Kornimate/medical-research-clean huggingface dataset:
diagnostic accuracy of nontuberculous mycobacterial lung disease based on chest ct

Conditions: Mycobacterium Infections, Nontuberculous

Summary: the aim of this study was to elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest computed tomography findings.

to elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest ct, two pulmonologists and two chest radiologists were requested to interpret chest ct of patients nontuberculous mycobacterial lung disease satisfying diagnostic criteria of american thoracic society as well as british thoracic society, or pulmonary tuberculosis. two pulmonologists and two chest radiologists \> 10 years of clinical experiences at a tertiary referral hospital participated as raters in this study. they were blinded to the any clinical information of the patients including the specific diagnosis, except age and sex. the interpretations of four raters were analyzed and compared.

Eligibility criteria:
inclusion criteria: * nontuberculous mycobacterial patients satisfying diagnostic criteria suggested by american thoracic society * patients with bacteriologically confirmed pulmonary tuberculosis * patients with bronchiectasis, confirmed by clinically as well as radiographically exclusion criteria: * none
minimally invasive distal chevron in comparison to the reverdin-isham osteotomy for hallux valgus correction

Conditions: Hallux Valgus and Bunion

Summary: this study analyses the reverdin isham procedure, which is the most popular minimally invasive surgical hallux valgus correction method and the minimally invasive chevron osteotomy, representing the standard technique of open surgery. it is hypothesized that the two techniques would show significant differences in regard to radiological outcome (hypothesis 1), clinical outcome (hypothesis 2) and development of radiological recurrence (hypothesis 3).

multiple different surgical techniques have been established for hallux valgus surgery so far, each technique with its unique advantages and limitations. the distal chevron method is widely accepted as a surgical method for correcting mild to moderate hallux valgus deformities. numerous publications presenting the radiological outcome of this surgical technique and the clinical outcome by means of well established score systems have been published and make this technique, today's benchmark in hallux surgery. due to scarring and decreased range of motion of the greater toe joint after open surgery and increasing patients' demands several minimally invasive techniques have been brought to public in the last few years. these techniques claim minor soft tissue damage and reduced surgical time. the efficiency and stability of correction, as well as the clinical outcome of these techniques have been discussed controversially. however, most studies present data from minimally invasive surgery without specific differentiation of the type of surgery and in regard to the clinical and radiological outcome. recently a prospective randomized study comparing the open versus the minimally invasive chevron technique has been published presenting data with comparable clinical and radiological outcome. given the above-mentioned lack of evidence it was the aim of the study to compare the results of two different minimally invasive techniques. the investigators analyzed the reverdin isham procedure, which is known as the technique, that made minimally invasive hallux surgery popular and the minimally invasive chevron osteotomy. it was hypothesized that the two techniques would show significant differences in regard to radiological outcome (hypothesis 1), clinical outcome (hypothesis 2) and development of radiological recurrence (hypothesis 3).

Eligibility criteria:
inclusion criteria: * patients after minimally invasive distal chevron osteotomy for hallux valgus deformity with a minimum follow up of 24 months * patients with informed written consent for being analyzed * patients, of whom radiographs are available from preoperative throughout the follow-up time of 24 months exclusion criteria: * patients under 18 years of age * pregnant patients, or women below the age of 50 ys, of whom the pregnancy status is not clear * patients with mental illness or patients, who cannot follow the required postoperative treatment or controls * patients, who refuse to participate * patients, who are assigned to other clinical studies
effectiveness of autologous adipose-derived stem cells in the treatment of knee cartilage injury

Conditions: Knee Osteoarthritis; Cartilage Degeneration

Summary: this study was aimed to evaluate the efficacy and safety of autologous adipose-derived mesenchymal stem cell gel combine with high tibial osteotomy therapy in the treatment of cartilage damage in the knee. investigator believe that this method will enable patients to recover better knee function and more repair of knee cartilage.

the patients who will underwent high tibial osteotomy were randomly divided into the experimental group and the control group. abdominal fat extraction before operation in experimental group to prepare adipose-derived mesenchymal stem cell gel, while the control group only underwent high tibial osteotomy. one month after operation, the experimental group was injected with adipose-derived mesenchymal stem cell gel into the joint cavity, and the control group was injected with sodium hyaluronate in the joint cavity. two groups of patients were followed up.

