cyrilzakka/clinical-trials huggingface dataset:
Pivotal Trial of SAT-014 for Trauma and Stressor-Related Disorder Symptoms

The aim of this study is to evaluate the efficacy of SAt-014, a software as a medical device (SaMD), in alleviating symptoms of trauma and stressor-related disorders in patients with post-traumatic stress disorder (PTSD) or adjustment disorder (AD), compared to standard treatment, and to assess its safety for regulatory approval by the Ministry of Food and Drug Safety (MFDS).

Stress-related mental disorders, including Post-Traumatic Stress Disorder (PTSD) and Adjustment Disorder (AD), are caused by traumatic experiences or significant stressors. These conditions can lead to social dysfunction, decreased quality of life, and increased suicide risk if untreated. With high global prevalence and rising patient numbers, existing treatments such as psychotherapy and pharmacotherapy have limitations. Digital therapeutics (DTx) offer a more accessible, cost-effective solution with less external exposure. Based on studies showing the effectiveness of therapies like EMDR and MBCT, SAT-014, a cognitive therapy software, was developed. An exploratory clinical trial was conducted to assess its initial safety and efficacy for alleviating symptoms of PTSD and AD. This trial, involving 110 participants over 19 years old, aims to evaluate SAT-014's efficacy in comparison with conventional treatments and assess its safety. The primary efficacy endpoint is the change in PCL-5 score at Week 6 (Visit 7) compared to baseline, while secondary endpoints include changes in PCL-5, IES-R, BAI, PHQ-9, HAM-A, CGI, and SF-12 scores at various time points.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 years or older
* Diagnosed with Post-Traumatic Stress Disorder (PTSD) or Adjustment Disorder (AD) according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
* A score of 3 to 4 on the Clinical Global Impression-Severity (CGI-S) scale
* Able to access the internet and respond to app activity instructions
* Voluntarily decided to participate in this clinical trial and provided written consent by signing the participant information sheet and consent form

Exclusion Criteria:

* Those diagnosed with schizophrenia, bipolar disorder type 1, or psychotic disorders
* Those diagnosed with neurodevelopmental disorders, neurocognitive disorders, or organic mental disorders
* Those with severe depression (Patient Health Questionnaire-9 (PHQ-9) ≥ 20)
* Those with severe personality disorders
* Those diagnosed with substance use disorders (excluding nicotine and caffeine) or severe alcohol use disordes
* Those exhibiting active suicidal tendencies (suicidal thoughts, suicide attempts, or suicidal behavior)
* Those who have had a change in the type, dosage, or regimen of anxiolytics or antidepressants within 4 weeks of baseline
* Those currently participating in another clinical trial or who have participated in a clinical trial within 90 days prior to the screening visit
* Those deemed unsuitable for participation in the trial at the discretion of the investigator
Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)

This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two MRI-based methods. The intra-class correlation coefficient (ICC) for the repeated measurements is expected to be greater than 0.6.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to travel to MRI centers
* All patients have a BMI ≥27 kg/m2 at the prestudy (screening) visit
* Patient is male or female and at least 18 years of age
* At least 5 patients have type 2 diabetes mellitus or pre-diabetes

Exclusion Criteria:

* Female patient is pregnant or has a positive pregnancy test at screening;
* Patient has known liver disease other than fatty liver
* Patient has a history of neoplastic disease
* Patient is HIV positive
* Patient has known claustrophobia or other contraindication to MRI
Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy

The purpose of this study is the efficiency of es-ketamine on postoperative delirium among old patients with elective lobectomy

This study aimed to investigate the effect of IV es-ketamine vs saline on the incidence of postoperative delirium. It was hypothesized that IV es-ketamine would reduce the incidence of in-hospital delirium during cardiac surgery lobectomy

Eligibility Criteria:
Inclusion Criteria:

* 60 years old; There is no limit on the gender, ASA (American Society of Anesthesiologists )Ⅰ-Ⅲ

Exclusion Criteria:

* Emergency surgery, severe hepatic and renal dysfunction, shock or coma, psychiatric disease or central nervous system disorder or a history of long-term use of psychiatric medications, cognitive dysfunction, severe arrhythmia or bradycardia, ketamine allergy,drug abuse history and used other sedatives for nearly a week
Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension

Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could help to detect hypotension.


