cyrilzakka/clinical-trials huggingface dataset:
A Dual Tandem Study - SC vs. CAD-EYE vs. CAD-EYE With G-EYE

Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices:

1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.
3. The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.

Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices:

1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.
3. The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.

Total of up to 372 patients will be randomized,186 to each of the two tandems

Eligibility Criteria:
Inclusion Criteria:

1. Screening and surveillance population for Adenoma and CRC.
2. The patient must understand and sign a written informed consent for the procedure.

Exclusion Criteria:

1. Subjects with inflammatory bowel disease;
2. Subjects with a personal history of hereditary polyposis syndrome;
3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
4. Subjects with diverticulitis or toxic megacolon;
5. Subjects with prior colonic surgery (exclusion appendectomy)
6. Subjects with a history of radiation therapy to abdomen or pelvis;
7. Pregnant or lactating female subjects;
8. Subjects who are currently enrolled in another clinical investigation.
9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
11. Any patient condition deemed too risky for the study by the investigator
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be randomized for treatment with either the TactiCath catheter or another ablation catheter with no contact force sensing capability. Patients will be followed for 12 months to compare the incidence of serious adverse events and freedom from recurring, symptomatic AF between the two study arms. Additional measures of treatment success including quality of life, recurrence of asymptomatic AF and procedural efficiency will also be studied.

A second phase of the study will treat up to 50 non-randomized subjects with a new version of the device under the same protocol.

It has been hypothesized that the ability to create durable lesions during radiofrequency (RF) ablation is directly correlated with a reduction in the recurrence of arrhythmia in patients with paroxysmal atrial fibrillation (PAF). Lesion depth is directly correlated with the contact force measured between the the tip of the catheter and the heart tissue. In this study, patients in whom a pulmonary vein isolation procedure has been prescribed for the treatment of PAF will be randomized for treatment with either a device incorporating contact force sensing or one without.

To be included in the study, patients 18 or older must demonstrate a history of atrial fibrillation and will have failed treatment using antiarrhythmic medications. In both study arms, ablation will be performed using an accepted treatment strategy and standard procedures. Patients will receive routine follow-up for 12 months after the procedure, with the addition of ambulatory monitoring to detect the recurrence of episodes of atrial arrhythmia. The study will compare the effectiveness of the procedure in the two arms, and will characterize any differences in safety outcomes primarily related to complications arising from the use of an ablation device and the ablation procedure.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic PAF refractory to at least one Class I-IV antiarrhythmic drug
* minimum one documented PAF episode \>30 sec duration within prior 12 months
* minimum three PAF episodes during prior 12 months
* 18 years or older

Exclusion Criteria:

* persistent or long-standing persistent AF
* four or more cardioversions in prior 12 months
* MI, CABG or PCI within preceding 3 months
* left atrial diameter \> 5.0 cm
* LVEF \< 35%
* NYHA class III or IV
* previous left atrial ablation procedure
* previous tricuspid or mitral valve repair surgery
Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision

St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.

This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.


Eligibility Criteria:
Inclusion Criteria:

* The patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) device
* The patient is recently (≤2 weeks) implanted with a SJM device compatible with the Merlin.net™ PCN - (inclusive of upgrade from ICD to CRT-D or an implantable pulse generator change)
* The patient has a life expectancy of greater than 12 months (based on the physician's discretion).
* The patient is mentally capable to participate in the investigation (based on the physician's discretion).
* The patient is 18 years of age or older

Exclusion Criteria:

* The patient is being actively considered for cardiac transplantation.
* The patient has primary valvular disease that has not been corrected.
* The patient had a myocardial infarction within the last month
* The patient had unstable angina within the last month.
* The patient has had Coronary Artery Bypass Grafting (CABG) within the last month.
* The patient had a Percutaneous Coronary Angioplasty (PTCA) within the last month.
* The patient is pregnant.
ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study

The purpose of this study is to find out how well ovarian sentinel lymph nodes (SLNs) can be identified with indocyanine green (ICG) dye during risk-reducing ovarian surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing surgery with the Gynecology Service at MSK.
* Women undergoing surgery for an adnexal mass without pre-operative suspicion of high stage disease, with or without a hysterectomy

