Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Conditions: Chronic Plaque Psoriasis; Moderate to Severe Plaque Psoriasis

Summary: this is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (pso).


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age * chronic plaque pso for at least 6 months prior to the screening visit * psoriasis area severity index (pasi) \>=12 and body surface area (bsa) affected by pso \>=10% and investigator's global assessment (iga) score \>=3 on a 5-point scale * subject is a candidate for systemic pso therapy and/or phototherapy * female subject of child bearing potential must be willing to use highly effective method of contraception exclusion criteria: * subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab * subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections * subject has concurrent acute or chronic viral hepatitis b or c or human immunodeficiency virus (hiv) infection * subject has known tuberculosis (tb) infection, is at high risk of acquiring tb infection, or has current or history of nontuberculous mycobacterium (ntmb) infection * subject has any other condition, including medical or psychiatric, which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study * subject has had previous exposure to adalimumab * presence of active suicidal ideation or positive suicide behavior * presence of moderately severe major depression or severe major depression * subject has any active malignancy or history of malignancy within 5 years prior to the screening visit except treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Keywords: bimekizumab pso psoriasis
concurrent treatment for substance dependent individuals with post-traumatic stress disorder (ptsd)

Conditions: Stress Disorders, Post-Traumatic; Substance-Related Disorders

Summary: this treatment intervention trial is designed for men and women with substance dependence and comorbid post-traumatic stress disorder (ptsd). participants will be randomly assigned to one of three conditions (two behavioral treatments \[concurrent treatment of ptsd and substance use disorders using prolonged exposure and relapse prevention therapy\] and an active monitoring control group) and will be evaluated at baseline and four follow-up points (post-treatment, 1-month, 2- month and 3-month post-treatment).

this study will enhance the knowledge and understanding of concurrently treating individuals with substance use disorders and ptsd in hopes of facilitating treatment retention and increasing the likelihood for more positive treatment outcomes. following nida's stage model for behavior therapies development, this study will take the next step building upon promising findings from stage ia work with an exposure-based therapy modified to use safely with substance dependent individuals. this study is a randomized clinical trial to assess the relative efficacy of two active treatment conditions versus an active monitoring control group for substance dependent individuals who also meet criteria for current ptsd according to the diagnostic standards set by the dsm-iv. eligible participants will be randomly assigned to either: (1) concurrent treatment of ptsd and substance use disorders using prolonged exposure (cope); (2) relapse prevention treatment (rpt) or an (3) active monitoring control group (amcg). the study is a three armed randomized controlled trial with repeated outcome measures at post treatment and 1-,2-, and 3-months post-treatment follow-up points for participants in cope and rpt.

Eligibility criteria:
inclusion criteria: 1. men and women who are a minimum of 18 years and maximum of 65 years. 2. participants meet dsm-iv criteria for current or past substance dependence 3. participants must have used alcohol or other drugs within the past 3 months 4. participants must speak english 5. participants must meet dsm-iv criteria for current ptsd in response to on an interpersonal, civilian trauma 6. participants are capable of giving informed consent and capable of complying with study procedures. 7. participants demonstrate no gross organic mental syndrome exclusion criteria: 1. participants who are currently suicidal or homicidal 2. participants who carry a diagnosis of bipolar i or psychotic disorders are exclusionary. 3. participants receiving ptsd-specific treatment 4. participants on anxiolytic, antidepressant or mood stabilizing medications which have been initiated during the 8 weeks prior to study participation 5. participants refusing to be audio or video taped

Keywords: co-morbid substance disorders and ptsd trauma alcohol and other drug use disorders treatment outcome post-traumatic stress disorder (ptsd) co-morbid alcohol and other drug use disorders (aod) behavioral treatment
caffeine for preterm infants with apnea of prematurity(aop)

Conditions: Caffeine; Apnea of Prematurity

Summary: nowadays,caffein is commonly used for aop, and it reduces the intubation rate in preterm infants. however, intubation is needed in about 20%-50% of partial neonates. how to reduce the intubation rate effectively is a challenge for neonatologists.

less evidences about more dose of caffein used in preterm infants.

Eligibility criteria:
inclusion criteria: * gestational age less than 32 weeks; * appear aop; * parents'consents are obtained. exclusion criteria: * major congenital abnormalities; * parents' rejection
a phase 2 open label trial of brentuximab vedotin (sgn-35) for systemic anaplastic large cell lymphoma

Conditions: Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin

Summary: this is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (sgn-35) as a single agent in patients with relapsed or refractory alcl.