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing elective cesarean delivery performed under spinal anesthesia

Exclusion Criteria:

* patients with a heart rhythm disorder, Raynaud's disease or a history of vascular surgery of the upper limb
Impact of Soft Tissue Grafts on Tissue Alterations After Immediate Tooth Replacement

This study evaluates the impact of soft tissue grafts on soft tissue recession following immediate implant, provisional and bone graft placement in compromised sockets. One third of the patients received a collagen matrix (CM group), another third received a connective tissue graft removed from the palate (CTG group) and the final third did not receive any soft tissue graft (CTL group).

Preventing soft tissue recession following flapless immediate implant and provisional placement (IIPP) in sockets with facial bone dehiscences is a challenge, mainly in esthetic areas. This study evaluated the impact of soft tissue grafts on peri-implant alterations after 1-year follow-up. Twenty-four patients with one single failing maxillary incisor presenting facial bone dehiscence and receiving IIPP were randomly divided in three groups (n= 8 in each group): Control (CTL); Collagen Matrix (CM); Connective tissue graft (CTG). In addition to soft tissue grafts, all groups were treated with collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen. Clinical, photographic and tomographic analyses were performed at baseline, 6 and 12 months after surgery to evaluate tissue alterations.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a failing maxillary incisor with neighbouring teeth and harmonic gingival contour;
* Operated area with appropriate palatal/apical bone to install the implant;
* A buccal wall defect confirmed by cone beam computed tomography;
* Clinical attachment level \> 3 mm;
* Good oral hygiene with visible plaque index \< 20%;
* No bone loss in the neighbouring teeth;
* Implant primary stability \> 32N

Exclusion Criteria:

* History of periodontal surgeries in the failing tooth;
* Occlusal instability;
* Systemic alterations that could compromise the surgical procedure, such ass smokers, bruxists; drug users; patients with diabetes or pregnants.
* Active infection involving the gingival margin
* Patients undergoing radiotherapy in the head and neck area. Patients presented history of bone associated diseases or medication affecting bone metabolism;
Cost-Effectiveness Study on Establishing a Warfarin Counseling Clinic for Egyptian Patients With Mitral Valve Prostheses

The outcome of poor adherence to medications can be life threatening with certain drugs like warfarin. For each 10% increase in non-adherence to warfarin, there was a 14% increase in the risk of under-anticoagulation with significantly higher rates of morbidity and mortality. Furthermore, warfarin therapy is fraught with several inherent problems. These include a wide variation in dose requirement, delayed onset of anticoagulant effect, prolonged continuation after cessation of therapy, serious interactions with a wide range of medications and food items, risk of major hemorrhage related to overdosing, unpredictable control in presence of co-morbidities such as hepatic and renal impairment.

There is ongoing evidence that better outcomes are achieved when anticoagulation is managed by a pharmacist with expertise in anticoagulation management rather than usual care by physicians. Pharmacists can contribute to positive outcomes of therapy by educating and counseling patients to prepare and motivate them to follow their therapeutic regimens and monitoring plans, which will result substantially in improving the quality of care, reducing complications, and lowering hospitalization rates. Thus, beneficial effects of the pharmacist-managed counseling clinic have been repeatedly reported in terms of cost-effectiveness, patients' adherence to and knowledge about pharmacotherapy, and the outcome of treatment.

The objective of this study is to evaluate the cost-effectiveness of establishing a Medication Counseling Clinic for outpatients with mitral valve prostheses taking warfarin therapy in an Egyptian Teaching Hospital setting. Availability of this information could be used to target further quality improvement efforts, which may significantly improve outcomes for patients and cost containment efforts in an era when cost-effectiveness is at the forefront of healthcare policy initiatives.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (18-70) years.
2. Post mitral valve surgery patients.
3. Patients with a prescription of warfarin.

Exclusion Criteria:

1. Pregnant patients.
2. Patients with double and aortic valve replacement surgery.
3. Patients with biological prostheses.
4. Patients with congenital blood disorders.
Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity

Hepatitis B virus (HBV) leads to life-threatening disease like liver failure and liver cancer. For most, a cure is unattainable as current HBV antiviral therapy (using nucleoside analogues) are not able to clear the virus from their liver. While HBV treatments are typically administered alone (monotherapy), this study will explore the use of Ribavirin in combination with standard therapy to enhance current treatment regimens. Ribavirin is commonly used to treat Hepatitis C Virus (HCV) but there is evidence that Ribavirin also induces immune effects that are beneficial in HBV treatment. The aim of this study is to determine whether combination of Ribavirin and a nucleoside analog is more effective compared to nucleoside analog treatment alone. Enrolled patients will be followed for treatment response according to standard clinical and virological tests, as well as immune response to HBV. Our ultimate goal is to find a more effective treatment and improve health outcomes for persons living with HBV.


