cyrilzakka/clinical-trials huggingface dataset:
Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice

Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive methods. The final surgical treatment is performed after jaundice reduction and normalization of hepatic functions. We suppose that the administration of the drug Remaxol (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid) during the perioperative period shortens jaundice duration and decreases the complications rate.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form.
2. Age from 18 to 70 years
3. Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice.
4. Total bilirubin level in the blood in the range from 102.5 to 246 µmol/l.
5. Jaundice duration according to the patient is not more than 7 days.
6. Scheduled two-staged surgical treatment: 1) common bile duct decompression (endoscopic papillosphincterotomy and endoscopic lithoextraction); 2) laparoscopic cholecystectomy.

Exclusion Criteria:

1. Presence of other pathology causing jaundice syndrome (tumors, constrictions, etc.).
2. Acute cholangitis. Acute cholecystitis. Acute pancreatitis.
3. History of chronic viral hepatitis, hepatic cirrhosis.
4. Other surgical pathology aggravating the condition and/or requiring treatment.
5. Use in the treatment of drugs containing ademethionine.
6. CHF, functional class III-IV according to NYHA.
7. History of chronic kidney disease and/or creatinine level of more than 130 µmol/l.
8. Respiratory failure.
9. Impairment of consciousness.
10. Diabetes mellitus.
11. Psychic diseases.
12. Autoimmune diseases.
13. Tuberculosis, HIV infection.
14. Pregnancy, lactation.
Cerebral Oxymetry in Traumatic Brain Injury

Vasopressor for current treatment protocols for acute traumatic brain injury can lead to vasoconstriction and thus cerebral hypoperfusion that can be detected with cerebral oxymetry as a drop in SCO2.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute traumatic severe brain injury requiring neuro intensive care.
* The patient admitted must be at least 18 years of age and under 60 years.
* Intoxication is not an obstacle for inclusion as we believe this will not affect the recording in relation to our problem.

Exclusion Criteria:

* Traumatic injury in the frontal lobes corresponding to the area where ScO2 monitored.
* Patients in pharmacological studies.
* Patients with severe heart / lung / blood vessel diseases.
Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF

Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization). It is hoped with this novel approach that:

* tumor cells will die due to a loss of their blood supply,
* local inflammatory reactions induced by GM-CSF will kill remaining tumor cells, and
* a systemic immune response against tumor cells may develop.

Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization).

Eligibility Criteria:
Inclusion Criteria:

* Metastatic uveal melanoma in the liver with histological confirmation
* Ability/willingness to give informed consent
* ECOG performance status of 0 or 1
* Adequate renal, liver and bone marrow function

Exclusion Criteria:

* Solitary liver metastasis that is amenable to surgical removal
* Presence of symptomatic liver failure including ascites and hepatic encephalopathy
* Presence of extra-hepatic metastases
* Untreated brain metastases
* Uncontrolled hypertension or congestive heart failure or acute myocardial infarction within 6 months of entry
* Presence of any other medical complication that imply survival of less than six months
* Uncontrolled sever bleeding tendency or active GI bleeding
* Significant allergic reaction to contrast dye or GM-CSF
* Immunosuppressive treatments such as systemic steroids, radiation to pelvis or systemic chemotherapy within 4 weeks
* Previous embolization of the hepatic artery or intrahepatic arterial chemotherapy of liver metastasis
* Active hepatitis with serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) greater than 5 x normal
* HIV infection positive by ELISA
* Pregnancy or breast feeding women
* Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy
* Significant arteriovenous shunt identified on angiography of the hepatic artery
* Occlusion of main portal vein or inadequate collateral flow around an occluded portal vein
Use of Stem Cells Cultured on a Scaffold for the Treatment of Aneurysmal Bone Cysts (ABC)

Patients qualified for this study are those diagnosed with ABCs and failed to be treated with other forms of classical therapies. In which, these patients will be engrafted with biodegradable scaffolds seeded with Mesenchymal Stem Cells (MSCs) supplemented with Platelet lysate.

Aneurysmal bone cysts (ABC) are relatively rare, benign, tumor-like, expansile osteolytic lesions of unknown etiology which are predominantly found within the long bones and characterized by frequent idiopathic fractures. Despite the large variety of bone substitutes that have been used to fill these cystic lesions, to date there is no graft material which can be regarded as completely satisfactory, with a recurrence rate that ranges from 5-40% of treated cases. Autologous bone marrow derived mononuclear cells have been used previously to treat ABCs. Poly lactic-co-glycolic acid (PLGA) scaffolds have been used in bone tissue engineering due to their biodegradability and biocompatibility. Human platelet lysate (PL) contains a number of mitogenic growth factors and has been demonstrated to enhance mesenchymal stem cell (MSC) proliferation and expansion rate in vitro. This study is designed to assess the safety and effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs and supplemented with osteogenic media and platelet lysate in healing bone lesions of patients suffering from aneurysmal bone cysts. This study will be conducted at the Cell Therapy Center (CTC), Jordan. Four ABC cases will be included. Patients qualified for this study are those diagnosed with ABCs and failed to be treated with other forms of classical therapies; such as allografts or who are not candidate of autografts.

