cyrilzakka/clinical-trials huggingface dataset:
Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain

This study aims to investigate whether the use of nociception monitoring during general anesthesia with remimazolam-based total intravenous anesthesia has an effect on intraoperative opioid requirements and postoperative pain. This study is a randomized trial with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.


Eligibility Criteria:
Inclusion Criteria:

Adult patients between 19 and 64 years of age, ASA class I\~III, scheduled for arthroscopic knee surgeryunder general anesthesia.

Exclusion Criteria:

Patient refusal, patients unable to read consent form, active URI or uncontrolled asthma, pneumonia, history of allergies to benzodiazepines, decreased liver or kidney function, heart failure of ejection fraction\<55%, pregnant or breastfeeding patients, history of substance abuse/addiction
The Effect of AFOs on the EMG of Children With CP

Children with cerebral palsy (CP) have altered gait patterns as a result of primary and secondary symptoms. Ankle-foot orthoses (AFOs) are frequently used to improve their gait. Despite evidence of AFO-effects on gait kinetics and -kinematics, the effects on muscle activity remain unclear.

This study will investigate the effect of AFOs on the amplitude and timing, as well as the co-activation of lower limb muscle activity in children with spastic CP.

With a prevalence of two to three per 1000 live births, Cerebral Palsy (CP) is the most common motor disability of childhood. Improving disturbed gait in ambulatory children with CP is an important treatment goal because it is associated with functional independence and participation of children in the society. It is a common practice to prescribe ankle-foot orthoses (AFO) for ambulatory children to improve their gait, prevent secondary deformities, provide an improved base of support, and compensate for muscle weakness.

Previous research highlighted that there is a direct effect on the muscle activity of the distal muscles and an indirect effect on the proximal muscles. However, the impact of the AFO on the muscle activity of the plantar and dorsiflexors is clinically relevant since reduced muscle activity may lead to muscle atrophy and altered motor control. Therefore, more research is needed on the effect of AFOs on the medial gastrocnemius and the tibialis anterior, in both unilaterally and bilaterally involved children. Moreover, the impact of the AFO on the muscle activity of the quadriceps, apart from the hamstrings, needs to be further explored as well.

The purpose of the current study is to investigate the effect of the AFO on muscle activity in the distal and proximal leg muscles of children with CP while walking.

On the measurement day, subjects will first receive a standard clinical examination preceding the clinical overground three-dimensional gait analysis (3DGA) that is planned as a routine clinical follow-up at the CMAL (clinical motion analysis laboratory), extended with an additional 3DGA on the treadmill. The treadmill gait laboratory and overground gait laboratory are across the hall from each other, which makes it possible for the subject to walk from one to the other gait laboratory in just a minute. During the 3DGA, kinematic, kinetic and EMG-data will be collected.

Eligibility Criteria:
Inclusion criteria:

* Gross Motor Function Classification System (GMFCS) level I - III
* CP (bilateral \& unilateral)
* Age: 6 - 17 years
* Prescribed AFO by the medical team (as part of the standard care)

Exclusion criteria:

* Severe contractures or spasticity, which makes it impossible to wear a conventional AFO
* Cognitive or visual impairment that hinder them to understand instructions
* Previous surgery on bones and/or muscles of the legs in the last 12 months prior to assessment
* Presence of ataxia or dystonia
Evaluation of Sun's Scoring System Use in Post-pancraticodoudenectomy Pancreatic Fistula

Evaluation of sun scoring system for predication of pancreatic fistula after Pancreaticoduodenectomy to facilitate timely intervention after Pancreaticoduodenectomy.

Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. \[1\]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers\[2,3\]. Pancreatic fistula(PF) is one of the most important complications after Pancreaticoduodenectomy, with an incidence of about 10% to 28%.\[4\].There are multiple risk factors for the predication of development of pancreatic fistula after pancreaticoduodenectomy which include soft gland texture, non-pancreatic cancer non-chronic pancreatitis pathology, small pancreatic duct diameter (\<3 mm), and high intraoperative blood loss (\>1000 mL) , excess intraoperative fluid administration and increased pancreatic parenchymal remnant volume \[5,6,7\]. Other reported risk factors as increased body mass index (BMI), poor preoperative nutrition, and male gender which preoperative may lead to pancreatic fistula \[8.9\]. Recent studies are deficient in evaluation and predication of pancreatic fistula . So the interest of our study to evaluate and predicate the risk factors and management of pancreatic fistula after Pancreaticoduodenectomy .

Eligibility Criteria:
Inclusion Criteria:

* All the cases indicated for Pancreaticoduedenectomy with :

  1. age less than 70 years.
  2. resectable tumour,
  3. fitness patients

Exclusion Criteria:

* 1_patients with jaundice with serum bilirubin above 200mml/dl. 2_patients with bleeding tendency until corrected. 3_patients with advanced and metastatic malignancy. 4_patients with cardiopulmonary diseases.
Lung Ultrasound Versus Dynamic Lung Compliance to Detect the Optimum PEEP After Alveolar Recruitment for Patients Undergoing Laparoscopic Gastric Sleeve Surgery

The aim of this study is to evaluate The role of transthoracic lung US as a clinical tool in Comparison to dynamic lung compliance for detection of optimum PEEP for obese patients undergoing laparoscopic gastric sleeve surgery.


Eligibility Criteria:
Inclusion Criteria:

* physical status American Society of Anesthesiologist(ASA) I or II

Exclusion Criteria:

* Patients refuse ASA physical status more \> II
* Patients with pre-existing significant pulmonary disease with abnormalities in spirometry, previous lung surgery, home oxygen therapy and signiﬁcant cardiac dysfunction.
* Patients with pulmonary hypertension.
Impact of Best Practice Alerts in Cardiology Outpatient Clinics

This quality improvement intervention seeks to implement two Best Practice Alerts (BPAs) for use in cardiology clinics while simultaneously evaluating the impact of each BPA- one for patients with uncontrolled blood pressure and one for patients with atrial fibrillation not on anticoagulation.

Best Practice Alerts based will be created for hypertension and atrial fibrillation. Outpatient cardiology providers will be randomly allocated into one of three groups. The first group will receive the BPA for hypertension alone. The second group will receive the BPA for atrial fibrillation alone. The final group will receive both BPAs. The rate of blood pressure control for all patients and anticoagulation in patients with atrial fibrillation in each group will be evaluated prior to and after the implementation of the BPAs to determine the effect of the BPA.

Eligibility Criteria:
Inclusion Criteria:

* all patients seen routinely by cardiologists at Duke

Exclusion Criteria:

* none
Feedbacks' Influence on Decision Making Processes

The purpose of this research is to identify and probe the neural networks involved in feedback processing. It aims at translating this knowledge to clinical populations in which this network is disrupted or compromised.

It includes two studies: 1) with fMRI in healthy subjects to identify the neural bases of feedback processing on decision making using different types of feedback (neutral, social and monetary) presented either infra- or supra-laminary and 2) probing the role of one structure, the anterior cingulate cortex, using Galvanic Vestibular Stimulation (GVS) in healthy subjects. The interventional part consists in the administration of Galvanic Vestibular Stimulation (GVS), which by means of small intensity currents activates the vestibular organs and subsequently vestibular-related brain areas. GVS will be delivered to healthy participants engaged in behavioural tasks requiring the processing of feedbacks of different nature (e.g. social or monetary feedbacks)


Eligibility Criteria:
Inclusion Criteria:

* Benefit of social health security
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Anamnesis of neurological of psychiatric illness
* Pregnancy or breastfeeding
* Administrative measures restricting legal rights
* Epilepsy (including familiarity), migraines, chronic headaches
* presence of pacemakers, cochlear implants, surgical clips, or any metallic component fixed in participants' body
* Current treatment with psychotropic drugs
* Alcohol assumption during the last 24 hours
* Sleep deprivation
* Recent participation to other brain stimulation studies (\< 1 week)
Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects

This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.

