cyrilzakka/clinical-trials huggingface dataset:
Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion

Granulation tissue, or excess tissue, forms around gastrostomy tube sites and is a common problem seen in the pediatric surgery population. There is no standard treatment that has been identified in clinical practice to treat granulation tissue effectively. Clinicians prescribe treatments of varying nature to help treat this condition. By conducting this study, the investigators hope to identify if there is any difference in the treatment groups and if there is any superiority for one treatment over the other. The three arms in the study are Silver Nitrate treatment, treatment with Kenalog, and Washcloth abrasion. Treatments will continue over a period of three weeks, and the progress will be followed using surveys and photographs.

Hypergranulation tissue surrounding gastrostomy tube sites in pediatric patients is a significant problem. This tissue may cause drainage or bleeding that bothers patients and parents. Numerous methods of treatment are used for treatment of hypergranulation tissue, but no data exists to support one method of treatment over another. The investigators plan to perform a prospective randomized trial of three different therapies (silver nitrate cauterization, topical kenalog, and soap cloth abrasion) to identify the best treatment modality. Participants will be followed via office visit at four and eight weeks after initiation of therapy. Measurements of the granulation tissue and photographs will be obtained pre treatment and at each post treatment visit. In addition parents will be asked to fill out a pre and post treatment survey regarding improvement in symptoms. Investigators plan to enroll 120 patients total with the intention of having 40 participants in each group.

Eligibility Criteria:
Inclusion Criteria:

* Any patient falling within age group with granulation tissue around G tube site

Exclusion Criteria:

* Patients falling outside of age group range
Efficiency, Safety and Portability of Neovasculgen

In 2010, we completed a phase 1 to 2a clinical trial of pCMV-vegf165 in patients with chronic lower limb ischemia (stage 2a to 3 according to Fontaine classification modified by A. V. Pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. This study demonstrated the safety, feasibility, and short-term(3 months) efficacy of pCMV-vegf165 gene transfer,12,13which lead to conducting a phase 2b to 3 multicenter clinical trial. The study was conducted under the control of the Russian Ministry of Health and was completed in 2011. Patients enrolled in the study were subjected to a 6-month

We conducted a phase 2b/3 multicenter randomized controlled clinical trial of the intramuscular transfer of a plasmid DNA encoding vascular endothelial growth factor (VEGF) 165 with cytomegalovirus promotor (CMV) in patients with atherosclerotic lower limb ischemia. A total of 100 patients were enrolled in the study, that is, 75 patients were randomized into the test group and received 2 intramuscular injections of 1.2 mg of pCMV- vegf165, 14 days apart together with standard pharmacological treatment. In all, 25 patients were randomized into the control group and received standard treatment only. The following end points were evaluated within the first 6 months of the study and during a 1.5-year additional follow-up period: pain-free walking distance (PWD), ankle-brachial index (ABI), and blood flow velocity (BFV).

Eligibility Criteria:
Inclusion Criteria:

* age more than 40 years;
* a history of stable claudication for at least 3 months;
* stage 2 to 3 chronic ischemia according to Fontaine classification (modified by A. V. Pokrovsky);
* presence of hemodynamically significant (stenosis \>70% and/or occlusion) diffuse lesions of the interior and (or) posterior tibial arteries (distal lesion);
* voluntary informed consent signed and dated by the patient.

Exclusion Criteria:

* chronic lower limb ischemia of nonatherosclerotic genesis; stage 4 chronic ischemia according to Fontaine classification modified by A. V. Pokrovsky (ischemic ulcers and necrotic lesions);
* severe concomitant pathology with life expectancy \<1 year;
* infectious diseases, history of cancer, or suspected malignancy;
Use of a Metronome in Cardiopulmonary Resuscitation: A Simulation Study

The purpose of this study is to determine if the use of a metronome improves chest compression rate and depth during cardiopulmonary resuscitation (CPR) on a pediatric manikin.

The study will be conducted in the simulation laboratory at Miami Children's Hospital. Chest compressions will be performed on a compression pediatric simulator. It will consist of two main groups randomly assigned to chest compressions without an audible metronome and chest compressions with audible metronomic tones that beep 100 times per minute for chest compressions. The metronome will be used to coach the correct rate. The same people will complete both arms of the study at one visit. Specifically, the participants will do 2 minutes of chest compressions followed by a 15-minute break then another 2 minutes of chest compressions (to avoid fatigue) with an acceptable range for rate 90-110 BPM and depth of 38-51mm. The subjects will be informed about the metronome, but will not be informed about the measured variables, such as rate and depth of chest compressions. However, the participants will be reminded at the beginning of their visit about the PALS card, i.e. appropriate rate and depth. The use of "talking people noise" from YouTube will be played in the background to fully model a cardiac arrest scenario (to see if participants ignore the metronome) and will be used during each group session. A noise dosimeter will be used to ensure this noise level is the same for each scenario. The manikin's airway will be secured with an endotracheal tube with continuous ventilations so chest compressions can be continued without interruption. Recommendations for chest compression rate and depth are per Pediatric Advanced Life Support (PALS) according to the 2010 American Heart Association (AHA) guidelines.

