Kornimate/medical-research-clean huggingface dataset:
pilot study to assess cat-2003 in patients with severe hypertriglyceridemia

Conditions: Hyperlipidemias; Hypertriglyceridemia; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Summary: the purpose of this study is to determine the safety and efficacy of multiple doses of cat-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy. the study will evaluate effects of cat-2003 on fasting and postprandial total triglycerides and chylomicron triglyceride levels in patients with severe hypertriglyceridemia. this is a single-blind study. all patients will receive placebo for a 14 day treatment period and cat-2003 for a 28 day treatment period.


Eligibility criteria:
inclusion criteria: * between 18 and 74 years at screening * severe hypertriglyceridemia (tg ≥ 500 mg/dl). if on lipid lowering therapy including statins, fibrates, and/or omega-3 fatty acids, stable dose for at least 4 weeks prior to screening * body mass index (bmi) ≤ 45 kg/m2 exclusion criteria: * history of any major cardiovascular event within 6 months of screening * type i diabetes mellitus or use of insulin * history of pancreatitis
opioid consumption after knee arthroscopy

Conditions: Surgical Procedure, Unspecified; Orthopedic Disorder

Summary: this is a prospective, randomized trial of patients undergoing outpatient knee arthroscopy surgery and receiving a peripheral nerve block. patients will be randomized to either receive standard discharge teaching or specialized teaching regarding pain control following a nerve block. patients will be asked to complete a journal for 5 days recording their pain scores, opioid medication usage, and overall satisfaction with pain control at home.


Eligibility criteria:
inclusion criteria: * patient of age less than 20 years presenting to nch main campus for knee arthroscopy * american society of anesthesiology physical status i or ii exclusion criteria: * anterior cruciate ligament repair or reconstruction * admission to hospital * inability or refusal to receive femoral nerve blockade * body mass index \> 99 percentile * hydrocodone allergy or intolerance * acetaminophen allergy or intolerance * non-steroidal anti-inflammatory allergy or intolerance * pregnancy * interpreter requirement * opioid use within 3 months prior to surgery * previous knee surgery at wsc after jan. 1, 2017 * history of opioid abuse or dependence
a trial to evaluate the safety, tolerability and preliminary efficacy of ncr201 in the treatment of subjects with parkinson's disease

Conditions: Parkinson Disease

Summary: the goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that ncr201 has on parkinson's disease (pd) patients.

parkinson's disease (pd) is a common neurodegenerative disease in the middle-aged and elderly. it is the "third killer" of the middle-aged and elderly after tumors and cardiovascular and cerebrovascular diseases. its main clinical manifestations are resting tremor, reduced voluntary movement, muscle rigidity, postural reflex impairment, and autonomic dysfunction, which seriously affect patients' work ability and quality of life. it is estimated that nearly 100,000 people in china become new parkinson's patients every year. experts from the world health organization predict that the number of parkinson's patients in china will reach 5 million in 2030, which will be more than half of the world's total. as the disease progresses, the symptoms of parkinson's patients will become increasingly severe. the high prevalence and high disability rate of parkinson's disease bring heavy burdens to individuals, families, and society.

Eligibility criteria:
inclusion criteria: * ages between 40 and 75 years; * diagnosed to be parkinson's disease according to parkinson's disease diagnostic criteria; * disease history over 5 years; * stable dose of dopamine treatment; * able to undergo pet/ct/mri detection; exclusion criteria: * patients who have previously undergone brain surgery; * past use of stem cell therapy or participation in stem cell clinical research; * cognitive impairment; * history of mental disorders; * patients with other serious systemic diseases; * past or current metastatic malignant tumors.
cardiovascular imaging registry of canada

Conditions: Cardiovascular Diseases

Summary: a multi-site, multi-modality prospective observational clinical outcomes study focussed on the development of phenotype-dirven risk prediction modelling in patients with known or suspected cardiovascular disease.

the cardiovascular imaging registry of canada (ciroc) was conceived to provide a common standardized architecture for the collection of clinically reported imaging biomarkers, demographic information, resource utilization and clinical outcomes among patients referred to non-invasive cardiac imaging. the registry was designed to assess the feasibility of implementing personalized care strategies through automated high quality data collection and patient engagement. the ciroc registry was launched with inaugural focus on cardiac mri base phenotyping, however has evolved to encompass cardiac cta and echocardiography. clinically referred patients are engaged by automated, tablet-based tools to collect informed consent and deploy standardized patient health assessments. standardized reporting of disease features are captured using bespoke reporting tools. all patients are prospectively followed for a period of 10-years using linkage to administrative health data, inclusive of icd-coded events, laboratory test results, ecg and vital statistics.

