cyrilzakka/clinical-trials huggingface dataset:
L-Menthol Injection as a Novel Technique During Colonoscopy

The primary objective of this double-blinded, prospective, randomized placebo-controlled study is to evaluate for change in endoscopic adenoma detection rates (ADR) with the use of peppermint oil solution vs placebo application during colonoscopy. The investigators hypothesize that ADR will be increased with the use of the peppermint oil solution and thus further reduce the risk of colon cancer by means of colonoscopy.

Adult subjects who are undergoing colonoscopy for primary colorectal cancer screening or surveillance. The study will be carried out as a prospective, double-blinded, fully-masked randomized controlled trial. Prior to the trial entry, the participant's labs and medical record will be reviewed in the electronic records system. If the subject meets inclusion/exclusion criteria, he or she will be consented at bedside prior undergoing their scheduled procedure and receive standard care as otherwise. Experimental and placebo solution ingredients will be serially numbered and randomized in a 1:1 ratio using a variable block strategy and provided by the institutional investigational pharmacy. Research staff will draw up experimental or placebo solution in 4 syringes with a total of 20mL in each solution.

The solutions are identical in appearance and endoscopic delivery. To prevent olfactory detection of the peppermint oil solution an essential oil diffuser will be used in all endoscopy rooms using the same oil as in the experimental solution. Endoscopists will be instructed to deliver the contents of one syringe sprayed via the endoscope in the cecum and one in the sigmoid colon. The contents of the other two syringes are to be delivered at the discretion of the endoscopist. After the procedure, endoscopists and study participants will be surveyed to determine if blinding was effective and to assess patient comfort levels, respectively. The primary and secondary end points will be determined on an intention to treat basis.

Eligibility Criteria:
Inclusion Criteria:

1. At least 50 years of age in Caucasians or 45 years of age in African-Americans.
2. Patients undergoing primary screening colonoscopy (either average risk or increased-risk) or surveillance colonoscopy after prior screening/surveillance colonoscopy.
3. Capable of understanding instructions, adhering to study schedules and requirements, and willing to provide informed consent.

Exclusion Criteria:

1. History of colectomy, partial or complete
2. Symptoms suggesting possible colorectal stenosis or cancer
3. Inflammatory bowel disease
4. Familial polyposis syndromes
5. History of, or current diagnosis of colorectal cancer
6. American Society of Anesthesia Physical Stats (ASA PS) score of IV or greater
7. Non-correctable coagulopathy
8. Currently receiving anti-thrombotic therapy, with an INR \> 1.5
9. Poor prep, total BBPS score \< 6, or any part of the colon \< 2.
10. Patients with known allergy to peppermint oil or peppermint containing products.
11. Patients taking calcium channel blockers (Amlodipine, Nifedipine, Verapamil, Diltiazem, Dihydropyridine, Felodipine, etc).
Diamond Bur Microblepharoexfoliation, Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye

The goal of this clinical trial is to assess the efficacy and safety of microblepharoeexfoliation (MBE), intense pulse light (IPL) and meibomian gland expression (MGX) combination in patients with meibomian gland dysfunction (MGD).

The main question it aims to answer are:

* Does MBE-IPL-MGX treatment improve dry eye symptoms?
* Does MBE-IPL-MGX treatment improve dry eye signs?

Participants were assigned to receive either three sessions of MBE-IPL-MGX treatment and home-based therapy (treatment group) or home-based therapy alone (control group).

The investigators will compare both groups to see if MBE-IPL-MGX treatment is superior to home-based therapy.

MBE is a novel in-office treatment that works by exfoliating the eyelid margins to remove the accumulated biofilm debris, epithelial keratinization and capped meibomian glands, resulting in better meibum outflow . Different studies have shown that MBE improves DED symptoms \[1,2\], demodex blepharitis \[1-4\] and meibomian gland function \[2,3,5\] In addition, meta-analyses recommend combining IPL with meibomian gland expression (MGX) compared to IPL or MGX alone \[6-8\]. However, the investigators have not found any studies evaluating the benefits of MBE combined with IPL and MGX.