Data will be collected via the manikin which will wirelessly transmit the data (chest compression rate and depth) to a computer. The manikin has CPR sensing and recording technology software built in. This software records sternum movement depth and rate of chest compressions. Criteria for adequate CPR quality are defined as compression rate between 90-110 per minute and compression depth between 38-51mm.

Eligibility Criteria:
Inclusion criteria:

* health professionals with a minimum of basic life support training according to the 2010 AHA guidelines capable of performing chest compressions.
IL-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction

Remote ischemic preconditioning has proven beneficial in patients undergoing percutaneous coronary intervention and coronary artery bypass surgery. Animal studies suggest remote ischemic preconditioning increases levels of interleukin 10. The investigators aim to determine whether remote ischemic preconditioning results in an increase in IL-10 levels in patients following acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

- Acute myocardial infarction

Exclusion Criteria:

- Cardiogenic shock Active ischemia
Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

The goal of this study is to create new retinal imaging processing software useful for the development of novel retinal biomarkers of cognitive impairment associated with Alzheimer's disease (AD).


Eligibility Criteria:
Inclusion Criteria:

1. Result of the standard neuropsychological assessment
2. Are men or postmenopausal women, at least 55 years of age. Postmenopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years;
3. Fluency in English
4. Participants in mild cognitive impairment (MCI)/prodromal and mild-to-moderate dementia groups must assign a surrogate for purposes of informed consent and help with protocol compliance.

Exclusion Criteria:

1. Known or suspected diagnosis of non-AD, associated dementia;
2. Major ophthalmologic comorbidities: Ruptured globe, retinal vascular occlusive disease, retinal artery occlusion, anterior ischemic optic neuropathy, media opacification due to corneal abnormalities or cataract that prevent ocular and OCT examination, glaucoma, wet (neovascular) age-related macular degeneration, history of intravitreal injections, and macular edema. If two eyes satisfy the inclusion criteria, both eyes will be included in the study.
EVL Plus Drug to Prevent Variceal Rebleeding

Both medications with beta-blockers and isosorbide-5-mononitrate and endoscopic variceal ligation have been proven plausible in the prevention of variceal rebleeding. However, the relative efficacy and safety of the combined treatment for preventing rebleeding remains unresolved.

Bleeding from esophageal varices is a severe complication of portal hypertension. After initial control of acute variceal bleeding, patients still carry a high risk of rebleeding. Of those do rebleed, there is a 20%-35% mortality (1). Therefore, preventive procedures are required in patients surviving an episode of acute variceal bleeding. In recent years, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the management of bleeding esophageal varices (2-3). On the other hand, nonselective beta blockers have been well documented to be effective in reducing variceal rebleeding (4-5). The addition of isosorbide-5-mononitrate (ISMN) has been shown to be even more effective than propranolol alone in the reduction of portal pressure and in the prevention of variceal rebleeding (6). Some studies showed that the combination of nadolol and ISMN is more effective than EIS or EVL in the reduction of variceal rebleeding (7-8). It is still unknown whether EVL combined with nadolol and ISMN is superior to nadolol and ISMN in the prevention of variceal rebleeding. This study was undertaken to compare the effectiveness and complications of ligation plus nadolol and isosorbide mononitrate vs. nadolol plus isosorbide mononitrate for the prevention of variceal rebleeding.

Eligibility Criteria:
Inclusion Criteria:

1. Acute bleeding from esophageal varices (defined below);
2. the etiology of portal hypertension was cirrhosis; and
3. age was between 20 and 75 years old. The diagnosis of cirrhosis was based on pathology, clinical, biochemical, and sonographic or computed tomographic findings. Acute esophageal variceal bleeding was defined as when blood was directly seen by endoscopy to issue from an esophageal varix, or when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified.

Exclusion Criteria:

1. association with hepatocellular carcinoma or other malignancy,
2. association with cerebral vascular accident, uremia, sepsis or other debilitating disease,
3. had history of gastric variceal bleeding,
4. received beta blocker within one month prior to entry,
5. had history of contraindication to the use of beta blockers, such as asthma, heart failure, atrioventricular block, bradycardia (pulse rate \<55/min) or arterial hypotension (systolic blood pressure\<90 mmHg).
6. had history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt), EIS or EVL,
7. deep jaundice (serum bilirubin \>10mg/dl),
8. encephalopathy greater than stage II,
9. failure in control of index variceal bleeding,
10. death within 24 hours of admission, or
11. refused to participate in the trial.
OPTimizing Treatment Focused Genetic Testing IN Cancer

This two-part randomized controlled trial aims to evaluate the impact of pre-test video education as compared to pre-test Chatbot education.

