cyrilzakka/clinical-trials huggingface dataset:
Felodipine Event Reduction Study

FEVER is an investigator-designed, prospective, multicentre,double-bind, randomized, placebo-controlled,parallel-group trial. The primary objective is to compare the long-term effects on the incidence of fatal and non-fatal stroke (and secondarily of other cardiovascular events) of administering a small dose of the calcium antagonist felodipine (5 mg once a day) or of a placebo, in hypertensive patients whose blood pressure had preliminarily been reduced by administering a low-dose diuretic (hydrochlorothiazide,12.5 mg once a day) to be continued in association with felodipine or placebo, throughout the trial.


Eligibility Criteria:
Inclusion Criteria:

* SBP of 210 mmHg or less and DBP less than 115 mmHg if under antihypertensive treatment; SBP 160-210 mmHg or DBP 95-115 mmHg if untreated. Presence of at least one or two risk factors or cardiovascular diseases Informed consent obtained

Exclusion Criteria:

stroke or myocardial infarction during the previous 6 months; secondary hypertension; unstable angina; cardiomyopathy or significant valvular disease; serum creatinine greater than 178 mmol/l (2.0 mg/dl); gout; uncontrolled diabetes(fasting plasma glucose \> 10 mmol/l, 180 mg/dl despite therapy); serious pulmonary or hepatic disease; known contraindications to study drugs; unwillingness to cooperate
The Effect of a High Protein Diet Versus a Low Fat Diet on Body Weight After Smoking Cessation

The purpose of this study is to determine whether subjects following a high protein diet will gain less in weight after smoking cessation compared to subjects following a low fat diet due to the effects of protein on metabolic rate and hunger.

Sustained smoking cessation is one of the most effective therapies to avoid premature morbidity and mortality. However, weight gain associated with nicotine withdrawal may attenuate some of the beneficial health effects and is cited as a major obstacle to quit smoking. The mechanism for the weight gain is not elucidated but reduced resting metabolic rate, reduced total energy expenditure, increased caloric intake and changes in fat metabolism may be involved. Elucidating effective strategies to prevent or reduce post-cessation weight gain may improve health outcomes of smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* Smoking 10 cigarettes per day, BMI 25-40

Exclusion Criteria:

* Recent change in weight, contra-indications to use varenicline, a medication to assist smoking cessation
Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer

The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT in treating patients with multiple brain metastases from NSCLC.

Brain metastases occur in 25-40% of patients with non-small cell lung cancer (NSCLC). It is one of the primary reasons resulting in treatment failure and the death. Whole-brain radiation therapy (WBRT) is the standard approach to the treatment of multiple brain metastases from NSCLC. Regardless of the treatment of brain metastases by WBRT combined with systemic chemotherapy,outcomes of NSCLC with brain metastases are still very poor. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC. Icotinib shows nearly the same effect as gefitinib in advanced NSCLC patients failed with chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Cytologic or histological diagnosis of non-small cell lung cancer
* Patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with EGFR mutation status who have not been treated
* Patients are diagnosed with multiple brain metastases for the first time in 4 weeks
* Diagnosis of brain metastases is made based on Magnetic resonance imaging (MRI).
* Doctors consider the patient will benefit from WBRT
* No prior brain radiotherapy
* ECOG performance status 0-2
* age:18-75 years
* Neutrophil count ≥1.5×10 to the 9th power/L and platelets≥100×10 to the 9th power/L. hemoglobin ≥90 g/L
* Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement)
* Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)
* Patients with measurable brain metastases according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study

Exclusion Criteria:

* Prior brain radiation therapy
* Solitary brain metastasis according to Magnetic resonance imaging (MRI)
* Mort than 3 extracranial organs have metastatic lesions
* Prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible).
* pregnant or breast feeding women
Bioavailability of Hesperidine and Narirutin From Orange Juice to Identify Metabotypes in Hypertension

Flavonoids are polyphenolic compound mainly found in fruits and vegetables with numerous beneficial health effects as protection against cardiovascular diseases by an antihypertensive effect. The intestinal microbiota plays a key role in the metabolization of these compounds, so that differences in the composition and activity of the microbiota between individuals can generate different metabotypes. Flavonoids are found mainly in their conjugated form linked to the monosaccharide rhamnose and need to be metabolized by the intestinal bacteria, releasing the rhamnose, to be absorbed and, thus, bioactive. The bacterial enzyme responsible of rhamnose hydrolysis is α-L-rhamnosidase, whose activity can vary considerably depending on the composition of the microbiota. In fact, a great interindividual variability has been observed in the ability to absorb flavonoids, which allows to classify individuals according to the corresponding metabotype. In a previous project, the investigators confirmed the interindividual differences in the bioavailability of hesperidin and narirutin, two flavonoids naturally present in orange juice. However, the role of the intestinal microbiota in the metabolism of hesperidin and narirutin needs to be elucidated.

