Kornimate/medical-research-clean huggingface dataset:
modulation of biomarkers in patients with flesh-eating bacterial infections after with hyperbaric oxygen treatment

Conditions: Necrotizing Soft Tissue Infection; Necrotizing Fasciitis; Gas Gangrene; Fournier Gangrene

Summary: the purpose of this study is to investigate the effects of hyperic oxygen treatment on the immune response in patients with necrotizing soft tissue infections

necrotizing soft tissue infections (nsti) is a complex, multi-factorial disease and the bacteria show a diverse microbial etiology. the exentisive inflammatory response caused by these bacteria is thought to be a main course of death. in denmark, most nsti patients are treated with hyperic oxygen therapy (hbot). however, the effects of hbot have never been investigated in nsti patients. location: copenhagen university hospital, rigshospitalet, denmark. design: observational cohort study. cohort: nsti patients in denmark treated with hbot. biomarkers: cytokines, acute-phase proteins, vasoactive biomarkers and other inflammatory biomarkers. sample size calculation: the investigators expect a mean il-6 concentration before hbot of 3500 pg/ml (standard deviation 1500 pg/ml) and consider a reduction of 800 pg/ml to be clinically relevant. with an alpha = 0.05 and a power of 80%, 112 patients will be required. data: the danish data protection agency has approved the processing of personal data for the nsti patients (j. no. 30-0900). ethics: the trial will adhere to the helsinki declaration and the danish law. the national ethics committee and the regional scientific ethics committee of copenhagen have approved the study (cvk-1211709 and h-2-2014-071). analysis: biomarker analyses will be performed once the recruitment of patients has ended.

Eligibility criteria:
inclusion criteria: * necrotizing soft tissue infection based on surgical findings * admitted to/planned to be admitted to the icu at rigshospitalet and/or operated for nsti at rigshospitalet * receving a minimum of 1 hbot exclusion criteria: * patients who at the operating theatre were categorized as a non-nsti patient

Keywords: fasciitis fasciitis, necrotizing soft tissue infections fournier's gangrene immunopathogenesis
molecular analysis of oncogenes and resistance mechanisms in lung cancer

Conditions: Lung Neoplasms

Summary: the mechanisms of sensitivity and resistance to oncogene-targeted therapy can be determined from tumor tissue or tumor cell lines derived from available archival samples and/or from standard-of-care re-biopsy upon suspected tumor progression.

to identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers. to estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies.

Eligibility criteria:
inclusion criteria: 1. patients undergoing investigation or treatment for thoracic cancers with oncogene-targeted therapies 2. aged 18 years or older 3. either a) have suspected tumor progression or other condition that dictates a standard-of-care palliative, therapeutic, or diagnostic intervention including but not limited to procedures such as bronchoscopic biopsy, computed tomography (ct) or ultra-sound (us)-guided biopsy, thoracentesis, video assisted thoracoscopic (vats) pleurodesis, lobectomy, adrenalectomy or pleural catheter placement, providing tumor specimen appropriate molecular analysis or b) have previously had biopsy/surgical intervention with tumor tissue at university of colorado or an outside institution available for medullar analysis. 4. patients must have the ability to understand and willingness to sign an informed consent document. exclusion criteria: -

Keywords: oncogenes lung and other thoracic cancers
evaluation of blood loss during knee arthroplasty

Conditions: Primary Knee Arthroplasty

Summary: primary arthroplasties are frequent interventions that can present hemorrhagic complications: postoperative hematoma, deglobulization justifying monitoring blood tests and blood transfusion if necessary. the attitude regarding the drainage of the surgical site supposed to limit these events differs from one surgeon to another, even in the same team. its use is common practice; for some, systematic. for others, depending on intraoperative findings or the patient's condition. for others, the drain is never laid. faced with the divergence of data from the literature on the benefit of the placement of a drain for intra and postoperative bleeding in knee arthroplasty, the lack of randomized prospective studies on large series of patients, and in a desire to homogenization and standardization of the operating procedure of our surgeons, investigators decided to conduct this prospective interventional, comparative and randomized study.

