cyrilzakka/clinical-trials huggingface dataset:
Physical Exercise and Pollution: Cardiorrespiratory, Cerebral and Molecular Aspects

Modern society increasingly seeks healthy life style, and regular physical activity is considered one of the main factors that improve the quality of life. The evidence shows that the aerobic physical training in controlled environments benefit various aspects of human health, including cognition in the elderly population. However, when exercise is performed in a polluted environment, the individual is subjected to grater exposure to pollutants due to increased ventilation (breathing).

Modern society increasingly seeks healthy life style, and regular physical activity is considered one of the main factors that improve the quality of life. The evidence shows that the aerobic physical training in controlled environments benefit various aspects of human health, including cognition in the elderly population. However, when exercise is performed in a polluted environment, the individual is subjected to grater exposure to pollutants due to increased ventilation (breathing). It is well known that inhaled pollutants can cause oxidative modification in biomolecules and oxidative stress is a cause of diverse diseases. This scenario raises important questions: the deleterious effects of pollution can abolish the beneficial effects of exercise? This issue is currently relevant given the increasing level of air pollution in large urban centers such as Sao Paulo city and at the same time, outdoor physical activity in public places is largely stimulated by public organizations, particularly for elderly. Thus this multidisciplinary project aims to investigate the deleterious effects of urban air pollution in elderly people who practice aerobic physical exercise outdoors in Sao Paulo and compare with those who practice in Laboratory. This study can provide important knowledge for public health and welfare of the population.

Eligibility Criteria:
Inclusion Criteria: Health Subjects that lives in São Paulo city for at least 10 years.

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Exclusion Criteria: Neuropsychological issues.

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The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for breast cancer experience negative sequelae in the form of pain following treatment. Chronic pain is known to be associated with impaired social and emotional functioning, and thus presents a particular concern.

Mindfulness-based intervention is among the complementary, psychological treatments, which cancer patients commonly seek out in relation to the course of their illness. Despite the popularity of mindfulness-based intervention among cancer patients, no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients. While no studies so far have focused on pain, there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer. Furthermore, non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences.

The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment for breast cancer and who experience chronic pain, will be randomized to an intervention group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the same time points, i.e. before the intervention (baseline), and three times after the intervention/control condition, with the last follow-up 6 months after the intervention. In addition, a number of potential moderators and mediators of the outcome will be explored. For example, recent studies indicate that adult attachment style may constitute an important moderator and/or mediator in the development of pain, and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention.

The results will provide valuable new knowledge about the potential of MBCT as a treatment strategy for chronic pain in breast cancer patients, will contribute to the clarification of underlying mechanisms in the experience of and coping with pain, which could help the development of more effective, individualized interventions.


Eligibility Criteria:
Inclusion Criteria:

* A timeframe of \>3 months from surgery, radiation- and chemotherapy and a minimum score of \>3 on a pain scale from 0-10 corresponding to moderate pain

Exclusion Criteria:

* Breast cancer recurrence, bilateral breast cancer, other cancer, psychiatric illnesses, insufficient ability to speak and understand Danish, and chronic pain otherwise associated with the musculoskeletal system
Translational Assessment of Vitiligo According to Body Locations

Vitiligo affects 0.5 to 2% of worldwide population and has a demonstrated impact on the quality of life.

Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), but also to induce the differentiation of melanocyte stem cells (to induce repigmentation). There is a well demonstrated discrepancy in the repigmentation response between anatomical areas of the body. Face and neck are the best responder with complete or almost complete repigmentation achieved in most cases under treatment. Trunk and limbs could have a complete or almost complete repigmentation in approximately half of the cases. The repigmentation is much more difficult in wrists, elbows, knees, proximal part of the hands. Finally, some areas such as the extremities of hands and feet, palms, soles, are almost impossible to repigment.

The investigator hypothesize that there are some factors that are produced in the skin that prevent (or at least decrease) the differentiation but also probably the migration and proliferation of melanocytes.

