Kornimate/medical-research-clean huggingface dataset:
ruxolitinib, human chorionic gonadotropin (uhcg/egf), and dose de-escalated corticosteroids

Conditions: Acute-graft-versus-host Disease

Summary: this multi-center center phase i/ii study to establish the lowest possible recommended phase 2 dose (rp2d) of corticosteroids in conjunction with ruxolitinib and uhcg/egf (a novel combination) for high-risk agvhd. this is a single arm study designed to determine the lowest dose of corticosteroids required (toxicity endpoint) without impairing gvhd complete response or partial response (cr/pr) at day 28 when given in conjunction with uhcg/egf and ruxolitinib. after completion of the corticosteroid dose finding, the final dose will be carried forward into a two-stage phase ii extension trial to confirm safety and make a preliminary determination of efficacy of this novel drug combination for high-risk agvhd.


Eligibility criteria:
inclusion criteria: hct recipients over 12 years of age within the first 7 days of initial treatment of high-risk agvhd, defined as: * newly diagnosed minnesota high-risk agvhd -or- * newly diagnosed minnesota standard risk agvhd with plasma amphiregulin ≥ 33 pg/ml tested at the umn cytokine reference lab. for amphiregulin lab ordering information, see fairview lab guide: http://labguide.fairview.org/showtest.asp?testid=6766\&format=long -or- * newly diagnosed minnesota standard risk agvhd ann arbor 3 biomarkers tested by viracor. for ordering information, see: https://www.viracor-eurofins.com/test-menu/403572p-agvhd-symptomatic- onset-algorithm/ * renal: serum creatinine ≤2.5x upper limit of normal (uln) * cardiac: left ventricular ejection fraction (lvef) ≥ 35% * voluntary written consent (adult or parent/guardian with minor assent for 12 through 17-year-olds). exclusion criteria: * progressive malignancy * uncontrolled bacterial, fungal, parasitic, or viral infection at initiation of protocol treatment * unwilling or unable to stop supplemental sex hormone therapy (estrogen, progesterone, and/or testosterone preparations) * unwilling or unable to stop gnrh antagonists, aromatase inhibitors, or anti-androgens * history of a hormone responsive malignancy * current thromboembolic disease requiring full-dose anticoagulation - patients receiving pharmacologic prophylaxis for thromboembolic disease will be eligible * active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status * pregnancy * women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 30 days after the last treatment

Keywords: agvhd
endogenous lithium clearance in acute kidney injury

Conditions: Acute Kidney Injury Due to Sepsis; Proximal Tubule Function; Lithium Clearance

Summary: critically ill patients are at high risk of developing acute kidney injury (aki). lithium is freely filtrated at the glomerulus and almost completely reabsorbed in the proximal tubule, which provides a quantitative estimation of proximal tubule reabsorption. the investigators hypothesized that endogenous lithium reabsorption is impaired in the early stages of critical illness. investigators would like to study 10 icu patients with aki diagnosed, 10 patients without aki, and 10 healthy controls.

blood and urine samples will be obtained at 08:00, 14:00 and 20:00 during one day. renal clearance of creatinine (ccr) and lithium will be calculated.

Eligibility criteria:
inclusion criteria: * icu patients diagnosed with aki, without aki and healthy controls exclusion criteria: -
stereo-postop 01 (postoperative hypofractionated stereotactic body radiotherapy ) - gortec 2017-03

Conditions: Head and Neck Neoplasms

Summary: the main objective of this national, open-label, non-randomized phase ii trial is to evaluate severe late toxicity of postoperative hypofractionated stereotactic radiotherapy (sbrt) in the treatment of early stage oropharyngeal and oral cavity cancer with high risk margins.


Eligibility criteria:
inclusion criteria: * operated squamous cell carcinoma of oral cavity (lips excepted) or oropharynx * pt1 or pt2 ((uicc 7th edition 2009) * indication of postoperative tumor site irradiation (retained in multidisciplinary tumor board) with at least one of the following criteria : * positive r1 margin (re-resection not proposed) * close margin \< 5 mm (re-resection not proposed) * margin estimated at risk, with uncertain pathological margin (re-resection not proposed) * n0 after surgical management of the neck (neck dissection or sentinel lymph node biopsy) or pn1 without extracapsular extension (carcinological neck dissection) * age ≥ 18 years * ecog status ≤ 2 * written signed informed consent before any specific procedure of the protocol * affiliation to a social security scheme or beneficiary of such a scheme exclusion criteria: * other histology than squamous cell carcinoma * pt3 or pt4 * pt2\>3cm and r1 with concurrent chemoradiotherapy decided in multidisciplinary tumor board * lymphovascular invasion justifying neck irradiation * neck irradiation decided in multidisciplinary tumor board * lack of at least one of the following elements : * pre-operative medical imaging (ct scan or mri) * endoscopy report * surgery report * pathological report * prior radiotherapy to the head and neck area * distant metastasis * pregnant or nursing (lactating) woman * women or men of childbearing age not taking adequate contraceptive measure * participation in another investigational study within 4 weeks prior to inclusion * history of other malignancy within 5 years prior enrollment except for basal cell carcinoma of the skin or carcinoma in situ of the cervix * persons deprived of their liberty, under guardianship or curatorship, or unable to follow the trial for geographical, social or psychological reasons

