cyrilzakka/clinical-trials huggingface dataset:
Phytosterols and Oxyphytosterol Concentrations

Plant sterols and stanols (also called phytosterols and phytostanols) are structurally related to cholesterol, but absorbed to a much lesser extent. Due to this structural similarity, plant sterols and stanols inhibit intestinal cholesterol absorption and lower serum LDL cholesterol concentrations by about 10% at daily intakes of 2.5 g. Plant sterol- and stanol-enriched food products are therefore widely available on the market to lower the risk for coronary heart disease. Plant sterols can undergo oxidation, which results in the formation of oxyphytosterols. Animal studies have now suggested that oxyphytosterols are atherogenic. Although oxyphytosterols have been identified in human serum samples, the effect of an increased intake of plant sterols on serum oxyphytosterol concentrations in humans is not known. On the other hand, plant stanols cannot be oxidized and lower not only cholesterol absorption, but also plant sterol absorption.

The major objective of the present study is to examine the effects of dietary plant sterols and stanols on fasting serum concentrations of oxyphytosterols. The minor objective is to investigate the effects of these products on postprandial serum oxyphytosterol concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 20-30 kg/m2
* mean serum total cholesterol \< 7.8 mmol/L
* mean serum triacylglycerol \< 3.0 mmol/L
* mean plasma glucose \< 6.1 mmol/L

Exclusion Criteria:

* unstable body weight (weight gain or loss \> 3 kg in the past two months)
* active cardiovascular diseases like congestive heart failure or recent (\<6 months) event (acute myocardial infarction, cerebral vascular incident)
* severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis
* indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
* use of medication such as corticosteroids, diuretics or lipid lowering therapy
* abuse of drug or alcohol (\>21 units per week)
* not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in sterol or stanol esters 4 weeks before the start of the study (wash-in period)
* use of an investigational product within another biomedical study within the previous month
* pregnant or breast-feeding women
* not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
* current smoker
* anemia. with a Hb-level below 7.5 mmol/L for men and below 7.0 mmol/L for women, as indicated by the blood bank of Maastricht
Treatment of Oral Premalignant Lesions With 5-ALA PDT

Oral leukoplakia within the mouth is a visible white patch which can develop into cancer if not treated. There is no good treatment for these lesions, apart from surgery which is associated with significant side effects and physical deformation of the treated area.

The investigators hypothesized that photodynamic therapy can be used safely and effectively to induce significant regression of oral leukoplakia.

This is a combined Phase I/II non-randomized prospective study designed to determine the safety and assess the clinical efficacy of PDT in the treatment of oral leukeplekia with 5-ALA and 585-nm PDL with 1.5 ms pulse time. In the first part of the study we determined the maximum tolerated dose (MTD) of the PDL radiant exposure in combination with 5-ALA. In the second phase of the study, this dose is used to treat subjects at the MTD in order to determine the efficacy of the treatment by documenting the regression of the treated lesions.

Eligibility Criteria:
Inclusion Criteria:

* At least one grossly visible premalignant lesion (i.e. leukoplakia or erythroplakia) in the oral cavity or oropharynx, with a confirmed diagnosis of leukoplakia with or without dysplasia,measuring ≥ 10 mm in diameter.
* Informed of alternative treatment methods including watchful waiting, laser ablation, or surgical resection.
* Eligible for long-term follow-up for at least one year and be able to tolerate biopsies.
* Subject has signed an informed consent.
* Subject is between the ages of 18 - 80 years of age.
* Male or Female
* Zubrod performance status of 0 or 1 at screening. See Appendix A

Exclusion Criteria:

* Known sensitivity to porphyrins or photoactive medications - See Appendix B
* Invasive carcinoma of the lesion as demonstrated by biopsy.
* Subjects with inherited or acquired blood clotting defects
* Women who are breast feeding, have a positive (+) urine pregnancy test, or refuse to use 2 effective means of contraception during drug exposure and up to 48 hours after.
* Subjects with porphyria
* Life expectancy less than 12 months
* Inability or unwillingness of subject to give written informed consent
Vitamin D Supplementation in HIV

The purpose of this study is to evaluate safety and efficacy of vitamin D supplementation in children, adolescents and young adults with Human Immunodeficiency Virus and acquired immunodeficiency syndrome (HIV/AIDS). The study is a 12-month randomized, double blind, placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on evidence from the Vit D Dose Finding Study-IRB 09-007332.

Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy using clinically important outcomes, and this will overcome the critical barrier for use of vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit D supplementation may prove to be an effective and feasible treatment for symptoms and prevention of side effects for people of all ages living with HIV/AIDS in the US and around the world.

