cyrilzakka/clinical-trials huggingface dataset:
Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study

It has been shown that reactions of human retinal photoreceptors to a light stimulus can be measured with custom-made, research prototype optical coherence tomography (OCT) systems. This can be used as a biomarker for the function of the photoreceptors. Due to the high technical demands on the system, however, the technique is currently not available for clinical purposes. In this pilot study a protocol to measure changes in retinal photoreceptor layer thickness before and after light stimulation shall be developed based on a commercial OCT system and newly developed algorithms. Other variables, such as circadian processes shall be investigated as well. After measurements in healthy volunteers, the protocol is planned to be applied in patients with primary open angle glaucoma (POAG) and age-related macular degeneration (AMD) to test for feasibility of the method in these patient groups.


Eligibility Criteria:
Inclusion Criteria:

* men and women aged over 18 years
* signed informed consent form
* ametropia below 3 diopters
* ability and willingness to follow instructions

for healthy volunteers:

* normal ophthalmologic findings

for primary open angle glaucoma patients (POAG):

* diagnosed POAG
* MD \<= 10 dB

for age-related macular degeneration (AMD):

* diagnosed dry AMD
* diagnosed stage II or stage III AMD

Exclusion Criteria:

* Presence of any abnormalities preventing reliable measurements
* Ocular inflammation and ocular disease interfering with the study aims
* Use of photosensitizing medication (phototoxic drugs, photoallergic drugs) in the 3 months preceding the study
* Presence of any condition with the possibility of causing photosensitivity, including systemic lupus erythematosus SLE, Porphyria, Vitiligo, Xeroderma Pigmentosum and Albinism
* Presence of any form of epilepsy
* Ocular surgery in the 3 months preceding the study
* Pregnancy, planned pregnancy or lactating
* Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents. Sierra 75 Study

This prospective registry is intended to evaluate the safety and efficacy of the XIENCE Sierra stent.

This prospective registry is intended to analyze clinical outcomes in elderly patients treated with XIENCE Sierra stent and in pre-established subgroups (stable and unstable coronary artery disease).

Eligibility Criteria:
Inclusion Criteria:

* Age\> 75 years.
* With indication of percutaneous revascularization.
* Presence of de novo coronary artery lesions located in a native coronary artery.
* Informed consent signed

Exclusion Criteria:

* Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention)
* Cardiac arrest before the PCI
* Life expectancy of the patient under 1 year
* Participation in another study with a drug or device in clinical research
* Clinical decision that excludes the use of drug-eluting stents
* Confirmed allergy to aspirin and / or thienopyridines.
Stratification for F-L Therapy After LT

Objective: To stratify recipients who underwent adjuvant FOLFOX plus lenvatinib (F-L) therapy following liver transplantation (LT) for hepatocellular carcinoma and provide guidance for clinical adjuvant therapy.

Methods: Liver recipients in the Shulan (Hangzhou) Hospital from January, 2017 to December, 2021, including 106 in the F-L therapy group and 229 in the non-adjuvant (N-A) therapy group were included in the analysis. A 1:1 propensity score matching (PSM) analysis was performed to minimize group imbalances. Disease-free survival (DFS) and overall survival (OS) were compared among recipients. Radiomics features that demonstrated predictive value for recurrence were employed, either independently or in conjunction with prognostic clinical features, to formulate predictive models. The combined model was used to perform further subgroup analysis for recipients in the F-L therapy group.


Eligibility Criteria:
Inclusion Criteria:

* patients fulfilling the Hangzhou criteria or exceeding the Hangzhou criteria with type 1 or 2 portal vein tumor thrombus (PVTT) before LT

Exclusion Criteria:

* 1) individuals less than 18 years old; 2) individuals with malignancies other than HCC; 3) individuals who survived less than 30 days after LT; and 4) individuals who lacked important prognostic variables, such as contrast-enhanced CT imaging information one month before transplantation, preoperative alpha-fetoprotein (AFP) levels, and tumor differentiation data
Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840

This exploratory study will investigate the effects of ALXN1840 on copper balance in participants with Wilson disease (WD).

Participants who are treatment experienced (which includes standard-of-care therapies or ALXN1840) and treatment naïve are eligible for this study.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of WD by Leipzig Criteria ≥ 4.
2. Able to reside in the clinical research unit for intensive metabolic monitoring of copper and molybdenum.
3. Participants willing to adhere to copper/molybdenum-controlled diet during the study.
4. Willing and able to follow protocol-specified contraception requirements.
5. Capable of giving signed informed consent.

