Kornimate/medical-research-clean huggingface dataset:
xarelto for thromboprophylaxis after total hip and total knee arthroplasty

Conditions: Venous Thromboembolism; Arthroplasty

Summary: venous thromboembolism is a serious complication after total hip replacement (thr) and total knee replacement (tkr). previous studies have reported the incidence of both asymptomatic and symptomatic deep vein thrombosis (dvt) after tkr were higher in taiwan than other countries in asia. therefore, the usage of prophylactic antithrombotics should be considered. the efficacy and safety of xarelto (rivaroxaban) for preventing venous thromboembolism has been proved. however, there is a lack of study using prospective design to evaluate the efficacy and safety of xarelto after thr and tkr for taiwanese. in this study, the investigators use a randomized controlled trial design comparing the incidence of dvt, pulmonary embolism, and complications between intervention and control groups.

this parallel study is conducted in a single hospital. the participants are divided into two groups. one group is provided with xarelto, and the other one group is provided without any prophylactic antithrombotic. to check the presence of a deep vein thrombosis of the lower limb, bilateral sonographic examinations are arranged for all participants preoperatively and at 3 and 14 days postoperatively. one radiologists who was blinded to the nature of the study interpreted the results of the sonographic examination. the present of pulmonary embolism, dvt-related symptoms, and complications are recorded during the 3-months follow-up in orthopedics outpatients. the symptom which associated with dvt is defined as the signs of leg such as unusual pain, edema, swelling, warm skin, and red or discolored skin. complications related to xarelto include major bleeding, infection, and non-healing wound. the expected number of participants in each group is 89, which is calculated by g \* power version 3.1. the intention to treat analysis is used in this study. the investigators compare the incidences of dvt, pulmonary embolism, and complications between the two groups.

Eligibility criteria:
inclusion criteria: * undergo total knee replacement or total hip replacement exclusion criteria: * recent antithrombotics use * a history of a coagulopathy * recent thromboembolic disease * preoperative deep vein thrombosis screening presents positive * age below 20
intrathecal mg in gynecologic laparoscopic surgeries.

Conditions: Gynecologic Laparoscopic Surgery

Summary: the investigators aim to investigate the differences between intrathecal bupivacaine + mg sulfate in spinal anesthesia versus bupivacaine on surgeon satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

the investigators aim to investigate the differences between intrathecal bupivacaine + mg sulfate in spinal anesthesia versus bupivacaine on surgeon satisfaction, patient satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

Eligibility criteria:
inclusion criteria: * female patient. * more than 18 years. * undergoing elective gynecologic laparoscopic surgeries. exclusion criteria: * allergy to local anesthesia. * contraindication to spinal anesthesia. * significant cardiac, liver or renal dysfunction. * inability to informed consent
the correlation of myodural bridges to biomechanical parameters in patients suffering from primary chronic neck pain

Conditions: Neck Pain

Summary: in recent years, an anatomical connection of suboccipital muscle fibers to the dura has been found in pathological studies. the physiologic function of these fibers is still unknown. using magnetic resonance tomography (mri), this study will investigate whether these fibers undergo changes in patients suffering from primary chronic neck pain. in addition, the biomechanical parameters of neck movements in these patients will be correlated with the imaging findings.


Eligibility criteria:
inclusion criteria: * chronic neck pain exclusion criteria: * have undergone cervical spine surgery * known cerebral vascular disease of the carotid or vertebral arteries * malignant disease of the cervical spine
preventive effect of proprioceptive stimulation on muscle atrophy

Conditions: Knee Arthritis

Summary: confinement to bed, which occurs in many pathological situations, induces a muscle atrophy and a loss of muscle strength. muscle atrophy is associated to impaired performance in motor tasks, such as posture and locomotion, and is therefore a major cause of loss of autonomy. it requires a stay in follow-up and rehabilitation service, and thus lengthens the duration of hospitalisation. data underline the importance of afferent input integrity in the maintenance of muscle characteristics and postural control, and suggest that countermeasure programs based on the stimulation of proprioceptive inputs could be efficient to prevent muscle atrophy and falls. in particular, fundamental studies performed in rodents by the investigators laboratory have demonstrated that the adverse structural and functional adaptations which occur during muscle deconditioning can be counteracted through adequate physiological stimuli such as activation of proprioceptors. based on this scientific expertise, the investigators aim is thus to prevent muscle atrophy and its functional consequences on posture and locomotion, following a surgical intervention in humans . the investigators will develop a device allowing stimulation of foot and ankle proprioceptors. in order to facilitate the evaluation of its efficiency, the device will be tested on a selected population confined to bed during a post-operative period (knee replacement). it efficiency will be evaluated by means of three parameters: muscle force of ankle plantar flexor, muscle volume of lower limb muscles, functional outcome (gait and balance analysis). the technique developed in the present project could bring benefits to patients confined to bed, or in elderly. preventing or retarding development of muscle atrophy will beneficiate to health and quality of life of these patients. in addition, this device might allow to consider therapeutic strategies for prevention of atrophy in neuromuscular pathologies.

