cyrilzakka/clinical-trials huggingface dataset:
Emotional Fluctuations in the Flow of Daily Life. Ecological Analysis of Depressive Symptoms in the General Population.

The aim of this study is to analyze both depressive symptomatology and psychological well-being fluctuation in a day-to-day basis in the general population, in order to identify contextual determinants of the mood and well-being changes

Introduction: The Experience Sampling Method is a research tool to study what people do and feel in their day to day. It allows to analyse temporal relationships between variables and has a high ecological validity.

Aim: To evaluate fluctuations of depressive symptoms and subjective well-being and to analyse the factors related to these fluctuations.

Methodology: Longitudinal study that will follow up for two weeks a representative sample of the population aged 18 to 65 years living in Madrid using the Experience Sampling Method. An interviewer will visit the participants at their home to carry out a structured interview on mental health and well-being and to install a mobile app on the smart phone of participants in order for them to fill out information about their emotional state during the following two weeks. Participants will use the smart phone screen to fill out a brief questionnaire about their feelings, the activities they are doing and the people with whom they are interacting. Multilevel analysis based on lineal hierarchical models will be employed for data analysis as well as methods based on machine learning.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Non-institutionalized resident in Madrid
* To own a smart phone

Exclusion Criteria:

* To present noticeable cognitive or other limitations that impede following the interview
Heart Watch Study: a Pragmatic Randomized Controlled Trial

This will be a prospective multi-center, randomized, controlled trial of 150 patients conducted to assess the impact of individual use of the Apple Watch compared to the Withings Move on patient-reported and clinical outcomes at 6 months and up to 1 year.

This is a a randomized, controlled trial to determine the impact of the Apple Watch Series 6 compared to the Withings Move on both patient-reported outcomes and clinical utilization over 6 months and up to 1 year. Our research method will employ a patient-centered health data sharing platform (called Hugo) for real-world surveillance of outcomes in 150 total patients after they receive elective direct current cardioversion (DCCV) or catheter ablation for treatment of atrial fibrillation or atrial flutter. Patients will be enrolled at each of 3 clinical sites: Yale-New Haven Hospital, the Mayo Clinic, and Duke Health. Half of the patients will be randomized to receive the Apple Watch Series 6, while half will receive a control device (Withings Move). Patients will then be queried about specific symptoms related to atrial fibrillation and medication adherence monthly. This project will provide novel and needed post-market data about the Apple Watch Series 6 ECG and irregular rhythm detection notification features and, on a larger scale, help delineate the impact of an innovative digital health technology on real-world patient outcomes.

Specific Aim 1: To assess the impact of using the Apple Watch ECG and irregular rhythm notification features on patient-reported outcomes and clinical utilization after patients receive cardioversion or catheter ablation for atrial fibrillation or atrial flutter.

Specific Aim 2: To determine the accuracy of the Apple Watch ECG compared to physician interpretation of 12-lead ECGs obtained in routine clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Age \>22
* English-speaking
* Planned for direct current cardioversion or catheter ablation for atrial fibrillation or atrial flutter, as noted by referring clinical staff or on chart review
* Participant is willing and able to read and sign consent and participate in study
* Participant lives independently and does not require continuous care
* Participant has an email account (or is willing to create one)
* Participant has a compatible smartphone (iPhone 6s or later)
* Participant is willing to wear only the device they are randomized to receive for the study period for as many hours during the day as they are able, except for time spent charging the device or in environments that may be suboptimal for the device
* Participant is willing to use the Hugo mobile health platform and Apple Watch Series 6 or Withings Move
* Participant has cardiology care at YNHH, Duke Health, or Mayo Clinic

Exclusion Criteria:

* No exclusion criteria
The Healthy Cantonese Diet on Cardiometabolic Syndrome

The DASH diet (Dietary Approaches to Stop Hypertension) have been proven to lower risk of cardiovascular diseases. But the DASH diet is inconsistent with Chinese dietary pattern. In this study, based on the typical Cantonese diet, the healthy Cantonese diet is developed according to the DASH diet and the balanced dietary pattern of the Chinese Dietary Guidelines 2016. The randomized control trial is designed to investigate whether the healthy Cantonese diet has benefit to blood pressure, blood lipid, blood glucose and other cardiometabolic biomarkers among adults with cardiometabolic syndrome in Guangdong, China.