Eligibility criteria:
inclusion criteria: * aged 18-65 years, male and female, patient can tolerate surgery; * clinical diagnosis of degenerative arthritis by radiographic criteria; * obviously extra-articular malformation; * good contralateral interventricular cartilage; * course of disease ≥ six months; * there was no obvious abnormality in tumor marker detection,or patient was evaluated has not at the risk of cancer; * subjects who understand and sign the consent form for this study. exclusion criteria: * acute joint injury; * patients with severe primary diseases, such as cardiovascular,cerebrovascular, liver, kidney and hematopoietic system, and psychosis; * cancer patients; * women who are pregnant or breast feeding,or allergic constitution patient; * positive serology for hiv-1 or hiv-2, hepatitis b (hbsag, anti-hepatitis c virus -ab), hepatitis c (anti-hepatitis c virus -ab) and syphilis; * receive other open surgery related to knee operation within 6 months; * participation in another clinical trial; * failing to comply with the inclusion criteria, unwilling to comply with the research approach, or incomplete data affecting the curative effect or safety judgment.

Keywords: knee osteoarthritis stem cell cartilage repair
use of high flow nasal cannula during sedation of morbidly obese patients in the endoscopy suite

Conditions: Morbid Obesity; Noninvasive Ventilation; Deep Sedation

Summary: this study evaluates the ability of high flow nasal cannula versus nasal cannula to oxygenate morbidly obese patients undergoing moderate to deep sedation for gastrointestinal procedures.

the respiratory physiology of morbidly obese patients is altered due to restriction of the chest wall motion which decreases pulmonary compliance. in addition, anatomical changes lead to an increased incidence of airway obstruction in morbidly obese patients during periods of sedation. both a typical nasal cannula and high flow nasal cannula provide supplemental oxygen to the patients to prevent desaturation and hypoxia. however, the higher flow rates of high flow nasal cannulas are able to produce allows for washout of carbon dioxide from the respiratory system aiding with ventilation and creates 3 to 5 cm h2o of positive end expiration pressure which helps prevent collapse of the airway aiding with oxygenation.

Eligibility criteria:
inclusion criteria: * body mass index greater than or equal to 40 * scheduled for a gastrointestinal endoscopy that requires mac sedation exclusion criteria: * body mass index less than 40 * pregnant * require either invasive or non-invasive ventilation for respiratory failure * use home oxygen * ventilation is via a tracheostomy * the procedure is emergent
uterosacral ligament suspension clip

Conditions: Pelvic Organ Prolapse

Summary: this study seeks to gain a more thorough understanding of the postoperative location of the sutures placed during uterosacral ligament suspension. characterization of the surrounding anatomy in a living model will enhance surgical technique by delineating safer suture locations and decrease the incidence of morbid complications for patients.

uterosacral ligament suspension is a commonly performed procedure to support the vaginal apex at the time of pelvic reconstructive surgery for pelvic organ prolapse (pop). despite being a well established durable option for patients, there is little research detailing ligament suspension suture location in the living model. the available literature is limited to cadaveric studies, which suggest suture placement is in close proximity to vital structures such as the ureter, blood vessels, rectum and nerves. this study seeks to describe suture location in relation to the surrounding anatomy in postoperative patients following high uterosacral ligament suspension. the secondary aim is to determine safe zones for suture placement. seventeen women (aged 18-85) under the care of cincinnati urogynecology associates, a physician group of trihealth, who have chosen vaginal hysterectomy with uterosacral ligament suspension (usls) as the treatment choice for pelvic organ prolapse (pop) will be enrolled. at the time of surgery, a titanium vascular clip (size small) will be applied to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging. on postoperative day (pod) 1, patients will undergo ct pelvis scans. the ct scan will involve administration of iv contrast for imaging of the ureters and vascular structures. the clip will fall off when the sutures dissolve at 12 weeks postoperatively. all patients will be asked to complete a lower extremity neurological questionnaire preoperatively and postoperatively.

Eligibility criteria:
inclusion criteria: * women aged 18-85 with pelvic organ prolapse (pop) who have elected uterosacral ligament suspension (usls) for treatment exclusion criteria: * contraindication to computed tomography (ct), or intravenous (iv) contrast * those with claustrophobia * previous pop surgery * previous pelvic surgery to the fallopian tubes, ovaries, or rectum * previous pelvic radiation * known pelvic inflammatory disease or endometriosis * those with preexisting ureteral or vascular pathology or sacral anatomic abnormality * those with connective tissue disorders * those with preexisting neuropathy, chronic lower extremity pain disorders, or neurological disorders * those with renal anomalies such as pelvic kidney, duplication of the collecting system, prior nephrectomy * those with allergy to titanium * removal of the uterosacral sutures due to ureteral obstruction intraoperatively
a clinical trial to evaluate the safety and efficacy of fycompa in subjects with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is a pilot trial to test perampanel (fycompa; eisai, inc.) in als patients. the investigators will focus on safety and preliminary signs of efficacy. perampanel is approved by the fda for treatment of seizures in patients with epilepsy. in this study, perampanel will be used off-label for adults with als at an oral medication dose on the low end of the recommended dose range for epilepsy. this study will consist of two treatments arms: perampanel and matching placebo randomized at a 1:1 ratio. subjects will receive medication for 9 months.