the aim of the study is to study the efficacy of a proprioceptive stimulation device on prevention of calf muscle atrophy after a total knee replacement. the investigators developped a safe vibration and pressure stimulation device for le lower limb. the investigators want to carry out a rct in order to demonstrate the efficacy of the stimulation device, compared to a not stimulated controle group.

Eligibility criteria:
inclusion criteria: * patients waiting for knee replacement exclusion criteria: * neurologic disease

Keywords: knee arthritis muscle atrophy proprioceptive stimulation vibrations
a study of bb-401 in recurrent or metastatic head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of intratumoral injections with an epidermal growth factor receptor (egfr) antisense dna (bb-401) in patients with metastatic/recurrent hnscc.


Eligibility criteria:
key inclusion criteria: * histologically or cytologically confirmed hnscc * failed (or are ineligible/decline to receive) all available standard therapies * stable, treated brain metastases * one target lesion defined as measurable (via recist v1.1), with a maximum longest diameter of 4 cm, and suitable for injection * eastern cooperative oncology group (ecog) 0-2 * agree to biopsies of a selected primary lesion and where possible of a second untreated lesion at baseline and end of treatment * ceased anti-cancer therapy for at least 3 weeks or 5 half-lives for chemotherapy based treatment regimen, or 4 weeks from any therapy with therapeutic biologicals or any type of investigational therapy key exclusion criteria: * nasopharyngeal carcinoma * concomitant anti-cancer therapy * unresolved toxicities from prior treatments * patients in whom the indicator lesion is at risk of hemorrhage or clinically significant swelling/inflammation
a study of epi-7386 in combination with abiraterone acetate plus prednisone, or apalutamide in metastatic castration-resistant prostate cancer (mcrpc)

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (rp2d) of epi-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (aap) and (b) apalutamide (dose-finding) and to determine the antitumor activity of epi-7386 in separate combinations with (a) aap and (b) apalutamide (dose-expansion).


Eligibility criteria:
inclusion criteria: * histologically confirmed prostate adenocarcinoma * must be able to continue gonadotropin-releasing hormone agonist (gnrha) during the study if not surgically castrate * eastern cooperative oncology group (ecog) performance status grade of 0, 1, or 2 * must be able to swallow oral medicines * contraceptive use by men (and female partners of men enrolled in the study who are of childbearing potential or are pregnant) (birth control) use should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies * willing and able to adhere to the prohibitions and restrictions specified in this protocol exclusion criteria: * known central nervous system (cns) metastases * non-metastatic castration-resistant prostate cancer (crpc) (biochemical or locoregional disease only) is excluded from trial participation * evidence of predominant neuroendocrine/small cell carcinoma features in archival or baseline tumor biopsy specimen(s) * symptomatic or impending spinal cord compression, except if participant has received definitive treatment and demonstrates evidence of clinically stable disease * known disorder affecting gastrointestinal absorption
a phase 1 study of amg 330 in subjects with myeloid malignancies

Conditions: Relapsed/Refractory AML; Minimal Residual Disease Positive AML; Myelodysplastic Syndrome

Summary: the purpose of this first-in-human phase 1 study is to determine if amg 330 given as a continuous iv infusion is safe and tolerable in adult subjects that have myeloid malignancies, and to determine the maximum tolerated dose and/or a biologically active dose. the study will be conducted in multiple sites and test increasing doses of amg 330. the safety of subjects will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests.


Eligibility criteria:
inclusion criteria: * informed consent provided * 18 years or older * relapsed/refractory aml: aml as defined by the who classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (apml) exclusion criteria: * active extramedullary aml in testes or central nervous system (cns) * known hypersensitivity to immunoglobulins or to any other component of the ip formulation (eg, sucrose, captisol, potassium, polysorbate 80, citrate, lysine) * prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for \> 1 years before screening

Keywords: amgen phase 1 clinical trial oncology/hematology relapsed/refractory aml immunotherapy
post-operative cognitive dysfunction and the change of regional cerebral oxygen saturation in elderly patients undergoing spinal surgery

Conditions: Elderly Patients Undergoing Spinal Surgery

Summary: post operative cognitive dysfunction (pocd) is a well-recognized complication of patients undergoing cardiac surgery. previous studies reported near-infrared spectroscopy provides information on the occurrence of cerebral desaturation resulted in pocd. but evidence of pocd after general surgery has been lacking. especially, the prone position is used primarily for surgical access to the posterior spine, if there is any significant lowering of the legs or tilt of the entire table, venous returns may be decrease or augmented accordingly. the purpose of this study was to examine the relationship between pocd and intra-operative cerebral oxygen saturation after spine surgery in elderly patients.


