Kornimate/medical-research-clean huggingface dataset:
treatment of insomnia secondary to chronic pain

Conditions: Insomnia; Pain

Summary: several studies have shown that behavioral therapy for chronic pain can be beneficial for chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia. however, seldom do chronic pain patients with insomnia receive a behavioral treatment for insomnia. the purpose of this study is to evaluate whether treatment for insomnia is helpful for pain and whether treatment for pain is helpful for insomnia. it will also assess whether a combined treatment is any more or less effective for pain or for sleep. finally, the study will assess whether any of these treatments leads to improvements in immune function.

the investigators' primary goal is to assess the extent to which three forms of cognitive-behavioral treatment (cbt for insomnia, cbt for pain, and combined insomnia \& pain) diminishes insomnia symptoms in patients with chronic pain compared to a group not receiving cbt. this will be evaluated in a randomized trial with before and after evaluations using standard sleep diary measures of sleep continuity. the investigators' secondary goal is to assess whether treatment responses to any of the interventions are associated with alterations in immune function. the investigators' tertiary goals are to evaluate whether improved sleep has effects on patient reports of pain severity, frequency, and tolerability as well as on mood and quality of life.

Eligibility criteria:
inclusion criteria: * ages 35-75 * chronic non-malignant painful condition of the spine of \> 6 months duration * insomnia (\> 30 minutes sleep latency and/or wake after sleep onset time for \> 3 days/week for \> 6 months) * insomnia developed after the onset of the painful condition * preferred sleep phase between 10:00 p.m. and 8:00 am * on stable medical regimen for medical and pain conditions (no surgery planned) * willingness to discontinue hypnotic medications exclusion criteria: * unstable medical or psychiatric illness * history of seizures * evidence of active illicit substance use or fitting criteria for ethanol (etoh) abuse or dependence * symptoms suggestive of sleep disorders other than insomnia * polysomnographic data indicating sleep disorders other than insomnia * inadequate language comprehension * fibromyalgia * pregnancy

Keywords: insomnia sleep pain pain, chronic behavior therapy cbt cbt-i cognitive-behavioral
trans-parenchymal compressing suture in major liver resection

Conditions: Liver Carcinoma Resectable

Summary: non-anatomical liver resection with appropriate resection margin was regarded as a potential curative treatment for selected major hepatic carcinoma due to preserving maximal normal liver, especially in cirrhotic patients. but occurrence of cutting surface related complications become a main challenge.

in order to better manage the cutting surface after liver resection, we further applied trans-parenchymal compressing suture to "not good" cutting surface in hope of decreasing cutting surface related complication. a majority of studies investigating cutting surface management are limited to non-surgical treatments, such as the application of hemostasis agents including fibrin sealants, oxidized cellulose, and absorbable gelatin sponge13-15 . but there is no consensus regarding the necessity of the hemostatic agent application to the liver cutting surface. up to date, few studies investigate surgical suture management of the cutting surface in liver resection.

Eligibility criteria:
inclusion criteria: 1. tumor size more than 5cm 2. non-anatomical liver resection; exclusion criteria: 1. intravascular infiltration with tumor embolus; 2. previous liver surgical treatment (e.g. microwave ablation; preoperative transcatheter arterial chemoembolization (tace); 3. other concomitant extrahepatic procedures (e.g. splenectomy). 4. exposed glisson shealth, main hepatic veins or (and) retro-hepatic inferior vena cava.
preventing mid- and later-life work limitations

Conditions: Depression

Summary: the work and health initiative (whi) trial is testing an innovative, community-based program that provides mental health and vocational services to workers 50 years or older to improve functioning and reduce productivity loss. the purpose of this study is to test the hypothesis that relative to usual care, the whi improves the work outcomes of depression and reduces depression-related productivity loss.

national demographic, economic and cultural trends are creating a need for hiring and retaining older workers. however, while many older people will prefer and/or need to work, chronic health problems occurring in mid-life or later can severely disrupt employment. this study will conduct a randomized controlled trial (rct) of the work and health initiative (whi). the whi is an innovative community-based program that provides mental health and vocational services to workers with depression to improve functioning and reduce productivity loss. this study will focus on workers 50 years of age and older. this study will test the hypothesis that relative to usual care, the whi improves the work outcomes of depression. study results potentially will result in a new multi-disciplinary method for addressing a serious public health and employment issue.

