cyrilzakka/clinical-trials huggingface dataset:
Magnesium Sulfate For Brain Injury

The purpose of the study is to determine whether magnesium sulfate, given within 8 hours of a moderate or severe traumatic brain injury improves survival, decreases the number of people developing seizures, improves the survivors' mental and psychological functioning, including the ability to return to daily life, live independently, and return to work or school.

The purpose of the study is to determine if treating head-injured patients with magnesium sulfate will improve medical, mental, and psychological recovery. In particular, the study will assess each patient's ability to return to daily life, live independently, and return to work or school as done before the head injury occurred. The study will also assess magnesium sulfate's ability to reduce the risk of developing seizures (epilepsy) as well as to improve survival rates after a traumatic brain injury. Patients on the study are assigned randomly (by chance) to either the magnesium sulfate group or the group which gets a placebo. This means they have an equal chance of being in either group. Before the first dose is given, two teaspoons worth of blood are drawn from a vein in the arm. The first dose of magnesium sulfate is 1meq/kg given intravenously within 8 hours of injury. Then a five day continuous intravenous infusion of magnesium sulfate 0.24meq/kg per hour is begun. Daily magnesium levels are checked and the dose changed in order to keep the Magnesium blood level at approximately 4meq/L. If the person does not receive magnesium sulfate, he receives a placebo which looks just like magnesium sulfate but contains no active medication. If the person leaves the hospital before the five days are over, the magnesium or placebo is stopped. Patients on the study will receive a brief exam in person or over the phone at one and three months after the injury to determine whether they have had any seizures and to evaluate how they are functioning and recovering from their head injury. Each evaluation will last about one hour. At six months after the injury, they will have full neuropsychological and psychosocial evaluations done at Harborview. These tests will take about five hours to complete and include tests of vocabulary, problem solving, and coordination. There will be questions about how the injury has affected the way they feel and interact socially. For example, there will be questions about their ability to work, manage personal affairs, what their moods are like, and how anger is handled.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic brain injury with post-resuscitation Glasgow Coma Scale of 3-12 or, if intubated, motor score of 1-5, or who require emergent neurosurgical intervention precluding the accurate assessment of Glasgow Coma Scale.

Exclusion Criteria:

* Injury greater than 8 hours old
* Age under 14 years
* Compromised renal function (creatinine of 2.0 mb/dl or greater)
* Membership in a vulnerable population (e.g. pregnant woman, prisoner, etc.)
* Residence making follow-up unlikely (e.g. lives outside U.S.)
* Refusal to participate
Nodal Upstaging in VATS Anatomical Resections for NSCLC

This study investigates peropeative nodal upstaging during anatomical resections for non-small-cell-lung-cancer in an era of rising numbers of VATS anatomical resections. In case of comparable study groups, unchanged pretreatment staging and equal quality of pathologic examination, lymph node upstaging is a marker of surgical quality and can be used to study the quality of a new surgical technique.

Vats lobectomy is becoming the standard of care for early stage lung cancer. Several studies have shown feasibility and safety in dedicated centres. Compared to thoracotomy the procedure is believed to achieve equal oncologic results and survival, perhaps better.

Publications have shown that mediastianal lymph node dissection during VATS is similar.

However, two recent reports have shown potential lower N1 (hilar and intrapulmonary) upstaging in VATS surgery After optimal staging the percentage of unforeseen N+ the percentage of unforeseen positive nodes can reach 15%

Nodal upstaging at final pathology is dependent on the quality of:

* pretreatment staging, the better, the less upstaging
* surgery, ie mediastinal, hilar and intrapulmonary lymphadenectomy
* pathologic examination If we accept that pretreatment staging and pathologic examination are equal in two comparable surgical cohorts, the finding of unforeseen N+ or nodal upstaging is a quality marker of surgery. When surgical techniques are changing, it is important to look at this marker.

In absence of a randomized trial, we believe a cohort analysis is useful. By including all patients, open or vats, and comparing cohorts instead of the surgical technique used, the selection bias is absent. We compare three cohorts. In the first (20007-2009) almost all patients where operated through a thoracotomy. In a second cohort, (2010-2011) the experience with vats was early. In the third period (2012-2013), a standardized vats technique with extensive intrapulmonary and mediastinal lymphadenectomy was used.