Primary objective To compare the mRNA expression of each types of cells in the skin of vitiligo patients compared to healthy volunteers according to body locations


Eligibility Criteria:
Inclusion Criteria:

* Men and women with non-segmental vitiligo for the vitiligo group and men and women without any auto-immune disorder for the control group
* ≥ 18 and \<70 years
* For women of child-bearing age, a urine pregnancy test (βHCG in urines) will be performed.
* Affiliation to a social security system
* Signed informed consent

Exclusion Criteria:

* Pregnant women
* Segmental or mixed vitiligo
* Vitiligo with less than 2 years duration
* Skin auto-immune or inflammatory skin disorders other than vitiligo (ie. active atopic dermatitis, psoriasis, lichen planus...)
* Exposure to sun (with intent to tan or repigment the skin) or artificial UV (UV cabins, lamps or lasers) during the month before inclusion
* Concomitant use of topical or systemic immunosuppressive medication or steroids
* Contra-indication to xylocaine with 2 % adrenalin
* Pregnant or breast-feeding women
* Vulnerable people: minors, adult under guardianship or deprived of freedom, adult under curatorship
* Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
Rosuvastatin Pre-Treatment Influences the Risk of Coronary Intervention Study

The aim of this study is to determine whether a pre-treatment with high-dose statin (one day prior and just before intervention, rosuvastatin 20mg/day) has a positive impact on the occurrence of periprocedural myocardial infarction during percutaneous coronary intervention (PCI).

The aim of this study is to attest whether a short-term treatment with high-dose statin (one day prior and before intervention, rosuvastatin 20mg/day) can have a positive impact over the occurrence of periprocedural myocardial infarction during percutaneous coronary intervention (PCI). Patients with stable or unstable (with negative troponin) angina pectoris receiving statins (or not, except rosuvastatin 40mg a day) therapy referred for coronary angiography and subsequently PCI will be enrolled and randomized (ratio 1:1) to pre-treatment with rosuvastatin (20mg 12 hours prior + 20mg immediately before PCI - Rosuvastatin group), or immediate PCI (control group). Serum concentration of troponin I will be measured prior to, 12 hours and 24 hours after PCI.

Power of study (200 vs 200 pts; p1 = 0.2; p2 = 0.33; alfa = 0.05, n1 = 200, n2 = 200; power 0.84).

The primary end-point will be the TnI concentration ≥ 1.5 times the ULN. The secondary end-point witl be the TnI concentration ≥ 3 times ULN.

The Cox regression model will be used to identify the predictors of primary end-points (age, diabetes, smoking, symptomatic peripheral artery disease, statin pre-treatment, level of total cholesterol, pre-treatment with clopidogrel, multi-vessel disease, unstable angina, hs-CRP, therapy with beta-blockers, treatment of complex coronary lesion).

The patient included shall fulfill all the criteria: 1) significant coronary artery stenosis or occlusion indicated for percutaneous coronary intervention and 2) signed informed consent.

The criteria excluding the inclusion in the study are: 1) positive troponin I (≥ 1 ULN), 2) previous inclusion in this study, 3) renal insufficiency, 4) chronic treatment with rosuvastatin 40mg or more, and 5) disagreement to be included in this study.

This study will be multicenter. The Motol University Hospital will participate as the project coordinator.

Eligibility Criteria:
Inclusion Criteria:

* significant coronary artery stenosis or occlusion indicated for percutaneous coronary intervention
* signed informed consent

Exclusion Criteria:

* positive troponin I (≥ 1 ULN)
* previous inclusion in this study
* renal insufficiency (creatinine ≥ 200 umol/l)
* chronic treatment with rosuvastatin 40mg or more
Potency and Precision Investigation

The overarching goal of this study is to establish initial proof of mechanism for precision interventions in an adult population.

This exploratory single-arm trial will provide initial learning on the current implementation of precision interventions and generate data and hypotheses to inform the exploration of future interventions by identifying mechanisms and moments in the user journey to target. The DISC-MA app uses a relational agent (Woebot) to engage users in conversations. Eligible participants will be assigned to use DISC-MA, in which Woebot selects from a list of responses based on natural language processing. Participants will receive instructions on downloading and using the DISC-MA app in order to access the intervention. Participants will use the app as instructed and will complete assessments for the primary endpoint as Week 4 (EOT) with additional measures being collected as Baseline, Week 1, and Week 2. Results from this study will provide data on baseline participant clinical and psychological characteristics and their engagement with DISC-MA, and associations between the two.

