cyrilzakka/clinical-trials huggingface dataset:
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy

The purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (ExactVu) and by multiparametric magnetic-resonance imaging (mpMRI).

This is a pilot clinical trial with 30 patients with either: 1) suspected prostate cancer (based on elevated PSA or abnormal digital rectal exam (DRE), or 2) known low-risk prostate cancer being managed with active surveillance.

Enrolled patients will undergo MRI fusion biopsy and standard-template 12 core TRUS biopsy as the standard-of-care. Patients will also undergo micro-ultrasound evaluation and targeted biopsy if lesions are identified. Detection rates of clinically significant lesions by ExactVu and by MRI will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled to undergo biopsy and with one of the following:

   * Men with suspicion of prostate cancer
   * Men on active surveillance
2. Age ≥18 \[30\]
3. Have available multiparametric prostate MRI
4. Able to provide written, informed consent
5. No significant medical illness which in the opinion of the Investigator would preclude entry to study procedures
6. Be willing and able to comply with scheduled visits

Exclusion Criteria:

1. Previously confirmed prostate cancer diagnosis with Grade Group \>= 2
2. Unable to undergo prostate biopsy
3. Prostate MRI unable to be evaluated using the PI-RADS v2 criteria
4. Men with contraindication for MRI or a prostate biopsy
5. Prostate biopsy within 8 weeks prior to mpMRI.
6. Any history of prostate treatment
Acute Effects of Dietary Medium-chain Fatty Acids on Lipid Profile

In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover.

Four participants ingested MCT or LCT oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consumed a eucaloric control diet, and abstained from alcohol and vigorous physical activity to ensure similar conditions on experimental days.

On the test days, participants arrived by passive transport in the overnight fasted state (12 h) at 8 a.m., and a catheter was inserted into an antecubital vein. Following 30 min in supine rest, an overnight-fasted, basal venous blood sample was obtained. Subsequently, participants ingested the same test drink as in study 1 (containing 35g of MCT or LCT oil diluted in 100g of low-fat, low-carbohydrate cocoa milk) within five min. 100 ml water was provided together with the test drink. Venous blood samples were drawn every 30 min for the first two hours and every 60 minutes for the last two hours following intake. Participants rested in a bed throughout the test day. this This process was repeated on the second test day.

Eligibility Criteria:
Inclusion Criteria:

healthy males BMI:20-27 recreationally physical active non-smoker no medicine

-

Exclusion Criteria:

* high habitual intake of MCT-rich foods as coconut, coconut oil and dairy products
An Observational Research Study of the Health of Joints in People With Haemophilia Taking the Medicine Esperoct

This study will collect information on the long term health of joints in people with haemophilia A who have started treatment with Esperoct within twelve months prior to participation to the study. This study is conducted to look at how joint health of people with haemophilia changes over time when they are receiving the medicine Esperoct. The participants will get Esperoct as prescribed to the participants by the study doctor. The participant's treatment will not be affected by their involvement in the study. Every six months, the participants will be asked to answer some questionnaires about their joints, their pain and their ability to be physically active. Their participation in the study will last for no more than 2 years. The participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male, greater than or equal to 18 years of age at the time of signing informed consent, diagnosed with severe (FVIII activity below 1%) or moderate congenital haemophilia A (FVIII activity 1-5%).
* The decision to initiate treatment with commercially available Esperoct has been made by the patient and the treating physician before and independently from the decision to include the patient in this study.
* Switched, within two months prior to enrolment, OR planned to switch, within one month post enrolment, to prophylaxis treatment with Esperoct from previous therapy; the decision to initiate treatment with Esperoct must be made prior to and independently from the decision to enrol in the study.
* Must have baseline data (HJHS, target joints, and medical history) collected in routine clinical practice within two months prior or up to one month post switch to Esperoct therapy.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Previous terminated treatment regimen with Esperoct prophylaxis.
* Current or previously terminated treatment regimen with Esperoct on-demand.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Previous participation in a clinical trial within the 30 days prior to switching to Esperoct.
Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity

Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. However, the impacts of TRE combined with aerobic exercise training in individuals with overweight and obesity have been insufficiently investigated.

