cyrilzakka/clinical-trials huggingface dataset:
Communities Fighting COVID-19!

To create and evaluate effective COVID-19 testing uptake strategies that focus on underserved individuals who are exposed but have not accessed testing, and underserved individuals who are not routinely tested because they are unaware of their exposure or risk status in order to increase testing among these populations and reduce Covid-19 related disparities.

Communities Fighting COVID is a partnership between San Diego State's School of Public Health and numerous communities in San Diego focused on providing community-based testing to specific language-speaking communities and vulnerable populations. This partnership is funded by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics-Undeserved Populations (Radx-UP), with the aim of ensuring all Americans have access to timely COVID-19 testing and diagnosis. Many communities, particularly immigrant and people of color communities, have a harder time accessing existing COVID-19 resources due to transportation, language barriers, or other barriers.

Eligibility Criteria:
Inclusion Criteria:

* African American, Arabic speaking, Filipino, and Latino/a populations

Exclusion Criteria:

* Younger than 6, not in focus populations
The Safety and Immune Response to Influenza Vaccination in Pregnant Women

The purpose of this study is to evaluate the antibody response to the influenza vaccine (AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks post immunization in pregnant women in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96). Besides, the vaccine safety will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant female aged ≥ 18 years old.
2. Subject is pregnant for at least 3 months, inclusive.
3. Subject is willing and able to adhere to visit schedules and all study requirements.
4. Subject has read and signed the study-specific informed consent.

Exclusion Criteria:

1. Subject with previous complicated pregnancy or preterm delivery, spontaneous or medical abortion;
2. Subject with history or concurrent high risk of dangerous gestation such as gestational diabetes mellitus (GDM), pregnant induced hypertension, or preeclampsia;
3. Subject received any influenza vaccine within the previous 6 months;
4. Subject has a history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study vaccine;
5. Subject or her family has the history of Guillain-Barré Syndrome;
6. Subject has current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;
7. Subject with influenza-like illness as defined by the presence of fever (temperature over 38ºC) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
8. Subject receive any treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
9. Subject has immunodeficiency or is under immunosuppressive treatment.
10. Subject received any vaccine within 1 week prior to study vaccination or expected to receive one within 1 week after study vaccination;
11. Subject received any blood products, including immunoglobulin, in the past 3 months before consent;
12. Subject has underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;
Evaluation of the Effect of Dietary PI and TAC on the Outcome of Pregnancy in in Vitro Fertilization Treatment

The aim of this study is to determine the relationship between dietary total antioxidant capacity, phytochemical index, inflammatory index, dietary polyphenol intake and ongoing pregnancy outcome in couples receiving IVF treatment.

In this context, the objectives are:

Determining the relationship between diet's antioxidant capacity, phytochemical index, inflammatory index, and dietary polyphenol intake and ongoing pregnancy outcome, Determining the relationship between total serum antioxidant capacity, serum oxidant capacity and CRP levels and ongoing pregnancy outcome, It is the determination of the relationship between body composition and ongoing pregnancy.

With this study, it is aimed to obtain reliable data on the effects of diet's antioxidant capacity, phytochemical index and dietary polyphenol intake and inflammatory index on reproductive functions. In this way, it is thought that nutritional recommendations that can be given to patients who will undergo IVF treatment before treatment will be developed.

In this study, which is a first in terms of examining many parameters related to diets of women and men, it will be evaluated whether the parameters to be examined are effective in IVF cycles.

The aims, objectives and hypotheses the researchers put forward within the scope of the study have not been studied extensively before. If the planned project is carried out successfully, new nutritional approaches will be paved in in-vitro fertilization treatment, and it will be possible to contribute to reducing the financial burden of the treatment. In addition, an important step will be taken to increase the total fertility rate (number of children per woman) within the scope of the 11th Development Plan (2019-2023). It also conforms to the 3rd Sustainable Development Goals, "healthy and quality life" (UNDP Turkey 2018)


Eligibility Criteria:
Inclusion Criteria:

* Females \<41 years
* Males \< 55 years
* BKI ≤ 32 kg/m2

Exclusion Criteria:

* Smoking cigarettes
* Chronic and inflammatory diseases
* Dietary changes in last 6 months
* Using antioxidant supplements
* Females diagnosed with infertility for anatomical reasons, endometriosis, tubal factor, or low ovarian reserve
* Males diagnosed with azospermia
* Couples who have had more than two failed cycles
Caffeine, Resistance Exercise and EMG

Introduction: Several studies have evaluated and confirmed the ergogenic effects of acute caffeine intake on sports performance. However, some studies suggest that this effect predominantly occurs in large muscle groups, potentially due to increased skeletal muscle electrical activity.