Keywords: head and neck cancers radiation oncology stereotactic radiotherapy
ani and spi guided intraoperative analgesia

Conditions: Anesthesia

Summary: there is accumulating evidence that inappropriate analgesia is asssociated with increasing risk of perioperative complications. the aim of the study is to compare intraoperative analgesia guided according to different methods of intraoperative analgesia monitoring, ani and spi respectively.

the surgical pleth index (spi) and ani (analgesia nociception index) has been developed for monitoring of adequacy of analgesia during surgery. the investigators want to compare anesthesiologist guided intraoperative analgesia with intraoperative analgesia guieded by ani or spi. the following hypotheses have been made: 1. anesthesiologist guided analgesia will result in lower surgical stress 2. anesthesiologist guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia

Eligibility criteria:
inclusion criteria: * patients undergoing scheduled neurosurgical procedures under general anesthesia * gcs 15 * asa physical status i - iii * elective procedures with estimated duration 1 - 3 hours exclusion criteria: * presence of non-sinus rhythm * pacemaker * planned postoperative ventilation * procedures with planned awake intervals * chronic pain with opioid medication * opioid addiction * epidural administration of local anaesthetic in combination with opioid * corticosteroid use * hormonal contraception * chronic respiratory disease with known respiratory failure

Keywords: opioids analgesia pain anesthesia
reconstruction of ankle and foot defects

Conditions: Foot Injury

Summary: reconstruction of soft tissue defects around the foot and ankle region is a challenging problem for reconstructive surgeons due to the lack of locally available tissues for transposition, the relatively poor skin circulation, and the special structural characteristics of this area, bones and tendons can easily become exposed due to trauma. so foot injuries are often associated with a loss of soft tissues and exposed bones . the plantar skin is thick, with solid anchorage to the deep structures. therefore, the reconstructive aim is to restore the stability of the foot skin to adapt to weightbearing and to resist shearing forces. in addition, good sensibility should be considered in the reconstruction. additional considerations the ankle region has great tension during movement, and good stability is required for shoes wearing. the medial plantar flap has been effectively used in the reconstruction of soft tissue defects localized to the plantar foot, forefoot, posterior heel, and ankle in small to medium sized defects . this flap can be transferred to the defect as a proximally or distally pedicled island flap . the distally based sural artery flap frequently used for reconstruction of soft tissue defects of the lower leg, foot and ankle in medium and large sized defects .fascio-cutaneous flaps are highly effective and easy to perform. this study is a comparative study designed for assessment of the clinical applications of distally based sural flap versus medial plantar artery flap regarding the size of the defect , operative technique and their outcomes (success and complications) as a reconstructive option for foot and ankle defects.


Eligibility criteria:
inclusion criteria: patients aging 5 to 70 years. defect at the foot and ankle. defect size (5- 15) cm2. exclusion criteria: severe infection. unhealthy skin of posterior or lateral aspect of leg . defect more than 15 cm . injury to vascular pedicle of the aimed flap .
typhoid fever: combined vs. single antibiotic therapy

Conditions: Typhoid Fever

Summary: the current study goal is to examine the effect of cephalosporins, azithromycin and the combination of both on typhoid fever therapy in endemic population. the investigator's hypothesize that the combination of azithromycin and ceftriaxone may prove superior to each drug, ceftriaxone or azithromycin, alone.

typhoid fever is a highly prevalent infection in the indian subcontinent. due to multidrug resistant strains in these areas, third generation cephalosporins, such as ceftriaxone, are the treatment of choice. however, the latter regimen exhibits a slow response with mean time of 5 to 7 days or even longer to defervescence, which could be attributed to poor penetration capability of the drug into cells, and thus difficulty to eradicate the bacteria from the intracellular niche. attempts have been made to overcome this setback by introducing alternative antibiotic regimens, such as azithromycin. however studies comparing between azithromycin and a third-generation cephalosporin for the treatment of typhoid fever in adult population in the indian subcontinent are lacking. over the last few years our approach towards non-immunized travelers, who acquired typhoid fever in the indian subcontinent, was to administer a combination therapy of intravenous ceftriaxone with oral azithromycin. the rationale of this dual regimen was its pharmacokinetic profile, which suggests a complimentary action of the two agents - ceftriaxone on the extracellular compartment and azithromycin on the intracellular compartment. moreover, in our clinical experience, preliminary published data has proven combination therapy significantly superior to ceftriaxone alone albeit in a small group of travelers. in the current study the investigators intend to compare the efficacy of ceftriaxone vs. azithromycin and vs. combined therapy of both agents for the treatment of uncomplicated typhoid fever in terms of time to defervescence. 4 different treatment strategies will be examined (as mentioned in the arm section). all participants will be checked for vital signs, will undergo physical examination, ecg, laboratory testing, blood, urine and stool culture and tests for susceptibility to antibiotics.

