cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Shape Up Rhode Island Campaign

Obesity is a major health problem that has reached epidemic levels. Efforts are needed to develop cost-effective public health approaches for weight loss and maintenance. One such approach is to develop team-based programs that may motivate people to lose weight and/or increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI). The purpose of this project is to evaluate the overall effectiveness of SURI and to test if a behavioral intervention can enhance the effectiveness of the original program. The current trial is investigating whether adding a behavioral intervention delivered online would enhance the outcomes of SURI participants.

Background: Given the epidemic of obesity, approaches to weight loss that can be applied on a community, state, or national level are needed. This project is an ongoing evaluation of Shape Up Rhode Island (SURI) program, a state-wide Internet based program involving team-based competition to increase physical activity and achieve weight loss.

Aim: To enhance the effectiveness of SURI utilizing a minimal contact intervention delivered online.

Design: SURI 2008 participants were invited to join a research study focusing on weight loss. Interested participants were randomized to two groups including a SURI Enhanced (behavioral intervention presented in 12 weekly online presentations) or a SURI Standard group (group given a list of previously existing online resources to aid with weight loss).

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese
* Current participant in the Shape Up RI program weight loss competition

Exclusion Criteria:

* None
Observational Study of CT Dye Administration Through the Intraosseous Vascular Access Route

Intraosseous vascular access can be used to effectively and safely deliver contrast dye for CT examination.

intraosseous vascular access in the proximal humerus can be used to delivery contrast dye for CT examination.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Has received intraosseous vascular access at the proximal humerus insertion site via EZ-IO as standard of care
* Requires CT examination with contrast media delivery via proximal humerus intraosseous catheter, as standard of care
* Cognitively and physically able to give written consent to participate in the study

Exclusion Criteria:

* Fracture in target bone, or significant trauma to the site
* Excessive tissue and/or absence of adequate anatomical landmarks in target bone
* Infection in target area
* IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
* Allergy to contrast media
* Imprisoned
* Pregnant
* Requires English language translation other than Spanish
* Has received IO access with an IO catheter other than the EZ-IO system
Impact of Baduanjin Exercise Combined With Rational Emotive Behavior Therapy on Sleep and Mood in Patients With Post-stroke Depression

Patients and their families all agreed .


Eligibility Criteria:
Inclusion Criteria:

1. Conformity to the diagnostic criteria for stroke in the \&#34;Diagnostic Essentials of Various Cerebrovascular Diseases\&#34; revised by the Fourth National Cerebrovascular Academic Conference, and confirmed by cranial CT or MRI.
2. The course of stroke was 2 weeks to 6 months, with steady conditions and stable vital signs.
3. The age ranged from 30 to 80 years old, with at least a junior high school education.
4. The patients had no serious intellectual, language comprehension and behavioral disorders, and could complete the assessment of scales.
5. Achieving a sitting balance of at least reaches level 3, Brunnstrom stage IV or above, and being able to complete Baduanjin training.
6. The National Institutes of Health Stroke Scale (NIHSS) ≤ 15 points.
7. Conforming to the diagnostic criteria for depression in the \&#34;Chinese Experts Consensus on Clinical Practice of Post-Stroke Depression\&#34;.

Exclusion Criteria:

The exclusion criteria:

1. Disturbance of consciousness, unable to cooperate with polysomnography (PSG) and scale evaluators.
2. Pre-existing diagnosis of depression before stroke.
3. Severe pre-existing sleep disorders before stroke.
4. Patients with mental illness, immune system disorders, severe liver and kidney dysfunction, and severe cardiopulmonary dysfunction
Heat Application on Gastrointestinal System Functions

Complications related to the gastrointestinal system can occur in patients receiving enteral nutrition. These complications may include nausea, vomiting, diarrhea, constipation, decreased bowel sounds, abdominal distension, increased gastric residual volume, and abdominal pain. To prevent and treat food intolerance, as well as to increase gastric emptying, the use of prokinetic agents is often preferred. However, these drugs have various side effects, such as abdominal cramps, allergies, bronchospasm, cardiac issues, and pancreatic disorders. One non-pharmacological method that can be applied to increase bowel motility and reduce abdominal distension and constipation is heat application. The aim of this study is to determine the effect of heat application to the abdominal and lumbar regions, using a hot water bag, on gastrointestinal system functions in patients receiving continuous enteral nutrition.