In this research study, the investigators are introducing the option of two alternatives to genetic counseling before genetic testing: Chatbot and video education.

The first part of this research study is a Pilot Study, which is the first-time investigators are examining the use of a Chatbot to deliver pre-genetic test education. The Chatbot will converse with you about germline genetic testing by text message.

The Pilot study will enroll 200 participants with a metastatic breast or ovarian cancer diagnosis and will assess the uptake of genetic testing among the two possible groups of pre-genetic test counseling.

The second part of this research study will utilize findings from the Pilot Study for 1000 participants with a diagnosis of breast, ovarian, pancreatic or prostate cancer.

In both parts of this research study, participants will be randomized to either the video education or Chatbot. Participants may request in-person genetic counseling after their respective education prior to testing.

Other studies at both DFCI and outside institutions have started to investigate alternative methods of educating patients about genetic testing. These studies have suggested that alternatives to standard genetic counseling may increase access to genetic testing with similar satisfaction to standard of care.

The investigators are hoping to get a sense of participants' preferences for pre genetic test education, understanding, and reactions to the alternative methods of genetic counseling. The investigators are also hoping to understand preferences for communication of their result and whether any treatment changes have been made after they receive their result.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over the age of 18
* With a diagnosis of advanced cancer (defined as Stage 3 or 4), or
* Any stage for pancreatic cancer and
* No prior cancer genetic panel testing

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women (if known at the time of participation)
* Prisoners
* Non-English speakers
Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery

This is a prospective randomized study of 114 patients. The purpose of this study is to compare the efficacy of two standard methods of analgesia for pain control in patients undergoing elective colon and rectal surgery, as measured by the Numeric Pain Scale (NPS) and by the need for supplemental narcotic analgesics. This study is designed to determine if postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q Silver SoakerTM catheters (CPA) is equivalent to continuous epidural analgesia (CEA).

Background Perioperative analgesia is a vital part of the management of patients undergoing colon and rectal surgery, affecting well being and length of hospital stay. Neuraxial anesthetics infused through epidural or spinal catheters have become commonplace pain management agents for patients. These techniques, however, are labor-intensive and expensive. Alternatively, local analgesics may be administered directly to the surgical wound via silver catheters.

Aim Two standard methods of analgesia for pain control for colon and rectal surgery will be evaluated systematically to determine if these two approaches are equivalent in terms of patient pain scores and supplemental narcotic use.

Study Design This is a prospective randomized study of 114 participants undergoing elective colon and rectal surgery at an independent academic medical center. The primary outcomes are post-operative pain control and supplemental narcotic usage.

Other variables of interest

* Surgical site infections
* The post-operative time to return of bowel function
* The hospital expenses/cost differences
* Quality of life measured with the SF- 36 questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Age \> = 18 years
* Scheduled for elective colon or rectal surgery
* Surgical procedure either through open laparotomy or via minimal invasive approach (laparoscopic)
* Able to provide informed consent
* Able to complete patient questionnaire

Exclusion Criteria:

* Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl
* Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, etc)
* Urgent surgery precluding epidural catheter placement
* Systemic Infection contraindicating epidural catheter placement
* Unwillingness to participate in follow up assessments
* Prisoners
QIPB in Inguinal Hernia

Inguinal hernia repair is one of the most commonly performed surgical procedures. It is generally performed under regional anesthesia techniques, such as local anesthesia, peripheral nerve blocks, or neuraxial anesthesia (spinal or epidural anesthesia), or under general anesthesia. Despite various available analgesic regimens, numerous studies have demonstrated that postoperative pain control remains inadequate. Opioids, nonsteroidal anti-inflammatory drugs, and analgesics are frequently used for postoperative pain management. However, these medications are associated with uncertain efficacy and undesirable side effects. Pain is a critical factor in the postoperative period, contributing to delayed ambulation and paralytic ileus, ultimately hindering early discharge.

