cyrilzakka/clinical-trials huggingface dataset:
Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation

The purpose of this study is to evaluate the effects of angiotensin receptor 1 blocker versus calcium channel blocker on atherosclerotic plaque inflammation using serial FDG PET/CT imaging of carotid artery.


Eligibility Criteria:
Inclusion Criteria:

* Men or Women at least 18 years of age inclusive
* Patients with acute coronary syndromes or unstable angina pectoris
* Hypertension or blood pressure more than 140/90mmHg
* FDG PET/CT shows at least 1 hot uptakes at carotid and or ascending aorta
* The patient or guardian agrees to the study protocol and the schedule of clinical and FDG PET/CT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* Patients treated with carotid endarterectomy or stent placement
* Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
* Untreated hyperthyroidism, or hypothyroidism
* Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
* Evidence of congestive heart failure, or left ventricular ejection fraction \< 40%.
* Significant renal disease manifested by serum creatinine \> 2.0mg/dL, or creatinine clearance of \< 40 ml/min (by Cockcroft-Gault method).
* Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal).
* History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
* Unwillingness or inability to comply with the procedures described in this protocol.
* Patient's pregnant or breast-feeding or child-bearing potential.
* Type I Diabetes
A Default Option for Health: Improving Nutrition Within the Financial and Geographic Constraints of Food Insecurity

Food insecurity is associated with an increased risk of obesity. The availability of a default option (i.e., option a consumer selects if no active choice is made) has been shown to effectively nudge consumer behavior. An online default option (i.e., prefilled grocery shopping cart) was previously shown to positively impact the food purchases of individuals with food insecurity.The present study aims to extend these findings bye examining efficacy of an online default option in enhancing the nutritional quality of online grocery purchases in individuals with food insecurity over the course of a month.

Food insecurity is associated with an increased risk of obesity and weight-related illnesses. The present study is the first longitudinal randomized control trial to examine if an online prefilled grocery shopping cart (i.e., a default cart) nudges individuals with food insecurity to purchase healthier groceries compared to receiving nutrition education.

It was hypothesized that the prefilled online grocery shopping cart (i.e., default condition) will result in a significant improvement in the nutritional quality of groceries purchased compared to those receiving nutrition education.

Thirty-eight food pantry users recruited from food pantries in New York in 2018 were enrolled in the present study and were given $48.50 to purchase groceries weekly using an online grocery website for five weeks. At baseline, participants were instructed to purchase groceries keeping in mind nutrition, cost, and taste. For the subsequent four weeks (T1-T4), participants were randomized to receive 1) nutrition education or 2) a prefilled online grocery shopping cart that met their nutritional needs based on age and sex (Default).

Our primary nutritional outcomes included HEI scores, calories (kcal), and energy density (kcal/grams).

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Residing in a single person household
3. Receiving assistance at a food pantry
4. Able to read and write in English
5. Able to provide informed consent
6. Current residence in a zip code served by Price Chopper's delivery program
7. None of the following dietary restrictions: Vegetarian/vegan, Gluten-free/celiacs, Lactose intolerance, egg allergy
Far Infrared Radiation Treatment for Prostate Cancer

A study to determine the use of far infrared radiation for the treatment of prostate cancer.

Our initial assessment indicates that electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to cure a number of diseases, including prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Persons with Prostate, Bladder or Testicular Cancer.

Exclusion Criteria:

* None
PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: the PROMOTE Trial

To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes.


Eligibility Criteria:
Inclusion Criteria:

* Age between 8.0 to 16.9 years of age.
* Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
* Established Crohn's Disease (CD) diagnosis with the site of disease involving at least the terminal ileum or ascending colon.
* CD is in clinical remission or with mild stable disease activity (weighted Pediatric Crohn's Disease Activity Index of 0 to 39.5).
* Receiving infliximab or adalimumab anti-TNFa monoclonal antibody medication for treatment of CD.
* No changes in medical treatment for the previous month and without anticipated changes for the next month.
* Ability and willingness to comply with study procedures (e.g., stool collection) for the entire length of the study.