Eligibility Criteria:
Inclusion Criteria:

* All cN0, cN1 patients that underwent segmentectomy, lobectomy, sleeve lobectomy for NSCLC.

Exclusion Criteria:

* cN2
* cM+
* Pneumonectomy
* Previous lung cancer surgery - lymphadenectomy
* Neo-adjunvant therapy
* Lung Tx
* Bilateral lesions
Drug-eluting Balloon in Bifurcations Trial

The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of:

1. Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard balloon prior to the implant of the Liberty Bare Metal Stent in bifurcation lesions (with side branch involvement).
2. Comparison of the results above with the results of using a standard balloon prior to provisional T-stenting with the Paclitaxel-eluting stent TaxusTM LibertéTM.


Eligibility Criteria:
Inclusion Criteria:

* Stable angina pectoris (CCS class 1,2,3,4) or unstable angina and documented ischemia or silent ischemia
* Patients eligible for coronary revascularisation
* The target bifurcation lesion has a major native coronary artery (\>2.5mm) with a stenosis \> 50% (on visual assessment) located at a side branch (\>2mm)
* Patient must be acceptable for CABG
* De novo lesion
* The main vessel lesion can be covered by one stent (up to 32mm)
* Only one target lesion can be included in the study: other lesions in different vessels are successfully treated before the treatment of the target lesion (residual stenosis \<30%, stent well deployed, no residual dissection, normal TIMI flow, no chest pain, ECG unchanged compared to pre-procedural ECG)
* Signed patients informed consent

Exclusion Criteria:

* Patient unable to give informed consent
* Patients with a previous PCI in the target vessel
* Patients with in stent restenosis of target lesion
* Left ventricular ejection fraction more than 30%
* Patients with left main disease
* Severe calcifications with an undilatable lesion during balloon predilatation
* History of bleeding diathesis
* Untreated significant lesion greater than 50% diameter stenosis remaining proximal or distal to the target intervention.
* Patient has suffered a stroke or TIA within the past 3 months
* Life expectancy \< 1 year
* Any major surgery planned or required during the next 6 months
* Acute Myocardial Infarction
* Only one target lesion can be included in the study
* Allergy to contrast and/or required anti-platelet medication
* Patients unwilling to return for follow-up at 6 months
A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.


Eligibility Criteria:
Phase 1 Inclusion Criteria:

* Subjects with advanced and/or metastatic solid tumors who are either refractory to or have relapsed from standard therapies, or for whom a standard therapy does not exist.
* ECOG performance status ≤ 2
* Accessible for treatment, PK sample collection and required study follow-up
* Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 2.5 x ULN

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Subjects with known or suspected brain metastasis, primary brain tumors, or brain as the only site of disease
* Exposure to any investigational agent within 4 weeks of study drug administration
* Subjects a history of gastrointestinal disease
Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin

Primary Objective:

* To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.

Secondary Objectives:

* To evaluate the percentage of patients reaching HbA1c \< 7% or HbA1c ≤ 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
* To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
* To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg).

The study consists of an up to 2-week screening period, a 20-week treatment period, and a 3-day safety follow-up period. Total study duration is up to 23 weeks.

Eligibility Criteria:
Inclusion criteria:

* Chinese patients with type 2 diabetes mellitus, as defined by World Health Organization, diagnosed for at least 1 year at the time of screening visit and inadequately controlled with metformin
* Signed written informed consent

Exclusion criteria:

* Type 1 diabetes mellitus
* HbA1c \< 7% or \> 10%
* Fasting plasma glucose \> 250 mg/dL (\> 13.9 mmol/L)
* Age \<18 years or Age ≥ 80 years
* Patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening
* Patients currently receiving or who have received anti-diabetic drugs other than metformin within 3 months prior to screening

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

Working in partnership with Montefiore-Einstein's Department of Translational Psychiatry, the study team investigators have designed a prospective randomized clinical trial (2:1) study for 45 AIS patients (10-19 yrs.). This protocol includes a baseline assessment of mental health, pain, and function in AIS patients utilizing validated patient reported outcome measures. The investigators will implement and test a structured perioperative psychological intervention program, based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which was developed based on evidence-based cognitive behavioral therapy (CBT) protocols for the management of pediatric pain and childhood anxiety disorders

