Kornimate/medical-research-clean huggingface dataset:
a study of at-02 in subjects with systemic amyloidosis.

Conditions: Amyloidosis; Systemic

Summary: this is a phase 2 open-label extension study to evaluate the long-term safety, tolerability, and clinical activity of at-02. at-02 is an investigational medicinal product being developed to treat systemic amyloidosis.

the study will enroll subjects with systemic amyloidosis who have participated in at02-001 study. the study includes screening period (56 days), treatment period (week 104), follow up (week 112). the total duration of participant in study is up to 120 weeks. a safety review committee (src) will periodically convene and review all available clinical and laboratory data during the study. a single src will monitor safety across all at-02 studies to ensure that safety signals are assessed in aggregate.

Eligibility criteria:
inclusion criteria: 1. subject understands the study procedures and can give signed informed consent. 2. subject is willing and able to comply with this protocol and will be available for the entire duration of the study. 3. subject must have a confirmed diagnosis of sa per the diagnostic criteria specified in the parent study protocol. 4. subject must have participated in the study at01-001 and wishes to receive open-label at-02. 5. at02-001 part 2: a. subjects must have completed the last follow-up visit in at02-001 part 2 without significant adverse events, as determined by the investigator. 6. at02-001 part 3: a. subjects must have completed the post-treatment imaging studies in at02-001part 3 (e.g., cmr, echocardiogram) without significant aes in the parent study as determined by the investigator. 7. must continue to satisfy the eligibility criteria in the parent study protocol for wocbp, woncbp, or male participants exclusion criteria: 1. is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during this study and follow-up period. 2. is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis. 3. has acquired any new, clinically significant underlying illness since enrollment in the parent study. 4. has any clinically significant worsening of organ function associated with underlying sa or clinically significant change in concomitant medications for the treatment of sa since enrollment in the parent study. 5. estimated glomerular filtration (egfr) ≤30 ml/min/1.73 m2. 6. currently using any prohibited concomitant medications. 7. any contraindication to mri or mri contrast. 8. is currently participating in an interventional clinical study or has participated in another clinical study (other than at02-001) within the last four (4) weeks or within five (5) half-lives of the prior study treatment, whichever is longer.
post-market clinical follow-up study of alcon total30® contact lenses (lehfilcon a)

Conditions: Ametropia; Myopia; Hyperopia; Astigmatism

Summary: the purpose of this post-market clinical follow-up (pmcf) study is to continuously assess the visual performance and safety of total30 sphere and total30 for astigmatism contact lenses in a real-world setting across a broad variety of patients through routine clinical practices.

the baseline visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a total30 sphere or toric contact lens prescription was released. baseline visit data will be collected retrospectively (chart review). the year 1 visit is defined as the visit that occurs 1 year (-2/+6 months) since the baseline visit during which period the subject is wearing test lenses of the same design in both eyes, and a contact lens examination is performed. year 1 data will be collected either retrospectively or prospectively (eye exam).

Eligibility criteria:
key inclusion criteria: * wearers of lehfilcon a (sphere or toric) contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at the baseline timepoint; * best corrected spectacle visual acuity (va) 20/25 or better at baseline; * healthy, non-diseased eyes; * other protocol-specified inclusion criteria may apply. key exclusion criteria, as determined or known by the investigator: * any ocular disease or condition that would contraindicate contact lens wear present at baseline; * the use of systemic or ocular medications that would contraindicate contact lens wear at baseline; * participation in a contact lens or contact lens care product clinical trial during the period of the retrospective chart collection or during prospective study participation; * other protocol-specified exclusion criteria may apply.

Keywords: contact lenses
clinical trial on the safety and efficacy of optimized transcranial direct current stimulation for the swallowing function in patients with post-stroke dysphagia

Conditions: Deglutition Disorders

Summary: the goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia.


