cyrilzakka/clinical-trials huggingface dataset:
Broccoli, Peas and PIN

This is a parallel human intervention trial to determine to what extent a dietary intervention of broccoli or peas can change the expression (switching on or off) of genes in prostate tissue in men diagnosed with high-grade Prostate Intraepithelial Neoplasia (PIN).

Cancer is one of the main causes of death among humans in the world. Prostate cancer affects 20,000 men in the UK alone each year. Diet is known to be a major factor that influences risk of cancer. Therefore, changes to the diet may alter cancer risk. Cruciferous vegetables, particularly broccoli, provide the diet with a substantial source of plant chemicals called glucosinolates. Previous research has indicated that glucosinolates break down to form isothiocyanates (ITCs) that can be absorbed in the body. Further research has indicated that ITCs may protect the body against the development of prostate cancer. However, the mechanisms behind this effect are not fully understood.

ITCs are thought to be powerful anti cancer agents as they can modulate the expression (switching on or off) of specific genes involved in the removal of toxic substances such as carcinogens from the body. In this study we wish to evaluate the effect of consumption of a conventionally bred cultivar of broccoli containing high levels of ITCs on gene expression in prostate tissue to gain a better understanding of its mechanism of action. Several studies suggest a further protection against cancer amongst individuals who have a deletion of certain genes.

This pilot study comprises a 12-month intervention of either 400g ITC-enriched broccoli per week of 400g garden peas in men at high risk of developing prostate cancer. Changes in gene expression of prostate biopsy tissue will be compared before and after 6 and 12 months of intervention in both dietary groups.

Eligibility Criteria:
Inclusion Criteria:

* Men with a previous diagnosis of high-grade Prostatic Intraepithelial Neoplasia
* BMI \>18.5 or \<35
* Aged between 30-70 years

Exclusion Criteria:

* Undergoing chemopreventive therapy
* Receiving testosterone replacement medicines
* Active infection requiring treatment
* BMI \<18.5 or \>35
* Diagnosed with diabetes
* Unable to give informed consent
Spironolactone Against Anthracycline-induced Cardiomyopathy

This study sought to investigate the whether spironolactone protects the heart against anthracycline-induced cardiotoxicity.

Anthracyclines are the cornerstone in the treatment of numerous hematological and solid cancers. The most common side effect of anthracycline is cardiotoxicity and this may limits its use and increases the rate of mortality and morbidity. Cardiotoxicity is cumulative, dose dependent, and irreversible. Improvements in protective mechanisms against the cardiotoxicity of anthracycline are important to prevent the discontinuance of these chemotherapeutics.

Spironolactone is an aldosterone antagonist which blocks the last step of the rennin angiotensin aldosterone system (RAAS). The RAAS is one of the most effective systems in remodeling of the myocardium in post-myocardial damage. According to the RALES study, in patients with severe heart failure, 25 mg spironolactone per day in addition to the standard therapy has positive effects, particularly on cardiac fibrosis and on remodeling, and substantially reduces the risk of both morbidity and death. In the EPHESUS study, it has been shown that, after the myocardial damage due to infarction, the administration of aldosterone antagonists had positive effects on the remodeling process, left ventricular ejection fraction and primer end-points. In the present study, we tested the hypothesis that RAAS blockage with spironolactone may reduce the cardiotoxicity of anthracycline group chemotherapeutics.

Eligibility Criteria:
Inclusion Criteria:

* LVEF \>50%
* first diagnosed breast cancer
* female sex

Exclusion Criteria:

* Prior breast cancer and/or prior anthracycline exposure history
* LVEF \<50%
* Use of angiotensin converting enzyme inhibitors, angiotensin receptor blockers and beta blockers
* Creatinin value \>2 mg/dl
* Presence of chronic kidney failure
* Potassium value \>5.3 mg/dl
* Presence of adrenal gland diseases,
* Presence of severe liver failure
* Co-morbidities such as coronary heart disease, hypertension, atrial fibrillation, and valvular heart disease.
* Male patients were excluded for the homogenization of the study
Vaccine Response in Patient With Sepsis

Vaccination is established as an effective means of individual and collective protection. Hospitalization is an opportunity not to be missed to catch up on vaccinations in certain fragile patients. Patients hospitalized in infectious diseases are generally treated for an acute or chronic infection that can modulate their immunity and therefore their vaccine response. Current vaccine immunogenicity data in immunocompromised patients support a lower percentage of responders than observed in immunocompetent patients.

There is little data to assess the vaccine response (VR) in patients treated for an infection (bacteremia, pneumonia, urinary tract infection, etc.). In order to respond to this problem, the investigators have chosen to evaluate the vaccine response to Prevenar 13 (PCV13), a conjugate vaccine recommended as a prime-boost since 2013, which must be followed by a vaccination at 2 months with Pneumovax, an unconjugated vaccine of 23 valences.

