Kornimate/medical-research-clean huggingface dataset:
neurovascular embolization cover for treatment of intracranial aneurysms and carotid/vertebrobasilar fistulae

Conditions: Intracranial Aneurysms; Cavernous Carotid Fistula; Vertebrobasilar Fistula

Summary: the purpose of this study is to determine whether the nec device can effectively occlude the intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel patency

sah (subarachnoid hemorrhage) is a devastating medical emergency. as many as 60% of patients who are afflicted die in the first 30 days as a result of the sah, or remain severely disabled from the bleed. existing treatment options include: medical management; endovascular therapy and surgical therapy. endovascular techniques using detachable coils have now been refined to include stents which serve to prevent the coil mass from dislodging. further improvement is believed to be possible with the nec which creates a seal to exclude the aneurismal lumen from blood flow without the need for coils. this study involves the endovascular placement of the nec across the aneurysm neck in order to treat a subset of aneurysms without coils.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of unruptured aneurysm or ruptured aneurysm in clinically stable patients in whom coils alone are not an efficient treatment in the opinion of the investigator (i.e., large neck or fusiform aneurysm) or direct fistulae (type a - traumatic or aneurismal) and indirect if dural branches come from the internal carotid or vertebral artery and cannot be embolized selectively * subject has a confirmed diagnosis of an intracranial (including intracavernous and intrapetrous regions) sidewall saccular aneurysm or carotid vertebrobasilar fistula * parent artery reference diameter is \>2.5mm and \<4.5mm * subject is an adult above age 18 * subject is able to provide written informed consent * subject has good general health, is clinically stable, and is considered to be mentally sound * subject is able and is willing to meet all expected requirements of the clinical protocol, including attending the scheduled follow-up examinations for the duration of this trial. exclusion criteria: * subject has subarachnoid hemorrhage (sah) \< three (3) weeks prior to nec procedure * subject has had prior stenting of the target aneurysm. * subject is contraindicated for antiplatelet therapy,anticoagulant therapy, or radiographic contrast media. * subject has collagen vascular disease. * subject has a contraindication to angiography (e.g., serum creatinine level \> 2.5 mg/dl) * subject has evidence of active infection at the time of treatment * subject is pregnant or breastfeeding or unwilling to use birth control for duration of study * subject has participated in a study involving an investigational drug or device within 30 days prior to proposed entry into subject study * subject is unable to comply with study procedures or protocol * subject has co-morbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
testing a precision psychotherapy system for low-income patients

Conditions: Major Depressive Disorder; Dysthymic Disorder; Specific Phobia; Social Anxiety Disorder; Panic Disorder; Agoraphobia; Generalized Anxiety Disorder

Summary: the purpose of this study is to evaluate the feasibility of an evidence-based system to recommend core interventions, before the beginning of treatment, to psychotherapists treating low-income patients with depressive or anxiety disorders.

after providing a written inform consent, potential patients will undergo a 2-weeks screening period to determine if they meet eligibility criteria. baseline information (i.e., derived from semi-structured intake interviews and baseline clinical measures) from patients who meet eligibility criteria and consent to participate in the study, will be use to feed a machine learning algorithm, developed in a previous study, to perform individual predictions and determine which interventions (i.e., cognitive, behavioral, interpersonal, or patient-centered) will be recommended for the individual patient. this recommendation (i.e., about the most personally well-suited intervention for a given patient) will be provided to therapists before the beginning of treatment. patients will be treated with 15 sessions of psychotherapy. the investigators will examine the extent to which therapists adhered to the recommended interventions as the primary outcome. the investigators will also examine patient symptomatic/functional improvement as a secondary outcome.

Eligibility criteria:
inclusion criteria: * diagnoses of a depressive disorder (i.e., major depressive disorder or dysthymic disorder) or an anxiety disorder (i.e., specific phobia, social anxiety disorder, panic disorder, agoraphobia or generalized anxiety disorder) determined with the mini-international neuropsychiatric interview (mini) * a score of at least two (mild) in any the five items from the depression and anxiety domains of the dsm-5 self-rated level 1 cross-cutting symptom measure-adult * a total family income below the poverty index threshold, determined by a licensed social worker * aged 18 to 65 * fluency in spanish language * capacity to consent exclusion criteria: * psychosis * mania * suicidal ideation with intent and/or plan * substance abuse disorders * history of organic mental disease.

Keywords: depressive disorders anxiety disorders
the effect of the distance between mesh and the urethra on sexuality in patients who underwent transobturator tape.

