Kornimate/medical-research-clean huggingface dataset:
mi-stitch™ and mi-knot™ device technologies - improvement of mitral valve repair

Conditions: Mitral Regurgitation; Mitral Valve Insufficiency

Summary: the objective of this study is to analyze the safety and efficacy of a novel device for minimally invasive mitral valve repair. data of the early and intermediate postoperative period will be collected within routine clinical follow-up in order to assess morbidity and mortality as well as echocardiographic parameters.

this study is a clinical, single-center pilot-study to evaluate safety and performance of a novel device in minimally invasive mitral valve surgery. twelve (12) patients with mitral valve regurgitation planned for surgery at vienna general hospital (akh) will be enrolled in the study considering inclusion and exclusion criteria. mitral valve repair is achieved by replacing the chordae tendinea with expanded polytetrafluoroethylene (eptfe) sutures either with or without concomitant procedures, such as annuloplasty, resection, or gap closure. these eptfe sutures are placed between a mitral leaflet and the corresponding papillary muscle using a novel suturing device (mi-stitch™). by adjusting the length of the suture, the appropriate coaptation is achieved and prolapse is avoided - resulting in an adequate seal of the valve. the procedure will be assessed according to the primary safety endpoint (30 day mortality) as well as the implantation time. likewise midterm safety endpoints at 12 months (mortality and observed rate of serious adverse events \[sae\]) and procedural times will be analyzed.

Eligibility criteria:
inclusion criteria: * severe primary mitral valve regurgitation according to current guidelines with indication for mitral valve repair * with or without concomitant procedures such as: coronary artery bypass grafting (cabg), other valve repair/replacement, pacemaker implantation, exclusion of left appendage and maze (or pvi) procedure, aortic procedures * euroscore ii \< 8 * left ventricle ejection fraction \> 35% * life expectancy above 1 year after the intervention based on operator assessment * willing to sign informed consent * willing to undergo all medical follow-ups necessary for the clinical investigations until study termination (echocardiography, blood tests, physical investigation) exclusion criteria: * age \<18 years * active endocarditis or myocarditis * previous cardiac surgery * heavily calcified mitral valve annulus * severe mitral stenosis * female pregnant patients * emergency procedures * patient not able to read or understand informed consent * patient not willing to sign informed consent

Keywords: minimal invasive surgery novel surgical device mitral valve repair cardiac surgery
justice-involved veterans and moral reconation therapy

Conditions: Antisocial Personality Disorder; Substance Use Disorder

Summary: the purpose of this study is to determine whether moral reconation therapy (mrt) is effective for reducing risk of criminal recidivism and improving other health-related outcomes (substance use, mental health, housing, and employment problems) among justice-involved veterans entering residential mental health treatment programs in the department of veterans affairs (va).

approximately 146,000 veterans are released each year from correctional settings; however, two thirds will likely reoffend and return to the justice system. antisocial cognitions and behaviors are the strongest predictors of reoffending and are highly prevalent among justice-involved veterans (jivs). however, in the absence of treatments with demonstrated effectiveness with jivs, no systematic approach to address antisocial cognitions and behaviors has been implemented in va. moral reconation therapy (mrt) is a cognitive-behavioral intervention that aims to reduce antisocial cognitions and behaviors. mrt has the best empirical support for reducing risk for criminal recidivism among civilian offenders, and its associated mechanisms (improvements in interpersonal functioning and impulse control) have been linked to improvements in health-related outcomes that are also risk factors for recidivism (substance use, mental health, housing, and employment problems). however, no trials have been conducted with jivs. differences between jivs and justice-involved civilians (e.g., prevalence of traumatic brain injuries; interpersonal problems) suggests prior research on mrt with civilians may not be generalizable, and prompted the va's veterans justice programs (vjp) and the developers of mrt to develop a veteran-specific curriculum of this intervention. using the new veteran-specific manual, the overarching objective of the current proposal is to implement and evaluate mrt as an intervention to reduce risk for criminal recidivism and improve health-related outcomes among jivs in va mental health residential rehabilitation treatment programs (mh rrtps). using a hybrid type 1 design, this project will test the effectiveness of mrt in a multisite randomized controlled trial (rct) (palo alto, little rock, and bedford vas) and conduct a formative evaluation to facilitate future implementation of mrt in va.

Eligibility criteria:
inclusion criteria: * veterans who * (a) are entering a mental health residential rehabilitation treatment program (mh rrtp) at one of three study sites (palo alto, little rock, or bedford va), and * (b) had been arrested and charged and/or released from incarceration in the past 5 years prior to mh rrtp admission will be eligible for participation exclusion criteria: * the only exclusion criterion is being too cognitively impaired to understand the informed consent process and other study procedures.

