cyrilzakka/clinical-trials huggingface dataset:
Vitamin D2, Muscle Damage, NASCAR Pitcrew

Hypothesis: Six weeks of supplementation with vitamin D (4000 IU/day) using Dole's Vitamin D Portobello Mushroom Powder will increase winter serum vitamin D levels, and improve muscle function and strength, and innate immunity (granulocyte/monocyte phagocytosis and oxidative burst activity), and attenuate exercise-induced muscle damage and DOMS.

Vitamin D2 is found naturally in sun-exposed mushrooms, and vitamin D3 is synthesized in the skin when exposed to sunlight and is present in oil-rich fish such as salmon, mackerel, and herring. Mushrooms contain very little or any vitamin D2 but are abundant in ergosterol, which can be converted into vitamin D2 by ultraviolet (UV) illumination (Eur J Clin Nutr. 2011;65:965-71).

In recent decades, there has been increased awareness of the impact of vitamin D on muscle function (Scand J Med Sci Sports. 2010;20:182-90). In the early 20th century, athletes and coaches felt that ultraviolet rays had a positive impact on athletic performance, and evidence is accumulating to support this view. Both cross-sectional and longitudinal studies support a functional role for vitamin D in muscle, and the discovery of the vitamin D receptor in muscle tissue provides a mechanistic pathway for understanding the role of vitamin D within muscle. Studies in athletes have found that vitamin D status is variable and is dependent on outdoor training time (during peak sunlight), skin color, and geographic location (Pediatr Clin North Am. 2010;57:849-61).

25(OH)D is the best indicator and major form of vitamin D in the blood, with a circulating half-life of 2-3 weeks. Vitamin D deficiency is defined as a plasma vitamin D \[25(OH)D\] level of less than 20 ng/ml, with vitamin D insufficiency defined as 21-29 ng/ml. Estimates are that 20-100% of children, young and middle-aged adults, and community-dwelling elderly men and women are vitamin D deficient (J Clin Endocrinol Metab. 2011;96:1911-30).

Purpose: To determine if 6 weeks supplementation with Dole Vitamin D Portobello Mushroom Powder (4,000 IU/day) can, 1) increase winter serum vitamin D levels, and measure whether vitamin D supplementation 2) has a chronic influence on muscle function and strength, and innate immune function, and 3) can attenuate exercise-induced muscle damage and delayed onset of muscle soreness (DOMS) in athletes.

Eligibility Criteria:
Inclusion Criteria:

* NASCAR pit crew members
* Willing to avoid food and supplement sources (during the 6-week supplementation period) that are high in vitamin D (specifically canned fish, cod liver oil, salmon, and supplements with high-dose vitamin D).
* Agree to train normally.
* Avoid the use of large dose vitamin/mineral supplements (above 100% recommended dietary allowances), and medications known to affect immune function.
* Avoid the use of tanning beds.
* Willing to adhere to all aspects of the study design.

Exclusion Criteria:

* Not allergic to mushrooms.
* Do not have a heart problem or have been told by your doctor not to engage in vigorous exercise.
Influence of Electronic Patient Reported Outcomes (ePROMs) in Surgical Therapy for Prostate Cancer on Postoperative Outcome

The study investigates the influence of structured follow-up using ePROMS in the 1st year after prostatectomy on the postoperative course. It will be examined whether this intervention leads to early detection of postoperative symptoms and whether the subsequent initiation of further measures lead to an improvement of incontinence, symptom burden, quality of life and patient competence.

PRO-P is planned as a multicenter, prospective, and two-arm randomized control group study in which ePROMs will be performed in a standardized fashion once before and six times (intervention group) or three times (control group) after primary prostatectomy in patients with PCa. PROMs are collected either web-based or through a dedicated app and entered by the patient using either a mobile device or computer. Patients are invited to enter ePROMS into the app or web tool through email and app-driven push messages. Patients who are incontinent (at least one pad in 24 hours) at the 6-week postoperative survey are randomized into two groups: The intervention group and the control group. In the intervention group, when the respective questionnaire cut-off values are exceeded in the ePROM survey, an alarm is triggered at the treating prostate cancer center and contact is made by the center as well as subsequent measures, if necessary. This is done at 6 weeks postoperatively and at 12, 18, 24, 36 and 52 weeks postoperatively. In the control group, ePROMs are recorded 24 and 52 weeks after radical prostatectomy, but without triggering an alarm with subsequent measures - the control group thus receives treatment in accordance with the current clinical routine. The mechanisms of action of the intervention will be investigated within the framework of a qualitative process evaluation. Characteristics on the patient level (e.g., treatment-related attitudes, comorbidity, social support), on the practitioner level (e.g., communication skills), on the organizational level, and the interactions between the levels (e.g., patient-doctor relationship) will be explored. The goal is to develop an intervention model, or to describe the effective elements of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 y
* legal capacity
* sufficient knowledge of the German language
* prostate carcinoma, TNM T1-4 NX N0-1 M0-1c
* primary radical prostatectomy planned
* mobile input device or PC available
* ability to either receive emails or install a special app on cell phone and receive push messages, with guidance or assistance if necessary
* ability to complete electronic questionnaires, with guidance or assistance if necessary

Exclusion Criteria:

* palliative treatment situation (life expectancy \< 1 year)
* preoperative urinary incontinence (at least one pad per 24 hours)
Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.