Eligibility criteria:
inclusion criteria: 1. diagnosis of als 2. first clinical weakness within past 3 years 3. slow vital capacity \>= 60% of predicted within 1 month of treatment 4. may be on stable dose of riluzole for at least 30 days, or otherwise agree to not initiate riluzole for duration of the trial 5. may be on stable dose of edaravone for at least 30 days, otherwise agree to not initiate edaravone for duration of the trial 6. can travel to stony brook to receive medical care 7. must have a monitor who can be contacted at regular intervals to report on subject's clinical/psychiatric status exclusion criteria: 1. use of tracheostomy or mechanical ventilation within last 3 months 2. hepatic insufficiency or abnormal liver function 3. renal insufficiency 4. clinically significant psychiatric disorder 5. active malignancy 6. history of hiv, clinically significant chronic hepatitis, or other active infection 7. history of stomach or intestinal surgery or condition that could interfere with absorption, distribution, metabolism or secretion of study drug 8. history of alcohol or substance abuse within 3 months prior to entry (subjects will be instructed to refrain from alcohol during the study) 9. use of strong cytochrome p4503a inhibitors or inducers, anticonvulsants or other drugs known to interact strongly with perampanel. 10. pregnancy or lactation 11. clinically significant medical condition (other than als) that would pose a risk to the subject if they were to participate 12. know hypersensitivity to perampanel 13. currently participating, or has participated in a study with an investigation or marketed compound within 3 months of entry
intraoperative ultrasound guided compared to stereotactic navigated ventriculoperitoneal shunt placement

Conditions: Ventriculoperitoneal Shunt (VPS); Hydrocephalus

Summary: this study is to prospectively compare ultrasound guided (us-g) ventriculoperitoneal shunt (vps) placement to stereotactic navigation in a randomized controlled fashion with the surgical intervention time as primary outcome. all patients entering the university hospital of basel for elective or emergent vps surgery will be randomized in 1:1 fashion to one of the study groups at admission or the day before the operation.

ventriculoperitoneal shunt (vps) placement is one of the most frequent procedures in neurosurgical practice. the position of the proximal ventricular catheter is important since it influences possible malfunction of the vps. for the improvement of accuracy in proximal vps placement, navigation-based insertion techniques have been developed. vps placement using stereotactic navigation has shown a high accuracy of catheter placement been developed. vps placement using stereotactic navigation has shown a high accuracy of catheter placement, while the main limitations are that for referencing, the head of the patient needs to be fixed in a head holder and the preoperative set-up can be time-consuming. us-g vps placement using a burr hole probe was described as an alternate for image-guided vps placement technique. for us-g vps placement head fixation or preoperative registration is not needed. this study is to prospectively compare ultrasound guided (us-g) ventriculoperitoneal shunt (vps) placement to stereotactic navigation in a randomized controlled fashion with the surgical intervention time as primary outcome.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * patients undergoing elective or emergent vps placement (frontal or occipital shunt ) exclusion criteria: * revision surgery due to former vps placement using the same side and location for vps placement or when no complete shunt is revised (proximal and distal), resulting in a shorter operation time * ventriculoatrial or ventriculopleural placement * women who are pregnant or breast feeding * intention to become pregnant during the course of the study * previous enrolment into the current study * enrolment of the investigator, his/her family members, employees, and other dependent persons

Keywords: ventriculoperitoneal shunt (vps)-dependency vps placement stereotactic navigated ventriculoperitoneal shunt placement ultrasound guided (us-g) ventriculoperitoneal shunt placement
effect of deksmedetomidine and remifentanil in extubation agitation

Conditions: Agitation

Summary: to compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation.

nasal septum operation cause agitation because of nasal package. this research aims determine which agent , deksmedetomidine remifentanil or placebo, is more beneficial to the patient.

Eligibility criteria:
inclusion criteria: * adult patients exclusion criteria: * patients with any sensitivity each drug

Keywords: nasal septum operation agitation
npc study : tax + cis neoadjuvant in patients with loco regionally advanced undifferentiated carcinoma of nasopharyngeal type (ucnt)

Conditions: Head and Neck Neoplasms

Summary: primary objective: to estimate the overall response rate after neo-adjuvant chemotherapy of docetaxel 75 mg/m2 in combination with cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in ucnt. secondary objectives: to evaluate: * the radiological response after chemotherapy and radiotherapy * the pathological response after chemotherapy by cavum biopsy to estimate: * the duration of overall response * the time to progression (t.t.p) to analyze: * the overall survival * the safety profile