Keywords: crime mental health substance abuse homelessness veterans
metabolic changes in the activated human visual cortex during mild hypoxia

Conditions: Brain Hypoxia

Summary: the primary objective of this research is to measure changes in neurochemical concentrations during stimulation of the primary visual cortex, in both conditions of normoxia (normal oxygen availability) and induced mild hypoxia (reduced oxygen availability).

the goal is to determine the effect of mild hypoxia on human brain energy metabolism of healthy young adult subjects. for this purpose, the investigator will utilize non-invasive imaging modalities based on functional magnetic resonance spectroscopy (fmrs) to estimate metabolic changes during a visual stimulus, while subjects are exposed to well-controlled gas mixtures that resembles conditions of either normoxia or mild hypoxia. identifying the impact of mild hypoxia on functional brain energy metabolism in the healthy human brain is a crucial step for generating hypotheses in multiple patient populations that experience mild hypoxia as consequence of their pathological condition, such as in sleep apnea and traumatic brain injury. the investigator hypothesize that the energetic demands of neuronal activation as revealed by fmrs will not be affected by mild hypoxia.

Eligibility criteria:
inclusion criteria: * those volunteers who are evaluated as normal and not met exclusion criteria will be potential candidates for this study. exclusion criteria: * subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.). * subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc. * females. * subjects that exhibit noticeable anxiety and/or claustrophobia. * subjects who cannot adhere to the experimental protocol for any reason. * subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function). * subjects who have known conditions which can lead to emergency medical care. * been diagnosed by a physician as having a psychiatric disorder, substance abuse, neurological, cardiovascular. * been diagnosed by a physician as having respiratory diseases. * had a brain tumor or stroke. * started taking chemotherapy or immunomodulatory agents, or had any radiation treatment that could affect the brain. * had two or more seizures, or been given a diagnosis of epilepsy. * gotten a non-removable piercing or permanent eyeliner. * had a head injury that caused you to lose consciousness for more than 30 minutes or have amnesia for more than 24 hours. * anyone with a history of sleep apnea or head trauma that may have caused traumatic brain injury (tbi). * gotten some type of metal in your body, either from a medical procedure or an injury. * male subjects with long beard which wouldn't allow a complete seal between the mask and the face. * anyone who is not able to see long distance without glasses or contacts.

Keywords: functional mrs glutamate
the impact of the biologist performing the embryo transfer on the cycle outcome

Conditions: Infertility

Summary: this is a retrospective single center analysis which includes all the fresh, ioc (insemination of in vitro matured oocytes) and frozen embryo transfer (et) performed between january 2000 and december 2019 at humanitas fertility center after ivf-icsi (in vitro fertilization - intracytoplasmic sperm injection) cycles. the primary objective is to determine the impact of the biologist performing the embryo transfer on the pregnancy probability, in terms of ongoing pregnancy rate (opr), defined as the number of viable pregnancies that had completed at least 12 weeks of gestation on the total number of et performed. secondary end point is to evaluate whether the biologists improve their performances as their experience increases, allowing the drawing of an et learning curve in term of pregnancies for the different biologists. the biologist's experience was assessed in terms of number of previous interventions performed prior to the day of et. a total of 28 operators were eligible to participate in the study. any biologists who performed less than 100 ets was excluded from the analysis.


Eligibility criteria:
inclusion criteria: exclusion criteria: any biologist who performed less than 100 embryo transfers was excluded from the analysis.
sleep disordered breathing and alzheimer's disease biomarkers in normal aging and mild cognitive impairment

Conditions: Sleep Disorder

Summary: the purpose of this study is to determine the sleep patterns of subjects with or without sleep disturbances (insomnia, sleep apnea) and compare these findings with their previous fdg/pib pet, structural mri and brain blood flow scams performed during their participation in the following studies 'alzheimer's disease core center (adcc) clinical evaluation' (irb: 2942), mri progression markers of cognitive decline in the elderly' (irb:09-0586), or 'imaging neuro inflammation in alzheimer's disease with \[11c\] arachidonic acid (aa) and pet'(irb: 10-00442).


Eligibility criteria:
inclusion criteria: * all subjects will have participated in prior cbh studies and have agreed to an fdg, pib and mri scans. exclusion criteria: * diagnosis of sleep apnea and under treatment with a continuous positive airway pressure (cpap) machine. * active depressive episode during the evaluation with a geriatric depression scale score \>7 and/or a clinical global impression scale for depression score \>4. * moderate cognitive decline (gds \>3). * severe primary or secondary insomnia except insomnia due to sdb.
the proverum first in man prove study

Conditions: Benign Prostatic Hyperplasia

Summary: a clinical evaluation to assess the safety and performance of the proveetm urethral expander system, designed to alleviate the symptoms of benign prostatic hyperplasia (bph).