Phase IIIb, randomized, longitudinal, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia.

To assess the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia. Assessing the magnitude of change in lipid profile numbers. And describing the effect on anthropometric, biochemical and clinical indicators, as well as events and adverse reactions that may occur. In patients diagnosed with type 2 diabetes and dyslipidemia (triglycerides\> 150 mg / dl, LDL (Low density lipoprotein) cholesterol\> 100 mg / dl) and who require pharmacological treatment for lipid control.

Eligibility Criteria:
Inclusion Criteria:

* That the subject agrees to participate in the study and gives their informed consent in writing.
* Both genres.
* Age 18 to 75 years old.
* Diagnosis of type 2 diabetes mellitus with adequate glycemic control defined by HbA1c ≤ 7.5% at the time of selection.
* Diagnosis of dyslipidemia prior to the start of the study (LDL cholesterol\> 100 mg / dl and triglycerides\> 150 mg / dl).
* Willing to avoid sexual contact or to use a barrier method of contraception while conducting the study.

Exclusion Criteria:

* The drug is contraindicated for medical reasons.
* Consumption of oral contraceptives, cyclosporine or strong cytochrome p450 (CYP) 3A4 inhibitors, protease inhibitors, erythromycin and azoles.
* Patients with Type 1 Diabetes Mellitus.
* Acute or Severe renal dysfunction (glomerular filtration \<30 ml / min / 1.72 m2).
* History of chronic liver disease or ALT and / or AST ≥ 2 times the upper limit of normal, or GGT ≥3 times the upper limit of normal.
* Chronic or acute pancreatitis except for acute pancreatitis due to severe hypertriglyceridemia (defined by the presence of triglycerides\> 1000 mg / dl and / or milky plasma, in the absence of other etiological factors of pancreatitis).
* Patients with active gallbladder disease (defined as acute or chronic gallbladder disorders associated with clinical signs or symptoms).
* Patient with a history or presence of myopathies.
* Pregnant or lactating women.
* Known contraindication or hypersensitivity to the use of any of the components of the investigational drug.
* The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
* At the medical discretion, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: end-stage cancer, kidney, heart, respiratory or liver or mental failure or with scheduled surgical or hospital procedures.
* Be a patient with a working relationship with the principal investigator or the research center or prisoner.
Myoslow Lens Study to Control Myopia in Children

A Prospective, randomized, controlled double masked trial to assess the performance of Myoslow lens in slowing myopia progression in children.

The following study measures will be assessed:

* Demographics and medical history
* Current spectacles
* Best Corrected Visual Acuity (BCVA) assessed by Measurement and Summation (M\&S) system
* Biometry
* Cover test
* Stereopsis
* Ocular Motility
* Pupil responses
* Cycloplegic refraction
* Fundus Examination
* Vision related quality of life using the questionnaire Pediatric Refractive Error Profile (PREP)2
* Adverse Events


Eligibility Criteria:
Inclusion Criteria:

* Children, 6-12 years old
* Spherical Equivalence Refraction (SER): -1.00 to -5.00 Diopter (D).
* Astigmatism and anisometropia of 1.50 D or less.
* Best Corrected Visual Acuity (BCVA) (6 / 7.5) or higher.

Exclusion Criteria:

* Eye and systemic disorders.
* Previously treated for myopia
Development of New Methodologies and Innovative Tools for the diagnoSi and Therapeutic Treatment of uMAni Epithelial Tumors

The main objective of the SISTEMA project is to develop non-invasive diagnostic tests for the detection and quantification in blood of markers of Mesenchymal Epithelial Transition, a mechanism that characterises certain types of cancer such as breast and lung cancer. Cancer is still one of the leading causes of death in Western countries. In 2014, there were an estimated 1,665,540 new cancer cases and 585,720 deaths in the United States alone. The World Health Organisation (WHO) and Eurostat predict 1,323,600 deaths in Europe, a figure slightly down on previous statistics but still underlining the existence and seriousness of the problem. It is no coincidence that cancer is one of the main areas of investment in the European Horizon 2020 programme. In recent years, the hypothesis that the process of carcinogenesis is driven by the activation of a particular panel of genes/proteins that enable cancer cells to acquire malignant characteristics has become increasingly popular. This process goes by the name Epithelial Mesenchymal Transition (EMT) and characterises all human epithelial tumours. This process allows epithelial tumour cells to acquire mesenchymal characteristics giving them stem, invasive, and chemoresistant properties.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects over the age of 18 years with an established clinical picture of breast or lung cancer (including mesothelioma) who have not yet started chemotherapy or biological therapies for the treatment of the neoplastic disease and who have read, understood and signed the study information sheet with attached Informed Consent to Participation, signing the attached consent.