Additionally, aerobic training performed in a fasted state appears to promote physiological adaptations that may improve the metabolic health in individuals with overweight and obesity.

The present study investigates the effects of 8 weeks of TRE associated with aerobic training in a fasted state versus a fed state on body composition and cardiometabolic parameters in women with overweight and grade 1 obesity.


Eligibility Criteria:
Inclusion Criteria:

* Female;
* Body mass index (BMI) between 25 and 34.9 kg/m²;
* Age between 20 and 40 years;
* Not engaged in any structured exercise program;
* Weight stable for \~3 months before the beginning of the study;
* Able to give written informed consent.

Exclusion Criteria:

* Current smoker;
* Habitual drinkers (\>1 serving/day) of alcoholic beverages;
* Cardiometabolic diseases (dyslipidemia, diabetes, hypertension, etc);
* Current treatment with medication or supplements which significantly affect the main studied variables;
* Bariatric surgery;
* Night-shift workers;
* Strict vegetarian/vegan;
* Pregnancy, planned pregnancy (within the study period), lactating;
* Postmenopausal women;
* Self-reported menstrual cycle irregularities;
* Habitual fasting window \>16 hours;
* Concomitant participation in other studies.
Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion

The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension


Eligibility Criteria:
Inclusion Criteria:

* Subjects who agree to participate in this study and give written informed consent
* Subjects whose sitting diastolic blood pressure measured at placebo visit and baseline are more than 90 mmHg and/or systolic blood pressure are more than 140 mmHg
* Subjects who are naive to anti-hypertensive treatment
* Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study

Exclusion Criteria:

* Subjects who are hypersensitive to angiotensin type 1-receptor blockers
* Subjects with secondary hypertension
* Subjects with severe hypertension (systolic blood pressure \>= 180 mmHg OR diastolic blood pressure \>= 110)
* Severe cardiac disease (heart failure, ischemic heart disease, peripheral vascular disease, moderate valvular disease, arrhythmia requiring treatment, cardiomyopathy, etc.)
* Subjects with chronic obstructive pulmonary disease or history
* Clinically significant renal dysfunction (Creatinine 2.0 mg/dL) and liver dysfunction (ALT, AST \> 2x UNL)
* Subjects with life expectancy of less than 2 years due to non-cardiac disease
* Subjects with history or evidence of abuse of drugs or alcohol within 2 years
* Severe insulin-dependent diabetes mellitus or intractable diabetic patient (dose/regimen change of oral hypoglycemic agent, insulin use)
* Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, within 6 months)
* Wasting diseases, autoimmune diseases (rheumatoid arthritis, systemic lupus anticoagulants, etc.), history of connective tissue disease or ongoing disease.
* Women with pregnancy and breast feeding
* Women planning to be pregnant or without admitted contraception despite of probability of pregnancy (Women who underwent sterilization operation are excluded. Fertile women without such surgery should undergo pregnancy test and can participate only with negative result. Intermittent abstinence like basic body temperature method, natural period method are not considered admitted contraception and no hormonal contraception is allowed.).
* Subjects who are participating in other clinical trials for investigating agents or have taken other clinical trial medication within 4 weeks before screening visit.
* Subjects judged to be inappropriate by the investigator
Study of Recovery and Blood Rheology Changes in Ultra-endurance Runners (ERUPTION-3)

While the acute consequences of an ultratrail are beginning to be well documented, data on the study of recovery in the aftermath of an event are much rarer.

In order to overcome these various limitations, the main study of the ERUPTION-3 project is set up on the Grand Raid de La Réunion 2022 races.

In the context of exercise responses, the rheological properties of blood can impact the endurance performance. In contrast to short-distance events, the study of blood rheology and red blood cells integrity in long-distance events such as ultra-endurance races is poorly documented in the literature.

In the ancillary study, the work that is intended to be carried y out will complement the initial results found by a previous research on 23 runners during the Ultra Trail du Mont Blanc. This ancillary study will also be an opportunity to complete the data from the main study by studying the kinetics of biomarker recovery.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Participating in the Grand Raid de la Réunion race (Mascareignes, Trail de Bourbon or Diagonale des fous)
* Affiliated or beneficiary of a social security scheme
* Not opposed to the research for the main study
* Having given their written consent for the participants of the ancillary study

Exclusion Criteria:

* Not understanding French
* Protected adult (guardianship or curatorship) or under court protection
* Who have difficulty swallowing paracetamol capsules and for whom it will therefore be difficult to swallow the e-Celsius® Performance capsules (for the ancillary study)
Creatine Supplementation in Patients With Intermittent Claudication.