Eligibility Criteria:
Inclusion Criteria:

1. Age 25-75 years old, male or female;
2. have lived in this community for the past six months, and have no plans to move out or go out in the next three months;
3. the systolic blood pressure is within 130-159mmHg regardless of medication.
4. maintaining the current medication (mainly drugs for hypertension, diabetes or hyperlipidemia) throughout the research period, with the category and dose unchanged;
5. the number of test meal consumed is no less than 18;
6. community feeding mode: eat a meal at least once a day at the research center (preferably lunch or dinner); or home delivery mode: upload meal pictures for three meals every day, and eat a meal and have physical examination at the research center at least once a week;
7. sign the informed consent form.

Exclusion Criteria:

1. fasting blood glucose ≥10.0mmol/L;
2. total cholesterol ≥7.2mmol/L;
3. injected inulin within a month;
4. unwilling or unable to change the original dietary pattern, or have special dietary needs (such as vegetarians);
5. alcoholism;
6. BMI ≥30kg/m\^2, or losing weight currently;
7. have acute cardiovascular and cerebrovascular events occurred in the past six months;
8. have a history of chronic kidney disease, intestinal irritation or asthma;
9. women who have been/are preparing for pregnancy or lactation;
10. in combination with other serious diseases such as cancer, chronic heart failure, severe depression or other mental disorders, long-term bedridden or unable to move freely;
11. have a history of common food allergies (eggs, seafood, peanuts, etc.);
12. have undergone gastrointestinal surgery;
13. currently suffering from acute phase of diseases such as respiratory infections, fever, severe diarrhea;
14. have deaf-mutism, dementia, unable to communicate properly.
Impact of the Inspiratory Cortical Control on the Outcome of the Ventilatory Weaning Test in Patients Intubated in Resuscitation

In case of respiratory distress, patients are intubated to be connected to an artificial respirator to ensure gas exchanges. Before any ventilatory weaning, a breathing test in spontaneous ventilation under artificial nose is practiced. The patient keeps the endotracheal tube but is no longer assisted by the ventilator. Mortality is markedly increased with the prolongation of the weaning period. Despite the presence of all weaning criteria and the success of a breathing test in spontaneous ventilation under artificial nose, failure of extubation occurs in 20% of patients.

Experimental application of an additional inspiratory load in awake healthy subjects causes a compensatory increase in respiratory work to maintain effective ventilation, and the subject does not develop hypoventilation. This respiratory drive to breathe has been demonstrated by quantified electroencephalography in inspiratory load tests in the form of pre-inspiratory negative deflections of low amplitude similar to the potential described during the preparation of the voluntary movement of a limb. These inspiratory pre-motor potentials begin about 2.5 seconds before the start of a movement in the additional motor area.

Does the simple and noninvasive analysis of inspiratory cortical control during the spontaneous ventilation breath test under artificial nose predict the outcome of this test as well as weaning at 7 days?


Eligibility Criteria:
Inclusion Criteria:

* All intubated-ventilated patients eligible for an artificial nose breathing test in spontaneous ventilation, according to the physician in charge, and to the protocol of the medical resuscitation service and good clinical practice,
* at least 18 years of age;
* intubated-ventilated for at least 24 hours;
* express consent given by patients or "relatives" after clear and fair information on the study.

Exclusion Criteria:

* Patients are secondarily excluded from the study only if EEG or pressure monitoring are uninterpretable.
Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules

This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.

A multicenter, randomized controlled study with a blinded control arm. Open label arm is observational for lung nodule management. The clinical trial will evaluate the clinical utility of the Nodify XL2 integrated classifier when used in the clinical management of newly identified solid lung nodules assessed as \< 50% risk of cancer by Mayo risk prediction algorithm.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements
2. Subject is \> 40 years of age at the time of the discovery of the lung nodule of concern
3. Subject's lung nodule of concern meets the following:

   * Was incidentally identified or detected during lung cancer screening
   * Is a solid nodule
   * Has maximal dimension of \> 8mm and \< 30mm
4. The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment
5. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less

Exclusion Criteria:

1. Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern
2. Nodule of concern is part-solid or Ground Glass Opacity (GGO)
3. Prior diagnosis of lung cancer
4. Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer
5. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment
6. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern
7. Any illness or factor that will inhibit compliance with study participation
Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia

In this study the investigators will investigate the following hypothesis

* that hypoxia induce migraine headache and migraine aura
* the aura phase is associated with a spreading reduction in cerebral blood flow
* the migraine headache is associated with dilatation of intra- and extracerebral arteries
* the migraine headache is associated with changes in brain metabolism
* the pre-ictal stage of a migraine attack with aura is associated with specific patterns in neural activity.

