cyrilzakka/clinical-trials huggingface dataset:
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

Achalasia is a chronic disease of altered esophageal motility with resulting functional obstruction to the passage of food leading to poor quality of life and significant morbidity. The two main treatments available in the US are endoscopic balloon dilation and surgical myotomy. Each therapy has advantages and drawbacks and at present both are considered a first choice approach depending on patient preferences and local expertise. Surgical myotomy provides long lasting improvement in dysphagia but even when done laparoscopically is invasive and complex. Extensive acid reflux resulting in significant morbidity is routinely seen after surgical myotomy and additional anti-reflux operation is typically done at the time of the myotomy. Endoscopic balloon dilation is a simple minimally invasive outpatient procedure but improvement of symptoms tends to be shorter in duration and repeat dilations are commonly needed. Both therapies improve on dysphagia but tend to provide suboptimal control of chest pain which is one of the cardinal symptoms of achalasia.

The peroral endoscopic myotomy (POEM) was first introduced in Japan to address the suboptimal results with endoscopic balloon dilation and surgical myotomy. POEM is incisionless minimally invasive but in addition may have some further advantages over surgical myotomy including unlimited length of the myotomy with expected better control of chest pain and preservation of the anatomical anti-reflux barrier (angle of His and the cruse of the diaphragm) with expected lower incidence of acid reflux.

In Japan POEM has become the preferred modality for therapy of achalasia due to the excellent results and exceptional safety record. In the US, dedicated POEM devices were approved by the FDA just recently. As a result the bulk of the published data comes from Japan and very little is known regarding outcomes in US population. Therefore the investigators want to prospectively record our experience with POEM as done as part of routine medical care in US population. This will be a data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

Information about the subject's medical history, leading up to the need for an Achalasia treatment, the procedure itself and how the subject does after the procedure, including after the subject gets home, will be collected. This will be done by gathering relevant information from the subject's medical chart and/or by talking with the subject prior to and after the subject's medical procedures. There are no specific study procedures or tests. All information collected is part of the subject's medical care and will be collected even if the subject is not in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Scheduled to undergo POEM treatment

Exclusion Criteria:

* Any contraindication to performing endoscopy
* Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
* The subject is unable/unwilling to give informed consent.
Early Detection of Cardiovascular Disease

The investigators plan to evaluate the correlation between carotid plaque enhancement on Contrast-enhanced ultrasound (CEUS), significant coronary artery disease (CAD), and cardiovascular (CV) outcomes in a systematic manner. The investigators hypothesize that increased levels of CEUS-detected vulnerable carotid plaque will be predictive of CV risk determined by angiography and future cardiovascular events.

Study Design: The investigators will conduct a prospective, single-center, observational study at the Cardiovascular Imaging Network at Queen's (CINQ, www.CINQLab.com). This facility allows a CEUS protocol to be conducted on the same day as the angiogram. It is anticipated that 100 participants can be recruited per month with a total target enrolment of up to 1000 participants.

Objectives

1. To determine the test characteristics (sensitivity, specificity, negative/positive predictive values) of carotid plaque by CEUS (Definity(R)) for predicting significant CAD (≥50% stenosis) in participants referred for angiography
2. To determine the test characteristics (sensitivity, specificity, predictive values) of carotid plaque by CEUS for predicting future CV events, such as death, stroke, myocardial infarction, and cardiovascular interventions.

Eligibility Criteria:
Inclusion criteria:

1. \>18 years of age
2. Outpatients referred for clinically indicated angiography for assessment of CAD
3. Low - Intermediate Framingham risk (\<20%)
4. Absence of clinical contraindication to angiography
5. Able and willing to give informed consent

Exclusion criteria:

1. Patients presenting with acute coronary syndrome
2. Patients with previously known significant CAD (any lesion \>50%) or percutaneous coronary intervention or coronary artery bypass surgery
3. Previous carotid surgery or angioplasty
4. Documented allergy to echo contrast
High Versus Low Bicarbonate Bath in Critically-ill Patients Receiving Continuous Renal Replacement Therapy

Researchers are trying to determine which dialysis solution, low bicarbonate fluid (22 mmol/L) or high bicarbonate fluid (32 mmol/L), is better in subjects with acute kidney injury (acute kidney failure) and metabolic acidosis that are admitted to the intensive care unit and require continuous renal replacement therapy (also known as continuous dialysis).