Exclusion Criteria:

* Allergy to RS or excipients.
* Co-existing diagnosis with diabetes mellitus type 1.
* Treatment with another investigational drug or intervention throughout the study.
* Current illicit drug or alcohol dependence.
* Inability or unwillingness of an individual or legal guardian to give written informed consent.
* Other conditions requiring immunomodulating or biological medications.
* Pregnancy.
* Participant's microbiota does not increase butyrate production utilizing any RS from the assembled panel as measured through the RapidAIM ex vivo assay.
Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

Since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration, we designed this study to investigate the effect of administering dexamethasone at-night before surgery versus at-induction (the standard timing) in prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy.

A pilot randomized controlled study (60 cases) will be started to explore the potential difference, ensure correct and rigorous data collection, and calculate the sample size for a larger pragmatic trial.

Background:

Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. The aim of this study is to evaluate the efficacy of administration of prophylactic dexamethasone 12-hours prior to induction of anesthesia in preventing PONV after elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts for 72 hours after intravenous (iv) administration.

Methods:

This is a parallel two-arm, randomized (1:1), double-blind, controlled, single-center trial. Adults (≥18 years) with American Society of Anesthesiology (ASA) physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg IV Dexamethasone at time of induction of anesthesia or 8 mg IV Dexamethasone at 12 hours prior to induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 60 patients will be recruited as a pilot study.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery at gastrointestinal surgery center.

Exclusion Criteria:

* patient refusal
* use of steroids or antiemetic agents within 1 week of surgery
* chronic opioid therapy
* history of allergy to any study medications
* serum creatinine \> 1.4 mg/dl
* liver enzymes more than triple normal limits
* pregnancy
* psychiatric or neurologic diseases or socioeconomic status that would hinder postoperative quality of recovery questionnaire
* Patients whose laparoscopic surgery is converted to open surgery after enrollment will be excluded.
Ready. Set. ACTION! A Theater-Based Obesity Prevention Program for Children

The goal of Ready, Set, ACTION! (RSA) is to test the feasibility of implementing a theater-based after-school program to promote healthy eating, physical activity, and positive body image with children in grades four through six.

The goal of Ready, Set, ACTION! (RSA) is to test the feasibility of implementing a theater-based after-school program to promote healthy eating, physical activity, and positive body image with children in grades four through six. This study, funded by the National Institutes of Health (NIDDK), is a collaboration between the University of Minnesota, Division of Epidemiology and Community Health, Saint Paul Public Schools, and Illusion Theater of Minneapolis. Four participating Saint Paul schools were randomly assigned to receive either a control or intervention after school program led by artists/educators from Illusion Theater. Students in the intervention schools received a fourteen-session curriculum with eight booster sessions, in which they received the following messages: increase fruit, vegetable, and water consumption, decrease soda pop, increase physical activity, and decrease television. Families received nutrition and activity information packets themed for each session. The messages were reinforced by theater education, dance, and music. A play structured around the aforementioned messages that included scene vignettes, choreographed dance, and professionally composed music was developed and rehearsed by the children. In December 2006 the children performed the play for their families at Illusion Theater in downtown Minneapolis. They later performed for their peers at school and again for family and school administrators at the conclusion of the program.

Eligibility Criteria:
Inclusion Criteria:

* 4th-6th grade children at intervention and control schools
* Parent or guardian of participating children

Exclusion Criteria:

* Other ages
Dual Wavelength OCT

The purpose of this research is the evaluation of a combined coaxial optical coherence tomography (OCT) system to image retina/choroid and to evaluate if post processing of the data can give us insights into property of the tissue imaged.

Histology studies have shown that many disorders of the retina and choroid such as age-related macular degeneration is associated with a build up abnormal deposits, in the retina or subretinal space. Being able to detect subtle changes in retina and choroidal structure is crucial for better understanding and monitoring of this potentially blinding condition. This study aims to commercially available Spectralis® OCT-system with a central wavelength of 880nm explore the ability of a confocal scanning laser ophthalmoscope (cSLO) for OCT imaging utilising a modified by the addition of a longer wavelength OCT (1075nm , a wavelength deployed on other commercially available OCT scanners). Other commercially available OCT scanners used longer wavelengths to allow deeper penetration and enhanced visualisation of subretinal tissue but less inner retinal detail. Combing both wavelengths could have the advantage of allowing optimum viualisation of inner and subretinal structures. The ability of the systems to acquire repeatable and good quality images of retinal and choroidal structural detail at matching location and compare the results from the two instruments will be evaluated. In addition processing of the images reflectivity with two different wavelength should give us insight into the nature of any abnormal material.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* Ability to consent
* Abnormal reflectivity detected in at least one eye in the retina or choroid on OCT testing undertaken as part of routine
* clinical care

