cyrilzakka/clinical-trials huggingface dataset:
A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

This is a Phase 3, open-label extension study to evaluate the long-term safety of repeat BOTOX treatments in adult participants with Platysma Prominence. Participants who completed the lead-in Phase 3 Study M21-309 and met eligibility requirements could enroll in this open-label extension study.

Planned study enrollment was approximately 270 participants. Participants who met treatment criteria could receive up to 3 administrations of BOTOX. Day 1 (study entry) was the same day as Day 120/study exit visit of the lead-in Phase 3 study. The first administration of study drug could occur at the Day 1 visit, and the last administration of study drug could occur at the Day 180 visit (60 days prior to Day 240/study exit). Once a subject was enrolled in this study, monthly follow-up visits occurred.


Eligibility Criteria:
Inclusion Criteria:

- Completion of all phases of the lead-in Phase 3 study (Screening Period, Treatment Period \[randomization/treatment with 4-month follow-up visit\] and Study Exit visit)

Exclusion Criteria:

* Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
* Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
* Anticipated need for surgery or overnight hospitalization during the study
* Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study
* Known immunization or hypersensitivity to any botulinum toxin serotype
* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months
* Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest
Effect of Exergame Program Structured Via Analytic Hierarchy Process on Trunk Control and Upper Extremity Functionality

The aim of the study is to investigate effects of structured exergame program on upper extremity functions and trunk control in children with Cerebral Palsy (SP). A 3 phase randomized controlled trial has planned to conduct. In the first phase, baseline assessments will be completed for all participants who are eligible to participate. After the baseline assessments, randomisation will be completed for Exergame and Activity Based Exercise groups. During this phase suitable video games for exergame program will be selected. Analytical Hierarchy Process (AHP) will be used to collect expert opinion for most effective video games for upper extremity functionality, postural control, GMFCS I-II-III levels. Second phase of the study will be started afterwards. Upon completing second assessments, interventions for both groups will be conducted. Third assessments will be completed after interventions and outcomes will be analyzed for primary results. The third phase of the study planned as follow-up period. All participant will continue their routine NDT trainings and follow-up assessments will be completed after 3 moths of the second assessments. Final results will be analysed for all participants.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with spastic cerebral palsy
* Gross Motor Level should be in between I-III according to Gross Motor Function Classification System (GMFCS)
* Manual ability levels should be in between I-IV according to Manual Abilities Classification System (MACS)
* No Botulinum toxin injections 6 months prior to study

Exclusion Criteria:

* Surgery history related to the musculoskeletal system (upper and lower extremities)
* Having communication problems
* Having secondary cognitive-behavioral problems addition to cerebral palsy (intellectual disability)
Sex Related Differences in Cardiac Function

The aim of the study is to investigate sex-specific differences in LV and RV function (systolic and diastolic) with regarding the development and progression of heart failure with preserved ejection fraction based on a retrospective data analysis. Lifestyle modification factors will be assessed for multivariate analyses in order to detect influencing factors. Progression will be analysed in a retrospective time series analysis.

Compared to men, women show a different cardiovascular risk profile, In this context, it has already been shown that mortality in women with cardiovascular diseases is increased. Along with this, there are first indications of an echocardiographic altered cardiac function. It was shown that women are more prone to heart failure with preserved ejection fraction. However, the underlying mechanisms and driving factors have not yet been fully explored. Moreover, the role of associated factors such as smoking, bodyweight or cardiovascular risk factors and menopause status remain nut fully understood.

In this project differences differences in sex-specific LV and RV function depending on defined risk factors will be investigated. For this purpose, a retrospective follow-up analysis willl be carried out. This is based on test results from patients who underwent transthoracic echocardiography in the echocardiography department of the Department of Cardiology, Pneumology and Angiology University Hospital Düsseldorf.

The aim is to evaluate possible differences in the sex-specific risk profile. This may allow us to define the cardiovascular risk profile in dependence from each sex more concretely.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent at least one transthoracic echocardiography in between 2019-2022

Exclusion Criteria:

* \< 18 years
Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. On this background, the TRIPLACE Registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic TTVR.