Inguinal hernia repair is one of the most commonly performed surgical procedures. It is generally performed under regional anesthesia techniques, such as local anesthesia, peripheral nerve blocks, or neuraxial anesthesia (spinal or epidural anesthesia), or under general anesthesia. Despite various available analgesic regimens, numerous studies have demonstrated that postoperative pain control remains inadequate. Opioids, nonsteroidal anti-inflammatory drugs, and analgesics are frequently used for postoperative pain management. However, these medications are associated with uncertain efficacy and undesirable side effects. Pain is a critical factor in the postoperative period, contributing to delayed ambulation and paralytic ileus, ultimately hindering early discharge. Recently, Tulgar and colleagues introduced a novel fascial plane block known as the "quadro-iliac plane block". Quadro-iliac plane block is performed within the quadro-iliac plane, located between the inner surface of the iliac crest and the posterior surface of the quadratus lumborum muscle. In their study, Tulgar et al. bilaterally injected 40 mL of methylene blue into the quadro-iliac plane. They observed widespread dye dispersion along the anterior and posterior surfaces of the quadratus lumborum muscle, transversalis fascia, ilioinguinal, iliohypogastric, subcostal, and genitofemoral nerves, as well as the lumbar plexus. Based on these findings, quadro-iliac plane block has been proposed as a potentially effective technique for managing acute or chronic pain in the lumbosacral, abdominal, and hip regions.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years
* Undergoing elective,
* unilateral laparoscopic inguinal hernia repair
* Receiving general anesthesia

Exclusion Criteria:

* Patients who refuse to provide consent
* Patients with contraindications to regional anesthesia
* Patients with impaired consciousness
* Patients with coagulopathy
* Patients with infections at the block site
* Emergency cases
Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer

The purpose of this study is to learn why certain drugs stop working in patients.In lab studies, tumors become resistant in several ways. Specific molecules seem to change and this may be why therapy stops working. However, we do not know if the same molecules change in patients. This study is being done to see if they do change. If we learn more about how patients become resistant, we may be able to offer better treatment in the future.


Eligibility Criteria:
Inclusion Criteria:

All patients:

* Diagnosed with breast cancer.
* Patient must be able to consent to a biopsy
* Patient must be able to safely undergo a secondary biopsy, if needed.

Cohort 1

* Patients who previously received treatment with anti-HER2 therapy (including trastuzumab, pertuzumab, TDM1, lapatinib, neratibin, or DS8201) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer or, patients who previously (or currently) received anti-HER2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced.
* Evidence of disease progression or recurrence after prior therapy (e.g. radiologic progression by RECIST criteria or new metastasis).
* Prior tumor biopsy (may be original) defined as HER2+ by amplification by FISH (\>1.9 gene copy number) or IHC 3+.

Cohort 2

* Patients who previously received treatment with hormonal therapy (including aromatase inhibitors or SERMs or SERDs) as a part of adjuvant therapy and now have progressive or recurrent breast cancer or patients who previously (or currently) receive hormonal therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression.

Cohort 3

* Patients not eligible for Cohorts 1 or 2.

Exclusion Criteria:

* Patients who are unable to consent to a biopsy.
* Patients for whom a repeat biopsy would be medically unsafe
A Study in Cancer Patients to Evaluate the Effect of a Single Dose of NKTR-102 (Etirinotecan Pegol) on the QTc Interval and to Assess Pharmacokinetics and Safety

The purpose of this research study is to evaluate the effect of NKTR-102 on the QT/QTc interval in patients with advanced or metastatic solid tumors

This is an open-label study that will assess the effect of NKTR- 102 on cardiac ventricular repolarization, as characterized by QTcF (QT interval with Fridericia correction) interval values, in patients with advanced or metastatic solid tumors following administration of a single dose of NKTR-102.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic solid tumor refractory to standard therapy
* Measurable or non-measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Resolution of acute toxic effects of prior chemotherapy and other cancer treatments
* Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram
* Adequate bone morrow and organ function
* Electrolytes within normal limits
* Stopped tobacco use for 4 weeks prior to day 1 and during the study
* Agree to use adequate contraception

Exclusion Criteria:

* Previous anti-cancer therapy for malignancy within 4 weeks (6 weeks for the nitrosoureas or mitomycin C) before day 1
* Treatment with antiarrythmic drugs and any medication known to cause QTc prolongation within 4 weeks before screening and during the study
* Prior extensive anthracycline exposure
* Administration of cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks before day 1 and during the study
* Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1 and during the study
* History of serious cardiovascular disease
* Abnormal systolic blood pressure, diastolic blood pressure and/or heart rate
* History of additional risk factors for Torsade de Pointes
* Prolonged QTcF
* Important abnormalities of the ECG that may interfere with the interpretation of QTc interval changes at screening
* Implantable pacemaker or automatic implantable cardioverter defibrillator
* UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1\*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1\*37)
* Any major surgery within 4 weeks prior to day 1
* Concurrent treatment with other anticancer therapy
* Untreated central nervous system metastases
* Chronic or acute GI disorders resulting in diarrhea
* Pregnancy or lactation