Kornimate/medical-research-clean huggingface dataset:
behavioral activation + cognitive processing therapy for ptsd and comorbid mdd

Conditions: Posttraumatic Stress Disorder; Major Depressive Disorder

Summary: this study is a randomized controlled trial comparing an integrated treatment, behavioral activation + cognitive processing therapy (ba + cpt), to cpt alone among active-duty service members with posttraumatic stress disorder (ptsd) and comorbid major depressive disorder (mdd). participants will complete assessor-administered and self-report measures at pre- and post-treatment assessments, as well as a 3-month follow-up. additionally, participants will complete self-report measures of ptsd and mdd symptoms at each therapy session.

major depressive disorder (mdd) is the psychological condition most commonly comorbid with posttraumatic stress disorder (ptsd). ptsd and mdd comorbidity is associated with greater symptom severity, lower levels of functioning, greater disability, and increased suicide potential relative to ptsd or mdd alone. unfortunately, no psychological treatment intervention specifically addresses this comorbidity. individuals with comorbid ptsd and mdd often receive evidence-based treatments for ptsd, such as cognitive processing therapy (cpt); although such treatments typically reduce both ptsd and depression symptoms, few studies have specifically examined these outcomes in individuals with ptsd and comorbid mdd. the primary goal of this randomized controlled trial is to evaluate whether greater improvement in depression symptoms can be achieved by augmenting cpt with behavioral activation (ba), a standard depression treatment, for active-duty service members with ptsd and comorbid mdd. participants will be evaluated at three assessment time-points (pre-treatment, post-treatment, and three-month follow-up), as well as complete self-report measures of ptsd and mdd symptoms at each therapy session.

Eligibility criteria:
inclusion criteria: * active-duty service member seeking mental health treatment at naval medical center san diego (nmcsd), branch clinics, or naval hospital camp pendleton (nhcp) * meet current diagnostic criteria for ptsd based on the dsm-5 as a consequence of any index traumatic event (e.g., combat, military sexual trauma, child abuse, accidents, etc.) * meet current diagnostic criteria for mdd based on dsm-5 criteria. exclusion criteria: * unmanaged psychosis or manic episode in the past year * substance use disorder warranting primary substance use treatment or detoxification * participation in concurrent psychotherapies directly targeting ptsd * participation in concurrent psychotherapies directly targeting depression

Keywords: posttraumatic stress disorder major depressive disorder behavioral activation cognitive processing therapy comorbidity military
fame ii-10-year follow-up

Conditions: Coronary Artery Disease

Summary: the fame-ii trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design. the overall purpose of the fame-ii trial was to compare the clinical outcomes, safety and cost-effectiveness of ffr-guided pci plus optimal medical treatment (omt) versus omt alone in patients with stable coronary artery disease and in whom both pci and medical treatment can be considered on the basis of the presently existing scientific evidence. fame-ii was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published. the purpose of this 10-year follow-up is to evaluate the 10-year major adverse cardiac event rate (mace, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization). patients will have to sign a specific informed consent for the present 10-year follow-up. this study will be conducted for about approximately 6 months.


Eligibility criteria:
inclusion criteria: 1. patients with 1. stable angina pectoris (canadian cardiovascular society class \[ccs\] 1, 2, 3) 2. or, angina pectoris ccs class 4 subsequently stabilized medically (minimum 7 days) or, 3. atypical chest pain or no chest pain but with documented silent ischemia on non-invasive testing. 2. in whom at least one stenosis was present of at least 50% in one major native epicardial coronary artery with a diameter of at least 2.5 mm and supplying viable myocardium 3. eligible for pci 4. signed written informed consent was obtained. patients will have to sign a specific informed consent for the present 10-year follow-up. exclusion criteria: 1. patients in whom the preferred treatment is cabg 2. patients with left main coronary artery disease requiring revascularization 3. patients with a recent (less than 1 week) stemi or non-stemi 4. prior cabg 5. contra-indication to dual antiplatelet therapy 6. lvef \< 30% 7. severe lv hypertrophy (defined as a septal wall thickness at echocardiography of more than 13 mm) 8. planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.) 9. extremely tortuous or calcified coronary arteries precluding ffr measurements 10. a life expectancy of less than 2 years 11. age under 21 12. pregnancy or intention to become pregnant during the course of the trial 13. refusal or inability to sign an informed consent. mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent 14. potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits 15. participation or planned participation in another cardiovascular clinical trial before two year follow-up is completed
child and infant learning project

Conditions: Craniosynostosis

Summary: to learn more about the cognitive and motor development of infants and young children born with a craniofacial defect called craniosynostosis.

in the first phase of this multi-site, 10-year longitudinal study, infants with one of four types of single-suture craniosynostosis were recruited: sagittal, metopic, right unilateral coronal, and left unilateral coronal. a case-matched "control" group of healthy, normal infants was also followed. this study, which is now in its second phase, is following this same cohort of children at the age of 7 years.