On this basis, the following hypothesis is presented: individuals with arterial hypertension can be classified into 3 different metabotypes that are the result of the ability to absorb hesperidin and narirutin, determined by the urinary excretion of their respective metabolites, and these metabotypes are associated with different microbiota enterotypes and with different fecal α-L-rhamnosidase activity.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women over 18 years of age
2. Systolic blood pressure ≤159 mm Hg
3. Sign the informed consent

Exclusion Criteria:

1. Body mass index (BMI) ≥ 35 kg / m2
2. Glucose \> 126 mg / dL
3. Systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure \> 100 mm Hg or taking antihypertensive drugs
4. LDL cholesterol \> 189 mg / dL
5. Triglycerides \> 350 mg / dL
6. Anemia (hemoglobin ≤ 13 g / dL in men and ≤ 12 g / dL in women)
7. Tobacco addiction
8. Consumption of medicines, antioxidants or vitamin supplements 30 days before the study
9. Use of antibiotics during the last 30 days prior to the study
10. Consumption of prebiotics and / or probiotics during the 30 days prior to the study
11. Clinical history of gastrointestinal disease or presence of intestinal disorders at the time of inclusion
12. Chronic alcoholism
13. Monitoring a vegetarian diet
14. Pregnant or with intent to get pregnant
15. Being in breastfeeding period
16. Participation in a clinical trial or nutritional intervention study, in the last 30 days.
17. Inability to follow the study guidelines
Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer

This is a monocentric, prospective cohort study evaluating the feasibility of a perioperative e-follow-up protocol in patients with ambulatory surgery for breast cancer.

This protocol will be based on:

* A coordinated ambulatory follow-up performed by a dedicated nurse
* An electronic follow-up tool used in pre- and post-surgery

Patients will be followed 8 days before the surgery until 30 days after the surgery of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patient eligible for an ambulatory surgery of breast cancer (partial mastectomy with or without lymph node sampling)
2. Ambulatory surgery planned 10 days or more after inclusion date
3. Age \> or = 18 years old
4. Affiliated to the french social security system
5. Patient must provide written informed consent prior to any study-specific procedure or assessment

Exclusion Criteria:

1. Surgery other than breast cancer surgery in ambulatory (benign breast surgery, other surgical specialities)
2. Patient who cannot connect to the electronic tool at home (no computer, no tablet computer or no internet connection)
3. Pregnant or breastfeeding women
4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
5. Patient protected by law
Ergospirometric Values and WBV in Elderly

this study aims evaluate the ergospirometric values after 03 months of training with WBV in elderly health people. The hypothesis is increases of ergospirometric values.


Eligibility Criteria:
Inclusion Criteria:

* aged 60-74 years,
* Sedentary or Moderate A in accord with IPAQ short form (International Physical Activity Questionnaire) and those without disease.
* furthermore, the subjects should reach the ventilatory threshold 1, considered after meeting two of the following events:
* respiratory quotient (R) increases (R ≥1,1);
* loss of linearity between the pulmonary ventilation curve (VE) and oxygen consumption (VO2), plateau of VO2 or plateau of heart rate (HR) and increases of end-tidal PO2 (Pet O2)

Exclusion Criteria:

* Were excluded subjects with changes in Mini-mental state examination (MMSE) scores by age and educational level where the minimum score represents: illiterate 13 points, less than 8 study years is 18 points, 8 or more study years is 26 points 11.
* Were also excluded current smokers or previous, subjects with thrombosis, labyrinthitis, diabetes, hemodynamic instabilities, obesity, osteoporosis, neuromuscular diseases, pulmonary or cardiac diseases, changes in resting electrocardiogram or in exercise, ingestion of drugs to metabolism bone / muscle / heart chronotropism or with difficulties in adapting protocols
How Effective is the Dose-graded Aerobic Training in Children Survivors of Acute Lymphoblastic Leukemia?