Eligibility Criteria:
Inclusion Criteria:

* Intensive care unit patients
* Individuals aged 18 and above
* Patients receiving enteral nutrition via nasogastric tube
* Patients on the first day of enteral nutrition
* Those receiving standard enteral nutrition solution
* Patients without wounds in the abdominal region
* Individuals who have not undergone abdominal surgery in the last 6 months
* Patients not undergoing radiation/chemotherapy
* Those with a high-output fistula without ileus problems
* Patients without diarrhea and constipation
* Patients with a Glasgow Coma Scale (GKS) \> 3
* Those with an APACHE II score \> 16
* Patients not taking prokinetic agents
* Patients not taking laxative medications
* Patients without any contraindications for the application of heat, such as neuropathy (to be determined in consultation with the primary doctor).

Exclusion Criteria:

* Patients in whom enteral nutrition is discontinued during the study
* Patients transitioning to a product other than the standard one in enteral nutrition
* Patients who temporarily pause enteral nutrition
* Patients who have started prokinetic agents
* The study will be terminated in patients who have started taking laxative medications.
Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.

The causative agent of dengue fever is Dengue Virus (DENV), a member of the flavivirus genus. There are four DENV serotypes. Infection with one serotype results in lifelong immunity against that serotype, but only limited short-term cross-protection from infection with the other serotypes. Immunity to one serotype has a downside as subsequent infections by other serotypes increase the risk of developing more severe forms of dengue, which includes the most lethal form of the disease, dengue hemorrhagic fever. Traditional epidemiologic and serologic-based estimates suggest a range of 50 to 100 million DENV infections per year distributed over 100 countries. Recent cartographic-based modeling studies suggest that up to 390 million of dengue infections per year, of which 96 million are associated with clinical symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Women: non-pregnant, non-lactating; if of childbearing potential, on specified contraception measures during the study period
* Men: using barrier contraception measures during the study period

Exclusion Criteria:

* Health conditions
* Taking prescription and non-prescription drugs (exceptions: acetaminophen, vitamins, hormonal birth control)
Evaluation of Carbohydrates - Glycemic Index

This study is an open-label with a randomized, cross-over design using standard GI methodology.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are males or non-pregnant females in good health
* Subjects must be eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.

Exclusion Criteria:

* Subjects with any type of food allergy or known history of AIDS, hepatitis, diabetes or a heart condition
* Subjects taking medication, or with any condition which might, in the opinion of the PI either make participation dangerous to the subject or to others or affect the results
A Theory Based HIV Prevention Video For Rapid HIV Testing: A Randomized Trial

OraQuick is a safe, rapid test that accurately identifies HIV in as little as 20 minutes. By providing an accurate, quick method for detecting a person's serostatus and access to immediate post-test counseling, rapid testing has a crucial role in identifying HIV status and improving post-test counseling rates in populations who are at high risk of HIV infection and high failure to return rates. This prospective randomized control trial compared the educational effectiveness of a fifteen-minute post-test counseling video with the normal practice of a session with an HIV counselor.

A convenience sample of stable patients presenting to the walk-in section of the Jacobi Medical Center Adult ED were recruited for rapid HIV testing. After consenting for the rapid HIV test and completing measures on condom intention and condom use self-efficacy, participants were randomized to either a fifteen-minute HIV post-test educational video available in English or to an HIV counselor for post-test counseling. Afterwards, both groups completed a measure of HIV knowledge assessing relevant testing information and level of satisfaction. An equivalence analysis was carried out to assess whether the video was at least as good as counseling, measured by total score on the knowledge questionnaire, with a lower equivalence bound of -5%.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients presenting to the Urgent Care Area at Jacobi Medical Center

Exclusion Criteria:

* Patients that were in to much pain, unable to understand the consent process or spoke another language other than the languages offered via the video or were HIV tested with in 6 months.
OCTA and Retinal Angiomatous Proliferation

To investigate, using optical coherence tomography angiography, the retinal vascular features in patients affected by RAP.

Retinal vascular anomalous complex represents a distinct form of neovascularization in patients with age-related macular degeneration.