Eligibility Criteria:
Inclusion Criteria:

* Bone cyst diagnosed with MRI, CT-scan, or X-Ray
* Intact cyst wall with high risk for fracture
* Cysts with minimum diameter of 6mm
* Diagnostic test performed on cyst fluid
* Diagnosed ABC patients whom treatments with other forms of classical therapies ;such as allograft failed or who are not candidate of autografts
* Provided written consent form

Exclusion Criteria:

* Patients with diagnosis of cancer
* Patients enrolled in other clinical trial
Diabetes Toolkit at Discharge

The purpose of this randomized clinical trial is to implement the DM Discharge Toolkit into hospital discharge and assess the effect of the DM Discharge Toolkit on patients newly requiring insulin.

This study is a randomized controlled trial with a parallel group design of up to 120 study participants in a 1:1 ratio to receive either current standard of care discharge DM training (control) or current standard of care discharge DM training and the DM Discharge Toolkit (intervention) before or immediately after being sent home to assume self-DM care with insulin.

Eligibility Criteria:
Inclusion Criteria:

* English speaking patients
* 18 years of age and older
* Expected survival \>90 days
* Need for new insulin at time of hospital discharge

Exclusion Criteria:

* Patients with the inability to give informed consent
* Non-English speaking
* Not diagnosed with diabetes
* Not been newly prescribed insulin
Latin-American Von Willebrand Disease Registry

Establish a Latin-American network of centers and professionals with the aim of:

* To register VWD patients in retrospective/prospective study, using a database, available online, common to all
* To register the bleeding history, the treatment and the events of VWD patients in the region
* To investigate the influence of VWD on quality of life

von Willebrand disease (VWD) is the most common autosomal bleeding disorder, mostly inherited as dominant trait. VWD is due to deficiency/abnormality of von Willebrand factor (VWF). The prevalence of VWD is unknown, but estimated as 0.1% to 1% of the general population. Although the autosomal inheritance pattern would suggest an equal distribution of male and female patients, the disease is diagnosed in more females because of female-specific hemostatic challenges: menses, ovulation, pregnancy and childbirth. Diagnosis of VWD is made by assessing personal and family history of bleeding, physical examination and completed with specific laboratory tests.

There is limited information on the epidemiology of VWD in developing countries. Some countries in Latin America have registries of severe disease that, although it is the rarest form, carries the highest costs for regional health systems. So that the prevalence of clinical symptoms and laboratory features of the disease as well as the management of the disease in Latin America is unknown.

The present project aims to establish a network of centers and professionals with the objective to register and investigate all patients with VWD in Latin America, using a database available online common to all, to gain understanding about phenotype, genotype and management of VWD in the region.

Eligibility Criteria:
Inclusion Criteria:

* Historically lowest VWF:Ag and/or VWF:RCo and/or VWF:CB \< 0.50 IU/ml and/or FVIII:C \< 0.50 IU/ml
* All types of VWD
* All ages

Exclusion Criteria:

* Patient without consent to participate
Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis

The purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized patients. Factors taken into account are clinician and patient satisfaction with the insertion system, patient satisfaction with voice, speech, performance, and maintenance. Voice and speech will also be evaluated for the different prostheses by means of perceptual evaluations and acoustic analysis.


Eligibility Criteria:
Inclusion Criteria:

* Total laryngectomy
* Use Provox ActiValve

Exclusion Criteria:

* Current problems with TE puncture
Lipid-lowering Effects of Gefarnate in Statin-treated Coronary Heart Disease Patients With Residual Hypertriglyceridemia

Dyslipidemia is an independent risk factor for cardiovascular events. Statins have become the cornerstone for the prevention and treatment of atherosclerotic vascular diseases. However, after the comprehensive control of the traditional risk factors, including unhealthy lifestyle, hypercholesterolemia, hypertension, hyperglycemia and obesity, there is still a high risk of residual cardiovascular disease in patients with dyslipidemia. Triglyceride elevation is the most common type of dyslipidemia and constitutes an important component of cardiovascular residual risk.