Exclusion Criteria:

* Media opacities on conventional OCT testing taken on the day of the study visit, that prevents adequate visualisation of
* the retina and/or choroidal substructures in the opinion of the investigator
* Inability to undertake to undertake two additional OCT scans on each eye in addition to their conventional OCT.
Assuring Ophthalmologic Follow up

The goal of this study is to quantify the improvement in completed ophthalmology referrals and quantify the number of children identified and treated for amblyopia or pre amblyopic strabismus resulting from the implementation of a new referral and tracking system.

Children who fail instrument vision screens at Dartmouth Hitchcock (D-H) Community Group Practice (CGP) Pediatric Clinics will be scheduled at a community vision specialist office before departure from the Pediatric clinic. If the patient does not attend the appointment (a no show) at the vision specialist office , this will be tracked and the patient will be rescheduled.

Eligibility Criteria:
Inclusion Criteria:

* All pediatrics patients without pre-existing vision problems undergoing instrument vision screening at DH Pediatric CGP Clinics in at ages 2,3,4,5, and 6 years of age.

Exclusion Criteria:

* All pediatric patients with pre-existing eye problems that would cause them to be excluded from the study.
* All patients of parents who choose to go to an eyecare provider other than the one participating in the study (as we would be unable to make appointments or track appointments).
* All patients of parents who refuse to make an appointment
Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique

In pregnant term patients, we intent to use a non invasive cardiac output monitor to detect the changes in cardiac output as the patient is being placed in different positions.

The patient will be placed on her back, flat, and in left lateral tilt at two different angles. Measurements of cardiac output will be recorded.

Aortocaval compression compromising tissue perfusion has always been of a concern in term pregnant women undergoing caesarian delivery or regional anesthesia when placed in the supine position. It is believed that this phenomena happens when the gravid uterus compresses the inferior vena cava (IVC)resulting in decreased venous return and hence cardiac output (CO) leading to low placental perfusion and associated fetal heart rate changes.

Hence, due to these concerns, left lateral tilt is currently a common practice in obstetrics and it is believed to relief aortocaval compression and to improve blood flow to the fetus.

Supporting evidence for this intervention remains controversial, and shows conflicting results. Some studies suggest that lateral tilt does not affect neonatal outcomes (1) or changes in cardiac output in patients with no regional anesthesia (2). While others suggest it can actually increase the volume of the IVC, especially when the patient is tilted 30 degrees or more (3) and may lead to increases in CO (4).

Non-invasive hemodynamic monitoring (NICOM, Cheetah Medical), an FDA approved device, is currently being used to detect changes in CO in the United States. Its use has been validated in different clinical settings (5,6).

Our hypothesis is that CO is increased in pregnant women that were placed in the lateral tilt position.

We intend to compare CO measurements using the non-invasive hemodynamic monitoring among term pregnant patients in supine vs lateral tilt position.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 18-50.
* Elective repeat cesarean section or induction of labor.

Exclusion Criteria:

* Incarcerated patients
* Patient unwilling or unable to provide consent
* Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians).
Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Adult subjects with elevated intraocular pressure who have successfully undergone placement of iStent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of open-angle glaucoma or ocular hypertension
* qualifying IOP in the study eye

Exclusion Criteria:

* unmedicated (washed out) IOP of \>36 mmHg in the study eye
* hypersensitivity to travoprost or any other components of the travoprost intraocular implant
* vertical cup/disc ratio \> 0.8 in the study eye
* best spectacle corrected visual acuity of worse than 20/80 in either eye eye
* any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum

The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids

This was a double-blind, placebo-controlled trial. Participants were recruited from the Pediatric Dermatology clinic at Montefiore Medical Center. One hundred eligible participants were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with occlusion, placebo, or placebo with occlusion. Treatments were applied at weeks 0 and 3 (blinded phase). At week 6, all participants were treated with open-label, topical cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label phase).