Objectives: This study aims to evaluate the acute effects of caffeine intake on strength, power, muscle endurance, and muscle electrical activity in young adults. It will also analyze the influence of circadian rhythms (morning vs. afternoon) on exercise performance (bench press vs. squat).

Methods: Twelve healthy, physically active participants will be recruited for the study. Using a triple-blind, crossover, randomized, and controlled design, participants will ingest either caffeine (3 mg/kg body mass) or a placebo (maltodextrin, 3 mg/kg) 60 minutes before the trial. Muscular strength, power, and endurance performance will then be assessed through 1RM tests, and at 25%, 50%, 75%, and 90% of 1RM, along with muscle endurance tests at 65% of 1RM, for both squat and bench press exercises. EMG will be used to measure skeletal muscle electrical activity during the tests. The experimental sessions will be conducted in the morning (8:00 am to 10:00 am) and the afternoon (4:30 pm to 6:30 pm).


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 35 years.
* Body Mass Index (BMI) \&lt; 25 kg/m².
* Resistance-trained individuals (more than 2 years of structured training).
* Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from exercising.
* Participants must be able to perform the tests described in the following section.

Exclusion Criteria:

* History of neuromuscular diseases, heart disease, or conditions that may affect liver or muscle metabolism.
* Use of drugs, stimulants, or sports supplements that could interfere with the dietary supplement used in the study.
* Sedentary habits (less than 150 minutes/week of moderate exercise).
* Having undergone prolonged periods of physical inactivity in the 6 months prior to the study.
* Engaging in strenuous exercise within 48 hours prior to the tests.
* Failure to replicate the same food intake on both experimental days.
* Consumption of caffeine or any other stimulant after 6 pm on the day before the tests, to avoid headaches, discomfort, or lethargy in regular caffeine consumers.
Validation of myStrength's Macropersonalization Engine

This is a study to validate myStrength's macropersonalization algorithm. Specifically, the study seeks to answer: Does myStrength's macropersonalization algorithm match what a clinician would offer as a diagnosis following an expert assessment? Participants will be treatment-seeking adults, ages 18 to 65, recruited from an evidence-based group psychotherapy practice. Participants will be asked to complete myStrength onboarding and a clinician-conducted initial assessment. Inter-rater reliability will be assessed to determine the consistency between myStrength and clinician in primary focus area of digital program.

Rationale and Background: Macropersonalization refers to the rules applied to a member's onboarding data that dictate their primary clinical focus and available interventions that will be recommended. Macropersonalization is a new myStrength feature that is meant to enable myStrength's ability to deliver evidence-based stepped care.

Research Questions: To examine the inter-rater reliability between myStrength's macropersonalization engine and expert clinical recommendations for members' primary clinical focus.

Study Design: This is a one-arm, prospective study.

Population: Study participants will be adults, ages 18 to 65, seeking therapy at an evidence-based psychotherapy group practice.

Data Sources: Anticipated data sources include members myStrength onboarding data, macropersonalization outputs, and clinician-administered clinical assessments.

Data Analysis: A Cohen's kappa will be generated for agreement between myStrength macro-personalization primary focus area and clinician diagnosis to fulfill the primary objective. Conditional kappas based on stratification, as well as a logistic regression, will be used to determine whether demographics or treatment history are associated with concordance, and qualitative analyes will be used to describe sub-clinical or secondary focus areas associated with clinician diagnoses.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 85, inclusive
* Able to read, write, and speak in English
* Has access to the Internet to complete study procedures
* Currently engaged in therapy or has schedule an initial appointment with the Pacific Anxiety Group

Exclusion Criteria:

* None
Dual Endpoint Nerve Stimulation Versus Ultrasound in Infraclavicular Block for Hand Surgery

Current best practice for performance of infraclavicular block dictates the use of a dual-endpoint nerve stimulation technique that still only results in a 79% success rate. Use of an ultrasound-guided technique has the potential to significantly improve success. A randomized, controlled study to evaluate this area remains to be performed and is required to demonstrate to anesthesiologists that an ultrasound-guided approach should supersede nerve stimulation as the technique of choice for infraclavicular block.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective upper limb surgery at or below the elbow.
* Patients aged \>18 and \<80 years
* ASA I-III
* BMI\<35

Exclusion Criteria:

* Inability to read, write or speak English. (This is necessary because subjects will have to follow detailed instructions to allow testing of motor and sensory function. It is not feasible to have an interpreter present in the block room during performance of these procedures)
* Contraindication to brachial plexus block
* Existing neurological deficit in the area to be blocked
* Known loco-regional malignancy or infection
* Coagulopathy
* Allergy to local anesthetic agents.
* Chest or shoulder deformities
* Severe respiratory disease
* Healed but dislocated clavicle fracture
Comparing Local Anesthetic Techniques for Clavicular Surgeries

Surgical fixation for acute clavicular fractures is increasingly preferred among orthopedic surgeons to improve healing and decrease the risk of malunion. Regional anesthesia for clavicular fractures allows rapid recovery, prolonged postoperative analgesia, and less opioid consumption, and so decreases the hospital stay. There is no consensus regarding the best regional anesthetic technique for surgical fixation for acute clavicular fractures. Selective supraclavicular nerve block combined with either superior trunk or clavipectoral fascial plane block is a promising regional anesthetic technique for midshaft clavicular surgeries.

