cyrilzakka/clinical-trials huggingface dataset:
Non Contrast CT in Acute Appendicitis

To evaluate Diagnostic accuracy of Non-contrast CT in correlation with ultrasound in diagnosis of acute appendicitis in adults

Acute appendicitis is a prevalent cause of abdominal pain, with an estimated lifetime risk of 7 to 9%.\[1\] Diagnosing appendicitis on CT has a sensitivity and specificity of 87% and 76%, respectively. Classically, diagnosis of acute appendicitis is by identifying an enlarged appendix (greater than 6 mm in diameter) .

Some studies suggest using a cut-off value of over 7 mm to improve the prognostic capability of CT.

On the other hand, appendicitis is regularly diagnosed using radiology studies. In fact, imaging is often the deciding factor between operative and non-operative management. Though the diagnosis can be clinical following a thorough history and physical, imaging is regularly employed to confirm the diagnosis in question. The most commonly used radiographic study is the CT scan, given its speed, sensitivity, and specificity. US is also relatively useful modality to diagnose acute appendicitis, it has its limitations. Ultrasound is highly operator dependent and tends to work best on individuals with less fat and muscle content in their abdomen (i.e., children). Currently, the negative appendectomy is less than 12% in men but can be up to 33% in women; accurate imaging studies could reduce the number of unnecessary surgeries performed on patients. It is, therefore, essential to know which study will provide the clinician with the most accurate information for their specific clinical scenario.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (male or female) with clinical suspicion of acute appendicitis .

Exclusion Criteria:

* pregnant ladies and patients with history of appendectomy
Cerebral Hemodynamics and Oxygenation in Critically Ill Patients

Critically-ill patients frequently experience marked changes in mean arterial pressure and carbon dioxide partial arterial pressure, the two major determinants of the cerebral blood flow. In addition, many therapeutics (fluids, vasopressors or inotropes administration, blood transfusion, prone positioning...) can influence these two determinants of cerebral blood flow and thus cerebral blood flow, especially in patients with altered cerebral autoregulation. Nevertheless, cerebral hemodynamics and oxygenation, as well as the effects of the different therapeutics on it have been poorly studied in critically-ill patients. In addition, it has been suggested that impaired cerebral blood flow and impaired cerebral microcirculation may be involved in the pathophysiology of septic encephalopathy in patients with sepsis and/or septic shock. In this study, we aimed to characterize and investigate the effects of different therapeutics on cerebral hemodynamics and oxygenation in critically-ill patients.


Eligibility Criteria:
Inclusion Criteria :

* Patients under mechanical ventilation and sedated within the first 72h of ventilation onset
* Indication to one of the studied therapeutics left at the discretion of the attending physician Exclusion criteria
* Age \< 18 years
* Pregnancy
* Inability to obtain a Doppler signal
* Medical history or clinical evidence of neurological disease
* Known severe carotid stenosis (\>70%)
* Significant cardiac arrhythmias
* Care-limitation decision.
A Comparison of Factors of Symptoms Generation and Evaluation of Role of Biofeedback in Patients With Different Types of Functional Esophageal Disorders (Functional Heartburn and Functional Chest Pain)

There is supposed that patients with functional esophageal disorders such as functional heartburns and functional chest pain have common underlying mechanisms of symptom generation. These include esophageal dysmotility, non-acidic gastro-esophageal reflux, duodeno-gastro-esophageal reflux, esophageal hypersensitivity, and psychological comorbidity.

The treatment of these patients is the growing challenge in the primary care medicine and in the gastroenterological practice. It was postulated that functional disorders of the esophagus are the main reason for PPI failure in patients with heartburn.

The aim of the study is to evaluate the role of biofeedback in the treatment of patients with functional chest pain and functional heartburns.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women ages 18-75.
2. Willing to participate and sign an inform consent.
3. Having heartburns, acid regurgitations and/or chest pain at least twice a week for at least 3 months.
4. Ability to stop anti-acid and anti-pain medications for at least two weeks.

Exclusion Criteria:

1. History of upper gastrointestinal surgery.
2. Concomitant diseases that may affect esophageal perception (diabetes mellitus, neuropathy).
3. Concomitant medications that may affect esophageal perception (anti-inflammatory, anti-depressants drugs).
4. Pregnancy.
5. Severe conditions such as cardiac failure, renal failure and other that may be contraindication for upper endoscopy.
6. Erosive esophagitis on upper endoscopy or pathological result of ambulatory 24-hour pH monitoring.
Hospital-based Usual cAre Versus Tele-monitoring Rehabilitation

Knee osteoarthritis (OA) is a common, chronic, and costly condition, and patients with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Although outpatient rehabilitation attendance is associated with better functional outcomes, access to rehabilitation care is limited as outpatient rehabilitation is costly and inconvenient for patients and their caregivers, resulting in suboptimal adherence. A tele-monitored home-based exercise program provides the best access to rehabilitation care and is a potential alternative for the majority of patients who do not require intensive "hands-on" rehabilitation therapy.

