Kornimate/medical-research-clean huggingface dataset:
comparison of ultrasound-guided serratus combination plane blocks and local wound infiltration for postoperative analgesia management in minimally invasive cardiac surgery (mics)

Conditions: Pain, Postoperative; Heart Surgery; Analgesia

Summary: this randomized, prospective, single-blinded study aims to compare the efficacy of ultrasound-guided serratus anterior plane (sap) block combined with serratus-intercostal interfascial plane (sip) block versus local wound infiltration (lwi) for postoperative analgesia in patients undergoing minimally invasive cardiac surgery (mics). the primary outcome is total perioperative and postoperative opioid consumption. secondary outcomes include postoperative pain scores (nrs), opioid-related side effects, block-related complications, and icu stay duration.

minimally invasive cardiac surgery (mics) has gained popularity due to reduced surgical trauma and faster recovery. however, postoperative pain management remains a challenge. this study evaluates the analgesic effectiveness of combining two interfascial plane blocks-sap and sip-under ultrasound guidance, compared to traditional local wound infiltration. a total of 60 patients scheduled for mics with cardiopulmonary bypass will be randomized into two groups (sap+sip vs lwi). pain scores, opioid usage, and complications will be recorded at predetermined intervals up to 72 hours postoperatively.

Eligibility criteria:
inclusion criteria: * age 18-75 years * undergoing mics with left-sided 4th-5th intercostal incision * asa i-iii * informed consent provided exclusion criteria: * coagulopathy or on anticoagulants * allergy to local anesthetics or opioids * local infection at block site * pregnancy or lactation * bilateral thoracic incisions * refusal to participate

Keywords: pain, postoperative heart surgery, minimally invasive analgesia bupivacaine opioid-related disorders
lung protective one-lung ventilation with fix and variable tidal volume

Conditions: Hypoxemia; Pulmonary Sepsis; ARDS, Human; Pneumonia

Summary: during one-lung ventilation, the use of lower tidal volumes (vt) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis. nevertheless, it is not known if, during one-lung ventilation with constant low vt, moderate levels of peep combined with lung recruitment maneuvers are superior to variable low tidal volume for intraoperative oxygenation and protection against ppcs. aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable tidal volume with recruitment maneuvers during thoracic surgery in adults. we hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized olv with variable tidal volumes, modearte peep and recruitment maneuvers as compared to constant without recruitment maneuvers prevent ppcs. patients will be randomly assigned to one of two groups: fix tidal volume group (groupfix): mechanical ventilation with constant (6 ml/kgibw) tidal volume and peep of 5 cmh2o with recruitment maneuvers variable tidal volume group (groupvar): mechanical ventilation with variable (6 ml/kgibw ± 33%) tidal volume with variable respiratory rate to maintain constant minute ventilation and peep of 5 cmh2o with recruitment maneuvers.

lung separation will be performed by dlt technique. mechanical ventilation will be applied in volume-controlled mode. during two-lung ventilation, vt will be set at 8 ml/kg predicted body weight. during one-lung ventilation, in groupfix vt will be decreased to 6 ml/kg pbw with 5 cmh2o peep. in groupvar vt will be 6 ml/kg predicted body weight ±33% with 5 cmh2o peep. respiratory rate will be adjusted to maintain same minute ventilation as during two-lung ventilation.

Eligibility criteria:
inclusion criteria: * patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring olv (no emergency surgery) * bmi \< 35 kg/m2 * age ≥ 18 years * expected duration of surgery \> 60 min * expected duration of anesthesia \> 90 min exclusion criteria: * copd gold 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax * uncontrolled asthma * nyha 3+4, ccs 3+4 * previous thoracic surgery * ards (berlin definition) * documented pulmonary arterial hypertension \> 40 mmhg syst * documented or suspected neuromuscular disease (thymoma, myasthenia) * planned mechanical ventilation after surgery * bilateral procedures * lung separation with other method than dlt (eg diff. airway, tracheostomy) * surgery in prone position * persistent hemodynamic instability, intractable shock * intracranial injury or tumor * enrollment in other interventional study or refusal of informed consent * pregnancy (excluded by anamnesis and/or laboratory analysis)
a study to evaluate pharmacokinetics of ly3209590 in pediatric participants with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the main purpose of this study is to evaluate how much of ly3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with type 2 diabetes mellitus (t2dm). the study will last for approximately 100 days.