Eligibility criteria:
inclusion criteria: * males ≥ 50 years of age * moderate-to-severe symptomatic bph * ipss of \> 15 * peak urinary flow rate (qmax) of \<12 ml/s * prostate volume of ≥ 30 and ≤80 cc * prostatic urethral lengths ≥ 4cm exclusion criteria: * a prostatic urethral length of less than 4cm * a prostatic volume \ 80cc * an obstructing intravesical prostatic median lobe * urinary incontinence due to an incompetent external sphincter * urethral pathologies that may prevent insertion of delivery system * a current symptomatic urinary tract infection * current significant visible haematuria * patients with known allergy to nickel or titanium * history of significant medical co-morbidity or prior surgery that may confound the results of the study * another medical condition that would pose an unacceptable patient risk * known or suspected urological condition that may affected voiding function * neurogenic bladder and/or sphincter abnormalities * patients with cognitive disabilities unable to understand and give informed consent to the research study
effects of the quantity of repetitive transcranial magnetic stimulation(rtms) on the recovery after stroke

Conditions: Stroke; Hemiplegia

Summary: the aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rtms and the efficacy in the treatment of upper extremity motor deficits of stroke patients.

repetitive transcranial magnetic stimulation (rtms) can modulate excitability of the brain via non-invasive methods. in that sense, rtms has been used to treat a variety of symptoms of stroke during last two decades. especially, improvement of upper extremity function has been proved by many studies. however, it remains uncertain about the optimum amount of rtms. the aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rtms and the efficacy in the treatment of upper extremity motor deficits of stroke patients. fifty-seven patients will be included with written consent. after randomization, the subject will receive 3 different amount of treatment rtms-rtms, sham-rtms, sham-sham) in double blind methods.

Eligibility criteria:
inclusion criteria: * single mono-hemispheric ischemic or hemorrhagic stroke * 1st onset stroke patient * upper extremity functional deficit attributable to acute stroke * a stage of at least 3 on brunnström pre-treatment * written signed consent exclusion criteria: * multiple lesion * bilateral cortical lesion and motor problems * cerebellar, or brainstem lesions * history of more than one stroke * uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease; * increased intracranial pressure * history of seizure confirmed by interview and medical chart review * any individual who is on medication which is known to lower seizure threshold * other conditions that increase the risk of side effects due to rtms procedures: a metal plate or metal object in the skull or eye, intracardiac line, increased intracranial pressure, cardiac pacemaker, implanted medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family * an age of less than 20 years old * any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke * complications that would prevent participation in the intervention, such as severe pain and severe spasticity * inability to cooperate outcome measure-related task * severe language disturbances * serious cognitive deficits * non-vascular cause for the neurological symptoms other central nervous system * disorder or peripheral neuropathy of the upper extremity * taking medication which interrupt brain activity * women who are pregnant

Keywords: stroke cerebrovascular disease hemiplegia transcranial magnetic stimulation repetitive transcranial magnetic stimulation rtms rehabilitation upper extremity
cross-validating the itbs-induced hemodynamic response from fnirs and fmri: a concurrent itbs-fmri-fnirs study

Conditions: Healthy Adults

Summary: intermittent theta-burst stimulation (itbs) targeting the left dorsolateral prefrontal cortex (dlpfc) is well established in treating patients with major depressive disorder (mdd). however, the itbs-induced hemodynamic response during or immediately after a full session of stimulation has not been fully investigated. although several concurrent itbs/functional near infrared spectroscopy (fnirs) and itbs/functional magnetic resonance imaging (fmri) studies have investigated the hemodynamic response during or immediately after left dlpfc itbs, they revealed inconsistent findings in the stimulated dlpfc. given that the variability in itbs-induced hemodynamic response in the stimulated dlpfc could be modulated by various inter- and intra-individual factors, cross-validating the findings from both techniques (fnirs and fmri) in the same group of participants under the same conditions through a simultaneous fmri/fnirs setting enables a straightforward comparison and interpretation of results from each technique. however, to our knowledge, cross-validation of itbs-related fnirs and simultaneous fmri data has not been conducted yet, even the implementation of a simultaneous itbs/fmri/fnirs setup is technically feasible with the mutually compatible equipment. therefore, the current study has two primary objectives: firstly, to establish a novel and practical methodological pipeline for simultaneously conducting itbs/fmri/fnirs. secondly, to cross-validate the hemodynamic responses during and immediately after itbs, respectively monitored by fnirs and fmri.