Working in partnership with Montefiore-Einstein's Department of Translational Psychiatry, the investigators have designed a prospective randomized clinical trial (2:1) study for 45 AIS patients (10-19 yrs.). This protocol includes a baseline assessment of mental health, pain, and function in AIS patients utilizing validated patient reported outcome measures. The investigators will implement and test a structured perioperative psychological intervention program, based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which was developed based on evidence-based cognitive behavioral therapy (CBT) protocols for the management of pediatric pain and childhood anxiety disorders

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of scoliosis prior to age 20
* Healthy, non-obese aged 10-19 years, with a diagnosis of idiopathic scoliosis, undergoing elective posterior spinal fusion

Exclusion Criteria:

* Diagnosis of scoliosis after age 20
* Permanent cognitive impairment
* Pregnant or breastfeeding women
* Use of opioids in the last 6 months
* Liver or renal diseases and developmental delays
Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction

Serotonin and oxytocin play a role in fear conditioning and fear extinction learning, psychological processes that are critically involved in psychiatric disorders such as posttraumatic stress disorder (PTSD). Specifically, administration of oxytocin has been shown to facilitate fear extinction in humans. Similarly, substances that release serotonin and oxytocin such as MDMA have been shown to enhance the extinction of fear memory in animals. However, there are no data on the effects of MDMA on fear extinction in humans. Therefore, the primary aim of this study is to investigate the role of acute serotonin release in the effects of fear extinction. MDMA will be used as pharmacological tool to induce serotonin release in this study.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 18 and 50 years.
* Understanding of the German language.
* Understanding the procedures and the risks associated with the study.
* Participants must be willing to adhere to the protocol and sign the consent form.
* Participants must be willing to refrain from taking illicit psychoactive substances during the study.
* Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
* Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
* Body mass index 18-29 kg/m2.

Exclusion Criteria:

* Chronic or acute medical condition
* Hypertension (\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
* Current or previous major psychiatric disorder
* Psychotic disorder in first-degree relatives
* Illicit substance use (with the exception of cannabis) of more than 5 times or any time within the previous month.
* Participation in another clinical trial (currently or within the last 30 days)
* Use of medications that may interfere with the effects of the study medications (any psychiatric medications)
* Tobacco smoking (\>10 cigarettes/day)
* Consumption of alcoholic standard drinks (\>10/week or \>120 g ethanol/week)
Study of Tadalafil Vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology

The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old.
* Have previously undergone a Fontan Palliation.
* Able to exercise using a supine bike.
* Ability and willingness to provide written consent.
* Undergoing a clinically indicated Cardiac Catheterization

Exclusion Criteria:

* Patients \< 18 years old.
* Current intravenous inotropic drugs.
* Current use of alpha-blockers, pulmonary vasodilators, or nitrates.
* Unable to exercise.
* Pregnancy or lactating.
* Unable or unwilling to consent.
Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children

The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP) and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung functions in asthmatic children patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children (aged ≥ 5 and \< 12 years)
* Partly controlled asthma children according to Global Initiative for Asthma guidelines (GINA)
* Symptomatic asthmatic patients treated with BDP up to 400 micrograms or equivalent
* FEV1 ≥ 60% and ≤ 95% of predicted normal values

Exclusion Criteria:

* Patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever.
* Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks before study entry
* History of near fatal asthma
* History of cystic fibrosis, bronchiectasis or primary ciliary dyskinesia
* Diagnosis of restrictive lung disease.
* Patients treated with systemic corticosteroids
* Significant medical history and/or treatments
"How do Contrast Medias in Bone Cement Affect DXA Measurements After THR"

Joint replacement is a well-documented and cost effective treatment of degenerative diseases in the hip (1,2). There are two different principles of fixation of prosthesis components; cemented and uncemented. The most common mode of fixation in Scandinavia has historically been with bone cement. In the recent years a reverse hybrid combination (uncemented stem and cemented cup) is gaining popularity, especially in Norway.

Beside luxation, infection and venous thromboembolism, the problem with aseptic loosening is a known complication. A marker for aseptic loosening is local bone loss around the components. This is measured with a densiometer and the method is Dual Energy X-ray Absorbtiometry (DXA). Periprosthetic bone loss is evaluated by series of DXA scans around the components over time. This enables us to follow changes in bone mineral density (BMD) close to the prosthesis.

