cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery

The purpose of this study is to test the efficacy and accuracy of the Aquamantys device.

The primary objective of this study is to assess the efficacy of placement and accuracy of the Aquamantys device in 20 patients that require general surgery. High frequency electrosurgery is the application of frequency in the range of 300 kHz up to several MHz in order to coagulate or destroy tissue. Due to technological advancements, knowledge of how frequency and other physical modes interact with biological materials has become increasingly important in order for the surgeon to provide a safe and consistent surgery. The Aquamantys system utilizes radiofrequency energy and saline irrigation for cutting tissue and stopping excessive bleeding.

The Aquamantys system features the following:

1. Cone-shaped electrodes designed to aid blunt dissection;
2. Large bipolar electrode configuration allowing for hemostatic sealing across broad planes of tissue;
3. Bipolar electrodes alleviate the need for grounding pad;
4. Transcollation technology allows for controlled depth of energy penetration.

During surgery, the Aquamantys device will be utilized in order to stop excessive bleeding and to cut vessels. The patient will be monitored by the surgeon and research nurse coordinator before surgery, intra-operatively and post-operatively until discharge from the hospital. The study participant will follow-up post-operatively with the surgeon per standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Indication for general surgery to include: liver resection and pancreatectomy
* Male or females age 18 years of age or older

Exclusion Criteria:

* Indication for emergency surgery
* Suspected inability, e.g. language problems or the inability to comply with trial procedures
* Employee at the investigational center, Sponsor or Sponsor's representative, relative or spouse of the investigator
* Females who are pregnant or breastfeeding
The Effect of Aromatherapy on COVID-19-induced Anxiety

The purpose of this study is to assess the potential for a non-invasive sensory based intervention to reduce the stress associated with a COVID-19 diagnosis.

After being informed about the study, participants who provide consent will be randomized to one of two groups. Participants will receive one of two aromas to inhale with one being active and the other a control comparison.

Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy
* Documented COVID-19 exposure, suspected infection, or diagnosed infection
* Has been tested for or diagnosed with COVID-19
* adults age 18-65 living in the US
* understands and agrees to comply with study procedures
* provides informed consent

Exclusion Criteria:

* Smoker in household
* Pregnant or may become pregnant
* Difficulty breathing
* Pain or pressure in the chest
* Confusion
* Hospitalization
* Asthma, COPD, or other respiratory condition
* demonstrated inability to comply with study procedures
* has participated in an interventional clinical study within 31 days prior to enrollment
Liver Regeneration

The liver is the only visceral organ with a tremendous capacity to regenerate. We don't yet understand how normal liver regeneration occurs (on a molecular level) or how to distinguish between normal and "abnormal"/neoplastic regeneration. This study will characterize the role of the different liver cell types in the regeneration process and will examine gene expression changes in the various liver cell types.

New studies are demonstrating that rodent models of the liver and liver disease are inadequate. The human liver is quite different and needs to be studied directly. The cell expression of human liver cells during regeneration has many implications for treatment of patients with cirrhosis and cancer.

This study will characterize the role of the different liver cell types in the regeneration process and will examine gene expression changes in the various liver cell types. We hypothesize that there is significant crosstalk among hepatocytes, macrophages, and T-cell subsets in the human liver, stimulating the regenerative process.

Tissue will be obtained from serial biopsies of "healthy" liver that is regenerating in patients who undergo liver resection for metastatic colorectal cancer. All participants must first provide written informed consent and meet study eligibility criteria. The first tissue sample will be collected intraoperatively, then serial fine-needle aspiration biopsies (FNAB) will be performed approx. 1 week following surgery, and 1 month following surgery. Liver regeneration will also be assessed using routine imaging of the liver at approx. 3 months.

Retrospective (previously collected diagnostic or biobanked) tissue is also being included for study, given lower than anticipated enrollment.