To investigate migraine with aura symptoms during and after hypoxia.

With magnetic resonance imaging the investigators will investigate changes in

* regional cerebral blood flow (rCBF)
* resting state functional connectivity
* circumference of the middle cerebral artery(MCA), internal carotic artery, superficial temporal artery, medial meningeal artery, external carotic artery
* brain metabolism

And compare these changes with a aged match healthy control group.

Eligibility Criteria:
Inclusion Criteria:

Migraine with aura patients and Helthy volunteers as controls:

* Aged 18-40
* 50-100 kg

Exclusion Criteria:

* Tension type headache more than 5 days/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Headache or migraine attack within the last 48 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
* smoking

Extra exclusion Criteria for healthy volunteers:

* migraine at present or earlier in life
* parents, sibling or children who suffer or have suffered from migraine
Cryotherapy and Laser Therapy on Muscle Damage

This study propose investigate the effect of cryotherapy and laser therapy in response to strenuous exercise-induced muscle damage on the biceps brachii muscle (muscle of the arms). All the individuals underwent to an strenuous exercise protocol (2 series of 10 contractions of non-dominant elbow flexors) and three assessments (pre, post and 48hr after the exercise), composed of pain sensation, measure of the strength and muscle activation.


Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Aged between 18 and 28 years
* Healthy, considered active according to the International Physical Activity Questionnaire -Short Form (IPAQ)
* Engaging in physical activity involving upper limbs at least 2 times a week
* Exhibiting shoulder joint, elbow and non-dominant hand integrity
* Not having a history of osteo-myoarticular injuries in the assessed limb in the last 6 months, or neurological, visual and/or non-corrected auditory impairments.
* Furthermore they could not be allergic to ice (verified by the ice cube test) or any absolute contraindication for the use of laser (cancer and pregnancy).

Exclusion Criteria:

* Not understanding the commands given in the protocols and/or inadequate performance during assessments.
Exploiting Pathogenic Tp53 Mutation for Early Diagnosis of Ovarian Cancer by Mean of Papanicolau Test

The aim of the project is to corroborate them on a large retrospective cohort of HGS-EOC and confirm the possibility of identify TP53 mutations in high grade endometrioid tumors.

This will consequently allow to confirm the previous results and define with a greater precision the temporal windows in which it will be possible to detect, through the TP53 analysis, tumor material by vaginal swab sampling. The results of the study will be the first step of a multiphase prospective validation program for the development of a novel approach for early diagnosis of EOC.

All participating women will be identified through the ovarian cancer audit implemented by the "Oncological Network of Piedmont and Valle d'Aosta" and the Clinical Epidemiology Unit of CPO Piemonte between 2015 and 2020. Women with EOC, and the center where they have been treated for the tumor, will be identified by linking the databases of the "Oncological Network of Piedmont and Valle d'Aosta" with those of the "Prevenzione Serena" project.

A few clinical information from EOC patients will be collected by clinical investigators at each center using an electronic case report form (e-CRF) developed at the Mario Negri Institute. These information will include age, date of diagnosis, histological subtype and grading, tumor stage according to FIGO 2014 classification2,3, previous gynecologic conditions and surgical operations, date of Pap Test collection, and Pap Test cytological reports. Participants' data will be identified by a unique patient code.

Eligibility Criteria:
Inclusion Criteria:

age ≥18 years;

* confirmed histologic diagnosis of HGS-EOC or high grade endometrioid tumor;
* presence of one FFPE primary tumor biopsy with at least 40% of tumor cells based on Hematoxylin and Eosin staining, in the archive of the Pathology Departments of the hospital centers where they have been treated;
* presence of one or more Pap Tests sampled up to eight years before EOC diagnosis during routine cervical cancer screening;
* negative history for other gynecologic malignancies;

Exclusion Criteria:

* pap test not available in patients with ovarian cancer
The Predictive Value of Retinal Vascular Signs for Intracranial Artery Stenosis (RVS-ICAS)

Intracranial artery stenosis (ICAS) is a leading cause of ischemic stroke worldwide, contributing to the global burden of stroke, particularly in the Asian population. However, there is no non-invasive, easy to popularize and economic for intracranial artery stenosis in mass population screening. This study aims to evaluate the predictive value of retinal vascular signs for intracranial artery stenosis (ICAS) and explore a new screening method.

