cyrilzakka/clinical-trials huggingface dataset:
Understanding the Impact of Physical Activity Calorie Equivalent (PACE) Labelling in Secondary Schools

The aim is to undertake a cluster randomised controlled trial to assess the effectiveness of PACE food labelling in reducing young people's purchasing of discretionary foods in secondary school canteens. Physical activity calorie equivalent (PACE) food labelling aims to show the number of minutes or miles/kilometres of physical activity equivalent to the calories contained in food/drinks.

Physical activity calorie equivalent (PACE) food labelling aims to show the number of minutes or miles/kilometres of physical activity equivalent to the calories contained in food/drinks. Evidence suggests that PACE food labelling may influence food/drink choice. Most research in this area however have tested PACE food labels with adults and/or have tested hypothetical food choice scenarios. Studies in real world contexts with young people are needed to see if PACE food labels could help them make healthier food choices.

The aim is to assess the effectiveness of PACE food labelling in reducing young people's purchasing of discretionary foods in secondary school canteens. A cluster randomised controlled trial with a nested qualitative study will be conducted. Secondary schools will be randomised to either display PACE labelling near discretionary foods or continue with their usual practice. The intervention period will be up to 6 weeks. Anonymised purchase data will be collected throughout the study period.

Qualitative interviews will be conducted with students in the intervention schools to explore their views of the PACE labels such as perceived influence of the PACE labelling on their food selection.

Eligibility Criteria:
Secondary schools:

Inclusion Criteria:

* Secondary schools that admit young people aged between 10 to 19 years.
* Sell at least one type of cake and/or at least one type of sweet biscuit for at least 2 days per week up to a 6 week period (or equivalent), and have sold the same cake(s)/biscuit(s) before the study (for a minimum of 4 weeks).
* Able to provide to the researcher with anonymised purchase data for study periods. Data to include number of units sold and dates sold of the chosen food item(s).
* A PACE label could feasibly be placed near to the study elected food item(s) in a school canteen used by students.
* Not participating in any other school trials or initiatives.

Exclusion Criteria:

* Secondary schools not meeting the inclusion criteria.
* Secondary schools that admit young people below the age of 10 years or above the age of 19 years.
Comparison of the New Algorithm of STOP-Bang in the Detection of Severe OSA Patients

The aim of this study was to compare the ability of clinical scores (P-SAP, OSA50, DES-OSA, STOP-Bang with former algorithm, and STOP-Bang with new algorithm).

Severe OSA (Obstructive Sleep Apnea) patients are at higher risk of postoperative complications.

STOP-Bang has been proposed to detect OSA patients. It has been validated. New algorithm of STOP-Bang was proposed by the end of 2016. This aim of this study was to evaluate the ability of this new algorithm to detect severe OSA patients (patients with more than 30 events per hour). The new algorithm was also compared in this same ability with three others clinical score (P-SAP, OSA50 and DES-OSA).

Eligibility Criteria:
Inclusion Criteria:

* All patients in the preoperative anesthesia visit between 01/08/2016 and 31/12/2017

Exclusion Criteria:

* Patient's refusal
FreeStyle Libre Monitoring in T2DM

The goal of this clinical trial is to learn if blood sugar monitoring using a FreeStyle Libre device can improve overall Diabetes control in people with Type 2 Diabetes.

The main questions it aims to answer are:

* What is the effect of monitoring using the FreeStyle Libre device for a period of 12 weeks on the blood sugar control of people with Type 2 Diabetes?
* Can monitoring using the FreeStyle Libre device improve the quality of life of people with Type 2 diabetes?

Participants will be asked to wear one of two brands of FreeStyle Libre devices. In one group, participants will have 3 visits, while those in the second group, they will have 4 visits.

Researchers will compare the improvement in the sugar control for the individuals but also compare between the 2 groups.