Eligibility Criteria:
Inclusion Criteria:

1. Must be 18-75 years of age
2. Must own or have regular access to a smartphone with a recent operating system installed (Android: OS 8.0 or higher, Apple: iOS 13.0 or higher) with reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
3. Must be available and committed to engage with the program and complete assessments for a 4-week duration
4. Must be able to read and write in English
5. Must have primary residence in the United States
6. Must have mild or greater symptoms of depression and/or anxiety at Screening/Baseline, indicated by a score \> 4 on the Patient Health Questionnaire (PHQ-8) and/or Generalized Anxiety Disorder (GAD-7)

Exclusion Criteria:

1. Current suicidal ideation with a plan and/or intent or a suicide attempt within the past 12 months
2. Previous Woebot use
3. Involuntary inpatient psychiatric hospitalization any time within the past 30 days
4. Lifetime diagnosis of bipolar disorder
5. Lifetime diagnosis of a psychotic disorder
Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of chemotherapy.

This is a single-arm, open-label, multicenter, phase II clinical trial design with an early stopping rules. PHA-848125AC will be administered to patients with recurrent metastatic unresectable B3 thymoma or thymic carcinoma who have received more than one line of prior systemic therapy for advanced / metastatic disease. The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of the patients. The primary end point for this study is a progression free survival rate of 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated IRB/Approved Informed Consent
* Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after more than one prior systemic therapy for advanced / metastatic disease
* Presence of measurable disease
* Age \>=18 years old
* ECOG performance status 0-1
* Negative pregnancy test (if female in reproductive years)
* Use of effective contraceptive methods if men and women of child producing potential
* Adequate liver function Total Serum Bilirubin \<=1.5 x upper limit of normal (ULN) Transaminases (AST/ALT) \<=2.5ULN (if liver metastases are present, then \<=5ULN is allowed) ALP \<=2.5ULN (if liver and/or bone metastases are present, then \<=5ULN is allowed)
* Adequate renal function Serum Creatinine \<=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula \> 60 mL/min
* Adequate hematologic status ANC \>=1,500cells/mm3 Platelet Count \>= 100,000cells/mm3 Hemoglobin \>=9.0g/dL
* Two weeks must have elapsed since completion of prior chemotherapy, minor surgery, radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated)
* Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3.0) grade \<=1

Exclusion Criteria:

* Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
* Grade \>1 retinopathy
* Known brain metastases
* Known active infections
* Pregnant or breast feeding women
* Diabetes mellitus uncontrolled
* Gastrointestinal disease that would impact on drug absorption
* Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline
* Patients with previous history or current presence of neurological disorders (with the exception of myasthenia gravis), including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that make the patient inappropriate for entry into this study
Beverages for Thought: Exploring the Relationship Between Blood Glucose and Cognition

The objective of this study is to conduct novel research on the relationship between blood sugar and cognition.

This study is an acute parallel study design with one intervention visit needed per participant. There are 2 groups and 80 participants will be randomized into each group. Following the consent process, participants in each group will be seated individually in quiet rooms, with written instructions, several magazines, and a mini-fridge with beverages containing 110-120 kcals/8 fl oz. Participants will be provided instructions for the study, stating, "The study we are conducting explores the relationship between blood glucose and cognitive abilities. After consuming food or drink, your body regulates your blood glucose. Physical exertion can also affect blood glucose. Therefore, we ask that you relax in this space for 10-15 minutes. You can read the provided magazines during this time. Drinking a beverage will bring your body's blood glucose into the right phase for our questionnaires. In the fridge are some beverages, and we ask that you drink something."

After 10-15 minutes, participants will be given a cognitive test (a questionnaire on paper) and asked to complete as much of it as they can within 5 minutes. Then, moving to a separate area, weight and height measurements will be taken.

Eligibility Criteria:
Inclusion Criteria:

* No food allergies or food intolerances
* Healthy (no chronic disease) as determined by online questionnaire
* Non-pregnant and non-lactating
* Not currently dieting or planning to follow a special diet
* Minimal restricted eating practices

Exclusion Criteria:

* Pregnant or lactating
* Currently dieting or planning to follow a special diet
A Safety Study of Mirikizumab (LY3074828)

The main purpose of this study is to evaluate the safety of the study drug known as mirikizumab. The study will investigate how the body processes the study drug and how the drug affects the body. The study will last about 3 months for each participant.