Eligibility criteria:
inclusion criteria: * men and women \>19 years old * patients with stroke confirmed by neuroimaging * first-time stroke patients * patients in subacute or chronic phases of stroke with 3 weeks or more after onset * stroke patients with confirmed dysphagia through videofluoroscopic swallowing study (vfss). exclusion criteria: * patients with recurrent stoke, traumatic brain injury, spine cord injury, and degenerative brain disease, such as parkinson's disease, etc. * patients with deteriorated cognitive function unable to perform the clinical trial as instructed * patients with evidence of delirium, confusion, or other impairment of consciousness * patients with uncontrolled medical disease or surgical conditions * patients ineligible for transcranial direct current stimulation (due to scalp condition, metallic material at the electrode attachment area, presence of a pacemaker or cochlear implant) * patients with previous experience within the last year using a stimulation device similar to the one use in this clinical trial or who have participated in related clinical trials * patients with severe neurologic disorder with concomitant major psychiatric disorder such as major depressive disorder and dementia * patients with history of uncontrolled epilepsy within 6 months * patients with medical contraindications for neuroimaging test, such as mri; * patients who are taken contraindicated medications or require medication changes during the trial period that could influence cognitive/motor function changes via brain activation changes * patients who are pregnant, breastfeeding, or planning pregnancy during the trial period * patients considered medically ineligible for participation in the present trial beyond the criteria listened above.
substrate ablation guided by high density mapping in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: to evaluate a new af substrate mapping method based on automatic high density cfae detection with a multipolar catheter (pentaray) and the " sci 30-40 " setting of carto cfae algorithm.

this study is observational : this substrate ablation method is performed routinely in the centers involved in the study so, patients were not assigned by the investigators to undergo a specific procedure because of the study, in all cases patient would have beneficiate from this substrate mapping ablation method. we assessed procedural and follow up outcomes of this subatrate ablation group and compared them with an historical control group undergoing conventional ablation.

Eligibility criteria:
inclusion criteria: * patient from 18 to 85, with af\* (paroxysmal, and persistent af) and indication of af ablation (including redos)\* \*in accordance with the recommendation of european society of cardiology (2010). exclusion criteria: * organized atrial activity (atrial tachycardia or flutter)
study to assess the effect of renal impairment on the pharmacokinetics of ctp-543

Conditions: Renal Impairment

Summary: this is an open-label, single-dose, sequentially designed, single-period study to determine the effect of moderate renal impairment on the pharmacokinetics (pk) of ctp-543 and its major metabolites following administration of a single 12 mg oral dose of ctp-543.


Eligibility criteria:
inclusion criteria: * adult males or females aged 18-75 * body mass index (bmi) ≥ 18.0 and ≤ 42.0 kg/m2 at the time of screening * if of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication * capable of giving informed consent and complying with study procedures additional inclusion criteria for subjects with renal impairment: * egfr of 30-59 ml/minute/1.73 m2 as calculated by the mdrd equation * no clinically significant change in disease status within the last 30 days before screening * the subject must have a condition consistent with renal impairment and associated symptoms, but otherwise be determined to be in good health in the opinion of the investigator * concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed with the exception of strong cyp3a4 inhibitors and inducers exclusion criteria: * history of any clinically significant medical condition, psychiatric disease, social condition, or illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study * known history of any gastrointestinal surgery or any condition possibly affecting drug absorption * history of prolonged qt syndrome or a qtc interval with fridericia's correction (qtcf) \> 470 msec for males or qtcf \> 480 msec for females at screening visit * positive for human immunodeficiency virus, hepatitis b virus, or hepatitis c virus * females who are nursing or pregnant prior to drug administration * positive results for coronavirus infection (covid-19) at screening or check-in * positive drugs of abuse or alcohol results at screening or check in (day -1) additional exclusion criteria for subjects with renal impairment: * history of renal transplant * significant bleeding diathesis that could preclude multiple venipuncture or deep intramuscular injections * acute or exacerbating renal disease * history of drugs of abuse or alcohol misuse within 6 months prior to screening * poorly controlled type 1 or type 2 diabetes

Keywords: ctp-543
multicenter evaluation of patients using latitude monitoring system

Conditions: Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Sudden Cardiac Death

Summary: the multitude is a registry of patients who receive commercially available cieds that remotely communicate through the latitude monitoring system and transfer data to a central database. the registry is designed to constitute a shared environment for the collection, management, analysis and reporting of clinical and diagnostic data, adopted by a network of european scientifically-motivated physicians who use rhythm management diagnostic and therapeutic solutions from boston scientific in their clinical practice. the multitude study will facilitate the sharing of scientific proposals within a large network of researchers, and it will allow researchers to record the experience with medical devices throughout the device and patient lifecycle.


Eligibility criteria:
inclusion criteria: * subject is willing and capable of providing informed consent to collect/store/process personal health information by the sponsor or such consent is provided by a legally designated representative, if required by local law or regulation. * subject is: 1. prospectively scheduled for receiving a device monitored through the latitude monitoring system 2. retrospectively enrolled after having received a device monitored through the latitude monitoring system exclusion criteria: * subject foreseen not to be followed at the enrolling center for at least 1 year after having received the device. * subject is receiving a device that is not approved for commercial use at the time of procedure.