Eligibility criteria:
enrollment criteria at phase 1: * confirmed diagnosis of single-suture, nonsyndromic craniosynostosis (sagittal, metopic, unilateral coronal, or lambdoid) * corrective (cranioplastic) surgery not yet performed * child born at 34 weeks gestation or later * absence of neurological conditions/significant health problems * 33 months or younger at time of enrollment (male or female). enrollment criteria at phase 2: all participants enrolled in phase 1 are invited to participate in phase 2.
reverse remodeling effects of cdr132l in patients with heart failure with mildly reduced or preserved ejection fraction and cardiac hypertrophy

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: this is a phase 2, multicenter, randomized, double-blind, placebo-controlled study including approximately 130 randomized hf patients with heart failure with mildly reduced or preserved ejection fraction (lvef ≥45%), to assess efficacy and safety of cdr132l on reverse remodeling. in this study, patients with hfpef (ef ≥50%) or hfmref (lvef 45-49%) will be included.


Eligibility criteria:
main inclusion criteria: 1. provision of signed informed consent prior to any study-specific procedures. 2. male or female of non-childbearing potential patients age ≥40 and \<85 years. 3. documented diagnosis of symptomatic heart failure (nyha class ii-iv) at enrollment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrollment with at least intermittent need for diuretic treatment. 4. ejection fraction ≥ 45% (determined by echocardiography at site laboratory) 5. increased intraventricular wall thickness (≥11 mm for female and ≥12 mm for male patients by echocardiography at site laboratory) 6. nt-probnp \> 300 pg/ml (sinus rhythm); \>900 pg/ml (atrial fibrillation at time of screening/inclusion or documented with the last 6 months) 7. bmi between 22 kg/m² and 45 kg/m². main exclusion criteria: 1. hemoglobin a1c (a1c) ≥10.5% 2. egfr \<35 ml/min/1.73m² 3. systolic blood pressure (bp) \<90 mmhg on 2 consecutive measurements at 5-minute intervals, at screening. 4. systolic bp≥180 mmhg on 2 consecutive measurements at 5-minute intervals, at screening. 5. planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement. 6. stroke or transient ischemic attack (tia) within 12 weeks prior to enrolment.

Keywords: hfpef heart failure cardiac hypertrophy
pilocarpine use after kahook goniotomy

Conditions: Glaucoma

Summary: the goal of this study is to determine whether using pilocarpine provides added benefit to the success of combined cataract + kdb surgery.

glaucoma is the leading cause of irreversible blindness worldwide, and its treatment consists of lowering intraocular pressure to prevent damage to the optic nerve and loss of vision\[1\]. current methods for lowering intraocular pressure (iop) include topical and oral medications, laser trabeculoplasty, microincisional glaucoma surgery (migs), and traditional incisional surgeries such as trabeculectomy and aqueous tube shunts. migs have become more popular in recent years as less invasive methods than traditional surgeries that effectively reduce iop and help reduce the medication burden on patients\[1\]. there are multiple available migs procedures, most of which act by increasing trabecular outflow. one such procedure is the goniotomy via kahook dual blade (kdb), which is usually performed in combination with cataract surgery. kdb is an fda approved device used to perform a goniotomy via an internal approach. strips of the nasal angle trabecular meshwork are removed providing a direct pathway for aqueous outflow from the anterior chamber into the collector channels\[2\]. pilocarpine, a parasympathomimetic agent, is a glaucoma medication that works by causing contraction of the ciliary muscle leading to opening of the trabecular meshwork\[3\]. due to its frequent dosing requirement and large number of ocular and systemic side effects, pilocarpine has largely fallen out of favor for the treatment of primary open angle glaucoma (poag), except in patients for whom few other alternatives exist. however, pilocarpine is often used after goniotomy surgery. the rational for its use after goniotomy procedure is for its miotic effect, which theoretically may prevent the formation of peripheral anterior synechiae. formation of peripheral anterior synechiae can lead to the closure of the cleft that is generated and the possibility of failure of the procedure. while the theoretical benefit of pilocarpine has been proposed, its actual benefit has never been proven. this study will evaluate whether goniotomy via kdb / cataract surgery without pilocarpine is non-inferior to the same surgery procedure followed by treatment with pilocarpine.