Eligibility Criteria:
Inclusion Criteria:

* willing and able to provide written informed consent
* No history of liver disease or dysfunction

Exclusion Criteria:

* Patients who receive chemotherapy within the 6 weeks prior to their hepatectomy and/or would be started on active chemotherapy within the first 4 weeks post-hepatectomy.
* Patients requiring long-term anticoagulation
Resistance to Lamivudine in HBV Egyptian Patients

On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

Primarily: To study the correlations between the following parameters in adult Egyptian patients with chronic viral hepatitis B before treatment:

* ALT.
* HBeAg.
* HBV-DNA by quantitative PCR.
* Biopsy (if possible). Secondarily: After receiving lamivudine therapy we will identify the impact of these parameters on viral breakthrough at 1 year of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>18 years old
* Egyptian nationality
* Positive serology for HBsAg for more than 6 months
* Positive HBV viremia (above 2000IU/ml).
* Lamivudine monotherapy

Exclusion Criteria:

* Anti-HBcIgM seropositivity
* Positive serology for HCV
* Positive serology for HDV
* Patients complicated with HCC
Physical Activity as Self-Management Approach to Improve Health Outcomes in AML

Physical Activity as a Self-Management Approach to Improve Health Outcomes in Acute Myeloid Leukemia

Guided by the information-motivation-behavioral skills model and using a quasi-experimental cohort control research design, the primary aim of this study is to: Determine the feasibility of the biobehavioral self management approach (BSMA) program involving physical activity (PA) in patients receiving consolidation treatment for AML. The primary feasibility outcomes for this aim will be rates of recruitment, refusal, retention and attrition; in addition investigators will test methods and procedures of the prescribed BSMA PA program, including assessing adherence, participant acceptance and perceived benefit.

Eligibility Criteria:
Inclusion criteria:

* ≥18 years
* diagnosis of AML
* hospitalized for consolidation chemotherapy within 1 day (+/- 2 days)
* read and write in English
* able to stand independently
* not experiencing psychiatric neurological disorders (assessed through clinical team members) that would prevent obtaining consent.

Exclusion criteria:

* currently experiencing psychiatric or neurologic disorders that would prevent their ability to provide consent.
A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

laparoscopic pancreaticoduodenectomy(LPD) and Robot Pancreaticoduodenectomy (RPD), as two minimally invasive methods of pancreaticoduodenectomy(PD), have obvious advantages over traditional open pancreaticoduodenectomy(OPD) in terms of reducing surgical trauma and hospitalization time, but there are few studies on their perioperative safety and prognostic effects.However, there are few studies on the perioperative safety and prognostic effects of both procedures. In this trial, the perioperative data and prognosis of both procedures were collected and analyzed through a prospective, multicenter approach to investigate the advantages and disadvantages of both procedures.

In this trial, subjects proposed for PD were randomly divided into two groups, LPD and RPD, according to inclusion and exclusion criteria. Patients in both groups were operated and received perioperative management under the same surgical team and were operated according to the standard PD surgical approach. Subsequently, perioperative clinical data and long-term prognostic data of subjects in both groups will be collected and statistically analyzed to explore a better surgical approach.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Preoperative imaging suggested the presence of space occupying in the head of the pancreas, ampullary abdomen, and distal common bile duct tumor lesions to be treated with Pancreaticoduodenectomy
* No distant transfer
* No significant vascular invasion was received

Exclusion Criteria:

* With tumors of other organs
* Patients unable to tolerate anesthesia and operation due to serious abnormalities in functions of heart, lung and other important organs
* Patients found intraoperative peripheral organ metastasis combined with excision of other organs or found intraoperative radical excision could not be performed and underwent palliative drainage surgery or end the surgery
* Preoperative adjuvant therapy was given
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.

This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (60 mg and 90 mg) with that of Lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last up to 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).