  °For this protocol, "suspected high stage disease" will be defined as any patient with radiologic or clinical evidence of ovarian cancer which has spread outside of the ovary. Thus, only patients with an adnexal mass, or bilateral adnexal masses, are eligible.
* Women in whom MIS surgery is converted to a laparotomy will not be excluded as both surgical approaches, MIS and open, will be utilized.
* Women \>/= 18 years of age
* Able to provide informed consent
* Albumin levels within normal range

Exclusion Criteria:

* Current non-GYN primary malignancy
* Prior or current history of uterine, cervical, peritoneal, or vulvovaginal malignancy
* Ongoing anticancer therapy
* Prior bilateral oophorectomy
* Known severe anaphylactic iodide allergy
* Known history of cirrhosis or other chronic liver disease, or women with hepatic dysfunction.
* Elevated transaminases (ALT, AST) and/or Alk Phos will be evaluated by the treating physician on a case by case basis.
Reducing Cardiovascular Disease (CVD) Risk in HIV on Antiretroviral Therapy Over 12 Months

This is a cohort study which follows two groups of participants over a 12 months period. One group will access a team approach to care with the aim of reducing their cardiovascular disease (CVD) risks from a team of doctors, nurses and health care professionals. The other group will continue to access standard care from their treating doctor. Both groups will have CVD risk score evaluated after a 12 month period.

The team care approach will involve specific tests to measure CVD risk as well as smoking cessation, exercise and dietary advice and support, including monitoring such as blood pressure and cholesterol levels


Eligibility Criteria:
intervention study intervention arm

Inclusion criteria:

1. Documented HIV-1 infection
2. Age 50 years or older
3. Stable on ART ≥ 3/12
4. Undetectable plasma HIV RNA (\< 50 copies/ml)
5. Moderate or high Framingham CVD risk score
6. Life expectancy \> 12 months
7. Regular patient under care of non-director physician
8. Willing to adhere to pharmacological CVD risk reduction intervention
9. Willing to participate in lifestyle change advice intervention

Exclusion criteria for intervention study

1. Life expectancy \< 1yr
2. Unable to undertake exercise
3. Drug dependency
4. Cognitive impairment affecting ability to participate in study
5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5mI U/ml)
6. Women of childbearing potential who are unwilling to use reliable contraception for the duration of the study

Inclusion criteria for intervention study control arm (Group 2)

1. Documented HIV-1 infection
2. Age 50 years or older
3. Stable on ART ≥3/12
4. Undetectable plasma HIV RNA (\<50 copies/ml)
5. Moderate or high Framingham risk score (\>10%)
6. Life expectancy \> 12 months
7. Regular patient under care of non-director physician
Safety and Efficacy of a Probiotic Supplement

Exercise-induced gastrointestinal dysfunction is common amongst endurance athletes and is characterized by gastrointestinal permeability, also known as "leaky gut." Probiotics have been shown to improve gut permeability through the secretion of mucin, immunoglobulin A and improvement in stability of tight junctions between epithelial cells. This study will determine the efficacy of a probiotic containing the bacterial strains P. acidilatici, CECT 7483, L. plantarum CECT 7484, L. plantarum CECT7485) in altering markers of gut inflammation and dysfunction, and symptoms of gastrointestinal distress.

This study is a randomized, placebo-controlled, double-blinded crossover study where trained runners that experience moderate gastrointestinal discomfort with exhaustive runs will be subjected to the probiotic intervention/placebo supplementation for one month with a one month washout period. The intervention consists of the probiotic strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1 at a dose of 3b cfu/day. Probiotic/Placebo capsules will be taken once daily. Biological samples and symptom data collection will be collected at baseline and after one month of probiotic/placebo supplementation. Data are also collected after an in-house treadmill run after one month of supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Males, females between 18-50 years of age
* Healthy and injury free as determined by screening questions and medical history
* Distance runners as determined by physical activity questionnaire; run = 15 miles/week, run = 3 time or more/week
* VO2max level of = 40ml/kg/min for males or = 35ml/kg/min for females
* Agree to maintain normal diet and exercise routine throughout study
* Agrees to collect stool samples as needed
* Agree to complete questionnaires, records

Exclusion Criteria:

* Women who are pregnant or breastfeeding, or plan to become pregnant during course of the study will not be included as the effect of probiotic on pregnancy and lactation is not established.
* Subjects with a known allergy to the test material (active and placebo)
* Subjects taking NSAIDs, Metformin, probiotics, or supplements that might alter the gut microbiome;these will be assessed individually. (Multivitamin and protein supplementation are allowed)
* Subject that have abnormal test results during screening.
* Alcohol or drug abuse within past year (alcohol can impair gut barrier).
* History of GI surgery within past year as it would alter the gut microbiome (excluding appendectomy and herniorrhaphy).
* Severe heart, liver, kidney, neurological, oncological or psychiatric disease, or immunosuppressed subjects will be excluded.
* Coeliac disease, inflammatory bowel disease or acute pancreatitis (all 3 can impair gut barrier)
* Regular use of antacid medication (can significantly alter microbiota)
* Subject following a low FODMAP (fermentable oligo-, di-, mono-saccharides and polyols) diet will be excluded as this dietary pattern can alter the intestinal response to exercise in some people.
Orthodontic Archwire Comparison Trial

The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi archwires and a recently marketed multiforce version of the same material for the initial alignment and leveling of dental arches, as well as the expression of EARR in adult orthodontic patients.

This is a randomized clinical trial utilizing multiforce and CuNiTi orthodontic archwires to align and level dental arches and compare their results. A three group double blind parallel single site study at IUSD will be used.

Patients that meet the inclusion and exclusion criteria will be recruited from the IUSD orthodontic clinic. The subjects will be randomly assigned to one of the three groups by the study statistician. Subjects, examiners providing subject treatment, and examiners measuring study outcomes will be blinded to treatment assignment.

Study population indicates a sample size of 105 subjects, each group containing 35 clinical subjects.

Patients will be treated with Ormco Titanium Orthos fixed appliances and defined archwire sequence according to a clinical protocol. During the six-month study period, subjects will be seen approximately every 4 (four) weeks for regular standard of care appointments that will include archwire monitoring, photography and questionnaire completions. Final study records will be taken at the end of the study period.

Eligibility Criteria:
Inclusion Criteria:

* Adult \>14yrs of age
* Amenable to treatment with metal brackets
* Crowding of 3-8mm in one or both arches (non-extraction treatment)
* Overbite \>3mm
* Read and speak English without a translator
* Individuals in good general health at the discretion of the investigator(s)

Exclusion Criteria:

* Medical/Dental History (Hx):

  * Documented metabolic disorder(s)
  * Nickel allergy
  * Bisphosphonate treatment
  * Amelogenesis, dentinogenesis or osteogenesis imperfect
  * Active caries or periodontal disease
  * Root resorption (moderate to severe)
  * Patients who are pregnant or breast feeding or plan to be pregnant during the study
A Peri-intubation Oral Intervention to Reduce Oral Flora and VAP

The purpose of this study is determine if a single, early dose of chlorhexidine applied within 12 hours after endotracheal tube insertion will reduce the bacteria in the oral cavity and the incidence of pneumonia in trauma victims.

Pneumonia is the leading cause of death from nosocomial infections. Intubation and mechanical ventilation greatly increase the risk of ventilator associated pneumonia (VAP) which is highest in trauma, burn, neurosurgical and surgical patients. Oral bacteria have been shown to be responsible for the development of VAP since the endotracheal tube provides a pathway for direct entry of bacteria from the oropharynx to the respiratory tract. Therefore, reducing the number of microorganisms in the mouth reduces the pool of organisms available for translocation to and colonization of the lung. The Tri-Service Oral Health Survey showed that military recruits had inferior oral health when compared to their civilian cohorts. Further, oral hygiene is likely to deteriorate in combat situations, increasing oral microbial flora. Intubation of combat casualties in the future will likely be performed in the field by the EMT-B trained combat medic (91W) under adverse conditions. Therefore, interventions to reduce oral microbial flora with intubation are attractive to reduce the incidence of VAP in combat casualties. This study will test the effect of a single peri-intubation oral intervention on oral microbial flora and the development of VAP in traumatic injury. Two hundred trauma patients requiring endotracheal intubation will be randomly assigned to either the intervention or control group over an 18-month data collection period. Data related to oral microbial flora (measured by semi-quantitative oral culture) and VAP (measured by the clinical pulmonary infection score-CPIS) will be obtained on study admission, at 24 (oral culture data only), 48 and 72 hours after intubation. The exact Wilcoxon two-sample one-sided test will be used to test for difference between groups. CPIS data will be compared using an analysis of covariance model. Covariates such as baseline oral culture category, trauma-injury and severity score (TRISS), illness severity (APACHE III) and frequency and timing of usual oral care will also be included. The findings from this study will be the first report of an empirically based peri-intubation oral intervention to reduce VAP and can be easily applied to the care of traumatic injury in both combat and civilian casualties.

