cyrilzakka/clinical-trials huggingface dataset:
Effects of a Multidimensional Exercise Program on Cardiac Surgery Patients

This randomized controlled trial study aims to examine the effects of a multidimensional exercise program in cardiac surgery patients. The following hypotheses were tested: patients who received the exercise program will report significant improvement in frailty after the 12-week multidimensional exercise program. Subjects are randomly assigned to the intervention or control group. Patients in the intervention group will receive a 12-week multidimensional exercise program. Data are collected by using medical records and structural questionnaires, measuring handgrip strength, and a four-meter walk test at baseline, 6 weeks, and 12 weeks.

This study aims to develop a multidimensional exercise program and examine the effects of an exercise program on cardiac surgery patients. An experimental design is used. Subjects are recruited using convenience sampling and randomly assigned to the intervention or control group using the block randomization method. Patients in the intervention group will receive a 12-week multidimensional exercise program, including individual nursing consultation, an exercise program that includes moderate intensity walking for 30-45 minutes per day, three days per week combined resistance exercise, nutrition assessment, and instructions, and support. Data are collected by using medical records and structural questionnaires, measuring handgrip strength, and a four-meter walk test at baseline, 6 weeks, and 12 weeks. The data were analyzed using SPSS version 22.0, and data analysis methods include descriptive statistics, independent t-test, chi-square, and generalized estimating equation.

Eligibility Criteria:
Inclusion criteria:

1. aged above 40 years old and received cardiac surgery via median sternotomy with a stable physical condition;
2. at least met one of the frailty phenotypes, including unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity proposed by Fried et al. (2001);
3. had clear consciousness (Mini-Mental State Examination score\>24) and can communicate with Mandarin or Taiwanese;
4. consent to participate in this study.

Exclusion criteria:

1. bed-ridden, cannot stand or depends on others to complete all activities of daily living;
2. received emergency cardiac surgery;
3. with a mental illness history;
4. had exercise contraindications including: in infectious or acute phases, uncontrolled hypertension, arrhythmia, or diabetes mellitus;
5. had a musculoskeletal disease, which might be aggravated by exercise;
6. participate in phase two of cardiac rehabilitation.
Coated Devices to Decrease Infection in the Intensive Care Unit

Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated (Bactiguard®) or habitual (non-coated) devices.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the intensive care unit which will require simultaneous insertion of all three devices (endotracheal tube, central venous catheter and urinary catheter) due to illness severity as defined by the attending physician.

Exclusion Criteria:

* Patients admitted to the intensive care unit for more than 48 hours or admitted in the hospital for more than seven days
* Presence of any of the invasive devices (endotracheal tube, central venous catheter or urinary catheters) before randomization and absence of the intention to exchange the devices;
* Previous use of any type of coated devices;
* Age \< 18 years;
* Known pregnancy
* Known allergy to gold, silver and palladium;
* Suspected or confirmed brain death;
* Previously enrolled in the study

Newly added exclusion criteria in version 2.0:

* Severe chronic pulmonary obstructive disease which may limit catheter site selection
* Previous irradiation and/or thrombosis in site selected for catheter insertion
Stem Cell Educator Therapy in Alopecia Areata

Alopecia Areata (AA) is one of the most common T cell-mediated autoimmune diseases, leading to the chronic and relapsing hair loss. The prevalence of AA worldwide is 0.1 to 0.2%, affecting an estimated 5.3 million people in the United States. To date, the clinical therapies are limited and disappointed for the treatment of AA. Alternative approaches are needed. Increasing evidence demonstrates that stem cells possess the function of immune modulation. We established the Stem Cell Educator therapy by using cord blood-derived multipotent stem cells (CB-SCs)(Zhao Y, et al. BMC Medicine 2012). A closed-loop system that circulates a patient's blood through a blood cell separator, briefly co-cultures the patient's lymphocytes with adherent CB-SCs in vitro, and returns the educated lymphocytes (but not the CB-SCs) to the patient's circulation. Our clinical trial reveals that a single treatment with the Stem Cell Educator provides lasting reversal of autoimmunity that allows regeneration of islet beta cells and improvement of metabolic control in subjects with long-standing type 1 diabetes (T1D), which is another most common T cell-mediated autoimmune disorder in the United States. Here, we develop and explore the therapeutic effectiveness of Stem Cell Educator therapy in AA patients.