Subjects will be monitored non-invasively with pulse oximetry, end-tidal carbon dioxide, tissue oxygenation and ECG. The mean seal level oxygen saturation will be recorded.Subjects exposed to an altitude of 14,000 feet will experience moderate hypobaric hypoxia. The mean oxygen saturation at this altitude is 83%. Subjects will receive oxygen from both an oxygen concentrator or a cylinder of oxygen following exposure to hypobarism. Oxygen from each source will be increased in 1 liter per minute increments until the oxygen saturation returns to the baseline sea level oxygen saturation.

The oxygen requirement to return oxygen saturation to baseline values will be recorded. The flow from the concentrator and the cylinder will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Current altitude chamber certification
* Age 18 years - 60 years

Exclusion Criteria:

* Current upper respiratory infection
* Current symptoms of lower respiratory infection -- productive cough
Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566

To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.


Eligibility Criteria:
Inclusion Criteria:

* Part A1 only: Patients with histological or cytological diagnosis of HNSCC, HCC, melanoma, or clear cell RCC who progressed on or are intolerant to standard therapy, for which no standard therapy is available or who decline standard therapy.
* Part A2 only: Patients with histological or cytological diagnosis of advanced/metastatic HCC who are treatment naïve and have declined standard of care, or have had at least 1 prior line of systemic therapy. Prior anti PD L1/PD 1 therapy is allowed.
* Part B1 only: Patients with histological or cytological diagnosis of NSCLC, HNSCC, melanoma, urothelial bladder carcinoma (including renal pelvis, ureters, urinary bladder, and urethra), gastric or squamous cell carcinoma of the uterine cervix who progressed on or are intolerant to standard therapy, for which no standard therapy is available, or who decline standard therapy.
* Part B2

Arm 1 only:

1. Ocular melanoma patients with advanced/metastatic disease, or
2. Cutaneous/acral melanoma patients with advanced/metastatic disease who have received checkpoint inhibitor (anti PD L1, anti PD 1, or anti CTLA4) based treatment on which disease progressed. \[Note: Checkpoint inhibitor may have been part of a combination therapy, as long as the combination did not contain OX40 or 4 1BB agonist.\] Any questions on prior treatment may be discussed with the Sponsor.

Arm 2 only:

* Histological or cytological diagnosis of NSCLC with advanced/metastatic disease. Patients must have previously received prior anti PD L1 or anti PD 1 mAb on which disease progressed. \[Note: Previous anti PD L1 or anti PD 1 mAb may have been part of a combination therapy, eg, in combination with chemotherapy, as long as the combination did not contain OX40 or 4 1BB agonist.\]
* Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function

Exclusion Criteria:

* Brain metastases requiring steroids
* Major surgery, Radiation therapy within 4 weeks of starting study treatment (except: palliative radiotherapy to a limited field is allowed after consultation with sponsor's medical monitor at any time during study participation, including during screening), or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
* Active and clinically significant bacterial, fungal, or viral infection
* History of active autoimmune disorders
* History of immune-mediated adverse events requiring immunosuppressive therapy or were grade 3 or higher related to prior immune-modulatory therapy
* Prior treatment with an OX40 agonist and 4-1BB agonist (for Part B1/B2)
* Prior anthracycline treatment and at risk of cardiac failure (New York Heart Association Class 2)
A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction

This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain either perioperatively or postoperatively in a third molar extraction pain model, and to further evaluate the drug's safety. Approximately 150 subjects from the US will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Scheduled for outpatient oral surgical procedure to remove 2 ipsilateral third molars, at least 1 of which is mandibular and fully or partially impacted by bone.
* Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures.
* Body weight \>50 kg (110 lbs).
* Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance.
* Additional criteria exist.