The primary aim of this non-inferiority randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of an innovative tele-monitored rehabilitation program versus that of currently standard, hospital-based outpatient rehabilitation program among patients post TKR.

Study Hypotheses

Primary hypothesis: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to an 10-week hospital-based rehabilitation at 3 and at 6 months after total knee replacement (TKR) in improving physical function (fast gait speed).

Secondary hypothesis 1: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to a 10-week hospital-based rehabilitation at 3 and at 6 months after TKR in improving knee pain, physical impairments, and health-related quality of life.

Secondary hypothesis 2: A 10-week tele-monitored home-based exercise program will be more cost-effective than the 10-week hospital-based rehabilitation in total TKR-related costs

Approach and Methods

This will be an assessor-blinded, parallel design, non-inferiority randomised controlled trial, with assessments preoperatively(baseline), 3 months, and 6 months after total knee replacement surgery. The protocol conforms to the CONSORT guidelines for non-inferiority randomized controlled trials. Post TKR, all participants will undergo daily inpatient rehabilitation. At discharge, they will be given a standard booklet with advice on ice therapy and home exercises to be performed. Two weeks post TKR, randomization will occur and participants will be randomised to receive either the telemonitored home exercise program or the hospital-based rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Primary unilateral total knee replacement
* Age \>= 45 years
* Willingness to be randomized to either tele-monitored home exercise program or outpatient rehabilitation program
* Ability to provide informed consent

Exclusion Criteria:

* Further lower limb joint replacement surgery anticipated within the next 6 months
* Rheumatoid arthritis and other systemic arthritis
* A previous history of stroke and other major neurological conditions
* An intention to transfer to step-down care facilities post-operatively.
The Utility of Osteopathic Manipulative Medicine in Weaning Patients from the Ventilator Pilot Trial

The objectives of this research are to determine the treatment effect size of OMM to wean patients off of the ventilator, determine the number of patients needed for a larger study (power), determine the willingness of patients/POAs to be recruited, identify the correct dosing of OMM and whether there are concerns for the safety of treatment, and determine whether the hypothesis is feasible for a larger study. The primary outcome measure is the duration of time until a subject is weaned off of mechanical ventilation using Osteopathic Manipulative Medicine (OMM). The secondary outcome measures (see the next section for further explanation) are to determine if OMM affects changes in morbidity and mortality, such as VBG/ABG, NIF, RSBI, P 0.1, FiO2, PEEP, mental status, hemodynamic stability (blood pressure), spontaneous TV, reintubation after extubation, and death.


Eligibility Criteria:
Inclusion Criteria:

1. Acute respiratory failure (hypoxic, hypercapnic, or neuromuscular)
2. Not making satisfactory progress with weaning after being on the ventilator for more than 48 hours
3. Clinical stability for pressure support trial with ventilator to monitor ventilation progression
4. Pulmonology must be following the patient for standardized ventilator management approach and interventions as needed
5. Medical power of attorney (POA) or legally authorized representative (LAR) who is able to consent subject for trial enrollment and treatment
6. Patients who were not referred to the OMM service

Exclusion Criteria:

1. Age less than 18 years old or more than 85 years old
2. BMI\>60
3. Moderate/severe neurological disease with expectation of non-progression off the ventilator or poor quality of life predicted (including end-stage dementia with the expectation of non-progression off ventilator, multiple sclerosis, ALS, anoxic brain injury, etc)
4. Status epilepticus or EEG result pending
5. Post-arrest hypothermia protocol
6. Acute stroke
7. Acute rib fractures preventing the implementation of the treatment protocol
8. Acute spinal injury preventing the implementation of the treatment protocol
9. Recent head injury requiring close clinical monitoring
10. Ejection Fraction less than 15%
11. Pleural effusion requiring procedural intervention or inhibiting ventilator progress
12. Pericardial effusion or tamponade requiring procedural intervention or inhibiting ventilator progress
13. ACLS/cardiac arrest within the past 72 hours
14. Confirmed opioid overdose with positive urine drug screen and response to naloxone
15. Patients who were referred to the OMM service
Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia

The purpose of this protocol is to determine wether the initial protocol in the treatment of subfoveal choroidal neovascularization associated to High Myopia with bevacizumab intravitreal injections is more effective when using 3 doses vs using 1 single dose in the load period


Eligibility Criteria:
Inclusion Criteria:

* Active subfoveal/juxtafoveal choroidal neovascularization in high myopia confirmed by Fundus Fluorescein angiography and Optical Coherence Tomography
* Best corrected visual acuity loss with less than 6 months of evolution, caused mainly by the neovascular lesion (based in investigator´s criteria)
* No atrophy or fibrotic component that may prevent visual acuity improvement
* Patients previously treated with Photodynamic Therapy are allowed to participate in this study
* Signed informed consent
* Signed data protection consent
* Negative pregnancy test in potential childbearing women at screening, with accepted contraceptive method during the whole study

Exclusion Criteria:

* Previous vitreous surgery in study eye
* Tractional maculopathy or epiretinal membrane found in Optical Coherence Tomography
* Media opacities that may prevent correct fundus assessment
* Lack of posterior capsule integrity in pseudophakic patients
* Patients with great possibilities of not being able to attend to study visits / follow visit procedures (investigator´s criteria)
* Patients previously treated with intravitreal antiangiogenic injections
Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Blood Triglyceride

This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Blood Triglyceride.

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting triglyceride profiles before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-80 years with Triglyceride 130-200 mg/dL

Exclusion Criteria:

* Lipid lowering agent within past 6 months
* Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)
* Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)
* Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
* Autoimmune disease
* Diabetes mellitus
* Allergic or hypersensitive to any of the ingredients in the test products
* History of disease that could interfere with the test products or impede their absorption
* Under antipsychotic drugs therapy within past 2 months
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test by show the following results

  * aspartate aminotransferase, alanine aminotransferase \> Reference range upper limit treble
  * Serum Creatinine \> 2.0 mg/dl
* Pregnancy or breast feeding
* Not Contraception(except: Surgery for female infertility)
Pharmacokinetic Study of Raltegravir in Human Immunodeficiency Virus/Hepatitis C Virus (HIV/VHC) Coinfected Patients With Advanced (Child-Pugh C) Hepatic Cirrhosis

Raltegravir is the first integrase inhibitor used in humans. It has been shown to be highly efficacious and well tolerated in phase III clinical trials in multidrug experienced human immunodeficiency virus(HIV)-infected patients, as well as initial therapy in untreated patients. Pharmacokinetic studies in healthy adult subjects indicate that the major mechanism of clearance of the drug is glucuronidation mediated by UGT1A1, with a minor contribution of renal excretion of unchanged parent compound. Unlike CYP-based metabolism, glucuronidation is generally found to be relatively unaffected by hepatic disease. A single dose pharmacokinetic study of raltegravir in patients with mild to moderate hepatic insufficiency (Steigbigel et al. 2008) found no clinically important effect on the drug pharmacokinetic profile, with no dosage adjustment being necessary. The liver safety and tolerability of boosted atazanavir (ATV/r) has been evaluated in human immunodeficiency virus and hepatitis C virus (HIV/HCV) coinfected patients with advanced liver disease (decompensated cirrhosis) (Hermida JM et al. 4th IAS: Sidney, 2007). Similar to Raltegravir, ATV is also mainly metabolized by conjugation through UGT1A1. There is an urgent need for potent and efficacious ARV drugs with a clean safety liver profile even in patients with severe liver disease. The investigators hypothesized that pharmacokinetics will not be altered in HIV/HCV patients with advanced (Child-Pugh grade C) cirrhosis or in those with no histologic liver damage.


Eligibility Criteria:
Inclusion Criteria:

* Adults, clinically stable HIV/HCV coinfected patients on HAART with controlled viremia (\<50 copies/ml) for at least 6 months. HAART will be based on a boosted protease inhibitor (lopinavir, fosamprenavir or darunavir). Hepatic Stability is defined by the absence of new events of descompensation (Child-Pugh score) in the previous six weeks with no data of progressive hepatic insufficiency.
* Liver biopsy performed during the previous year showing no liver damage (F0-F1 in the Metavir score) or by elastometry results ≤ 6 Kpa, to classify patients in group B.
* Liver cirrhosis guided by biopsy (F4 in the Metavir score) or elastometry: results ≥ 14 Kpa, to classify patients in group A.
* Body mass index (BMI) in the range of 19-35 kg/m2.