Eligibility Criteria:
Inclusion Criteria:

* trauma victim
* endotracheal intubation within the past 12 hours
* mechanical ventilation

Exclusion Criteria:

* diagnosis of pneumonia at the time of intubation
* previous endotracheal tube placement in the last 48 hours
* burn injuries
Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis

Timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography for acute biliary pancreatitis is a controversial issue. There are still many confounding findings offering either early laparoscopic cholecystectomy within 72 hours following endoscopic sphincterotomy or delayed surgery after 6 weeks. Peritoneal plasmin system is known to be an important factor in peritoneal healing and adhesion formation. Measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.

Peritoneal fibrinolysis is crucial in peritoneal healing processes and subsequent adhesion formation. It is expected that endoscopic retrograde cholangiography is a trauma causing adhesions around the hepatobiliary area. Such adhesions may cause some difficulty for consequent gallbladder surgery. For that reason, tissue measurements of factors indicating degree of peritoneal healing and adhesion is helpful for timing of such surgical interventions.

Patients are going to be randomized to early and delayed surgery groups. Sampling of peritoneum around the gallbladder during laparoscopic cholecystectomy in patients after endoscopic retrograde cholangiography is performed. Tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are going to be studied by using commercial assays.

Peritoneal fibrinolytic activity and surgical outcomes are going to be compared.

Eligibility Criteria:
Inclusion Criteria:

* cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis

Exclusion Criteria:

* contraindication to laparoscopy
* unsuccessful endoscopic retrograde cholangiography
* complicated acute biliary pancreatitis
Effects of Denosumab on Bone Fusion in Osteoporotic Patients After Lumbar Fusion

Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative disease. As the population ages, disability associated with spinal pathology and spinal surgery is rapidly increasing and there is a concomitant increase in prevalence of osteoporosis which is a detrimental factor for Lumbar fusion and instrumentation. Osteoporosis-related bone fragility is a primary reason for spinal fusion failure, implant fixation failure, and vertebral compression fractures above or below the fusion sites.

Denosumab is a human monoclonal antibody against RANKL, it inhibits osteoclast mediated bone destruction and has been found to be effective in treating osteoporosis, including reducing bone turnover markers, increasing bone mineral density (BMD), and reducing fractures. But few studies focus on the effects of Denosumab on lumbar fusion. In this study, we include osteoporotic patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. The patients were randomized to either treatment of Denosumab or no treatment. All these patients are followed at 3, 6, 9, 12 months postoperation. During these periods, we detect bone metabolism and bone fusion of these patients. Finally, we would report whether Denosumab can improve bone metabolism and promote bone fusion or not.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of degenerative lumbar diseases with symptoms of low-back pain and/or leg pain for at least 3 months, which was not be adequately controlled by nonoperative treatments.
2. Diagnosis of osteoporosis, defined as a bone mineral density (BMD) at lumbar or femoral neck with 2.5 standard deviations or more below the mean peak bone mass (T scores \<-2.5 SD) measured by dual-energy X-ray absorptiometry (DXA).
3. Patients will be underwent single-level or two-level lumbar interbody fusion.

Exclusion Criteria:

1. Paget disease of bone,
2. Low laboratory tests for calcium,
3. Previous radiation treatment or fusion surgery to lumbar spine,
4. Bone tumors,
5. Bone infection,
6. Acute vertebral fractures
7. Severe spinal deformities such as degenerative scoliosis,
8. Other metabolic bone disease,
9. History of a anti-osteoporosis medication
10. Combined with severe morbidities,
11. Uncorrected bleeding diatheses
12. Application of steroids.