Eligibility criteria:
inclusion criteria: * blood culture-proven typhoid fever (s. typhi or s. paratyphi) * signed informed consent to participate in the study. exclusion criteria: * allergy to ceftriaxone or macrolides * major typhoid fever-associated complications * inability to swallow oral medication * underlying illness * pregnancy * lactation * treatment within the past 4 days with an antibiotic that may be effective against typhoid fever
a study of oral suberoylanilide hydroxamic acid (saha) in patients with malignant lymphoma (0683-030)

Conditions: Lymphoma

Summary: the primary purpose of this trial is to determine the maximum tolerated dose (mtd), or the maximum acceptable dose (mad) and evaluate the dose limiting toxicity (dlt) of oral vorinostat in patients with malignant lymphoma.


Eligibility criteria:
inclusion criteria: * patients who relapsed after complete or partial response, or ineffective in previous chemotherapy exclusion criteria: * patients with history of chemotherapy, antibody therapy, radiotherapy, during the previous 4 weeks (6 months for radioisotope-labeled antibody) * any uncontrolled concomitant illness * are pregnant or breast-feeding * serious drug or food allergy
does nicotine influence the risk of preeclampsia?

Conditions: Preeclampsia (PE); Endothelial Dysfunction; Hypertension in Pregnancy

Summary: this prospective cohort study explores the long-term impact of pre-pregnancy smoking on vascular health in women predisposed to preeclampsia, conducted at the medical university of graz. the study specifically targets women at high risk for preeclampsia who are taking aspirin as a preventative measure. the main question it aims to answer is: does smoking before pregnancy influence the development and severity of preeclampsia and its associated vascular changes in high-risk women? participants, divided into former smokers and non-smokers, underwent comprehensive assessments throughout their pregnancies. measurements included hemodynamic parameters such as heart rate and blood pressure, assessed with an upper arm cuff, and arterial stiffness, evaluated using pulse wave velocity with the vicorder device. retinal microvasculature was examined through digital imaging, and the vascular health marker adma, nicotine exposure marker cotinine, blood pressure regulatory enzyme neprilysin, and cellular aging indicator telomere length were quantified from blood samples. cortisol levels were also measured from hair samples to assess stress responses.

the investigators collected extensive data on each participant, including age, bmi (body mass index), and medical history, to understand their baseline health. routine laboratory tests were conducted to monitor the health status throughout the pregnancy. preeclampsia biomarkers and doppler ultrasound examinations of the uterine and umbilical arteries to assess fetal and placental blood flow were conducted. the investigators tracked the development of preeclampsia, gestational hypertension (gh), and gestational diabetes mellitus (gdm). outcomes for the babies, such as birth weight, delivery method, gender, and the gestational week at delivery, were meticulously recorded to evaluate the broader impacts of maternal smoking and vascular health on neonatal outcomes.

Eligibility criteria:
inclusion criteria: * a positive preeclampsia screening or a history of preeclampsia, daily intake of 150mg aspirin , and age over 18 years exclusion criteria: * twin pregnancies, fetal anomalies, maternal chronic renal diseases and discontinued aspirin intake.

Keywords: preeclampsia risk smoking endothelial function arterial stiffness retinal microvasculature
comparison of the role of losartan alone vs hydrochlorothiazide plus losartan

Conditions: Proteinuria

Summary: losartan, an angiotensin ii receptor blocker, has already been established as a treatment for diabetic nephropathy due to its ability to reduce blood pressure and mitigate the progression of kidney damage. however, the addition of a diuretic like hydrochlorothiazide may offer synergistic benefits in reducing proteinuria by addressing both the underlying renal pathology and potential volume overload in these patients. the current study aims at determining and comparing the role of losartan alone vs hydrochlorothiazide plus losartan in reducing proteinuria in diabetic nephropathy patients.