Eligibility criteria:
inclusion criteria: * patients with relapsed or refractory systemic alcl who have previously received front line chemotherapy. * documented anaplastic lymphoma kinase (alk) status. * histologically-confirmed cd30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of cd30 expression via slides or tumor block. * fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography. * received any previous autologous stem cell transplant at least 12 weeks (3 months) prior. * at us sites, patients greater than or equal to 12 years of age may be enrolled. at non-us sites, patients must be greater than or equal to 18 years of age. exclusion criteria: * previous treatment with brentuximab vedotin. * previously received an allogeneic transplant. * patients with current diagnosis of primary cutaneous alcl (patients who have transformed to systemic alcl are eligible). * known cerebral/meningeal disease.

Keywords: antigens, cd30 antibody-drug conjugate antibodies, monoclonal lymphoma, non-hodgkin lymphoma, large-cell, anaplastic monomethyl auristatin e drug therapy immunotherapy hematologic diseases lymphoma
identification and referral of women at risk for hereditary breast/ovarian cancer

Conditions: Hereditary Breast and Ovarian Cancer

Summary: the purpose of this study is to identify the most effective means of follow-up for women who screen positive on b-rst (breast cancer genetics referral screening tool) applied in the standard clinical setting of mammography, to maximize the number who are referred to and receive cancer genetic counseling services. the clinical utility of b-rst 3.0 will also be evaluated by determining the number seen who are appropriate for genetic testing, undergo genetic testing and are found to carry a hereditary cancer gene mutations with medical management implications for the patient and family. the long-term goal is to reduce the morbidity and mortality associated with hereditary causes of breast and ovarian cancer among patients seen in the emory/winship system.

the three aims for this study are: 1. to develop an electronic version of the revised b-rst (breast cancer genetics referral screening tool) with a hipaa compliant database for integration within the winship cancer institute at emory website. 2. to identify the most effective means of follow-up to maximize the number of screen positive individuals who are referred to and complete cancer genetics counseling. 3. evaluate the clinical utility of b-rst 3.0 by analyzing the number of individuals who were referred to and received genetic counseling and were considered appropriate for genetic testing and underwent genetic testing, and were identified with a brca1/2 mutation, and/or were identified with a mutation in a different hereditary cancer gene, or were not appropriate for genetic testing, but were appropriate for referral to high-risk follow-up services. the b-rst is a simple yet effective screening tool to identify individuals who may be at risk for hereditary breast and ovarian cancer. this study will seek to determine the most effective method of follow-up to maximize referral to and completion of cancer genetic counseling services following a screen positive result on the b-rst tool, and to understand clinical outcomes following participation in genetic counseling (i.e., whether patients who receive counseling undergo genetic testing, genetic testing results, and recommendations for enhanced screening and preventions).

Eligibility criteria:
inclusion criteria: * patient at one of the participating clinics (winship cancer institute and emory university hospital midtown) who arrive for a screening mammogram appointment. exclusion criteria: * patients receiving a diagnostic mammogram will not be invited to participate in the study.

Keywords: breast cancer ovarian cancer b-rst
clinical performance evaluation of the neumodx™ flua/flub/rsv/severe acute respiratory syndrome-cov-2 assay

Conditions: Respiratory Disease

Summary: to demonstrate the clinical performance of the neumodx™ flua/flub/rsv/sars-cov-2 assay on the neumodx systems by determining clinical sensitivity and specificity of the assay.

to evaluate the clinical performance of the neumodx™ flua/flub/rsv/sars-cov-2 assay on the on the neumodx™ 288 and 96 molecular systems, collectively referred to as neumodx systems. the results of this study will be used to support regulatory registration and product release in the us, europe and other markets.

Eligibility criteria:
inclusion criteria: * fresh specimens shall be collected from all comers across the study duration * collected from individuals of any age presenting with influenza-like illness (ili) * nasopharyngeal (np) swab specimen obtained using a flexible mini-tip flocked swab and collected into 3 ml copan® universal transport media (utm) \[cat. no.305c\] or beckton dickinson (bd™) universal viral transport (uvt) \[cat. no. 220531\] * minimum volume for residual specimen approximately 2 ml * fresh specimens to be tested within 3 days of collection. * fresh specimens to be stored under the recommended stability conditions (2-8°c). exclusion criteria: * required information unable to be obtained from associated medical chart. * specimens not fitting criteria outlined above.
adaptive optics (ao) analysis of retinal arteries in patients with recent stroke (strokao)

Conditions: Stroke

Summary: the eye has long been recognized as a window to pathological processes occurring in the brain. by imaging the vascular system of the retina scientific understanding and clinical practice have been improved for a wide range of pathologies from diabetes to stroke and dementia. adaptive optics (ao) reveals retinal details that remain invisible with other current imaging techniques. indeed, vessels can be perfectly visualized, making it possible to detect wall irregularities, accurately measure their different structures and monitor their evolution under treatment if necessary. in ao, studies on retinal vessels involve the calculation of wall thickness (wt), outer diameter (od), inner diameter (id), wall cross-sectional area (wcsa) and wall to lumen ratio (wlr). an increase in wlr \> 0.31 is characteristic of hypertensive microangiopathy and predictive of cardiovascular and brain damage. this accurate assessment of microvascular structure may even be required in the near future in all patients with arterial hypertension. for vessels \> 300 microns in diameter, the increase in vessel wall thickness occurs without changing the id, a process known as external hypertrophic remodeling. for small arteries \< 300 microns, remodeling occurs differently. the total volume of the vessel wall remains constant, but the od and id each decrease, a process known as inward eutrophic remodeling. the objective of this study is to describe the parameters measured in ao in patients in the acute phase of a stroke and then at 3 months.