The purpose of this study was to evaluate the impact of a 12-week dose-graded aerobic exercise program (D-GAE) on cardiopulmonary fitness and physical performance in children survivors of acute lymphoblastic leukemia (ALL). A total of 58 ALL survivors were randomly assigned to the D-GAE group (n = 29, who underwent a combination of traditional physical rehabilitation and intensity- and duration-graded aerobic training three times per week for 12 weeks) or the control group (n = 29, who underwent only traditional physical rehabilitation).

Cardiopulmonary fitness and physical performance were evaluated in both groups before and after treatment.

Fifty-eight survivors of ALL were recruited from the hematology-oncology polyclinic at King Khalid Hospital and two referral pediatric hospitals in Riyadh, Saudi Arabia. The study included survivors aged 10-18 years, who completed maintenance therapy, had no abnormalities of the lower limbs or spine and did not participate in a regular exercise program (in the past six months). survivors who had secondary malignancies, significant musculoskeletal/neurological issues affecting the capacity to participate in exercises or neurocognitive impairments were excluded.

Outcome measures

1. Cardiopulmonary fitness: The peak oxygen uptake was assessed through the McMaster cycling protocol.
2. Physical Performance: Three tests were used; the 6-minute walk test, the timed up and down stairs test, and the 4x10 meter Shuttle Run test.

Interventions

The D-GAE group received a 12-week aerobic training, three times in addition to the traditional physical rehabilitation. The D-GAE program commenced with a training intensity corresponding to 50% of the maximum age-predicted heart rate for 25 minutes in the first two weeks, which progressed on a two-week basis, and ended up with a training intensity corresponding to 75% of the maximum age-predicted heart rate for 50 minutes in the last two weeks. The D-GAE program included a warm-up for 5 minutes and a cool-down for 5 minutes. The control group received the traditional physical rehabilitation only, 45 minutes per session, three times a week for 12 consecutive weeks. The program consisted of flexibility exercises, strengthening exercises, balance training, and general conditioning exercises.

Eligibility Criteria:
Inclusion Criteria:

* Survivors of childhood ALL
* Age of 10-18 years
* Completion of maintenance therapy
* Free of lower limb or spinal deformities
* Not participating in regular exercise regimens in the past six months

Exclusion Criteria:

* Secondary malignancies
* Significant musculoskeletal/neurological issues
* Neurocognitive impairments
An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.


Eligibility Criteria:
Inclusion Criteria:

* Serum sodium levels less than or equal 130mEq/L
* Euvolemic or Hypervolemic hyponatremia

Exclusion Criteria:

* Clinical evidence of volume depletion or dehydration
* Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
* Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment
ESM in Functional Dyspepsia

Background:

Reliable patient reported outcome measures (PROM's) for symptom assessment in functional dyspepsia (FD) are essential in order to evaluate dyspeptic symptoms, identify potential symptom triggers and optimize therapeutic strategies, since biological markers are unavailable. Currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires, have considerable limitations. The Experience Sampling Method (ESM), an electronic questioning method characterized by random and repeated, momentary assessments in the subject's current state and environment, might overcome these limitations. The aim of this study is to assess the validity and reliability of an FD-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and identification of symptom triggers in patients with functional dyspepsia.

Objective:

The aim of this study is to assess the validity and reliability of an FD-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and identification of symptom triggers in patients with functional dyspepsia. In order to measure this, internal consistency, test-retest reliability, concurrent validity and the accuracy to differentiate between dyspeptic patients and healthy controls of the developed ePRO will be assessed. In addition, to objectify specific triggers for the onset of gastrointestinal symptoms in dyspepsia, using the FD-specific ESM tool.


Eligibility Criteria:
Both patients with functional dyspepsia (36) as healthy controls (36) will be included

Inclusion Criteria for patients with functional dyspepsia:

• A diagnosis of functional dyspepsia according to ROME IV criteria (2):

* One or more of the following:
* Bothersome postprandial fullness
* Bothersome early satiation
* Bothersome epigastric pain
* Bothersome epigastric burning

AND

* No evidence of structural disease (confirmed by upper endoscopy) that is likely to explain the symptoms.
* Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.

