Kornimate/medical-research-clean huggingface dataset:
using exercise and electrical brain stimulation to improve memory in dementia

Conditions: Mild Cognitive Impairment; Alzheimer Disease

Summary: mild cognitive impairment and alzheimer's disease are conditions that involve memory difficulties. transcranial direct current stimulation is a type of brain stimulation. it may help improve these memory difficulties. however, it works better on active brain areas. this study looks at if combining exercise and applying current to important parts of the brain can help improve memory in people with mild cognitive impairment or alzheimer's disease.

objectives: to assess the efficacy of a combined exercise and tdcs treatment for improving cognitive outcomes in mild cognitive impairment and mild alzheimer's disease. study design: eligible participants will be randomized to one of three interventions: exercise and tdcs, treatment as usual (tau/exercise education) and tdcs, or exercise and sham tdcs. participants randomized to an exercise group will undergo exercise, followed by either sham or active tdcs. participants randomized to tau will receive written information in accordance with the canadian physical activity guidelines for older adults and tdcs for the same duration. cognition, neuropsychiatric symptoms and blood samples for biomarker analysis will be collected.

Eligibility criteria:
inclusion criteria: * males or females ≥50 years of age * dsm-5 criteria for major or mild neurocognitive disorder due to ad or mixed ad/vascular disease * mild severity of impairment (standardized mini-mental state examination (mmse) score ≥19) * read and communicate in english exclusion criteria: * change in cognitive enhancing medications (cheis and/or memantine) less than 3 months prior to study screen * change in anticonvulsants or psychotropic medications less than 1 month prior to study screen * currently taking benzodiazepines * presence of metal implants that would preclude safe use of tdcs (e.g. pace-maker) * significant neurological condition (e.g. epilepsy, parkinson's disease, multiple sclerosis) * current psychiatric disorders (e.g. schizophrenia, bipolar disorder, depression, psychosis) or current substance use disorder * medical contraindications to increasing activity level according to the canadian society of exercise physiology questionnaire

Keywords: alzheimer disease cognition transcranial direct current stimulation exercise mild cognitive impairment
safety and performance study of the neochord device

Conditions: Mitral Valve Regurgitation

Summary: the purpose of this study is to demonstrate the safety and performance of the neochord ds1000 artificial chordae delivery system in implanting eptfe sutures(s) as artificial neochordae in patients with mitral regurgitation.


Eligibility criteria:
inclusion criteria: * age \>= 18 and \< 80 years * candidate for surgical mitral valve repair or replacement * isolated posterior leaflet prolapse * moderate to severe or severe mitral valve regurgitation that is degenerative in nature exclusion criteria: * anterior or bi-leaflet prolapse * functional or ischemic mr * nyha class iv * complex mechanism of mr (leaflet perforation, etc) * significant tethering of leaflets toward lv apex * severely calcified mitral valve annulus * inflammatory valve disease * severe lv dilation

Keywords: neochord ds1000 mitral valve mitral valve regurgitation mr mitral valve repair mitral valve prolapse artificial chordae
a study assessing the efficacy and safety of sm03 in patients with active rheumatoid arthritis receiving mtx

Conditions: Rheumatoid Arthritis(RA)

Summary: * to demonstrate that sm03 added to methotrexate (mtx) reduce signs and symptoms of rheumatoid arthritis (ra) in chinese ra participants with an inadequate response to mtx. * to assess the safety of sm03 added to mtx in chinese ra participants with an inadequate response to mtx

the total duration of study was expected up to 58 weeks (screening period of 6 weeks, randomized treatment period of 24 weeks and open-label treatment extention period of 24 weeks , and a 4-week post treatment observation).

Eligibility criteria:
inclusion criteria: * adult patients 18-75 years of age. * rheumatoid arthritis (ra) for ≥ 6 months, diagnosed according to the revised 1987 american college of rheumatology (acr) criteria, or 2010 acr/eular for the classification of rheumatoid arthritis. * moderate to severe active ra with swollen joint count (sjc) ≥ 6(66 joint count), and tender joint count (tjc) ≥ 8 (68 joint count) at screening and baseline. * at screening, either high sensitivity c-reactive protein (hs-crp) ≥ 1.5 unl, or erythrocyte sedimentation rate (esr) ≥ 28 mm/hour, or morning stiffness of joint for ≥ 45 minutes. * inadequate response to methotrexate, having received and tolerated at a dose of 7.5-20 mg/week for ≥ 12 weeks, at a stable dose over the past 4 weeks. exclusion criteria: * rheumatic autoimmune disease other than ra. * use of any biological dmards for ra. * concurrent treatment with any disease modifying anti-rheumatic drug (dmard) other than methotrexate * active infection, or history of serious or chronic infection the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
ascending dose study of genome editing by the zinc finger nuclease (zfn) therapeutic sb-318 in subjects with mps i