This is a prospective randomized trial that will be conducted at Mayo Clinic in Rochester Minnesota. It will be based on Good Clinical Practice Standards and performed under IRB supervision. This will be a pragmatic clinical trial due to the nature of the intervention and short interval for making a clinical decision. While dialysis in general is valid in cases of severe AKI and metabolic acidosis, there remains uncertainty as to which replacement fluid to use. In one retrospective study, using high bicarbonate replacement fluid was associated with worse outcomes, even after accounting for several important confounders. While this intervention is valid in cases of severe metabolic acidosis (pH\<7), there has not been much data to support the use of either intervention in cases of any metabolic acidosis in general.

While both interventions are equally valid, to our knowledge, there is no randomized clinical trial evaluating the difference of either intervention on outcomes. There is limited evidence in the literature on benefit or harm associated with either of the interventions on the outcomes thus generating a clinical equipoise. This pivotal study should help guide nephrologists and intensivists on the appropriate prescription of CRRT.

Eligibility Criteria:
Inclusion Criteria

* Adult patients (≥ 18 years of age)
* Ability to obtain informed consent, either from patient or legally authorized representative (LAR)
* Diagnosis of AKI according to KDIGO definition \[an increase in serum creatinine concentration of greater than or equal to 0.3 mg/dL within the first 48 hours of injury, a relative increase in serum creatinine of greater than or equal to 50% (1.5-fold from baseline) within the first 7 days of injury, or a reduction in urine output (\<0.5 mL/kg/h for more than 6 hours)\]
* CRRT initiated for the first time during current ICU admission.
* Bicarbonate ≤ 22 mEq/L
* Arterial pH between 7.05 and 7.25(if an ABG is not available, venous pH must be between 7.00 and 7.20)

Exclusion Criteria

* Pregnancy (women of child-bearing potential must have a negative pregnancy test)
* Diagnosis of End-Stage renal disease and receiving Hemodialysis or peritoneal dialysis prior to ICU admission (this information will be easily obtained by the nephrology team)
* Arterial pH \<7.05 or \>7.25 (if an ABG is not available, Venous pH \<7.00 or \>7.20)
* Potassium level \>6.0 mmol/L
* Severe acute liver failure meeting all the following criteria):

  * INR \>2
  * AST/ALT more than 500 U/L and
  * Bilirubin more than 12 mg/dL)
* Previous enrollment in this study
Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics

Reducing the quantity of morphinomimetics during the operative period reduces the prevalence and intensity of adverse effects.

However, morphinomimetics are indispensable during surgery, as they limit the autonomic nervous system's deleterious reactions to nociception. The administration of these drugs in intravenous boluses during surgery is usually guided by their duration of action and by variations in heart rate and blood pressure. Other events, such as hypovolemia or extreme surgical position, may stimulate the autonomic nervous system outside of nociception. These events, along with routine drug administration, can lead to undue consumption of morphinomimetics.

The Nol index, a multiparametric monitor of nociception, is based on analysis of variations in plethysmography waveform, heart rate and skin conductance. It has been demonstrated that the use of this type of monitor can reduce intraoperative consumption of morphinomimetics and optimize their administration. Does intraoperative morphinomimetic administration optimized by the NOL index have an impact on the occurrence of dose-dependent adverse effects?


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Subject aged ≥ 18 years
* Affiliated with a social security scheme
* Having given written informed consent to participate study
* Admitted for major surgery expected to last more than 2 hours
* Under general anesthesia with tracheal intubation
* For a planned hospital stay of at least 48 hours
* Participant's ability to understand the nature and objectives of the study to comply with study requirements.

Exclusion Criteria:

* Contraindication to one of the drugs used for anesthesia
* Urgent surgery
* Intracranial surgery
* Transplant surgery
* Cardiac surgery
* Surgery with scheduled local anesthesia
* Patient requiring postoperative intubation
* Neuromuscular disease
* Patient chronically using morphinomimetics
* Chronic pain patient
* Patients with a history of sleep apnea
* Conditions likely to interfere with photoplethysmograph signal acquisition or skin conductance (excessive or tremors of the extremities, skin lesions or burns)
* Patients wearing false nails and/or nail polish
* Contraindication to the use of the PMD 200 ™ medical device (including cardiovascular resuscitation and cardioversion/defibrillation);
* Patient with an implanted pacemaker or defibrillator
* Treatment with β-blockers
* Preoperative cardiac arrhythmia
* Pregnant or breast-feeding women. A β-HCG test will be systematically performed prior to inclusion of non-menopausal women menopausal women
* Patients under legal protection (safeguard of justice, curatorship guardianship) or deprived of liberty
* Participation in other interventional research involving an experimental drug or medical device.
Irrigation Endoscopic Decompression

To evaluate a new endoscopic technique for lumbar spinal canal decompression.