Keywords: cardiac implantable electrical device implantable cardioverter defibrillator pacemaker cardiac resynchronization therapy subcutaneous defibrillator implantable cardiac monitor remote monitoring latitude monitoring system
body weight support harness system in spinal muscular atrophy

Conditions: Spinal Muscular Atrophy Type I; Spinal Muscular Atrophy Type II

Summary: the goal of this pilot interventional study is to learn about the use of an in-home harness system in children who have been treated for spinal muscular atrophy. the main questions it aims to answer are: 1. is the in-home body weight support harness system a feasible option for families to use? 2. is the in-home body weight support harness system a useful tool for children treated for spinal muscular atrophy? 3. is the in-home body weight support harness system a safe tool for children treated for spinal muscular atrophy? participants will be given an in-home body weight support harness system and taught how to use it. families will document how often and for how long they use the system over 6 months. children will be given tests of motor function at the beginning, 3-months, and 6-months. at the end of the study, families will be asked to fill out a questionnaire about thier experience using the system.


Eligibility criteria:
inclusion criteria: * confirmed heterozygous mutation in smn1 gene and 2 or 3 copies of smn2 (historically, sma type 1 and type 2) * past or current treatment with nusinersen, onasemnogene abeparvovec, or risdiplam * upright head control (defined as the ability to lift head from full forward flexion) * weight under or 50lbs * confirmed motor delay exclusion criteria: * 4+ copies of smn2 (historically, sma type 3 and 4) * evidence of lower limb injury or recent fracture * in the opinion of the investigator, it was unsafe for the child to participate

Keywords: exercise physical therapy
performance of dailies total1® contact lenses for astigmatism in symptomatic habitual reusable toric lens wearers

Conditions: Astigmatism

Summary: to subjectively evaluate dailies total1® contact lenses for astigmatism (dt1fa) performance compared to other common weekly/monthly contact lenses in symptomatic patients.

this study is a single site, prospective, subject-masked, observational study of the subjective performance of dt1fa in symptomatic patients. subjects will be assessed at a screening visit, and 2 follow-up visits. clinical evaluations will include measurement of visual acuity, manifest refraction, and patient questionnaires.

Eligibility criteria:
subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. inclusion criteria: * willing and able to provide informed consent * adult (18-38 years of age) * adapted and optimized current reusable soft toric lens wearer who has at least 3 months of wearing experience, and typically wears lenses every day, or at least 5 days per week, ≥10 hours per day * prescription needs with sphere and cylinder values that can be appropriately fit with current available parameters in the dailies total1® contact lenses for astigmatism product line * vision correctable to 20/25 snellen (0.1 logmar) or better in each eye at 6m * willing to wear lenses every day or at least 5 days per week, 10 or more hours per day and attend all study visits and follow instructions * cldeq-8 minimum score of 12 exclusion criteria: if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * ocular anterior segment infection, inflammation, abnormality, or active disease including diagnosed dry eye, that would contraindicate contact lens wear * use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator * monocular (only 1 eye with functional vision) or fit with only 1 lens * fitted with monovision * prior refractive surgery * history of herpetic keratitis, ocular surgery, or irregular cornea * pregnant or lactating the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
safety, pharmacokinetics, and pharmacodynamics/efficacy of sbc-103 in mucopolysaccharidosis iii, type b (mps iiib)

Conditions: Mucopolysaccharidosis IIIB

Summary: study to evaluate the safety and tolerability of intravenous (iv) administration of sbc-103 in participants with mucopolysaccharidosis iii, type b (mps iiib, sanfilippo b) with evaluable signs or symptoms of developmental delay.

this study was designed as a 3-part study to evaluate the safety and tolerability of iv administration of sbc-103. participants enrolled in part a (0.3, 1.0, or 3.0 milligrams \[mg\] per kilogram \[kg\] of sbc-103 administered every other week \[qow\] for 24 consecutive weeks). participants who completed part a were eligible for part b (an increase to 1.0 or 3.0 mg/kg qow). participants who completed part b were eligible for part c (5.0 and/or 10.0 mg/kg to continue through week156; no participants received both 5.0 and 10.0 mg/kg). due to the early termination of the sbc-103 development program, including this study, all participants withdrew from part c at the sponsor's decision. as a result of the early termination of this program, this report provides only safety data.