Eligibility Criteria:
Inclusion Criteria (Psoriasis participants):

* Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline
* Plaque psoriasis involving \>2% body surface area (BSA) in affected skin other than the face and scalp at screening and baseline
* Are willing and able to washout topicals for at least 14 days before baseline on the 2 target lesions

Inclusion Criteria (Healthy participants):

* Are overtly healthy males or females, as determined by medical history and physical examination
* Are women not of childbearing potential
* Are between the ages of 18 and 65 years, inclusive, at the time of screening
* Have a body mass index between 18.5 and 32.0 kilogram per square meter (kg/m2), inclusive, and a minimum body weight of 55 kg
* Have clinical laboratory test results within normal reference range for the central laboratory, or results with acceptable deviations that are judged to be not clinically significant by the investigator
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
* Have given written informed consent approved by Lilly and the ERB governing the site

Exclusion Criteria (Psoriasis and healthy participants):

* Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy). Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval
* Within 28 days prior to baseline: have received systemic nonbiologic psoriasis therapy
* Within 14 days prior to baseline: have received topical psoriasis treatment
* Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of data
* Have had clinically significant symptomatic herpes zoster within 3 months of screening
* Show evidence of active or latent tuberculosis (TB)
* Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study
* Have significant allergies to humanized monoclonal antibodies or any components of the mirikizumab product formulation or have a history of significant atopy
* Have had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years and cervical carcinoma in situ, with no evidence of recurrence within 5 years prior to baseline
Effects of Wheat Bran Extract on Cognitive and Memory Function

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of water extract from wheat Triticum aestivum L on cognitive and memory function. The investigators measured changes in cognitive function parameters, including CNT, WMT, K-MMSE, BCRS, PRMQ, PSS, SF-36 and BDNF

Based on reports about the neuroprotective effects of water extract from wheat Triticum aestivum L. or its bran, the investigators hypothesize that extract of wheat bran (WBE) is beneficial to elderly people with age-associated cognitive impairment. The investigators investigated the efficacy and safety of WBE on improvement of cognitive function through measuring the neuropsychometric assessments in adult with subjective cognitive impairment by a randomized clinical trial.

Seventy participants aged from 50 to 80 years old with subjective cognitive impairment were randomly assigned to receive either WBE (3,000 mg/day) in this 12-week, double-blind placebo-controlled and parallel trial. Neuropsychological assessments including Computerized Neurocognitive function test (CNT), Working Memory Test (WMT), Korean Mini-Mental State Examination (K-MMSE), Brief Cognitive Rating Scale (BCRS), Prospective and Retrospective Memory Questionnaire (PRMQ), Perceived Stress Scale (PSS), 36-Item of Short-Form Health Survey (SF-36) and blood Brain-derived neurotrophic factor (BDNF) were used to assess the cognitive function before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* subjects with subjective cognitive impairment
* able to give informed consent

Exclusion Criteria:

* history of underlying neurodegenerative disease
* allergic or hypersensitive to any of the ingredients in the test products
* history of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* history of alcohol or substance abuse
* participation in any other clinical trials within past 2 months
* laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study etc.
Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants

The aim of the study is to allow Groupe SEBBIN to communicate to competent authorities and to the scientific community data relative to the safety and effectiveness of SEBBIN silicone gel-filled breast implants.


Eligibility Criteria:
Inclusion Criteria:

* The patient is at least 18-year-old.
* The patient is genetically a woman.
* The patient is candidate to a breast augmentation or breast reconstruction with silicone gel-filled breast implants.
* The patient gets all information regarding the study and signs the informed consent relative to the use of her personal data.

Exclusion Criteria:

* The patient is pregnant or breastfeeding.
* The patient has silicone implants somewhere else than in the breast.
* The patient was diagnosed with one of the following pathologies:

  * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
  * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
  * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
* The patient has a pathology that could delay healing (does not apply to the reconstruction group).
* The patient has cancer (does not apply to the reconstruction group).
* The patient has anatomical or physiological conditions that could lead to postoperative complications.