cyrilzakka/clinical-trials huggingface dataset:
Investigation on the Sustained Effect of Anthocyanins on Endothelial Function in Postmenopausal Women

Anthocyanins are the most common polyphenols in berries and red wine, along with other flavonoids, phenolic acids, minerals and vitamins. Anthocyanins are extensively metabolized and they are transformed into glucuronides and phenolic acids. The investigators have recently shown that the acute consumption of blueberries leads to an increase in endothelium-dependent vasodilation measured as flow-mediated dilatation (FMD) in young male volunteers. There were significant correlations of these effects with the plasma concentration of phenolic acids and anthocyanin metabolites. Therefore, the present study aims at understanding to which extent the anthocyanins contained in berries are related with positive effects in endothelial function. A large part of the absorbed anthocyanin circulate in the blood in as methyl, glucuronyl and sulfate metabolites, as well as phenolic acids. The formation of these metabolites begins right as early as 2h after consumption due to metabolism at the small intestine and a second plasmatic peak occurs around 6h due the metabolism of colonic bacteria. Whether and which metabolites are associated with biological effects and the mechanisms underlying this effect remains unclear.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal female subjects without clinical signs or symptoms of cardiovascular disease, no menstruation cycle for more than 1 year, postmenopausal status conformed by female hormone analysis
* \> 50 years

Exclusion Criteria:

* cardiovascular disease
* acute inflammation
* cardiac arrhythmia
* renal failure
* heart failure (NYHA II-IV)
* diabetes mellitus
* C-reactive protein \> 0.5 mg/dL
* malignant disease
* hypotension (≤100 / 60 mm Hg)
Measuring the Metabolic Cost of Fever

Fever is part of the body's immune response, often triggered by infection. Fever is commonly treated with medicines such as paracetamol, mainly because people feel unwell with fever. However fever does have a role in fighting infection: it enables the rest of the immune system to function more efficiently, and may directly stop bacteria and viruses from multiplying. In most cases however treating fever does not matter because the rest of the immune system can cope well enough to fight the infection (with or without additional treatment, like antibiotics).

In critically ill patients however any advantage in the fight against infection may be crucial. In a large observational study of adult patients in the intensive care unit, patients who developed an early fever with temperature between 38.5-39.5 degrees C fared relatively better than patients who were colder. So it is possible that in critical illness fever may be beneficial. However in critical illness the body does have limited energy resources. In order to raise the body temperature energy is required. However the investigators do not know how much energy is required to generate a fever in critically ill children. This study will aim to try and measure the energy required to generate a fever in a critically ill child. The investigators will measure energy expenditure directly in children admitted to the intensive care unit by measuring the levels of oxygen and carbon dioxide they breathe in and out (a method called indirect calorimetry). This will enable the investigators to judge whether the benefits of a fever can be justified by the energy costs in the energy depleted state that is critical illness.


Eligibility Criteria:
Inclusion Criteria:

- all children on the paediatric intensive care unit at Great Ormond Street Hospital who

1. are likely to or have developed a fever (suspected infection, following trauma, post major surgery)
2. are over 10kg (approx 1 year of age)
3. are invasively ventilated

Exclusion Criteria:

- Children who

1. have a brain injury, where active temperature control may be instituted
2. patients post cardiac surgery
3. patient with or at risk of cardiac arrhythmias
4. patients post cardiac arrest
5. patient with refractory status epilepticus
6. children with a greater than 5% leak around the endotracheal tube
7. children with a fraction of inspired oxygen \>0.6
Determining the Maximum Tolerated Dose of Low Dose Interferon-alpha in Conjunction With Nilotinib in Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP)

This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in pretreated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP).


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic myeloid leukemia in chronic phase (CML-CP) at screening
* Initial diagnosis of CML cytogenetically confirmed by the presence of the Ph+ metaphases from the bone marrow
* Patients who have been treated with nilotinib for a minimum of 6 months (1 month represents 28 days) after switch from previous CML treatments
* Patients who have been treated with stable dosing of 2x400mg nilotinib within the last month before start of study treatment
* No grade 3-4 CTC toxicities on nilotinib alone in the last month preceding the start of the study regimen

Exclusion Criteria:

* Patients who are considered Ph- because they do not have a confirmed cytogenetic diagnosis of the t(9;22) translocation in their bone marrow metaphases
* Evidence of a point mutation within the BCR-ABL gene leading to a clinically relevant amino acid exchange in the kinase domain at position T315 (gatekeeper mutation T315I)
* Impaired cardiac function
* Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).