Eligibility criteria:
key inclusion criteria: * a participant was greater than or equal to 2 years of age but less than 12 years of age at the time of informed consent. * definitive diagnosis of mps iiib. * documented developmental delay. key exclusion criteria: * received treatment with gene therapy at any time. * previous hematopoietic stem cell or bone marrow transplant. * had any internal or non-removable external metal items that presented a safety risk for study assessments that utilized magnetic fields, or any other medical condition or circumstance in which magnetic resonance imaging was contraindicated according to local institutional policy. * known hypersensitivity to eggs.

Keywords: mps iiib mucopolysaccharidosis mucopolysaccharidosis type iiib sanfilippo syndrome metabolism, inborn errors metabolic diseases genetic diseases, inborn carbohydrate metabolism, inborn errors connective tissue diseases lysosomal storage diseases mucinoses mucopolysaccharidoses pathologic processes
a study to evaluate the drug levels, safety, and tolerability of bms-986036 in participants with normal liver function and participants with moderate and severe liver impairment

Conditions: Moderate Liver Impairment; Severe Liver Impairment

Summary: the purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of bms-986036 in participants with moderate and severe liver impairment. results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.


Eligibility criteria:
inclusion criteria: * healthy participants or participants with hepatic impairment, as determined by medical history, physical exam, electrocardiogram (ecg), and clinical laboratory determinations * body mass index (bmi) of 18.0 kg/m\^2 to 40.0 kg/m\^2, inclusive. bmi = weight (kg)/height (m\^2) exclusion criteria: * any history of known or suspected congenital or acquired immunodeficiency state or condition that would have compromised the participant's immune status * history of biliary disorders, including gilbert's syndrome or dubin-johnson disease other protocol-defined inclusion/exclusion criteria apply

Keywords: cirrhosis hepatic impairment liver impairment nonalcoholic steatohepatitis (nash)
platelet rich plasma during radical prostatectomy

Conditions: Prostate Cancer

Summary: can platelet rich plasma applied to nerve bundles at time of surgery help the nerve bundles heal? subjects undergoing a radical prostatectomy who meet study inclusion/exclusion criteria will be consented to receive an intraoperative application of platelet-rich plasma, made from their own blood at the time of surgery, for application onto their neurovascular bundles in an effort to improve the healing process. subjects will be followed for an additional 18 months to determine the efficacy and safety of this procedure.


Eligibility criteria:
inclusion criteria: * newly diagnosed, clinically localized prostatic adenocarcinoma * age 50 - 60 years * male gender * normal preoperative sexual function * normal urinary continence exclusion criteria: * unable or unwilling to provide informed consent * vulnerable study populations * active systemic infection * diabetes mellitus diagnosis * preexisting erectile dysfunction or urinary incontinence * metastatic or locally advanced prostatic adenocarcinoma on preoperative evaluation * men found grossly or pathologically to have locally advanced or metastatic disease at the time of radical prostatectomy * an estimated blood loss of \> 750 ml at the time of radical prostatectomy * treatment prior to surgery with any form of hormones, anti-androgens or androgen deprivation therapy * use of an antidepressant, beta blocker or erectile dysfunction medication at the time of study screening * men without a regular sexual partner * use of aspirin or heparin 2 weeks before radical prostatectomy * need for use of aspirin or heparin for 2 weeks or more after radical prostatectomy
randomized study of intensive one-on-one behavioral treatment for preschool aged children with autism

Conditions: Autistic Disorder

Summary: objectives: i. determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism. ii. identify intake measures that predict differences in outcome between subjects in the experimental group.

protocol outline: this is a randomized study. children are randomized to receive either 35 hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years or individualized, in home parent training for 6 months. a common group of tests to evaluate autism are administered at intake, 12 and 24 months into treatment, and when patients reach age 6.

Eligibility criteria:
inclusion criteria: --disease characteristics-- diagnosis of autism based on the autism diagnostic interview using the icd-10 research criteria ratio iq score greater than 35 determined from the bayley scales of infant development --patient characteristics-- other: must reside within 60 km (37.5 miles) of a treatment site exclusion criteria: severe medically induced limitations defined as: * any condition requiring prosthetic devices (e.g., blindness, deafness, or cerebral palsy) * any illness that has prevented or would prevent a subject from participating in 30 hours a week of treatment for six consecutive weeks or more (e.g., metastasized cancer or end stage renal disease) * any known genetic disorder (e.g., fragile x, pku, or down syndrome) * any other disorder that rules out autism according to icd-10 criteria (e.g., rett's syndrome)

Keywords: autism neurologic and psychiatric disorders rare disease