Eligibility Criteria:
Inclusion Criteria:

1. HBV Hepatitis B surface antigen (HBsAg) positive for a minimum of 24 weeks
2. HBV DNA level \>20,000 IU/mL
3. ≥ 18 years of age

Exclusion Criteria:

1. Willingness and ability to sign an informed consent
2. HBV nucleos(t)ides and/or interferon exposure within 24 weeks of study medication dosing
3. HIV and other immune compromising condition (e.g. cancer with the exception of non-invasive cutaneous malignancy, autoimmune condition) or therapy (i.e. systemic steroids, chemotherapy)
4. HCV co-infected
5. Cirrhosis (defined by biopsy criteria or as \>18.4 kilopascal (kPa) by transient elastography)
6. Creatinine Clearance \<60 ml/min
7. Baseline hemoglobin \<130 g/L in males and \<120 g/L in females
8. Unwilling or unable to use contraception (unless confirmed surgical sterilization)
9. Pregnancy confirmed by blood test
Diagnostic Performance of an Antigen Test for SARS-CoV-2 Infection (COVID-19)

A comparison of a direct antigen test for SARS-CoV-2 obtained by mid-turbinate swab with the reference standard rt-PCR test obtained by nasopharyngeal swab in outpatients with symptoms compatible with COVID-19.

This study plans to compare a direct antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) obtained by mid-turbinate nasal swab with a reverse transcription polymerase chain reaction (rt-PCR) test obtained by nasopharyngeal swab (the current reference standard) in a population of patients with symptoms suggestive of COVID-19 for fewer than 5 days. Subjects whose physicians have already ordered an rt-PCR test at a Carilion testing center will be screened and recruited by phone during a required scheduling call. The study coordinator will describe the study by phone, and the subject will be consented when they arrive at the testing center. After consenting, a mid-turbinate swab direct antigen test will be obtained just prior to the ordered nasopharyngeal swab and any other ordered tests. The subjects will receive their rt-PCR test results through the usual channels of clinical notification. The subjects will not receive their nasal antigen results. The antigen test results will be analyzed in a batch process and the results entered into RedCap by the study staff. The rt-PCR results will be extracted from the Epic electronic health record using patient identifiers and paired with the corresponding antigen result for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Acutely ill with one or more COVID-19 symptoms

Exclusion Criteria:

* Unable to speak English
* Unable to provide written informed consent
* Symptoms have lasted longer than 5 days
* Currently hospitalized
The Influence of Nocturnal Food Intake in Eating Behavior of Night Workers

This study aimed to verify the influence of night work and food intake during the night shift on the eating behavior of fixed night workers the next day.

Night work causes restriction of sleep time and circadian misalignment and, therefore, have been associated with nutritional and metabolic impairments. The objective of the present study is to verify the influence of night work and food intake in this period on the behavior of the following day. The workers selected by criteria and inclusion and exclusion will be evaluated at the baseline: anthropometric parameters, food consumption and perception, duration of food consumption, sleep habits and chronobiological pattern (sleep monitoring by actigraphy, chronotype, social jet lag), parameters biochemical (blood count, lipidogram, C-reactive protein, cortisol, glucose, insulin).Subsequently, 30 workers will integrate a randomized and controlled crossover clinical study with three randomly established interventions: (1) two nights of work without meals during the shift; (2) two nights of work with a meal during the shift; (3) two nights sleep. Participants will go to the laboratory the morning after the second night of each condition to offer a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating). It is expected to determine how nocturnal versus nocturnal work, and nocturnal fasting versus nocturnal fasting affect the next day's food choices.

Eligibility Criteria:
Inclusion Criteria:

* Agree to participate in the study and sign the Informed Consent Form (EHIC).
* No significant changes in body mass in the last 6 months.
* With stable food and sleep routine in the last two months.

Exclusion Criteria:

* Failure to provide the information or material necessary for the development of the study.
* Report of chronic non-communicable diseases.
* Report of diagnosed and untreated psychiatric disorders.
Sleep Device Testing to Promote Sleep in Infants

Infants often have sleep challenges. Most of these challenges in otherwise healthy children and due to behavioral insomnia. The goal for infants is to become independent sleepers by learning the process of self-soothing. This study hopes to determine if technology based on sensors is able to help teach self-soothing to infants.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 2-12 months.
2. Meets clinical criteria for behavioral insomnia of childhood, sleep association subtype, as defined by the International Classification of Sleep Disorders Manual.