The study is a 12-month randomized, double blind, placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on evidence from the Vit D Dose Finding Study-IRB 09-007332 in 58 subjects with both Perinatally Acquired (PA) and Behaviorally Acquired (BA) HIV/AIDS to assess the long-term safety in terms of serum calcium and 25OHD concentrations, and efficacy in terms of the effect of vit D supplementation on 25OHD, cathelicidin, growth (pre- and peripubertal participants), body composition, bone, muscle, immune and inflammatory status and HIV/AIDS disease severity and progression.

Primary Hypotheses:

H1: Vit D supplementation is safe and does not result in an increased incidence of elevated serum calcium (above age-specific range) associated with elevated serum 25OHD (\>160 ng/mL) in treated subjects compared with the subjects receiving placebo.

H2: Vit D supplementation is significantly associated with both increased 25D and cathelicidin in treated subjects compared with subjects receiving placebo.

Eligibility Criteria:
Inclusion Criteria:

1. HIV seropositive diagnosed with standard techniques
2. Age for PA Group: 5.0 to 24.9 y
3. Age for BA Group: 15.0 to 24.9 y
4. In usual state of good health (no hospitalizations, emergency room or unscheduled acute illness visits for 2 weeks prior to enrollment)
5. Subject and/or family commitment to the 12-month study

Exclusion Criteria:

1. Other chronic health conditions that may affect growth, dietary intake, and/or nutritional status
2. Pregnancy
3. Participation in another HIV intervention study with impact on 25D serum concentrations
4. Use of vit D3 supplementation for the purpose of treating vit D deficiency
5. Use of vit D3 supplementation not part of a prescribed treatment plan for vit D deficiency (subjects willing to discontinue supplementation will become eligible after a minimum of a 2 month washout period)
6. Non-English Speaking
Centella Asiatica (Gotukola) Mouthwash as an Adjunct to Mechanical Plaque Control

This study evaluates the adjunctive use of Centella Asiatica (gotukola) to scaling in the reduction of plaque and gingival inflammation. Patients were divided into three groups of which group 1 received scaling and gotukola mouthwash, group 2 received scaling only and group 3 received gotukola mouthwash only.

Mechanical plaque control by tooth brushing is considered to be the ideal way of preventing plaque associated gingivitis. However due to various factors individuals fail to perform an adequate quality of self performed plaque control. Centella Asiatica (gotukola) possess wide range of biological activities like anti-inflammatory, anti-psoriatic, anti-ulcer, hepato-protective, anticonvulsant, immunostimulant, cardioprotective, antidiabetic, antiviral, antibacterial, antifungal, etc. So, it could be used as adjunctive to mechanical periodontal therapy.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 22 natural teeth
* Participants with Chronic generalized gingivitis
* Participants with plaque index score ≥1

Exclusion Criteria:

* Participants with fixed or removable appliances
* Participants with more than full coverage restorations
* Medically compromised participants
* Participants on long term medications
* Smokers
* Participants who had used any type of antibacterial mouthwash in 4weeks of commencement.
* Patients with history of recent periodontal therapy
Education and Exercise Program for Adults With Type 2 Diabetes

The purpose of this two phase study is to: 1) develop and 2) assess a program titled: Merging Yoga, Occupational Therapy and Nutrition Education (MY-OT-Ed) designed for low income adults with Type 2 Diabetes. Half of the participants will participate in the Nutrition Education, and the other half of the participants will participate in Nutrition Education plus Occupational Therapy group and group yoga.

Merging Yoga, Occupational Therapy and Nutrition Education (MY-OT-Ed) is an interdisciplinary program designed to help low income adults with Type 2 Diabetes engage fully in life while learning to manage their diabetes. The aim is to empower individuals to embed diabetes self-management into everyday activities and routines while upholding quality of life. Currently Extension Services bring nutrition education to the under-served population in the local communities through the Expanded Food and Nutrition Education Program (EFNEP). Colorado EFNEP uses the evidence-based, healthy eating and active living curriculum, Eating Smart • Being Active (ESBA), with adult participants. While EFNEP may be helpful in the management of some aspects of diabetes care, it is not designed to address the established self-care behaviors and routines essential for effective diabetes self management. Therefore, it is critical to merge nutrition education programs such as EFNEP with other established interventions to best meet the needs of the individual with diabetes. Likewise, yoga is an effective form of physical activity to manage some aspects of diabetes care and outcomes. However, yoga is also not enough to address all of the needs of the individual. Furthermore, evidence for the success of occupational therapy's role in diabetes self-management is growing as a way to manage some aspects of the complexity of diabetes care or routines in everyday life. Our aim in this study is to follow best practice and create and evaluate an interdisciplinary approach to type 2 diabetes self-management by merging together yoga, occupational therapy and nutritional education to improve diabetes related outcomes in our population.

