Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety and efficacy of torcetrapib/atorvastatin in subjects with familial hypercholerolemia

Conditions: Hypercholesterolemia, Familial; Hyperlipidemia

Summary: the torcetrapib project was terminated on december 2, 2006 due to safety findings. to evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia

for additional information please call: 1-800-718-1021

Eligibility criteria:
inclusion criteria: * diagnosis of heterozygous familial hypercholesterolemia * at least 18 years of age exclusion criteria: * women who are pregnant or lactating, or planning to become pregnant. * subjects with a clinically indicated need for statin (hmg-coa reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on ldl-c and hdl-c including fibrates and nicotinic acid (high doses) * subjects taking any drugs known to be associated with an increased risk of myositis in combination with hmg-coa reductase inhibitors * subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study
percutaneous coronary intervention registry fribourg

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention

Summary: the registry aims to follow clinically all consecutive patients treated by percutaneous coronary interventions at hospital \& university fribourg.


Eligibility criteria:
inclusion criteria: * all consecutive patients treated by percutaneous coronary intervention at our institution * able to give informed consent and willing to participate exclusion criteria: * unwillingness to participate * enable to provide inform consent

Keywords: pci
axillary reverse mapping in breast cancer

Conditions: Lymph Node Cancer Metastatic

Summary: the axillary mapping reverse (arm) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema. a significant decrease of lymphedema rates in patients who was possible associate arm technique during the axillary surgery improving the quality of life of these patients. there are different visualisation techniques like fluorescence dye.

axillary lymph node dissection (alnd) was the standard therapy until 1990-2000, when the technique was replaced, when possible, by another procedure associated with less morbidity: the sentinel lymph node biopsy (slnb). however, actually, alnd is still the gold standard in some patients. this procedure is associated with substantial morbidity, like lymphedema, shoulder pain, arm numbness, axillary web syndrome and decreased upper-extremity range of motion (rom), that severely conditions the quality of life of these patients. in 2007, the investigators had the first reports about a new surgical technique, the axillary mapping reverse (arm), that consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema. the current literature shows a significant decrease of lymphedema rates in patients who was possible associate this technique during the axillary surgery improving the quality of life of these patients. there are different visualisation techniques. with the use of indocyanine green, the visualisation rates in the axilla of arm lymphatics are from 88%, similar to other techniques. some advantages of fluorescence dye are that no systemic allergic reactions have been reported and the 'green tattoo' disappears quickly. hyphotesis the axillary mapping reverse (amr) is able to identify the lymph nodes responsible for lymphatic drainage of the ipsilateral upper limb (arm nodes) in breast cancer patients who underwent an axillar lymph node dissection.

Eligibility criteria:
inclusion criteria: patients who will undergo alnd in the treatment of breast cancer: * ct4a, ct4c and ct4d. * ct4b with extensive involvement of the skin. * cn0 with slnb positive (pn+) that need to associate alnd: * ct3-t4b. * \>2 lymph node macrometastasis if ctis, ct1 and ct2. * patients who underwent mastectomy and it is not possible associate adjuvant radiotherapy. * cn1: * if primary surgery treatment. * after neoadjuvant systemic treatment, if there is not a clinical-radiological complete response and/or slnb positive (ypn+). * cn2: * if primary surgery treatment. * after neoadjuvant systemic treatment, if luminal tumours or there is not a clinical-radiological complete response in triple negative or her2 overexpressed tumours. * cn3. exclusion criteria: * patients with previous axillary surgery (except sentinel node biopsy) * patients who did previous axillary radiotherapy treatment. * patients who do not wish to participate in the study.

Keywords: lymphedema sentinel lymph node axillary lymph node dissection
use of ngal for fluid dosing and crrt initiation in pediatric aki

Conditions: Acute Kidney Injury; Renal Replacement Therapy; Pediatric Intensive Care Units

Summary: this study follows a group of patients admitted to the picu who are identified as being at risk for developing acute kidney injury. the investigators will use risk-stratification, biomarker testing, and a functional assessment to predict patients who will become fluid overloaded and develop acute kidney injury.

in the pediatric population, acute kidney injury (aki) is commonly observed in critically ill patients. at this time, there are no standardized care pathways that begin at identifying patients at risk for developing aki and progress through to early recognition and treatment. through previous work, the investigators have developed, tested, and integrated an aki risk-stratification/clinical recognition tool (rai) and a urine biomarker (ngal) to try to identify patients at risk vs. not at-risk for developing aki. however, these factors alone have yet to be integrated into clinical decision support to optimize aki therapies and patient outcomes. the furosemide stress test (fst), previously described in adults, may be a good predictor for the patients who need acute dialysis for aki versus those that can be managed medically. through this study, the investigators will be following a cohort of patients admitted to the picu who are identified as being at risk for developing aki through rai and ngal results. the aim is to standardize the fst in this population, as well as determine the accuracy of the rai-ngal-fst clinical decision tool in predicting patients who become fluid overloaded and develop aki.

