cyrilzakka/clinical-trials huggingface dataset:
Machine Learning Model to Predict Postoperative Respiratory Failure

The main objective of this study is to develop a machine learning model that predicts postoperative respiratory failure within 7 postoperative day using a real-world, local preoperative and intraoperative electronic health records, not administrative codes.

Postoperative pulmonary complications are known to increase the length of hospital stay and healthcare cost. One of the most serious form of these complications is postoperative respiratory failure, which is also associated with morbidity and mortality. A lot of risk stratification models have been developed for identifying patients at increased risk of postoperative respiratory failure. However, these models were built by using a traditional logistic regression analysis. A logistic regression analysis had disadvantages of assuming the relationship between dependent and independent variables as linear. Recent advances in artificial intelligence make it possible to manage and analyze big data. Prediction model using a machine learning technique and large-scale data can improve the accuracy of prediction performance than those of previous models using traditional statistics. Furthermore, a machine learning technique may be a useful adjuvant tool in making clinical decisions or real-time prediction if it is integrated into the healthcare system. However, to our knowledge, there was no study investigating the predictive factors of postoperative respiratory failure using a machine-learning approach. Therefore, the main objective of this study is to develop a machine learning model that predicts postoperative respiratory failure within 7 postoperative day using a real-world, local preoperative and intraoperative electronic health records, not administrative codes and evaluate its performance prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients undergoing general anesthesia for noncardiac surgery

Exclusion Criteria:

* Age under 18 years
* Surgery duration \< 1 hr
* Cardiac surgery
* Surgery performed only regional or local anesthesia, peripheral nerve block, or monitored anesthesia care
* Organ transplantation
* Patient with preoperative tracheal intubation
* Patients who had tracheostoma prior to surgery
* Patients scheduled for tracheostomy
* Surgery performed outside the operating room
* Length of hospital stay \< 24 h

If the patients had multiple surgeries during the same hospital stays, we included the first surgical cases in the dataset.
Alterations in Subgingival Microbiota and Hypoxia in Occlusal Trauma

Present study suggests that excessive occlusal forces did not cause a significant change in hypoxia and vascular markers, however a slight alteration in subgingival microbiota was observed.

Occlusal trauma is defined as tissue destruction and/or injury resulting in tissue changes in the periodontium as a consequence of excessive occlusal forces or hyper-occlusion. Previous studies suggested accelerated periodontal destruction around teeth with occlusal trauma and increased mobility, however, the evidence is lacking. Recent animal studies found that occlusal trauma increased osteoclastic activity and alveolar bone loss. One possible mechanism suggested for the progression of periodontal destruction with occlusal trauma is that tooth mobility creates a subgingival environment conducive to overgrowth by periodontal pathogens. However, the association of occlusal trauma and subgingival microbiota was not evaluated in previous studies. Therefore, present study aimed to evaluate subgingival dental plaque components and compare with healthy individuals and periodontitis patients without occlusal trauma.

Eligibility Criteria:
Inclusion Criteria:

* Systemical health
* No drug use
* No pregnancy or lactation For group 3 and 4;
* Bruxism at least for 2 years
* Occlusal trauma
* Existence of at least 20 functioning teeth

Exclusion Criteria:

* Smoking
* Pregnancy/lactation
* Systemical disease
* Drug use
* Absence of at least 20 functioning teeth
Evaluate the Performance of JOURNEY II CR and JOURNEY II BCS in TKA Populations

Background:

The JOURNEY II BCS Total Knee System (JOURNEY II Bi-cruciate Stabilized Total Knee System) consists of femoral component made from oxidized zirconium (OXINIUM)

The JOURNEY II CR Total Knee System (JOURNEY II Cruciate Retaining Total Knee System ) consists of femoral component made from oxidized zirconium (OXINIUM)

Purpose:

Post-market evidence generation for JOURNEY II BCS and JOURNEY II CR Total Knee System

Objectives:

1. Evaluate the performance of JOURNEY II TKA in Asia-Pacific (APAC) patient populations
2. Establish the equivalent performance between JOURNEY II BCS and JOURNEY II CR to support adoption of JOURNEY II CR

Research participants / locations:

A total of at least 176 knees' information will be collected in up to 10 sites. There will be at least eighty-eight (88) knees for JOURNEY II CR TKA group and at least 88 knees for JOURNEY II BCS TKA group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with degenerative osteoarthritis.
* Subject is planning to have bilateral Total Knee Arthroplasty (TKA) using JOURNEY II BCS \& CR or have unilateral TKA using JOURNEY II BCS or JOURNEY II CR.\*
* Subject is able and willing to provide voluntary consent to study participation.
* Subject is 18-80 years old (inclusive).