Eligibility criteria:
inclusion criteria: * participants with type 2 diabetes mellitus (t2dm) for at least 3 months * have glycated hemoglobin (hba1c) level of 6.5 percent (%) to 9.5% at screening * have a body mass index equal to or less than 45.0 kilograms per square meter (kg/m²) * participants are insulin naïve or have been without insulin treatment for at least 3 months prior to screening exclusion criteria: * have had a severe hypoglycemia in the past 6 months * have a history of renal impairment * have had a blood transfusion or severe blood loss within last 90 days * have had a significant weight gain or loss of approximately 6% or more within 3 months prior to screening. * have a history of an active or untreated malignancy * are receiving or received systemic glucocorticoid therapy * are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product

Keywords: insulin
study to evaluate the safety and efficacy of androxal treatment in men with secondary hypogonadism

Conditions: Secondary Hypogonadism

Summary: subjects who completed za-003 were eligible to receive an additional year of treatment in this extension study.

the objectives of this study were to evaluate the safety and efficacy of androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed za-003.

Eligibility criteria:
inclusion criteria: * total serum testosterone concentrations \< 300 ng/dl at baseline exclusion criteria: * presence or history of prostate cancer * elevated psa \> 3.5 ng/ml additional inclusion and exclusion criteria may apply.

Keywords: secondary hypogonadism
pragmatic trial comparing telehealth care and optimized clinic-based care for uncontrolled high blood pressure

Conditions: Hypertension

Summary: this pragmatic trial will compare two team-based care models for managing hypertension, best practice clinic-based care and telehealth care with pharmacist management, in a large care system in minnesota. clinics in the study are randomized to offer one of the two treatment models to participants with uncontrolled hypertension. the investigators aim to determine a) whether one model is more effective than the other for lowering patient's blood pressure and b) which model patients prefer.

the objectives of the study are: aim 1: compare the effects of two evidence-based strategies on lowering blood pressure and other outcomes important to patients: best-practice clinic-based care and home-based telehealth care. * hypothesis 1.1: compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will have a 5 mm hg greater change in systolic blood pressure over 12 months of follow-up. * hypothesis 1.2: compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will report: a) fewer treatment side effects; b) better ratings of patient experience of hypertension care; and c) higher self-monitoring rates and confidence in self-care. aim 2: conduct an evaluation of the reach, adoption, implementation, and maintenance of the telehealth care and clinic-based care interventions using a mixed-methods approach supported by the re-aim framework and the consolidated framework for implementation research (cfir).

Eligibility criteria:
inclusion criteria: * hypertension diagnosis code in medical record, twice in last 24 months * attends study clinic for primary care visit within study period with uncontrolled blood pressure * systolic blood pressure \>=150 mm hg or diastolic blood pressure \>=95 mm hg at current visit * systolic blood pressure \>=150 mm hg or diastolic blood pressure \>=95 mm hg at most recent previous visit exclusion criteria: * pregnancy * end stage kidney disease * patients in hospice care and patients who permanently reside in a nursing home

Keywords: clinic care team-based care medication therapy management (mtm) telehealth cluster-randomized home blood pressure monitoring pharmacist
a study to evaluate efficacy and safety of oral bay63-2521 in patients with cteph.

Conditions: Pulmonary Hypertension

Summary: the aim of the study is to assess the efficacy and safety of different doses of bay63-2521, given orally for 16 weeks, in patients with chronic thromboembolic pulmonary hypertension (cteph).

adverse event data will be covered in adverse events section.

Eligibility criteria:
inclusion criteria: * male and female patients with cteph either inoperable or with persistent or recurrent ph after surgery. exclusion criteria: * all types of pulmonary hypertension except subtypes 4.1 and 4.2 of the venice clinical classification of pulmonary hypertension.