The study investigated the changes in retinal vascular network using optical coherence tomography angiography, a novel and non invasive diagnostic technique that allows to better understand the pathophysiologic mechanism of this neovascularization.

Eligibility Criteria:
Inclusion Criteria:

* age older than 65 years
* diagnosis of retinal angiomatous proliferation and reticular pseudodrusen
* absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* absence of significant lens opacities, low-quality OCT-A images.

Exclusion Criteria:

* age older than 80 years
* absence of diagnosis of retinal angiomatous proliferation and reticular pseudodrusen
* presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* presence of significant lens opacities, low-quality OCT-A images.
Prediction of Post-Cesarean Section Pain

The purpose of this study is to determine if dynamic psychophysical testing along with genetic screening will allow to identify pre-operatively women who will suffer severe acute pain post-operatively and the subset who may experience chronic pain following cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Women age 18-50 scheduled for an elective cesarean section (1st or 2nd cesarean section)

Exclusion Criteria:

Women who:

* have taken opioids, acetaminophen, or NSAIDs 48 hrs prior to psychophysical testing
* have had more than two previous cesarean sections
* have a vertical abdominal incision from a prior cesarean section
* are non-English speaking
* have mental health issues
* have a failure of spinal anesthetic and require conversion to general anesthesia
* have a vertical uterine incision performed during ongoing cesarean section
* have a previous vertical uterine scar discovered during ongoing cesarean section
Once a Day Use of Lactobacillus Casei Shirota on HIV-infected Patients Infected Patients

In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral control after treatment with antiretroviral therapy will be enrolled to receive once a day Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion. Immune parameters will be monitored for 12 weeks in both arms.

The main outcome is CD4+ T cell recovery. Secondary outcomes will include NK cells and T cells immune parameters.

In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral control after treatment with antiretroviral therapy will be enrolled to receive once a day Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion.

The main objective is to investigate whether the continuous, once a day, 12-weeks use of Yakult product containing Lactobacillus casei Shirota could affect immunological parameters in HIV-infected patients on suppressive antiretroviral treatment with poor CD4+ T cell recovery. A total of 48 volunteers will be followed for 12 week after initiation of daily use of Lactobcillus casei Shirota or placebo, randomized in a 1:1 ratio.

We hypothesize that use of the Yakult product containing Lactobacillus casei Shirota after 12 weeks of continuous use will increase the level of CD4+ T-cells, at least, 50 cells/mm³.

We also propose to investigate several markers of immune response, including T cellular activation and NK cells function, and changes in the intestinal microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Male or female HIV-1 infected patients aged between 18 and 60 years.
* Patient on suppressive antiretroviral treatment with poor CD4+ T-cell recovery.
* No change in antiretroviral therapy in the last six months or intended change in the next 12 weeks.
* Availability for the study procedures during the study period.
* Giving informed consent to participate in the study

Exclusion Criteria:

* Diagnosis of any concomitant infections or diseases that might affect immunity or natural history of HIV-1 infection including active Hepatitis B infection, Hepatitis C infection, diabetes mellitus, neoplasias and autoimmune diseases.
* Use of treatments that might affect immunity in the last four weeks including immunomodulators, corticosteroids (only systemic use for two weeks or more), or antineoplasic agents.
* History of intolerance or allergy to cow milk or any other component of the study product including lactose intolerance, casein allergy, etc.
* Pregnancy, nursing mother or intention of became pregnant during the study period (only female participants).
* Unable to safely store the study product at home in the conditions recommended by the manufacturer.
* Any other condition that might interfere with the study procedure according to the investigators.
Potential Benefits of Laser Treatment on Skin Blood Flow and Sweating in Burn Survivors

The purpose of this study is to examine effects of laser therapy on blood flow and sweating responses in burn-injured skin.

This is a longitudinal study in which the effects of laser therapy on cutaneous vascular responses and sweating of the treated areas are assessed. Specifically, burn survivors who will undergo standard of care laser therapy to treat burn-related scars will perform whole-body heating and local heating procedures prior to the initiation of laser therapy, at an intermediate point during the laser therapy regimen, and upon conclusion of the laser therapy regimen.

For this pilot investigation a placebo will not be incorporated.