after obtaining the patient's consent and randomisation, the operating surgeon will have the information of placing or not a drain, lately at the end of the intervention so that the course of the intervention is not influenced by the prior knowledge of the patient randomization arm. investigators will carry out especially within the framework of this research 3 samples of a total of 10.7 ml of whole blood (appendix. 12.5) distributed as follows: sample no. 1 : 2.7 ml of blood in a hemostasis tube (sodium citrate tube) one day before the procedure (d-1) for the determination of the prothrombin level (pt), activated partial thromboplastin time ( tca) and the inr or international normalized ratio. sample no. 2 : 4 ml of blood in a purple edta tube for nfs, one day before the operation (d-1) for the determination of hemoglobin ( hb ) and hematocrit ( hct ) sample no. 3 : 4 ml of blood in a violet edta tube for nfs for the determination of hemoglobin ( hb ) and hematocrit ( hct ) on the fifth postoperative day (d5). this last assessment will be prescribed to the patient to be carried out in the rehabilitation center.. the knee prosthesis implantation surgical technique is performed according to the standard operating procedure of the orthopedic surgery team. according to the operating standard procedure of our orthopedic department, the drain is non-aspirated for 6 hours and then put back under vacuum until the morning after the knee prosthesis operation. three months after the intervention the patient will be seen again in consultation and examined.

Eligibility criteria:
inclusion criteria: * patient consent * patient aged over 18 years * patient scheduled for primary knee arthroplasty exclusion criteria: * patient expresses his/her opposition to participating in the study * patient scheduled for revision, revision or totalization arthroplasty * primary arthroplasty after septic arthritis * patient requiring an additional planned or unplanned surgical procedure such as ttta, osteosynthesis for an intraoperative fracture and/or removal of material

Keywords: blood loss drainage without drainage
roentgen stereophotogrammetric analysis (rsa) and dual energy x-ray absorptiometry (dexa) to evaluate fixation of periapatite coated triathlon total knee arthroplasty (tka) components

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is twofold: 1) to use rsa to determine the migration patterns of the pa coated triathlon total knee arthroplasty components during the first 2 years postoperatively and thus determine the proportion of cases where adequate fixation is achieved, and 2) to use dexa scanning to document peri-prosthetic bone mineral density changes in response to the pa coated triathlon total knee arthroplasty over the first two postoperative years. in addition, gait assessment and validated outcome questionnaires will be utilized to quantify changes in functional status of subjects after surgery and migration patterns will be compared to results obtained from previous studies of uncemented total knee arthroplasty components conducted at this centre. questions to be asked are: 1. do the components achieve adequate fixation to the underlying bone? 2. what are the migration patterns (translations and rotations) of the pa coated arthroplasty components during the first two years postoperatively and are they different from that seen for other implants that have been studied with rsa at this institution? 3. for what proportion of implants does migration continue to increase during the two year follow-up? 4. are inducible displacements, measured at weight-bearing follow-ups, consistent over time and do they indicate that adequate fixation has been achieved? 5. are there changes over time in bone mineral density of peri-prosthetic bone in the pa coated triathlon total knee arthroplasty? 6: where do changes in bone mineral density occur? 7: is there a significant difference in health status and functional outcome before and after total knee arthroplasty using pa coated triathlon total knee arthroplasty components? 8: are there changes in gait symmetry and centre of mass (com) displacements as assessed with the walkabout portable gait monitor pre- and post-operatively and how does study gait data compare to asymptomatic gait? and finally, question 9: are there differences in the micromotion patterns between the when compared to other samples of knee implants in our rsa database?


Eligibility criteria:
inclusion criteria: * symptomatic osteoarthritis of the knee indicating surgical intervention * ability to give informed consent exclusion criteria: * significant co-morbidity affecting ability to ambulate * range of motion measurements that are beyond the realm of normal * a bmi \> 40 (morbid obesity) * severe osteoporosis or osteopenia or neuromuscular impairment * women who are pregnant will also be excluded due to the risks of the surgery

Keywords: knee arthroplasty rsa migration micromotion osteoarthritis
facial mucosal level determinants for single immediately placed implants evaluated by novel ultrasonography

Conditions: Gingival Recession

Summary: a single center, prospective clinical trial is planned to investigate the effect of different emergence angles of implant restorations on peri-implant soft tissue recession and implant marginal bone loss. the primary outcome is to systematically evaluate the association of implant-, peri-implant tissue-, and restoration-related factors with facial mucosal level changes.