Eligibility criteria:
inclusion criteria: * the patient undergoing the lumbar spine surgery in severance hospital exclusion criteria: * patients who had previous cerebral disease, dementia, severe problems in hearing and understanding, or who were unable to provide informed consent were excluded.

Keywords: post-operative cognitive dysfunction regional cerebral oxygen saturation elderly
confocal laser endomicroscopy (cle) during medically induced neurosurgery in craniobasal and glioma tumours

Conditions: Cerebral Tumors

Summary: purpose of the study is to answer the question whether confocal laser endomicroscopy (cle, also named 'optical biopsy') might improve the results of medically necessary neurosurgery to prove practicability, safety and harmlessness of cle during neurosurgical procedures

in patients requiring neurosurgical oncological intervention using endoscopic devices, a mini laser probe will be administered through the endoscopic device to characterize in vivo the tissue by thousandfold magnification down to the cellular level (so-called optical biopsy). magnification is presented to the neurosurgeon in time to better differentiate between healthy and pathological tissue. post-surgery results of in-vivo differentiation will then be compared to histocytopathological findings.

Eligibility criteria:
inclusion criteria: * patients administered to the department of neurosurgery requiring neurosurgery due to either diagnosed gliomata (40 patients) or diagnosed subcranial tumors adjacent to or already invading neuronal structures (20 patients) * patients having given informed consent exclusion criteria: * severe concomitant diseases probably negatively influencing the participation in this clinical trial * cardial infarction or stroke within the preceding 12 months * treatment resistant hypertonus (systolic blood pressure \>200 mmhg or diastolic blood pressure \>120 mmhg or a combination of both * pulmonic diseases that might result in an advanced risk for anesthetic measurements * patients being vaccinated with live vaccines (14 days prior) or contra influenza (7 days prior) to start of the study * all concomitant findings that might increase in the eyes of the investigator the risk of participation

Keywords: optical biopsy
humoral and cellular immunity against sars-cov-2 vaccine in hiv-infected patients immunosuppressed

Conditions: SARS-CoV-2 RNA Vaccines; HIV Infection

Summary: prospective, non-equality, cohort study, where investigators propose to analyze humoral and cellular immunity after two doses of sars-cov-2 rna vaccines in hiv-infected participants severely immunosuppressed. a total of 92 hiv-infected subjects over 18 years old with ≤200 cd4/μl (experimental group; n=46) and ≥ 350 cd4/μl (as control group; n=46) who have completed two doses vaccination against sars-cov-2 will be included in the study. primary objectives: * to analyze the percentage of participants with sars-cov-2-specific igg after 1, 6, and 12 months after vaccination in subjects with ≤200 vs ≥350 cd4/μl by electrochemiluminescence immunoassay (elecsys® anti-sars-cov-2. roche diagnostics). * to analyze the percentage of subjects with specific t and memory b lymphocyte response against sars-cov-2 after 1, 6, and 12 months after vaccination with \<200 vs ≥350 cd4/μl. multiparametric flow cytometry in peripheral blood mononuclear cells (pbmcs) will be performed to detect the production of cytokines (il-2, tnf-α and ifn-γ), cytolytic (perforin and granzyme b) and degranulation (cd107a) molecules from t cells, as well as to identify memory b cells specific to sars-cov-2 igg+. secondary objectives: to analyze in participants with \<200 vs ≥350 cd4/μl after 1, 6, and 12 months after vaccination: * quantification of specific igg titers against sars-cov-2 * the association of the t response to sars-cov-2 with humoral response parameters. * the association of the t response against sars-cov-2 with other parameters of immune activation, inflammation and immunosenescence. the phenotypes of maturation (cd45ra and cd27), activation (hla-dr and cd38), senescence (cd57+cd28-) and markers of immune exhaustion (tigit, lag-3, tim-3 and pd-1) in cd4 and cd8 lymphocytes t will be determined by multiparametric flow cytometry.