A 16-gauge IV needle is placed in the left (or right) median cubital vein, and the patient's blood is passed through a Blood Cell Separator MCS+ (Haemonetics®, Braintree, MA) at 35 mL/min for 6 to 7 hours to isolate lymphocytes in accordance with the manufacturer's recommended protocol. The collected lymphocytes are transferred into the device for exposure to allogeneic CB-SCs (or process control without CB-SCs), and other blood components are returned to the patient. After 2 to 3 hours in the device, lymphocytes are returned to the patient's circulation via a dorsal vein in the hand under gravity flow control (2 to 3 mL/min) with physiological saline. Approximately 10,000 mL of blood is processed during the procedure resulting in approximately two repeated educations for the lymphocyte fraction. Patients are hospitalized for two days to monitor temperature and conduct routine laboratory blood tests for adverse reactions following treatment. Follow-up visits are scheduled 4, 12, 24, 40, and 54 weeks after treatment for clinical assessments and laboratory tests

Eligibility Criteria:
Inclusion Criteria:

* Patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards recommended by the National Alopecia Areata Foundation (www.naaf.org).

Exclusion Criteria:

* Exclusion criteria are any clinically significant diseases in liver, kidney, and heart. Additional exclusion criteria are no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.
Additional Effects of Steroid and Dextrose to Hyaluronic Acid on Knee Osteoarthritis

Using double-blind, randomized controlled design to compare the immediate, short-term and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection of hyaluronic acid injection on patients with knee osteoarthritis, under the basis of International Classification of Functioning, Disability, and Health.

A total of 60 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid combined corticosteroid group and hyaluronic acid combined dextrose group. The balance, physical activity (10 meters normal and fast walk, up and downstairs, and 5 repeated chair-rising time, timed up and go test), functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score) will be evaluated. All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six months after injection. Subjects and evaluators will be both blinded to the group's classification during the whole course of study.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of knee osteoarthritis can walk for 15 meters Kellgren-Lawerence grade 2 or greater than 2 can follow up for 6 months

Exclusion Criteria:

* major diseases will affect balance, such as stroke, infectious diseases, rheumatoid arthritis, dizziness, or vertigo fractures malignance pregnancy or prepare to pregnant received knee injections in the past 6 months previous operation of knee joints
Comparison Between Shear Bond Strength of Different Commercial Metal Bracket Brands: an in Vitro Study

some orthodontic brands are more expensive than others, one of the primary outcomes of this study is to know if is it worth using expensive brands? will it provide better quality treatment, in particular, bond strength? The treatment duration is long therefore it is expensive, either for the orthodontist and/or the patient.

This study will be comparing the bond strength of different commercial brands of stainless steel brackets.

There are a plethora of studies in the science of orthodontics discussing different massive advances in the orthodontic adhesion concepts that allowed orthodontists to successfully bond brackets and tubes to teeth. the bond strength between the bracket and tooth should be sufficient to withstand the forces of mastication and the aggressive conditions of the oral environment. a commonly encountered problem is the failure of the bond between the bracket and tooth during treatment.

There are a lot of orthodontic in vitro studies that discussed bond failure and strength. multiple studies have studied the bracket-enamel bond strength with different curing systems and found that there was no significant difference in terms of bond strength. Several other studies discussed the effect of different adhesive systems on the bond strength to the enamel.

There are many studies that debated the shear bond strength of different metal bracket base shapes and sizes concluding that no differences in SBS for the surface area within the range of 6.82-12.35mm2 as well as the shape of the bracket base had no effect on shear bond strength.

The effectiveness or the success of the orthodontic treatment is arbitrated by achieving better aesthetics, better function, and better judgment for the patient too.

Even if there was a plethora of studies comparing the bond strength of different bracket shapes and sizes and also between metal and ceramic brackets, however, none have considered comparing shear bond strength of different bracket brands to enamel, Considering its cost and repeated failure which has its implication on both patient and orthodontist.

Eligibility Criteria:
Inclusion Criteria:

* sound extracted upper and/or lower permanent premolars.
* Intact buccal enamel surface with n erosion and cracks.
* the teeth must be free from caries, restoration, white spot lesions, or any sign of decalcification.
* No pretreatment with any chemical agents such as hydrogen peroxide or formalin.

Exclusion Criteria:

* teeth with amelogenesis or dentinogenesis imperfecta.
* labially restored teeth.
* endodontically treated teeth.
* teeth with fluorosis.
Predictive Factors of the Difficult Intubation When Using the Videolaryngoscope

The usefulness of videolaryngoscope has been verified by several studies, and the frequency of videolaryngoscopy is increasing in clinical practice. Data on the use of videolaryngoscopes, however, were not sufficiently accumulated when compared with data on the use of previously used macintosh laryngoscopes. In addition, videolaryngoscopy increases the success rate of endotracheal intubation compared to conventional macintosh laryngoscopy, but endotracheal intubation with videolaryngoscope is not successful in all cases with one intubation attempt. Therefore, if the difficult endotracheal intubation with the videolaryngoscope can be predicted in advance, it may be possible to improve the success rate of intubation by reducing unnecessary use of the videolaryngoscope and preparing other equipment. There are many studies on the preoperative examination that can predict the difficulty of intubation when using a macintosh laryngoscope. However, there are still attempts to find screening tests that predict precisely the difficult endotracheal intubation because the accuracy of screening tests is not high. In particular, there is a lack of research on factors that can predict difficult endotracheal intubation when using videolaryngoscope. Therefore, the investigators aimed to investigate the factors predictive of difficult endotracheal intubation when attempting intubation using videolaryngoscope.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are scheduled for endotracheal intubation using a videolaryngoscope for general anesthesia