Other protocol-defined inclusion/exclusion criteria may apply
Relationship Between Self-compassion and Treatment Adherence in Schizophrenic Spectrum Disorders

Treatment adherence is defined by the World Health Organisation (WHO) as the extent to which the patient's history of therapeutic drug-taking coincides with the prescribed treatment. In patients suffering from psychiatrical diseases, especially in those who are suffering from schizophrenic spectrum disorders, the quality of treatment adherence has to be improved. Indeed, non adherance to anti-psychotic treatment increases the risk of hospitalization, of substance use, violent behaviour and of functionnal and cognitif impairment. Selfcompassion, which involves being touched by and open to one's own suffering and to heal oneself with kindness and without judgement and self-criticism has never beed studied as a possible factor infuencing treatment adherence.

This study aims to evaluate if a link between selfcompassion and treatment adherence exists in patients suffering from schizophrenic spectrum disorders.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with schizophrenia spectrum disorder ( ICD 10 and DSM 5 criteria)
* stabilized (PANNS score under 80)
* aged 18 or above
* In case of tutor or curator, agreement of this person is requiered
* psychiatrist who's following the patient agrees with the study

Exclusion Criteria:

* underage
* non stabilized patient (PANSS score under 80 )
* patient suffering from toxic psychosis
* difficulties to understand french or cognitive impairment which are making it to difficult to answer the different self-administered questionnaires.
Effects of Baduanjin Sequential Therapy on Post CABG Patients.

To determine the effects of Baduanjin sequential therapy (BST) on physical functioning and quality of life among post-CABG patients. Many studies have focused on the effects of standing Baduanjin on chronic diseases and it's an evidence-based therapy.

There exists limited data from large-scale randomized trials that have addressed the effect of Baduanjin exercise on the quality of life and cardiac function in the patient with CABG. Therefore, this study aims to determine the effects of Baduanjin sequential therapy (BST) on physical functioning and quality of life among post-CABG patients.

Eligibility Criteria:
Inclusion Criteria:

* Vitally Open heart surgery patients Discharged from the hospital and enrolled as outpatient Able to perform 6MWT

Exclusion Criteria:

* Prolonged intubation Unstable vitals Patient needs maximum assistance for mobility Decline consent
Inspiratory Support Improves Preoxygenation in Healthy Subjects

Preoxygenation optimizes oxygen content in the functional residual capacity (FRC). Adequate preoxygenation is defined by an expiratory oxygen fraction (FEO2) \> 90%. Inspiratory support and positive end expiratory pressure (PEEP) can create a better reservoir, improve gas exchange and shorten the time needed for adequate preoxygenation. The goal of the study is to evaluate the efficacy and tolerability of different levels of inspiratory support and positive end expiratory pressure during preoxygenation in healthy subjects.

We conducted a double blind prospective randomized trial on 20 healthy volunteers. Each subject went through three modes of preoxygenation in random order: normal breathing (SP), breathing under inspiratory support 4 cmH2O/PEEP 4 cmH2O (PSM-4) and inspiratory support 6 cmH2O /PEEP 4 cmH2O (PSM-6). Each mode lasted for 3 min and parameters were recorded every 10 s. We evaluated subject's tolerance, leaks and easiness of each mode of preoxygenation according to a simplified (1 to 4) scale. Two-way ANOVA was used to compare FEO2 while simple ANOVA was used for time to reach FEO2=90%.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged between 20 to 40 years

Exclusion Criteria:

* Body mass index \> 30
* Mustache, beard
* Claustrophobia
Bicarbonate Administration in CKD

Low serum bicarbonate levels, even within the normal laboratory range, are strongly associated with increased risks of hypertension, endothelial dysfunction, cardiovascular disease and death. The current proposal will investigate whether bicarbonate administration in patients with chronic kidney disease (CKD) will improve the health and function of arteries and reduce the size of the left ventricle of the heart. Overall, the proposed research will provide important new scientific evidence upon which physicians can base recommendations to patients with CKD to decrease the risk of developing cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years
* Serum bicarbonate 22-25 mEq/L on 2 separate measurements (at least 1 day apart)
* CKD stage 3B or 4 at time of screening (eGFR 15-44 ml/min/1.73m2)
* Blood pressure \<130/80 mm Hg prior to randomization
* BMI \< 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
* Able to provide consent
* Stable anti-hypertensive regimen for at least one month prior to randomization
* Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).

Exclusion Criteria:

* Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* Uncontrolled hypertension
* Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening
* New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
* Factors judged to limit adherence to interventions
* Anticipated initiation of dialysis or kidney transplantation within 12 months
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Chronic use of supplemental oxygen
* Use of immunosuppression in past 3 months
* Metal implant or implanted electrical device (patient will be unable to get MRI)
Quality of Life in Postmenopausal Women Who Are Receiving Either Exemestane or Anastrozole With or Without Celecoxib for Stage I, Stage II, or Stage IIIA Primary Breast Cancer

RATIONALE: Quality-of-life assessment in postmenopausal women who are receiving hormone therapy for breast cancer may help to determine the effects of treatment on these patients and may improve the quality of life for future breast cancer patients.