Consequently, the purpose of the current study is to evaluate whether MBE combined with IPL and MGX leads to an improvement of symptoms and signs in patients with DED due to MGD.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. DED diagnosis according to DEWS II meeting one of the following conditions: (2.1) ocular surface disease index (OSDI) score ≥ 13; (2.2) NIBUT \< 10 seconds; and (2.3) ocular surface staining with \> 5 or 9 corneal or conjunctival stains, respectively.
3. MGD diagnosis according to the international workshop on MGD meeting two of the following conditions: (3.1) irregularity of the eyelid margin or mucocutaneous junction; (3.2) vascularity of the eyelid margin; (3.3) plugged or capped Meibomian gland orifices; (3.4) Meibomian gland atrophy; or (3.5) decreased meibum quality and quantity

Exclusion Criteria:

1. Skin pathologies that prevent IPL treatment
2. All corneal disorders that affect diagnostic tests, such as: (2.1) active corneal infections; and (2.2) corneal dystrophies.
3. Active ocular allergy.
4. Pregnant or lactating women..
5. Patients who did not understand or comprehend the informed consent.
The Role of Platelet TLRs in Platelet Activation During VTE

Venous thromboembolic disease (VTE) is a frequent and potentially serious pathology. Therapeutic management has improved considerably over the last few decades, enabling the application of codified management in line with the recently updated French management recommendations.

One of the main remaining difficulties concerns VTE sequelae, mainly post-thrombotic syndrome after deep vein thrombosis, and post-pulmonary embolism syndrome after pulmonary embolism. The mechanisms leading to the absence of complete repermeabilization of vessels affected by Venous thromboembolic disease (VTE) are still poorly understood.

The concept of immunothrombosis, closely associating immunity, inflammation and thrombosis, could (in part) explain the appearance of these sequelae. Platelets appear to play a key role in the onset of sequelae: Platelets are known to be involved both in the onset of a VTE episode and in the inflammatory response. This involvement is illustrated by the expression of inflammatory receptors such as TLR (toll-like receptor) 2 and TLR4.

Th aim to investigate the role of platelets in the occurrence of sequelae, mainly via their role in the inflammatory response, in Venous thromboembolic disease (VTE) patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Venous ThromboEmbolic (VTE) / Proximal Deep vein thrombosis (DVT) of the lower limb and/or pulmonary embolism ≤ 72heures
* Patients are 18 years of age or older at diagnosis.
* Patients received informed written consent
* Patients benefiting from social security coverage

Exclusion Criteria:

* Diagnosis of Venous ThromboEmbolic (VTE) more than 72 hours old
* Isolated sub-segmental pulmonary embolism
* Patients on antiplatelet agents
* Patients on non-steroidal anti-inflammatory drugs (NSAIDs)
* Life expectancy \> 3 months
ML Models for Predicting Postoperative Peritoneal Metastasis After Hepatocellular Carcinoma Rupture

This study aimed to address the issue of peritoneal metastasis (PM) following the rupture of hepatocellular carcinoma (HCC) and its adverse impact on patient prognosis. Clinical data from 522 patients with ruptured HCC who underwent surgery at seven different medical centers were collected and analyzed. Machine learning models were employed for analysis and prediction.


Eligibility Criteria:
Inclusion Criteria:(1) HCC confirmed by pathologists (2) two preoperative imaging findings suggestive of tumor rupture (3) R0 resection (4) first tumor detection -

Exclusion Criteria:(1) previous antitumor therapy (2) combination of other types of tumors (3) incomplete clinical data

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Mindfulness Based Stress Reduction App for African American Caregivers (MBSR)

The study investigators are developing and testing a mobile-friendly web-based app that contains features related to mindfulness and reducing stress for African American informal caregivers of people with chronic conditions. The purpose of the app is to help a vulnerable population reduce stress by learning and practicing mindfulness activities.

For Aim 1, the study investigators conducted 10 formative interviews with African American caregivers and key informants to elicit recommendations for features to be included in the app as well as feedback on preliminary ideas for features. For Aim 2, the study investigators developed the programming for the app with the desired features, which included modules for journaling, tracking stress ratings, practicing mindfulness exercises by using two videos and two audio tracks developed for the app, and viewing weekly suggestions for caregiver/care recipient bonding activities, inspirational quotes and positive affirmations. For Aim 3, the study investigators are testing the app using a feasibility trial with 30 caregiver participants. The study participants answer questions on depression, anxiety, perceived stress, overload and self-compassion at baseline and follow-up. Participants are instructed to use the app for four weeks and to return for their follow-up visit to fill out the same surveys assessed at baseline plus a satisfaction questionnaire to assess their evaluation of the app. These data will inform future enhancements, which will be proposed in a Phase II SBIR/STTR application.

Eligibility Criteria:
Inclusion Criteria:

* Informal caregiver participants will be screened for the ability to speak English. In addition, the caregivers must currently be providing support for a person living with HIV. Support can include: 1) emotional support, 2) physical support, 3) financial support, 4) opportunities for social participation, and/or 5) health advice.