The geraniol has a variety of pharmacological effects, such as anti-inflammatory, antioxidant, regulating cell apoptosis. Recent studies have confirmed that geraniol plays an important role in regulating glucose and lipid metabolism, and may have a synergistic role with statins. Gefarnate Tablets is a kind of anti-ulcer and gastritis treatment. It can increase the defense ability of gastric mucosa by improving the prostaglandin level and the concentration of amino hexose in the gastric mucosa. Geraniol is the main components of Gefarnate Tablets. In the previous study, the investigators found that geraniol induced autophagy through the SIRT1-AMPK-mTOR pathway and accelerated the degradation of triglycerides in liver cells, thus reducing the level of triglyceride in the serum of high fat diet mice. 6 patients with hyperlipidemia were received Gefarnate Tablets (100mg/ times, 3 times per day). A month later, the levels of serum triglyceride, total cholesterol, and low density lipoprotein cholesterol were decreased significantly. However, the above results need to be confirmed by the larger clinical research.

Therefore, the aim of this study is to evaluate the effect of Gefarnate Tablets on blood lipid levels in patients with hypertriglyceridemia and coronary heart disease treated with statins, provide more options for the treatment of lipid lowering treatment, reduce the risk of cardiovascular remnant, and improve the long-term prognosis of the coronary heart disease patients with residual hypertriglyceridemia.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease
* Treatment with statins for more than 1 month
* Plasma triglyceride level more than 1.7mmol/L

Exclusion Criteria:

* Atherosclerotic cardiovascular disease (ASCVD) patients with high risk
* Patients with active liver disease or unexplained elevated levels of aminotransferase
* Patients with prostatic hypertrophy or those with prostaglandin drugs such as glaucoma
* Creatinine clearance \< 30ml/min
* an allergy to any component of Gefarnate Tablets or statin
Direct Resuscitation of the Open Peritoneum

The DROP trial evaluates two ways of treating patients whose abdomens are left open after their abdominal surgery. The current standard of care at Sanford is for patients to have their wound covered with a sterile dressing connected to a vacuum with suction, which removes fluid from the abdomen. In this trial, we are evaluating the benefits of adding dialysis fluid to the abdomen periodically, prior to suctioning it out with the vacuum system. This trial will show if the addition of this fluid lowers the risk of complications and death, and allows the surgeon to close the abdomen sooner


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Have index operation performed by one of the Trauma and Acute Care surgeons at Sanford Medical Center Fargo
* Require an open abdomen due to a non-traumatic cause and placement of an Abthera™ wound vacuum
* Cognitively impaired adults will be included if a Legally Authorized Representative is available to provide informed consent.

Exclusion Criteria:

* Patients under the age of 18
* Vulnerable populations such as pregnant women and prisoners
* Patients with open abdomens as the result of trauma
* Non-English speaking (Due to time constraints pre-operatively and the length of time necessary to secure translation services, non-English speaking patients will not be enrolled).
Active Surveillance in Prostate Cancer, Imaging to Detect Radiographic Progression as an Endpoint (ASPIRE)

The objective in this study is to determine if MRI-identified progression can decrease frequency or need for repeated prostate biopsy in men on active surveillance (AS).

Our hypothesis is that MRI alone is adequate to detect progression of prostate cancer in men on active surveillance (AS) after a MRI-US fusion prostate biopsy.

MRI Fusion prostate biopsy will transform Active Surveillance (AS) for men with low risk prostate cancer. Treatment for prostate cancer, usually surgical removal or radiation delivered to the whole prostate, is associated with significant morbidity including incontinence and impotence.

The goal of this and future research is to maximize the effectiveness of prostate imaging in order to minimize the morbidity of prostate biopsy and hence improve the quality of life of patients with prostate cancer. There are many applications to improved imaging of prostate cancer, but several the investigators are interested in include: improved risk stratification to limit unnecessary treatment while providing appropriate treatment to prevent progression; limiting the number of biopsies needed for diagnosis and/or decreasing the frequency of biopsies and hence decreasing biopsy-related morbidity; focal therapy for confirmed focal disease rather than treating the entire prostate in order to limit the significant morbidity associated with whole-gland treatment.

This is an investigator-initiated, multi-center, prospective observational phase II trial evaluating MRI to detect prostate cancer progression in patients with low risk prostate cancer on Active Surveillance. The two centers involved will be the Yale-New Haven Hospital Smilow Cancer Center (Yale) and the VA Connecticut Healthcare System (VACT). The Yale School of Medicine will serve as the central data-coordinating center for this study.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-80
* Completed MRI Fusion prostate biopsy either in the past that demonstrated Gleason 6 prostate cancer and are either currently enrolled in Active Surveillance or are interested in Active surveillance, or have completed an MRI Fusion prostate biopsy at the first visit that demonstrates Gleason 6 prostate cancer and are interested in Active Surveillance
* Diagnosed with Gleason 6 prostate cancer
* PSA \<20
* \<cT3 prostate cancer
* Ability to receive an MRI with IV gadolinium contrast
* Life expectancy \>10 years (by physician estimate)
* Understanding and willingness to provide consent
* English speaking

Exclusion Criteria:

* Received treatment for prostate cancer (hormone manipulation, surgery, radiation).
* Known metastatic disease
* High risk prostate cancer by Epstein Criteria
* Any Gleason 7 or higher prostate cancer on prostate biopsy
* Inability to receive an MRI with IV gadolinium contrast
* Life expectancy \<10 years
* Unwillingness to undergo monitoring and imaging studies
* Non-English speaking
Evaluation of Patients With Unusual Diagnostic or Treatment Considerations

This study offers evaluation and treatment of patients with unusual diagnostic or treatment considerations. It is not designed to test new treatments; rather, patients will receive current standard of care treatments. The purposes of the study are: 1) to allow NIDCR staff an opportunity to maintain and improve their clinical skills; and 2) to evaluate referred patients for research potential. (Participants in this protocol will not be required to join a research study; the decision will be voluntary.)

Patients in need of dental/oral diagnosis and therapy of interest to NIDCR staff dentists may be eligible for this protocol. Participants will have a comprehensive dental examination and may receive part or all of their treatment at the NIDCR clinic. Diagnostic procedures, materials and treatments used in this study are limited to those widely accepted in dentistry and are non-experimental in nature.

The proposed pilot project will allow the staff of the Dental Clinic Oral Medicine Fellowship Program to accept patients, for diagnosis and conventional therapy, which do not otherwise meet the criteria for any of the current NIDCR research protocols. This clinical examination and therapy by Dental Clinic practitioners will provide an excellent forum for the observation of oral conditions and phenomena that may generate scientific inquiries and provide valuable educational experiences consistent with the goals of the Oral Medicine Program.

Eligibility Criteria:
Patients in need of dental/oral diagnosis and therapy which are of interest to one or more of the staff dentists.
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued in Subjects in the US Only

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the US only.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
* A gastric ulcer \>= 5mm in diameter, but no ulcer \>25 mm at its greatest diameter, at the baseline endoscopy.
* Other key inclusion criteria, as specified in the protocol.

Exclusion Criteria:

* History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
* History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
* Many other conditions and criteria, as specified in the protocol.
Feasibility and Efficacy of Portable Non-invasive Negative Pressure Ventilation in Fontan Patients

The human heart has 4 chambers: 2 collecting chambers (atria) and 2 pumping chambers (ventricles) to allow blood flow within two distinct circuits: "pulmonary" and "systemic". The pulmonary circuit directs the blood to the lungs to receive oxygen and the systemic circuit delivers oxygen-rich blood throughout the body. In children born with a single ventricle, blood from these two circuits mixes within the heart resulting in lower oxygen levels in the blood delivered to the body (cyanosis).

The Fontan procedure is a palliative surgery which bypasses the need for a ventricle to deliver blood to the lungs, as blood from the body flows passively to the lungs by a man-made connection (whereby two large body veins \[cavae\] are sewn to the pulmonary arteries), thereby preventing mixing of blood through restoration of two distinct circuits without mixing of blood. Although the Fontan operation effectively eliminates cyanosis and enables survival into adulthood, increased systemic venous pressure is an unavoidable systemic complication and low cardiac output (CO) is pervasive finding.

Despite excellent pediatric surgical results, the risk of late complications and death dramatically increases in the decades following Fontan surgery. A chronically low CO state secondary to decreased forward flow of blood to the lungs can result in end-organ dysfunction and shortened life expectancy. Short of heart transplantation, deemed suitable only for a minority of patients, effective therapies for low CO are largely absent. The investigators aim to investigate a novel, non-invasive, ambulatory therapy which can augment CO. Specifically, external suction is applied intermittently to the chest wall, much like a vacuum, to increase CO, called negative pressure ventilation (NPV) using a Cuirass® ventilator (Hayek Medical). Although used in patients with lung disease, the investigators' proposal is to evaluate this novel, portable, ventilation system would be the first study of its kind in adults with congenital heart disease, specifically those with a Fontan palliation.


Eligibility Criteria:
Inclusion Criteria:

* Fontan patients age \> 13 years.

Exclusion Criteria:

* unable to complete MRI (pacemaker/defibrillator/retained wires, pregnancy, claustrophobia);
* evidence of Fontan failure (requiring ongoing medical / device therapy) protein-losing enteropathy, intracardiac thrombus, anatomical obstruction to the Fontan circuit;
* patent Fontan fenestration;
* oxygen saturation \< 90%;
* ongoing arrhythmia;
* ejection fraction \< 50% on echocardiography or CMR;
* moderate or severe valve insufficiency on echocardiography or CMR;
* Obesity (BMI \>35);
* severe obstructive sleep apnea (AHI\>20);
* chronic obstructive lung disease (FEV1/FVC\<60%);
* severe chest wall deformities (scoliosis, kyphosis, kyphoscoliosis);
* acute or chronic kidney disease (eGFR\<60)
* unable to provide informed consent.