This study will assess if there is a difference in the quality of surgical anesthesia between selective supraclavicular nerve block combined with either superior trunk or clavipectoral fascial plane block for clavicular fractures. Aiming to achieve high-quality surgical anesthesia and postoperative analgesia for middle clavicular fracture surgeries with optimum hemodynamic stability and high patient and surgeon satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-45 years old.
* Sex: both sexes.
* The American Society of Anesthesiologists (ASA) Physical status: ASA I \& II.
* Body mass index (BMI): 18.5 - 24.9 kg/m2.
* Type of operations: surgical repair of the midshaft clavicular injuries.

Exclusion Criteria:

* Patient refusal.
* Known hypersensitivity to lidocaine or bupivacaine.
* Patients with respiratory insufficiency.
* Coagulation disorders or taking drugs affect surgical hemostasis.
* Patients with pre-existing neurological deficits
* Uncooperative patient or with altered mental status.
Poorly Differentiated Adenocarcinoma With Signet Ring Cells of the Gallbladder Producing a High Level of Alpha-fetoprotein: a Case Report

Alpha-fetoprotein (AFP) can become elevated in hepatocellular carcinoma (HCC), yolk sac tumors and other malignant tumors of various organs. Herein, the investigator present a case of AFP-producing gallbladder carcinoma with signet ring cells successfully treated with laparoscopic whole-layer cholecystectomy.


Eligibility Criteria:
The study eligibility criteria for patient were as follows: AFP-producing gallbladder carcinoma (cT2aN0M0, cStage IIa, UICC 8th) or gallbladder metastasis from HCC.
A Study of LY3473329 in Healthy Japanese Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3473329 in healthy Japanese participants. The study will also assess how fast LY3473329 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to about 71 days, inclusive of screening period.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined through medical history and physical examination.
* Are males who agree to follow contraception requirements or females not of childbearing potential.
* Are 1st generation Japanese defined as the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.

Exclusion Criteria:

* Have a history or presence of medical illness.
* Have significant history of or current psychiatric disorders.
* Have abnormalities in the 12-lead ECG and blood pressure.
* Have received treatment with siRNA within the past 12 months or any antisense oligonucleotide within the past 6 months for lipoprotein(a) \[Lp(a)\].
Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation

The study will follow a cohort of CI-candidates becoming CI-user, till two years postoperative. A through-out assessment of both their audiological and vestibular status will be carried out at multiple fixed timepoints over 2 years, evaluating both subjective (patients reported) and objective outcomes over time. For the audiological part of the study both pure-tone and speech audiometry results will be held against the patient perceived benefit of the treatment as assessed by the questionnaires NCIQ and SSQ-12. The vestibular part of the study will evaluate the function of the SCCs and the sacculus. This is will be put in concert with functional tests of the vestibular system, and the patient perceived outcome measure DHI. Correlations between vestibular and audiological performances will be examined. A collection of specific hypotheses will be tested by predefined statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Adults (At or above 18 years of age and capable of giving an informed consent)
* Cochlear implant candidacy
* Profound bilateral post-lingual hearing loss
* Proficiency in Danish
* Expected ability to participate on both all pre- and postoperative examinations
* No previous CI experiences

Exclusion Criteria:

* Later abandonment of CI candidacy
* Blindness or visual handicap compromising eye movement evaluation
* Distinct neck mobility handicap hindering either vHIT- or cVEMP examination
* Patient reluctance, such as consistent no-show or cancellations of appointments
* CI-surgery before preoperative evaluation could be obtained
* Simultaneous bilateral cochlea implantation.
* Sequential CI within the follow-up period
Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents

The purpose of this study is to evaluate a mobile application (app) called "Goal2QuitVaping" to help adolescents quit vaping nicotine. Goal2QuitVaping was developed by our research team to assist with quitting vaping. Participants will be randomly assigned to either download the mobile app, "Goal2QuitVaping", or not. If provided with Goal2QuitVaping, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. age 16-20
2. vaped nicotine on ≥20 days out of the last 30
3. elevated depressive symptoms, defined as a score of ≥10 on Patient Health Questionnaire-8 (PHQ-8) during preliminary screening and the Adolescent Patient Health Questionnaire-9 (PHQ-9A) at final eligibility
4. currently own an iOS or Android smartphone
5. report willingness to utilize an app for quitting vaping nicotine (response of "yes" on yes/no item)
6. have a valid e-mail address that is checked regularly or regular access to text messages (for follow-up assessments)
7. ability to read the consent form
8. has been seen (in person or remotely) by a primary care physician within the last year