Exclusion Criteria:

1. Diagnosed comorbid health problem that may disrupt sleep.
2. History of birth prior to 37 weeks gestational age.
Pelvic Area Extension Measurements for Four Types of Lumbopelvic Balance Using Three Different Methods

The main objective of this study is to describe for the first time the expansion reserve of the pelvic area (measurements using the EOS system) for each of the four morphotypes (Roussouly classification) commonly found in a population of healthy volunteers.

Secondary objectives:

A. The intra-judge reproducibility and the interrater reliability for the different tools used to measure hip extension will be evaluated. Intra-judge reproducibility (photography) and interrater reliability (goniometry and photography) for the different tools used for measuring hip extension will be evaluated.

B. The concordance between EOS measurements and measurements acquired via goniometry and photography will be evaluated.

C. Describe certain radiographic measurements via the EOS system for the four morphotypes

Eligibility Criteria:
Inclusion Criteria:

* The healthy volunteer must have given his/her informed and signed consent
* The healthy volunteer must be insured or beneficiary of a health insurance plan

Exclusion Criteria:

* The healthy volunteer is participating in another study
* The healthy volunteer is in an exclusion period determined by a previous study
* The healthy volunteer is under judicial protection, under tutorship or curatorship
* The healthy volunteer refuses to sign the consent
* It is impossible to correctly inform the healthy volunteer
* The healthy volunteer is pregnant, parturient, or breastfeeding
* The healthy volunteers had a history of chronic pain or surgery at the hip, the thoracolumbar spine or the sacroiliac area
* The healthy volunteer has a hip, knee or ankle abnormality
Glistenings and PCO Evaluation for the Envista MX60

Posterior capsule opacification (PCO) and glistenings development is among the primary reasons for sub-optimal visual capacity following cataract extraction surgery. Primary objective of this study is to evaluate the incidence of PCO and glistenings of the popular envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who underwent phacoemulsification at least 1 year prior to their enrollment at the study


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

Endothelial cell count less than 1900, glaucoma, IOP-lowering medications, former incisional surgery, former diagnosis of corneal disease, diabetes or autoimmune diseases
The Induction of IL-6 by NF-kB in PBMC in OSA

Aim of study:

1. To compare the level of IL-6 mRNA expression in peripheral blood monocytes between normal subjects and patients with OSAS
2. To compare the activation of NF-B in peripheral blood monocytes between control subjects and patients with OSAS; Check the correlation between level of L-6 mRNA expression and activation of NF-kB
3. To determine the effect of CPAP on the activation of NF-kB and IL-6 in peripheral blood monocytes in patients with moderate -severe OSAS

Obstructive sleep apnea syndrome (OSAS) has emerged in recent years as an important risk factor for cardiovascular morbidity. The mechanisms responsible for developments of cardiovascular sequelae in patients with OSA include hypoxia, hypercapnia, exaggerated negative intrathoracic pressure and bursts of sympathetic activity provoking surges in blood pressure and heart rate. Meanwhile, increase of inflammatory mediators, which included C-reactive protein (CRP), oxidative stress, adhesion molecules, vascular endothelial growth factor (VEGF) and proinflammatory cytokines (interleukin (IL) -1, IL-2, IL-6, IL-8, IL-10 and tumor necrotic factor- (TNF-)), also involve in the development of cardiovascular disease in patients with OSAS.

According to our preliminary study, serum levels of IL-6 and CRP were higher in patients with OSAS than control subjects and levels of both IL-6 and CRP were highly correlated with the lowest pulse oxygen saturation. Hypoxia triggered the production of IL-6 through the induction of NFB, which was demonstrated in ischemic heart disease and pancreatitis. However, this mechanism has not been prooved in OSAS.

Therefore, we conduct this study to prove our hypothesis (1) The mRNA expression of IL-6 in peripheral blood monocytes was significantly higher in patients with OSAS than control subjects (2) The activation of NF-k B in peripheral blood monocytes was more significant in patients with OSAS than control subjects, and the level of NF- kB activation is associated with the level of IL-6 mRNA expression (3) CPAP therapy could lower both the activation of NF-kB and IL-6 mRNA expression in patients with moderate-severe OSAS.

Eligibility Criteria:
Inclusion Criteria:

* severe obstructive sleep apnea (AHI\>=30 /hr) male older than 18 y/o

Exclusion Criteria:

* refuse participate, chronic lung disease active infection neurologic event