Eligibility Criteria:
Inclusion Criteria:

* Ability to speak English and answer questions/communicate
* Self-report diagnosis of Type 2 Diabetes
* Self-report of children living at home
* Self-report of low socioeconomic status or use of food assistance programs

Exclusion Criteria:

* pregnant or anticipation of becoming pregnant in the next 6 months
* completion of Type 2 Diabetes self-management or participation in occupational therapy with an emphasis on managing diabetes or other chronic condition in the last year.
Telemedicine in Age-Related Macular Degeneration

This study seeks to evaluate a system for the automated early detection of Age-Related Macular Degeneration (AMD). AMD is a condition in which there is breakdown of the macula of the eye, the part of the retina that is responsible for sharp, central vision. We will take pictures of subjects' eyes using an automated camera. These photographs will be securely transmitted and and then analyzed by a computer program which has been developed in other studies. The outcome of the computer program analysis will be compared with human analysis of these same pictures. If the computer analysis is has good enough accuracy, then this computer system could be used for wide-scale screening for AMD.

iPredict,an AI and telemedicine based software which used individual's color fundus image for early diagnosis of AMD and predict if an individual is at risk of progression to late AMD. iPredict platform integrates the server-side programs (the image analysis and deep-learning modules for AMD severity screening and prediction) and local remote computer/mobile devices (for collecting patient data and images). DRS plus camera will be used in the doctor's office. The remote devices will upload images and data to the server to analyze and screen AMD automatically. The telemedicine platform has been developed for web-based platform. The automatic analysis will be performed on the server, and a report will be sent to the patient/remote devices with an individual's AMD stage as referable or non-referable AMD, and a risk prediction score of developing late AMD (within a minute), and further recommendations to visit a nearby ophthalmologist.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent
2. Gender of Subjects: Both males and females will be invited to participate.
3. Age of Subjects: Patients will be over 50 years and older

Exclusion Criteria:

1. Unable to provide informed consent.
2. Other retinal degenerations and retinal vascular diseases such as diabetic retinopathy or macular edema, prior retinal surgery.
Impact of a Technology Mediated Dance Intervention

This study aims to investigate whether a technology-mediated dance impacts on psychosocial, physical and cognitive functions of the old adults when compared to usual activities.

This study aims to investigate whether a technology-mediated dance impacts on psychosocial, physical, and cognitive functions of old adults when compared to usual activities. It will have two arms one of which will receive a dance mat and perform dance sessions for 8 weeks, while the other group will continue their usual activities. Participants will be assessed for psychosocial, physical, and cognitive aspects at baseline, end of the intervention, and at 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* People living independently in the community
* 65 years old or older
* With no cognitive impairment defined based on the 6-item cognitive decline test \[4\]
* Independent at walking without walking aids
* Access to a personal computer and internet
* For older adults unable to use a computer, a patient or carer with digital literacy needs to be identified for the older adult to enter the study.

Exclusion Criteria:

* Reporting cardiovascular pathology that limits the performance of the dance or dizziness or imbalance prior to using the mat
Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma

The purpose of this study is to investigate whether the addition of oral maintenance chemotherapy with O-TIE (Etoposide, Idarubicin, Trofosfamide) for 6 months improves the event free survival (EFS) in patients with localised high-risk RMS and RMS-like Soft Tissue Sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
* pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
* Rhabdomyosarcoma of the "High Risk" Group, i.e.:

  * RME, N0, M0, IRS II\&III, \>5 cm or \>10 years in EXT, HN-PM, OTH, UG-BP
  * RME, N1, M0, any IRS-group, any size or age
  * RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
* Rhabdomyosarcoma of the "Very High Risk" Group, i.e.:

  * RMA, N1, MO, IRS II\&III, any size or age or
  * localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
  * EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
  * SySa, any N, M0, any size or age (exception: SySa IRSI\&II, not T2b, N0, M0 are not eligible)
* no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction; hypersensitivity)
* no previous malignant tumours
* available for long term follow up through the treating centre
* in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance

Exclusion Criteria:

* pregnant or lactating women
* other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
* for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)
Characterization of Placebo Responses in Stable Asthma

The investigators hypothesize that different placebos will have different effects on subjective and objective asthma outcomes compared with actual therapy and natural history. .

Subjects with asthma are randomly treated with placebo inhaler, placebo acupuncture, albuterol inhaler, or "no treatment" in random order, on three different occasions each. At each of the 12 visits, spirometry is performed repeatedly over 2 hours. Maximum FEV1 achieved and an 11-point, self-reported scale of improvement are examined.