  * Age between 18 and 75 years;
  * Ability to understand and speak the Dutch language;
  * Ability to understand how to utilize the ESM tool.

Inclusion criteria for healthy volunteers:

* Age between 18 and 75 years
* Ability to understand and speak the Dutch language
* Ability to understand how to utilize the ESM tool.

Exclusion Criteria for patients with functional dyspepsia:

* Any organic explanation for the gastrointestinal complaints;
* Initiation of regularly used medication from one month before inclusion until the end of study participation;
* A history of upper digestive surgery influencing end points
* A history of radiation therapy of the abdomen
* Pregnancy

Exclusion Criteria for healthy controls:

* Current diagnosis of any gastrointestinal disorder
* Current gastrointestinal symptoms suiting the ROME IV criteria for FD
* Initiation of regularly used medication from one month before inclusion until the end of study participation
* Pregnancy
Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers.

The devices compared in this study are 'retainers', i.e. fixed orthodontic retainers applied to the lingual surface of the central and lateral incisors and lower canines bilaterally. Their function is to maintain dental alignment once fixed orthodontic therapy has ended. In particular, the CAD/CAM device Keeppy patented by the company Leone SpA (Via Ponte a Quaracchi 50, Sesto Fiorentino, Florence) will be compared with the standard retainer made from a steel braided wire (Ortho FlexTech, Reliance Orthodontic Products Inc., 1540 West Thorndale Ave, Itasca, Illinois, USA).

This is a single-center, national, controlled, superiority, randomized, crossover, open-label study.

The aim of this study is to evaluate whether the CAD/CAM retainer results in fewer failures (fractures or detachments) over a period of 6 months and 2 years compared to the standard retainer. In addition, the aim of the study is to evaluate whether the Keeppy device results in the maintenance of better periodontal health as judged by the use of plaque and bleeding indices on the surfaces of the lower six anterior teeth compared to the standard retainer. Other objectives consist of the patient's assessment of pain, difficulty in speaking and esthetic satisfaction and the stability of the lower anterior tooth sector.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed fixed orthodontic therapy between the ages of 13 and 20 years;
* Patients whose parents will sign the informed consent

Exclusion Criteria:

* Presence of dental anomalies in number (excess or deficiency) in the lower anterior teeth
* Patients with metal allergies.
The Role of Microparticles as a Biomarker

The investigators propose to characterize MPs in aHUS and TTP both at the onset and throughout treatment. The investigators believe that the number, size, and cell origin of MPs will differ between these two diseases. The hypothesis is that endothelial derived MPs will be higher in number and comprise a larger portion of the MP population in aHUS and that platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The investigators believe that MP identity and number can be used to reliably differentiate between aHUS and TTP at disease onset.


Eligibility Criteria:
Inclusion Criteria:

* Patients with MAHA, TTP, and/or aHUS

Exclusion Criteria:

* Prisoners
The Effect of a Phospholipid Drink on Cognitive Performance Under Acute Stress

The study will explore the effects of a 6-week phospholipid drink intervention on the cognitive performance and physiological and subjective stress parameters of males following a repeated psychosocial/physical stressor.

The study conforms to a randomised, double-blind, placebo controlled, parallel groups design examining cognitive performance and physiological/subjective stress responses after a psychosocial/physical stressor before and after a six week daily intake of an phospholipid containing drink vs. placebo.

The study will examine:

Cognitive performance following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue.

Physiological and subjective stress responses following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue

Eligibility Criteria:
Inclusion Criteria:

* Male ≥18 years old
* Healthy (self-report health questionnaire)
* BMI \<30 kg/m²
* Free from medication (prescribed and 'over-the-counter')

Exclusion Criteria:

* Current psychological affective/mood disorders
* Self-reported physical disorder/disease (significant cardiovascular, autoimmune, endocrine, gastrointestinal or neurological conditions, chronic pain, or sleep disorders)
* High chronic stress
* Smokers
* Recreational drug use (within the last month)
* Night shift work
* Hypertension (resting blood pressure exceeding 160/95 mmHg)
* Skin conditions (e.g. eczema) on hands
* Food allergies
* Participation in a clinical study within a month prior to screening or during participation
* Participation in any of our previous stress induction studies