Anti-pneumococcal vaccine coverage in frail people (immunocompromised, heart failure, respiratory failure, kidney failure, diabetics) remains low and is estimated at less than 10% in 2011, while the bacteria is responsible for severe invasive infections.

In total, the investigators would like to study the vaccine response at 1 month of vaccination with Prevenar 13 in patients hospitalized in infectious disease for sepsis, in order to demonstrate the benefit of vaccination per hospitalization.


Eligibility Criteria:
Inclusion Criteria for all patients:

* Age ≥ 18 years old and \<80 years old
* Planned length of hospital stay in infectious disease department ≥ 48 hours
* Indication for vaccination against pneumococcus according to the 2013 HAS recommendations
* Vaccination planned as part of the usual care
* Patient hospitalized for sepsis meeting the sepsis criteria according to the latest consensus of 2016 or SIRS ≥ 2 with documented infection
* Patient having signed the free and informed consent form
* Subject affiliated to social security

Inclusion Criteria for patients positive to Covid-19:

* PCR SARS-COV 2 \> 0 within 28 days priodi admission and/or,
* scanner compatible with SARS-COV 2 infection.

Exclusion Criteria:

* Pregnant or breastfeeding women,
* Vulnerable people
* Pneumococcal vaccination according to the prime-boost scheme already carried out less than 5 years old
* Pneumovax vaccination \<1 year
* Known hypersensitivity to the active substances or to any of the excipients or to diphtheria toxoid.
* IgG level\> 1 µg / mL among more than 75% of serotypes at inclusion
* Withdrawal of consent
Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients

Cystic Fibrosis (CF) is an inherited disorder in which mucus-secreting glands in the lungs produce considerable quantity of thick, sticky secretions that clog the airways, promote bacterial growth and lead to chronic obstruction, inflammation and destruction of the airways.

The purpose of this study is to collect data about the resolution of the chronic inflammatory state in addition to assure the safety of the therapy in CF patients.

In CF patients the unregulated inflammatory response overwhelms the normal protease (elastase)/antiprotease (AAT) balance, leading to the accumulation of elastase in the lung, destruction of the lung architecture, severe pulmonary dysfunction, and ultimately death.

Administration of AAT is to address the elastase/antiprotease imbalance in order to prevent destruction of the lung tissue and reduce the inflammatory dysregulation that causes pulmonary dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF by clinical symptoms and positive sweat test or disease inducing mutation.
* Age \>5 yrs
* Proven ability to perform reproducible PFTs
* FEV1 \>25% predicted
* Steady disease state for 3 months and no decrease in lung function exceeding 10% during that period
* Colonization
* Stable concomitant therapy \>2 weeks prior to visit 1 and during the study
* Non-tobacco user of any kind
* Ability for sputum induction
* Written informed consent

Exclusion Criteria:

* Severe CF with an FEV1 of \<25% predicted
* History of lung transplant
* Active allergic bronchopulmonary aspergillosis (ABPA)
* Treatment with additional antibiotics (beyond standard CF treatment) for a period of 14 days before study entry (routine antibiotics permitted)
* Treatment with additional oral and/or IV steroids (beyond standard CF treatment) for a period of 14 days before study entry (screening day)
* Known hypersensitivity to plasma products
* IgA deficiency
* Uncontrolled hypertension
* Lung surgery in the previous two years
* Being on any thoracic surgery waiting list
* Severe concomitant disease
* Hospitalization within 1 month before study entry, not due to an airway disease
* Severe liver cirrhosis with ascites
* Hypersplenism
* Grade III/IV oesophageal varices
* Active pulmonary exacerbation within the 4 weeks prior to screening
* History of significant hemoptysis within the previous year
* Use of tobacco products or recreational drugs
* Pregnancy or breastfeeding
* Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with patient treatment, assessment, or compliance with the protocol.
* Being a female of child-bearing age without adequate contraception
* Participation in research study within 1 month
Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

This prospective study will investigate the characteristics of mRCC patients at time of CR in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some answers/ refection leads to the following questions :

Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify potential predictive serum biomarkers of recurrence? (With the aim of isolating blood biomarker that can help on treatment discontinuation decision?)

The main objective of the study is to describe the characteristics of mRCC patients on CR with Sunitinib (Cases) and compare them to the characteristics of mRCC patients non on CR (controls) in order to identify factors associated with the occurrence of complete remission.

The results obtained on the sample must be representative of the population targeted by the study. The most appropriate method to obtain a representative sample is probability sampling.