Eligibility criteria:
inclusion criteria: 1. hiv-infected subjects over 18 years old and ≤200 cd4/μl who have completed vaccination against sars-cov-2. 2. hiv-infected subjects with ≥350 cd4/μl who have completed vaccination against sars-cov-2 matched by age and sex as control group. 3. sign the informed consent. exclusion criteria: 1. neoplastic or autoimmune disease known. 2. treatment with steroids, immunomodulators, interferon, chemotherapy or any pathology that may impact immunological parameters after vaccination against sars-cov-2. 3. active infections at the time of sampling.
new method to close nasal septal perforation

Conditions: Nasal Perforated Septum

Summary: the goal of this clinical trial is to investigate if a 3-dimensional fabricated nasal mesh works to close nasal septal perforations. under general anesthesia, during nasal septal perforation repair surgery, the investigator will place the mesh between the elevated mucoperichondrial flaps opposite the site of the perforation and confirm its original position at both sides under nasal endoscope. endoscopic examination for septal mucosa status will be done monthly for a three months follow up period.


Eligibility criteria:
inclusion criteria: * patients undergoing nasal septal perforation repair surgery. exclusion criteria: * patients with known allergy to polycaprolactone. * pregnancy or lactation.

Keywords: nasal septal perforation
stayok - an innovative measuring instrument for the early identification and treatment of psychosocial risks

Conditions: Mental Health Disorder

Summary: the validity and the sensitivity of different measures implemented in the web application stayok are investigated. the measures are used primarily for the assessment and the early identification of psychosocial risks. secondarily, the results of the assessment are applied to generate health-promoting advices for the user of the web application.


Eligibility criteria:
inclusion criteria: * at 16 years of age * mild to moderate psychological distress exclusion criteria: * serious cognitive impairment due to dementia or cerebrovascular insult * insufficient knowledge of one of the following languages: german, french, italian or english

Keywords: mental health assessment health promotion case management health insurance
pilot testing a novel approach to pediatric obesity treatment

Conditions: Overweight Adolescents; Obese Adolescents

Summary: the goal of this clinical trial is to learn if an emotion regulation and self-monitoring intervention can help treat overweight and obesity in teens. the main question it aims to answer is: * does emotion regulation and self-monitoring help reduce biases in teens with overweight and obesity? * do changes in biases relate to changes in health functioning and health behavior? researchers will compare the intervention to the provision of educational handouts about overweight and obesity to see if the intervention is more effective. participants will: * complete self-report questionnaires, an fmri scan, and have their blood drawn * received educational handouts or attend weekly telehealth group sessions weekly for four weeks and be asked to self-monitor their mood and behavior between sessions * return to complete the same questionnaires, fmri and blood draw procedures


Eligibility criteria:
inclusion criteria: * being english-proficient * ages 11-14 * at or above the 85th bmi percentile based on age and sex norms * having access to wifi or cellular data to attend the telehealth groups * living in a home in lubbock county (tx) or surrounding areas. exclusion criteria: * having a psychiatric or medical diagnosis that interferes with participation (e.g., significant developmental delay; pregnancy) * current enrollment in overweight/obesity treatment. * because the study will include entering an mri scanner, additional standard exclusion criteria will be considered (e.g., having immovable medical devices with batteries, body piercings on the head/face, and having substantial visual impairment that cannot be corrected with staff-provided glasses)

Keywords: overweight obesity adolescents neuronal responsiveness emotion regulation
feasibility and accuracy of a novel xpert cartridge

Conditions: Tuberculosis

Summary: consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. in the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis.

* for each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational xpert test for detection of drug resistance, using phenotypic drug susceptibility testing as the reference comparator * for each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational xpert test for detection of drug resistance, using mycobacterial dna sequencing as the reference comparator * sensitivity and specificity, for detection of m. tuberculosis in sputum, of the investigational xpert test and of the conventional xpert mtb/rif test, using culture as the reference comparator * diagnostic yield (for tuberculosis) of the investigational xpert test and of the conventional xpert mtb/rif test * for the investigational xpert test, the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error' * proportion of study participants with m. tuberculosis detected in sputum * proportion of participants with drug resistant tuberculosis, by drug resistance pattern and by tuberculosis categorization (new case or not new case)

Eligibility criteria:
inclusion criteria: * individuals must meet all of the following inclusion criteria in order to be eligible to participate: * age ≥ 19 years (age of majority) if enrolled in south korea; age ≥ 18 years (age of majority) if enrolled in china * provision of informed consent * clinical signs and/or symptoms suggestive of pulmonary tuberculosis * meets one of the following criteria: a. suspected or confirmed new pulmonary tuberculosis case who has received anti-tuberculosis drugs for less than 3 (three) days (target enrollment for group a is approximately 50 participants). b. confirmed pulmonary tuberculosis with documented rifampin resistance, who has received anti-tuberculosis drugs for 31 days or less c. history of prior tuberculosis plus ongoing signs and/or symptoms of pulmonary tuberculosis plus suspected drug resistance exclusion criteria: * inability to provide a sputum specimen