facial mucosal recession still poses a threat to long-term success of implant therapy especially esthetic appearance. to study the timing and extent of mucosal recession and the associated risks, a prospective study is strategically important. this will allow the collection of valuable longitudinal data about facial mucosal level changes, peri-implant tissue dimensions, and implant/restoration parameters that are considered critical for determining the mucosal level. forty adult patients who meet the inclusion criteria will be recruited to participate in this study. patients that had an implant crown placed a minimum time frame of 6 months and have existing relevant clinical data (mucosal level and thickness, radiographs, cone beam computed tomogram (cbct) scans, study casts and intra-oral photographs) at baseline and if possible at other follow-up visits will be invited to participate in this study. patients that volunteer to be screened will not be examined for study eligibility until an informed consent has been obtained. patient information will be protected according to hipaa. the enrolled subjects will have research measurements taken, an ultrasound scan, intraoral photos and an impression of the arch including the study implant. one dental cone beam computed tomography (cbct) scan will be taken to evaluate the implant position in relation to the alveolar ridge and to evaluate relative bone quality. the primary outcome will analyze the changes in the facial mucosal level, by superimposing the digital images of the stone models that were taken previously. on ultrasound images, peri-implant tissue parameters, implant positions, restoration contour, etc., will be measured and recorded. the primary outcome will then be equated with clinical and radiographic readings, and ultrasound parameters, along with timing of provisionalization or final restoration, in regression analysis to identify factors related to facial mucosal recession.

Eligibility criteria:
inclusion criteria: * subjects 18 years old or older * one immediate maxillary implant placement with 2 adjacent neighboring teeth * available pre-surgery model * radiographic documentation (either peri-apical x-rays or cbct) * have final restoration for at least 6 months. exclusion criteria: * are under 18 years of age. * are unwilling or unable to read and sign this informed consent document. * have any medical conditions that we believe may influence the outcome of the study.
research of endobronchial optical coherence tomography in pre-copd

Conditions: Chronic Obstructive Pulmonary Disease; Optical Coherence Tomography; Pulmonary Function

Summary: the pre-stage of chronic obstructive pulmonary disease (pre-copd) is challenging to diagnose. however, identifying pre-copd is a crucial step in the prevention and management of copd. endobronchial optical coherence tomography showed the value of diagnosis in pre-copd and copd in previous researchs.

we recruited copd patients (stage i-ii, n=15; stage iii-iv, n= 15), pre-copd (n= 20) and healthy never-smokers (healthy human, n=21). age,gender,bmi, smoking history, spirometry, chest computed tomography (ct), bronchoscopy and eb-oct were performed. inner luminal area (ai) and airway wall area (aw) of bronchi which inner perimeter was 10mm, 20mm and 30mm were measured using eb-oct respectively. by analyzing and studying the above situation, we aim to discover the application value of oct in pre-copd

Eligibility criteria:
inclusion criteria: * non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (ct). exclusion criteria: * (1) patients with contraindication of bronchoscopy, (2) patients who are participating in other clinical studies, (3) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (4) women who were pregnant.

Keywords: chronic obstructive pulmonary disease optical coherence tomography pre-stage
diagnosis-related outcomes in neurocritical care: prognostic estimate by health-care providers versus risk scores in intracerebral and subarachnoid hemorrhage

Conditions: Intracerebral Hemorrhage; Subarachnoid Hemorrhage

Summary: the aim of the observational multicenter trial encompasses the comparison of estimation of the long-term prognosis (functional and cognitive outcomes, quality of life) after intracerebral and subarachnoid hemorrhages assessed by clinical scores, treating physicians and nurses. the scores and the assessment of the treating physicians and nurses are recorded on admission, at 7 and 14 days after symptom onset.

the physicians and nurses responsible for the individual patient's care will be given a questionaire. they are asked to estimate the functional and cognitive status as well as quality of life of their patient. the patient with intracerebral hemorrhage and subarachnoid hemorrhage is examined and assessed with respective established and validated prognostic scores and models at the same time points. the actual prognosis is assessed by telephone interview and questionaires at 3 and 6 months, either from the patient or his/her caretaker.

Eligibility criteria:
inclusion criteria: * spontaneous intracerebral hemorrhage or nontraumatic subarachnoid hemorrhage * treatment in centers with neurocritical care expertise exclusion criteria: * language other than german and english * restriction of diagnostic and therapeutic measures during acute hospitalization according to advanced directives * admission \> 48 hours after symptom onset * hemorrhage due to trauma
susceptibility to pathological gambling

Conditions: Pathological Gambling

Summary: the goal of this study is to assess the risk factors for the development of pathological gambling.

this study will track up to 600 young adults (ages 18 to 29) for a two-year period, collecting variables such as gambling behavior, drug and alcohol use, psychiatry and medical history, family history, impulsivity, quality of life, self-esteem, and cognition. for some individuals who meet criteria as being impulsive, they will be randomized to receive an intervention to help reduce their impulsivity.