Eligibility criteria:
inclusion criteria: * written or witnessed oral informed consent prior to beginning specific protocol procedures \>histologically proven undifferentiated carcinoma of nasopharyngeal type (ucnt- stage ii-iii oms) at first diagnosis * staging of disease: stage iii, iv a, iv b (uicc/ajcc, 1997 classification), any t, n2 - n3 ucnt, without metastasis * adenopathy \> 3 cm * patients are required to have an unidimensionally measurable disease with recist method * performance status 1 or karnofsky index 3 * previous therapy: chemotherapy :none radiation therapy: none surgery: none * laboratory requirements exclusion criteria: * prior chemotherapy or / and radiotherapy * metastatic disease (m as per the ucci/ajc classification) * past or current history of neoplasm other than ucnt, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix or other cancer,curatively treated and with no evidence of disease at the previous 5 years * pregnant, or lacting, patients of childbearing potential must implement adequate contraceptive measures during study participation * pre-existing motor or sensory neurotoxicity of a severity 3 grade 2 according to nci criteria * others serious illness or medical condition: 1.congestive heart failure or unstable angina pectoris even if it is medically controlled 2.previous history of myocardial infraction within 1 year from study entry 3.uncontrolled hypertension or high risk uncontrolled arrhythmias 4.uncontrolled peptic ulcer, unstable diabetes mellitus susceptible to contraindicate any use of corticoids 5.concomitant treatment with corticoids initiated \> 6 months prior to study entry is given to the dose of methylprednisolone or equivalent 3 20 mg 6.definite contraindications for the use of corticoids 7.concurrent treatment with other experimental drugs 8.participation in another clinical with any investigational drug within 30 days prior to study entry 9.performance status = 2,3,4 or karnofsky index \< 80 10. history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
haemodynamic feasibility study of sensors within a tilting table examination

Conditions: Syncope

Summary: this study´s aim is to explore physiological associations concerning pulse wave velocity, heart rate and blood pressure in order to make taking the blood pressure more comfortable.


Eligibility criteria:
inclusion criteria: * patients with syncope and planned tilting table investigation * male and female patients aged at least 18 years * persons being able to understand and to follow the study stuff´s instructions exclusion criteria: * pregnancy or breast feeding * patients not being able to consent * cardiac pacemaker / defibrillator * illness of skin
prospective monitoring of non-vitamin k oral anticoagulants in older adults with atrial fibrillation and frailty

Conditions: Atrial Fibrillation; Frailty; Anticoagulant-induced Bleeding; Stroke

Summary: the objective of this study is to establish a near-real-time prospective monitoring program in medicare, optum and marketscan research data to evaluate the benefit of new cardiovascular disease (cvd) drugs for older adults with frailty. prospective monitoring program seeks to find early effectiveness and safety signals of new drugs by updating the analysis at regular intervals as new medicare data become available. this study specifically aims to emulate a prospective surveillance of the effectiveness and safety of non-vitamin k oral anticoagulants (noac) vs. a comparator, warfarin, in older adults with atrial fibrillation and different frailty status. this program will be enhanced by incorporating a novel claims-based frailty index, which has been shown useful in assessing how the benefits and harms of drug therapy vary by frailty.

data sources of use for this study are: medicare database, optum database, and marketscan research database. all data from years 2013-2020 (available data may vary depending on the database) will be analyzed in the study. this study follows a sequential cohort monitoring design. the monitoring analysis will include 1) retrospective analysis of available data (2013-2018) at the time of first analysis (april 2021) and 2) prospective analysis of new data (2019-2020) as they become available to the researchers. within each database and by frailty status (frail vs non-frail), the investigators will emulate annual updating of data by creating a propensity score (ps)-matched cohort of new users every 1-year interval. each sequential cohort will be followed for development of the outcomes of interest. at the end of each interval, time-to-event data from all sequential cohorts will be pooled for outcome analysis. the surveillance will be performed by frailty status (frail vs non-frail) at the time of drug initiation.

Eligibility criteria:
inclusion criteria: * initiation of a noac or warfarin (day 0 is the initiation day) * continuous enrollment in medical and drug insurance in \[-183, 0\] days * diagnosis of af in \[-183, 0\] days * cha2ds2-vasc score ≥2 (moderate or high risk for stroke) * no prior use of noac or warfarin in \[-183, -1\] days * no recent hospitalization for stroke or major bleeding in \[-60, 0\] days * no recent nursing facility stay in \[-60, 0\] days exclusion criteria: * contraindication to either drug in \[-183, 0\] days * valvular heart disease or mechanical heart valve in \[-183, 0\] days * intracranial or retroperitoneal hemorrhage in \[-183, 0\] days * chronic kidney disease stage v, end-stage renal disease, or dialysis in \[-183, 0\] days * other indications for anticoagulation therapy in \[-183, 0\] days