Exclusion Criteria:

1. Decompensated cirrhosis or model for end stage liver disease score \> 13.
2. Modified Nazer score \> 7.
3. Clinically significant gastrointestinal bleed within past 3 months.
4. Alanine aminotransferase \> 2 × upper limit of normal.
5. Hemoglobin less than lower limit of the reference range for age and sex.
6. Significant medical history (current or past).
7. Previous treatment with zinc within 30 days prior to the Screening Visit.
8. Participants in renal failure, defined as in end-stage renal disease on dialysis (chronic kidney disease stage 5) or creatinine clearance \< 30 milliliters/minute.
Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA

To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy and are unresectable. With "lung," "heart," "liver," "spinal cord," and "esophagus" as common risk organs in the treatment plan for BNCT using therapeutic CT to evaluate the safety and efficacy of BNCT in patients with unresectable and recurrent thoracic solid tumors which are difficult to treat with standard radiation and drug therapy.

To evaluate the safety of ［18F］FBPA synthesized with MPS200FBPA. In addition, the usefulness of ［18F］FBPA-PET testing to determine the appropriateness of performing BNCT will be evaluated in an exploratory manner.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained from the subject.
* Patients with histopathological diagnosed malignant tumor (except cutaneous angiosarcoma)
* Measurable disease, as defined by RECIST v1.1.
* Patients diagnosed with recurrent malignant tumors that are unresectable and perceived challenging to treat with standard treatment.
* Patients with ECOG performance status score of 0 or 1.
* Patients whose longest diameter sum of the lesions to be treated is 15 cm or less.

Exclusion Criteria:

* Patients with active disease or active double cancers other than target lesions.
* Patients with imaging findings that affect imaging evaluation of the tumor, such as ground-glass opacities
* Patients who received radiation therapy exceeding 65 Gy as a prior treatment for the target lesion.
* Any serious concomitant disease that precludes completion of the study treatment.
* Patients with remaining complications of Grade 3 or higher related to prior radiation therapy in the irradiation field.
PortionSize Study 1 Laboratory-based Evaluation)

The objective is to test the accuracy and user satisfaction of the PortionSize™ app and the MyFitnessPal© app during laboratory controlled test meals.

Accurately quantifying food intake is vital to promoting health and reducing chronic disease risk. Food intake encompasses energy intake, nutrient intake (macronutrients, micronutrients, vitamins, minerals), and intake of various food groups (e.g., fruits, vegetables), and thus reflects the nutritional status of individuals. Nutrition affects disease risk, including risk of developing obesity, diabetes, and cancer, all of which negatively affect the United States (U.S). Nonetheless, accurate assessment of food and nutrient intake has remained challenging, despite an improvement in methods. Self report methods, namely food records, are a mainstay of nutritional epidemiology research, with food recall being another popular method. These methods rely on the participant to accurately estimate portion size and, for food recall, remember what was consumed. The accuracy of these methods have been questioned and the problems with human recall have been comprehensively outlined. As a result, there remains a significant need for methods that are sufficiently accurate to provide researchers with good outcome data and to guide health promotion efforts.

The PortionSize™ app was designed by our laboratory to overcome the limitations outlined above, and to guide users to follow specific diets. PortionSize relies on users capturing images of their food selection and waste. Food intake data are immediately provided since the user relies on built in tools, including templates, to estimate portion size. However, despite promising early indications, the PortionSize app's validity has yet to be extensively tested. Determining the accuracy of PortionSize is vital before users can utilize the app to obtain immediate feedback about their food intake. We accordingly aim to test the validity of PortionSize in a controlled laboratory setting. We will also test the validity of the MyFitnessPal© app, which is similar to an electronic food record.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18-70 years
* Body mass index (BMI) 18.5 - 50
* Ownership of an iPhone model 6s or later, which the participant is willing to use for the study
* Access to Apple ID, password, and email address and willing to use them in the course of the study
* Willing to use data and any accompanying charges as part of study participation
* Willing to be re-contacted for future research and/or follow-up

Exclusion Criteria:

* Center employee
* Any condition or circumstance that could impede study completion
Improving the Reproductive Outcome of Poor Quality Ova by Injection of Autologous Somatic Mitochondria

A prospective randomized controlled trial (RCT) to determine the effect of injecting an autologous somatic mitochondria concentrate, together with the spermatozoon during ICSI, into oocytes of older and or poor prognosis in vitro fertilization (IVF) patients.

Maternal age at first delivery constantly rises in developed countries. Oocyte quality decreases with advanced age, thus the rate of age-related infertility continuously increases. Presently oocyte donation is the only prompt solution for this widespread problem. Deterioration of mitochondrial function was suggested as one of the explanations for the age-related deterioration of oocyte quality. The supplementation of the ageing oocyte with autologous mitochondria from dividing somatic cells can be a possible solution for energetic enrichment, without introducing foreign mtDNA.