Exclusion Criteria:

* Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
* Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
* Use of antacids \[except for study supplied Gelusil®\]
* Need for continuous anticoagulant therapy (Blood Thinners)
* Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
* History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
* Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
* History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
* Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy
XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy

Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity of the Oxaliplatin and 5-FU/LV chemotherapy, in patients with metastatic colorectal carcinomaPrimary objectives : Compare the risk of occurence of grade 3-4 peripheral sensory neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo group ; Compare the response rate between treatment group and placebo group.Secondary objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free survival, overall survival) ; safety profile.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven adenocarcinoma of the colon or the rectum
* age \> 18 years
* WHO performance status : 0,1,2
* Signed written informed consent prior to study entry
* Disease stage : metastatic disease not amenable to potentially curative treatment (eg : inoperable metastatic disease)
* Measurable disease
* No prior chemotherapeutic regimen for metastatic disease ; prior adjuvant chemotherapy allowed (disease free interval from end of adjuvant therapy of at least 6 months)
* Prior radiotherapy permitted, if completed at least 3 weeks before randomization, and if not administered to target lesions identified for the study

Exclusion Criteria:

* Chemotherapeutic agents other than 5-FU/LV or 5-FU/Levamizole as part of adjuvant therapy
* Prior therapy with Oxaliplatin
* History of cardiac toxicities under 5-FU/LV therapy or myocardial infarction within the 6 months before study entry ; Known Dihydropyrimidine Dehydrogenase deficiency
* History of intolerance to appropriate antiemetics
* Concurrent active cancer originating from a primary site other than colon or rectum
* Presence of any symptom suggesting brain metastasis
* Known peripheral neuropathy
* Interstitial pneumonia or extensive and symptomatic fibrosis of the lung
* Allergy to Xaliproden/excipients
Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer

The purpose of this study is to evaluate the effectiveness and safety of albumin bound paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients with advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.
* Male or female.
* Age 18 -75.
* Previous one line of non-taxane chemotherapy for advanced/metastatic disease.
* Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST)
* ECOG Performance status 0, 1 or 2
* Haematological, Biochemical and Organ Function: Neutrophil count \>2.0 × 10 9/L, platelet count \> 100 ×10 9/L. Serum bilirubin\< 1.5 × upper limit of normal (ULN); or, AST or ALT \< 2.5 × ULN (or \< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\< 2.5 × ULN (or \> 5 × ULN in patients with liver metastases,Creatinine clearance \> 60 mL/min.
* Signed informed consent.

Exclusion Criteria:

* No prior chemotherapy for gastric cancer.
* Received any investigational drug treatment within 30 days of start of study treatment.
* Patients with active gastrointestinal bleeding.
* Neurological toxicity ≥ grade 2 NCI-CTCAE.
* Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
* History or clinical evidence of brain metastases.
* Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
* Pregnancy women.
* Subjects with reproductive potential not willing to use an effective method of contraception.
* Patients with known active infection with HIV.
* Known hypersensitivity to any of the study drugs
CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study

This study is to determine if the BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) can facilitate safe and effective placement of a guidewire in the true lumen of coronary vessels distal to a chronic total occlusion (CTO).

The hypothesis is that the BridgePoint Medical System can do this without an increase in major complications.


Eligibility Criteria:
Inclusion Criteria:

* Suitable for coronary intervention
* de novo or restenotic CTO at least 3 months old, in proximal or mid coronary artery segment, 3.0-5.0 mm in diameter
* Mild/moderate proximal vessel tortuosity
* Mild/moderate lesion angulation
* Mild/moderate calcification
* Satisfactory distal vessel visualization
* Mild/moderate side branch interference
* 19 years old
* BMI\<40
* LVEF\>20%
* Signed informed consent

Exclusion Criteria:

* Extensive dissection from guidewire manipulation
* SVG or in-stent CTO
* Aorto-ostial CTO
* Unable to take aspirin, Clopidogrel, or Ticlopidine
* Thrombus/vessel filling defects
* Severe cerebrovascular disease/stroke within 1 month
* Intervention within 2 weeks
* Renal insufficiency
* GI bleeding
* Active infection
* Life expectancy \<2 years
* Significant anemia
* Uncontrolled hypertension
* Severe electrolyte imbalance
* Anaphylaxis to contrast
* NYHA class IV
* Unstable angina requiring intervention
* MI within 2 weeks
* Uncontrolled diabetes
* Participating in another protocol
* Unwilling/unable to comply with protocol
* Angina/ischemia caused by target vessel
Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN Participants

This study investigated whether fosmetpantotenate (RE-024), a phosphopantothenate replacement therapy, was safe and effective in treating participants with PKAN.


