Kornimate/medical-research-clean huggingface dataset:
sex and gender-based analysis of the effectiveness of advanced therapies in psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: sex and gender are important factors that influence treatment response in psa. the goal of this multi-centre observational study is to understand how sex and gender influence response to advanced therapies in psoriatic arthritis (psa). the investigators hope to discover biological and socio-cultural mechanisms that explain the differences in treatment response between men and women with psa. the study investigators plan to recruit patients from approximately 30 sites across the world. men and women with active psa will be assessed before and after they start advanced therapies and information will be collected about sex- and gender-related factors through questionnaires and physical examination. physicians will assess the patient response to treatment. the investigators will compare the response to treatment in men and women and assess what biological and socio-cultural factors contribute to differences in treatment response.

study investigators will perform a prospective, multi-center, international cohort study involving approximately 30 sites that specialize in care of patients with psa. 540 patients with a rheumatologist-confirmed diagnosis of psa who are initiating advanced therapy for peripheral musculoskeletal manifestations of psa will be enrolled. the study will include 2 in-person physician visits. visit 1 (baseline) will take place prior to drug initiation (up to 3 months prior). visit 2 (follow-up) will occur 3-6 months following drug initiation. in addition, study sites will be asked to report persistence status on the study drug at 1 year.

Eligibility criteria:
inclusion criteria: * rheumatologist confirmed diagnosis of psa according to caspar criteria * age ≥18 years * active psa with any of the following manifestations detected on physical examination: peripheral arthritis, dactylitis, and enthesitis. the patient may have axial involvement in addition to the peripheral manifestations of psa * plan to start treatment with advanced therapies for peripheral musculoskeletal manifestations of psa exclusion criteria: * unable to read or write * unable to sign informed consent * cannot return for a follow up visit * the drug is given for another indication and not for active psa (e.g. psoriasis, ibd) * pregnant women

Keywords: psoriatic arthritis inflammatory arthritis sex gender advanced therapies
espb versus pvpb regarding their effect on peri-operative opioid consumption in patients undergoing minimally invasive mitral valve replacement

Conditions: ERAS; Post Operative Pain

Summary: in recent years , the popularity of ultrasound-guided fascial plane blocks has increased in achieving an effective postoperative analgesia and hence achieving enhanced recovery after surgery (eras) . mastering the use of ultrasound encourages anesthetists on the frequent use of regional anesthesia . fascial plane blocks are increasingly becoming a part of multimodal analgesia as an alternative pain management strategy in cardiac surgery. various regional techniques especially paravertebral plane blocks have been recently described to reduce the postoperative pain in cardiac surgery with enhanced recovery . ultrasound-guided erector spinae plane block is a recently introduced technique for regional analgesia in thoracic neuropathic pain, rib fractures, and breast surgeries. this study aims to compare between the two techniques regarding their peri-operative analgesic effect and their impact on enhanced recovery after surgery.

this study aims to compare between the effectiveness of erector spinae plane block and thoracic paravertebral plane block in reducing the perioperative need of opioids in patients undergoing minimally invasive mitral valve replacement as part of eras.

Eligibility criteria:
inclusion criteria: * patients with american society of anesthesiologists (asa) score iii. * patients aged ≥ 18 years old. * patients scheduled for minimally invasive mitral valve replacement through a right mini thoracotomy. exclusion criteria: * patients refusing to be involved in this study. * patients with asa score \> iii. * patients aged \< 18 years. * patients with local infection at the site of needle puncture. * patients with known hypersensitivity to local anesthetic (la). * patients with hepatic or renal impairment.
immediate versus early endovenous ablation in venous ulcer

Conditions: Venous Ulcer

Summary: the study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.

recently evra study showed that early endovenous ablation (foam sclerotherapy and/or endothermal ablation) is beneficial for venous ulcer healing. this randomized controlled trial is conducted to assess the effects of immediate foam sclerotherapy in the first visit to vascular outpatient clinic (immediate intervention). patients in control group will receive foam sclerotherapy at four weeks (early intervention). endothermal ablation is performed in early setting in both groups when truncal vein anatomy is suitable. the primary outcome for this study is the reduction of venous ulcer area at four weeks.

