cyrilzakka/clinical-trials huggingface dataset:
The Effect of Board Game-Based Nutrition Education on Primary School Children

The purpose of this study to design a board game that will enable primary school children to recognize foods by enabling them to distinguish between healthy and unhealthy foods by going beyond the traditional education patterns and to compare the effects of this board game-based nutrition education intervention on children's behaviors, self-efficacy, and attitudes with the control group in which no intervention was made.

Nutrition is an important part of health and development. In particular, the gaining of healthy eating habits in early childhood promotes growth and development and reduces the risk of many non-communicable diseases, especially obesity. In order to create healthy societies in the future, nutrition education is one of the effective methods for developing healthy eating behaviors and raising awareness starting from childhood. Game-based education approaches provide motivation for learning information that is made a part of the game by going beyond traditional education methods. Board games are used in nutrition education by giving children the opportunity to think interactively and make different choices with their immersive stories and designs.

Eligibility Criteria:
Inclusion Criteria:

* In the 3 schools where the study will be carried out
* 4th grade student
* Does not have any physical disability related to vision, hearing and speech
* Without any chronic or metabolic disease

Exclusion Criteria:

* Having any chronic or metabolic disease
* Can't read and write
Impact on Quality of Life of "Endo-App" (ELEA)

monocentric randomized controlled trial enrolment of endometriosis patients from certified endometriosis centers. Randomization to control group (no Endo App use) vs intervention group (Endo App use) 12 weeks use / no use of Endo App. Evaluation of quality of life at onset, at 4, 8 and 12 weeks by using endometriosis health profile (EHP) 5 as a global index. Statistical analysis of global index at the end minus global index at onset between control and intervention group.

randomized controlled trial enrolment of patients with diagnosed endometriosis 300 patients in total, 150 patients per group, randomization to control group (no Endo App use) vs intervention group (12 weeks Endo App use). The Endo App is a german language certified medical device which can be used to monitor the disease and gives support by providing complementary, multimodal interventions to standard therapy and is commercially available. Purpose of this study is the evaluation of quality of life at onset and then at 4, 8 and 12 weeks by using endometriosis health profile (EHP) 5 as a global index. The secondary endpoints of this study to evaluate are Fatigue symptoms (FSSsurvey), pain- specific self-efficacy (FESS), difficulty in everyday life due to pain (PDI) and emotional wellbeing (DASS- 21)

Eligibility Criteria:
Inclusion Criteria:

Legal capacity

* Living in Germany
* Adequate german language skills
* Female biological gender
* Ages eligible for study ≥ 18 years
* Medical Diagnosis of endometriosis

Diagnosis verification by following documents:

1. Operation Report
2. Histological finding
3. MRI finding
4. Other medical examination documents with endometriosis diagnosis (for example sonography, colonoscopy, cystoscopy)

Owning a smartphone and having an internet access

Willingness and capability of using the smartphone device and the Endo App

Motivation to regularly fill out the questionnaries

Owning an e-mail address for App registration

Absence of exlusion criteria

Exclusion Criteria:

* Absence of inclusion criteria
* Pregnancy existing at survey period
* Ongoing hormonal fertility treatment or planned treatment within the next 12 weeks (artificial insemination as part of in vitro fertilization, such as IVF or ICSI, hormone injections for fertility treatment)
* Ongoing or within the next 12 weeks planned rehabilitation or multimodal pain therapy
* Planned change in hormone therapy (change of active substance, new start or discontinuation of therapy) in the next 12 weeks or change in hormone therapy within the last 8 weeks before the start of the study
* Endometriosis surgery planned in the next 12 weeks or endometriosis surgery performed within the last 8 weeks prior to study start
* Previous or existing access to Endo app or current prescription
Efficacy Study of Protein Supplementation in Attenuating the Decline in Performance After Strenuous Concurrent Exercise

This study is designed to investigate whether protein supplementation can improve recovery of muscle function following a strenuous combination of both endurance and resistance exercise. It will specifically investigate the effect of protein supplementation on the recovery of strength, power and endurance exercise performance, along with measures of damage and inflammation of the muscle.