This is a prospective, randomised, open-labelled, non-CTIMP, pilot study. Participants meeting the inclusion criteria and who have consented to participate in the study will be randomised on a 1:1 ratio to receive either Libre 2 or Libre pro iQ. Randomisation will be carried out using an online randomisation tool to allocate a participant to a treatment group.

The study will consist of three visits (Libre 2 arm) and four visits (Libre pro iQ arm). The study will be completed over 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Males and females living with type 2 diabetes mellitus (T2DM) who are aged ≥ 18 and ≤ 75 years
* On one or more non-insulin glucose lowering agent(s)
* HbA1c ≥ 69 mmol/mol
* Able to provide written informed consent

Exclusion Criteria:

* Participants with a life expectancy of less than 1 year
* Participants with cognitive dysfunction or neurological disorder, which will interfere with regular, flash glucose monitoring
* Participants with chronic kidney disease (CKD) with eGFR \< 45ml/min/1.73m2 or decompensated liver disease or decompensated congestive cardiac failure
* Myocardial infarction in the preceding 3 months or if percutaneous coronary intervention planned in the next 6 months
* Participants on supra-physiological doses of steroids, for example, Prednisolone for the treatment of Rheumatoid arthritis
* Participants on active dialysis or planned for dialysis treatment during the study
* Currently participating in another device or drug study that could affect glucose measurements or management
* Women who are pregnant, breastfeeding or planning to become pregnant. Women should use a reliable form of contraception throughout the study
* Participants who are already using continuous glucose monitoring (CGM)
* Participants who have pacemakers, implanted cardioverter defibrillator devices or neurostimulators
* Participants with an allergy to medical grade adhesive
* A blood transfusion in the preceding 3 months or a planned blood transfusion during the course of the study
Effect of Probiotic on Depression

Depressive disorder, also known as depression, is a type of mood disorder characterized by persistent low mood. The incidence of depression worldwide is about 6%. Growing evidence suggested that the gut microbiota plays a key role in the development of depression. Probiotics can effectively regulate gut microbiota, and showed potential in alleviating depression. This study investigated the effect of formula probiotic (containing Lactobacillus paracasei, Bifidobacterium animalis, Bifidobacterium longum, Bifidobacterium bifidum and Lactobacillus plantarum) on depression.


Eligibility Criteria:
Inclusion Criteria:

* Normal body mass index ≥ 18.5 until ≤ 29.9
* Mild to moderate major depression diagnosed by psychiatrists according to the diagnostic criteria for depressive episodes in DSM-5 (American Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition))
* Hamilton Rating Scale for Depression (HAMD-17) score not less than 8
* Agreed to intake study product during the study period
* Agreed to sign written informed consent

Exclusion Criteria:

* Use of systemic antibiotics or antimycotics medication in the 30 days prior to the study
* Investigator's uncertainty about the willingness or ability of subject to comply with the protocol requirements
* Persons with a milk protein allergy, lactose intolerance
* Pregnant or breastfeeding women
* Subject had other serious diseases
Evaluation of S-600918 in Adults With Refractory Chronic Cough

The primary objective of this study is to determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
* If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
* Capable of giving signed informed consent.

Key Exclusion Criteria:

* Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
* Has chronic obstructive pulmonary disease or uncontrolled asthma.
* Has a clinically unstable medical condition.
* History of or ongoing significant psychiatric disorder.
* History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
* History of malignancy in the last 5 years.
* History of severe drug allergy.
* History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
* Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
* Has systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 90 mm Hg.
* Received S-600918 previously.
* Received an investigational drug in the last 3 months.
* Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
* Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
* If female, pregnant or trying to become pregnant or breastfeeding.
Corchorus Olitorius Buccal Films for the Treatment of Recurrent Minor Aphthous Ulcerations