Exclusion Criteria:

* Psychiatric problems such as untreated psychosis, which could preclude their ability to successfully adhere to the intervention
United States Hypophosphatasia Molecular Research Center

This study is being done to determine if cryptic alterations exist within or near to the ALPL gene in patients with a clinical diagnosis of hypophosphatasia, but without identifiable alteration on commercial testing. Additionally, the study aims to characterize functional effects of certain variants of uncertain significance in patients with clinical diagnosis of hypophosphatasia.

Primary Study Objectives:

Determine if cryptic alterations exist within or near to the ALPL gene in patients with clinical diagnosis of hypophosphatasia, but without identifiable pathogenic or likely pathogenic variant on commercial testing.

Secondary Study Objective(s):

Characterize functional effects of variants of uncertain significance in patients with clinical diagnosis of hypophosphatasia

Further characterize the differential diagnosis of hypophosphatasemia in patients with skeletal disease

Eligibility Criteria:
Inclusion Criteria:

Aim 1-

1. Diagnosis of Hypophosphatasia based on clinical features that include

   * History consistent with diagnosis of hypophosphatasia AND
   * Physical examination findings consistent with a diagnosis of hypophosphatasia AND
   * Presence of low serum alkaline phosphatase level for age and sex AND
   * Elevation of at least one natural substrate of alkaline phosphatase
2. Lack of detection of a variant on molecular analysis of the ALPL gene. When possible, first degree relatives (parents, siblings, or child) will be included for the sole purpose of trio testing. No additional information will be collected on first degree relatives.

Aim 2-

1. Missense variant in ALPL which is interpreted as a variant of uncertain significance by the American College of Medical Genetics Guidelines for Variant Interpretation
2. Variant has been interpreted as pathogenic, likely pathogenic, likely benign, or benign using ex-US interpretation guidelines

Exclusion Criteria:

Aim 1-

1. History and physical examination incompatible with a diagnosis of hypophosphatasia OR
2. Absence of hypophosphatasemia as measured by age and sex-matched control OR
3. Absence of at least one elevated natural substrate of alkaline phosphatase OR
4. Alternate diagnosis which could overlap with signs and symptoms of hypophosphatasia

Aim 2-

1. Inability to express variant in plasmid for residual enzyme and co-transfection analyses
Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study

The objective of the investigation is to evaluate the feasibility of detecting blood in healthy volunteers after ingestion of autologous blood mixed with water.

A total of 10 healthy volunteers were recruited to undergo a testing procedure. Subjects were instructed to ingest the PillSense Capsule with 100mL of water. The position of the capsule in the stomach was verified by fluoroscopy. Subjects were then asked to sequentially drink (every 5min) 2 mixtures containing 25mL of water and 25mL of their own blood obtained from a peripheral vein. The PillSense result ("blood detected" or " blood not detected") was recorded on Clinical Report Form after 5 minutes from capsule ingestion and after 5 minutes from the ingestion of both mixtures containing blood.

Subjects were followed-up for capsule passing.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 -60 years
2. Ability to give written informed consent

Exclusion Criteria:

1. Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure \<100 mmHg,heart rate \> 100 / min)
2. Known current stenosis of the GI tract
3. Presence of pacemaker or other implantable electronic device
4. Dysphagia or difficulties in swallowing pills the size of the capsule
5. History of achalasia or known esophageal dysmotility
6. History of gastroparesis
7. History of severe constipation (1 bowel movement per week or less)
8. Healthy volunteers who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation
9. Active psychological issues preventing participation
10. Stomach bezoar
11. History of severe esophagitis
12. History of Crohn disease
13. History of diverticulitis
14. History of bowel obstruction
15. Suspected gastrointestinal tumor disease
16. Planned MRI investigation (MRI needed before the capsule is excreted)
Assisted Fluid Management vs Manual GDFT

Goal-directed fluid therapy (GDFT) strategies based on cardiac output (CO) optimization have been shown to benefit moderate- to high-risk surgery patients and have recently been recommended by professional societies in the UK, in France, and in Europe. However, despite the growing evidence, these strategies are often not implemented in current practice. One of the reasons for this lack of implementation is that GDFT strategies, like any other complex clinical protocol, require significant provider attention and vigilance for consistent implementation and it is well known that even under study conditions protocol compliance rates are often not greater than 50%. To overpass this problem, our CO monitoring devices (EV1000, Edwards Lifesciences) have now an incorporated assisted fluid management software. This software determines fluid responsiveness by estimating the predicted change in stroke volume and suggests to the anesthesiologist when fluid is required .