A sample size of N = 40 (cases) and N = 80 (Controls) will provide a power of 80% in the detection of a frequency difference between cases and controls corresponding to an OR of 0.24 for a parameter frequency 10% in control arm and an OR of 0.30 for a parameter frequency of around 30% in control arm. The significance level was set at bilateral 5%.

The data will be analyzed using SAS software (version 9.1 - SAS Institute, North Carolina, United States).

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic renal cell carcinoma, histopathologically confirmed
* Treated with sunitinib according to Smpc
* For cases: Achieving a CR (local assessment according to RECIST V1.0 criteria) with Sunitinib in prior 6 months alone OR in combination with local treatment (surgery, radiation therapy, ablative techniques: cryotherapy, RFA)
* For controls: Life expectancy \> 3 months No prior Sunitinib treatment
* Patient \>18 years

Exclusion Criteria:

* Sunitinib administered in a non-approved label
* For cases: CR occurring without sunitinib treatment
* For controls: Prior systemic treatment
Point of Care Testing in Pediatric Patients Undergoing Major Surgery

The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and compare obtained results versus standard laboratory coagulation parameters prothrombin time (PT) and partial thromboplastin time (PTT). The time difference in obtaining the two results will also be examined. A total of 100 pediatric patients undergoing spinal surgery or cardiopulmonary bypass will be enrolled and consented per protocol. Blood samples will be obtained simultaneously tested on both the standard laboratory apparatus and the Coagcheck® device. If the two results are comparable, this could have immediate clinical application and impact in the operating room as POCT results are available within 2-3 minutes compared to 1-2 hours for standard laboratory samples.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective posterior spinal fusion surgery at Nationwide Children's Hospital
* Parents willing \& able to provide informed consent
* Child able to provide assent (if age appropriate)

Exclusion Criteria:

* Pre-existing bleeding disorders
* Any other circumstance which, in the opinion of the investigator, would put the patient at increased risk.
Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration

This is a Phase II/III vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate nonexudative Age-Related Macular Degeneration (AMD) will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2 years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for these patients.

An analysis of the primary and secondary endpoints will be conducted when all subjects have completed 12, 18 and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age ≥ 50 years and ≤ 85 years;
* Females must be at least 1 year postmenopausal (after last menstrual period) or sterilized;
* Better than 20/80 ETDRS best corrected visual acuity;
* Mild to moderate nonexudative AMD (AMD steps 3 through 8 on Age-Related Eye Disease Study (AREDS) Report No. 17 grading scale);
* Willing to sign informed consent, comply with study protocol requirements, and undergo up to 2.5 hours of testing at each visit;

Exclusion Criteria:

* Past or current exudative AMD or any geographic atrophy (on fundus autofluorescence) in study eye;
* Past or current other retinal or choroidal vasculopathy in study eye (e.g. pigment epithelial detachment, polypoidal choroidal vasculopathy, central serous retinopathy, retinal vein occlusion, sickle cell retinopathy);
* Uncontrolled hypertension (≥ 150 systolic or ≥95 diastolic);
* Diabetes mellitus;
* Glaucoma;
* Lens opacity ≥ grade 3 ARLNS on standard photographs;
* Unable to complete biophysical testing;
* Unable to give informed consent;
* Dilated pupil diameter less than 6 millimeters;
* Subjects with a history of a hypersensitivity reaction to the study drug or to any agent used in the components of the study assessment;
* Use of topical ocular medications (other than artificial tear products);
* Anticipated extra- or intraocular intervention during the study period;
* High myopia (refractive error spherical equivalent ≥ -6 diopters);
* Optic neuropathy;
* Neurological conditions that can impair vision (e.g. Parkinson's disease, multiple sclerosis, Alzheimer's disease);
* Liver disease (e.g. cirrhosis, hepatitis);
* History of GI surgery (e.g. bariatric surgery);
* Unwilling or unable to take an AREDS formula vitamin (without beta-carotene/vitamin A);
* Current or past use of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine (BCNU), or deferoxamine;
* Tobacco smoking (currently or within past 5 years);
* Contact lens wearers (not prepared to discontinue lens use);
* Ophthalmic surgery of any kind within 3 months prior to screening visit;
* Participation in any interventional clinical study requiring IRB approval within 3 months of enrollment;
* Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year study;
* Known to have AIDS/HIV
A First Time In Human Study To Assess The Compound GSK615915

GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's future generation of Metered Dose Inhalers (MDIs). A surfactant in a MDI would provide a more stable drug suspension, this in turn will produce a consistent dose of drug being delivered with each puff.