Eligibility criteria:
inclusion criteria: * patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with kdb exclusion criteria: * patients with previous history of eye surgeries (including laser procedures)

Keywords: cataract glaucoma surgery vision cataract surgery eye surgery
comparative study of bat2506 with simponi® in participants with active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this is a multicenter, double-blind, randomized, parallel-group study to compare the efficacy,pharmacodynamics (pd), pharmacokinetics (pk), safety, and immunogenicity of bat2506 versus simponi® in participants with active psa. the study will consist of up to 4-week screening period, a 52-week treatment period, and a 8-week safety follow-up period.


Eligibility criteria:
inclusion criteria: * participant has psa for at least 6 months prior to the first administration of the study drug and meets classification criteria for psa (caspar) at screening. * participant has active psa defined by the presence of ≥3 of 68 tender joint counts and ≥3 of 66 swollen joint counts at screening and randomization. * participant has active psa at screening despite previous dmard or nsaid therapy. dmard therapy is defined as taking dmard for at least 3 months, or evidence of dmard intolerance. nsaid therapy is defined as taking an nsaid for at least 4 weeks (or have intolerance to or contraindication to nsaid therapy). * participant has at least 1 active psoriatic lesion with a qualifying lesion of at least 2 cm in diameter at screening and randomization. * participant is negative for rheumatoid factor and anti-cyclic citrullinated peptide (accp) antibodies at screening. exclusion criteria: * participant is currently receiving or has previously received any biological agent or targeted disease modifying anti-rheumatic drugs (dmards) for the treatment of psa or psoriasis. * participant has previously received any other nonbiological dmards (apart from mtx), including sulfasalazine, hydroxychloroquine or apremilast within 8 weeks prior to the first administration of the study drug; or has previously received leflunomide within 12 weeks (except at least 4 weeks prior to the first administration of the study drug, the subject has documented completion of standard cholestyramine or activated charcoal washout procedure). * participant has received epidural, intra-articular, intramuscular, or intravenous (iv) corticosteroids during the 4 weeks prior to first administration of study drug. * participant has been treated with cytotoxic agents, (including but not limited to azathioprine, cyclosporine, cyclophosphamide), nitrogen mustard, chlorambucil, or other alkylating agents within 6 months prior to the first administration of the study drug. * participant has received or is expected to receive any live vaccinations from 3 months before first study drug administration and up to 3 months after the last study drug administration. * participant has received other therapeutic infectious agents within 8 weeks prior to first dose or expected to receive other therapeutic infectious agents during the study until sfu. * participant has received iv immunoglobulins or plasmapheresis within 6 months prior to the first administration of the study drug.
uab alzheimer's disease center core cohort - imaging substudy

Conditions: Alzheimer Disease

Summary: the primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the pet tracer \[c-11\]pib in participants in the uab alzheimer's disease center cohort. assessment of interactions between race and vascular risk factors, brain amyloid levels measured with \[c-11\]pib-pet, and cognitive status will be the primary outcome of this imaging study.

the primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the pet tracer \[c-11\]pib in participants in the uab-adc cohort. the amount and distribution of \[c-11\]pib in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing uab-adc study. assessment of interactions between race and vascular risk factors, brain amyloid levels measured with \[c-11\]pib-pet, and cognitive status will be the primary outcome of this imaging study. as a secondary aim, the investigators will assess the ability of the early flow frames from \[c-11\]pib-pet and brain volumetric measurements with mri to serve as a marker of neuronal injury and to predict cognitive status in conjunction with the amyloid-pet results.