We want to compare cemented and uncemented prostheses with this technique. This is a problem since we don't know how much different contrast medias in bone cement affect DXA scans. This area is poorly investigated. Attempts have been made to exclude the cement-mantle from the measurements both digitally and manually, but these have showed poor precision. A kind of consensus of assuming that contrast medias in bone cement give an increase in measured BMD of 20% (4). This is used when comparing cemented and uncemented components.

We have preformed laboratory tests of different cements. Zirconium oxide (ZrO2) and Barium sulphate (BaSO4) are used as radiopacifiers. These contrast medias have different properties. Our test showed that Zirconium give 63% higher BMD when we scanned cement alone.

This is supported by a cadaver study showing significant differences between contrast free cement and ZrO2 /BaSO4 containing cements.

It is our opinion that it is necessary to perform a prospective study to investigate this more thoroughly.

The hypothesis of this study is that it is not accurate enough to add 20% in BMD for cemented implants when comparing them with uncemented implants. It is probably necessary to take into account the amount of cement used and kind of contrast medium.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis

Exclusion Criteria:

* more than 80 yrs
* systemic disease
Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

All the subjects whom an investigator prescribes the first Detrusitol Capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects intend to treat their overactive bladder who are prescribed Detrusitol Capsule by their physicians.

Exclusion Criteria:

* Subjects who have been prescribed Detrusitol Capsule before.
Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)

This multicenter study aims to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. Up to 130 subjects will complete the study across approximately 5-10 sites in the US, with up to 30 patients in the training phase (3 per site) and 100 patients in the treatment phase of the study. All subjects will have had a CT scan as part of standard of care, confirming at least one solid organ abdominal injury. The study procedure will occur within 48 hours from time of injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The CT and ultrasound scans will be read locally and will undergo central review.

This is an interventional study which proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric trauma patients. Up to 130 subjects will be enrolled across approximately 5 to 10 sites in the US. Each site, including the coordinating center, will undergo the training phase; each site will enroll 3 participants in this phase successfully prior to entering the treatment phase. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury. At conclusion of enrollment of all subjects a centralized review of CT vs. CEUS will occur to compare to real-time readings.

Eligibility Criteria:
Inclusion Criteria:

1. Hemodynamically stable, as determined by the trauma team
2. Age 8 through 18 years (inclusive)
3. Interpretable CT of the abdomen and pelvis that demonstrates at least one solid organ injury among the liver, spleen, pancreas, and kidneys
4. Plan for observation or admission to the hospital
5. Candidate for abdominal ultrasound based on body habitus, as determined by the investigator
6. Glasgow Coma Score of 15
7. Able to complete the study procedures within 48 hours of injury

Exclusion Criteria:

1. Known cardiac abnormality
2. Pulmonary Hypertension
3. Known sensitivity to any Lumason components - including sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
4. Unable to be rolled onto side to allow lateral ultrasound windows if necessary
5. Unable to assent or consent
6. Pregnant
7. Lactating
8. CT images not available for transmission to central image repository
Acute Effect of Agiotensin-(1-7) in Healthy and Hypertensive Subjects

In the modern concept of Renin-angiotensin System, Angiotensin-(1-7) plays a key role and demonstrates promising therapeutic potential due to it is generally opposite effects to Angiotensin II. The aim is to evaluate the effect of Ang-(1-7) acute administration on systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) in healthy and hypertensive subjects.


Eligibility Criteria:
Healthy Group Inclusion Criteria:

* arterial pressure \<140/90 mmHg
* body mass index (BMI) between 18,5 and 29 Kg/m2

Hypertensive Group Inclusion Criteria:

* anti-hypertensive drug treatment
* ambulatory blood pressure monitoring (ABMP) \>130/85 mmHg
* body mass index between 18,5 and 29 Kg/m2

Healthy Group Exclusion Criteria:

* drug treatment
* recent surgeries
* pregnancy
* previous cardiovascular events
* high performance athletes
* dislipidemia
* diabetes
* renal injury
* obesity (BMI above 30 kg/m2)
* alcoholism
* smoking.

Hypertensive Group Exclusion Criteria:

* recent surgeries
* pregnancy
* beta-blockers drug treatment
* previous cardiovascular events
* high performance athletes
* dislipidemia
* diabetes
* renal injury
* obesity (BMI above 30 kg/m2)
* alcoholism
* smoking