cyrilzakka/clinical-trials huggingface dataset:
Effect of Motor Development, Motor Function and Electrophysiologic Findings of IOPD Under ERT

To investigate the motor development, motor function and electrodiagnostics presentation in IOPD under ERT.

Background

Pompe disease is an autosomal recessive disease, enzyme replacement therapy (ERT) and new born screen (NBS) had been initiated in Taiwan since 2008. However, residual muscle weakness were noted. Decrease in amplitude of nerve compound muscle action potential (CMAP) and increase spontaneous activity were reported before the imitation of ERT. However, the motor development, motor function and electrodiagnostic presentation which were important in further direction of treatment and rehabilitation program arrangement in infantile Pompe disease (IOPD) under ERT is lacking.

Aim

To investigate the motor development, motor function and electrodiagnostic presentation in IOPD under ERT.

Method

This is an observational, prospective, longitudinal, follow-up study. Motor development was assessed by Alberta Infant Motor Scale (AIMS) and Peabody Developmental Motor Scales, Second Edition (PDMS II); motor function was assessed by Pediatric Evaluation of Disability Inventory (PEDI) and Gross Motor Function Measure (GMFM). Electrodiagnosis studies include nerve conduction study (NCS) and electromyography (EMG).

Expect Effects

Obtain the characteristics of motor development, motor function and electrodiagnosis presentation of IOPD under ERT, and the relation between motor development, motor function and electrodiagnosis presentation.

Eligibility Criteria:
Inclusion Criteria:

* All patients with infantile onset Pompe disease (IOPD) who were diagnosed and follow-up at Taipei Veteran General Hospital (TVGH).

Exclusion Criteria:

* Patients whose guardian did not provide the inform consent.
Performance of Non-injected MR Enterography Compared to a Conventional MR Enterography Protocol With Contrast Agent Injection

Entero-MRI is indicated in Crohn's disease as part of the initial work-up or follow-up (to assess response to treatment, complications). The protocol for carrying out the examination complies with precise specifications set out in international recommendations. To perform the test, the small intestine must be distended with a hyperosmolar product. This protocol is applied to all patients, with no distinction or adaptation.

The total duration of the examination is sometimes difficult for patients to bear. Ingestion of the product to obtain distension of the small intestine is often poorly tolerated by patients.

In a number of cases, the entero-MRI may have been normal due to symptomatology regression or other diagnosis. The patient therefore underwent a complete examination similar to that of a patient with a pathology requiring characterization.

In this context, the investigators hypothesize that fast MR sequences are sufficient to discriminate between normal and abnormal examinations.


Eligibility Criteria:
Inclusion Criteria:

Patient with MR enterography examination for follow-up or suspected Crohn's disease

No Exclusion Criteria.
Concurrent Radiotherapy and/or Cisplatin With or Without Celecoxib in Patients With Primary Oral Squamous Cell Carcinoma

The research and development of novel anti-tumor agents in oral cancer is slow, the investigation of repositioning use of currently available drugs in clinical, such as a selective cyclooxygenase-2 (COX-2) inhibitor (Celebrex/Celecoxib) maybe a potential alternative strategy.

Celebrex (Celecoxib) is a form of non-steroidal anti-inflammatory drug that directly targets COX-2 enzyme to block the inflammatory signaling and has been approved to treat colon cancer. In our preliminary findings, Celecoxib significantly inhibited cell growth,proliferation, migration, invasion and epithelial-mesenchymal transition programs in oral squamous cell carcinoma cell (OSCC) lines. The Institutional Review Board in China Medical University Hospital (CMUH) has approved the combination treatment of concurrent radiotherapy (RT) and/or Cisplatin with or without Celecoxib in a phase II clinical trial for relapse-free primary OSCC patients.

Eligibility Criteria:
Inclusion Criteria:

1. OSCC patients with T1,2/ N0 and without pathological risk features
2. OSCC patients with T1,2/ N0,1 and pathological risk features
3. OSCC patients with T4a/ N2,3

Exclusion Criteria:

1. Pregnant women paitents
2. Taiwanese aboriginal patients
3. Not primary OSCC patients
4. OSCC patients with dysfunction of liver and/or kidneys
Association of COPD Maintenance Medication Adherence With Resource Use and Cost Among COPD Patients

The aim of this study is to examine the association of COPD maintenance inhalation medication (Inhaled Corticosteroid or ICS) adherence with COPD exacerbation healthcare resource utilization among COPD patients with exacerbation history.

Objectives: The primary objective of this study is to examine the association of COPD maintenance inhalation medication (Inhaled Corticosteroid or ICS) adherence with COPD exacerbation healthcare resource utilization among COPD patients with exacerbation history.