Eligibility criteria:
inclusion criteria: * for the patients with stroke: inpatients with confirmed stroke (clinical and imaging) for less than 10 days * for the controls: individuals presenting at the rothschild foundation hospital with no history of stroke who are matched to cases already included in the matching criteria: age ± 5 years, gender, high blood pressure (no history, untreated, treated) diabetes (yes, no), body mass index (bmi \< 25, 25 ≥ bmi \< 30, bmi ≥ 30) exclusion criteria: * pregnant or breastfeeding woman * insufficient state of consciousness or physical condition to perform the adaptive optics examination * for the patients with stroke: hemorrhagic post-traumatic hematoma stroke type, or symptomatic stroke of a brain tumour or an arteriovenous malformation.

Keywords: adaptive optics
effect of inhaled nitric oxide on pulmonary ventilation/perfusion ratio assessed by eit in patients with ards

Conditions: Critical Illness

Summary: electrical impedance tomography was used to monitor changes in pulmonary perfusion distribution and v/q ratio before and after ino in patients with acute respiratory distress syndrome to investigate the factors predicting ino reactivity and the physiological mechanism underlying changes in oxygenation.


Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 18 years; 2. patients are intubated and mechanically ventilated. exclusion criteria: 1. eit contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc; 2. with a history of cerebral hemorrhage in the past half year, as well as bleeding in any site of the body; 3. pneumothorax; 4. medium or massive pleural effusion; 5. refractory shock; 6. pregnant 7. with chronic kidney disease 8. atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output; 9. failure to sign informed consent
oct guided trans nasal imaging of the small intestine in adults

Conditions: Environmental Enteric Dysfunction

Summary: the investigators are seeking healthy adult volunteers 18-60 years and healthy pregnant women in their 2nd trimester of pregnancy for a research study to assess a new imaging device. the tearney laboratory at the wellman center for photomedicine at massachusetts general hospital is developing high-resolution imaging devices that can be used to improve diagnostics in gastrointestinal diseases.

the investigators have developed a device that can image the duodenum (the first part of the small intestine). the device consists of a thin, flexible tube with a small internal camera inside of it that takes high-resolution images of the gastrointestinal tract. the device will be introduced through the nose and then advanced into the stomach and duodenum. participant tolerability, imaging quality and the optimal imaging technique will be evaluated. the results of this study will be used as the basis for a larger study to be conducted at the aga khan university hospital in pakistan where subjects with suspected or diagnosed eed will be imaged.

Eligibility criteria:
inclusion criteria: * healthy subjects * subjects who are in their 2nd trimester of pregnancy * subject must be 18-60 years of age subject must be able to consent to the procedure. * subject must fast (no solid food) for at least 8 hours and have no liquids within 2 hours prior to the procedure. exclusion criteria: * subjects with a history of upper respiratory disease or surgery * pregnant women with high-risk pregnancies such as history of: hyperemesis gravidarum, hiv, severe anemia or any other high-risk pregnancy conditions at the discretion of the subject's physician and the pi * subjects with a history of upper gastrointestinal surgery * pregnant women with type 1 diabetes * pregnant women with type 2 diabetes on medication and gestational diabetes requiring medication * pregnant women with gestational thrombocytopenia * subjects with upper respiratory infection at least 7 days prior to the procedure * subjects with any contraindications to the placement of the nj tube including deviated septum or any other anatomical abnormalities of the nasopharynx or upper gastrointestinal region, history of trans-sphenoidal surgery, facial or cranial trauma and fractures, chronic sinusitis, esophageal strictures, varices etc. * subjects on medications that delay gastric emptying. * patients on drugs which impair clotting like anticoagulants and antiplatelet drugs, nsaids, history of bleeding disorders. * subjects using nasal steroids or any steroids for environmental allergies.