Eligibility Criteria:
Inclusion Criteria:

* Women of non-child bearing potential.
* Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m²
* The subject is a current non-smoker who has not used any tobacco products in the last 12 months with a pack history of = 10 pack years.
* The subject has demonstrated the ability to correctly use a metered dose inhaler device.
* If asthmatic:

The subject must be clinically stable The subject has a baseline FEV1 = 80% of predicted.

Exclusion Criteria:

* As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
* The subject has a history of allergy to excipients, MDI propellants, or a history of drug or other allergy that, in the opinion of the physician responsible makes the volunteer unfit to participate.
* The subject has recently participated in another clinical trial.
* The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johnâ€™s Wort) within 7 or 14 days.
* The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female, or an average daily intake of greater than 3 units regularly, where 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
* Any history of breathing problems (e.g. history of asthmatic symptoms).
* The subject is infected with the hepatitis B, hepatitis C, or HIV virus.
* The subject is has a positive drugs of abuse test.
* The subject has had a respiratory tract infection within 4 weeks of the start of the study.
* The subject has a past or present disease, which as judged by the Doctor, may affect the outcome of this study.
* The subject has a history of life-threatening asthma.
* The subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral steroids within 8 weeks of the start of the study.
* The subject has taken long acting inhaled beta 2 agonists within 96 hours before the screening visit.
* The subject has taken short acting inhaled beta 2 agonists within 8 hours before the screening visit.
* The subject is unable to abstain from other drugs that may interfere with the conduct of the study or its interpretation.
* The subject has ongoing rhinitis that requires treatment.
A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants

The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-954.

The drug being tested in this study is called TAK-954. TAK-954 is being tested in healthy participants in order to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-954.

The study will enroll approximately 10 participants. Participants will receive the following treatment sequences:

• TAK-954 0.2 mg; Itraconazole 200 mg + TAK-954 0.2 mg

Participants will be given an intravenous infusion of TAK-954 on Day 1 of First Intervention Period (6 days) followed by minimum 7-day washout period, after which participants will be given Itraconazole capsule on Days 1 to 8 along with TAK-945 infusion on Day 4 of Second Intervention Period (9 days).

This single center trial will be conducted in the United States. The overall duration to participate in this study is 7 to 8 weeks. Participants will visit the clinic on Day -1 and remained confined until Day 6 (First Intervention Period) and Day 9 (Second Intervention Period). Participants will return for a Follow-up Visit 10 to 14 days after last dose of study drug (approximately up to Day 34).

Eligibility Criteria:
Inclusion Criteria:

1. Is a man or woman (with no child bearing potential) aged 18 to 55 years, inclusive, at the Screening Visit.
2. Has a body mass index (BMI) from greater than or equal to (\>=) 18 and less than or equal to (\<=) 30 kilogram per square meter (kg/m\^2) and has a body weight greater than (\>) 50 kilogram (kg) at the Screening Visit.
3. Is a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the initial dose of trial drug/invasive procedure.

Exclusion Criteria:

1. Has a positive alcohol or drug screen.
2. Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter (mL)) within 8 weeks of the first dose of study drug.
3. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer \[354 mL/12 ounces\], wine \[118 mL/4 ounces\], or distilled spirits \[29.5 mL/1 ounce\] per day).
4. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
5. Has a substance abuse disorder.
Optimizing the Impact of the Healthy School Recognized Campus Program on Youth's CVD Risk Factors

Healthy School Recognized Campus is a Texas A\&M AgriLife Extension initiative that supports the delivery of school-based physical activity and nutrition programs for diverse youth across Texas. The purpose of this study is to improve the delivery of these programs and optimize the effect they have on youth's cardiovascular risk factors.

The investigators will conduct a group randomized factorial trial using the Multiphase Optimization STrategy (MOST) framework to evaluate the impact (i.e., implementation and effectiveness) of three implementation strategies on program implementation and youth's cardiovascular disease risk. HSRC is a Texas A\&M AgriLife Extension initiative that supports the delivery of school-based physical activity and nutrition programs.

Elementary schools in North and East Texas (n=16) of similar socio-economic status will be randomized at baseline to receive either 3, 2, 1, or no strategies to support HSRC program implementation. All schools will participate in HSRC during the full school year.

The investigators hypothesize that one strategy will result in significantly greater HSRC implementation and effectiveness than the other strategies tested.

Eligibility Criteria:
School Inclusion Criteria:

* located in North and East Texas
* Public elementary school

Student Inclusion Criteria"

* at least 10 years old by September 1, 2023 (2024 for the 2024-2025 school year)
* enrolled in the 5th or 6th grade
* able to read, speak, and write in English

Exclusion Criteria:

* any motor or cognitive impairments or other health conditions that would prevent them from completing a physical assessment