A methanol extract of Corchorus olitorius edible plant was perpared for extration of glycosideal compounds. the extract was tested for its efficacy as antiinflammatory and analgesic activity invitro and approved by the biomarkers. a fast dissolvinf mucoadhesive film was prepared by a certain amounts of highly safe polymers for a pilote study on human for treament of Aphthous Ulcerations. two groups of study, placebo and intrvention will be recurited and followed for pain, erthymia and size of ulcers for 6 days.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged 18-65 years old
2. Willingness to participate and sign the informed consent forms
3. Presenting with 1 to 5 aphthous ulcers (less than 72 hours' duration) with a size no greater than 5 mm in diameter
4. An expectation that their ulcers normally take 5 or more days to resolve without treatment

Exclusion Criteria:

* A known history of serious drug hypersensitivities 2. Pregnancy and lactation (Urine hCG-positive) 3. Concurrent clinical conditions that could pose a health risk to the subjects, including serious liver, kidney, and heart dysfunctions 4. A history of an immunologic problem
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fasting Condition

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Escitalopram Oxalate Tablet 20 mg \[Test formulation, Torrent Pharmaceuticals Ltd., India\] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) \[Reference formulation, Forest Laboratories Inc, USA\] . Dosing periods were separated by a washout period during fasted study.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

* Sex: male.
* Age: 18 - 45 years.
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Regadenoson vs Dipyridamole in Use as Pharmacological Stress Agent Before SPECT

Myocardial perfusion scintigraphy is to evaluate coronary perfusion as well as heart muscle function. This examination takes place in two stages, one imaging at rest and one after a cardiac stress caused. This stress can be triggered as a first-line stress test. A pharmacological stress is proposed when stress test is not possible or contraindicated, Several drugs have a marketing authorization in this indication (adenosine, dipyridamole, regadenoson, dobutamine).

Among them, the regadenoson is the most recent molecule. Marketed in France since 2013, it would allow a reduction of undesirable effects compared to other agents, especially adenosine. It is simple and quick to use thanks to a single dose administration. However, its cost is nearly 30 times higher than dipyridamole. In the investigational center, dipyridamole is currently the first-line pharmacological stress agent, whereas regadenoson is reserved for a limited number of doses, the indication of which must be justified (asthmatic patient or with severe COPD). Few studies in the literature specifically compare these two pharmacological agents (examination time, cost, tolerance) and the opinion on the use of regadenoson in the service is limited.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years
* Myocardial scintigraphy by pharmacological stress agent
* Used molecules = Dipyridamole or Regadenoson

Exclusion Criteria:

* Physical stress test by single or mixed effort (associating pharmacological stress)
* Pharmacological agent used = Adenosine
* Inclusion in the ERCAD protocol
* Double isotope protocol
* Patient refusal due to study information
The EMPOwER Study Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers

Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers

The clinical trial will be a prospective, two strata, non-blinded, single institution, Health Canada approved, Window of Opportunity trial with 2 weeks of pre-surgical endocrine therapy using either anastrozole or tamoxifen. Tissue from the initial biopsy and from surgery will be sent for Ki67 analysis using the NanoString® Assay.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with histologically confirmed newly diagnosed operable ER+, Her2 negative invasive carcinoma on diagnostic core biopsy that has a radiographic size ≥ 1.5 cm
* Histology has to be ductal, lobular or mixed
* Surgery date planned in the next 2-6 weeks
* Negative pregnancy test if of child baring potential
* Post-menopausal status verified by FSH and Estradiol (with 6 months of amenorrhea)

Exclusion Criteria:

* Previous treatment with endocrine therapy, chemotherapy or chest wall radiation within last 6 months
* Known metastatic or recurrent breast cancer.
TCHCCT-Zhong-Xing-Emergency-Department-airway

To investigate which shapes of stylet, hand techniques and possible condition that improve intubation successful rate and reduce the elapsed intubation time.