Eligibility Criteria:
Inclusion Criteria:

* 2-17years
* Healthy
* \<50 molluscum contagiosum lesions

Exclusion Criteria:

* Immunosuppressed
* Oral corticosteroids
* Sexually active/pregnant
Application of Watson for Oncology in Hepatocellular Carcinoma Surgery

The aim of this study was to evaluate the surgical decisions of Watson artificial intelligence in patients with hepatocellular carcinoma.

Hepatectomy is an effective treatment for patients with hepatocellular carcinoma, but liver failure after hepatectomy may lead to increased postoperative mortality. Therefore, it is very important to make preoperative surgical decisions, evaluate the safety of the operation and identify which patients are likely to suffer from liver failure. The artificial intelligence platform developed by IBM Watson for Watson tumor treatment decisions can provide treatment decisions and corresponding theoretical basis to guide surgical decisions based on the key clinical data of liver cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years≤ Age ≤80 years
2. Compling with the diagnosis criteria of complex hepatic carcinoma.
3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
4. Preoperative liver function is Child - Pugh grade A or B.
5. The patients are volunteered for the study.

Exclusion Criteria:

1. Patients with mental illness.
2. Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
3. The patients refused to take part in the study.
4. There are other co-existed malignant tumors.
5. Benign liver diseases
CoPing strategIes-psyChological flexibiliTy in Patients Hospitalized for Ischemic cardiovascUlaR disEase (PICTURE)

The aim of this trial is to investigate the coping strategies/physiological flexibility construct in patients hospitalized for ischemic cardiovascular disease and the possible association with recurrence of clinical events (any hospitalization and type thereof, myocardial infarction, stroke and death) during the follow up, the patient's decision to participate to clinical trials approved in the center and the adherence to cardiovascular medications.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Able to provide informed consent
* Able to speak and read in the local language spoken in hospital
* Admission to the hospital for ischemic cardiovascular disease

Exclusion Criteria:

* Cannot provide written informed consent
* Under judicial protection, tutorship or curatorship
* Unable to understand and follow study-related instructions or unable to comply with study protocol
* Cognitive impairment
* Severe psychiatric disorders according to DSM-5-TR criteria diagnosed in the last 6 months
Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population

To study the initial experience with implanting and fitting a new Bone Conduction system in pediatric patient population with conductive, mixed or single-sided deafness.

Experimental: Bone-conduction hearing device The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.

Device: Osia System An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea

Eligibility Criteria:
Inclusion Criteria: Individuals 5 through 18 years of age will be eligible for inclusion in the investigation if all of the criteria below are met:

Conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure-tone average (PTA4; mean of 0.5, 1, 2, and 4 kHz) of less than or equal to 55 dB HL.

Subject does not benefit from or will not wear a conventional hearing aid.

Note: Candidates may include individuals seeking new implantation unilaterally (in one ear) or bilaterally (both ears) as well as individuals already implanted with a bone-anchored device seeking a second-side implant.

OR

Single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure-tone average (PTA4; mean of 0.5, 1, 2, and 3 kHz) of less that equal to 20 dB HL in the good ear.

Subject does not benefit from or will not wear a conventional hearing aid

Exclusion Criteria:

Uncontrolled diabetes as judged by the investigator. Subject who has received radiotherapy in the area of implantation, or such radiotherapy is planned during the study period.

Current use of ototoxic drugs. Condition that could jeopardize osseointegration and/or wound healing or condition that may have an impact on the outcome of the investigation as judged by the investigator.

Insufficient bone quality and quantity for implantation of a BI300 Implant, as determined by the surgeon.

Unable to follow investigational procedures. Participation in another clinical investigation with pharmaceutical and/or device
Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin

The aim of this research is to study the effect of a loading dose of colchicine on the occurrence of periprocedural myocardial infarction (PPMI) in elective percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized with troponin negative events and scheduled for elective PCI

Exclusion Criteria:

* Significant renal dysfunction
* Significant liver dysfunction
* Severe left ventricular dysfunction
* Severe low weight
* Chronic colchicine treatment