The aim of this study was to assess an assisted fluid management strategy in a moderate-to-high risk surgical cohort and compare that cohort to matched patients who received manual GDFT. Our hypothesis was that the assisted fluid management system would result in higher mean percentage time spent during surgery with a SVV \< 13%

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing major abdominal surgery and requiring a CO monitoring for fluid management

Exclusion Criteria:

Emergency surgery Arrhythmia (e.g. atrial fibrillation) Aortic regurgitation
Percutaneous Irreversible Electroportion for Unresectable Breast Cancer

This trial is studying how well Irreversible Electroportion (IRE) therapy works in treating patients with breast cancer. IRE kills tumor cells by Electrical impulses creating nano-pore on the cell membrane and inducing target cell death.This may be an effective treatment for patients with unresectable breast cancer.

This is a phase I/II non-randomized exploratory study. All fully eligible and registered patients will undergo imaging by mammography, ultrasound, and breast MRI. The primary and secondary objectives of the study are described below.

OBJECTIVES

Primary

Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.

secondary

Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.

To describe the adverse events associated with IRE To prospectively gather pain assessment data on cryoablation and surgical resection Explore technical variables that may affect the success of IRE

Eligibility Criteria:
Inclusion Criteria:

1. Women 18 years or older with unresectable breast cancer, not amenable/willing to adenomammectomy.
2. breast carcinoma diagnosed by core needle biopsy.
3. Any menopausal status.
4. No history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer.
5. Tumor size ≤ 5.0 cm in greatest diameter. Largest size measured by required scans (mammogram, ultrasound and MRI) will be used to determine eligibility.
6. Tumor enhancement on pre-study MRI.
7. Tumor with \< 25% intraductal components in the aggregate.
8. Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy,
9. Non-pregnant and non-lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test.
10. Adequate breast size for safe IRE. Male breast cancer patients and female breast cancer patients with breasts too small to allow safe IRE are not eligible as the minimal thickness of the breast tissue does not lend itself to IRE. NOTE: For patients with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion will not contact or jeopardize the implant.
11. Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
12. Patient must agree to provide tumor tissue from metastatic tissue at baseline.

Exclusion Criteria:

1. Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive DCIS.
2. History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
3. Prior or planned neoadjuvant chemotherapy for breast cancer.
4. Patients with thrombocytopenia and or any other coagulation abnormality
Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

Study to evaluate the safety and performance of the Twelve TMVR System

The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high risk patients with severe, symptomatic mitral regurgitation.

Eligibility Criteria:
Key Inclusion Criteria:

* Severe mitral regurgitation (MR Grade 3-4+)
* Symptomatic mitral regurgitation (NYHA Class II-IV)
* Trans-apical access deemed feasible by the treating physician
* Native mitral valve geometry and size compatible with the Twelve TMVR

Key Exclusion Criteria:

* Left ventricular ejection fraction (LVEF) \< 20
* Evidence of intracardiac mass, thrombus, or vegetation
* Prior valve surgery or need for other valve surgery
* Prior stroke within 4 weeks
* Need for coronary revascularization
* History of, or active, endocarditis
* Renal insufficiency (Creatinine \> 2.5 mg/dL)
Fecal Calprotectin Collection Protocol

The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.

Stools will be collected and tested, at a later date, in a clinical performance study with an investigational Calprotectin assay. This study will be coordinated by the Sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Subject is of either gender and ≥ 4 years of age.
* Subject is showing signs and symptoms of IBD and/or IBS.
* Diagnosis of IBD, IBS or other gastrointestinal disorder is performed by colonoscopy.
* Subject or authorized legal representative is willing and able to sign the IRB approved Informed Consent form or able to provide Informed Consent in accordance with 21 CFR 50 CFR 50 Subpart B.
* Subject is able to understand and follow study sample collection procedure.

Exclusion Criteria:

* Subject has undergone a surgical resection or diversion procedure.
* Subject is currently taking NSAIDS (non-steroidal anti-inflammatory drugs, i.e. ibuprofen, Advil, Motrin, Naproxen, Aleve including regular dose and low dose aspirin) within 7 days of colonoscopy and sample collection.
* Subject who has taken immunomodulators or biologic therapies within the previous 6 months of colonoscopy and sample collection.
* Subject who is currently pregnant or lactating.
* Subject is unable or unwilling to follow informed consent.
* Inability or unwilling to perform required study procedures.