cyrilzakka/clinical-trials huggingface dataset:
Sphingolipidomic Profile in Anorexia Nervosa

: The objective of this research project will be to determine the sphingolipidomic profile in a group of women (\> 18 years) affected by Anorexia Nervosa (AN), phenotypically characterized (restricting \[AN-R\] vs binge-eating purging \[AN-BP\]). Specific questionnaires will be administered for the definition of the severity of the eating disorder and depressive state (suicidality), to which will be added the evaluation of gonadal function (i.e., plasma levels of estradiol/progesterone and use of oral contraceptives).

Based on the specific lipidomic profile, which the present research project hopes to characterize, it will be possible to appropriately modify the diet of rehabilitation programs and, in the future, improve the effectiveness of the treatment itself, especially in the long term.


Eligibility Criteria:
Patients with Anorexia Nervosa:

Inclusion Criteria:

* Female sex
* Age: 18 years or older
* Diagnosis of Anorexia Nervosa in the acute phase
* Hospitalized at the Division of Eating and Nutrition Disorders (END), San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy

Exclusion Criteria:

* Absence of signed Informed Consent

Control group:

Inclusion Criteria:

* Female sex
* Age: 18 years or older
* BMI between 18.5 and 24.9 kg/m2

Exclusion Criteria:

* Absence of signed Informed Consent
Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging

The primary goal of this study is to better understand how Transmyocardial Laser Revascularization (TMR) affects the functioning of the heart and, in turn, relieves angina in individuals with coronary heart disease using Magnetic Resonance (MR) images and Computed Tomography (CT) images in some patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or over
* Patients with medically refractory, severe, class III or IV angina based on the Canadian Cardiovascular Society angina scale as determined by a physician
* Ejection fraction 25% or greater
* Patients with significant ischemia in the myocardium and who are NOT candidates for treatment by direct coronary revascularization methods (i.e., CABG or PCI)
* Ability and willingness to consent and Authorization for use of PHI

Exclusion Criteria:

* Patient cannot undergo a surgical procedure or general anesthesia
* Patient not eligible for CMR study
* Severe unstable angina
* Q-wave MI within 3 weeks prior to TMR
* NQWMI within 2 weeks prior to TMR
* Decompensated heart failure (class III/IV) at the time of procedure
* Known increased bleeding risk
* Implanted pacemaker or defibrillator
* Clinically unstable arrhythmia
* Not able or willing to adhere to the study tests and procedures
* Inability or unwillingness to consent and Authorization for use of PHI
Online Family Support and Education for Schizophrenia

This study evaluated the benefits of providing relatives of patients diagnosed with schizophrenia the opportunity to interact with each other using the Internet. It was hypothesized that patients whose relatives had access to the internet intervention would have reduced symptoms and greater community tenure, compared to their counterparts who did not have relative access to the internet education and support program. We also collected information on how frequently the relatives used the website and how well they liked its features.

Although psychoeducational programs for schizophrenia can reduce patient relapse rates and reduce family distress, participation rates are often low. This study evaluated an online model to provide the families of schizophrenia patients with knowledge of illness management to reduce family burden and increase perceived social support.

Relatives of patients with schizophrenia who received 12 months of customary care with access to the educational website for the first year were compared to matched group of relatives of individuals diagnosed with schizophrenia who were receiving customary care and who consented to participate in a family education program. In the education condition, relatives were provided with private, secure access to the website, which features family-to-family chat capabilities, video lectures on the management of schizophrenia, written materials on important issues in schizophrenia management, professionally facilitated online discussions of the material, and additional resource links.

Relatives were assessed using 90-minute interviews at the beginning of the project and every 6 months for 12 months. The interviews were used to assess the family member's perception of the patient's symptoms, his or her knowledge of the illness, the illness's impact on the family member, and his or her perception of the website intervention.

Patients with schizophrenia or schizoaffective disorder were also asked to complete interviews and assessments at the beginning of the project and every 6 months for 12 months. The assessments include questions about symptoms, medication compliance and side effects, hospitalizations, and social functioning.

The major hypotheses were that relative participation in the online program would be associated with lower symptoms rates and hospitalizations in the patients.