Eligibility Criteria:
Inclusion Criteria:

* uncontrolled asthma

Exclusion Criteria:

* no bronchodilator response
LIFE - Lung Cancer, Immunotherapy, Frailty, Effect

The LIFE study (Lung cancer, Immunotherapy, Frailty, Effect) is investigating the unselected 'real life' non-small cell lung cancer (NSCLC) population treated with immune checkpoint inhibition.

The era of immune checkpoint inhibition (ICI) has changed the treatment regimen for incurable non-small cell lung cancer. With that the hope of a more long-term survival has been introduced. ICI is given as standard therapy for selected NSCLC patients with incurable advanced or metastatic (stage IV) disease. For this group of patients clinical trial reports present a 3 year overall survival rate of around 30%. Checkpoint inhibition is also known as programmed death 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors and the PD-L1 tumor proportion score is currently the only clinically applicable biomarker used for this patient selection. New prognostic and predictive biomarkers are therefore warranted.The real life unselected NSCLC patient eligible for treatment with immunotherapy (check point inhibition) may be both older, with more comorbidity, more widespread disease and in poorer performance status than patients treated in clinical phase III trials. In this prospective single center study, clinical patient data, peripheral blood and baseline pre-treatment tumor biopsies are collected from NSCLC patients treated in any given treatment line with nivolumab, pembrolizumab or atezolizumab. Besides baseline samples consecutive blood samples will be collected for cytokine profiling and measurement of circulating tumor DNA (ctDNA) and micro RNA analysis. Baseline MRI of the brain screening for brain metastases and an extended CT-scan of thorax, abdomen and the lower extremities will be performed screening for venous thromboembolism (VTE). This along with comorbidity screening tools and quality of life assessments will provide detailed mapping of both patient and disease characteristics of potentially more frail patients including those with untreated brain metastases. By also registering immune related adverse events (irAE) prospectively in this study and doing additional blood samples in case of grade 3-4 toxicity, identification of biomarkers as predictors for effect and toxicity is durable. Hopefully this will contribute to more optimized treatment courses for those NSCLC patients to come.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Stage IV NSCLC or recurrent NSCLC.
* Squamous or non-squamous histology
* Any treatment-line - Independent of prior treatment
* Candidate for checkpoint inhibitor (PD-1/PD-L1 targeting agents) immunotherapy
* No previously known allergy to PD-1/PD-L1 targeting agents.
* Able to give written consent

Exclusion Criteria:

* none
Mindfulness and Yoga or Resistance Exercise Training Fpr Parkinson's Patients

The investigators propose to compare the effects of a 16-week specially designed yoga program to a power-based resistance training program on affect trait mindfulness, anxiety, depression, functionality, and quality of life. As secondary measures, we propose to compare the effects of these exercise programs on measures of executive function (EF), sleep, disease stage, motor symptoms, muscle quality, rigidity, strength, power, and mobility.

Yoga has long been recognized as a therapeutic intervention for improving mindfulness and psychological well-being. Yoga represents a unique exercise activity that employs mindfulness-based practices and various balance postures to improve physical and mental health. Yoga is a gentle form of exercise that can be easily adapted to populations suffering from physical and mental limitations and has been shown to improve physical and psychological functioning in individuals with PD. Though research continues to support the positive psychological effects of yoga, it is unclear whether this is due to the unique mindfulness-rooted approach of yoga or general increases in physical activity.

Power-based resistance training has had promising results in the PD community. Improvements in balance, gait, and increases in leg muscle power and strength have been shown in PD patients after power training interventions. Although power training is a beneficial exercise modality in the treatment of motor symptoms, the effects of power training on nonmotor symptoms have yet to be established.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with mild to moderate PD \[Hoehn and Yahr (H\&Y) stage 1-3\];
* over 50 years of age;
* stable use of medication;
* able to walk 15 m independently with or without an assistive device;
* the ability to get up and down from the floor with minimal assistance;
* not currently participating in yoga or resistance training more than one time per week;
* able to understand and communicate in English; and,
* able to provide informed consent.

Exclusion Criteria:

* cognitive impairment as designated by a score of less than 23 on the Montreal Cognitive Assessment (MoCA)\]; and,
* any clinically significant medical condition, such as cardiopulmonary disease and musculoskeletal problems. Subjects providing affirmative answers on a Physical Activity Readiness Questionnaire (PAR-Q) or Health Status Questionnaire related to cardiopulmonary disease or musculoskeletal impairments will be required to present a physical activity clearance from their physician.