Eligibility criteria:
inclusion criteria: * age ≥ 45 years * working ≥ 15 hours/week * dsm-iv current major depression and/or dysthymia * work limitations: at-work productivity loss score ≥ 5% exclusion criteria: * severe physical health deficits * non-english speaking or reading * positive current alcoholism screening * psychosis * mania

Keywords: depression work performance and productivity worksite intervention
neoadjuvant darovasertib in primary uveal melanoma

Conditions: Uveal Melanoma

Summary: this is a phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma

the study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation. in cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm). in cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). subjects in the control arm will go onto immediate enucleation. subjects will then receive primary local therapy following neoadjuvant darovasertib. all patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.

Eligibility criteria:
inclusion criteria: * primary non-metastatic uveal melanoma * able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the investigator, to comply with all study requirements * ecog 0 or 1 * adequate organ function exclusion criteria: * previous treatment for um * evidence of metastatic um * attributes that necessitate enucleation regardless of response to therapy * evidence of progressive secondary underlying ocular disease that would confound longitudinal va assessments * presence of a malignant disease other than the one being treated in this study

Keywords: uveal melanoma plaque brachytherapy enucleation neoadjuvant darovasertib ide 196 ocular melanoma choroidal melanoma ophthalmology ocular oncology melanoma protein kinase c gnaq gna11
pulsecath mechanical support evaluation

Conditions: Coronary Artery Disease; Heart Failure; Cardiogenic Shock

Summary: the objective of this study is to determine ventricular loading conditions during and after pulsecath® ivac2l support, and assess its impact on specific load dependent humoral factors and cardiac enzymes. these specific patterns are so far unknown and will be evaluated invasively.

this is a mechanistic exploratory study. the objective is to determine the effects of the new pflvad pulsecath® ivac2l on ventricular loading using left ventricular pressure-volume loops, in association with systemic and pulmonary hemodynamic parameters obtained from right and left catheterization. additionally, assessments of specific load and flow-dependent humoral factors and cardiac enzymes will be made during and after the use of mechanical circulatory support. these specific patterns are so far unknown. knowledge of optimal patterns may help in determining the ideal circulatory device platform.

Eligibility criteria:
inclusion criteria: 1. patient is ≥ 18 years; 2. informed consent must be signed by the patient, prior to hr-pci; 3. the multidisciplinary heart team has reached consensus for high-risk pci. patients may present with left ventricular systolic dysfunction (ejection fraction ≤40%); 4. anatomical criteria: intervention to an unprotected left main coronary artery, left main equivalent or single remaining vessel; multivessel disease; intervention in a distal left main bifurcation. exclusion criteria: 1. no written informed consent; 2. left ventricular thrombus; 3. interventricular septal defect; 4. significant peripheral arterial disease or arterial lumen size \< 6mm at the level of the common femoral artery; 5. significant aortic valve disease (more than mild aortic stenosis/regurgitation); 6. cardiogenic shock; 7. previous stroke within the last 3 months; 8. major bleeding event within last 3 months; 9. chronic kidney disease with a gfr \< 25 ml/min;

Keywords: pressure-volume loops cardiac mechanics high-risk pci
device based therapy in hypertension trial

Conditions: Hypertension

Summary: the purpose of this study is to demonstrate the safety and efficacy of the rheos baroreflex hypertension therapy system in patients with refractory hypertension.

the debut-ht trial will investigate the safety and efficacy of rheos baroreflex hypertension therapy(tm) in patients with refractory hypertension despite full pharmacologic therapy. enrolled patients will be carefully assessed prior to receiving a permanently implanted rheos system. once the system is implanted, these patients will be followed closely for 1 month to establish baseline information. the rheos system will be programmed "on" at the 1 month follow-up and incrementally increased at 2 and 3-month follow-up evaluations. an assessment of safety and efficacy will be made at the 4-month follow-up. enrolled patients will be followed annually thereafter.