Eligibility Criteria:
Inclusion Criteria:

1. The participant had a diagnosis of PKAN as indicated by confirmed mutations in the pantothenate kinase 2 gene.
2. The participant was male or female aged 6 to 65 years, inclusive.
3. The participant had a score of ≥ 6 on the PKAN-specific activities of daily living measure.

Exclusion Criteria:

1. The participant had required regular or intermittent invasive ventilatory support to maintain vital signs within 24 weeks prior to randomization.
2. The participant had a deep brain stimulation device implanted within 6 months prior to screening.
3. The participant had taken deferiprone within 30 days prior to screening.
4. The participant was unable to maintain stable doses of allowed concomitant medications for the first 24 weeks of the study.
Improving Physical Activity Maintenance of Cancer Survivors

Participants enrolled in the BfitBwell Cancer Exercise Program at the University of Colorado Cancer Center will be randomized 1:1 to receive the current BfitBwell program, or BfitBwell plus six, group-based behavior change counseling sessions adapted from BEAT Cancer. We will stratify the randomization based on sex.


Eligibility Criteria:
Inclusion Criteria:

1. current patient at the University of Colorado Cancer Center
2. signed physician clearance to participate in a supervised exercise program
3. participant is actively receiving medical cancer treatment (chemotherapy, radiation or surgery) OR within 6 months of receiving medical cancer treatment.
4. Willingness to be randomized to receive six, PA behavior change counseling sessions as part of the BfitBwell program, and able to attend five out of six of these sessions
Surfactant Levels in the Lungs of COVID-19 Patients

NAME of STUDY: Surfactant levels in the lungs of COVID-19 patients BACKGROUND

* Infection with SARS-CoV-2 may induce respiratory failure.
* COVID-19 associated respiratory failure may require ventilatory support.
* SARS-CoV-2 uses alveolar type II cells for virus replication.
* Alveolar type II cells are responsible for surfactant production and lack of surfactant causes respiratory failure in preterm neonates.
* Lack of surfactant may play role for respiratory failure in COVID-19 patients DESIGN Exploratory prospective study design without therapeutic intervention of any kind. Lung fluid will be donated as part of standard care procedures.

HYPOTHESIS Surfactant is measurable in tracheal secretions by mid-infrared FTIR spectroscopy determined surfactant spectra. Surfactant is reduced in COVID-19 patients requiring ventilator support as compared to non- COVID-19 patients. Dysfunctional surfactant in COVID-19 patients regain its function when respiratory function improves.

POPULATION Main population is patients with COVID-19 pneumonia that requires ventilatory support.

OUTCOME MEASURES Primary outcome is the level of surfactant in lung fluid as obtained by tracheal suction.

SAMPLE SIZE In total 30 patients will be included: twenty COVID-19 patients and 10 non-COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients positive for coronavirus 2 (SARS-CoV-2) AND
2. Respiratory failure requiring mechanical ventilation support OR respiratory failure requiring oxygen supplementation AND
3. Age \> 18 years AND
4. Permission from next of kin

Exclusion Criteria:

Inability to obtain TS or BL as determined by clinical judgement by responsible clinician. Patients with known surfactant dysfunction (such as mutations in the SFTPB or ABCA3 gene). Imminent expected death within 24 hours. Stage 4 severe chronic kidney disease or requiring dialysis. Liver failure. Anticipated transfer to another hospital within 72 hours. Participation in another study which in the opinion of the investigator would prevent enrollment for safety purposes.
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia

The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA \< LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Severe hemophilia (defined as \< 1% factor activity level)
* Infection with the hepatitis C virus (HCV) with underlying hemophilia
* Males 18 years of age and above
* Have not been previously treated with an interferon

Exclusion Criteria:

* Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Chronic liver disease caused by any disease other than chronic HCV infection
* Presence of Bethesda inhibitor
* Current evidence of or history of portal hypertension