Eligibility criteria:
inclusion criteria: * healthiness based on history and psychiatric assessment exclusion criteria: * a medical history of a major systemic illness or a neurological or psychiatric disorder * pregnancy * common fnirs, mri and tms exclusion criteria such as a history of brain surgery, head injury, cardiac pacemaker, intracranial metallic particles or a history of seizures
cell therapy for motor neuron disease/amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the effect of autologous bone marrow mononuclear cells on motor neuron disease/amyotrophic lateral sclerosis patients.


Eligibility criteria:
inclusion criteria: * patients with the diagnosis of definite motor neuron disease/amyotrophic lateral sclerosis. * age 18-80 years exclusion criteria: * hiv/hbv/hcv * malignancies * bleeding tendencies * pneumonia * renal failure * severe liver dysfunction * severe anemia \[hb \< 8\] * any bone marrow disorder * space occupying lesion in brain * pregnancy and lactation * other acute medical conditions/infections such as respiratory infection and pyrexia * left ventricular ejection fraction \< 25% * patient on artificial ventilatory support

Keywords: motor neuron disease amyotrophic lateral sclerosis autologous mononuclear cell therapy stem cells
joint pain occurring during anti-tnf therapy in chronic inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: ibd (inflammatory bowel disease) are associated with various types of joint manifestations, especially inflammatory. patients with ibd treated with anti-tnf commonly report joint symptoms, with variable expressions and aetiologies, possibly responsible for impaired quality of life, and possibly leading to discontinuation of an effective and validated treatment.


Eligibility criteria:
inclusion criteria: * males or females over the age of 18 years at the time of inclusion * patients with ibd (crohn's disease or ulcerative colitis), diagnosed by a set of compatible clinical (chronic diarrhoea, haematochezia, anoperineal lesions, etc.), laboratory, histological and endoscopic arguments. patients will be included regardless of the severity of their disease, its clinical course, the type of lesions, and the presence or absence of associated manifestations. * patients treated with anti-tnf: infliximab or adalimumab. * informed patients not refusing to participate. * patients covered by french national health insurance. exclusion criteria: * patients under the age of 18 years at the time of inclusion. * patients previously treated with anti-tnf, but no longer treated with anti-tnf at the time of inclusion. * protected majors (under permanent or temporary guardianship).

Keywords: joint pain
treatment of social phobia over the internet

Conditions: Social Phobia

Summary: forty-eight people diagnosed with social phobia in an experimental study that randomized into two treatment groups: 1) internet-based cognitive behavioural therapy (icbt) (n = 24) or 2) computerized attention training (n = 24). after nine weeks we change the condition of the two groups of research participants, which should therefore be given both treatments. pre-and post measurement of functional magnetic resonance imaging (fmri) will take place in the first round of treatment. genotyping based on saliva samples takes place before the start of treatment, at the first fmri measurement, for those who voluntarily leave the sample. study hypothesis how is the brain activity of emotional processing and anxiety affected after completing an internet-based cbt compared with computerized attention training? does the treatment response of an internet based treatment affects by variations in serotonin-transporter-linked promoter region (5-httlpr) and tryptophan hydroxylase-3 (tph3) genes? how is the genetic variations related to symptoms in social phobia (pre treatment)?


Eligibility criteria:
inclusion criteria: * participants must meet criteria for social phobia using the international classification system diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv). exclusion criteria: * individuals with current depression and/or is suicide prone will be excluded from the study. * with fmri the following criteria must not be filled: previous surgery in the heart or brain, metals implanted in the body, dental braces or bridge; piercings that can´t be taken out, tattoos (shoulders, arms and back is not so good, the legs are okay if it is not too large); trouble to lie still for about an hour, pregnancy or history of neurological diseases.
treatment outcomes of retroperitoneal sarcoma

Conditions: Retroperitoneal Sarcoma

Summary: investigators tried condult a retrospective study to analysis the prognostic factors and oncological outcome analysis of retroperitoneal sarcoma treated in our high volume medical center.

retroperitoneal sarcoma (rps) which is a rare disease which incidence is 1.79/100,000. the treatment is difficult to due to it anatomy position which often invade to multiple organs and cause the complete surgical resection to be very complex and difficult. it was known to sacrifice one side kidney will improve the resection rate. to this days, successful surgical resection was still the gold standard that provide most benefit in overall survival. to reach that goal, pre-operative radiotherapy was applied to rps which intended to achieve similar effect in rectal cancer for the down staging effect and improved the respectability but with limited benefit. herein, investigators conducted this study to find the best way to achieve successful surgical resection and prognostic factor analysis.

Eligibility criteria:
inclusion criteria: * the patient who have retroperitoneal maliganacy and receive complete tumor excision in our hospital exclusion criteria: * the patient did not receive complete tumor excision in our hospital * the pathological report yielded not malignancy tumor

Keywords: retroperitoneal sarcoma surgery radiotherapy