Eligibility Criteria:
Inclusion Criteria:

* Understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary informed consent form and has received signed and dated copy of the informed consent form
* Male participants; age between 18 to 35 years, inclusive
* Well trained endurance cyclist (competing at a minimum of Category 3 road-racing/estimated 10 mile TT of \<23 minutes), with a training history \>1 year
* Good general and mental health

Exclusion Criteria:

* Currently taking any nutritional supplements, polyphenols or beta-blockers, Non-steroidal anti-inflammatory drugs (NSAIDs), recreational drugs
* Known or suspected intolerance or hypersensitivity to the study material or any of their stated ingredients
* Allergy to milk or wheat products
* Heart or any other medical condition that may contra-indicate participants from taking part in high intensity or exhaustive physical activity
* Previous participation in this study; another clinical study or receipt of an investigational drug within 30 days of the screening visit; participation in another study involving a protocol to elicit Exercise-Induced Muscle Damage (EIMD) within 6 months of the screening visit
To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706

To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706


Eligibility Criteria:
Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Daily Study of Caregiving Relationships and Health

The purpose of the Daily Study of Caregiving Relationships and Health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol.

This is a pilot study wherein the purpose is to test the feasibility and acceptability of study protocols.

The purpose of the Daily Study of Caregiving Relationships and Health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol. Investigators are asking caregivers to complete 14-days of surveys which ask about their relationships and health behaviors, in addition to 2 longer surveys (baseline and 3-month follow up). Investigators hypothesize that on days when caregivers receive more emotional support, they will report better health behaviors (e.g., improved sleep quality). On days when caregivers experience greater 1) strain and 2) loneliness, they will report poorer health behaviors. Information about which aspects of social relationships and social connectedness most affect health will be used to inform interventions programs.

Eligibility Criteria:
Inclusion Criteria:

* Spouse or partner to an individual living with ADRD who has received a diagnosis from a physician
* Aged 18 years or older Provides assistance with at least one instrumental activities of daily living or activities of daily living
* Not paid to provide care
* Cares for someone with a global deterioration score of 1 to 5 (early to mid-stage dementia)
* Has reliable access to email and text messaging, and smart phone device
* Live within 40 miles of UT Health San Antonio (if completing saliva collection protocol)

Exclusion Criteria:

* Inability to read and speak English or Spanish
* Vision or hearing impairment affecting ability to complete study protocols (e.g., blindness)

Additional exclusion Criteria if completing saliva collection protocol:

* Experiencing a major health event within the previous 6 months (e.g., stroke, myocardial infarction, in-patient surgery, cancer besides skin cancer)
* Symptoms of infectious disease within the previous 14-days (e.g., COVID-19, oral infection)
* Diagnosis of major depressive disorder
* HPA axis endocrine disorder (e.g., Cushings or Addison's disease)
* Use of corticosteroid medication
* Pregnancy
* Participation in overnight shift work
International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry

The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

The objectives of the Registry are:

* To enhance understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention.
* To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care.
* To characterize the Gaucher disease population.
* To evaluate the long-term effectiveness of imiglucerase and of eliglustat.

Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.


Eligibility Criteria:
Inclusion Criteria:

ICGG Gaucher Registry

* All patients with a confirmed diagnosis of Gaucher disease are eligible for inclusion in the Registry. Confirmed diagnosis is defined as a documented β-glucocerebrosidase deficiency and/or mutation in the β-glucocerebrosidase gene.
* For all patients, appropriate patient authorization will be obtained.

Gaucher Pregnancy Sub-registry:

* be enrolled in the ICGG Gaucher Registry.
* be pregnant, or have been pregnant with appropriate medical documentation available.
* provide a signed informed consent and authorization form(s) to participate in the Sub-Registry prior to any Sub-Registry-related data collection being performed.

Exclusion Criteria:

- No exclusion criteria for participation in the ICGG Gaucher Registry and Sub-registry.
Diagnostic Performance of [11C]Choline PET/CT In the Preoperative Assessment of Primary Hyperparathyroidism