Keywords: chronic thromboembolic pulmonary hypertension ph soluble guanylate cyclase stimulator sgc
safety and efficacy of intranasal epinephrine after administration of ars -1 in subjects with frequent urticaria flares

Conditions: Urticaria

Summary: determine the effect of ars-1 on a patient reported pruritus/hive score


Eligibility criteria:
inclusion criteria: * 1. male or female subject between the ages of 18 and 65 years. * 2. clinically diagnosed urticaria with acute symptom flares at least two (2) times a week while on a chronic treatment. * 3. body weight more than 30 kg and body mass index between 18 and 34 kg/m². * 4. has no medical history of hypertension and cardiovascular disease in the last 10 years. * 5. at screening, has stable vital signs. * 6. if female, is not pregnant or breastfeeding. * 7. if male (with or without vasectomy), agree to the use of highly effective contraceptive methods at screening until 7 days after the last day of study drug. 8. is able to communicate clearly with the investigator and staff. 9. provide written informed consent prior to participating in the study. exclusion criteria: * 1. history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease. * 2. patients receiving beta blocker due to potential interaction with the study drug. * 3. prior nasal fractures, severe nasal injuries or history of nasal disorders. * 4. clinically significant medical condition or physical exam finding. * 5. abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal ecg. * 6. mucosal inflammatory disorders. * 7. significant traumatic injury or major surgery within 30 days prior to study screening. * 8. has donated blood or had an acute loss of blood (\>50 ml) during the 30 days before study drug administration. * 9. known hypersensitivity to any compound in the test product. * 10. participated in a clinical trial within 30 days prior to the first dose of study drug.
a real-world study of ekosonic endovascular system in chinese populations with acute pulmonary embolism

Conditions: Acute Pulmonary Embolism

Summary: this study to collect the real-world clinical outcome data of ekosonictm endovascular system in chinese patients with acute pulmonary embolism during practical clinical care.

this is a multi-center, single arm, prospective, observational, real-world study.to collect the real-world clinical outcome data of ekosonictm endovascular system in chinese patients with acute pulmonary embolism during practical clinical care. up to 30 patients will be enrolled in this study and up to 30 patients will be enrolled in this study to observation safety and efficacy.

Eligibility criteria:
inclusion criteria: 1. the patients with acute symptomatic pulmonary embolism (symptomatic duration \< 14 days). 2. the right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image 3. investigator has selected the ekosonictm endovascular system with r-tpa to treat patient. exclusion criteria: 1. the patients with acute symptomatic pulmonary embolism (symptomatic duration \< 14 days). 2. the right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image 3. investigator has selected the ekosonictm endovascular system with r-tpa to treat patient.

Keywords: pe
regional cerebral hemodynamics related to global hemodynamics

Conditions: Critically Ill Patients

Summary: this prospective investigation studies changes in regional cerebral hemodynamics and oxygenation as a function of cardiac output and blood pressure in intensive care patients.

cerebral blood flow velocity (as an index of regional perfusion), dynamic cerebral autoregulation and regional cerebral oxygen saturation should be monitored if disturbances of cerebral perfusion and oxygenation have to be suspected. noninvasive monitoring techniques are established. when detected early, disturbed perfusion and oxygenation may be treated promptly and permanent damage of brain tissue can be avoided. in critically ill patients, hemodynamic changes occur due to the disease itself but also as a function of diagnostic and therapeutic procedures. systemic hemodynamic changes can be monitored using picco® system (pulse contour cardiac output, pulsion medical systems, munich, germany) that combines transpulmonal thermodilution and pulse contour analysis. picco® continuously monitors cardiac output (co), as well as static parameters like global enddiastolic blood volume index (gedvi), and dynamic parameters as difference in pulse pressure (dpp) and stroke volume variation (svv), respectively. cc nexfin® (bmeye, amsterdam, the netherlands) is a noninvasive hemodynamic monitor. this study investigates the effects of changes in cardiac output on cerebral blood flow velocity and regional cerebral oxygen saturation in intensive care patients that underwent major abdominal surgery.