\[\* Bilateral cases can be simultaneous bilateral or staged bilateral (which an interval of 6-8 weeks apart between both knees)\]

Exclusion Criteria:

* Subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis.
* Previous surgeries including High Tibial Osteotomy (HTO), Unicondylar Knee Arthroplasty (UKA) or Total Knee Arthroplasty (TKA) on the subject knee.
* Subject is pregnant or breast feeding or those at a child-bearing age planning to become pregnant during the follow up.
* Subject does not meet the indication or is contraindicated for JOURNEY II BCS \& JOURNEY II CR's Instructions For Use (IFU).
Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions

Interscalene brachial plexus block (ISB) constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. Continuous ISBs have not avoided this complication with the reported and regularly used local anesthetic dilutions (i.e. 0.125% bupivacaine, 0.25% ropivacaine, etc). This observational study will register the incidence of HDP in continuous interscalene block (CISB) using a very diluted solution of levobupivacaine (0.04%) in patients undergoing arthroscopic shoulder surgery.

The main objective of this study is to determine the frequency of HDP the first postoperative day before patient discharge(POD).


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* American Society of Anesthesiologists classification 1-3
* body mass index between 20 and 35

Exclusion Criteria:

* adults who are unable to give their own consent
* pre-existing neuropathy (assessed by history and physical examination)
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* allergy to local anesthetics (LAs)
* pregnancy
* prior surgery in the ipsilateral neck region
* chronic pain conditions
Allopurinol in Acute Gout

The objectives of the present study are to determine if starting treatement of hyperuricemia with allopurinol during an acute gout crises has an impact on the duration or the severity of the crises


Eligibility Criteria:
Inclusion Criteria:

More than 18 years old Able to sign informed consent Indication of long-term treatment with allopurinol Acute gout crisis

Exclusion Criteria:

Les than 18 years-old Unable to consent Contra-indication to allopurinol
Insulin Action: Role of Skeletal Muscle and Insulin-Mediated Blood Flow

The overall objective of this proposal is to examine the contribution of changes in total body fat, enhancement in insulin-mediated vasodilatation and enhancement in endothelium-derived nitric oxide production to the improvements in metabolic insulin action. In addition, the study will track whether these improvements are related to changes in blood pressure.


Eligibility Criteria:
Age 50 - 75 years, elevated blood pressure, BMI greater than 25 but less than 40 kg/m2
Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)

This is a phase III multicenter, open-label study designed to investigate the efficacy (hematological response, cytogenetic response and molecular response) and feasibility (tolerance, compliance and safety) of the tyrosine kinase inhibitor imatinib mesylate (formerly STI 571, GLIVEC, Novartis Pharma) at conventional dose (400 mg/daily) if compared with high dose (800 mg/daily) (serial number protocol ICSG/CML/022) in patients with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP) previously untreated, at high Sokal risk.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>/=18 years
2. First chronic phase, less than 6 months of duration
3. High Sokal's risk
4. Ph positive
5. No previous treatment or hydroxiurea only.
6. Performance status (ECOG/WHO) \< 2
7. Written informed consent

Exclusion Criteria:

1. Age \<18
2. Low or intermediate Sokal risk score.
3. More than 6 months from diagnosis.
4. Second chronic, accelerated or blastic phase
5. Scheduled allogeneic stem cell transplantation within 1 year from diagnosis.
6. Performance status (ECOG/WHO) \> 2
7. Inability to provide written informed consent
8. Pregnancy
9. Formal refusal of any recommendation of a safe contraception
10. Alcohol or drug addiction
11. Altered hepatic or renal function as defined by AST/ALT or bilirubine \> 3 times upper normal limits (UNL) and by creatinine \> 20mg/L
12. Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
Diagnostic Utility of Otosight Middle Ear Scope

Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.

The purpose of this study is to compare the successful exam completion rate, the detection of middle ear fluid (versus no fluid), and the categorization of middle ear fluid (purulent vs. serous vs mucoid,) of routine otoscopy examination versus otosight examination versus tympanogram.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 6 months to 12 years old who are seen in the outpatient Otolaryngology clinic at Texas Children's Hospital main and west campuses.

Exclusion Criteria:

* Patients who have a history of ear tube placement
Transfer of Standard Operating Procedures in Anesthesiology

Patients safety and high Quality Performance built up the centre of anesthesiology. Standard operating procedures based on the Helsinki declaration may help to increase the Patient safety and decreased adverse Events or complications.

The Primary endpoint is the comparison of a Intervention Group with audiovisually blended learning concept and a Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading.