Primary hyperparathyroidism (HPT) ranks as the third most common endocrine disorder, characterized by excessive secretion of parathormone (PTH), a hormone crucial for regulating calcium and phosphorus metabolism within the body. The only cure for HPT is surgically removing the hyperfunctioning parathyroid tissue, both in symptomatic and asymptomatic settings. With the advance of preoperative medical imaging techniques, a paradigm shift has taken place in the surgical approach of this condition, evolving from an inpatient bilateral cervical exploration to an outpatient minimally invasive procedure, which has proved to be superior in outcome. Due to the small size of the glands, preoperative visualisation and localisation are mandatory for the surgeon. Several imaging methods have been researched for identifying hyperfunctioning parathyroid glands, including morphological, functional and hybrid techniques, with no clear agreement on the optimal imaging approach.The preoperative localization modalities available are ultrasonography; parathyroid scintigraphy using technetium \[99mTc\]Tc sestamibi (MIBI), multiphase multidetector 4D computed tomography (4DCT); magnetic resonance imaging; and recently, positron-emission tomography/computed tomography (PET/CT) using 11C- and 18F-labelled radiotracers. While ultrasound and \[99mTc\]Tc-MIBI scintigraphy have been long used to diagnose and monitor patients with HPT, they can lead to numerous false negative results and therefore require additional examinations.Choline PET/CT is steadily replacing conventional imaging in many centres, allowing for the localization of adenomas in three quarter of patients with negative previous imaging examinations, but is still considered a relatively new method. \[11C\]C-Choline (\[11C\]CH) PET/CT is gradually gaining ground as a reliable method of localising HPT preoperatively, due to its fast uptake in hyperfunctioning parathyroid tissue, shorter acquisition time and lower radiation exposure compared to other nuclear medicine investigations and conventional methods. \[11C\]CH PET/CT has been suggested to be superior in diagnostic performances, compared to other imaging methods, reaching sensitivities up to 98.9%.The aim of our retrospective, single centre study is to evaluate the diagnostic performances and the inter-observer agreement of \[11C\]CH PET/CT for the preoperative detection of parathyroid adenomas in patients with suspected primary HPT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with biochemically proven HPT, either through elevated serum levels of PTH or normal PTH despite hypercalcemia;
* Age ≥ 18 years old;
* \[11C\]CH PET/CT for HPT before eventual surgery.

Exclusion Criteria:

* Pregnancy or breast-feeding.
Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer

We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen.

A multicenter Open-label, single-arm feasibility study is conducted on patients with histological stage IV colorectal cancer given oxaliplatin, leucovorin plus fluorouracil. The usefulness of this regimens as therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Eligibility Criteria:
Inclusion Criteria:

1. Histological diagnosis of colorectral adenocarcinoma.
2. Measurable or assessable lesions.
3. Age: 15 \~ 75 years.
4. Performance Status (ECOG): 0 \~ 2.
5. Prior chemotherapy within 2 regimens.
6. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 3.0mg/dl. Creatinine within the upper limit of normal. Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).

(10) Predicted survival for \>8 weeks. (11) Able to give written informed consent.

Exclusion Criteria:

1. Severe pleural effusion or ascites.
2. Metastasis to the central nervous system (CNS).
3. Active gastrointestinal bleeding.
4. Active infection.
5. Uncontrolled ischemic heart disease.
6. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
7. Active multiple cancer.
8. Severe mental disorder.
9. Pregnancy, possible pregnancy, or breast-feeding.
10. Patients with neuropathy ≥ grade 2
11. Judged to be ineligible for this protocol by the attending physician.
Supportive Therapy for Adherence to ART(STAART)

The purpose of this study is to determine whether a psycho-educational intervention can help people living with HIV handle the changes of treatment adherence.

Participants will be randomly assigned to one of two study groups:

* Group 1: participants in this group will engage in weekly psycho-educational sessions with an HIV therapist for four weeks prior to starting their regimens. The sessions will cover topics such as becoming active in treatment care, improving coping abilities and developing skills for treatment adherence. They will also involve questionnaires and readings.
* Group 2 (the control group):participants in this group will simply receive their regular treatment regimens.

Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* have viral load above 500 copies/ml
* not be currently on HAART
* be able to read and speak English/French

Exclusion Criteria:

* current Substance Abuse
* actively psychotic or suicidal
The Effect od Beetroot Juice on Forearm Muscle Strength and Muscle EMG Activity After BloodFlow Restriction

The primary aim of the current study is determine the effect of beetroot juice consumption on maximal grip strength and EMG muscle activity

In random order subjects will consume high nitrate beetroot juice or low level of nitrate beetroot juice. Grip strength and EMG will be measured at the beginning and repeated after 2h.

Using blood pressure cuff, occlusion will be induced to restrict blood flow in the brachial artery. Following the deflation of the cuff, assessments will be conducted for grip strength and electromyography (EMG) activation of the forearm muscles. These measurements will be taken both initially and after a 2-hour interval.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

-
Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

The purpose of this study is to clinically evaluate the efficacy, safety as well as patient satisfaction in the use of topical Centella asiatica (CA) on the cosmetic appearance of stretch marks.

Subjects with abdominal stretch marks will be enrolled in to this study. The presence of abdominal stretch marks will be confirmed by a board certified dermatologist. The right and the left side of the abdomen will be randomized by binary randomization to treatment with CA cream or the vehicle cream. Therefore each patient will serve as their own control.