Eligibility criteria:
inclusion criteria: * admitted to the pediatric intensive care unit (picu) * renal angina index (rai) greater than or equal to 8 * urine ngal greater than or equal to 150 ng/ml * indwelling urinary catheter exclusion criteria: * evidence of volume depletion * baseline chronic kidney disease (ckd) stage iv or v (estimated gfr \<60 ml/min/1.73m2) * history of kidney transplantation * active dnr order or clinical team is not committed to escalating medical care * known history of allergic reaction to furosemide (only for fst)

Keywords: ngal renal angina index
pilot study on the value of bedside pleuropulmonary ultrasound in patients with sickle cell disease presenting with vaso-occlusive crisis

Conditions: Sickle Cell Disease

Summary: describe the proportion of patients with major sickle cell syndrome in vaso-occlusive crisis presenting at least one pleuropulmonary ultrasound abnormality during one of the ultrasounds performed at d0, between d2 and d5 during hospitalization and at d-1 of discharge. we hypothesize that pleuropulmonary ultrasound will make it possible to detect the serious complications associated with vaso-occlusive crises in patients with major sickle cell syndrome earlier and more reliably, in departments where ultrasound tools are still underdeveloped, while avoiding the need for more conventional radiology examinations that cause radiation in multi-hospitalized patients.


Eligibility criteria:
inclusion criteria: * patient agreeing to participate in the study * patient with sickle-cell disease consulted to the emergency department or hospitalized in a conventional internal medicine department for a clinical picture of severe vaso-occlusive crisis (cvo) requiring hospitalization. * hospitalization in the internal medicine department * possible re-inclusion in the event of a subsequent episode of severe cvo exclusion criteria: * subject under guardianship or subject deprived of freedom. * primary acute chest syndrom (not following a crisis) * pulmonary pathologies interfering with pleuro-pulmonary echo analysis: pneumonectomy, pulmonary fibrosis.

Keywords: sickle cell disease pulmonary anomalies vaso-occlusive crisis acute chest syndrom pleuropulmonary ultrasound
a study to evaluate vaccines against covid-19 in the real world

Conditions: Chronic Liver Disease; Hepatic Carcinoma

Summary: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and the resulting coronavirus disease 2019 (covid-19) have afflicted tens of millions of people in a worldwide pandemic. considering its high mortality and rapid spread, an effective vaccine is urgently needed to control this pandemic. recently, mass vaccination campaigns using newly approved vaccines, ranging from conventional viral and protein-based vaccines to those that are more cutting edge, including dna- and mrna-based vaccines are beginning in many parts of the world. randomized clinical trials of different vaccines reported efficacies for preventing covid-19 in the range of 50% to 95%. although these randomized clinical trials are considered the "gold standard" for evaluating intervention effects, they have notable limitations of sample size and subgroup analysis, restrictive inclusion criteria, and a highly controlled setting that may not be replicated in a mass vaccine rollout. the aim of this study is to evaluate the safety, tolerability, immunogenicity, and efficacy of different vaccines against covid-19 under real-world practice conditions.


Eligibility criteria:
inclusion criteria: * subjects received covid-19 vaccines; * able to comprehend and provide written informed consent in accordance with institutional guidelines. exclusion criteria: * not received any covid-19 vaccines; * not willing to participate and/or give their written informed consent.
fotemustine and dacarbazine versus dacarbazine +/- alpha interferon in advanced malignant melanoma

Conditions: Malignant Melanoma; Recurrent Melanoma

Summary: this study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of malignant melanoma in advanced stage or recurrent after surgery, and not amenable to further surgery or local therapy. * presence of measurable disease * age \> or = 18 years and \< or = 75 years * performance status (ecog) 0 - 2 (appendix 2) * life expectancy ³ 3 months * adequate bone marrow function (anc ³ 2,000/mmc; ptl ³ 100,000/mmc; hb ³ 10 gr/dl), normal liver and renal function (bilirubin \< 1.25 x n, creatinine \< 1.25 x n, sgot, sgpt \< 3 times upper normal limit of testing laboratory. * written, informed consent prior to study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. * prior surgery \> 3 weeks from initiating . * if palliative radiation is needed, in case of non target lesions, it must be given prior to initiating chemotherapy. if palliative radiation is required during the study the patient should be permanently discontinued from further treatment. * adequate contraceptive measures during study participation for sexually active patients of child bearing potential must implement. exclusion criteria: * previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin. * prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed) * known hiv disease. * concurrent treatment with other experimental drugs. * concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy * pregnant or lactating females previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin. prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed) known hiv disease. concurrent treatment with other experimental drugs. concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy
safety and efficacy study of fibrin sealant grifols as an adjunct to hemostasis during peripheral vascular surgery

Conditions: Vascular Surgical Bleeding

Summary: the purpose of this study is to demonstrate that the application of fibrin sealant grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. this study has a preliminary part (i) in which all subjects are treated with fibrin sealant grifols and a primary part (ii) in which subjects are randomized in a 2:1 ratio to either fibrin sealant grifols or manual compression.