The aim of this study will be to verify the effect of creatine supplementation associated to clinical treatment of the functional capacity in patients with intermittent claudication.

The aim of this study will be to verify the effect of creatine supplementation associated to clinical treatment of the functional capacity in patients with intermittent claudication. The sample will be composed by patients with intermittent claudication of both sexes. The patients will be ramdomized in a double-blind procedure to receive during seven days (loading) and posteriorly 49 days (maintenance) a creatine (Cr) supplementation or placebo (PLA), associated to the clinical treatment. Before ("baseline"), after "loading" period and after the maintenance period of supplementation, the patients will go through a functional capacity evaluation. The fuctional capacity evaluation will be evaluated by a six minute-walking test. For statistical analysis it will be used the ANOVA of two factors for repeated measurements, having the (Cr and PLA) group and the time (pre, post-loading and post-maintenance), and when needed the post-hoc of Newman keuls. The adopted level of significance will be P\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* symptom of pain during the six-minute walk test limited by leg pain due to intermittent claudication.
* present peripheral artery disease (Ankle-arm index \< 0.90) in one or both limbs.
* Asymptomatic intermittent claudication determined from the clinical history.
* Not have muscle or joint injuries that make it impossible to practice physical activity.

Exclusion Criteria:

* not attending more than 15% of the intervention sessions or visits to the laboratory.
* Stick to a physical activity program in addition to that offered by the study.
* do not use medication regularly.
* aggravation of the disease
Crossover Drug-Drug Interaction Study to Determine Effects of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites

This is a Phase 1, single center, fixed sequence, open label, drug-drug interaction study of the effect of multiple doses of rifampin 600 mg daily, a strong CYP3A inducer, on the exposure of mifepristone at 2 dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Be healthy
* Have a BMI of 18 to 32 kg/m2, inclusive, and body weight more than 50 kg (110 pounds)
* Be judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings
* Have suitable veins for multiple venipuncture/cannulation
* Female subjects of childbearing potential must use highly effective contraception with low user-dependency. The only acceptable method is an intrauterine device (IUD), provided that the subject has tolerated its use for at least 3 months before the first dose of study drug and undertakes not to have it removed for 1 month after the last dose of study drug. Use of hormonal contraception (by any route, including intrauterine hormone releasing systems) or hormone replacement therapy is NOT acceptable.

Exclusion Criteria:

* Have multiple drug allergies, or be allergic to any of the components of mifepristone or rifampin
* Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
* Have a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia or endometrial carcinoma
* Breastfeeding
* In the 1 year before first study drug administration, have a history of drug or alcohol abuse
* In the 6 calendar months before first study drug administration, on average

  * Have smoked more than 5 cigarettes/day
  * Have consumed more than 21 units of alcohol/week for male subjects or 14 units for female subjects (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor)
* In the 2 calendar months before first study drug administration, have donated/lost blood or plasma in excess of 400 mL
* In the 30 days before first study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine
Treatment Patterns of Neratinib in HER2+ EBC in China

This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent approved by the reviewing Ethics Committee (EC).
* Adult patients (≥18 years of age, no upper limit).
* Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical/radiological assessed to be negative for recurrences or metastatic disease.

Exclusion Criteria:

* Presence of any contraindication with regard to the neratinib treatment.
* Current or upcoming participation in an interventional clinical trial. (Investigational treatment within four weeks of enrolment).
Electronic Recording of Compliance With Occlusion Therapy for Amblyopia

The purpose of this study was to determine whether compliance with occlusion therapy for amblyopia could be improved and, secondly, if risk factors for non-compliance could be identified.

Non-compliance is a limiting factor for success of occlusion therapy for amblyopia (lazy eye) in childhood. It is responsible for approximately 1% of the adult population being unable to read with the amblyopic eye. The researchers used electronic monitoring of compliance to investigate predictors and a remedy for non-compliance.