We established a non-hazardous clinical grade system to prepare functional autologous mitochondria concentrate from the granulosa cells aspirated during oocyte pick up. The mitochondrial preparation was examined and found to be non-toxic. The activity of the respiratory chain was constant and unaffected by age or ovarian response. Moreover, the mtDNA in the mitochondrial preparation was found to be intact in all samples examined, including those from older and low responding patients.

Eligibility Criteria:
Inclusion Criteria:

* Adequate sperm source and uterine cavity. And one or more of the following:
* Age \> 40
* 3 unsuccessful IVF cycles or
* \> 75% of embryos in previous cycles with \> 20-50% fragments or
* \< 50% fertilization rate in previous cycles

Exclusion Criteria:

* Inadequate sperm source. Inadequate uterine cavity.
Passive Body Heating, Sleep and Fibromyalgia

Objectives: To assess the effect of passive body heating on the sleep pattern of patients with fibromyalgia.

Methods: Six menopausal women diagnosed with fibromyalgia according to criteria determined by the American College of Rheumatology were included. All women underwent passive immersion in a warm bath at 36±1 °C, for 15 sessions of 30 minutes each over 3 weeks. Their sleep pattern was assessed by polysomnography at the following conditions: pre-intervention (baseline), on the first day of intervention (acute), on the last day of intervention (chronic) and 3 weeks after the end of interventions (follow-up). Core body temperature was evaluated by a thermistor pill at the above-mentioned conditions. The impact on fibromyalgia was assessed through of a specific questionnaire called fibromyalgia impact questionnaire.

Patients were attended at the Psychobiology and Exercise Studies Centre 5 times a week for 3 weeks between 6:00pm and 8:00pm for passive body-heating interventions for 30 min each session. The patients were accompanied by a researcher to a therapeutic water bath (Barritz Hydrotherapy Appliance, Germany) and were comfortably positioned in a supine position with their necks supported by an inflatable floating pillow to keep the body relaxed and safe during the intervention. The room temperature at the laboratory was maintained at 23±1 ºC, and the water temperature was 36±1ºC.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia diagnostic
* Women
* Post menopausal
* Sedentary

Exclusion Criteria:

* Other diagnosis of chronic illnesses
Embedding Comprehensive Smoking Cessation Programs Into Community Clinics

The study will evaluate a sustainable tobacco screening, treatment intervention, and cessation program implemented within both Los Angeles County (LAC)-Department of Health Services (LACDHS)-operated outpatient primary care clinics and in LAC-Department of Mental Health (LACDMH)-operated community mental health clinics. This is a three year implementation study funded by the University of California Office of the President Tobacco Related Disease Research Program (TRDRP). This project will support the implementation of smoking cessation services delivered in LACDHS and LACDMH clinics and will evaluate the effectiveness and feasibility of these services.

The research hypothesis is that training LACDHS and LACDMH staff and clinicians to screen for and treat tobacco use disorder will improve rates of remission from tobacco use disorder in the clients served by each system.

This is a cluster randomized comparative effectiveness trial that compares intervention clinics (offer smoking cessation group counseling and medication management) integrated into primary care and community mental health clinics with treatment as usual (offering information about the California Smoker's Helpline and informal provider counseling). The specific aim is to randomize 17 clinics (11 at LACDHS and 6 at LACDMH), with a 5:1 ratio in the assignment of clinical sites assigned to offer smoking cessation services as compared to the treatment as usual (TAU).

In addition to providing support for the implementation of the smoking cessation services, the study will enroll 1,200 clients with tobacco use disorder from all 17 participating clinics for an outcome study; 1000 people from clinical sites where smoking cessation treatment are being offered and 200 people with tobacco use disorder from the TAU clinical sites. The primary study outcome is to determine if there will be higher rates of smoking cessation in the implementation sites as compared with TAU sites that do not offer smoking cessation treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* smoke 3 or more cigarettes or cigars per day
* have thought about smoking cessation
* be enrolled in care at either LACDHS and/or LACDMH.

Exclusion Criteria:

* under 18 years
* smoke less than 3 cigarettes or cigars per day
* not interested in smoking cessation
* not enrolled in care at either LACDHS and/or LACDMH.
A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed the double-blind treatment period of the lead-in study RGH-MD-16 (NCT 00694707)
* Patients who have responded to double-blind treatment in the lead-in study as defined as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S) score of ≤ 3.
* Patients eligible to continue as outpatients based on the opinion of the Principal Investigator.
* Patients must have a caregiver to ensure treatment compliance.