Eligibility criteria:
inclusion criteria: * ability to understand the procedures and provide written consent * gambled at least 5 times in the past year * between the ages of 18 and 29 at intake exclusion criteria: * inability to understand the procedures and provide written consent
multicenter pilot study to define the marker as an alternate for tropism assay

Conditions: HIV Infections

Summary: the purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at day 4, 7 or 14) following a short course (14 days) of maraviroc added to a failing regimen, and the r5 result of the trofiletm assay at screening.

the study a4001060 has been discontinued on april 22, 2008. a review of the poor rate of enrollment has projected difficulties in completing the study in a timely manner, despite the best efforts by the sponsor and the sites. given the difficulties encountered in this pilot study and the need to conduct an even larger confirmatory study, the decision to discontinue the study has therefore been made. it should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility criteria:
inclusion criteria: * ≥ 16 years of age (or minimum adult age as determined by local regulatory authorities or as dictated by local law) at the screening visit. * have an hiv rna ≥ 1000 copies/ml, at screening. * subjects receiving another investigational antiretroviral compound through participation in a phase 3 or 4 clinical study are eligible to participate in this trial provided. * that the 2 investigational agents are required to offer the subject a regimen with 2 or 3 active antiretroviral drugs (i.e. one or fewer approved treatment is available to the subject due to prior resistance or intolerance), * neither protocol prohibits the use of the other antiretroviral agent, and the dosing of the two agents when used together is known and a letter from the pfizer clinical pharmacologists for maraviroc identifies the dose of maraviroc to be used with other investigational agents. * based on screening genotypic resistance testing results the subject must be able to receive at least 3 active drugs other than maraviroc in the new obt. this is defined as: * having three drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility); or, * having two drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility) and be willing to include raltegravir in the obt not having used raltegravir in the past. exclusion criteria: * potentially life threatening (grade 4) laboratory abnormality or medical condition. * severe hepatic impairment (child-pugh classification b or c). * end stage renal disease or other disease states requiring dialysis therapy.

Keywords: treatment experienced
ultrasonography evaluation of diaphragm kinetics in patients undergoing atrial fibrillation ablation with cryoballoon

Conditions: Atrial Fibrillation; Phrenic Nerve Paralysis

Summary: the purpose of this study to assess the diaphragm kinetics with tissue doppler imaging in patients undergoing atrial fibrillation ablation with cryoballoon

this study is designed to evaluate the diaphragm kinetics with ultrasonography parameters in patients who underwent pulmonary vein isolation (pvi) for atrial fibrillation (af) by cryoballoon. due to the proximity of the pulmonary veins to the phrenic nerve, phrenic nerve paralysis can be seen rarely during the procedure. in contemporary practice, phrenic nerve damage is detected by visual monitoring of diaphragm movement as a result of pacing with high output by placing the intracardiac stimulation catheter at the level of the superior vena cava. however, subclinical nerve damage may be critical regarding respiratory functions, especially in patients with comorbidities. it has been shown in the literature that the evaluation of diaphragm kinetics with tissue doppler imaging (tdi) can be used in effective ventilation monitoring and weaning. however, this technique has not been used in patients who have previously undergone cryoballoon therapy. it is aimed to investigate the positive or negative effects on diaphragm kinetics, as a very cost-effective and rapidly accessible technique, with the help of this technique.

Eligibility criteria:
inclusion criteria: * patients scheduled for af ablation with a cryoballoon * ≥18 years old * patients with interpretable diaphragm ultrasound before the operation * patients giving informed consent exclusion criteria: * patients who did not give consent * patients with phrenic nerve palsy * morbid obesity

Keywords: pulmonary vein isolation atrial fibrillation ablation arrhythmia phrenic nerve tissue doppler imaging diaphragm kinetics
the efficacy and safety of liraglutide compared to sitagliptin, both in combination with metformin in chinese subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to investigate the efficacy and safety of liraglutide compared to sitagliptin, both as add-on to metformin in chinese subjects with type 2 diabetes inadequately controlled on metformin monotherapy. eligible subjects will continue their metformin background treatment during the trial.


Eligibility criteria:
inclusion criteria: * male or female, age at least 18 years and below 80 years at the time of signing informed consent * subjects diagnosed type 2 diabetes mellitus and treated with metformin monotherapy at a stable dose of at least 1500 mg daily or maximum tolerated dose above or equal to 1000 mg daily for at least 60 days prior to screening * hba1c 7.0-10.0% (both inclusive) * body mass index below or equal to 45.0 kg/m\^2 exclusion criteria: * treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 60 days prior to screening. an exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness * history of chronic pancreatitis or idiopathic acute pancreatitis * any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol * screening calcitonin value above or equal to 50 ng/l * personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 * diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) * any contraindications to liraglutide, sitagliptin or metformin according to local labelling