavioral impairments significantly undermines the acquisition and execution of functional skills, autonomy in daily living, and active engagement in leisure activities. this study was planned to investigate and compare the impact of co-op and gdt on the occupational performance and functional status of children with cp.

Eligibility criteria:
inclusion criteria: * being between 5-10 years of age * being diagnosed with cp * having adequate language abilities to make contact with a therapist and be informed during intervention. exclusion criteria: * they were receiving any other treatment * they had been diagnosed with mental retardation * they had serious vision or hearing problems.

Keywords: cerebral palsy occupational performance functional status co-op goal directed training
the effects of virtual reality patients with obstetric brachial plexus injury

Conditions: Obstetric Brachial Plexus Injury

Summary: obstetric brachial plexus injury is the flask paralysis of the arm, which emerges from a difficult birth. this results from the damage to the nerves from the c5 cervical root to t1. following brachial plexus injury, movement impairment, a decrease in the joint range of motion, muscle contractures, motor disorders related to muscle weakness, and the loss of functional movements are commonly observed. many rehabilitation programs for the upper extremity aim at developing functional improvement in addition to increasing the active range of motion of the related limb in children with obstetric brachial plexus injury. obstetric brachial plexus injury treatment includes both conservative and surgical interventions. the first intervention in all the obstetric brachial plexus injury cases is conservative. in recent years, supporting the treatment with virtual reality exercises in addition to the conventional brachial plexus rehabilitation is a method being tested. the use of virtual reality treatment in physiotherapy and rehabilitation has substantially increased within the last 6-7 years. virtual reality is a method that enables working with task-based techniques by creating stimulating and entertaining environments and especially using children's interest and motivation. nintendo wii, which is used in the virtual reality treatment, is a device that can be controlled wirelessly, consists of a system console, remote control for activity control, and a sensor perceiving the change in movements, and a display screen, and gives the opportunity to work with the person individually. the aim of this study is to investigate the effects of the conventional physiotherapy approach and virtual reality applications with nintendo wii, applied additionally in this study, on upper extremity functions in children with obstetric brachial plexus injury. they can directly be mentioned as the effects on muscle strength, normal joint range of motion, and functionality.


Eligibility criteria:
inclusion criteria: * undergone primary or -if available- secondary surgery at least 6 months before * being between the ages of 5-13 * be affected by the c5-c6 (upper truncus) exclusion criteria: * patients with severe cognitive functional disorder * patients with cognitive functions inadequate for communication * patients with any neurological problems * patients who have a contracture preventing the upper extremity joints from performing activities
evaluating the success of habitual multifocal wearers when refit with a new lens design

Conditions: Presbyopia

Summary: the objective of the study was to adapt existing multifocal soft lens wearers to a control lens for 2 weeks and then evaluate the success of switching them to the test lens, with a review after 2 weeks.

this was a prospective, crossover, bilateral daily wear, and subject masked dispensing study. the habitual contact lenses were not optimized. there was no randomization of the study lenses, participants wore the control lenses for the first wear period and the test for the second wear period. participants wore each study lens for 3-7 days and then attend a prescription optimization visit. after this optimization visit, they wore each study lens for a 2-week period. during the 2-week wear period, participants recorded their subjective lens-wear experience remotely.

Eligibility criteria:
inclusion criteria: 1. is at least 42 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. self reports having a full eye examination in the previous two years; 4. anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week; 5. is willing and able to follow instructions and maintain the appointment schedule; 6. habitually wears multifocal soft contact lenses, for the past 3 months minimum; 7. has refractive astigmatism no higher than -0.75dc; 8. is presbyopic and requires a reading addition of at least +0.75d and no more than +2.50d; 9. can be fit and achieve binocular distance vision of at least 20/30 snellen (or +0.20 logmar) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00ds) exclusion criteria: 1. is participating in any concurrent clinical or research study; 2. has any known active\* ocular disease and/or infection that contraindicates contact lens wear; 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; 5. has known sensitivity to the diagnostic sodium fluorescein used in the study; 6. self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 7. has undergone refractive error surgery or intraocular surgery.
reduction of rocuronium-induced injection pain with aspiration of blood

Conditions: Anesthesia, General

Summary: the goal of this clinical trial is to learn about reduction of rocuronium injection pain in participants receiving general anesthesia. the main question aims to answer is whether diluting rocuronium with blood can reduce rocuronium injection pain. rocuronium is a rapid onset muscle relaxant used in general anesthesia. lidocaine is a local anesthetic. researchers will • inject diluted rocuronium in participant's intravenous catheter during induction. • record withdrawal movement and rocuronium onset time and duration measured by train-of-four (tof). researchers will compare between rocuronium diluted with blood, lidocaine and normal saline to see if blood can reduce rocuronium injection pain.