104 consecutive patients suffering of neurogenic claudication were included in the study.

Patients were operated using the irrigation endoscopic decompression technique. Mean Follow up was 28 months Primary outcome measures were assessed using the Oswestry Disability Index \[19\] and the modified Macnab Criteria All statistical calculations were done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 15 for Microsoft Windows

Eligibility Criteria:
Inclusion Criteria:

1. Neurogenic claudication or radicular leg pain with or without back pain, and/or a neurological deficit
2. Symptoms and signs correlating with moderate to severe spinal canal stenosis as shown on MRI. (Degenerative and congenital bony stenosis were included)
3. Failure of 3 months conservative treatment
4. Grade I degenerative spondylolisthesis and degenerative scoliosis

Exclusion Criteria:

1. Segmental Instability
2. Lytic Spondylolisthesis

2- Predominant low back pain
Minimizing Complications in Scoliosis Surgery in Children With Cerebral Palsy

Background:

Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of complications and mortality. Complication rates have been reported as high as 45%, and infection rates typically reported at 15%. Efforts to improve efficiency by reducing operative time and blood loss could decrease these risks. The purpose of this study is to investigate the impact of utilizing two attending surgeons on blood loss, operative time, and complications in this population.

Methods:

This is a prospective, matched cohort analysis with a consecutive series of patients with CP who underwent PSF, with two attending surgeons, in 2012. These are matched with a control group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident, PA, or RN-FA. The groups are compared using paired Student T-tests and chi square tests (significance set a p\<0.05).


Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy
* neuromuscular scoliosis requiring posterior spinal fusion (\>50 degree Cobb)
* PSF from 2008-2012 at Phoenix Children's Hospital
* GMFCS IV or V

Exclusion Criteria:

* Diagnosis other than CP
* GMFCS I-III
* Previous spine deformity surgery
Treatment of Common Bile Duct Stones

ABSTRACT Introduction: Common bile duct (CBD) stone is a common clinical situation, especially in Asia area. Laparotomy and laparoscopic surgical procedure are often used for treatment. This study compares outcomes of different surgical procedures treating for the disease.

Methods/design: This is a prospective, randomized, controlled multicenter trial with three treatment arms. One group underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + intraoperative endoscopic nasobiliary drainage ENBD + primary closure of CBD. The other underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP) and subsequent LC and the third arm underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + primary closure of CBD. The duration of the entire trial is two years including prearrangement, follow-up and analyses.

Discussion: Despite the fact plenty evidences provided by meta-analyses suggests that these approaches would appear comparable. It is hopeful to fully address which would be the better approach with this RCT design.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age between 18 - 80 years.
* Patients diagnosed with gallstones.
* Patients diagnosed with common bile duct stone by one of the three exam (US、MRCP and CT).
* Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
* Patients understood the trial and accepted one of the three managements.

Exclusion Criteria:

* Combined with Mirizzi syndrome and intrahepatic bile duct stones
* Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)
* History of upper abdominal surgery.
* Serious heart, brain, lung, metabolic diseases history.
* Pregnant women.
* Unwillingness or inability to consent for the study.
Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine

Regional anaesthesia has become the cornerstone of multimodal analgesia. With the advent of ultrasound guided nerve blocks regional anaesthesia has achieved both greater efficacy and a better safety profile as the injection of local anaesthetic is performed under direct vision. This has allowed a reduction of the amount of local anaesthetic injected as compared to peripheral nerve stimulation technique . Blockade of sciatic nerve combined with saphenous nerve provides anaesthesia and analgesia for ankle/foot surgeries. Various combinations of local anaesthetics have been used to provide optimal blockade . A mixture of lidocaine with a long acting local anaesthetic is commonly used. This provides a rapid onset of blockade, but of a consistently shorter duration compared to a long acting local anaesthetic alone. We hypothesize that sequential perineural injection of lidocaine and bupivacaine provides similar onset but a longer duration of sensory block compared to the same dose and volume of local anaesthetic mixed in advance.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA 1 - 3 status
* scheduled to undergo semi-elective ankle/foot surgery under regional anaesthesia +/- sedation/opioid free general anaesthesia will be recruited

Exclusion Criteria:

* Patients having surgery on the medial aspect of the ankle/ foot
* allergy to local anaesthetics
* coagulopathy
* malignancy or infection in the popliteal area
* significant peripheral neuropathy
* neurologic disorder of the lower extremity
* any other contraindication to sciatic nerve block
* pregnancy
* history of alcohol or drug dependency/abuse (defined as \>40 IU/week)
* a history of significant cognitive or psychiatric disorder that may affect patient assessment
Safety, Tolerability and Effects of L-Arginine in Boys With Dystrophinopathy on Corticosteroids

The purpose of the study is to assess the safety, tolerability, and effects of L-Arginine on muscles in boys with dystrophinopathy on corticosteroids. Specifically, to see if L-arginine reduces muscle signal abnormalities on MRI done pre and post 30 days of L-arginine administration.