Eligibility criteria:
inclusion criteria: * all patients referred for hospital-based cardiac imaging services exclusion criteria: * failure or provide informed consent
dendritic cell-based immunotherapy for advanced solid tumours of children and young adults

Conditions: Sarcoma; Central Nervous System Tumor

Summary: phase i/ii, open, prospective clinical trial, historically controlled. the objective is to evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor lysate) in patients affected of metastatic or relapsed sarcomas or (central nervous system) cns tumors.

phase i/ii, open, prospective clinical trial, historically controlled. patients affected of metastatic or relapsed sarcomas or (central nervous system) cns tumors will be included. the patients will receive standard treatment and experimental treatment based on a cellular therapy with vaccination with autologous dendritic cells pulsed with tumor lysate. the immunization schedule includes 4 monthly vaccines, 4 bimonthly and quarterly remaining vaccines. the vaccines will be administered intradermally in combination with standard treatment for each type of tumor.

Eligibility criteria:
inclusion criteria: * signed informed consent * diagnosis or metastatic or relapsed sarcoma or high grade central nervous system tumor * from 3 to 40 years * surgery feasibility. in the central nervous system tumors, residual tumor after surgery must be minimal. exclusion criteria: * toxicity or liver, medullar, renal insufficiency that advise against participation * pregnant or breast feeding women * diagnosis of other tumor than basal cell squamous carcinoma of the skin or in situ cervix carcinoma * immunosuppressive treatment * human immunodeficiency virus (hiv), hepatitis b, hepatitis c or syphilis infection

Keywords: dendritic cell vaccination sarcoma central nervous system tumor childhood adolescent immunotherapy
tlk286 (telcyta) vs. doxil/caelyx or hycamtin in platinum refractory or resistant ovarian cancer

Conditions: Ovarian Neoplasms

Summary: the purpose of this study is to demonstrate superiority in survival in favor of tlk286 as compared to active control therapy with doxil/caelyx or hycamtin in the intent-to-treat (itt) populations.


Eligibility criteria:
inclusion criteria include: * considered platinum refractory or resistant according to standard criteria * progressed during or following completion of one second-line treatment with doxil/caelyx or hycamtin * histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer * measurable disease according to recist criteria with documented tumor progression exclusion criteria include: * treatment with second-line chemotherapy other than doxil/caelyx or hycamtin * history of whole pelvis radiation therapy within 12 months of enrollment * clinically significant cardiac disease * evidence of gross hematuria at the time of study entry * any signs of intestinal obstruction interfering with nutrition at the time of study entry * pregnant or lactating women

Keywords: ovary
coronary ct-derived ffr-guided strategy versus medical therapy

Conditions: Coronary Artery Disease; Myocardial Ischaemia

Summary: the overall purpose of accurate ii trial is to compare the clinical outcomes of ct-derived ffr guided strategy versus medical therapy in patients with chronic coronary syndrome.

accurate ii is a prospective, multicenter, randomized clinical trial comparing the clinical outcome and cost-effectiveness of the two management strategies. ct-ffr-guided invasive treatment strategy versus optimal medical therapy, in management of patients with chronic coronary syndrome. the study is powered to detect if the primary endpoint by the ct-ffr-guided strategy is superior to the medical therapy strategy.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, with at least one vessel has ct-derived ffr≤0.80 * patients with chronic coronary syndromes * signed written informed consent exclusion criteria: * the patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, contrast media (patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled) * prior percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg) * sinus arrhythmia, cardiogenic shock, or severe heart failure (nyha≥iii) * inability or unwillingness to undergo ct scan or coronary angiography * patients on hemodialysis or with severe hepatic or renal insufficiency * left main coronary artery stenosis ≥ 50% * target vessel total occlusion * pregnancy or intention to become pregnant during the course of the trial * patients with a life expectancy less than 2 years
combination of bevacizumab and allogeneic nk immunotherapy for metastatic solid tumors

Conditions: Malignant Solid Tumour

Summary: the aim of this study is the safety and efficacy of bevacizumab plus allogeneic natural killer (nk) immunotherapy to many kinds of recurrent solid tumors.

by enrolling patients with recurrent solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using bevacizumab and nk cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: vascular endothelial growth factor (vegf) antibody solid tumor nk immunotherapy
ergonomic brace wear for adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: this study assesses the effectiveness of a new scoliosis brace design for adolescent idiopathic scoliosis (ais) patients, named ergonomic brace, by comparing the outcome with hard brace in terms of three aspects: 1. to assess the efficacy in spinal correction 2. to evaluate the improvement made to the body appearance of ais subjects 3. to evaluate the impacts on the quality of life (qol) of ais subjects all participants will be fitted with an ergonomic brace and required to wear it during the days of experiment only. the ongoing treatment with hard brace will not be substituted with the ergonomic brace, unless its immediate treatment effect is equivalent to hard brace and with approval from the doctor.