Key Exclusion Criteria:

* Positive urine drug screen.
* Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.
* Additional criteria exist.
CT Portography in Grading of Liver Cirrhosis

Esophageal variceal bleeding and hepatic encephalopathy are serious complications of hepatic cirrhosis, and they may lead to high mortality rate and severely threaten life quality of the patients

The occurrence and development of Esophageal variceal bleeding and hepatic encephalopathy are closely related with portal vein system diseases, such as collateral circulation of portal hypertension and portal vein thrombosis.

The prevention of Esophageal variceal bleeding and hepatic encephalopathy in hepatic cirrhosis has become a hot spot in clinical practice.

Three-dimensional reconstruction of images obtained by multi-slice spiral computed tomography portography (MSCTP) is clear, realistic, and accurate.

It can directly and quickly display all anatomical information of collateral portal vein system, and is recognized as a good method to display blood vessels

Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis and\\or portal hypertension diagnosed by; laboratory or radiological parameters.

Exclusion Criteria:

* Patients with ligation, disconnection or shunting of esophageal varices. Patients with combined hepatic malignant tumor Patients with splenectomy. Patients with renal dysfunction or iodine allergy.
Shared Decision Making and Satisfaction With the Diagnostic-therapeutic Process in the Shared Decision Making and Satisfaction With Colorectal Cancer Screening. The CyDESA Study

A cross sectional multicenter study (3 centers) to know the participation in decision making and the experience and satisfaction of participants with a positive immunological fecal test (FIT) result in relation to the screening process and the diagnostic-therapeutic process of cancer.

We will include 850 participants with a positive FIT result and will classify them by their final diagnosis (false positives of FIT; polyps; colo-rectal cancer).

Outcomes of interest will be measured by auto administered questionnaires:

collaboRATE, SDM-Q-9, OUT-PATSAT35 and a satisfaction questionnaire developed in a previous study.


Eligibility Criteria:
Inclusion Criteria:

* Participants in the colorectal cancer screening program, with a positive result in the FIT AND in whom the perform of a colonoscopy is indicated AND agree to be included

Exclusion Criteria:

* People for whom the performance of a colonoscopy is not indicated by medical reasons
* People who refuse to perform a colonoscopy
* People who do not understand Spanish or Catalan, with deterioration of the cognitive state that do not allow them to understand or answer the questionnaires on their own or with the help of a caregiver;
* People in which the process is not carried out completely in the study centers (eg. performance of the colonoscopy in a private center).
Impact of CES1 Genotype on Remimazolam

Remimazolam is primarily metabolized via CES1, and other drugs that are commonly metabolized by CES1 are known to have their pharmacokinetics and clinical effects affected by genetic polymorphisms in CES1.

The goal of this observational study is to investigate the impact of the CES1 genotype on the pharmacokinetics, safety, and efficacy of remimazolam in patients undergoing elective surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1 or 2
* Age 19-70 years
* Elective surgery

Exclusion Criteria:

* Concomitant regional anesthesia
* Uncontrolled hypertension (systolic blood pressure \>180 mmHg)
* Uncontrolled diabetes mellitus (HbA1c \>9.0%)
* Aspartate transaminase (AST), Alanine transferase (ALT), Total bilirubin \> more than 2 times the normal upper limit
* Estimated glomerular filtration rate \<60 ml/min/1.73m2
* Moderate to severe chronic pulmonary obstructive disease or respiratory failure
* Emergency
* Hepatectomy, Liver transplantation
* Cardiopulmonary bypass use
* Craniotomy due to head trauma, unstable intracranial pressure, or brain disease
* Use of benzodiazepine medications (if tolerance is present)
* Anxiety, alcohol/drug dependence, or addiction to tricyclic antidepressants
* Reported hypersensitivity and adverse reactions to benzodiazepines, flumazenil, and other agents used during anesthesia
* Lactose-related genetic disorders
* Myasthenia gravis or myasthenia gravis syndrome
* Newly diagnosed myocardial infarction/clinically significant coronary artery disease, cerebral ischemic attack/stroke within 6 months, or significant untreated coronary artery disease
* Implanted rate-responsive cardiac pacemaker with a bioelectrical impedance sensor.
* Intrinsic brain disorders or other conditions that make it difficult to determine the depth of anesthesia through EEG measurements (e.g., epilepsy)
* History of severe allergies
* Cognitive impairment that prevents comprehension of the instructions and consent form of this study, in case of sedation
* Expected intraoperative blood loss of 1000 ml or more
* Judged by the investigator to be unsuitable for participation in this study due to other reasons
Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium

The study will use the VereMTB tool for rapid diagnosis of TB or non-tuberculous mycobacterium (NTM) pulmonary infections in hospitalised patients, with positive results in acid-fast bacilli smears, which are emerging in many regions of the world.

Delay in diagnosis and treatment of tuberculosis was common in hospitalised patients all around the world, and was associated with poorer outcomes, including respiratory failure and mortality. Rapid and accurate tools for diagnosis of TB is of great importance in initial treatment and for better treatment outcomes. Other than TB, non-tuberculous mycobacterium (NTM) pulmonary infections are emerging in many regions of the world. These bacterium are more common to be found in respiratory specimens than MTB. With similar clinical presentation of NTM pulmonary infections and pulmonary TB, misdiagnosis of NTM pulmonary infections to pulmonary TB would lead to unnecessary intake of anti-TB medications and delay of the initiation of corresponding treatment.

This test aims to detect MTB as well differentiate the NTM species involved in pulmonary infections simultaneously using VereMTB.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. One or more symptoms compatible with mycobacterial pulmonary infections, including fever, cough, sputum production,hemoptysis dyspnea, chest pain and weight loss
3. One or more sputum samples with positive AFB smear

Exclusion Criteria:

1. Receiving anti-mycobacterial treatment for more than one week
2. Refusal to consent
Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study

It is well-established that myocardial infarction (MI) associated with coronary artery bypass graft surgery (CABG) predicts the poor outcome. Nevertheless, the cardioprotective therapies to limit myocardial injury after CABG are lacking. Previous studies have shown that curcuminoids suppress pro-inflammatory cytokines during cardiopulmonary bypass surgery and decrease the occurrence of cardiomyocytic apoptosis after cardiac ischemia/reperfusion injury in animal models. The investigators aim to evaluate whether curcuminoids prevent MI after CABG, compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

Patients undergoing CABG without valve surgery

Exclusion Criteria:

* emergency cardiac surgery
* any increase in CK-MB above upper limit of normal range (ULN) at the time of randomization
* patients with cholestatic jaundice (total bilirubin \> 2-fold ULN)
* severe liver disease (AST or ALT \> 3-fold ULN)
Brain Swelling During Dialysis

The proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration (HDF) and low flux hemodialysis (HD) regarding acute changes in the brain.

The study consist of two examination days placed one week apart. 12 HD patients will be recruited to the study. The patients will be randomly placed in two groups: Pre-dilution hemodiafiltration during the first examination and low flux hemodialysis during the second day or vice versa.

Brain Magnetic Resonance Imaging (MRI) will be obtained before and after both treatments. The MRI-data will later be processed to estimate brain volume changes during the two types of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Informed consent
* Patient with end-stage renal disease (ESRD)
* Stabile hemodialysis treatment (Kt/V ≥ 1.3)
* No contraindications against MRI (pacemaker or other metal implants, claustrophobia, severe adiposity)
* Weight \<140kg

Exclusion Criteria:

* Clinical signs of new structural, thromboembolic or vascular brain disease the last 3 month before entering the study
* Changes in corticosteroid treatment during the last two weeks
* Change in diuretics during the last two weeks
* Non-compliant with regard to salt and fluid intake
* Acute disease