Eligibility Criteria:
Inclusion Criteria for Patients:

* Diagnostic and Statistical Manual (DSM-IV) research diagnosis of schizophrenia or schizoaffective disorder
* Stable antipsychotic medication regimen for at least 1 month
* Willing to participate in in-person assessments

Inclusion Criteria for Relatives:

* At least 4 hours of weekly contact with patient
* Willing to participate in in-person assessments
* -Interested in a family education program for schizophrenia
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration

To compare brolucizumab to aflibercept in Chinese patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)

This was a randomized, double-masked, multicenter, parallel-group, active-controlled study. The study included 14 scheduled visits over 48 weeks. After confirmation of eligibility at baseline, participants were randomized in a 1:1 ratio to one of the 2 treatment arms:

* Brolucizumab 6 mg: 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.
* Aflibercept 2 mg: 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40. Disease activity assessments (DAAs) were conducted by the masked investigator for both treatment arms at Weeks 16, 20, 32 and 44 to determine the regimen of brolucizumab arm (i.e., q12w or q8w).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment was performed.
* Male or female Chinese participants ≥ 50 years of age at the time of screening.
* Active CNV lesions secondary to AMD that affect the central subfield (including retinal angiomatous proliferation lesions with a CNV component) in the study eye at screening and confirmed by the Central Reading Center (CRC).
* Total area of CNV (including both classic and occult components) must comprise \> 50% of the total lesion area in the study eye at screening and confirmed by the CRC.
* Intra and/or subretinal fluid affecting the central subfield of the study eye at screening and confirmed by the CRC.
* BCVA between 78 and 23 letters, inclusive, in the study eye at screening and baseline using ETDRS testing.

Exclusion Criteria:

* Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at baseline.
* Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by color fundus photography at screening and confirmed by the CRC.
* Total area of fibrosis ≥ 50% of the total lesion in the study eye at screening and confirmed by the CRC.
* Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at screening and confirmed by the CRC.
* Previous treatment with any approved or investigational drugs for nAMD in the study eye (other than vitamin supplements).
* Retinal pigment epithelium rip/tear in the study eye at screening.
* Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to baseline.
Child Behavior After Local Anesthetic Injection Using Needless Systems

The aim of this study is to evaluate the effect of needless injection (comfort in ject) on child behavior and its effect on adjacent oral mucosa and soft tissue in children during local anesthesia injection in comparison to the conventional injection technique


Eligibility Criteria:
Inclusion Criteria:

* According to Wright's classification of child behavior, children are classified as cooperative or possibly cooperative.
* Children who are medically fit.
* Children who are capable of interacting on a mental level.
* Children between the ages of 6 to 8.
* First dental visit.

Exclusion Criteria:

* Children who struggle with behavioral control (uncooperative).
* Children who have a history of allergic reaction to local anesthetic drugs.
* Parental rejection for participation.
The Use of Artificial Intelligence (AI) for Gait Analysis

The main purpose of this study will be to assess the consistency and reliability of measurements made using the Vicon three-plane gait analysis device (Vicon Motion Capture System Ltd, Oxford, UK) and a mobile application based on image recognition technology with the help of artificial intelligence.

The study will involve 50 healthy, physically active people aged 20-25. The participants will be subjected to movement analysis using the Vicon three-plane gait analysis system using reflective markers. Each of them will make 6 walks at their natural pace along a 10 m long path, during which a three-plane image of their walking will be recorded by the Vicon system. Additionally, during the examination, video recording of the full gait cycle in the sagittal plane from both sides, in the front plane from both sides and at an angle of 30, 45 and 60 degrees will be made using a smartphone camera. The recorded gait cycle using the camera will be analyzed in an image recognition application, which will generate angular values of the lower limb joints. First, the values generated by the Vicon system and the application from the sagittal plane recording will be compared. Then, the consistency of the values generated by the application from the recordings in the sagittal plane on both sides for the same lower limb will be checked. The last step will be to compare the compliance of the angular values from the Vicon system with the data generated in the application from recordings at angles of 60, 45, 30 and 0 degrees.