Eligibility criteria:
inclusion criteria: * patients of both genders with ≥18 years of age. * presence of proteinuria/albuminuria at time of screening. * creatinine clearance of 30 ml/min or higher. exclusion criteria: * a systolic blood pressure of 180 mm hg or higher, a diastolic blood pressure of 110 mm hg or higher. * presence of a second primary renal disease in addition to diabetic nephropathy. * patients with type 1 diabetes. * a history of a cardiovascular or cerebrovascular event within 3 months before inclusion. * serum potassium of 6.0 mmol/l or higher. * transplantation or immunosuppressive treatment. * contraindication for the use of losartan or hydrochlorothiazide. * pregnancy or lactation.
posterior wall osteotomy for old acetabular fracture

Conditions: Surgical Procedure, Unspecified

Summary: posterior wall osteotomy would be conducted to manage the old acetabular fracture. the outcome was reviewed to assess the feasibility of the surgical procedure.

more and more patients with old acetabular fracture were admitted in our institution during the past years. there is little literature especially depicts the therapeutic principle of the kind of damage. posterior wall osteotomy would be conducted to eliminate the fragments or callus from the hip joint. then, the deformed healing acetabulum could become mobile and the reduction may be achieved. however, the surgical procedure is technique demanding and some intraoperative risk may be accompanied. surgical time, blood loss, complication and fracture healing would be reviewed to assess the feasibility of the surgical procedure. the function outcome is evaluated with hhs score at the follow up.

Eligibility criteria:
inclusion criteria: * acetabular fracture * no surgical procedure has been obtained over 3 weeks * deformed healing * receive posterior wall osteotomy * completed more than one year follow-up exclusion criteria: * accompanied with other fracture * pathological fracture * reject the posterior wall osteotomy

Keywords: old acetabular fracture; posterior wall osteotomy
low-salt diet effect on th17-mediated inflammation and vascular reactivity in psoriasis

Conditions: Psoriasis Vulgaris

Summary: psoriasis presents an independent cardiovascular risk factor characterized by chronic low-grade systemic inflammation and oxidative stress which altogether might lead to endothelial dysfunction. it has been reported that increased oxidative stress has a pivotal role in high dietary sodium-induced endothelial dysfunction. previous studies on sodium accumulation in psoriatic skin lesions and the sodium-induced augmentation in th17 immune response, raise the question on the complex interplay between sodium and psoriasis, especially in the context of cardiovascular morbidity. this study aimed to investigate the effect of a 2-week low-salt diet on endothelium-dependent and endothelium-independent cutaneous microvascular vasodilation and th17-mediated inflammation in patients with psoriasis vulgaris.


Eligibility criteria:
inclusion criteria: * patients with diagnosed psoriasis vulgaris * subjects do not use topical corticosteroid therapy for at least 2 weeks before inclusion in the study and 2 weeks during the study * subjects do not use systemic or biological therapy for at least 3 months before and 2 weeks during the study. exclusion criteria: * age \< 18 years * existence of other immune-mediated diseases (with the exception of autoimmune thyroid diseases and psoriatic arthritis - people with these comorbidities can be included) * malignant diseases * current infectious diseases and allergic reactions within 6 weeks before the start of the study

Keywords: diet, sodium-restricted psoriasis laser-doppler flowmetry microcirculation endothelium
the effects of iabp prior to revascularization on mortality of acs patients complicated with cardiogenic shock

Conditions: Cardiogenic Shock

Summary: prevalence of cardiogenic shock in acute coronary syndrome patients is reported at about 5-8% with high fatality. revascularization approach has already known as the standard of care, but the usage of intra-aortic balloon pump (iabp) as mechanical circulatory support is still a controversy. iabp shock ii trial revealed that short-term mortality did not improved by iabp but there are several essential variabels related to mortality that are not considered in the study which are iabp initiation time and weaning protocol.this study aim to evalute the effect of iabp prior to revascularization on mortality of patients with myocardial infarction complicated with shock. 92 subjects will be enrolled in this randomized controlled trial into two groups, with and without iabp. iabp group will be receiving the intervention prior to revascularization. the primary outcomes to be sought are in-hospital and 30-day mortality after revascularization. iabp effects measured by various indicators such as global longitudinal strain by echocardiography on the 1st and 3rd day, ntprobnp and st2 level on the 1st, 3rd and 5th day, effective lactate clearance and ureum creatinine level on the 1st and 3rd day and will be compared between two groups. continous variabel will be presented in mean ± deviation standard or median, and analized with student's t test or mann-whitney u test as appropriate.


Eligibility criteria:
inclusion criteria: * age greater than 18 years old * myocardial infarction patients complicated with shock * willing to enroll in the study (signed consent) exclusion criteria: * age greater than 80 years old * heart and lung resuscitation for more than 30 minutes * cardiogenic shock onset \>12 hours (if known) or \>18 hours (if not known/patient presented in emergency department already with shock) * mechanical complication of myocardial infarction * moderate and severe aorta regurgitation * peripheral artery disease making iabp unfeasible * patients not receiving revascularization by percutaneous coronary intervention * patients who died before iabp insertion * care termination requested by family

Keywords: iabp cardiogenic shock myocardial infarction