this clinical trial uses a random table for sequential randomization, randomly assigning subjects to 3 groups, each consisting of 40 participants. researcher will confirm the patency of peripheral intravenous lines before induction. if peripheral intravenous lines cannot be used, they will be readministered at another injection site. if there are difficulties in peripheral intravenous injection, the participant will need to withdraw from this clinical trial. the neuromuscular monitoring device (nmt) is installed before the start of the clinical trial to monitor the effects of the drug. to avoid influencing the final results, fentanyl and 2%lidocaine will not be administered before injecting rocuronium. anesthesia induction begins with the administration of oxygen through a mask to assist breathing. initially, propofol is injected at a dose of 1.5 to 2mg/kg. once the participant is confirmed to have lost consciousness, researchers will inject diluted rocuronium immediately, with an injection speed of 10 to 15 seconds. the dose of rocuronium for each participant is 0.8 mg/kg. the first group is pre-diluted with 2ml of normal saline, the second group with 2ml of 2%lidocaine, and the third group with 2ml of the participant's blood. to avoid clotting of blood, the procedure of the third group involves using a syringe containing rocuronium to withdraw 2ml of blood from the vein, followed by simultaneous injection into the intravenous line. the nmt is used to monitor the drug's effects, defining the onset time as the time from rocuronium injection to the disappearance of train-of-four (tof) count t1 and the duration of action as the time from rocuronium injection to the appearance of tof count t1.

Eligibility criteria:
inclusion criteria: * willing to sign the written informed consent form. * males and females aged 18 to 65. * undergoing endotracheal intubation under general anesthesia. * anesthesia physical status classification ii or below. exclusion criteria: * estimated glomerular filtration rate less than 60 * history of cirrhosis or liver failure * neuromuscular disease or neurological symptoms * mental illness * arrhythmia

Keywords: rocuronium injection pain withdrawal movement rocuronium injection pain rocuronium withdrawal movement
recombinant human thrombopoietin (rhtpo) in management of immune thrombocytopenia (itp) in pregnancy

Conditions: Immune Thrombocytopenia; Pregnancy

Summary: this clinical trial is undertaking by qilu hospital of shandong university, aims at evaluating efficacy and safety of rhtpo in management of itp in pregnancy.

the investigators are undertaking a single-center, non-randomized, non-controlled trial of 30 itp patients in pregnancy from qilu hospital of shandong university. itp patients in pregnancy who failed to respond to prednisone, ivig and developed refractoriness to platelet transfusion will be given rhtpo intravenously at a dose of 300u/kg every day. dose will be tapered to 300u/kg every other day when platelet count rise over 50×10\^9/l. maintenance will be continued after delivery and the dose will be further reduced to 300u/kg per week. platelet count, bleeding and other symptoms will be evaluated before and after treatment. adverse events will be recorded throughout the study.

Eligibility criteria:
inclusion criteria: 1. subject is between 18-50 years old. 2. after 12 weeks gestation. 3. diagnosed with itp meeting the diagnostic criteria for immune thrombocytopenia. 4. patients who have no response or relapsed after corticosteroid or ivig. 5. patients developed refractoriness to platelet transfusion. 6. to show a platelet count \< 30×10\^9/l, and with bleeding manifestations. 7. willing and able to sign written informed consent. exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. received second-line itp-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit. 3. current hiv infection or hepatitis b virus or hepatitis c virus infections. 4. severe medical condition (lung, hepatic or renal disorder) other than chronic itp. unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5. have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 6. patients who are deemed unsuitable for the study by the investigator.

Keywords: recombinant human thrombopoietin immune thrombocytopenia pregnancy
multiple sclerosis self monitoring study

Conditions: Multiple Sclerosis

Summary: this study is a multicenter, prospective, randomized controlled trial (rct) to compare the effectiveness of a smartphone-based self-monitoring and self-management tool on control self-efficacy with respect to standard clinical practice for patients with relapsing-remitting multiple sclerosis (rrms). rrms patients will be recruited and screened for study eligibility at four dutch ms centers. following inclusion, participants will be randomly allocated to the intervention group (use of ms sherpa® in addition to standard care) or control group (standard care only). the duration of follow-up is 12 months with study visits at baseline and 12 months, and additional study assessments coupled with every clinical visit as part of standard care during the follow-up period.


Eligibility criteria:
inclusion criteria: 1. signed informed consent form. 2. able to comply with the study protocol, as judged by the investigator. 3. a minimum age of 18 years. 4. have a definite diagnosis of rrms according to the revised mcdonald 2017 criteria. 5. have a length of disease duration of ≥12 months, from date of ms diagnosis. 6. have clinical disease activity (one or more reported relapses) and/or radiological disease activity (new/enlarged t2 lesions or t1 contrast-enhancing lesions) within the past 12 months. 7. willing and able to install and use ms sherpa® on own smartphone with android (version 4.4 or higher) or ios (version 9 or higher) operating system. 8. willing to stay for treatment with the same hospital during the year of study. 9. willing to follow the rules of conduct as described in appendix a during the year of study. exclusion criteria: 1. edss of \> 6.5 at baseline screening. 2. presence of a cognitive, visual or upper extremity deficit that disables the use or measurements of ms sherpa® on the smartphone, as judged by the investigator. 3. concomitant use of health monitoring apps or devices for ms during the study. 4. concomitant participation in another intervention trial in ms.