1. to assess the efficacy in spinal correction the efficacy of the ergonomic brace refers to the magnitude of spinal correction that could be obtained for patients with ais. the assessments in this study focus on two aspects, which are i) the in-brace correction and ii) the interface pressure. in-brace correction is used to judge the quality of bracing and also a prognostic indicator for the long-term treatment outcome. clinical parameters such as cobb angle, vertebral rotation and trunk listing will be measured with radiographs by a single observer. interface pressure in this study refers to the pressure between the brace and the trunk of subject. the purpose is to assess the time response of trunk to the intervention of the ergonomic brace, and correlation will also be made with the extent of spinal correction. 2. to evaluate the improvement made to the body appearance of ais subjects the trunk aesthetic profile of ais subjects are being affected by spinal deformities. surface topography of the subjects will be captured by 3d body scanner, and followed by the evaluation of body aesthetics through the trunk asymmetry scales called potsi and atsi index. the purpose is to compare the surface topography change before and after wearing the ergonomic brace. 3. to evaluate the impacts on the qol of ais subjects bracing can negatively affect the qol of patients with ais. the chinese version of brace questionnaire (brq) will be adopted in this study to compare the impact of hard brace and ergonomic brace on the qol of ais subjects. difficulties experienced by ais subjects during bracing will be highlighted and used for future improvements in scoliosis brace design.

Eligibility criteria:
inclusion criteria: * age 10 or older when brace is prescribed * risser 0 to 2 * primary curve angles 25° to 40° * female, who were either pre-menarche or less than 1 year of post-menarche * undergoing hard brace treatment exclusion criteria: * low risk of curve progression * non-idiopathic scoliosis (e.g. congenital, neuromuscular deformities)

Keywords: scoliosis brace conventional treatment for adolescent idiopathic scoliosis in-brace correction trunk listing vertebral rotation interface pressure 3d body scanning surface topography trunk asymmetry quality of life
clinical pilot study to evaluate a new multi-parameter neuromonitoring device in brain-injured patients

Conditions: Brain Injuries

Summary: clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the measurement of regional cerebral blood flow (rcbf), intracranial pressure (icp), brain temperature monitoring and ventricular cerebrospinal fluid (csf) drainage in brain-injured patients.


Eligibility criteria:
inclusion criteria: * adult male or female patient, aged 18 - 75 years * brain injured patients with acute intracranial hemorrhage (including aneurysmal subarachnoid hemorrhage (sah) and spontaneous intracerebral hemorrhage (ich)) who are admitted to the icu and have an indication for icp monitoring and csf drainage, as per standard patient care * informed consent obtained for research in emergency situations according to hra art. 30 \& 31 at time of inclusion exclusion criteria: * known kidney disease, defined as plasma creatinine \> 120 μmol/l * known liver disease, defined as ast \> 200 iu/l * over-active thyroid or benign tumors of the thyroid * history of allergic disorders, including allergic reactions, against contrast agents containing iodine, or against icg * patients which have received one of the following medications before being admitted to icu: haloperidol, meperidine, methadone, morphine, phenobarbital and rifamycin. * patients with wounds or scars including the front orbital region. * cerebrospinal fluid infection or signs of meningo-encephalitis * anemia (hemoglobin \< 10 g/dl) or thalassemia * carbon monoxide poisoning * acquired pathological or congenital disorders of the cerebral system, being clinically significant, respectively interfering in the investigator's opinion with the conduct of study * documented history of bleeding, clotting or coagulation disorders * patients who are not suitable for a ct perfusion * subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical investigation or will not comply with requirements of the study * any disorder in the investigator's opinion that could interfere with compliance of safety evaluation * pre-existing disability and/or legal representative * patients who are kept lawfully in an institution * participation in another interventional clinical investigation within the last 30 days before start of treatment * history of, respectively diagnosis of pregnancy, or breastfeeding patients
interest of serratus plane block in postoperative analgesia for robot-assisted surgery

Conditions: Analgesia; Robotic Surgery

Summary: the aim of the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.

in our hospital, the current practice to provide post operative analgesia for patients scheduled for robot-assisted mitral repair or oncological thoracic surgery is to dispense local anesthetics at the orifices of the trocars at the end of the surgery and to give a patient controlled analgesia (pca). some of these patients are not comfortable and we observe a large percentage of chronic pain. recently we tried to use the serratus plane block realised before the beginning of the surgery, and it seemed that patients were more comfortable with a lower consumption of morphine. so we decided to perform a double blind, randomized study in this population of patients to compare the analgesia provided by the serratus plane block realized before the beginning of the surgery and the local infiltration of the wound at the end of the surgery.