Intracranial atherosclerosis stenosis (ICAS) is a leading cause of ischemic stroke worldwide, contributing to the global burden of stroke, particularly in the Asian population. Compared with the other stroke subtypes, patients with ICAS particularly the degree of stenosis≥50% had more severe stroke, stayed longer in the hospital and higher risk of recurrent ischemic events. However, there is no non-invasive, easy to popularize and economic for intracranial artery stenosis in mass population screening. Retinal imaging has great advantages including share the same embryological origin, anatomic features, and physiological properties with brain, non-invasive, easy to popularize, inexpensive and possess good economic benefits. Therefore, investigators design this study to assess the predictive value of retinal vascular signs for intracranial artery stenosis (ICAS) and hope to explore a new screening method.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥35
2. Accept TCD examination and fundus examination
3. Signed informed consent

Exclusion Criteria:

1. Non-atherosclerotic stenosis, such as arteritis, moyamoya disease, arterial dissection, vascular malformation, etc., which were clearly diagnosed.
2. Intracranial space-occupying lesions
3. Jugular vein and intracranial venous lesions
4. Patients with severe cardiac, hepatic, renal disease.
5. Life expectancy of less than 1 year due to co-morbid conditions.
6. Known pregnancy (or positive pregnancy test), or breast-feeding.
7. Pathological myopia fundus changes
8. Glaucoma
9. Refractive medium turbidity affects fundus observation
10. Anterior macular membrane of both eyes
11. Papilledema, optic neuritis and optic neuropathy
12. Patients who have had internal eye surgery in the last six months (including fundus laser)
13. Previous history of internal eye trauma
14. Poor image quality of fundus and images
15. Any condition which, in the judgment of the investigator, might increase the risk to the patient.
Coronary Artery Disease (CAD) in Postmenopausal Women

Aim of this study is the determination of a valid procedure for ischemia diagnositc in postmenopausal women.

In order to investigate which ischemia diagnostic presents which sensitivity and specificity for postmenopausal women, 100 consecutive patients presenting to our abmulance with stable angina pectoris and indication for myocardial szintigraphy will be enrolled in this study. An addidional stress-echocardiography and stress-MRI will be performed in this patients before they will reiceve their again routine coronay angiography.

The different methods for ischemia diagnostic will be compared in order to determine the most valid method for this specific population.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women presenting to the hospital with stable Angina pectoris complaints and an indication for myocardial szintigraphy

Exclusion Criteria:

* CABG
* Pacemaker or other metal implants
* Chronic bronchitis
* Asthma bronchiale
* Arterial Hypotension
Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects

The purpose of the study is to characterize the metabolism and excretion (ADME) of a single oral dose of \[14C\]varespladib methyl.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedure
* Healthy males, 19 to 55 years of age
* Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive

Exclusion Criteria:

* History or presence of any clinically significant disease or disorder in the opinion of the investigator
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, or vital signs at baseline in the opinion of the investigator
Diffusion Weighted MRI Enables Differential Diagnosis Between Pyocele and Mucocele

Diffusion MRI should allow for differentation of pus and simple retention in the paranasal sinuses, but this remained to be determined

On the basis of the apparent diffusion coefficient, the content of a para nasal sinus could be defined as simple mucus or pus. This differentiation is very important for the clinician for prompt treatment. The aim of this study is to retrospectively measure this coefficient and to correlate it to clinica data.

Eligibility Criteria:
Inclusion Criteria:

* paranasal sinus MRI with a diffusion weighted sequence

Exclusion Criteria:

* no clinical examination available
* no bateriologic sample available
Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

The purpose of this study is to investigate the effect of gastric pH changes due to famotidine administration on the drug levels of prototype BMS-986256 tablet formulation in healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participants having no clinically significant deviations from normal in medical history, physical examination (PE) findings, electrocardiograms (ECGs), vital signs, and clinical laboratory results that would compromise the ability to participate, complete, and/or interpret the results of the study
* Weight ≥ 50 kg and body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2 inclusive at screening
* Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Any significant acute or chronic medical illness
* Any major surgery within 4 weeks of study treatment administration
* Any other sound medical, psychiatric, and/or social reason as determined by the investigator

Other protocol-defined inclusion/exclusion criteria apply