Exclusion Criteria:

* Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
Self-Adaptive Immersive Virtual Reality Serious Game to Enhance Motor Skill Learning and Attention in Older Adults

While scientific evidence emphasizes the detrimental effect of sedentary behavior on health, the literature suggests that, on average, older adults spend 75% of their days in a sedentary manner, and often isolated (Petrusevski 2020). This lack of physical activity and social interaction not only leads to an increase in functional limitations and the risk of worsening an existing chronic disease but also elevates the risk of mortality. Furthermore, older adults face progressive functional decline, both in motor and cognitive aspects, as a result of aging, contributing to inactivity and sedentary behavior (Botö 2021).

The literature suggests that new technologies such as immersive virtual reality (iVR) and serious games serve as effective means to promote active leisure, thereby breaking isolation and reducing sedentary behavior. The development of these new technologies is also promising for objectively and quantitatively measuring motor and cognitive activity (e.g., kinematics, reaction time).

Serious games are defined as games whose primary objective is more focused on learning than entertainment. For instance, they allow the integration of physical and cognitive activity programs into a playful activity, conducive to long-term adherence. Their effectiveness is starting to be studied in hospitalized older adults (Cuevas-Lara 2021), especially as they also help combat age-related functional decline. Indeed, they provide the opportunity to promote and measure activity through enjoyable and self-administered exercises.

However, despite the growing interest in serious games, the impact of self-adaptive serious games, compared to traditional (non-adaptive) serious games, on motor skill learning and attention function in older adults remains unclear. This gap in knowledge necessitates a rigorous investigation. Therefore, this randomized controlled trial seeks to address this gap and achieve the following objectives:

1. Compare the effect of a self-adaptive serious game to a non-adaptive serious game on motor skill learning and attention in older adults.
2. Enhance the understanding of how motor skill learning in immersive virtual reality translates to older adults' activities of daily living.


Eligibility Criteria:
Inclusion Criteria:

* Normal-to-corrected vision
* Score \> 24 in the Montreal Cognitive Assessment
* Age \> or = 65 years old

Exclusion Criteria:

* Severe comprehension issues
* History of seizures
* Prior experience with serious games in immersive virtual reality
Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) in Metabolic Syndrome

The metabolic syndrome is associated with increased risk of cardiovascular disease and diabetes mellitus. The age-adjusted prevalence of the metabolic syndrome in the United States is 34% for men and 35% for women. Emerging alternative medicine worldwide led investigators to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit) in treatment of metabolic syndrome. Serum total cholesterol, serum LDL cholesterol, serum HDL cholesterol, serum triglyceride, Fasting Blood Sugar and hematocrit measured before and after 45 days of treatment.

In a randomized, placebo controlled, single-blind , efficacy trial with three treatment arms the investigators randomly assigned 105 patients with metabolic syndrome to receive barberry juice, saffron juice or placebo tablet.

The aim was to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit) in treatment of metabolic syndrome. The metabolic syndrome (syndrome X, insulin resistance syndrome) consists of a constellation of metabolic abnormalities that confer increased risk of cardiovascular disease (CVD) and diabetes mellitus (DM). The major features of the metabolic syndrome include central obesity hypertriglyceridemia, low HDL cholesterol, hyperglycemia, and hypertension. Based on data from the National Health and Nutrition Examination Survey (NHANES) III, the age-adjusted prevalence of the metabolic syndrome in the United States is 34% for men and 35% for Women. Review of literature revealed anti-inflammatory, radical-scavenging, antioxidant, cytoprotective, beneficial cardiovascular and neural system effects for saffron, potential use for treatment of hypertension, tachycardia and some neuronal disorders, such as epilepsy and convulsion, antihypertensive and vasodilatory activities. Barberry has promising and selective anti-cancer activities, beneficial effects in atherosclerosis, arthritis, coronary heart disease and hepatitis, hypotensive property and to promote immunity, prevention of insulin resistance and related diseases, neuroprotective, hypolipidemic and antioxidant properties for saffron in animal models.

Eligibility Criteria:
Inclusion Criteria:

* waist circumference of ≥ 94 cm (males) or ≥ 80 cm (females) plus any two of the following:
* blood pressure ≥ 130/85 or taking antihypertensive medication,
* fasting plasma glucose (FPG) \> 100 mg/dL,
* serum triglycerides (TG) \> 150 mg/dL,
* high-density lipoprotein (HDL) \< 40 mg/dL in men,and \< 50 mg/dL in women-

Exclusion Criteria:

* using insulin or glucose sensitizing medication
* preexisting cardiovascular disease
* psychiatric problems
* non-compliance of patients
* not presenting at times determined for treatment and evaluation