PURPOSE: This clinical trial is studying quality of life of postmenopausal women who are receiving either exemestane or anastrozole with or without celecoxib for stage I, stage II, or stage IIIA primary breast cancer.

OBJECTIVES:

Primary

* Compare treatment-related symptoms using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire in postmenopausal women with receptor-positive stage I, II, or IIIA primary breast cancer undergoing treatment with exemestane vs anastrozole with or without celecoxib on protocol CAN-NCIC-MA27.

Secondary

* Compare health-related quality of life using the FACT-ES questionnaire in patients treated with these regimens.
* Determine the extent to which differences in treatment-emergent symptoms affect overall quality of life in patients treated with these regimens.

OUTLINE: This is a multicenter, companion study. Patients receive treatment on CAN-NCIC-MA27.

Health-related quality of life and treatment-related symptoms are assessed using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire at baseline and at 3, 6, 12, and 24 months.

PROJECTED ACCRUAL: A total of 1,253 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive breast cancer

  * pT1-3; pNX, pN0-2 or pN3\*; M0 NOTE: \*Only when the sole basis for this classification is the presence of 10 or more involved axillary lymph nodes
* Registered on protocol CAN-NCIC-MA27 within the past week
* Hormone receptor status:

  * Estrogen receptor- and/or progesterone receptor-positive by immunohistochemistry or tumor receptor content ≥ 10 fmol/mg protein
  * At least 1 tumor must be receptor-positive in patients with bilateral breast cancer

PATIENT CHARACTERISTICS:

Age

* Postmenopausal

Performance status

* ECOG 0-2

Sex

* Female

Menopausal status

* Postmenopausal

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Able to read, understand, and complete quality of life questionnaires

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Non-Invasive Brain Stimulation and Substance Use

The will investigate the feasibility and effectiveness and initial efficacy of non-invasive transcranial alternating current stimulation (tACS) on distress tolerance and inhibitory control among treatment seeking substance users.

Disruptions in inhibitory control (IC) and distress tolerance (DT) are implicated in the development and maintenance of substance use disorders. Findings suggest that differential DLPFC engagement during affective and cognitive processing, and in particular, distress tolerance, in substance use disorder may be malleable, providing a promising intervention. Modulating neural oscillations with non-invasive, safe brain stimulation by targeting regions such as the DLPFC may provide an avenue to improve distress tolerance and inhibitory control in SUD. Transcranial alternating current stimulation (tACS) may be a particularly promising approach as it is a safe and non-invasive method of electric stimulation that has the potential to effectively modulate neural network and circuit dynamics, more closely aligning with a network-based conceptualization of affective and cognitive processesThis study will test the effects of tACS on distress tolerance and inhibitory control among treatment-seeking adults with substance use disorder.

Eligibility Criteria:
Inclusion Criteria:

* Current Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Substance Use Disorder
* Current smoker
* Abstinent from all substances (except nicotine) for at least the past 2 weeks

Exclusion Criteria:

* Current use of antiepileptic drugs and/or benzodiazepines
* Less than 6 months since an electroconvulsive therapy (ECT) session
* Current DSM-V Psychotic Disorder
* Pregnancy and/or nursing
* Ongoing or history of traumatic brain injury (TBI), reoccurring seizures, stroke, or brain tumors
* Medical or neurological illness
* Brain devices and/or implants
A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis

The purpose of this study is to examine the safety and efficacy of this antibody in participants with rheumatoid arthritis.

Part A of the study is an initial dose escalation phase

Part B of the study is a randomized allocation of the entire dosing group to parallel treatment assignments


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of rheumatoid arthritis
* regular use of methotrexate
* active rheumatoid arthritis

Exclusion Criteria:

* Juvenile Rheumatoid Arthritis
* evidence of tuberculosis
* women who are pregnant or become pregnant during study, or are breast-feeding
48 Hours Esophagal pH-monitoring With and Without Gaviscon

At a esophagal pH-monitoring will the classic 24-hour measurement be extended to 48 hours. During the first 24 hours are the measurements without medication. After 24 hours the treatment will be started with Gaviscon and will the next 24 hours the measurements under the medication happen. Normally is the medication required after the measurements. With this study the investigators will have multiple measurement points to compare.

This is an interventional, with questionnaires. 25 participants will be included.

Parents and children must be willing to have the esophagal pH-monitoring for 48 hours instead of 24 hours.

The restrictions are (like any other esophagal pH-monitoring) :

Do not detach the probe, no bath or shower, no bouncy castle, no swimming pool, ....