Eligibility criteria:
inclusion criteria: - 1. enrollment in the uab-adc study under a separate irb-approved research protocol (irb-300000169). 2. negative urine or serum b-hcg test within 2 days of \[c-11\]pib administration in women of child bearing potential. women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing. exclusion criteria: 1. meets any exclusion criteria for the uab-adc study (irb-300000169). 2. inability or contraindication for undergoing mri and/or pet imaging 3. inability to participate in the imaging studies due to severity of dementia
study to evaluate the safety and immune response of an investigational vaccine for the prevention of rsv (respiratory syncytial virus) and (hmpv) human metapneumovirus infection in participants aged 60 to 75 years

Conditions: RSV Infection; hMPV

Summary: vav00039 is a first-in-human (fih) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an rsv/hmpv vaccine candidate and rsv vaccine.

the duration of participation will be approximately 6 months for each participant.

Eligibility criteria:
inclusion criteria: * aged 60 to 75 years on the day of inclusion * a female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile exclusion criteria: * any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. * the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: rsv rsv infection rsv vaccine hmpv hmpv infection hmpv vaccine
a study of np001 in subjects with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is a phase 2 randomized, double-blind, placebo-controlled, multicenter study of np001 in subjects with als.

this is a randomized, double-blind, placebo-controlled study of np001 in subjects with als conducted in multiple centers. drug or placebo will be given intravenously. approximately 105 subjects will be enrolled. subjects will be allocated (1:1:1) to placebo and 2 dose levels of np001.

Eligibility criteria:
subjects with sporadic or familial als classified as definite, probable, or laboratory-supported probable als according to the revised el escorial criteria. a list of key criteria is listed below: inclusion criteria: * onset of symptoms less than 3 years prior to study entry. * forced vital capacity (fvc) at least 70% of that predicted for age and height. * stable dose of riluzole if undergoing treatment with this agent. * for females: not be of childbearing potential or agree to use adequate birth control during the study. exclusion criteria: * unstable medical condition(s) other than als. * life expectancy of less than 6 months. * require life-sustaining interventions for the 6 months following randomization. * have a tracheotomy or be using ventilatory assistance \[including bi-level positive airway pressure (bipap) or continuous positive airway pressure (cpap)\]. * active pulmonary disease. * immune modulator therapy within 12 weeks of study entry or participation in studies of other agents within the last 4 weeks prior to the randomization.

Keywords: als
deep brain stimulation (dbs) data base study

Conditions: Parkinson's Disease; Essential Tremor

Summary: the primary goal of this study is to evaluate and compare outcomes, trends, and effectiveness of both awake and asleep deep brain stimulation (dbs) surgical treatments, target selection, targeting accuracy and outcomes in patients with parkinson's disease and essential tremor.

deep brain stimulation (dbs) surgery is a treatment that can improve some of the motor symptoms associated with several movement disorder diseases. dbs is recommended for patients with parkinson's disease who respond well to medication, but still experience frequent wearing off of medications with return of symptoms. patients may also be experiencing troubling medication side effects such as dyskinesias, sleepiness, hallucinations, confusion, and behavioral/personality changes. dbs is also used for patients with essential tremor who have undergone long trials of medication therapy and are still symptomatic. the goal of dbs surgery is to capture that best response to medication and hold it through the day. the food and drug administration (fda) approved dbs as a treatment for essential tremor in 1997 and for parkinson's disease in 2002. the goal of dbs surgery is to improve the quality of life of patients and their families by reducing motor symptoms such as slowness, stiffness and tremor and possibly reducing medication. in order to help with our understanding of its effects, we will collect information on patients who will be undergoing or have undergone dbs surgery. st. joseph's hospital and medical center / barrow neurological institute is one of only a few hospitals in the united states offering a new procedure known as asleep dbs surgery, performed under general anesthesia, as well as the traditional awake dbs procedure; therefore it is important that this new asleep surgery option be studied and compared to awake dbs surgery. objectives include: * comparison of data collected for both the awake and asleep dbs procedures during the pre-operative and post-operative periods including testing, diagnosis, surgical treatment, target accuracy, complications, motor function and quality of life outcomes. * comparison of the differential effects of stn and gpi dbs on gait and balance control * investigate the effects of dbs on the saccadic eye movements.

Eligibility criteria:
inclusion criteria: * clinical diagnosis for parkinson's disease or essential tremor * subject has undergone dbs surgery exclusion criteria: * clinical diagnosis for parkinson's disease or essential tremor * subject has not undergone dbs surgery

Keywords: deep brain stimulation parkinsons disease essential tremor asleep dbs