Study design: This study is a retrospective database analysis using 2014-2016 Guangzhou City health insurance database.

Data Source(s): Guangzhou city health insurance database will be used for this study. All outpatient and inpatient visits for one patient during 2014-2016 were available.

Study Population: This study will include patients with a physician COPD diagnosis in Guangzhou city health insurance database during 2015 and with complete treatment data during 1 year before and 1 year after the index date. The rough sample size of the study population was 49,000.

Outcome(s):

1. Indicators of COPD control: exacerbations;
2. Health resource utilization: annual number of inpatient days, inpatient visit number, emergency department (ED) visit number;
3. Costs: COPD exacerbation hospitalization expenditures, all-cause hospitalization expenditure.

Statistical Analysis:

Descriptive statistics will be used for all variables, as appropriate. Continuous variables will be summarized by the number of observations, mean, standard deviation, median, minimum, maximum, first quartile and third quartile. Categorical variables will be summarized by frequency counts and percentages at each category. Number of patients and number of missing for each variable will be summarized.

Logistic regression will be used to estimate the risk of any hospitalization. Generalized Linear Models (GLMs) with a gamma distribution and log link will be used to approximate the highly right-skewed distribution of medical expenditure.

For exploratory objectives, Propensity Score Matching (PSM) will be used to explore the association of medication class and health resource utilization if applicable. The interaction of medication class \* adherence or subgroup analysis (by medication class) will be considered when conducting the regression model.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with COPD in 2015;
2. Patients had complete hospital visit data available during pre-index 1 year period and post 1 year follow-up;
3. Patients had at least one COPD exacerbation during 1 year prior to the index date;
4. Patients had at least 2 COPD maintenance medication claims during post index 1 year period, as 2 claims are recommended to calculate adherence.

Exclusion Criteria:

1. Inability to determine diagnoses from claims;
2. Individuals with other chronic respiratory conditions such as respiratory cancer, pulmonary fibrosis, asthma.
Pediatric Obesity Research Registry

The Pediatric Obesity Research Registry will function to collect and catalog historical and medical chart related clinical data of patients presenting with pediatric obesity and who agree to participate.

Individuals between age 1 and 18 years who present to the endocrinology clinic for management of elevated BMI/Obesity (Body Mass Index≥95th percentile of age and gender), will be given the opportunity to read the consent form, have any questions/ concerns addressed prior to obtaining informed consent from the research team (consisting of the PI and the Co-investigators) who are also part of the child's clinical care team. The child's clinician will introduce the study to the parents. The Investigator will obtain written informed consent from the child's parents. The clinical care team/research registry investigators will address any questions and concerns prior to obtaining written informed consent and any future questions and concerns. In this manner, Patients seen at the Phoenix Children's Hospital (PCH) Division of Endocrinology and Diabetes with an obesity diagnosis will be asked to provide their written informed consent to allow their past, current and future identifiable medical record information related to their obese condition to be placed in the Pediatric Obesity Research Registry.

For individuals who respond to Potential advertisement or who contact the research team over the phone, a verbal explanation will be given over the phone and an offer to send a copy of the consent via mail/fax/email, and if interested scheduling a follow up appointment. At the clinic visit, the above noted procedure will be followed.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between age 1 and 18 years who present to the endocrinology clinic for management of elevated BMI/Obesity
* Individuals between age 1 and 18 years who respond to advertisement or who contact the research team over the phone, for management of elevated BMI/Obesity (Body Mass Index ≥ 95th percentile of age and gender)

Exclusion Criteria:

* A Body Mass Index less than 95th percentile of age and gender
The Application Of Lung Ultrasound In Postoperative Hypoxemia Patients

Postoperative hypoxemia was persistent and common after surgery.Rapid diagnosis and subsequent therapeutic measures must be adopted by anesthesiologists.Lung ultrasound has been confirmed to be more sensitive and accurate for diagnosis of pulmonary ailment than chest radiography.The primary objective of the present study was to evaluate lung complications by bedside lung ultrasonography on patients suffered from hypoxemia after general anesthesia in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

- at least 18 years of age, hypoxemia after general anesthesia ( definded as a SPO2 \<92%,greater than 30s)

Exclusion Criteria:

* Covered with surgical dressings from opening thoracic and breast surgery, noncooperate from schizophrenia or delirium, a BMI higher than 40 kg/m2, unstable hemodynamics, dyspnea from residual opioids or muscle relaxants, hemoglobin of 8g/L or less, risk of bleeding, body temperature was more than 38℃ or less than 36℃
Clinical Study of Biostimulation With Low-Power Diode Laser After Dental Extractions

the objective of the present work is to assess the efficacy of photobiomodulation (PBM) with respect to pain, inflammation, and healing after tooth extractions as compared with a sham treatment