Exclusion Criteria:

* Pregnant female patients of either sex under the age of 18 years, undergoing previous drug therapy with corticosteroids, chemotherapies, immunosuppressants and anticancer drugs, as well as patients with a previous history of other malignancies or in a terminal state (life expectancy less than 4 weeks).

Furthermore, lung cancer patients with conditions that could potentially interfere metabolically with the L-fucose biomarker tested in the specific project arm will be excluded, i.e. lung cancer patients simultaneously suffering from: cirrhosis of the liver, gastric ulcer, diabetes mellitus, periodontitis, as well as subjects under stressful conditions (in which false positivity to the marker due to adrenalin release could occur).
High Risk Breast Cancer Screening Program

Objectives:

* To screen population with high risk for breast cancer
* To promote the concept and importance of surveillance mammography
* To find out the incidence of breast cancer in population who are in high risk for breast cancer
* To collect blood samples for molecular analysis


Eligibility Criteria:
Inclusion Criteria:

* Female
* \> 40 years of age
* Women who have first-degree relative suffered from breast cancer
* Women who have first-degree relative suffered from ovarian cancer
* Family history of male breast cancer
* Family history of breast cancer (not necessarily first degree relatives) diagnosed before age of 40
* Family history of breast cancer (not necessarily first degree relatives) affecting 2 or more family members
* Personal history of ovarian cancer
* Personal history of premalignant conditions of breast and ovary

Exclusion Criteria:

* Women with mammogram within one year
Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining

The goal of this observational study is to explore a standardized sample process for improving the accuracy of vaginal microbiota evaluation and to explore a more complete and comprehensive method for vaginal microbiota evaluation based on gram staining.

This study consists of two sub-studies:

1. Sub-study on Standardized method of Microscopic Slide Preparation: this sub-study aims to compare different slide preparation methods and dilution levels based on various aspects, including uniformity, impurities, clarity and so on, and then explore the optimal method and dilution level. Additionally, it will summarize the conversion method for white blood cells between wet mount and gram staining, and for white blood cells between high-power microscopy and oil immersion microscopy.
2. Sub-study on Vaginal Microbiota Evaluation on Gram Staining: For patients with diagnosed vaginal infection type, it will calculate the consistency of results between different laboratories. And it will evaluate the effectiveness combined artificial intelligence technology and other technological platforms. Besides, for patients without diagnosed vaginal infection type, different methods such as 16S rRNA gene sequencing and metagenomic sequencing are used for analysis and profiling to guide treatment.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant women who visit our research settings and conduct vaginal discharge examination based on Gram-stained smear.
* No sexual intercourse, vaginal douching, or vaginal medication within the last 72 hours.
* Not during menstruation (menstrual period ended ≥3 days ago).

exclusion Criteria:

* Receiving systemic or vaginal antifungal or antibiotic treatment within the past week.
Catheter Ablation Therapy for Persistent Atrial Fibrillation

Use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%). The investigators' previous study indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized that AF should not be initiated or sustained if the latter crucial regions for AF maintenance are abolished. This study aimed to describe the efficacy and safety of additional linear ablation on the left atrial anterior wall for PerAF.

Although studies and guidelines have helped establish catheter ablation as preferred treatment for patients suffering from paroxysmal atrial fibrillation (PAF), use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%).

The investigators' study indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized that AF should not be initiated or sustained if the latter crucial regions for AF maintenance are abolished. This was confirmed using a stepwise pure linear ablation protocol, consisting of a line across the LA roof and extending along the anterior wall of pulmonary veins (PV) antrum to mitral valve annulus (MVA) without PV isolation; the approach appeared safe and effective with long-term (5.2 years) follow-up success rate of 40% for PerAF.

This study will evaluate efficacy and safety of circumferential pulmonary vein isolation (CPVI) + LA roof linear ablation + LA anterior wall (LAAW) linear ablation combined with high density mapping and contact force sensing techniques for perAF. This study is expected to provide a practical and guided catheter ablation strategy with maximized safety and efficacy through use of contact force sensing technique, which will be accepted by other qualified electrophysiology laboratories.