Eligibility criteria:
inclusion criteria: * hemoglobin (hgb) ≥ 8.0 g/dl at baseline (within 24 hours prior to surgical procedure). * require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery. * require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated polytetrafluoroethylene grafts: a) femoral-femoral bypass grafting, b) femoral-popliteal bypass grafting, c) femoral-distal bypass grafting, d) ilio-iliac bypass grafting, e) ilio-femoral bypass grafting, f) ilio-popliteal bypass grafting, g) aorto-iliac bypass grafting, h) aorto-femoral bypass grafting, i)axillo-femoral bypass grafting, and j) upper extremity vascular access for hemodialysis. * a target bleeding site can be identified. * target bleeding site has moderate arterial bleeding. exclusion criteria: * undergoing a re-operative procedure. * undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed). * have an infection in the anatomic surgical area. * have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product. * have previous known sensitivity to any fibrin sealant grifols, heparin, or protamine component. * females who are pregnant or nursing a child at baseline (within 24 hours prior to surgical procedure). * have undergone a therapeutic surgical procedure within 30 days from the screening visit. * target bleeding site cannot be identified. * target bleeding site has mild or severe arterial bleeding. * occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure. * intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria.

Keywords: vascular surgery fibrin sealant polytetrafluoroethylene (ptfe) grafts
expanded indications of endoscopic submucosal dissection for early gastric cancer in china

Conditions: Gastric Cancer Stage

Summary: background: the main treatment methods for early gastric cancer (egc) include endoscopic submucosal dissection (esd) and radical gastrectomy. however, appropriate treatment for patients who exceed the absolute indications for esd remains unestablished. in china, evidence-based medicine for the expanding indications of esd and accurate diagnostic staging for egc patients are lacking. thus, clinical studies involving chinese patients with egc are necessary to select appropriate treatment options and promote china's expanded indications for esd and diagnostic staging scheme. methods: this is a multicenter, ambispective, observational, open-cohort study that is expected to enroll 554 patients with egc. the study was launched in may 2018 and is scheduled to end in march 2022. all enrolled patients should meet the inclusion criteria. case report forms and electronic data capture systems are used to obtain clinical data, which includes demographic information, results of perioperative blood- and auxiliary examinations, surgical information, results of postoperative pathology, and the outcomes of postoperative recovery and follow-up. patients are followed up every 6 months after surgery for a minimum of 5 years. the primary endpoint is the rate of lymph node metastasis (lnm), whereas the secondary endpoints include the following: consistency, sensitivity, and specificity of the results of preoperative examinations and postoperative pathology cut off values for lnm; logistic regression model of expanded indications for esd; and incidence of postoperative complications within the 30-day and 5-year relapse-free survival rates.

this study will explore and evaluate expanded indications for esd that match the characteristics of the chinese population in patients with egc and will introduce a related staging procedure and examination scheme that is appropriate for china. ethical approval was obtained from all participating centers. the findings are expected to be disseminated through publications or presentations and will facilitate clinical decision-making in egc.

Eligibility criteria:
inclusion criteria: patients aged 18-75 years (regardless of sex). patients with tumor diameter \> 30 mm, ulceration (ul)(+), and differentiated mucosal carcinoma (t1a). patients with tumor diameter \> 30 mm and differentiated, submucosal invasion depth \< 500 μm (t1b sm1). patients with tumor diameter ≤ 30 mm and differentiated submucosal carcinoma (t1b). patients with tumor diameter ≤ 20 mm, ul(-), and undifferentiated (t1a). patients with tumor diameter \> 20 mm, ul(-), and undifferentiated (t1a). patients with tumor diameter ≤ 30 mm, ul(+), and undifferentiated (t1a). patients with tumor diameter \> 30 mm, ul(+), and undifferentiated (t1a). exclusion criteria: patients with gastric stump cancer. patients with recurrent gastric cancer. patients with multiple primary malignant tumors.