Dystrophinopathy is a muscular dystrophy (includes Duchenne or Becker's Muscular Dystrophy) that can be a lethal muscle disorder resulting from defects in the gene for dystrophin, a structural protein required to maintain muscle integrity. Absence of functional dystrophin leaves the muscle membrane vulnerable to damage during contraction. This damage can be exacerbated by an inflammatory response leading to myofiber necrosis.

L-arginine is a widely available dietary supplement amino acid postulated to affect dystrophinopathy in several favorable ways: upregulation of utrophin, vasodilation in muscle via nitric oxide, enhanced synthesis of creatine, increase levels of growth hormone.

We hypothesize that administration of L-arginine may increase levels of creatine and growth hormone and in turn reduce the extent of myofiber damage in our patients with dystrophinopathy

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of diagnosis of dystrophinopathy, documented by clinical exam and dystrophin DNA mutation analysis
* Ambulatory male subjects between the ages of 7-11 years
* Stable dosage of corticosteroids for 3 months prior to entry (Screening/Baseline Day 0) and during treatment period
* Able to follow instructions and give assent
* Able to complete nonsedated MR

Exclusion Criteria:

* Presence of metallic orthopedic hardware in the lower extremity that could affect MRI/MRS measurements
* Routine MRI exclusion criteria such as the presence of a pacemaker, cochlear implant, or cerebral aneurysm clip
* Subjects not capable of cooperating during MR examination
* Known hypersensitivity to L-arginine
* Exposure to another investigational agent, investigational supplements, growth hormone within 3 months prior to entry (Screening/Baseline Day 0) or during treatment period
* Subjects must not be taking L-arginine for at least 4 weeks prior to entry (Day 0)
* Subjects who are non-ambulatory or with daytime ventilatory dependence
A Study for Non-Smoker Patients With Nonsquamous Non-Small Cell Lung Cancer

The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
* Patients must be non-smokers
* Patients must have at least one measurable lesion
* Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale
* Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.

Exclusion Criteria:

* Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
* Patients who have previously received treatment with drugs against the human epidermal growth factor receptors
* Patients who have previously received treatment with drugs which have similar targets as Pemetrexed
* Patients who have any known significant ophthalmologic abnormalities of the surface of the eye
* Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed
Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)

To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting

To assess physical and emotional symptoms of depressed patients

Eligibility Criteria:
Inclusion criteria:

* Meet criteria for major depressive disorder according to the DSM-IV diagnostic criteria
* Outpatients at least 18 years of age
* Sign the informed consent
* All females must test negative for a urine pregnancy test at visit 1. Females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
* Have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study

Exclusion Criteria:

* Are investigator site personnel directly affiliated with the study or immediate family
* Are employed by Eli Lilly and Company
* Have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
* Current substance dependence, excluding nicotine and caffeine
* Treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an MAOI within 5 days after discontinuation of study drug
* Acute liver injury or severe (Child-Pugh Class C) cirrhosis
MRI-changes in Morphometry and Cerebro Spinale Fluid (CSF) Flow in Spinal Cord Disorders

Understanding the onset and progression of spinal cord disorders is an important aim in clinical neurology. An early diagnosis with consequent therapy might prevent the progression of disability. Therefore, we aim to determine structural and dynamic changes in the microstructure of the spinal cord and CSF, and to explore the relationships between the MRI parameters, clinical disability, and electrophysiology.

In some patients that undergo decompressive surgery CSF pressure will be measured invasive perioperative for 24h to find out if functional limitations and structural changes correlate with the spinal pressure and the spinal perfusion when the spinal cord is damaged.


Eligibility Criteria:
Inclusion Criteria:

* Cervical injury
* Informed consent
* Age 18-80
* CSM

Exclusion Criteria:

* No other neurologic disorder and psychiatric disorder
* Seizure
* MRI incompatibility
* Pregnancy