Eligibility criteria:
inclusion criteria: * be at least 21 years of age. * have been assessed to have bilateral carotid bifurcations located at or below c3 - c4. * have blood pressure greater than or equal to 160 mmhg systolic and/or greater than or equal to 90 mmhg diastolic despite at least two months of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic. * must be certified by the investigator as compliant to taking full doses of medications. * have signed an approved informed consent form for participation in this study. exclusion criteria: * have been diagnosed with: * baroreflex failure or significant orthostatic hypotension * cardiac brady arrhythmias or chronic atrial fibrillation * have carotid atherosclerosis determined by ultrasound or angiographic evaluation with a stenosis of greater than 50%. * have prior surgery or radiation in either carotid sinus region * currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems. * are pregnant or contemplating pregnancy during the 4-month follow-up period. * are on dialysis * have hypertension secondary to a treatable cause * have clinically significant cardiac valvular disease * are unable to comply with protocol requirements. * are unlikely to survive the protocol follow-up period * are enrolled in another concurrent clinical trial

Keywords: drug resistant hypertension refractory hypertension high blood pressure baroreflex hypertension therapy
institut paoli calmettes cervical cancer database

Conditions: Uterine Cervical Neoplasms

Summary: database of institut paoli-calmettes patients diagnosed with cervical cancer


Eligibility criteria:
inclusion criteria: * patient with a diagnosis of cervical cancer exclusion criteria: * non applicable
prolonged exposure therapy versus active psychotherapy in treating post-traumatic stress disorder in adolescents

Conditions: Post-Traumatic Stress Disorder

Summary: this study will compare the effectiveness of prolonged exposure therapy versus active psychotherapy in treating post-traumatic stress disorder (ptsd) in adolescents.

ptsd is an anxiety disorder that can develop after exposure to an event in harm to the life or physical integrity of oneself or others has occurred or was threatened. people with ptsd have persistent frightening thoughts and memories of their ordeal and often feel emotionally numb, especially with people to whom they were once close. effective treatments for post-traumatic stress disorder are available, and research is yielding new, improved therapies that can help reduce symptoms of ptsd. prolonged exposure (pe) therapy is a brief cognitive behavioral therapy that has been effective in treating symptoms of ptsd in adults. however, no treatments have been proven effective for the treatment of ptsd in adolescents. this study will compare the effectiveness of pe therapy versus non-trauma directed active psychotherapy in reducing the symptoms of ptsd in adolescents. in addition, this study aims to refine the existing pe treatment protocol for adolescents with ptsd. participants in this single-blind study will be randomly assigned to receive either pe therapy or ap. all participants will receive 12 to 18 therapy sessions, which will be conducted weekly. assessments of ptsd symptoms, depression, and overall functioning will be conducted at baseline, immediately post-treatment, and 3 months post-treatment.

Eligibility criteria:
inclusion criteria: * primary diagnosis of ptsd * in grades 6-12 * no change in medication regimen for more than 6 weeks exclusion criteria: * diagnosis of adhd, conduct disorder, thought disorder, or bipolar disorder

Keywords: ptsd anxiety disorder trauma adolescents cognitive behavioral therapy
il35 level in vitiligo

Conditions: IL35, Vitiligo

Summary: the aim of this observational study is to evaluate the level of the il-35 protein in tissue biopsy from patients with active \& stable vitiligo.