Challenging airway is always a big issue in emergency room. However, better hand technique, stylet shapes and conditions affecting intubation successful rate, elapsed duration need further investigations. We compare two endotracheal tube holding position, two holding places, with or without epiglottis lift technique in this study. All intubation processes in the study will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* care givers with sufficient understanding of airway anatomy and management

Exclusion Criteria:

* N/A
Acute Excposure of High Altitude on ECG and Non-invasive Blood Pressure.

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response of High Altitude (Säntis, 2500m above sea level) on ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology.

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

During the exposure High Alitude (2500m above sea level) and low alitude (Zurich) up to 5 hours, the participants' ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding
Functional and Mechanistic Characterization of Limb Ulcers in Patients With Sickle Cell Disease

Sickle Cell Disease is the most frequent genetic disease in the world (representing one birth over 1900, in France). The polymerization of the abnormal hemoglobin (i.e., HbS) when deoxygenated is at the origin of a mechanical distortion of red blood cells (RBC) into a crescent-like shape. Sickled RBCs are very fragile and rigid, which lead patients to have severe anemia and to develop frequent and repeated painful vaso-occlusive crises. Furthermore, the repetition of sickling-unsickling cycles causes irreversible damages to the RBCs, which shorten their half-life. Accumulation of free hemoglobin and heme in the plasma is involved in blood vessels lesions in both the macro- and micro- circulation.

The resulting vascular dysfunction could explain why limb ulcers are 10 fold more frequent in patients with sickle cell disease compared to the general population and may happen at a younger age. Limb ulcers induce significant morbidity (delay of healing between 9 and 26 weeks in the french cohort), and are associated to significant pain (needing opioid pain-killer) and increase the risk of infection. Cost of care is also increased. Moreover, ulcers induce missed school and work days.

Data on cutaneous microcirculation and ulcers physiopathology in patients with sickle cell disease are scarce. We want to realise a microcirculatory and neurological functional study of patients with with and without ulcers and a characterization of biomarkers present in the blood or in the wound fluid which can participate to ulcers physiopathology.

To ensure healing, adapted therapeutics are essential. Several strategies are proposed such as: lifestyle measures (venous compression, lower limb elevation, rest), dressings, hyperbaric oxygenotherapy (also used in diabetic ulcers). The project is devoted to study the mechanisms involved in leg ulcers and the effects of therapeutical/behavioral strategies.


Eligibility Criteria:
Inclusion Criteria:

* Sickle Cell Disease (homozygous SS or Sb0)
* Age ≥ 18 years old
* Consent patients
* Social regimen

Exclusion Criteria:

* tutela or curatella
* Vaso occlusive crisis \< 1 month
Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly

The aim of this study is to demonstrate that in elderly and frail patients, a narrower control of intraoperative blood pressure (BP) by the use of a continuous and noninvasive BP monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of postoperative cognitive impairment and the hospital length of stay.

Postoperative cognitive impairment (delirium and cognitive dysfunction) are frequent and feared complications in the elderly; they increase the postoperative morbidity and mortality, worsen the cognitive and functional outcome with loss of independence and increase the hospitalization length and costs . However, the etiology of these postoperative cognitive impairment, although probably multifactorial, remains unclear and strongly debated.

The investigators hypothesize that excessive anesthesia depths associated with intraoperative hypotension may play a critical role in the pathogenesis of cognitive impairment following surgery.

Eligibility Criteria:
Inclusion Criteria:

* elderly patients (over the age of 70) undergoing elective moderate risk surgery requiring a general anesthesia
* Patients who provide written informed consent
* patient fluent in french

Exclusion Criteria:

* Patients under 70 years of age
* Surgery under locoregional anesthesia or emergent surgery or minor risk surgery
* Patients requiring invasive blood pressure monitoring (for medical reason or high risk surgery)
* Patients with arrhythmia and/or atrial fibrillation
* Patients with preoperative delirium or cognitive dysfunction (moca test \< 26)
* Patients not fluent in French
* Patients without the capacity to give written informed consent or refusal of consent
* Patients undergoing surgery or included in another protocol within 3 months