Eligibility criteria:
inclusion criteria: * venous ulcer \> 1 month * ulcer area \> 1cm2 * palpable distal pulses / ankle-brachial index \> 0,8 / toe-brachial index \> 70mmhg (at least one criteria must be met) exclusion criteria: * leg ulcers other than venous etiology * pregnancy * general contraindications for foam sclerotherapy * ulcers requiring operation theater revision

Keywords: venous ulcer venous insufficiency of leg varicose veins
certolizumab pegol for the treatment of patients with active rheumatoid arthritis (ra) and crohn's disease (cd)

Conditions: Rheumatoid Arthritis; Crohn's Disease

Summary: this is an observational trial in rheumatoid arthritis and crohn's disease patients treated with cimzia aiming to evaluate the risk and incidence of tuberculosis.

this is a prospective non interventional study. patients enrolled in this study will receive cimzia on prescription according to the instructions for use approved in russia and within the frame of current standard clinical practices. the patient is evaluated at the screening visit for enrollment. a baseline visit is to be scheduled no more than 28 days after the screening visit. subsequent evaluations are done routinely every 6 months.

Eligibility criteria:
inclusion criteria: * patients who have been prescribed cimzia exclusion criteria: * any contra-indication according to the russian summary of product characteristic

Keywords: certolizumab pegol cimzia
influence of nutrition on lung microbiota in traumatic brain injury

Conditions: Microbial Colonization

Summary: role of immunonutrition in modulating the lung microbiota of intubated tbj patients and how this interaction may affect the infections and outcomes. for these reasons, the aims of our study are the evaluation of the impact of immunonutrition on the lung microbiota and the relationship between lung microbiota and infection in tbj patients in icu.

traumatic brain injury patients, requiring mechanical ventilation admitted to icu will be randomly divide in two groups receiving standard nutrition or specialized formula. lower lavage (bronco alveolar lavage: bal) samples will be collected at admission in icu and at day 7 for the microbiota analysis. clinical follow-up at day 28 will be obtained

Eligibility criteria:
inclusion criteria: * adults (age \> 18 years), * paziente with traumatic brain injury exclusion criteria: * pregnant women, * patients with gastric content inhalation * patients with chronic inflammatory bowel diseases * patients underwent major abdominal surgery and/or organs/tissues transplant * patients on corticosteroid and/or immunosuppressive therapy
salud, estrés y resilencia en familias/ health, stress, and resilience among latino families in the us

Conditions: Substance Abuse; Intimate Partner Violence (IPV); HIV Infections; Depression; Anxiety

Summary: this study aims to prevent syndemic health conditions by decreasing acculturative stress and promoting resilience via ser familia (salud, estrés y resilencia en familias/ health, stress, and resilience in families), a family-based intervention. ser familia is a six-session intervention co-developed and delivered by community health workers (chws) that uses strategies to reduce acculturative stress, promote resilience, improve parent-child and family level health, while simultaneously helping families maintain strong social networks and better navigate community resources to address social determinants of health (sdoh). more specifically, investigators aim to: 1) examine the efficacy of ser familia to prevent or reduce the syndemic comprised of substance abuse, ipv, hiv risk, depression, and anxiety among parents and youth; and 2) identify how individual, family, and community mechanisms of change related to acculturative stress and resilience mediates the effect of ser familia.


Eligibility criteria:
inclusion criteria: * eligible participants must identify as hispanic/latino/a/x/e, * be a first generation immigrant parent or parental figure (parent) * have a child (youth) aged 12-17 * speak english and/or spanish exclusion criteria: * families planning to move within two years will be excluded

Keywords: family stress resilience
a comparison of lasik outcomes using two femtosecond lasers

Conditions: Myopia; Astigmatism

Summary: comparing lasik outcomes using two femtosecond lasers

patients will have a comprehensive eye examination once they express an interest in the study. this includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. if there is any pathology noted that would exclude the patient from the study, then the investigator will inform the patient and make an appropriate referral. patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. patients will undergo bilateral simultaneous eye surgery. which eye is treated with the intralase ifs 150 and which eye is treated with visumax will be randomized so there is a 50% chance for either eye to receive one treatment. patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. patients will receive topical antibiotics in each eye for one week following the procedure. patients will receive pred forte 1% ophthalmic drops for one week after treatment. patients will also receive vigamox ophthalmic drops for four days after treatment. all of this is within the usual and customary standard of care for the treatment of patients undergoing lasik surgery.