Conditions: Urinary Incontinence; Sexual Dysfunction; Ultrasonography

Summary: urinary incontinence, commonly observed among women aged 30 to 60, encompasses stress urinary incontinence (sui), responsible for the majority of cases. this condition significantly affects the quality of life, influencing physical, emotional, and sexual aspects. severe cases impact libido and cause vaginal dryness, affecting not just sexual function but also relationships, leading to an overall decline in quality of life. hence, examining sexual functions in those affected by sui holds significance. the study aimed to evaluate the impact of mesh-urethra distance on sexual functions using perineal ultrasound in continent patients post-transobturator tape (tot) surgery for isolated sui. patients achieving continence post-surgery were categorized based on the distance from the posterior of the urethra at the bladder neck to the nearest proximal edge of the tape: \ 5 mm. questionnaires, including the female sexual function index (fsfi) and the incontinence questionnaire urinary incontinence short form (iciq-ui sf), were administered preoperatively and at the 6-month postoperative follow-up.

urinary incontinence, often seen in women aged 30 to 60, involves stress urinary incontinence (sui) in most cases. it significantly affects life, impacting physical, emotional, and sexual well-being. severe cases can lower sex drive and cause vaginal dryness, affecting not just the individual's sex life but also relationships, leading to a lower quality of life overall. that's why looking at how sui affects sexual aspects is crucial. the study aimed to see how the distance between the mesh and urethra after transobturator tape (tot) surgery might affect sexual function in patients who no longer experienced incontinence. patients were divided based on this distance, and surveys like the female sexual function index (fsfi) and the incontinence questionnaire urinary incontinence short form (iciq-ui sf) were used before and six months after surgery.

Eligibility criteria:
inclusion criteria: -continent patients ages 18 to 45 who underwent mid-urethral sling (mus) surgery due to isolated sui were included in the study exclusion criteria: * patients who experienced surgical failure in incontinence surgery, * who had undergone previous vaginal surgeries, who had a history of hysterectomy, * who underwent additional surgeries during the same session, * who had pelvic organ prolapse, who had received radiation therapy, * who had a diagnosis of malignancy, * who were menopausal, who received external hormone treatment, * who were sexually inactive, whose partners had erectile dysfunction, * who did not attend postoperative follow-up appointments, * who became postoperatively pregnant, * who had undergone non-synthetic mesh (autologous fascia) surgery for sui were excluded from the study.

Keywords: female stress incontinence transobturator tape transperineal ultrasound
change in skin elasticity with rf and pemf

Conditions: Skin Abnormalities

Summary: this study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy.

this study is an open-label, baseline-controlled, single-center study to measure the change in skin elasticity after combined radio frequency (rf) and pulsed electromagnetic field (pemf) treatment. forty-five adult females will undergo weekly treatments over a period of 8 weeks. skin elasticity will be measured by a cutometer® prior to beginning treatment, week 7 and 3 months after completion of treatment. photographs will be taken prior to treatment, at week 4, week 7 and 3 months after completion of treatment. patient discomfort/pain and satisfaction questionnaires will be completed before, during and after treatment.

Eligibility criteria:
inclusion criteria: * healthy adult female subject, 18 years of age and older with fitzpatrick skin types i-iv * ability to tolerate the rf/pemf procedure, and willing to adhere to the treatment regimen exclusion criteria: * having any active electrical implant or permanent implant anywhere in the body, e.g. pacemaker, internal defibrillator * prior use of retinoids in treated area within 2 weeks of initial treatment * use of oral isotretinoin (accutane®) within 6 months of initial treatment * patient on systemic corticosteroid therapy 6 months prior to start of study * prior use of collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 4-6 weeks of initial treatment. treatment may not be performed at all over permanent dermal implants. * prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment * any other surgery in treated area within 12 months of initial treatment * history of keloid formation or poor wound healing in a previously injured skin area * epidermal or dermal disorders * open laceration or abrasion of any sort on the area to be treated. * history of immunosuppression/immune deficiency disorders (including hiv infection or aids) or use of immunosuppressive medications. * having any form of active cancer at the time of enrollment * significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the investigator would interfere with the treatment, or healing process * participation in a study of another device or drug within 1 month prior to study enrollment * tattoos in the treatment area.