Conditions: MPS I

Summary: the purpose of the study is to evaluate the safety, tolerability of ascending doses of sb-318. sb-318 is an intravenously delivered zinc finger nuclease (zfn) therapeutic for genome editing. it inserts a correct copy of the α-l-iduronidase (idua) gene into the albumin locus in hepatocytes with the goal of lifelong therapeutic production of the idua enzyme.

the objectives of the study are to provide long term expression of idua and improve the current clinical outcome of enzyme replacement therapy (ert) or hematopoietic stem cell transplantation (hsct) therapy in subjects with attenuated mps i, a recessive lysosomal storage disorder that results from mutations in the gene encoding idua. sb-318 is a therapeutic for zfn-mediated genome editing which will be delivered by adeno-associated virus (aav)-derived vectors. sb-318 is intended to function by placement of the corrective copy of the idua transgene into the genome of the subject's own hepatocytes, under the control of the highly expressed endogenous albumin locus, and is expected to provide permanent, liver-specific expression of iduronidase for the lifetime of an mps i patient.

Eligibility criteria:
inclusion criteria: * male or female ≥ 5 years of age * clinical diagnosis of attenuated mps i deficiency (hurler-scheie, scheie, or hurlers status post-hsct) exclusion criteria: * known to be unresponsive to ert * neutralizing antibodies to aav 2/6 * serious intercurrent illness or clinically significant organic disease (unless secondary to mps i) * receiving antiviral therapy for hepatitis b or c, or with active hepatitis b or hepatitis c or hiv 1/2 * lack of tolerance to laronidase treatment with significant iars or occurrence of anaphylaxis * markers of hepatic dysfunction * creatinine ≥ 1.5 mg/dl * contraindication to the use of corticosteroids for immunosuppression * current treatment with systemic (iv or oral) immunomodulatory agent or steroid use (topical treatment allowed) * participation in prior investigational drug or medical device study within the previous 3 months * prior treatment with a gene therapy product * elevated or abnormal circulating α-fetoprotein (afp) * weight \<20 kg at screening visit

Keywords: mucopolysaccharidosis i mps i hurler-scheie syndrome gene therapy gene editing zinc finger sb-318 rare genetic dna sangamo genome editing empowers zfn hurler gene specific targeted insertion
the use of heliox via nasal cpap to prevent early cpap failure in premature infants: a feasibility study

Conditions: Respiratory Distress Syndrome, Newborn

Summary: the purpose of this study is to evaluate the safety and utility of using heliox gas in combination with nasal cpap in premature infants. the investigators hypothesize that using heliox gas in combination with nasal cpap will results in decreased early nasal cpap failure requiring intubation and mechanical ventilation.

introduction: in recent years there has been an increased use of nasal continuous positive airway pressure (ncpap) in the management of premature infants with respiratory distress syndrome (rds). the use of early ncpap eliminates the need for endotracheal intubation and mechanical ventilation, and their associated morbidities. in clinical practice a significant number of extremely low birth weight (elbw) infants with rds fail ncpap therapy within the first 72 hours of life and require rescue endotracheal intubation. the clinical factors resulting in ncpap failure are hypoxemia, hypoventilation, muscular fatigue and/or apnea. helium is a biologically inert gas that is used in medicine as a carrier for oxygen. heliox (mixture of helium and oxygen) has been used safely in neonates for decades and its use has been consistently been shown to improve oxygenation, enhance ventilation and decrease the work of breathing. prior studies using heliox in the management of premature infants with rds have shown clear therapeutic benefits. the use of heliox delivered via a ncpap device (hx-ncpap) has recently been reported in infants with bronchiolitis. given the prior success of heliox in the management of rds combined with the recent advent of hx-ncpap we intend to investigate the utility of hx-ncpap in reducing the incidence of early ncpap failure in elbw infants with rds. research design: prospective, open-label, randomized, pilot study comparing conventional ncpap to hx-ncpap in the management of elbw infants being treated with ncpap for rds. methods: all spontaneously breathing infants born at \< 30 wks estimated gestational age (ega) admitted to the nicu at kmcwc with the diagnosis of rds and on ncpap since birth will be eligible for enrollment. volunteer infants will be randomly assigned to conventional ncpap or hx-ncpap groups. hx-ncpap will be provided to the study group infants for the first 72 hours of life. primary and secondary outcome measures will be compared between the heliox group and control group to determine if hx-ncpap results in a decreased incidence of early ncpap failure and/or improved clinical outcomes when compared to conventional ncpap.