Eligibility Criteria:
Inclusion:

* anesthesia residents
* anesthesia consultants

Exclusion:

* nurses
* students
Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.


Eligibility Criteria:
Inclusion Criteria:

* Ability and acceptance to provide written informed consent.
* A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
* Carrier of CRY1Δ11 variant.
* Men or women between 18 - 75 years, inclusive.
* Body Mass Index (BMI) of ≥ 18 and ≤ 40 kg/m\^2.

Exclusion Criteria:

* Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.
* Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
* A positive test for substances of abuse.
* Current tobacco user.
Observational Study to Evaluate the Current Neuromuscular Monitoring Practice Used After Different Types of Surgery, for Which Neuromuscular Blocking Agents Were Used, With or Without Blocking Reversal (P06556)

The intent of this observational study is to collect prospective data regarding neuromuscular monitoring practices and extubation standards (Train-Of-Four \[TOF\] value) during surgery, in countries of Central and Eastern Europe, Middle East and Africa (CEE/EEMEA countries). Secondarily the study will observe, for which surgical procedures neuromuscular blocking agents (NMBAs), and reversal agents to such, are used. This study is a non-interventional clinical trial, and administration of NMBAs, and respective reversal agents, (as well as all drugs used during anesthesia) will be done in accordance with routine anesthesiology practice, and labeling guidelines. Neuromuscular transmission will be monitored according to routine anesthesiology practice by means of acceleromyography. The assignment of the participant to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.


Eligibility Criteria:
Inclusion Criteria

All of the criteria below must be met for a participant to be eligible for study participation.

The prospective participant:

* Is an adult, 18 to 65 years-of-age;
* Is to undergo surgery requiring general anesthesia with non-depolarizing NMBA administration, with or without NMB reversal;
* Meets the inclusion criteria listed on the NMBA label in each country;
* Is willing to participate and sign an informed consent form (ICF).

Exclusion Criteria

Exclusion from the study will be determined by the treating physician. In addition the criteria below should be considered in determining those participants who should be excluded from the study.

The prospective participant:

* Is pregnant or breast feeding;
* Has a neuromuscular disorder;
* Has severe hepatic impairment;
* Has severe renal impairment.
Neonatologist-performed Lung Ultrasound in the Delivery Room

The objective of this study is to evaluate the role of the neonatologist-performed lung ultrasound (NPLUS) during immediate transition after birth of late preterm and full-term neonates using the lung ultrasound score to predict the need of respiratory support persisting more than 1 hour after birth.

Lung ultrasound is an emerging clinical tool to assess the lung in a dynamic way. Recently, the focus has been on establishing lung ultrasound in the neonatal intensive care unit (NICU) as a point-of care application.

Neonates born by a Caesarean section are particularly prone to have an altered adaption to extrauterine life. Especially in the first hours after birth, respiratory distress syndromes (RDS) may occur due to delayed lung fluid clearance after birth.

While acute RDS in the first hours after birth may be a self-limiting disorder and therefore a benign condition, it remains difficult to identify neonates in need for further respiratory support at the NICU. Admission to the NICU not only causes parental stress but also contributes to additional healthcare costs.

There is emerging evidence that NPLUS is a reliable tool to differentiate between the causes leading to RDS in neonates. Using a neonatologist performed lung ultrasound score for the early identification of neonates in need of respiratory support persisting more than 1 hour would be therefore highly advantageous.

Eligibility Criteria:
Inclusion Criteria:

* Late preterm neonates (born between 34 0/7 and 36 6/7 weeks of gestation) and full-term neonates (born later than 36 6/7 weeks of gestation) delivered by Caesarean section
* Presence of any sign of respiratory distress (defined as tachypnoea/ dyspnoea, grunting, flaring of the nostrils or chest retractions)
* Written informed consent obtained from the parents prior to birth.

Exclusion Criteria:

* Presence of cardiopulmonary malformations
* Patients with pneumothorax diagnosed by neonatologist-performed lung ultrasound
Treatment of Hepatocellular Carcinoma: Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone

Hepatocellular carcinoma (HCC) is a consequence of liver cirrhosis. In early tumour stages, tumour resection or liver transplantation are therapeutic options; later tumour stages may be treated with locally ablative treatments such as percutaneous ethanol instillation (PEI), transarterial chemoembolization (TACE) or radio-frequency thermoablation. This randomized study investigates the effect of PEI on survival of patients with HCC. All patients will receive hormonal treatment (long-acting somatostatin intramuscularly \[i.m.\]) and will be randomized for treatment with PEI or no additional treatment.