Keywords: rhytides wrinkle
a study to investigate the effect of food, gender, and age on the pharmacokinetic profile of suvn-g3031 in healthy subjects

Conditions: Cognitive Disorders

Summary: the purpose of the study is to investigate the effect of food, gender, and age on the pharmacokinetic profile of suvn-g3031 in healthy subjects


Eligibility criteria:
inclusion criteria: * healthy male or female aged 18 to 45 years with a bmi between 18 and 30 kg/m2, (inclusive) for food and gender effect * healthy male aged 60 to 70 years with a bmi between 18 and 32 kg/m2, (inclusive) for age effect exclusion criteria: * history or presence of gi, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by investigator. * any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study drug. * any positive result on screening for serum hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibody, and human immunodeficiency virus (hiv) antibody * history of any important clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
consolidative prostate radiotherapy in metastatic prostate cancer

Conditions: Prostate Metastases

Summary: this is a prospective, randomized phase ii trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.


Eligibility criteria:
inclusion criteria: * histologically-proven metastatic prostate cancer * presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.) * planned to or receiving systemic treatment adt +/- arat as per physician discretion (previous chemotherapy allowed if completed more than 6 weeks prior to randomization.) * planned for ebrt * ecog 0 or 1 * age 18 years or older exclusion criteria: * prior radiotherapy to pelvis * active ulcerative colitis or crohn's disease, at discretion of treating physician * any condition where radiotherapy is contraindicated
nitric oxide production in melas syndrome

Conditions: MELAS Syndrome

Summary: introduction baylor college of medicine and texas children's hospital are recruiting individuals with melas syndrome for a clinical study. melas syndrome is a mitochondrial disease; patients with this disease have muscle weakness and often develop brain strokes, where blood does not flow normally to different parts of the brain. it is believed that these strokes could be due to decreased production of nitric oxide, a naturally occurring compound important for normal blood vessel function. nitric oxide is made from arginine and citrulline that are normally found in our bodies. what is the purpose of this study? the purpose of this study is to measure nitric oxide in individuals with melas and see if giving arginine or citrulline will increase the formation of nitric oxide. nitric oxide is thought to be helpful in preventing strokes. therefore, if arginine and/or citrulline are shown to increase the formation of nitric oxide, they could be used to prevent or treat the strokes in patients with melas syndrome.

what does the study involve? individuals with melas syndrome will be admitted twice to the general clinical research center (gcrc) at texas children's hospital. each time they will stay for five days, during which a special diet will be provided. nitric oxide production will be measured by stable isotopes infusion technique that involves placing small tubes in veins (iv catheter), blood sampling, and injecting a harmless stable isotope. stable isotopes are forms of normal compounds that can be measured accurately. they are not radioactive and there are no known risks to giving them; they are already part of your body in small amounts. during the first admission nitric oxide levels will be measured, then arginine supplementation will be provided for 48 hours, after which nitric oxide levels will be re-measured to determine the effect of arginine supplementation. during the second admission, the effect of citrulline supplementation will be measured. who can participate in the study? adults or children affected with melas syndrome and carrying the dna change that causes the condition (3243 a\>g mutation) can participate. adults without melas disease will be recruited to participate as control subjects. how to get more information? subjects interested in participation or getting more information can contact dr. ayman el-hattab at email: elhattab@bcm.edu, office phone: 832-822-4289, cell phone: 646-660-5666, or pager: 832-824-7243 (5523).

Eligibility criteria:
inclusion criteria: 1. age from 3 - 65 years 2. clinical diagnosis of melas syndrome 3. carrying the m.3243a\>g mutation exclusion criteria: 1. having acute or chronic disease or physical disability that will interfere with the ability to undergo the study procedures 2. being pregnant
intraoperative radiotherapy for rectal cancer using the photon radiosurgery system

Conditions: Rectal Neoplasm

Summary: the investigators would like to test the safety and efficacy of intraoperative radiotherapy (iort) in rectal cancer using the photon radiosurgery system (prs).

rectal cancer is usually managed by a combination of surgery and x-ray treatments (radiotherapy). the standard way of delivering radiotherapy is with external 'beams' directed at the tumour site. however, although in rectal cancer these treatments are effective, patients are often troubled by late side effects. an alternative option is to deliver the x-rays at the same time as surgery. this is known as intraoperative radiotherapy, or iort, and a number of techniques have already been tried. there is a new iort technology known as the photon radiosurgery system (prs) which we are using to treat breast and brain cancers. our experience to date has informed us that iort with this x-ray source is safe and effective. we would like to use the technology to treat rectal cancer and believe that it may improve disease outcomes without the side effects associated with standard radiotherapy. we would also like to study the biological processes that follow radiation. it is not understood why some people are more sensitive to x-ray treatments than others. if we knew the reasons for this then we might be able to individualise treatments.