Eligibility criteria:
inclusion criteria: * gestational age \< 33 weeks * receiving cpap from the time of delivery exclusion criteria: * cyanotic congenital heart disease * congenital malformation

Keywords: respiratory distress prematurity heliox cpap
group cognitive processing therapy for combat-related posttraumatic stress disorder (ptsd)

Conditions: Posttraumatic Stress Disorder

Summary: the purpose of this study is to compare group-administered cognitive processing therapy-cognitive-only version (cpt-c), an evidence based treatment for posttraumatic stress disorder (ptsd), to present centered therapy (pct) in order to determine whether the results of cpt exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format.

estimates indicate that between 100,000 and 300,000 operation iraqi freedom (oif) and operation enduring freedom (oef) veterans are at significant risk for chronic post-traumatic stress disorder (ptsd), which can become a chronic disorder that impacts all areas of a person's life. ptsd treatment programs are being developed throughout the department of defense (dod) and the veterans affairs (va), but because of the large number of service members returning from deployment with ptsd, it is often necessary to provide psychotherapy in groups. cognitive processing therapy (cpt), an evidence-based treatment for ptsd, was originally developed as a group-based intervention. however, group-based cpt treatment has never been systematically compared to other forms of group treatment. the public policy implications of the results of this trial are significant. if group treatment is found to be effective, then group treatment would be a more efficient and cost-effective therapy modality in most cases. the purpose of this study is to compare group-administered cpt-cognitive-only version (cpt-c) to present centered therapy (pct) in order to determine whether the results of cpt exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format. one hundred (100) adult male and female active-duty oif/oef military personnel over 18 years of age will be enrolled into this study. participants will be randomized to receive either group pct or group cpt-c.

Eligibility criteria:
inclusion criteria: * adult male and female active duty, activated reservist, or activated national guard oif/oef military personnel or oif/oef veterans seeking treatment for ptsd * diagnosis of ptsd determined by a clinician-administered posttraumatic stress scale (pssi) * person has experienced a criterion a event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment in support of oif/oef. the diagnosis of ptsd may be indexed to that event or to another criterion a event. * be over the age of 18 * speak and read english * be stable on any psychotropic medications they may be taking. exclusion criteria: * current suicide or homicide risk meriting crisis intervention * active psychosis * moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires)

Keywords: posttraumatic stress disorder cognitive processing therapy combat military cpt group therapy
seroquel® combined with cognitive remediation therapy to conventional treatment in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to compare efficacy of quetiapine fumarate combined with cognitive remediation therapy (crt) to conventional treatment by evaluating change in social outcome in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * signed informed consent * documented clinical diagnosis of schizophrenia or schizoaffective disorder for at least 2 years. * clinically stable and in an outpatient setting before entering the study (visit 1). exclusion criteria: * use of clozapine and quetiapine within two months prior to visit 1. * if total points are ≤ 55 intelligence quotient (iq) according to score of wais-iii test at visit 1.
descriptive study of recombinant human insulin-like growth factor for osteoporosis in werner's syndrome

Conditions: Werner's Syndrome

Summary: objectives: i. assess the safety and efficacy of recombinant human insulin-like growth factor 1 in a patient with werner's syndrome and osteoporosis.

protocol outline: the patient receives subcutaneous recombinant human insulin-like growth factor 1 daily for 7 months. the dose is adjusted according to the serum hormone level and biological markers of bone turnover. concurrent therapy includes a metabolic diet, calcium citrate, and estradiol.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- werner's syndrome with osteoporosis and low serum insulin-like growth factor 1 level patient treated on protocol 04-9215300 "metabolic and skeletal effects of exogenous recombinant human insulin-like growth factor"

Keywords: werner's syndrome genetic diseases and dysmorphic syndromes rare disease
a study of paliperidone palmitate 3 month formulation for the treatment of patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (pp3m) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.

this is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study. the study consists of 4 phases: a screening phase (up to 3 weeks); a 17-week flexible dose open-label transition phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label maintenance phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the double-blind phase). patients who meet specific stabilization criteria will enter the double-blind phase at week 29. patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of pp3m or placebo. the double-blind phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.