Exclusion Criteria:

* HBV surface antigen positive.
* Clinical demonstration of a new descompensation event in the previous 6 weeks.
* Alcohol abuse as an average daily consumption \> 20g.
* Treatment with boosted atazanavir, saquinavir or indinavir.
* Concomitant treatment with phenytoin, phenobarbital and rifampinor other UGT1A1 inhibitors.
* Use of any investigational agents (other than ART on expanded access) within 90 days of randomization.
* Active or previous HCV treatment with Ribavirin and /or Peg-interferon if sustained virological response achieved.
* Women taking oral contraceptives
* Pregnancy and lactancy.
Frequency Domain Optical Imaging

This purpose of this clinical study to develop and test technology associated with near infrared (NIR) optical tomography of the breast (the use of light at NIR wavelengths to image the breast) as an adjunct to mammography and breast MRI.

The purpose of this clinical study is to demonstrate the feasibility of NIR absorption and fluorescence imaging of the female breast when the method is guided by breast MRI. The hypotheses to be tested are:

1. MR-guided NIR absorption and fluorescence imaging of the breast is feasible in the setting of a clinical breast exam
2. MR-guided NIR absorption and fluorescence imaging of the breast provides spatial localization and contrast of a breast abnormality that is superior to NIR absorption and fluorescence tomography alone.

Eligibility Criteria:
HEALTHY VOLUNTEERS

Inclusion Criteria:

1. Female, ≥20 years old
2. Breast size and epithelial integrity adequate to allow NIR imaging exams.
3. Ability to provide written informed consent
4. No serious associated psychiatric illnesses.

Exclusion Criteria:

1. Absolute or relative contraindication to MRI:

   1. the presence of an electronic implant, such as a pacemaker
   2. the presence of a metal implant, such as an aneurysm clip
   3. claustrophobia
   4. the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
2. Pregnancy

WOMEN WITH BREAST ABNORMALITIES

Inclusion:

1. Female, ≥ 20 years old.
2. Breast size and epithelial integrity adequate to allow NIR imaging exams.
3. Ability to provide written informed consent.
4. No serious associated psychiatric illnesses.
5. A recent screening mammogram that questions the presence of an abnormality, thus requiring further mammographic examination.

Exclusion:

1. Absolute or relative contraindication to MRI:

   1. the presence of an electronic implant, such as a pacemaker
   2. the presence of a metal implant, such as an aneurysm clip
   3. claustrophobia
   4. the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
2. Pregnancy
3. A history of allergy to iodides
4. A GFR \< 30 ml/min as determined by blood test on the day of NIR/MR imaging, or from lab results within 3 months of NIR/MR imaging.
Effects Rapid Atrial Pacing Has on the Electrocardiogram (ECG) in Patients With Dual Chamber Pacemakers

The purpose of this study is to learn what effect rapid atrial pacing (in patients with dual chamber pacemakers) will have on the electrocardiogram including the QT Interval. The investigators are also interested in the differences caused by genes.

This study requires a total of two study days as well as two follow up visits. During study day one, baseline blood will be drawn, a baseline electrocardiogram will be performed, and continuous QT Interval monitoring will be performed. The pacemaker rate will be increased to 90bpm at different time intervals and additional blood will be drawn to measure the effects of these rates changes.

On study day two, baseline blood will be drawn, a urine specimen will be obtained, an electrocardiogram will be performed, and continuous QT Interval monitoring will be performed. Following the acquisition of this information, the pacemaker rate will be decreased to 80bpm. We will obtain blood specimens, a urine specimen and an electrocardiogram at 30 minutes post rate change and again at 60 minutes post rate change.

Two days following the rate decrease to 80bpm, the patient will return to clinic to have their rate decreased to 70bpm. In two more days, the patient will return for a final rate change to 60bpm.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 21 years old
* Must have a dual chamber pacemaker implanted more than three months ago
* Must be followed by the Vanderbilt University Medical Center's Arrhythmia Device Clinic
* The indication for the pacemaker must not be related to coronary artery disease (CAD) or congestive heart failure (CHF)

Exclusion Criteria:

* Cannot be pacemaker dependent
* History of ventricular arrhythmias and/or implantable defibrillators (ICDs)
* History of paroxysmal, persistent, or permanent atrial fibrillation (AF)
* Congenital long QT syndrome
* History of coronary artery disease
* History of, or currently receiving, treatment for congestive heart failure
* Unable to tolerate dual-chamber pacing (DDD) at 90 bpm due to palpitations, chest pain, shortness of breath, lightheadedness, dizziness, or presyncope
* Pregnant women
* Any patient without specific documentation of an echocardiogram negative for CHF (systolic or diastolic dysfunction)within five years prior to study enrollment
* Any patient without specific documentation of an objective diagnostic test to rule out CAD within five years prior to study enrollment