This is a randomized two-arm parallel group study.

* Study group: PEI + long-acting somatostatin
* Control group: long-acting somatostatin alone

Aims of the study:

* Does treatment with PEI+ long-acting somatostatin prolong survival as compared to treatment with long-acting somatostatin alone?
* Can time to tumour progression be extended in patients treated with PEI + long-acting somatostatin as compared to treatment with long-acting somatostatin alone?

Eligibility Criteria:
Inclusion Criteria:

* Histologically-proven hepatocellular carcinoma
* Treatable with percutaneous ethanol instillation
* Inoperable tumour
* Age 18-85 years

Exclusion Criteria:

* Liver cirrhosis Child C
* Tumour diameter \> 8 cm
The Gut Microbiome in FLT3-ITD+ AML Undergoing Allo-HSCT With Or Without Sorafenib Maintenance After Allo-HSCT

This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3-ITD AML patients after allo-HSCT in terms of gut microbiome.

Hematopoietic stem cell transplantation (HSCT) is used as a potentially curative therapy for patients with hematopoietic malignancies. Sorafenib, an inhibitor of multiple kinases including FLT3, has shown promising activity in FLT3-ITD-positive AML. Our previous studies demonstrated that sorafenib maintenance post-transplantation could improve the outcomes of FLT3-ITD-positive AML patients, which is associated with sorafenib enhancing the graft-versus-leukemia (GVL) effect. Recent studies show that gut microbiome is associated with graft-versus-host-disease (GVHD) and GVL. However, the exact mechanism of sorafenib enhancing the GVL effect and the influence of gut microbiome on sorafenib maintenance after allo-HSCT remain unknown.

Eligibility Criteria:
Inclusion Criteria:

* FLT3-ITD Positive AML
* Allo-HSCT Recipients

Exclusion Criteria:

* Intolerance to sorafenib pre-transplantation
* Cardiac dysfunction (particularly congestive heart failure)
* Hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal)
* Renal dysfunction (creatinine clearance rate \< 30 mL/min)
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (according to the investigators' decision)
The Effect of Aerobic Exercise, on Fitness and Functional Muscle Strength, in Patients With Muscular Dystrophy

Muscular dystrophy is a group of disorders that are characterized by progressive muscle weakening and loss of muscle mass, caused by defects in muscle proteins. Muscular dystrophy is almost always inherited disorders, and so far, no curative treatments exist.

Previous studies have shown that endurance training significantly improves fitness and self-assessed muscle function in a variety of muscular dystrophies. In this study, we wish to investigate whether patients with Bethlem myopathy (a specific form of muscular dystrophy) also benefit from endurance training.

The study consists of two test days, a 10-week training period and five blood tests.

Patients will be required to train, three times per week, for 10 weeks, on a bike ergometer with a specific training intensity, under pulse rate monitoring.

The training period will be flanked by two test days, where we will determine, and compare the patients' muscle strength and fitness level, from before to after the training program. The patients conditioning level will be determined from a 15 minute cycle ergometer test and patients will undergo three functional tests to determine their functional muscle strength.

We will as a safety measure analyze blood tests before, during and after the training program for the muscle enzyme creatine kinase (an indicator of muscle damage) and through adverse effects as reported by patients during weekly telephone-consultations with the Principal investigator.

We anticipate, that Bethlem myopathy patients will have a similar rise in fitness level and functional muscle strength, as that seen in patients with other forms of muscular dystrophy, who undertake a similar training program.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Bethlem myopathy

Exclusion Criteria:

* Patients with disorders that would confound the interpretation of the effect from training (cardiomyopathy, pregnant women, etc.)
* Patients who are deemed mentally unfit for cooperation with the training program
Implementation of Genomics in Substance Use Disorder Treatment

Cigarette smoking remains one of the leading causes of preventable death. Effective smoking cessation medications exist but use of these treatments is low, making it difficult for most to quit smoking. Behavioral interventions are needed to engage current smokers in the process of quitting smoking and promote the use of evidence-based cessation medications.

At the same time, genetics influences one's smoking behaviors (e.g., how much they smoke, difficulty quitting) and risk of smoking-related diseases, yet these personalized factors have not been included in existing behavioral interventions. Incorporating these individualized factors into smoking cessation interventions may make them more personally engaging and thus motivating for treatment.

This study will pilot test a risk communication tool that is personalized to one's genetics and will demonstrate the feasibility of a larger trial to test the effect of this personalized genetically-informed intervention on smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Smoked combustible cigarettes in past 30 days
* Computer access for remote-based study visits

Exclusion Criteria:

* Younger than 18 years of age
* No computer access