Keywords: eed environmental enteric dysfunction environmental enteropathy tropical enteropathy gi tethered capsule endoscopy imaging diagnosis
ponv prevention via percutaneous nerve electrical stimulation on pc6

Conditions: Postoperative Nausea and Vomiting

Summary: this study aims to certify the effectiveness of percutaneous electrical nerve stimulation at pericardium 6 (pc6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting.

introduction: this study aims to certify the effectiveness of percutaneous electrical nerve stimulation at pericardium 6 (pc6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting. method and analysis: a total of approximately 302 patients undergoing elective laparoscopic surgery will be enrolled. participants will be randomly assigned to either a electrical stimulation group or a placebo group, with computer-generated randomization and concealed allocation using sealed envelopes. the electrical stimulation group will receive pc point electrical stimulation 30 minutes before surgery until 24 hours postoperatively, while the placebo group will wear a wristband without stimulation. the primary outcome will be the incidence of postoperative nausea and vomiting, with secondary outcomes including the incidence of nausea and vomiting within 24 hours after surgery, gastrointestinal and hemodynamic indices, postoperative recovery, hospital stay and cost, and complications.

Eligibility criteria:
inclusion criteria: 1. patients aged 18-65 years; 2. patients undergoing elective laparoscopic surgery; 3. american society of anaesthesiologists(asa) grade 1 to 3; 4. anesthesia: general anesthesia, tracheal intubation; 5. bmi: ≥18, \<28; 6. gender: female 7. patients or their family members are able to comprehend the study protocol and are willing to participate in this research by providing written informed consent. exclusion criteria: 1. there are incisions or scars in the wearing position of the device; 2. there is a local infection in the wearing position of the device; 3. upper extremity nerve injury; 4. history of spinal cord surgery; 5. participated in other clinical trials within 4 weeks; 6. suffering from severe central nervous system disease or mental disorder; 7. patients need to return to the icu after surgery.
intervention for sleep and pain in youth

Conditions: Headache Disorders; Migraine Disorders; Insomnia

Summary: this study tests the feasibility, acceptability, and preliminary efficacy of a seven-session cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages 11-17 with co-morbid headache and insomnia.

cognitive-behavioral interventions have been developed to treat childhood insomnia and childhood headache. in this study, we have combined strategies from these interventions into a single, seven-session protocol to treat sleep and pain problems in youth with co-morbid headache and insomnia. in this single-arm pilot study, we will test the feasibility, acceptability, and preliminary efficacy of this intervention.

Eligibility criteria:
inclusion criteria: * youth age 11-17 years * chronic headache and insomnia symptoms for the past 3 months as determined on screening interview with youth and parent. exclusion criteria: * youth and parent do not read or speak english * youth with active suicidal ideation or psychosis * youth with diagnosis of a comorbid serious health condition (e.g., cancer, diabetes) * youth with severe cognitive impairment * youth with another primary sleep disorder (e.g., sleep apnea, narcolepsy) or an unusual sleep/wake schedule or circadian rhythm disorder.

Keywords: pediatric children adolescent sleep pain cognitive-behavioral therapy
a multi-center study on the use of rho-kinase inhibitor to reduce or prevent pvr in rrd eyes at high risk for pvr

Conditions: Rhegmatogenous Retinal Detachment; Proliferative Vitreoretinopathy

Summary: the purpose of this study is to determine if a drug called netarsudil is safe and able to prevent the development of scar tissue after retinal detachment repair. patients eligible for this study are those diagnosed with a rhegmatogenous retinal detachment deemed at high risk for scar tissue formation (a process called 'proliferative vitreoretinopathy').


Eligibility criteria:
inclusion criteria: a patient must meet the following criteria to be eligible for inclusion in the study: 1. diagnosed with primary rrd at high risk for pvr development. specifically, the enrolled eye must include at least 1 but no more than 3 high risk features, which are designated as follows: multiple retinal breaks (3 or more); detachments involving two or more quadrants of the retina; duration of detachment \> 3 weeks; vitreous hemorrhage; and choroidal detachment. 2. consents to surgical repair with pars plana vitrectomy with or without scleral buckling 3. willing and able to comply with clinic visits and study-related procedures 4. able to provide a signed informed consent exclusion criteria: a patient who meets any of the following criteria will be excluded from the study: 1. age \< 18 years 2. presence of pvr grade b or worse (as defined by the revised retina society pvr classification system) at time of surgical repair 3. primary rrd repair is primary laser demarcation, primary cryotherapy, pneumatic retinopexy, or scleral buckling procedure alone. 4. primary use of silicone oil or retinectomy during surgical repair 5. prior incisional ocular surgery other than cataract extraction 6. history of or concurrent ruptured globe, intraocular foreign body, diabetic retinopathy, retinal vein occlusion, exudative age-related macular degeneration, macular hole, epiretinal membrane, sickle cell disease, uveitis or intraocular infectious disease 7. not willing or unable to comply with clinic visits and study-related procedures 8. unable to provide a signed informed consent

Keywords: retinal detachment rhegmatogenous proliferative vitreoretinopathy rho kinase netarsudil rhopressa