Primary outcome variables will be skin blood flow and sweating responses from skin treated with laser therapy and adjacent untreated/uninjured skin.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Experience a severe burn injury that warrant laser therapy.
* Free of any significant underlying medical problems based upon a detailed medical history and physical exam

Exclusion Criteria:

* Known heart disease
* Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia.
* Abnormality detected on routine screening suggestive of cardiac ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
* Subject with a body mass index \>35 kg/m2
* Pregnant or planning to become pregnant within the subsequent 6 months.
Efficacy of Music Listening to Shortening Time for Biophysical Profile

The goal of this clinical trial is to compare the timeing which assume for assesment of BPP in low risk pregnancy. The main question is the music can be shoetening the timing for BPP? Participants will in study froup will listening the music via headphone before and during the assessment and compre to control gruop which not listening to music during asseeement.

A single-blind randomized controlled trial conducted from February 2021 to December 2022. The study population consisted of 60 pregnant women with between 18 and 35 years old with gestational age of 32 weeks. An abdominal ultrasound was performed while listening to one song while wearing headphones in the experimental group preceding the biophysical profile assessment. As part of the control group, the same equipment was used and the same assessment protocol was followed, but music was not played during the test.

Eligibility Criteria:
Inclusion Criteria:

* Single pregnancy (Singleton)
* Gestational age from 32 weeks onward
* Pregnant women do not have underlying diseases such as pre-gestational diabetes. high blood pressure
* No abnormalities in the fetus were found, such as fetal deformities.

Exclusion Criteria:

* Pregnant women receiving certain drugs or substances that affect the interpretation of the Biophysical Profile (BPP), e.g., sleeping pills, cigarettes.
* Pregnant women have hearing problems. or hearing impaired
* Pregnant women who are unable to wear headphones, e.g., otitis externa - Pregnant women with body mass index greater than 30 kg/m2 prior to pregnancy
* Uterine contractions were observed during the examination
Avecure Flexible Microwave Ablation Probe For Lung Nodules

This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size.

This research study involves microwave ablation (MWA)

This will be a single arm, prospective cohort study.

The names of the study intervention involved in this study is:

* Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA)
* A rapid on-site evaluation (ROSE) will be performed before the MWA to confirm that the lesion is malignant, this can lead to longer procedure time and time under anesthesia.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

* Participants will receive the study intervention and will be followed for 30 days.
* It is expected that about 10 people will take part in this research study.

This research study is a Pilot Study, which is the first-time investigators are examining this intervention using a bronchoscopic approach for microwave ablation of solitary pulmonary nodules.

The U.S. Food and Drug Administration (FDA) has approved this intervention as a treatment option for this disease.

Eligibility Criteria:
Inclusion Criteria:

* Subject with Stage I - II primary lung cancer (Solitary nodules up to 3 cm) as defined by previous pathology or ROSE.
* Pathological proof of target nodule/tumor type and malignancy with specimen considered adequate per institutional laboratory standards
* Target nodule/tumor which can be accessed via navigational bronchoscopy and confirmed location with cone beam CT scan intra-operatively
* Resection/surgical candidate (lobectomy or greater)
* Participants must be at least 22 years old and able to provide consent

Exclusion Criteria:

* Subjects in whom flexible bronchoscopy is contraindicated
* Target nodule \< 1.0 cm
* Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor
* Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
* Pacemaker, implantable cardioverter, or another electronic implantable device
* Patient cannot tolerate bronchoscopy
* Patients with coagulopathy
* Patients in other therapeutic lung cancer studies
* Subject is pregnant or breastfeeding
* COVID-19 positive patient at the time of procedure.
HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome

This study aimed to assess the correlation between HCG levels after ovulation triggering and ICSI outcomes, affected by HCG formulation and dose

The aims of this study are:

1. To assess the correlation between serum human chorionic gonadotropin (hCG) level after ovulation triggering and intracytoplasmic sperm injection (ICSI) outcome including: oocyte maturity and quality, good quality embryo rate, blastocyst formation rate and pregnancy rate
2. To determine if there is an association between type and dose of the trigger and ICSI outcome.

Eligibility Criteria:
Inclusion Criteria:

* Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol

Exclusion Criteria:

* BMI \> 30 kg/m2
* Irregular menstruation
* Severe male factor abnormality
* Poor ovarian reserve
* Endometriosis
* Uterine abnormality