Eligibility criteria:
inclusion criteria: * operable rectal cancer exclusion criteria: * locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease

Keywords: rectal neoplasm c04.588.274.476.411.307.790 intraoperative radiotherapy
identifying the most accurate method for predicting the safe depth of orally placed neonatal endotracheal tubes (ett).

Conditions: Infant Showing No Response to Resuscitation; Ventilator Adverse Event; Apparent Life Threatening Event in Newborn and Infant

Summary: placing artificial airways in infants is often performed under emergent life-saving conditions, which necessitates a procedure that is both accurate and efficient. intubations of the newborn are often necessary before an accurate weight can be reported and estimations are often inaccurate. the current national standard uses body weight to predict the appropriate tube depth yet this approach tends to place the tube too deep for the smallest and most vulnerable neonate; and placement accuracy of any size infant is only 50-70%. the consequence of malpositioned etts resulting from poor oxygenation, lung hyperinflation, pneumothoraces and death has been suggested to cost $20 to $54 million annually. the morbidity and the financial impact suggest an optimal and accurate approach to place ett in neonates has not been identified. other methods to estimate the proper depth of the orotracheal tube have shown promise yet no comparison studies have been performed. identifying the most accurate method to safely place neonatal orotracheal tubes will improve placement precision and reduce adverse events and their associated costs. hypothesis compared to weight, sternal to xyphoid length and shoulder to elbow length, the nasal to tragus length will become the most accurate method for predicting the safe depth of orally placed neonatal endotracheal tubes.


Eligibility criteria:
inclusion criteria: * infants orally intubated and admitted into the neonatal intensive care unit. exclusion criteria: * previous intubation * hydrops fetalis * thoracic congenital anomalies * facial abnormalities * naso-tracheal intubation

Keywords: infant newborn neonate intubation neonatal resuscitation
hormonal status on blood flow and tissue in pelvic organ prolapse

Conditions: Pelvic Floor Disorders

Summary: our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.

our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments. we will perform in vivo evaluations with colposcopy and oct to determine epithelial thickness and overall mucosal health prior to surgery. at the time of surgery, we will obtain tissue for histologic and imaging analysis.

Eligibility criteria:
inclusion criteria: * 21 to 70 years of age * stage ii or greater pelvic organ prolapse (pop) * individuals electing surgery to treat their pop * willing and able to comply with study procedures * willing and able to provide written informed consent exclusion criteria: * contraindication for estrogen cream * any medical condition that in the opinion of the investigator would place the subject at increased risk for participation * history of connective tissue disease * previous hysterectomy or pelvic organ prolapse surgery * known allergic reaction to any agent required by the protocol * use of hormone therapy in postmenopausal women in the last 90 days * pregnant or lactating females * history of prior noncompliance or the presence or history of psychiatric condition that would in the opinion of the investigator make it difficult for the subject to comply with study procedures or follow instructions

Keywords: pelvic floor dysfunction pelvic organ prolapse vaginal estrogen effects
importance of meal fat content and gall bladder emptying for postprandial glp-1 secretion in type 2 diabetes patients

Conditions: Diabetes

Summary: purpose the goal of the present project is to unravel the importance of bile acid-induced glp-1 secretion (via the g protein-coupled receptor tgr5) in human physiology. in the present study the investigators examine the glp-1 secretion in healthy subjects and in type 2 diabetes mellitus (t2dm) patients. the investigators hypothesize that patients with t2dm of relatively long duration will be characterized by reduced gall bladder emptying, and, consequently, reduced intestinal tgr5 activation; resulting in attenuated postprandial glp-1 responses (primary endpoint).


Eligibility criteria:
inclusion criteria: (healthy) * hba1 \< 6 % * normal haemoglobin levels * informed content inclusion criteria: (t2dm) * t2dm \> 5 years * normal haemoglobin levels * informed content exclusion criteria: (t2dm) * treatment with insulin, dpp-iv inhibitor or glp-1 analogues * obesity (bmi \> 30) * age \> 70 years * gastrointestinal disease * nephropathy * liver disease * medication which cannot be on hold for 12h * gastrointestinal surgery exclusion criteria: (healthy) * 1st degree relatives with diabetes * obesity (bmi \> 30) * age \> 70 years * gastrointestinal disease * nephropathy * liver disease * medication which cannot be on hold for 12h * gastrointestinal surgery