Eligibility Criteria:
Inclusion criteria: adult patients who needed tooth extractions for any reason and who signed an informed consent form

Exclusion Criteria:patients who according to the ASA preoperative evaluation, did not meet the medical con-ditions for a surgical intervention. Immunocompromised patients. Patients with decom-pensated systemic diseases; undergoing chemotherapy treatment or taking immunosup-pressants. Pregnant women. Patients with severe mental disorders. Patients who had re-ceived head and neck radiotherapy

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TELEMS: Feasibility of Remote Patient Visits in MS

This trials randomizes patients with multiple sclerosis (MS, pwMS) to a remote visit (via phone or videochat) or a regular outpatient visit. Outcomes include satisfaction on the patients' and doctor's side.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of any type of MS
* own a phone/smartphone/computer
* informed consent

Exclusion Criteria:

* language barriers
Association of Gestational Cardiovascular Health With Pregnancy Outcomes

Pregnancy is a critical period for cardiovascular health risk assessment and interventions to reduce the incidence of cardiovascular disease in both mother and child generations. Recently, the American Heart Association proposed the latest cardiovascular health assessment indicator "Life's Essential 8". However, there is still a lack of application data for pregnant women. This project intends to explore the application potential of Life's Essential 8 in cardiovascular health assessment of pregnant women and establish appropriate gestaional cardiovascular health standards.


Eligibility Criteria:
Inclusion Criteria:

* Maternal age: 20-49 years;
* Natural conception;
* Single pregnancy;
* Plan to have routine prenatal examinations and give birth in the research center;

Exclusion Criteria:

* Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy;
* Assisted reproduction;
* Multiple pregnancy;
* Fetus has a known deformity or genetic defects;
* Incomplete clinical data.
A Study of Cognitive Health in Survivors of Prostate Cancer

The purpose of this study is to collect information that may help the researchers understand the relationship between prostate cancer survivors' experiences of cancer-related cognitive dysfunction (CRCD) and their other conditions (co-morbid factors), including anxiety, depression, and insomnia. The researchers will also find out how additional things may contribute to CRCD, including social factors, the characteristics of participants' prostate cancer, and the type of cancer treatment or other medications they received.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Age 18 years or older
* History of histologically documented PC of any stage
* No evidence of PC Disease

Exclusion Criteria:

* \<1 month since completion of surgery, radiation, chemotherapy, or ADT
* Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder
* Score \>10 indicative of dementia on Blessed Orientation Memory Concentration
A Study of Seltorexant in Healthy Participants

The purpose of this study is to evaluate the bioequivalence of Test 1 and/or Test 2 seltorexant tablet formulations with respect to Reference seltorexant tablet formulation in healthy participants receiving a single dose under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Be healthy on the basis of medical history (screening only), physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day-1 of Treatment Period 1 or prior to randomization
* Be healthy on the basis of clinical laboratory tests performed at screening
* All female participants (regardless of childbearing potential), must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day-1 of each treatment period
* Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2, inclusive (BMI = weight/height\^2), and body weight not less than 50 kilogram (kg)
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (estimated glomerular filtration rate \[eGFR\] less than (\<) 80 milliliter per minute (mL/min)/1.73 per meter square (m\^2) at screening only), thyroid disease, neurologic (including seizure disorders) or psychiatric disease (depression or anxiety disorder in remission and no longer requiring medication is acceptable), infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results. Significant past gastrointestinal medical history, or any disease/surgery that would with interfere drug absorption
* Has any significant or is suspected to have a primary sleep disorder, including but not limited to obstructive sleep apnea, restless leg syndrome, or parasomnias based on history and/or physical exam. Participants with insomnia disorder are allowed if not requiring medication
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, oral contraceptives, and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
* Known allergies, hypersensitivity, or intolerance to seltorexant or its excipients
* Positive test for human immunodeficiency virus (HIV)-1 and HIV-2 antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C antibodies at screening
Enhanced External Counterpulsation in Patients With Fontan Circulation

The purpose of the proposed study is to determine the safety of enhanced external counterpulsation (EECP), a system for compressing the blood vessels in the legs in synchrony with an individual's cardiac rhythm, in clinically well, adult Fontan patients, to document the acute hemodynamic and myocardial effects of EECP on the Fontan circulation, and to demonstrate acute changes in endothelial function after one hour of the procedure.