Exclusion Criteria:

1. Patients who are planned to receive awake intubation
2. Patients who have a tracheostomy tube
3. Patients who do not cooperate in evaluating the head and neck due to mental retardation
4. Trauma patient wearing a neck collar due to cervical fracture
5. Pregnancy
Multi-center Isoelectric EEG Study in Children Under General Anesthesia

Multi-center, prospective, observational study investigating the incidence of isoelectric electroencephalography (EEG) events and the associated peri-operative factors in infants 0-3yo undergoing general anesthesia.

Study will consist of placing a forehead EEG on the subject prior to induction of general anesthesia. EEG recording will continue until the end of anesthesia care. The anesthesiologist will be blinded to the EEG results during the study. Peri-operative factors such as demographics, vital signs, medications, etc... will also be recoded. Each site is expected to enroll up to 75 patients to provide at least 50 evaluable subjects. EEG files will be reviewed after recordings.

After informed consent has been obtained, the subject will receive standard anesthetic care as administered by the anesthesia provider, who will be blinded to the EEG display and data. EEG recording will continue until the end of anesthesia care.

After the recording, the EEG file will be reviewed and the number and duration of isoelectric events will be analyzed. Additional data that will be recorded include: patient demographic and perioperative factors (surgical procedure, anesthetic medications, end tidal anesthetic levels, induction and recovery room behavior, physiologic data, and time-stamps for intraoperative event. Post-operative questionnaire may also be sent to parents.

Eligibility Criteria:
Inclusion Criteria:

* Age 0 to 36 (inclusive) months
* Greater than 36 weeks post-menstrual age (PMA) on the day of study
* Undergo general anesthesia for surgery that is expected to last more than 30 minutes (combined anesthesia and surgical time).
* Anesthetic maintenance with Sevoflurane if using volatile anesthetic or Propofol infusion if using total intravenous anesthetic.
* Expected airway management with a Laryngeal Mask Airway (LMA) or tracheal tube.
* Parental/legal guardian permission (informed consent) obtained

Exclusion Criteria:

* American Society of Anesthesiology (ASA) (physical status) greater than 3
* Structural/anatomical frontal brain malformations or other circumstances that make it difficult to apply the sensor to the forehead.
* History of abnormal EEG or severe neurological abnormalities.
* Scheduled for surgery above the neck, cardiac, brain, or emergency surgery.
* Known allergy or adverse reaction to ECG adhesives.
* On a sedative infusion (eg, propofol, morphine, fentanyl, midazolam, dexmedetomidine, ketamine) or recently on a sedative infusion (discontinued \<24 hours ago)
* Received ketamine within 8 hours prior to the induction of general anesthesia
Study to Determine Mutations in the Gaucher Gene in Patients With Idiopathic Parkinson's Disease for Phenotype-genotype Correlation

The genotype-phenotype correlation in patients with Parkinson's disease with specific mutations in the glucocerebrosidase gene (Gaucher gene) is known from own clinical experiences as well as from case reports in the literature. The epidemiological study will determine the frequency of heterozygous mutations in the glucocerebrosidase gene and correlate to the clinical onset and development by measuring and documenting severity of symptoms (e.g. cognitive deficits, L-dopa responsiveness, depression) in clinically well-characterized Parkinson's patients.

Parkinson's disease (also known as Parkinson's, Parkinson disease, or PD) is a degenerative disorder of the central nervous system that impairs motor skills, cognitive processes, and other functions. The most obvious symptoms are motor-related, including tremor, rigidity, slowness of movement, and postural instability. Among non-motor symptoms are autonomic dysfunction and sensory and sleep difficulties. Cognitive and neurobehavioral problems, including dementia, are common in the advanced stages of the disease. PD usually appears around the age of 60, although there are young-onset cases.

Gaucher's disease is a genetic disease in which a fatty substance (lipid) accumulates in cells and certain organs. Gaucher's disease is the most common of the lysosomal storage diseases. It is caused by a hereditary deficiency of the enzyme glucocerebrosidase (also known as acid β-glucosidase). The enzyme acts on a fatty substance glucocerebroside (also known as glucosylceramide). When the enzyme is defective, glucocerebroside accumulates, particularly in white blood cells (mononuclear leukocytes). Glucocerebroside can collect in the spleen, liver, kidneys, lungs, brain and bone marrow.