Eligibility criteria:
inclusion criteria: * mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery exclusion criteria: * non robot-assisted surgery
therapeutic efficacy of phytosterols on metabolic syndrome

Conditions: Metabolic Syndrome x

Summary: the objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily supplemention on diagnosis criteria of metabolic syndrome.


Eligibility criteria:
inclusion criteria: * informed consent written * available subjects to follow-up visits * subjects with diagnoses of metabolic syndrome 5 years ago or with current diagnoses criteria * subjects with health visits ongoing * subjects with arterial hypertension under control. * subjects with mellitus diabetes under control. exclusion criteria: * subjects with alcoholism history. * subjects with history of sitosterolemia. * subjects with familiar hypercholesterolemia * subjects who are consuming phytosterols * pregnancy women * breastfeeding period women * subjects with personal history of: acute miocardical infarction, stroke, hypertensive emergency, acute or chronic diabetes descompensation
changes in capillary carbon dioxide partial pressure (pco2) while wearing ffp2 / ffp3 masks

Conditions: Hypercapnia

Summary: the aim of this study is to determine whether there are any changes in the carbon dioxide partial pressure in medical staff while wearing a filtering face piece (ffp) 2 or ffp3 mask. furthermore, changes in the capillary oxygen partial pressure, the subjective respiratory effort and the breathing rate are measured.

in the fight against the severe acute respiratory syndrome coronavirus type 2 (sars-cov-2), the personal protective equipment (ppe) of medical staff plays a special role. since the pathogen can be transmitted via droplets, particle-filtering half masks (filtering face piece - ffp) are a substantial part of the ppe. the current data indicate that there may be an increase in the carbon dioxide partial pressure (pcco2) in the blood when wearing an ffp2 / 3 mask during routine medical activity. the aim of this prospective cross-over study is to compare the pcco2 measured by capillary blood sampling from medical staff while wearing an ffp2 or ffp3 mask. the pcco2 determined without a mask serves as a reference value. while no mask is worn, the pcco2, the subjective respiratory effort, the breathing rate and the capillary oxygen partial pressure (pco2) is measured. the study participants then wear an ffp2 or ffp3 mask for one hour, and the same parameters are collected. subsequently, the participant switches to an ffp3 or ffp2 mask, and the last measurement is conducted after one hour.

Eligibility criteria:
inclusion criteria: * medical staff working at the vienna general hospital * oral and written consent to take part voluntarily in this trial exclusion criteria: * hypersensitivity / allergy against nonylvanillamid, nikotinsäure-beta-butoxyethylester or other component of "finalgon salbe" * not coronavirus disease-19 vaccinated * pregnancy * breastfeeding
aloe vera in chronic periodontitis with type 2 diabetes mellitus

Conditions: Chronic Periodontitis

Summary: the present study is designed to investigate the effectiveness of av gel local drug delivery as an adjunct to scaling and root planing (srp) in the treatment of subjects with chronic periodontitis (cp) and type 2 diabetes mellitus (dm).

background: advances in the field of alternative medicine have promoted widespread use of herbal agents, like aloe vera (av), for both medical and dental therapy. av has anti-inflammatory, antioxidant, antimicrobial, hypoglycaemic, healing promoting and immune boosting properties. the present study is designed to investigate the effectiveness of av gel local drug delivery as an adjunct to scaling and root planing (srp) in the treatment of subjects with chronic periodontitis (cp) and type 2 diabetes mellitus (dm). material and methods: a total of 60 subjects with probing depth (pd) ≥5mm and clinical attachment level (cal) ≥3mm were randomly divided into two groups. group 1 was treated with srp + placebo gel local drug delivery (ldd) and group 2 with srp + av gel ldd. clinical parameters including full mouth plaque index (pi), modiﬁed sulcus bleeding index (msbi), probing depth (pd) and clinical attachment level (cal) were recorded first at baseline and then at intervals of 3 months and 6 months.

Eligibility criteria:
inclusion criteria: * well-controlled type 2 dm * chronic periodontitis with moderate to deep pockets \[probing depth (pd) ≥5mm and clinical attachment loss (cal) ≥3mm\] * no history of antibiotic or periodontal therapy in the preceding 6 months. exclusion criteria: * any known disease/condition or on any medication that can affect the periodontal status * known or suspected allergy to herbal medications * systemic antimicrobial therapy * aggressive periodontitis * smokers * alcoholics * immunocompromised patients * pregnant or lactating females