Eligibility criteria:
inclusion criteria: * critically ill * mechanically ventilated * needing advanced hemodynamic monitoring (picco) exclusion criteria: * \<18years * \> 80years * rhythm other than sinus
bridging intestinal failure with teduglutide - a case report

Conditions: Short Bowel Syndrome

Summary: in this case report the investigators present a novel strategy for using teduglutide as a bridging therapy to intestinal reconstruction.


Eligibility criteria:
inclusion criteria: short bowel syndrome exclusion criteria: * \<18 years
trial of capecitabine with or without irinotecan driven by ugt1a1

Conditions: Locally Advanced Rectal Cancer

Summary: the study evaluate the addition of irinotecan in neoadjuvant chemoradiation. half of participants will receive capecitabine alone together with neoadjuvant crt, followed by a cycle of xelox, while the other will receive capecitabine and irinotecan during crt, followed by a cycle of xeliri. all participants will be scheduled to receive surgery 6-8 weeks after the completion of crt, then 5 cycles of adjuvant chemotherapy of xelox.


Eligibility criteria:
inclusion criteria: * pathological confirmed adenocarcinoma * clinical stage t3-4 and/or n+ * the distance from anal verge less than 12 cm * without distance metastases * kps \>=70 * ugt1a1\*28 6/6 or 6/7 * without previous anti-cancer therapy * sign the inform consent exclusion criteria: * pregnancy or breast-feeding women * serious medical illness * baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/l, hb≥90g/l, plt≥100×10\^9/l, alt/ast ≤2.5 uln, cr≤ 1 uln * dpd deficiency * ugt1a1\*28 7/7

Keywords: neoadjuvant chemoradiation irinotecan ugt1a1
the value of near-infrared spectroscopy and blood pressure measurements in estimating future fall risk in older adults

Conditions: Falls; Orthostatic Hypotension; Older Adults (65 Years and Older)

Summary: the investigators aim to study which measurements/definitions from continuous blood pressures measurements (using a finometer) and from cerebral oxygenation measurements (using near-infrared spectroscopy (nirs)) are associated with future fall incidents in older adults at risk of falls.

patients aged 65 years and over with a fall in the last 12 months are eligible for inclusion. after being informed about the study, all participants giving written informed consent will perform the active stand procedure (5min lying, 5 min standing). the hemodynamic measurements that will be performed during this procedure simultaneously consist of: 1. volume-clamp photoplethysmography on the finger in the digital artery (finapres medical systems, enschede, the netherlands) for continuous blood pressure measurements. 2. portalite mkii (artinis medical systems, elst, the netherlands) for continuous cerebral oximetry (nirs). after completing the measurements, participants will receive a falls calendar and will be instructed to record falls, fall-related injuries, and fall-related healthcare use on a weekly basis for 12 months.

Eligibility criteria:
inclusion criteria: * 65 years or older * history of a fall (in the past year) * ability to perform supine-to-stand manoeuvres. * ability to sign informed consent. * a mini-mental state examination (mmse) score of 21 points or higher or a montreal cognitive assessment (moca) - dutch score of 16 points or higher. * sufficient command of the dutch language exclusion criteria: * physically not able to perform sit-to-stand and supine-to-stand manoeuvres. * estimated life expectancy of less than one year.

Keywords: falls orthostatic hypotension blood pressure nirs older adults
factors associated with full recovery after surgical repair of shoulder instability

Conditions: Chronic Instability of Joint

Summary: case control study to evaluate different factors (e.g muscle strength, psychological factors) that are associated with full recovery and functional status 6 months after surgical repair of shoulder instability.

in this study the investigators will try to find correlations between different factors and functional abilities of patients 6 months post shoulder surgery. patients will be examined in a single encounter for muscle strength, fear avoidance beliefs and functional abilities. functional abilities will be examined using two validated questionnaires: 1. the western ontario shoulder instability index (wosi) 2. disabilities of the arm, shoulder and hand (dash) fear avoidance will be evaluated using the fear avoidance belief questionnaire (fabq) muscle strength of the rotator cuff muscles will be measured using biodex isokinetic system, model 4.