Each half of the abdomen will be subjected to topical treatment with CA 1% Cream formulated in PCCA Lipoderm® base or PCCA Lipoderm® base as the placebo vehicle treatment based on prior randomization. The creams will be given to the patient in blinded fashion: Cream A (containing CA) and cream B (vehicle/placebo) with instructions apply both formulations daily at night.

Patients will be asked to return to clinic at 6 weeks and 12 weeks for follow up assessment for a total of 3 sessions (baseline, 6 weeks, 12 weeks). High-resolution digital photographs of the stretch marks will be taken at baseline and at each follow-up visit to document clinical response. Two physician graders blinded to the photographs and the treatments will assess cosmetic outcome on a six-point analog scale

The width of the treated stretch marks in each subject will also be measured at the baseline and 8 weeks after the final treatment. The difference of the width will be converted into the percentage of reduction from the baseline.

Subjects will also be asked to complete two surveys at each visit. The two surveys include patient satisfaction with cosmetic and clinical outcome based on a five-point scale.

Eligibility Criteria:
Inclusion Criteria:

1. English-speaking subjects over the age of 18
2. Subjects clinically diagnosed with stretch marks

Exclusion Criteria:

1. History of keloid scarring
2. Isotretinoin use within the last 6 months
3. Oral prednisone use within the last 3 months
4. Non-ablative laser procedures to the abdomen within 1 year of study initiation
5. Ablative resurfacing procedures to the abdomen within 3 years of the study initiation
6. Pregnancy
7. Use of immunosuppressive drugs
8. Known hypersensitivity to Centella asiatica
CP-690-550 Ointment For Chronic Plaque Psoriasis

The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months;
* A target plaque of at least 9 sq. cm.

Exclusion Criteria:

* Demonstrates "rebound" or "flare" of chronic plaque psoriasis;
* Non plaque form of psoriasis;
* Currently have or history of psoriatic arthritis;
* Current drug induced psoriasis;
* Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months;
* Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months
Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

This trial examines the efficacy of cannabidiol (CBD) versus risperidone for treatment of psychosis in patients with non affective-psychosis and lifetime use of cannabis.

People with psychosis and comorbid cannabis use are particularly difficult to treat because cannabis use worsens psychotic symptoms and increases the risk that a first-episode psychosis will progress to schizophrenia. It is the THC (tetrahydrocannabinol) content in cannabis that aggravates psychotic symptoms whereas the CBD content has potential therapeutic effects. This trial investigates treatment with CBD (without THC) versus risperidone (an antipsychotic agent) in people with psychosis and lifetime use of cannabis. We hypothesize that CBD will ameliorate psychotic symptoms and reduce the frequency of cannabis use to a larger extent than risperidone. Sleep disturbances are often a limiting factor in the treatment of psychosis, and it is also examined how CBD affects objective and subjective sleep quality as well as circadian rest-activity cycles. Based on previous studies investigating CBD as monotherapy in patients with schizophrenia, it is expected that CBD will be associated with fewer adverse events than risperidone.

Eligibility Criteria:
Inclusion criteria:

* ICD-10 diagnosis of schizophrenia (DF20.X), paranoid psychosis (DF22.X), acute/intermittent psychotic disorder (DF23.X), schizoaffective psychosis (DF25.X), other/not specified nonorganic psychotic disorder (DF28/DF29), or cannabis induced psychotic disorder (DF12.5)
* PANSS ≥ 60 and score of ≥ 4 on ≥ 2 PANSS-Positive subscale items: Delusions (P1), conceptual disorganization (P2), hallucinatory behaviour (P3), grandiosity (P5), suspiciousness (P6)
* Lifetime cannabis use
* Age 18-45 years
* Female patients of childbearing potential need to utilize a proper method of contraception

Exclusion criteria:

* Treatment resistance as defined by treatment (ever) with clozapine
* Dependence syndrome of alcohol or psychoactive substances other than cannabis (DF1X.2 other than DF12.2)
* Psychotic disorder induced by alcohol or psychoactive substances other than cannabis (DF1X.5 other than DF12.5)
* Treatment with a long-acting injectable antipsychotic within the past month (or corresponding to the usual interval between two injections)
* Treatment with an oral antipsychotic within the past 7 days
* Use of self-administered CBD products during the trial
* Patients involuntarily admitted
* Pregnancy or lactation
* Severe physical illness that might influence the ability to comply with the protocol