The investigators plan to study the effects of enhanced external counterpulsation (EECP), on patients who have had Fontan surgery for treatment of complex congenital heart disease. Eligible patient volunteers will undergo a series of biophysical measurements at rest including echocardiographic assessment of ventricular function, pulmonary blood flow/cardiac output measurement using an inert gas rebreathing method (Innocor), and measurements of biomarkers of endothelial function (ET-1, NOx). Patients will then undergo 1 hour of treatment with EECP, during which additional echocardiographic assessment of ventricular function and pulmonary blood flow/cardiac output measurements will be performed at multiple levels of leg compression. Subjects will be assessed periodically for adverse effects and discomfort during the EECP treatment. At the completion of treatment, patients will be allowed 30 minutes to rest before undergoing one more echocardiographic assessment of ventricular function, pulmonary blood flow/cardiac output measurement, and measurements of biomarkers of endothelial function (ET-1, NOx). Measurements made during and after treatment will be compared to baseline measurements.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with Fontan physiology being seen in the Boston Children's Hospital cardiology clinic for outpatient care.

Exclusion Criteria:

* Current pregnancy
* Decompensated heart failure/pulmonary edema
* Severe aortic insufficiency
* Active tachyarrhythmias
* Frequent atrial or ventricular ectopy
* Symptomatic peripheral vascular disease
* Thrombophlebitis or history of deep vein thrombosis or stasis ulcer
* Aortic aneurysm
* Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure\>110 mmHg)
* Systolic blood pressure \<90 mmHg
* Active femoral site bleeding or hematoma
Effect of Three Side Hole Infusion Catheter on CT Image Quality Compared to a Standard Infusion Catheter

The purpose of this research study is to compare two types of catheters used for infusing the contrast dye necessary for viewing internal organs during computed tomography (CT) scanning. The standard catheter, which has one hole from which contrast dye enters veins, will be compared to the Becton Dickinson Nexiva Diffusics System catheter, which has three holes for diffusing dye into veins. The purpose of this study is to determine which catheter type gives the best image.

This will be a prospective, randomized, controlled trial. The catheter is already in use at our facilities. After informed consent, patients will be randomly given the standard or new catheter in our practice. Envelopes with the random assignment will be available to the individuals consenting patients. Randomization generally ensures that study groups are similar on average. As age, sex, and weight impact image quality, we will collect data on these factors in case randomization results in an imbalance. This will allow for control of these factors in analysis of the data. Data will be collected from CT abdomen pelvis examinations within a 6 month-1 year period in 2016 - 2017. Our primary outcome is image quality, measured as tissue density and distribution of contrast within the liver, spleen, aorta and IVC. Our secondary outcomes include Peak Contrast Infusion Pressure and Injection Flow Rate. Possible adverse events for use of any type of catheter include contrast infiltration into the subcutaneous tissues which is a minor limited event. All infiltrations will be recorded as part of the permanent medical record, documented in the chart, and the referring physician notified. The patient will be assessed by a physician immediately and referred to the ED if necessary for further evaluation. Current technology utilizes Power injector equipment which alerts the technologist to the pressure being achieved. If the injection pressure exceeds 325 psi the Power injector automatically shuts off.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing contrast enhanced CT abdomen pelvis examinations at Lyndon B. Johnson General Hospital in Texas
* Patients whose access point is the antecubital fossa
* Patients receiving 20 or 22 gauge catheters for their CT exam
* Patients scanned on two 64 slice CT scanners at the same hospital

Exclusion Criteria:

* patients whose access point is other than antecubital fossa
The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers

The purpose of this study is to study if lidocaine, given intravenously, reduces pain.

Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects. Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adult Volunteers, age \>19 years

Exclusion Criteria:

* History of Substance Abuse
* Coronary Artery Disease (CAD): unstable
* Congestive Heart Failure (CHF): unstable
* Heart Arrhythmia: symptomatic
* Chronic Obstructive Pulmonary Disease (COPD)
* Lidocaine Allergy
* Diagnostic and Statistical Manual of Mental Disorders (Rev IV): Axis I: Common Axis I disorders include depression, anxiety disorders,bipolar disorder, ADHD, and schizophrenia. Axis II: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation.
* Presence of Contraindications for MRI
* Presence of electronically, magnetically, and mechanically activated implants
* Electronically, magnetically, and mechanically activated implants
* Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators
* Cardiac pacemakers
* Metallic splinters in the eye
* Ferromagnetic haemostatic clips in the central nervous system (CNS)
* Claustrophobia
* Pregnancy
Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses

This is a comparative study on the survival and long-term quality of life of Jehovah's witnesses having undergone a cardiac surgery and having refused blood transfusions for religious reasons. This group will be compared with two other groups having no restrictions on this subject.

The purpose of the study is to evaluate the impact of this decision on survival and postoperative quality of life, in the long term.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery with extra corporeal blood circulation
* Informed consent given

Exclusion Criteria:

* Dementia (must be able to answer the questionnaire)
* Control group: refusal of blood transfusions