The primary aims of the registry will be:

* To examine the safety, efficacy, and long-term outcomes of TTVR
* To assess the incidence of procedural complications and their correlations with adverse clinical outcomes
* To investigate the impact of different pre/post-procedural factors on peri-procedural complications and long-term outcomes after TTVR
* To explore the characteristics of patients deemed eligible for TTVR.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Transcatheter Tricuspid Valve Replacement
* Native Tricuspid Valve disease
* Orthotopic Tricuspid Valve Implantation

Exclusion Criteria:

* Age under 18 years
Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis

The adjunctive topical subgingival application ozone gel creates a great improvements in the clinical, bacteriological and immunological parameters over the gold standard of periodontal pocket treatment alone.

The aim of this study is to compare the effect of using ozone gel as a locally delivered adjunct to scaling and root planning versus scaling and root planning alone on the clinical parameters in stageIII grade B in periodontitis patients with controlled diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with controlled diabetic type II. (HgA1C \<7) (Mori et al., 2021)
2. Adult patients above 18 years old.
3. Patients with stage III and grade B periodontitis.
4. Patients accept 3-months follow-up period (cooperative patients).
5. Patients provide an informed consent

Exclusion Criteria:

* 1. Presence of prosthetic crowns. 2. Extensive restorations. 3. Periodontal therapy within the last 12 months. 4. Having surgical therapy or undergoing orthodontic treatment. 5. Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.

  6. The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 3 months of follow-up.

  7. Smokers. 8. Pregnant females. 9. Any known allergies
Rheumatology Diet Study

This study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on their dietary habits and how it affects their autoimmune disease. The main objective is to see if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. It will also look at rheumatology patients' expectations for their rheumatologist when it comes to dietary advice and what resources they used to choose their new dietary habits. The study also seeks to measure the interest that rheumatology patients have in pursuing dietary changes as a means of controlling the symptoms of their autoimmune disease. It is expected that patients who changed their eating habits to healthier diets such as a Mediterranean diet would report less severe autoimmune disease symptoms. There are limited dietary recommendations for the management of many rheumatological diseases, so this study seeks to assess rheumatology patients' willingness to try dietary modifications, what improvements they had, and why they decide to make these changes in light of limited information.


Eligibility Criteria:
Inclusion Criteria:

* Adults (over 18 years old) patients
* established UCF Health patients
* diagnosed with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, dermatomyositis/polymyositis, Sjogren's Syndrome, systemic lupus erythematous, scleroderma, osteoarthritis, or fibromyalgia.

Exclusion Criteria:

* UCF Students, Faculty or Staff
* Children or Young Adults Under the age of 18
* Adults over 65
* Pregnant Women
* Prisoners
* Adults to Unable to Consent
Treatment Program for Anemia in AIDS Patients

The objective of the Eprex (erythropoietin) Treatment Program is to provide erythropoietin for the treatment of anemia in AIDS patients.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Life expectancy \< 3 months.
* = or \< grade 4 performance score.
* AIDS-related dementia.
* Uncontrolled hypertension.
* Acute symptomatic opportunistic infection or other AIDS-defining illness.

Patients with the following are excluded:

* Life expectancy \< 3 months.
* = or \< grade 4 performance score.
* AIDS-related dementia.
* Uncontrolled hypertension.
* Acute symptomatic opportunistic infection or other AIDS-defining illness.

Patients must have:

* A clinical diagnosis of AIDS.
* Hematocrit \< 30 percent.
* Endogenous serum erythropoietin level = or \< 500 U/ml.
* A life expectancy = or \> 3 months.
* \> Grade 4 performance score.
Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing

There are more than 2.1 million people in the United States with opioid use disorder, and according to preliminary data from the US Centers for Disease Control and Prevention opioid overdose deaths rose 36% to more than 69,000 deaths in 2020. Treatment with buprenorphine or methadone reduces overdose deaths in patients with opioid use disorder. However, most patients with opioid use disorder do not receive treatment. In addition to the rising rates of morbidity and mortality, the healthcare, social, and societal costs of the opioid epidemic are roughly one trillion dollars annually. Rapidly scalable strategies are needed to increase access to treatment and improve treatment retention.

The investigators propose a novel buprenorphine micro-dosing study to evaluate the pharmacokinetics, treatment retention, and qualitative outcomes in participants transitioning from methadone maintenance therapy to buprenorphine using a micro-dosing initiation in the outpatient setting. The proposed study will report participant pharmacokinetics, treatment retention, Clinical Opiate Withdrawal Scale (COWS) score, Treatment Satisfaction Questionnaire for Medication (TSQM) score, and other qualitative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Participants will include adults (at least 18 years of age) who have been enrolled and receiving consistent treatment in the methadone program for at least 6 months.