Eligibility criteria:
inclusion criteria: * 26-28 weeks s/p surgical repair of shoulder instability * at least 1 shoulder dislocation prior to surgery exclusion criteria: * previous surgery in either shoulders * any injury in the non-operated shoulder in the last 6 months * any history of shoulder dislocation or subluxation in the non-operated shoulder * any tendon repair during the surgery.
amnioderm+ medical device clinical study

Conditions: Non-healing Wound; Diabetic Foot

Summary: this is retrospectively-prospective clinical trial with medical device amnioderm+ intended for the non-healing wounds. retrospective data will contain information about the subject's history and wound treatment by soc. prospective data will contain information about wound treatment by amnioderm+®.


Eligibility criteria:
inclusion criteria: 1. males and females over 18 years of age 2. type 1 or type 2 diabetes mellitus 3. presence of a diabetic neuropathic or neuroischemic wound, anywhere on the leg, that has not healed at least 20% after the 6 weeks of the standard of care (soc) 4. history of an evaluable defect ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion 5. size of a wound to be evaluated 2 to 16 cm2 6. wound treatment can be provided either on an inpatient or outpatient basis, based on the doctor's decision 7. the subject agrees to periodic visits to the clinical trial site during their participation in the clinical trial 8. the subject is able to understand the clinical trial information 9. signed informed consent form 10. data on previous wound care are available in the subject medical documentation exclusion criteria: 1. necrotic wound requiring surgical treatment 2. pregnancy or breastfeeding 3. venous etiology of ulceration 4. burns or chemical burns 5. clinical manifestations of systemic infection 6. undermined wound edges 7. the wound involves deeper structures (bone, tendons, joints) 8. inadequately controlled diabetes mellitus with hba1c \> 12 % (dcct) diabetes mellitus 9. renal insufficiency with egf \< 30ml/min/1.73m2 10. infected ulceration either stage ≥2 according to ewma position document (2006) (appendix ii) or with crp \>10 11. topical treatment with any growth factor-based products

Keywords: medical device amnioderm+ non-healing wounds dfu
safety and efficacy of itacitinib in combination with corticosteroids for treatment of graft-versus-host disease in pediatric subjects

Conditions: Acute Graft-versus-host Disease

Summary: the purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of grades ii to iv acute graft-versus-host disease (agvhd) in steroid-naive pediatric participants.


Eligibility criteria:
inclusion criteria: * male and female participants: 12 to \ 8 kg to \< 2 years old (cohort 4), and 28 days old to weighing ≤ 8 kg (cohort 5). * undergone 1 allogeneic hematopoietic stem cell transplantation (allo-hsct) from any donor and source for hematological malignancies or disorders. recipients of myeloablative and reduced-intensity conditioning regimens are eligible. * clinically suspected grade ii to iv agvhd as per mount sinai acute gvhd international consortium (magic) criteria, occurring after allo-hsct and any gvhd prophylactic medication. * evidence of myeloid engraftment. exclusion criteria: * more than 1 allo-hsct. * received more than 2 days of systemic corticosteroids for agvhd before the first study drug administration. * presence of gvhd overlap syndrome. * presence of an active uncontrolled infection. * known hiv infection. * active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection that requires treatment or at risk for hbv reactivation. * evidence of relapsed primary disease or have been treated for relapse after the allo-hsct was performed. * any corticosteroid therapy for indications other than gvhd at doses \> 1 mg/kg once daily of methylprednisolone (or equivalent) within 7 days of the first study drug administration. * receipt of live (including attenuated) vaccines or anticipation of need for such vaccines during the study. * receipt of jak inhibitor therapy after allo-hsct for any indication. * treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment.

Keywords: acute graft-versus-host disease gvhd pediatric jak1 inhibitor corticosteroids