Methods: In a prospective randomised controlled trial, compliance was measured for one week every three months during 30 months in newly diagnosed amblyopic children in The Hague, Frankfurt and Leicester. The family's social-economic and ethnic background was assessed through a questionnaire. Children were randomised to receive either an educational cartoon story explaining, without text, the rationale for treatment to the child with reward stickers and an information sheet, or a picture to colour. All received standard orthoptic care by a treating orthoptist, who was unaware of the randomisation. The electronic device and educational programme were distributed via home-visits by researchers. The primary outcome measure was percentage of compliance (realised/prescribed occlusion time). The secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance.

Eligibility Criteria:
Inclusion Criteria:

* All newly diagnosed amblyopic children with an inter-ocular difference in visual acuity of at least 0.2 logMAR, strabismus and/or anisometropia or deprivation (e.g. cataract)

Exclusion Criteria:

* Previous treatment for amblyopia
* Neurological disorder
* Medication
* Other eye disorder
* Decreased visual acuity caused by brain damage or trauma
A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer

The main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic cancer.
* Able to swallow tablets.
* For Part B, you will need to have colon cancer or non-small cell lung (NSCLC) cancer with KRAS and/or BRAF mutations.
* Discontinued all previous treatments for cancer and recovered from the acute effects from the therapy.

Exclusion Criteria:

* Active infection (fungal, viral, or bacterial).
* Active cancer in your brain or spinal cord.
* Acute or chronic leukemia.
* Serious heart condition.
* Disease that requires immunosuppressant therapy.
* Diagnosis of inflammatory bowel disease.
* Major small bowel resection that interferes with your body's ability to absorb the oral medicine.
* Participated in other clinical trials investigating prexasertib or ralimetinib.
* Pregnant or breastfeeding.
* Other pre-existing conditions or medical history which your doctor will explain to you.
Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors

Study has two parts:

1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in patients with advanced solid tumors.
2. Dose-expansion: to assess safety and tolerability of RAD001 and BEZ235 at the MTD in patients with ER+/HER2- metastatic breast cancer and metastatic renal cell cancer


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18 years or older
* In the dose finding phase, patients with histologically or cytologically confirmed advanced solid malignancies that are metastatic or unresectable
* In the dose expansion phase, the enrollment will be limited to patients with:

Patients with metastatic renal cell carcinoma (mRCC) whose disease had progressed despite prior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine kinase inhibitor) therapy (at least one but no more than two lines of VEGFR-TKI therapy) Patients with metastatic breast cancer (MBC) which is ER+/HER2-, whose disease had progressed despite prior treatment with at least one but no more than two lines of chemotherapy and at least one prior line of endocrine therapy in the metastatic setting

* WHO performance status of 0-2
* Lab parameters within specifically defined criteria
* Patients with measurable disease per RECIST 1.0

Exclusion Criteria:

* Patients who have previously received mTOR inhibitors or PI3K inhibitors
* Patients with CNS metastases unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery plus the disease having been stable for at least 2 months without steroid use for at least 1 month prior to the first dose of RAD001 and BEZ235. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs.
* Major surgery within 2 weeks prior to study enrollment
* Patient taking anti-cancer drug concomitantly
* Received radiation within 4 weeks prior to study enrollment (2 weeks if limited field radiation)
* Receive chemotherapy 4 weeks prior to study enrollment
* Received live attenuated vaccines within 1 week prior to study enrollment
* History of HIV
* Any other severe and/or uncontrolled medical condition

Other protocol-defined inclusion/exclusion criteria may apply
Pilot Study of a Mobile Asthma Adherence Intervention

The purpose of this study is to assess the use of a mobile health intervention to improve adherence to asthma medication among adolescents. The intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. This study will assess medication use throughout the study in patients who receive a mobile app with reminders and asthma control as measured by the ACT \[asthma control test\].


Eligibility Criteria:
Inclusion Criteria:

* Age 11-19
* Asthma diagnosis
* Currently on a daily controller HFA (hydrofluoroalkane) medication for Asthma
* English-speaking
* Has a smartphone or access to a smartphone or tablet

Exclusion Criteria:

* Pregnant
* Foster Care
* Emancipated minor