Give your child time to get used to the probe. Give your child no carbonated beverages, limit sweets, avoid chewing gum!

Not study specific procedures : there will be placed a probe for the oesophagal pH-monitoring and this will be checked on children's radiology.

study specific procedures : questionnaires at specific times : Before start : SF 36 Every 6 hours during 48hours : FLACC Satisfaction scale at the start, after 1 day and after 2 days

Flowchart time 0: obtaining ICF, signed by both parents, placing of probe, explanation of questionnaires, completing SF36 and satisfaction scale time 6: FLACC time 12: FLACC time 18: FLACC time 24: FLACC, satisfaction scale, reading out pH monitoring from the first 24 hours, then starting of Gaviscon in function of the result. The Gaviscon is supplied by the service, at no cost to the patient time 30: FLACC time 36: FLACC time 42: FLACC time 48: FLACC, satisfaction scale, remove pH monitoring

Calculation of the number of participants :

since there is never such a study was carried out, we started this pilot study. An analysis will be carried out after 15 patients.

Analysis of the results :

the results of the first and second 24 hour data will be compared (automatically by computer analysis).

Eligibility Criteria:
Inclusion Criteria:

* children in whom a pH-monitoring was asked
* pre school-age children
* hospitalized children
* parents have the informed consent signed.

Exclusion criteria :

* children over 6 years
Gas Exchange Derangement Physiopathology in Critically Ill Patients With COVID-19

The study was designed to understand the pathophysiology of gas exchange derangement in critically ill patients with COVID-19. Specifically we will evaluate the effect of 3 different levels of positive end-expiratory pressure (PEEP) and two different levels of inspiratory oxygen fraction (FiO2) on gas exchange by analyzing shunt and dead space. Furthermore, complete respiratory mechanics and distribution of ventilation and perfusion by electrical impedance tomography will be assessed at each level of PEEP.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in intensive care unit for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring invasive mechanical ventilation

Exclusion Criteria:

* Pregnancy
* Hemodynamic instability (80-90 mmHg increase or 30-40 mmHg decrease systolic arterial pressure compared to baseline value or need of vasopressors to maintain systolic blood pressure higher than 85 mmHg or electrocardiogram evidence of ischemia/arrhythmias)
* Presence of pneumothorax and/or pneumomediastinum
* Contraindications to Electrical Impedance Tomography (pacemaker, implantable cardioverter defibrillator, thoracic drainages)
Healthy Kids Pilot

Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and healthy weight among children and their parents.


Eligibility Criteria:
Inclusion Criteria for Child:

* Have at least one participating parent
* Have a BMI percentile \> 85
* Be physically capable of exercise
* Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or type 2 diabetes, HIV/AIDS, and cancer

Inclusion Criteria for Parent:

* Have a smartphone
* Be willing to use the smartphone for the mHealth intervention

Exclusion Criteria for Child:

* Significant cardiovascular disease or disorders via self-report from parent
* Other significant medical problems that would prevent them from engaging in regular physical activity.
Float First: An Index of Floating: Factors Affecting Floating in Different Populations

The study involves measurements of body composition using a DEXA scanner, lung function, buoyancy and floating technique. An understanding of the effects of physiological and anthropometric measures on an individual's ability to float may lead to the creation of a 'Floatability Score' to aid current public information. With this floatability score a set of actions that people of certain body types should adopt in water will be created, to tailor the current public safety messaging in an attempt to ensure more people are aware of how they can float in water

Between 2000 and 2013 an average of 425 people in the UK drowned per annum, and a reported 100,000 people were involved in water-related emergencies involving search and rescue services. Approximately half had not intended to go into the water. Research identifies that in the first 1-3 minutes of immersion, during the "cold shock response" (CSR), there may be an increased probability of drowning fatalities. As a result of this, a theme of 'Float First' was created whereby individuals are advised to float for 1-3 minutes following immersion (by undertaking the minimum amount of activity possible to maximise the amount of air trapped in clothing layers and hence creating additional buoyancy) until the effects of the CSR have declined. However, a number of people have come forward indicating that despite the advice given, they are unable to float. This study is designed to establish the minimum activity level a person needs to stay afloat and combine this with anthropomorphic and physiological measures to develop advice for people of different shapes, sizes and body compositions.

Eligibility Criteria:
Inclusion Criteria:

* All participants who feel confident in water which they can stand up in, aged 18 years and older (18-29 years for Phase 1).
* The participant is willing and able to give informed consent for participation in the study.
* Be able to climb up and down a set of steps to access the swimming flume

Exclusion Criteria:

* Have allergies to water or chlorinated water.
* The participant is pregnant or suspects they may be pregnant.
* Not able to climb up and down a set of steps to access the swimming flume