Exclusion Criteria:

* Participants will be excluded if they are on a methadone dose \> 80 mg, have concurrent alcohol use or benzodiazepine use disorder, require opioids for a pain-related diagnosis, are a current suicide or homicide risk, have a current psychotic disorder (DSM-V) or untreated major depression, have a life-threatening or unstable medical problem, or are pregnant.
The Effect of Sedation on Eye Movements

The purpose of this study is to determine whether sedation affects saccadic eye movements.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, human volunteers, age 19-65.
* American Society of Anesthesiology (ASA) class I-II for inclusion criteria

Exclusion Criteria:

* Pregnancy
* Respiratory disease (severe asthma, emphysema)
* Cardiac disease (coronary artery disease, congestive heart failure)
* Symptomatic reflux disease
* Advanced rheumatic disease involving cervical spine
* Propofol or egg allergy
* Neurological disease (stroke, intracranial processes)
* Severe anemia
Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability

This protocol will investigate physiological parameters including insulin sensitivity and counterregulatory function using a mixed meal test and induced hypoglycemia in subjects with type I diabetes.

The principal idea of the proposed research is: in order to be successful, closed-loop control of glucose in diabetes must adapt to individual physiologic characteristics and to the behavioral profile of each person. We propose to build a system that will use observers of patients' behavior and metabolic state and control modules that are responsible for insulin delivery and hypoglycemia prevention. In this phase of the project, we will investigate relationships of insulin sensitivity and impaired counterregulation with blood glucose variability, aiming to develop algorithmic physiology observers, which will track specific parameters of glucose variability and recurrent hypoglycemia as markers of change in a person's insulin sensitivity and counterregulatory ability.

Eligibility Criteria:
Inclusion Criteria:

* Type I diabetes mellitus (TIDM) (as defined by the American Diabetes Association criteria or judgment of a physician) for at least two years prior to the enrollment in the study.
* Use of an insulin pump to treat their diabetes for at least six months prior to the study.
* Ability to use a bolus calculator function with the current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
* Age 21 - 64 years. Adults age 65 and over are likely to have medical exclusions for the follow-up Phase 2 study, which involves induced hypoglycemia.
* Completed Phase 1 of the Institutional Review Board (IRB) #14956 "Development of a Behavioral Observer for Type 1 Diabetes Mellitus"
* Willingness to use lispro (Humalog) insulin two days prior to and during inpatient admission.
* Willingness to perform Self-Monitoring Blood Glucose (SMBG) 4 times per day at times before meals and bedtime.
* Demonstration of proper mental status and cognition for completion of the study.

Exclusion Criteria:

* Pregnancy
* Psychiatric disorders that would interfere with study tasks (e.g. mental retardation, substance abuse)
* History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans
* Known bleeding diathesis or dyscrasia
* Active enrollment in another clinical trial
* Medical condition that would make operating an insulin pump difficult (e.g. blindness, severe arthritis, extensive scar tissue at sites where devices are inserted).
* Anemia (hematocrit \<36% \[females\], \<38% \[males\]),
* Allergy or adverse reaction to lispro (Humalog) insulin
* Conditions which may increase the risk of induced hypoglycemia such as symptomatic heart disease, congestive heart failure, history of a cerebrovascular event, atrial fibrillation, renal insufficiency (creatinine \>1.5) or uncontrolled hypertension (resting blood pressure \>140/90).
Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers

The purpose of this study was to compare the safety and pharmacokinetic characteristics of DWP422 25 mg with those of ENBREL 25MG PFS INJ. after subcutaneous injection in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males, 20 to 45 years of age the moment of screening
2. Body mass index is between 19.0 and 27.0 kg/m2

Exclusion Criteria:

1. Hypersensitivity response to the experimental and comparator drugs
2. The tuberculosis patient or latent tuberculosis patient
Bridging the Adherence Gap in Internet Interventions: A Randomized Controlled Trial Protocol

Low adherence in self-guided internet interventions might lead to worse outcomes. This randomized controlled trial aims to test whether adherence can be improved if self-efficacy regarding adherence to internet interventions is boosted before the intervention starts. It is expected that enhancing this specific type of self-efficacy will increase people's adherence and help them fully benefit from the intervention, namely experience lower job stress and higher work engagement.