Symptoms of Parkinson's syndrome in classical type 1 Gaucher patients were first systematically described in 1996. In GD patients, a marked heterogeneity is detected in terms of disease-causing mutations. In 17 Gaucher patients with symptoms of Parkinson's disease, 12 different genotypes were sequenced and compared to other Parkinson's patients, a lower L-dopa responsiveness, a higher frequency of cortical dysfunction and a relatively early onset of the symptoms was described. Many of these Gaucher patients with clinical Parkinson's symptoms had a positive family history of Parkinson's disease among relatives with heterozygous mutations in the Gaucher gene that could be confirmed in systematic studies.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients at 18 years old
* Patients with confirmed diagnosis of Parkinson's disease
* Signed informed consent

Exclusion Criteria:

* Male or female patients being younger than 18 years old
* Patients without confirmed diagnosis of Parkinson's disease
* Missing signed informed consent
Prognostic Accuracy of Coronary CT and Dobutamine Stress Echocardiography in Patient Undergoing Non-cardiac Surgery

This study aimed to compare dobutamine stress echocardiography (DES) with computed tomography coronary angiography (CTCA) in patients with undergoing intermediate to high risk noncardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Elective surgery
2. Intermediate or high-risk noncardiac surgeries 1) intermediate risk surgery: intrathoracic, intraperitoneal, orthopedic,head and neck, and prostate 2) high risk surgery: vascular
3. Revised cardiac risk index score ≥1 (more than one of the following criteria) 1) vascular surgery, intraperitoneal, intrathoracic surgery 2) history of ischemic heart disease 3) history of heart failure 4) history of cerebrovascular disease 5) diabetes with insulin treatment 6) chronic kidney disease (serum creatinine \> 2.0 mg/dL)

Exclusion Criteria:

1. Need for emergency surgery
2. Active cardiac conditions 1) recent (within 1 month) myocardial infarction 2) acute decompensated heart failure 3) severe valvular disease 4) fatal cardiac arrhythmia 5) acute pulmonary embolism 6) acute myocarditis
3. Relative contraindications or immeasurable coronary stenosis of the CTCA
A Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC

This is a dose escalation study based on 3+3 design with the aim to establish MTD and provide RP2D. PLM60 is to administered by multi-cycle intravenous infusion.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from the patient；
* ECOG performance status of 0 or 1;
* Histologically/cytologically confirmed diagnosis of advanced HCC;
* Adequate washout period for previous anti-tumor therapy;
* Measurable disease according to RECIST v1.1;
* Life expectancy ≥ 12 weeks;
* Adequate organ function;
* Child-Pugh grade A or partial grade B; BCLC stage B or C;V

Exclusion Criteria:

* Prior treatment with Mitoxantrone or Liposome-entrapped Mitoxantrone, or other anthracyclines, with the total cumulative dose of \> 360 mg/m2 ;
* Any drug-related adverse event derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects, that has not recovered to grade1 or less;
* Active central nervous system (CNS) metastases (brain or leptomeningeal metastases, etc.);
* Any history of other malignancy within 5 years;
* Untreated hepatitis infection;
* HIV positive;
* History of liver transplantation, severe cirrhosis, hepatic encephalopathy;
* Inadequate cardiac function;
* Pregnant or lactating women.
Home Apnea Testing in CHildren Trial

This clinical trial will compare home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent/child acceptability in children referred for evaluation of obstructive sleep apnea.

In-lab attended polysomnography (PSG) is recommended for the diagnosis of obstructive sleep apnea (OSA) in children, but testing is limited by high cost and limited facilities. 90% of children who undergo adenotonsillectomy to treat OSA never have the diagnosis made by PSG. Home sleep apnea testing (HSAT) is an accepted means of evaluating adults for OSA. However, in children there is insufficient evidence comparing HSAT to PSG, so it is not currently recommended in the pediatric population. This single-center comparative effectiveness trial will compare the diagnostic accuracy of HSAT with PSG and will assess the agreement in therapeutic decision-making between the two tests and parent- and child-reported acceptability of HSAT and preference of test.

Participants will be randomized to the initial test (HSAT or PSG) and then complete the alternate test within one week. Off-site investigators who are pediatric sleep medicine physicians will provide a therapeutic decision based on clinical data and either HSAT or PSG data, and families will complete questionnaires assessing acceptability of HSAT and preference between the two tests.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children age 5-12 years old inclusive
* Referred for diagnostic PSG at the Children's Hospital of Philadelphia (CHOP) Sleep Laboratory for evaluation of OSA as part of clinical care
* Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

* Children without Down syndrome who have had a PSG within 3 years of enrollment
* Children with Down syndrome who have had a PSG within 1 year of enrollment.
* Children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep
* Children with a tracheostomy or tracheocutaneous fistula
* Children who live in a facility without their parent