Exclusion Criteria:

1. smoked cigarettes or used other tobacco products on ≥9 days out of the last 30
2. severe visual impairment
3. currently receiving treatment for vaping or tobacco use
4. current suicidal ideation, defined as a response ≥1 on item nine of the PHQ-9A or ≥2 on item 9 of the BDI-II
5. household member currently enrolled in the study
6. inability to read the consent form
VIsual Pathways Model in Neuro-inflammatory Disorders

In neuroinflammatory diseases of the central nervous system (CNS) such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD) and anti-MOG antibody-associated disorders (MOGAD), neuronal degeneration is the consequence of inflammatory and demyelinating lesions in the brain, optic nerve and spinal cord. Both white and grey matter are systematically affected. Lesions of the perivascular spaces containing cerebrospinal fluid (CSF) and meningeal inflammation seem to play an important role in the pathophysiology of these neuroinflammatory diseases. Currently, the interrelation of all these aspects is not clearly established in the pathophysiology of these diseases. In order to better understand the mechanisms that lead to and underlie the clinical disability of patients with these diseases, we need in vivo study models that allow the in-depth study of the neurodegenerative process and the identification of its causes. In this perspective, we make the hypothesis that the visual pathways model is very relevant to measure neuro-axonal loss and to explore the different mechanisms involved in neurodegeneration during MS and other CNS demyelinating diseases. Researchers have at their disposal many tools that allow them to analyse and quantify the neurodegenerative process in a reproducible and very precise manner from a structural and functional point of view, while taking into account possible vascular involvement (MRI, optical coherence tomography - angiography, etc...).


Eligibility Criteria:
Inclusion Criteria:

* - Male or female
* Aged between 18 and 65 years
* Presenting a clinical picture of optic neuritis for less than 4 weeks, confirmed by neuro-ophthalmological assessment
* Patient having given written consent to participate in the study
* Patient with social insurance
* Patient willing to comply with all study procedures and duration

Exclusion Criteria:

* - history of optic neuritis on the same side as the recent episode for which the patient is being treated
* history of retinal pathology (retinal detachment, glaucoma, retinopathies, retinal surgery)
* diabetes
* chronic alcohol intoxication
* contraindications to MRI
* pregnant women
* persons under protective supervision (ex : guardianship)
* minors
* persons deprived of their liberty
* administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent

A history of pre-existing CNS inflammatory demyelinating disease is not a criterion for non-inclusion.
Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease

Freezing of gait (FOG) is a common, disabling symptom of later stage Parkinson's disease (PD), and can induce significant morbidity and mortality by increasing risk of falls as the disease progresses. Despite optimum medical management and deep brain stimulation therapy, many patients with PD are incapacitated by FOG and gait disorders. Non-invasive vibrotactile stimulation has been reported to potentially improve FOG of patients with PD. However, results of studies were variable, and there is a lack of convenient vibrotactile devices ready for daily use with reliable clinical trial data. In the proposed study, the investigator will test the effect of a newly developed vibrotactile foot device (Smart shoe) on participants diagnosed with PD and FOG. EEG and fMRI are obtained in order to investigate the underlying neurological mechanism.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-80 years
* Diagnosed with Parkinson's Disease according to MDS Clinical Diagnostic Criteria
* Stable drug therapy without any change in the past one month
* Subjective presence of FOG more than once per day
* Objective presence of FOG by provoking tasks, e.g., gait initiation, rapid full turn, et al.
* Able to walk unaided at least 20 meters
* Provide written informed consent

Exclusion Criteria:

* Stroke and other diseases interfering ambulation
* Severe foot sensory impairments disabling the individual to perceive vibratory stimulation
* History of deep brain stimulation surgery
Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38

Spinocerebellar ataxia 38 (SCA 38) is a very rare autosomal dominant inherited disorder caused by a mutation in ELOV5 gene, specifically expressed in cerebellar Purkinje cells, encoding an enzyme involved in the synthesis of fatty acids. The present study aimed to assess the effect of cerebellar anodal transcranial direct current stimulation (tDCS) administered employing deltoid (CD-tDCS) and spinal (CS-tDCS) cathodal montage. Clinical evaluation was performed at baseline (T0), after 15 sessions of tDCS (T1) and after one month of follow-up (T2).


Eligibility Criteria:
Inclusion Criteria:

1. age ≤ 80 and \> 18 years
2. diagnosis of SCA 38 with the presence of clinical symptoms.

Exclusion Criteria:

1. Inability to understand and sign the informed consent
2. Presence of other severe neurological disorders
3. presence of significant medical or psychiatric illnesses
4. Pregnancy.