Eligibility criteria:
inclusion criteria: * subjects age 21 and older with healthy eyes. nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters. exclusion criteria: * subjects under the age of 21 * subjects over the age of 60 * subjects with corneal ectatic disorders

Keywords: femtosecond laser visumax intralase ifs150 lasik
acute effects of dietary proteins on postprandial lipemia, incretin responses and subclinical inflammation in obese subjects

Conditions: Obesity; Postprandial Lipemia; Atherosclerosis; Inflammation; Postprandial Incretins

Summary: the purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal. hypothesis: certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. the effect is dependant of both the quality and the quantity of protein ingested.


Eligibility criteria:
inclusion criteria: * bmi \> 30 kg/m2 \& \< 45 kg/m2 exclusion criteria: * diabetes * lipid lowering drugs * liver-, kidney- and/or heart disease * serious hypertension (160/110)

Keywords: postprandial period postprandial lipaemia incretins subclinical inflammation obesity atherosclerosis triglyceride lipoproteins postprandial inflammation
the effect of abdominal binders on patient's wellbeing after cesarean delivery

Conditions: Effect of Abdominal Binders on Patient ( Pain, Quality of Recovery ) After Cesaean Section

Summary: the effect of abdominal binders on patient's wellbeing after cesarean delivery

the effect of abdominal binders on patient's wellbeing after cesarean delivery 12 hours and one week after cesarean section

Eligibility criteria:
inclusion criteria: any female post cesarean section of singleton 34 wks gestaion fetus with previous cs exclusion criteria: primary cs any hypertensive disorder with pregnancy any neurologiacal disease general anasthesia or vertical incision

Keywords: binders, cesarean section , vas, qor 40
renal safety of bowel preparation with polyethylene glycol

Conditions: Acute Kidney Injury

Summary: this study evaluates the changes of renal function after taking bowel cleansing agent polyethylene glycol for elective colonoscopy.

polyethylene glycol (peg) is the most commonly used bowel cleansing agent for colonoscopy in the world. pegs are non-absorbable isosmotic solutions that pass through the bowel without net absorption or secretion. significant fluid and electrolyte shifts are therefore attenuated. however, several studies have shown that peg may also impair renal function. one recent population-based study reported that the use of peg was associated with an increased risk of acute kidney injury. the renal safety of peg in taiwanese patient has not been reported.

Eligibility criteria:
inclusion criteria: * subjects 40 yrs of age or older scheduled for elective colonoscopy. exclusion criteria: * severely reduced kidney function (egfr\] \<30 ml/min/1.73 m2) * serum electrolyte abnormalities at screening * uncontrolled congestive heart failure (american heart association classification iii or iv) * unstable angina * untreated dysrhythmia * myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft surgery within the previous 3 months * ascites * current acute exacerbation of chronic inflammatory bowel disease * toxic colitis or toxic megacolon * ileus and/or acute obstruction or perforation * ileostomy * right or transverse colostomy * subtotal colectomy with ileosigmoidostomy * 50% of colon removed * idiopathic pseudo-obstruction * history of gastric stapling or bypass procedure * difficulties swallowing * treatment with an investigational drug or product * participation in a drug study within 30 days prior to receiving study medication * treatment with another bowel preparation within 21 days prior to colonoscopy * known allergy or hypersensitivity to peg solution
a drug-drug interaction study to evaluate the effects of itraconazole, carbamazepine, quinidine and fluconazole on the pharmacokinetics and safety of edp-323.

Conditions: RSV Infection; Drug Drug Interaction (DDI)

Summary: the primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of edp-323 in healthy adult participants. each participant's duration in the study will be dependent upon which study part they are enrolled.