Low adherence can lead to poor outcomes in self-guided (i.e., self-administered) internet interventions that is psychological programs designed to improve mental health. One modifiable personal factor that may improve adherence is context-specific self-efficacy. In this two-arm randomized controlled trial, participants (medical students, N = 720) will undergo an internet intervention called Med-Stress Student designed to enhance resources such as self-efficacy to cope with stress and perceived social support. In the experimental group, Med-Stress Student will be preceded by an exercise designed to boost self-efficacy to adhere to this internet intervention. In the control condition, participants will only access Med-Stress Student. Conditions will be compared on adherence as well as on the intervention outcomes (i.e., job stress and work engagement) at posttest, and at six-month, and one-year follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* must be at least 18 years old
* must be a medical student or intern who already has direct contact with patients

There are no criteria for exclusion.
How Simplified Language Affects Comprehension and Learning in Young Autistic Children

The long-term study goal is to experimentally evaluate the components (and likely active ingredients) of early language interventions for young children with ASD. The overall objective is to determine how single-word and telegraphic simplification affects real-time language processing and word learning in young children with ASD (relative to full, grammatical utterances). The proposed project will investigate three specific aims: 1) Determine how single-word and telegraphic simplification affects language processing. 2) Determine how single-word and telegraphic simplification affects word learning. 3) Evaluate child characteristics that may moderate the effects of linguistic simplification on language processing and word learning. Aim 1 will test the hypothesis that children with ASD will process full, grammatical utterances faster and more accurately than single-word or telegraphic utterances. Aim 2 will test the hypothesis that full, grammatical utterances will support word learning better than telegraphic or single-word utterances. Aim 3 will test the hypothesis that language and cognitive skills significantly moderate the effects of linguistic simplification on language processing and word learning in young children with ASD.


Eligibility Criteria:
Inclusion Criteria:

* Existing or suspected autism spectrum disorder, confirmed through ADOS-2
* English as primary language
* 1-4 years old

Exclusion Criteria:

* Known genetic condition (e.g., Down syndrome, fragile X)
* Cerebral palsy
* Acquired brain injury
* Uncorrected vision or hearing impairment
Causes of Fetal Death: Comparison of Diagnostic Accuracy Between Extensive and Selective Protocol Testing

Intrauterine fetal death (IUFD) is defined as the occurrence of fetal death at \>20 weeks' gestation. IUFD affects about 1 in 160 pregnancies (6-7 per 1000 births). Optimal diagnostic evaluation for cases of IUFD is generally based on extensive protocol testing i.e. maternal and fetal blood tests, fetal bacteriology, cytogenetic analysis, autopsy, and placental examination. This extensive protocol testing may vary in clinical practice and interpretation of the results is rarely performed by multidisciplinary staff to establish cause of death. These findings are related to the fact that there are very few epidemiological studies to validate optimal protocol, no French recommendations on this subject, and a relative lack of pathologists with expertise in perinatal pathology. Only, one recent prospective study from the Netherlands has concluded that extensive protocol testing should be redefined and some diagnostics tests may only be performed with suggestive clinical circumstances. However these recommendations may not be applicable to all populations and countries. To date, there are no French published series on IUFD to evaluate causes of death in France and thereafter to better define optimal diagnostic evaluation tests. Improvement in prenatal diagnosis in France may contribute to detection of the vast majority of severe chromosomal abnormalities and malformed fetuses and particularly those at risk of death. Retrospective cohort unpublished data on IUFD from Lille and Caen have reported exceptional deaths attributable to chromosomal or malformation abnormalities. In fact in these two series, most deaths were related to placental diseases or fetal growth retardation. The hypothesis is that extensive protocol testing is not helpful in clinical practice and selective protocol testing focused on specific risk situations can be as efficient.


Eligibility Criteria:
Inclusion Criteria:

* Singleton fetus
* Intrauterine fetal death diagnosed antepartum
* Gestational age \> 22 weeks
* Woman informed
* No women aged under 18 years

Exclusion Criteria:

* Pregnancy termination
* Intrapartum death
* Person placed under judicial protection, guardianship