Eligibility criteria:
inclusion criteria: * patients with active and stable vitiligo exclusion criteria: * pregnant and lactating women. * patients with associated autoimmune or other dermatological diseases e.g., alopecia areata and lupus erythematous. * patients already on both topical and systemic treatment at the time of recruitment. * patients on immunosuppressive drugs. * other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post inflammatory hypopigmentation and leprosy as excluded by lack of accentuation by wood's light examination.
inflammatory and degenerative muscle disease

Conditions: Inflammatory Muscle Disease

Summary: correlation between clinical , ultrasonographical, neurophysiological and histopathological findings in muscle diseases of different etiologies.


Eligibility criteria:
inclusion criteria: 1. muscle diseases of different etiologies. 2. any age. exclusion criteria: 1. patient refuse to participate. 2. the anatomy is altered due to severe trauma, tumor , or surgery. 3. severe deformity preventing examination.
the effects of i-prf on gingivectomy and gingivoplasty

Conditions: Wound Heal

Summary: the study aims to evaluate the effects of injectable platelet-rich fibrin (i-prf) applications on early wound healing after gingivectomy and gingivoplasty surgery. in this randomized controlled single-blind study, gingivectomy and gingivoplasty surgeries were performed on 46 patients. the postoperative i-prf-applied surgery areas were compared with control regions. the surgical areas were stained with mira-2 tone and evaluated in the imagej program. wound healing was evaluated by using the modified manchester scar (mms) scale and landry, turnbull, and howley (lth) index. vascular endothelial growth factor (vegf) and fibroblast growth factor 10 (fgf-10) concentrations were assessed by enzyme-linked immunoabsorbent assay (elisa). the seven-day visual analog scale was used to assess pain level. considering the results found, i-prf applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations.


Eligibility criteria:
inclusion criteria: (a) systemically healthy patients ages 15-40 years, (b) pregnancy or lactation, (c) patients with chronic inflammatory gingival overgrowth in the mandibular and maxillary anterior area, (d) no attachment and bone loss, (e) not using immunosuppressive agents, systemic corticosteroids, chemotherapy, and/or radiotherapy drugs taken or prescribed 2 months before the study attempt, which may affect the study results, wound healing, and coagulation mechanism, and (f) patients with sufficient oral hygiene. exclusion criteria: (a) patients who had a history of periodontal treatment in the last 6 months, (b) smokers and alcohol users, those who used drugs that may cause gingival enlargement in the last 6 months, (c) patients with poor communication, and (d) patients who did not attend controls at designated times.

Keywords: vegf, fgf-10, i-prf,gingivectomy
localization of intercostal perforating vessels reduces wound complications from nipple sparing mastectomy

Conditions: Breast Cancer

Summary: approximately 100 women scheduled for nsm will be consented pre-operatively to participate in the study. us will be performed after induction of general anesthesia, prior to surgery using sonosite™ portable us, 5-12mhz transducer using doppler mode.

nipple sparing mastectomy (nsm) has been increasingly utilized over the last ten years for risk-reducing surgery and surgical treatment for breast cancer. the oncologic safety has been well established in multiple studies in appropriately selected individuals. additionally, rates of wound complications and risk factors for wound problems are well documented. the intercostal perforating vessels (ipv) have been demonstrated to provide a significant proportion of the blood supply to the nipple-areolar complex1-3. thus, preservation of these vessels is essential to reducing ischemic necrosis of the nipple-areolar complex. we propose that localization of these vessels utilizing intra-operative ultrasound (us) will reduce ischemic necrosis complications of nsm. objectives * demonstrate that us is an effective means of localizing the ipv intraoperatively. * evaluate the frequency of ipv preservation with the use of us. * measure rate and severity of ischemic necrosis when us is utilized to preserve ipv. * compare observed rate with historical controls.