Eligibility Criteria:
Inclusion Criteria:

* healthy people aged 20-25 years

Exclusion Criteria:

* orthopaedic disease
* neurological disease
* rheumatological disease
* pain in lower limbs in the last 6 months
* pain in lumbar spine in the last 6 months
* surgeries of lower limbs in the last 6 months
* surgeries of spine in the last 6 months
* musculoskeletal injuries in the lower limbs in the last 6 months
* musculoskeletal injuries in the lumbar spine in the last 6 months
* overweight and obesity, determined on the basis of the BMI value
Study of the Role of Innate Lymphoid Cells and Natural Killer Cells in Immune Activation of Vitiligo - INNATE Vitiligo

The cohort included only major patients with non-segmental vitiligo and no other autoimmune or inflammatory associated diseases (except thyroiditis). Control subjects should have no autoimmune or inflammatory diseases. Patients and controls should not take treatment with corticosteroids or other potentially immunomodulatory therapies. Patients and controls are recruited in the Dermatology Department of the University Hospital of Nice and the Hospital of Fréjus. The investigators have already initiated the collection of tissues and blood from patients and control subjects and we have succeeded in isolating ILCs and NKs from a blood volume of 50ml. We were able to sort the ILC subpopulations. Early data suggest an increase in Natural Killer (NK) and Innate Lymphoïdes Cells 1 (ILC1) in the blood of vitiligo patients compared to control subjects. The investigators also managed to extract the melanocytes from the skin biopsies of the first patients and control subjects.

The investigators want study the presence and type of ILC and NK in the blood and skin of vitiligo patients compared to control subjects.

Eligibility Criteria:
Inclusion Criteria:

vitiligo subjects :

* patients in the cohort with non-segmental vitiligo
* without other autoimmune or inflammatory diseases associated

control subjects :

* subject without autoimmune or inflammatory disease
Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar

The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.

Pediatric Bipolar Disorder (PBD) severely impairs a child's emotional development, and is associated with alarming rates of suicide, school failure, aggression, risk taking behaviors and substance abuse (Geller et al, 1998; 2001; Carlson et al, 1998). At present, very little is known about the pathophysiology or optimal treatment of PBD. The long range goals of this proposal are threefold: to investigate a range of pharmacotherapeutic agents that are safe and efficacious for PBD, to use fMRI techniques to examine abnormalities in brain function in this disorder, as well as any change in brain function after treatment.

In contrast to the adult literature, we are aware of only two prospective studies assessing the efficacy of standard mood stabilizers in a pediatric sample. In one, lithium was found to be moderately effective in PBD with comorbid substance abuse (Geller et al, 1998). In the other, divalproex sodium, lithium and carbamazepine produced a maximum of 50% symptom reduction (Kowatch et al, 2000). Subsequently, Kafantaris et al (2001) observed a potentiation of lithium's antimanic effect when combined with risperidone. Further, a prospective, open trial of olanzapine for PBD reported a 70% symptom reduction (Frazier et al, 2001) with a retention rate of 96% compared to only 7% with classic mood stabilizers (Kowatch et al, 2000).

Thus, parallelling adult studies (Sachs et al, 2000), novel antipsychotics are a promising treatment in this population. Further, up to 60% of acute PBD episodes present with psychotic features (Geller et al, in press). Finally, the time to full effect with mood stabilizers is often 4 weeks in children (Kowatch et al, 2000; Geller et al, 1998; Kafantaris et al, 2001), whereas antipsychotics usually have a more rapid response onset (Pavuluri et al, in press). Given the potential efficacy of novel antipsychotics for PBD, the aim is to conduct a randomized trial comparing a novel antipsychotic to a standard mood stabilizer:

Eligibility Criteria:
Inclusion Criteria:

* Children with Bipolar Disorder
* Must be able to swallow tablets

Exclusion Criteria:

* Children with general medical condition such as head injury, epilepsy, endocrine disorders
* Those who are on mood altering medications such as steroids, and those diagnosed with mental retardation are excluded to avoid confounding and contributing factors to mood swings.
* If we discover during the interview that the parent and/or child does not understand the consent/assent procedures, we will exclude them.