Eligibility criteria:
inclusion criteria: * patients with schizophrenia for more than 1 year * a total score in the positive and negative syndrome scale (panss) \< 120 * signed informed consent * women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control * men must agree to use a double-barrier method of birth control * be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ecg) exclusion criteria: * a diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis * relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the investigator (ie, obesity, diabetes, heart disease etc) * a diagnosis of substance dependence within 6 months before screening * history of neuroleptic malignant syndrome (nms) or tardive dyskinesia * clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness * clinically significant findings in biochemistry, hematology, ecg or urinalysis results * any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments

Keywords: schizophrenia r092670 paliperidone palmitate paliperidone palmitate 3 month formulation (pp3m)
an investigational scan (mri) in imaging patients with newly-diagnosed or recurrent thymoma

Conditions: Recurrent Malignant Thymoma; Thymoma

Summary: this trial studies the accuracy of a magnetic resonance imaging (mri) scan in imaging the inside of the chest in patients with thymoma that is newly diagnosed or has come back. an mri scan may be able to detect if and how far the tumor has spread more accurately than a standard computed tomography (ct) scan.

primary objectives: i. to determine whether thymoma staging by mri is as accurate as staging by ct as compared to surgical staging. secondary objectives: i. to determine whether evaluation of phrenic nerve paralysis by functional mri is as accurate as the fluoroscopic "sniff test" as compared to surgical evaluation of phrenic nerve involvement. ii. to determine whether fast novel mri sequences are as accurate as conventional mri sequences for staging thymoma, when comparing to surgical staging. outline: patients undergo an mri scan over 45-60 minutes and a diaphragm fluoroscopy 30 days before surgery.

Eligibility criteria:
inclusion criteria: * all adult patients scheduled to meet with a thoracic surgeon from md anderson cancer center (acc) for resection of newly diagnosed thymoma or thymoma recurrence in the chest and scheduled for surgery exclusion criteria: * children, defined as individuals younger than 18 years old on the preoperative visit with the thoracic surgeon * pregnant patients * patients unable to understand the consent form * patients with metal within the chest and pacemakers * patients with a known allergic reaction to gadolinium, who will have their mri performed without contrast * patients with glomerular filtration rate (gfr) \< 60 ml/min, who will have their mri performed without contrast * patients with an allergy to iodinated contrast material will follow departmental routine policy, that is those with anaphylaxis will have their ct performed without intravenous contrast and others will be prepped as for departmental guidelines for routine chest ct * patients with abnormal renal function will have their ct study perform as per di's iodinated contrast administration guidelines, and no contrast will be administered with gfr lower than 30 ml/min
moderate hypofractionated boost to the prostate with pelvic rt in high risk prostate cancer

Conditions: Prostate Cancer

Summary: this is a single-arm phase ii prospective trials that is recruiting 100 participants. the study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * able to provide informed consent. * histologic diagnosis of prostate adenocarcinoma. * ecog performance status 0-1. * high-risk localized disease by nccn criteria (\>ct3, grade group \>4, or psa \>20 ng/ml) or clinical n1 disease. * clinical m0 by conventional imaging (computed tomography (ct) and bone scan (bs)) and/or molecular imaging (prostate specific membrane antigen (psma)- positron emission tomography (pet)) exclusion criteria: * prior pelvic radiotherapy. * contraindications to radiotherapy

Keywords: prostate cancer high risk prostate cancer high-risk prostate cancer node positive prostate cancer nod-positive prostate cancer hypofractionation
nicotine patch - multidose bioequivalence study

Conditions: Healthy Smokers

Summary: the purpose of this study is to compare the relative bioavailability of nicotine following repeated applications of a new transdermal formulation to that of a reference formulation. up to day 7


Eligibility criteria:
inclusion criteria: * healthy subject aged 18 to 45 years (inclusive) * current smoker of \>or = 5 and \< or = 15 cigarettes/day * fagerström score \< or =5 at selection * absence of any clinically significant abnormal finding at physical, vital sign, electrocardiogram ecg, biological examinations in the investigator's opinion. exclusion criteria: * presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator * any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or assessment of transdermal patch

Keywords: smoking cessation nicotine tobacco use disorder central nervous system agents