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive. * screening body mass index (bmi) of 18 to 30 kg/m2 with a minimum body weight of50 kg * female subjects of childbearing potential must agree to use two effective methods of contraception from the date of screening until 30 days after the last dose of edp-323. a male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of screening to 90 days after his last dose of study drug. exclusion criteria: * clinically relevant evidence or history of illness or disease * pregnant or nursing females * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection * a positive urine drug screen at screening or day -1 * current tobacco smokers or use of tobacco within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy) * history of regular alcohol consumption exceeding protocol limits * participation in a clinical trial within 28 days prior to the first dose of study drug * for part 2 and part 3 participants, the following cardiovascular abnormalities: * qrs duration \>110 ms * incomplete right bundle branch block or any complete bundle branch block * heart rate \ 90 beats per minute (per vital sign capture while rested) * history of unexplained syncope, structural heart disease, or clinically significant arrhythmias * personal or family history of long qt syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or brugada syndrome * pr interval \>220 ms or any 2nd or 3rd degree av block * ventricular pre-excitation * other exclusions for part 2 (carbamazepine) participants * participants of asian ancestry with hla allele b\*1502 in this population * platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine

Keywords: drug drug interaction
paclitaxel-carboplatin alone or with m2es for non-small-cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: a phase ii, multicenter, randomized, double-blind, placebo-controlled study was carried out. patients were randomly assigned to the treatment (pc + pegylated endostatin) or the control group (pc+ placebo). the efficacy was evaluated every six weeks.follow-up continued until disease progression or death.

a randomized phase 2 study, involving patients with advanced non-small-cell lung cancer who had not previously received chemotherapy, compared paclitaxel and carboplatin plus placebo with paclitaxel and carboplatin plus pegylated endostatin, with pegylated endostatin at a dose of 10 mg/m2 intravenously every weeks.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed, newly diagnosed stage iiib or stage iv cancer or recurrent non-small-cell lung cancer for which they had not received chemotherapy, targeted therapy. 2. prior radiation therapy was allowed provided that the only sites disease were not located in lung. 3. measurable disease as defined by the response evaluation criteria in solid tumors (recist). 4. ≥18 years of age. 5. ecog performance status of 0 or 1. 6. life expectancy of at least 12 weeks. 7. adequate hematologic, hepatic, and renal function. 8. patients are voluntary to participate and sigh the informed contents. exclusion criteria: 1. major surgery within the prior 4 weeks. 2. participating any clinical trial within the prior 4 weeks. 3. patients had clinically apparent cns disease ( primary brain tumors, tumor related apoplexy, cns metastases, carcinomatous meningitis.) 4. another active malignancy, or any history of other malignancy within the past 3 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix. 5. pregnant or lactating women. 6. radiation therapy have not been completed 4 weeks before enrollment. 7. pulmonary embolus, deep venous thrombosis or bleeding diathesis. 8. uncontrolled intercurrent illness as following: prior or ongoing uncontrolled hypertension;angina pectoris; congestive cardiac failure; myocardial ischemia, infarction, uncompensated coronary artery disease within the past 12 months; uncontrolled arrhythmia; uncontrolled diabetes mellitus; uncontrolled infection. 9. grade 2 hemoptysis within the past 6 months. 10. acute or chronic renal disease. 11. active hepatitis or hiv. 12. ecg: qtc ≥ 480 ms. 13. patients on therapeutic doses of heparin. 14. other conditions that are regarded for exclusion by the investigator.

Keywords: nsclc
vr embodiment for stress evaluation in a return to work simulation

Conditions: Virtual Reality; Stress; Burnout

Summary: comparing the emotional effect of two different versions of one vr experience. the vr experience will simulate a typical return to work situation after an absence due to burnout. the difference of the vr scenario is the point of view. in the first version, the 'standard' version, the user is looking at the vr experience from a neutral point of view, as if s/he was watching a 2d screen. in the second version, the 'embodiment' version, a vr features is added to have the user feeling incarnated in a digital human. this will enhance the feeling of being present in the virtual world and will enhance the emotional answer. the measured endpoint will be the evoked emotions, in particular stress.


Eligibility criteria:
inclusion criteria: * working in the office building where the study will be conducted exclusion criteria: * neurologic disorder precluding the use of vr goggles (epilepsy, ...), * facial wounds precluding the use of vr goggles. * a preliminary test evaluating the stress level will be conducted, dass -21: stress levels above moderate is an exclusion criteria

Keywords: virtual reality stress embodiment burnout