Keywords: expanded indications for esd lymph node metastasis staging diagnosis scheme chinese population
project home: home-based treatment options and mechanisms for eating disorders

Conditions: Anorexia Nervosa; Eating Disorders

Summary: this randomized, controlled effectiveness trial will assess outcomes, implementation, and mechanisms of two psychological treatments for adolescent anorexia nervosa (an) delivered in the home setting, in the context of community-based mental health. adolescents with an-spectrum disorders (n=50) and their caregivers will be randomly assigned to either family-based treatment or integrated family therapy delivered in the home. caregivers and adolescents will provide data on weight, eating, and putative treatment mechanisms, including caregiver self-efficacy, adolescent distress, and generalizability of treatment skills. treatment feasibility, acceptability, and appropriateness will be measured among providers and participating families. the proposed study has clear potential to advance scientific and clinical understanding of the real-world effectiveness of psychological treatments for an, including whether adapting them for the home setting may improve accessibility and effects on treatment outcome


Eligibility criteria:
inclusion criteria: * meets criteria for an or atypical an according to dsm-5 diagnostic criteria. * currently living at home with caregivers who are willing to engage in family treatment. * medically stable for outpatient treatment according to the recommended thresholds of the american academy of pediatrics and the society of adolescent medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute) and receiving medical monitoring from a clinician throughout treatment. * if on psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication for a co-morbid condition. * available for follow-up. exclusion criteria: * associated physical illness that necessitates hospitalization. * psychotic illness/other mental illness requiring hospitalization. * current dependence on drugs or alcohol. * physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight. * concurrent involvement in other psychological treatment for an eating disorder. * developmental delay that would preclude participation in the intervention.
irb-hsr# 14145 r,s methadone: analgesia and pharmacokinetics in adolescents undergoing scoliosis correction

Conditions: Scoliosis

Summary: this is a pilot study to determine the pharmacokinetics of (r,s) methadone in adolescents. a total of approximately 15 patients will be required. the purpose is to determine the levels of r, s methadone at various time intervals after drug administration. patients will receive methadone 0.25 mg/kg iv at induction and a standardized anesthetic of remifentanil and propofol. at the conclusion of surgery (45 minutes prior to the completion), the patients will receive a loading dose of morphine based on respiratory rate. a morphine pca will be utilized for postoperative analgesia. pharmacokinetic data will be collected in addition to vas scores, patient and parental satisfaction with analgesia, and a functional pain assessment.

study procedures following surgery: * vas scores will be recorded at intervals of 1,2,3,4,5,6,8,12,16,20,24, 36, 48 , 72 hrs (after extubation). * blood samples for pk will require 5ml per sample and may be obtained from an existing iv or direct phlebotomy and will be obtained at 0min, 5min, 10 min, 15min, 20 min, 40 min, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10 hrs, 12hrs, 24hrs, 48 hrs, 72hrs, and 96hrs after study drug administration.

Eligibility criteria:
inclusion criteria: * pediatric scoliosis surgery secondary idiopathic scoliosis, congenital scoliosis, * age 12 - 19 inclusive * asa class i-ii. exclusion criteria: * preoperative opioid therapy in previous 2 weeks * known hepatic or renal impairment * inability to assess pain score due to neurological impairment, hearing impairment * allergy to methadone, morphine, fentanyl, propofol or remifentanil * pregnant or nursing * taking ssri's, maoi,anticonvulsants, gabapentin or lyrica * asa iii or greater patients are excluded * pre-existing chronic pain

Keywords: methadone pharmacokinetics in adolescents
low grade inflammation in type 1 diabetes children

Conditions: Type 1 Diabetes; Inflammation

Summary: the study propose to measure the inflammation level in type 1 diabetes children with the cytokine analysis compared to non diabetic children of the same sibling and to healthy children.

the increase of type 1 diabetes incidence, particularly in young children leads to conduce new diagnostic and therapeutic strategies, notably for associated chronic morbidity.measurement of chronic inflammation, with modification of the balance between pro-inflammatory cytokines and anti-inflammatory cytokines, could lead to detect patients with high risk to diabetes chronic morbidity. after parental consent, blood sampling will be carried out by micromethod for cytokine (500 µl) and crphs dosages and glycemia (100 µl) and glycated hemoglobin (1 µl). urine will be collected (50 ml) in the morning for further researches.

Eligibility criteria:
inclusion criteria: type 1 diabetes children group : * children aged 2 to 17 years * type 1 diabetes children controlled group : * children aged 2 to 17 years * brother or sister of type 1 diabetes children exclusion criteria: * per os or inhaled corticoid in the previous month of inclusion * acute infectious disease in the previous week of inclusion * other chronic disease than diabetes type1

Keywords: type 1 diabetes children low grade inflammation cytokine crp