Eligibility criteria:
inclusion criteria: * females 18 years of age or older * planned nipple sparing mastectomy exclusion criteria: * contraindication to nipple sparing mastectomy

Keywords: nipple sparing mastectomy ultrasound
evaluation of coblation channeling in treating chronic tonsillitis

Conditions: Tonsillitis

Summary: the investigators wish to evaluate coblation channeling in the treatment of chronic tonsillitis.

the tonsillar crypts play an important role in chronic tonsillitis. they are covered by stratified epithelium and may be initiated via the epithelium to mount immune responses to various presenting antigens. go m. et al, investigated the expression and function of tight junctions in the epithelium of human palatine tonsils from patients with tonsillar hypertrophy or recurrent tonsillitis. these studies suggested unique expression of tight junctions in human palatine tonsillar epithelium, and it was suggested that the crypt epithelium may possess an epithelial barrier different from that of the surface epithelium. bacteria within biofilms are resistant to host defenses and antibiotics. the presence of bacterial biofilms within the tissue and crypts of inflamed tonsils may explain the chronicity and recurrent characteristics of some forms of tonsillitis. there is strong anatomical evidence for the presence of bacterial biofilms in chronically diseased tonsils. our hypothesis was that treatment of the crypts and tonsillar tissue may decrease the possible antigen-immune system interaction and inflammation. the combination of the radio frequency energy and the fluid creates a "plasma" field containing highly ionized particles. the ionized particles have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and damage the surrounding tissue. employing this new technique, the investigators will try to eliminate the cause for chronic tonsillitis. the combination of the radio frequency energy and the fluid creates a "plasma" field containing highly ionized particles. the ionized particles have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and damage the surrounding tissue. employing this new technique, the investigators will try to eliminate the cause for chronic tonsillitis. our hypothesis was that treatment of the crypts and tonsillar tissue may decrease the possible antigen-immune system interaction and inflammation.

Eligibility criteria:
inclusion criteria: * suffering from at least 4 episodes of tonsillitis in past year. * suffering from recurrent or chronic sore throat. * suffering from irregular tonsils with crypts, slight redness or enlargement. exclusion criteria: * suffering from mouth ulcers or other oral מחלת ריריות * allergic to the type of medication included in the study. * suffering from gastrointestinal (gi) reflux or chronic הפרשה הוסטנזלית * contraindication to medical or surgical treatment. * suffering from peritonsillar abscess.

Keywords: chronic tonsillitis radio-frequency coblation radio-frequency coblation in chronic tonsillitis treatment
a phase 1 dose escalation trial of asg-5me in pancreatic or gastric adenocarcinoma

Conditions: Gastric Neoplasms; Pancreatic Neoplasms

Summary: this is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and tolerability of asg-5me and identify the maximum tolerated dose in patients with pathologically confirmed metastatic pancreatic adenocarcinoma, and to evaluate safety and tolerability in patients with relapsed or refractory gastric adenocarcinoma.


Eligibility criteria:
inclusion criteria: * pathologically confirmed metastatic pancreatic adenocarcinoma or pathologically confirmed ags-5-positive gastric or gastric esophageal junction adenocarcinoma * measurable disease (at least one nonresectable, non-nodal lesion greater than or equal to 10 mm in longest diameter or nodal lesion greater than or equal to 15 mm in shortest axis) * ecog performance status of 0 or 1 * may be untreated or have previously received treatment for pancreatic adenocarcinoma or must have relapsed or refractory disease following 1 prior systemic therapy for metastatic gastric adenocarcinoma. for patients who have previously received treatment, it must be at least 2 weeks since the last systemic therapy or radiation, and at least 4 weeks since treatment with any monoclonal antibody (other than bevacizumab). exclusion criteria: * evidence or history of central nervous system metastases * history of another primary malignancy that has not been in remission for at least 3 years * documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with nyha class iii-iv within 6 months prior

Keywords: monomethyl auristatin e (mmae) immunotherapy ags-5 antigen slc44a4 antigen gastric neoplasms pancreatic neoplasms antibody-drug conjugate antibodies, monoclonal drug therapy