Eligibility Criteria:
Inclusion Criteria:

- The main inclusion criterion is patients suffering from drug refractory persistent atrial fibrillation and referred to catheter ablation therapy. Persistent AF is defined as continuous AF for over 7 days, or lasting no more than 7 days but requiring pharmacological or electrical cardioversion.

Exclusion Criteria:

1. Patients without spontaneous ongoing AF at the beginning of the procedure;
2. Age: \<18 years or \>70 years;
3. LA size \> 55mm measured on echocardiogram;
4. Previous AF ablation history including surgical ablation;
5. Documented LA thrombus;
6. Severe pulmonary diseases;
7. Previous cardiac surgical history.
Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells

The recent developments of research on iPS (induced pluripotent stem) cells lead to the establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with genetic and cellular characteristics of the donors. These cells represent a biological material more readily available to identify the pathophysiological mechanisms involved in the diseases of BrS or ERS patients, which will lead to the identification of genetic markers.


Eligibility Criteria:
Inclusion criteria:

* Patient with a family history of inherited arrhythmia or valvulopathy
* Age : 22-60 yo.
* patient no confine to bed
* Male or female
* Written consent
* Patient affiliated to the French social security

Exclusion criteria:

* Pregnant woman
* Patient under 22 yo or adults under guardianship
* Indication against local anesthesia
* Anticoagulant treatment
* Absence or positivity of HIV, HBV, HCV serology
A Drug-drug Interaction Study with TS-172 in Healthy Adult Male Subjects

An open-label, single-center, single-sequence study to evaluate the drug-drud interaction between the CYP3A substrate triazolam and TS-172 (part A) and the potent CYP3A inhibitor itraconazole and TS-172 (part B) in healthy male subjects on their pharmacokinetics, safety and tolerability


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy adult males whose age is \>=18 and \<40 years at the time of obtaining informed consent
* Subjects whose body mass index is \>=18.5 and \<25.0 at the screening test
* Subjects who are judged by a principal investigator or a sub-investigator to be eligible for participation in the study based on the results at the screening test and before administration of the drugs used in the study
* Subjects who have been informed of the clinical trial, understand the details of the trial, and give their written consent prior to participation in the trial

Exclusion Criteria:

* Subjects with medical history ineligible for participation in the study such as of respiratory, cardiovascular, gastrointestinal, hepatic, renal, urologic, endocrine, metabolic, hematologic, immunologic, dermatologic, neurologic, or psychiatric diseases
* Subjects with medical history of disease (e.g., stomach or intestinal ulcers) or surgery (e.g., gastrectomy, gastric bandage, gastric bypass) that may affect the absorption of the drugs used in the study
* Subjects who have been hospitalized with any treatment or undergone surgery within 12 weeks prior to receiving the drugs used in the study
* Subjects with medical history of drug allergies (limited to severe symptoms such as anaphylaxis) or significant allergic predispositions (e.g., asthma that requires treatment)
* Subjects who have used medications (including over-the-counter drugs) within 2 weeks prior to receiving the drugs used in the study
Self-Guided Personalized Treatment for Women

The investigators plan to collect preliminary data on the feasibility, acceptability, and user uptake of a personalized self-guided mobile intervention for disordered eating (DE) and test the initial clinical efficacy of this intervention. Women (N=50) who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones. The investigators will assess engagement with the modules throughout two months and administer baseline, week 5, and week 8 assessments for acceptability, uptake, and initial clinical efficacy (e.g., DE symptoms, anxiety, quality of life). The investigators will also complete a focus group (n=10) with a subset of users to receive input on the mobile-application assessment and ease of self-guided intervention modules.


Eligibility Criteria:
Inclusion Criteria:

* Endorse disordered eating (score of 2.3 or above on EDE-Q6)
* Age 18-65
* Ability to read and write English
* Own a smartphone or tablet

Exclusion Criteria:

* Active mania
* Active suicidality
* Active psychosis
Evaluating Anodal tDCS Preceding Aphasia Therapy

The purpose of this study is to determine if non-invasive brain stimulation (transcranial direct current stimulation) delivered prior to language therapy will improve word-finding in individuals with aphasia who are 6 months or greater post-stroke.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. First single focal unilateral left hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
3. Pre-morbidly right handed
4. Pre-morbidly fluent English speaker
5. Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist)
6. A baseline Aphasia Quotient score between 10 to 94 out of 100 points on the Western Aphasia Battery (neither completely without language comprehension/expression nor fully recovered from aphasia).

Exclusion Criteria:

1. Ongoing use of CNS-active medications
2. Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
3. Presence of additional potential tDCS risk factors:

   * Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
   * Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
   * Metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation)
   * A history of medication-resistant epilepsy in the family
   * Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
4. Pregnancy in women, as determined by self-report