We expect only a small number of children to be excluded from the study due to exclusionary criteria. Selection of the subjects is not based on sex, race, or ethnic group.
PSA TOOL for Prostate Cancer Screening Discussions

The study team created a tool to help identify patients who may benefit from shared decision making in the primary care setting. This tool is a guide to aid in decision making for prostate cancer screening. The team proposes the topics to be discussed in the screening conversation include the risk for developing prostate cancer based upon age, race/ethnicity, family history of prostate cancer, history of previous digital rectal exam, and history of previous prostate specific antigen (PSA) as well as self-reported health status and preferences for treatment. The team now proposes 1) testing this tool first for ease of use in primary care clinics 2) revising this tool based upon feedback from patients and providers, then 3) testing this tool for effectiveness in improving patient knowledge that they have an option to be screened for prostate cancer and of specific factors to be considered in the screening decision.

Objectives:

1. To pilot test a decision making tool, the PSA TOOL, for prostate cancer screening for usefulness and ease of use in primary care practices.
2. To revise the PSA TOOL based upon provider and patient feedback.
3. To assess patient knowledge about the option to be screened for prostate cancer and factors to consider in the prostate cancer screening decision before and after use of the tool.

Study Design:

This protocol is for field testing of a brief tool to improve prostate cancer screening discussions that occur at previously scheduled primary care outpatient visits.

Eligibility Criteria:
Inclusion Criteria:

Provider:

* Provider at selected primary care practices in the Cleveland Clinic Health System
* Willing to utilize a guide to aid in decision making for prostate cancer screening

Patient:

- Patient of participating Cleveland Clinic primary care provider who is scheduled for a routine appointment with the provider

Exclusion Criteria:

* Not a patient or provider of the Cleveland Clinic Health System
Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers

To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male Japanese subjects between the ages of 21 and 50 years inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Positive result for HIV, Hepatitis B surface antigen (HbsAg) or HCV antibody.
* Hypersensitivity/allergic reactions to any component of maraviroc, including soy lecithin.
rTMS Over S1 Enhance Motor Learning in Healthy People

The purpose of this study is to compare the effectiveness of different repetitive Transcranial Magnetic Stimulation protocols for enhancing motor learning in healthy peolple.

This randomized clinical trial aims to compare the effectiveness of different repetitive Transcranial Magnetic Stimulation (rTMS) protocols in enhancing motor learning in healthy individuals. It focuses on two key brain areas: the primary motor cortex (M1) and the primary somatosensory cortex (S1), recognized for their roles in motor skill acquisition and execution.

Motor learning involves two distinct neural networks: the associative/premotor and sensorimotor networks. Studies suggest that the associative/premotor network predominates initially, followed by the sensorimotor network. M1 stores movement patterns, whereas S1 appears crucial for initial motor learning and movement adaptation.

rTMS, a non-invasive technique modulating neuronal excitability, has been used to improve motor function in patients with brain injuries. However, its effectiveness in healthy individuals has been variable, especially when stimulating M1 and S1. Prior research suggests that inhibitory rTMS in S1 may influence motor learning, but findings regarding its excitatory effect and comparison with M1 stimulation are mixed.

The primary hypothesis posits that excitatory rTMS in S1 will yield superior motor learning improvements compared to M1 stimulation in healthy individuals. The secondary hypothesis predicts improvements independent of the stimulated area.

The study will involve healthy participants, utilizing tests for accuracy and time. Methodology includes randomization, blind evaluation, and rTMS application based on assigned groups.

With a sample size of 35 subjects per group, data will be analyzed using parametric and non-parametric statistical tests to compare the effects of rTMS on M1 and S1 concerning motor learning in healthy subjects. Results will be considered significant with p \< 0.05, and effect size will be evaluated.

This trial aims to provide clarity on the effectiveness of excitatory rTMS in specific brain areas to enhance motor learning in individuals without neurological pathologies, potentially impacting rehabilitation and motor performance.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old and younger than 65

Exclusion Criteria:

* Presenting any neurological pathology
* Pain during the study
* Any contraindications to rTMS, such as metal implants, history of epileptic seizures or taking medication that lowers the seizure threshold
Study Evaluating Single Doses of ILV-095 in Healthy Subjects

The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women of non-childbearing potential ages 18 to 50 years old.
2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to50 kg.
3. Healthy as determined by the investigator on the basis of screening evaluations.
4. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
5. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Any subject who had orthopedic surgery within 12 weeks of the screening visit or has planned (elective) orthopedic surgery within 12 weeks of study drug administration.
3. Acute disease state (eg, nausea, vomiting, fever, active infection, or diarrhea) within 7 days before enrollment.