cyrilzakka/clinical-trials huggingface dataset:
Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI

Investigators propose here to study the brain consequences of hypertension in patients without cognitive complaints and neurological signs. The evaluation of brain suffering requires considering various possible brain damage. The team developed a multimodal MRI approach capable of detecting and quantifying numerous indices (e.g. morphometric, microstructural) to evaluate possible brain suffering. This project aims to identify individually signs of cerebral suffering in hypertensive patients compared to a population of normotensive volunteers, using advanced multiparametric MRI methods.

Hypertension is a risk factor for many brain pathologies, such as ischemic and hemorrhagic neurodegenerative diseases or stroke. The literature seems to agree on the relationship between hypertension and brain damage, and on the benefit of the management of hypertension to prevent certain neurological pathologies. However, to our knowledge, no single study has shown signs of subclinical brain damage in patients with hypertension. At present, no brain MRI is recommended in these patients. In the present study, hypertensive and normotensive patients will undergo a neurological exam, a neuropsychological exam, a biological exam and a MRI exam to individually identify signs of cerebral suffering.

Eligibility Criteria:
Inclusion Criteria:

* Male and female 35 to 50 y.o.;for patients: diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure;
* For normotensive participants:Absence of HTA confirmed by Ambulatory Blood Pressure Measure

Exclusion Criteria:

* Known neurological history, stroke, symptomatic headache, long-term use of neuroleptic, tricyclic, MAOI, anti-serotonergic antidepressant medications, diabetes mellitus, treated dyslipidemia, body mass index greater than 30 kg / m, participants who smoked or smoked more than 10 packs-year, MRI contraindication ;
* For HTA patients only: Renal artery dysplasia responsible for hypertension, clinical Cushing Syndrome.
Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers

The incidence of Thyroid Cancer (TC) has increased over the last thirty years, in France and worldwide. This increase is mainly due to good prognosis microPapillary TC (mPTC). Sixty percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment of these cases. The increase of diagnosis of mPTC and its treatment inevitably leads to an increase of medical resources consumption and corresponding costs.

The primary aim of this study is to estimate the cost related to different care management pathway of TC patient during a lifetime period using a multi-state Markov model.

This is a retrospective, observational population based cohort study, using data from a cohort study of TC patients implemented by the ONCOMIP network which initially aimed to perform an audit of clinical practices for the management of TC, and from database of the French social health insurance of Midi-Pyrenees region to calculate observed costs of TC management during 24 months.


Eligibility Criteria:
Inclusion Criteria:

* all patients with a good prognosis of the TC
* diagnosed in 2014
* whose medical file discussed in MultiDisciplinary Team Meeting (MDTM) in Midi-Pyrenees

Exclusion Criteria:

* patients whose surgical management was carried out outside Midi Pyrenees are excluded and other morphological types are excluded (medullar, anaplastic, lymphomas, sarcomas)
RedStroke - Reducing Europe's Stroke Incidence

In the RedStroke study, the effect of a smartphone application in detecting Atrial Fibrillation (AF) will be assessed in a double-blind randomised controlled multicenter trial. Outpatients with an elevated risk for atrial fibrillation will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). Both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. All patients will continue their prior therapy with their general practitioner and obtain every medical treatment indicated. This study will not cause any restrictions on the usual treatment of the study patients.

The only difference between the two groups will be, that patients in the app group will be informed by their local PI, if the recordings of the app indicate AF (and obtain a 14 day Holter ECG for AF verification), whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* CHA2DS2-VASc score of 3 and above, if patients are aged under 65 years
* CHA2DS2-VASc score of 2 and above, if patients are aged 65 years or older

Exclusion Criteria:

* history of Atrial Fibrillation
* current anticoagulation treatment,
* cardiac implanted electronic device (ICD or/and PM)
* app cannot be installed due to technical problems (smartphone type, reduced smartphone storage capacity, other)
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* enrollment of the investigator, his/her family members, employees and other dependent persons
Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne

Acne vulgaris is a common cutaneous inflammatory condition of sebaceous follicles that can profoundly affect patients' quality of life, especially at a young age. In this context the use of teledermatology can potentially reduce the healthcare costs associated to traditional consultations as well as the costs related to travel and loss of school/working time for the patient, with a clear benefit for the whole community. Since 2016, the Department of Dermatology at Inselspital Hospital in Bern has a portal and a smartphone app for online advice service.

Hereby the investigators propose to explicitly investigate the efficacy of this system in reducing healthcare costs as compared to traditional face-to-face consultations, in a cohort of patients with mild-to-moderate acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Given written informed consent
* Mild-to-moderate acne as assessed by IGA scale
* Willingness and ability to adhere the study protocol

Exclusion Criteria:

* Need for systemic therapy for acne with Isotretinoin
* Inability to use the teledermatology system
Clopidogrel And Ticagrelor in Healthy Subjects

To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers compared with standard Clopidogrel agent.

Consist with previous study Ticagrelor had greater, faster and more the platelet inhibition effect than Clopidogrel in both healthy subjects and stable coronary artery disease patients. Moreover, Asian subjects exposed higher active metabolite and stronger pharmacodynamics response than European subjects with same oral dose of antiplatelet agent. However, previous report comparing the efficacy and safety of Ticagrelor and Clopidogrel in healthy Asian ethnicity is lacking. Therefore, the aim of this study is to evaluate the pharmacodynamic responses of a lower Ticagrelor dose using laboratory platelet function tests in healthy Korean volunteers.

Eligibility Criteria:
Inclusion Criteria:

* 12 healthy men
* Aged between 19 and 59 years
* Body mass index (BMI) is between 18.5 and 29.9 kg/m2
* Baseline maximal platelet aggregation (MPA) 10 μmol/L ADP is more than 65%
* To screen for standard results on usual clinical tests

Exclusion Criteria:

* A history of bleeding within 6 months
* Bleeding diathesis
* Hemoglobin \< 12g/dl
* History of antiplatelet or anticoagulation treatment within 1 month
* contraindication to the study drug
* Severe hepatic dysfunction (serum liver enzyme or bilirubin \>3 times normal limit)
* Patients with hereditary disease such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption
* Previous experience of clinical trials within three months
Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System

This interventional device study aims to compare mainly standard Multiple Daily Injection (MDI) therapy vs. Accu-Chek® Solo Micropump System and investigates participant satisfaction. In addition, a third arm is included to compare to only similar product on the market which is OmniPod. The third arm is for data collection purpose.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed type 1 diabetes mellitus
* At least 6 months experience with MDI therapy
* Age ≥18 years and age ≤ 65
* Able to perform carbohydrate counting
* Clinically suitable for CSII including willingness to measure blood glucose at least 4 times per day or to use flash or real-time continuous glucose monitoring consistently
* HbA1c between 7.5% (58 millimoles per mole (mmol/mol)) and 9.0% (75 mmol/mol) (determined within the last 2 months)
* Ability and willingness to read and understand study materials (participant information, data protection and written consent form, all questionnaires etc.) and to comply with study procedures
* Ability and willingness to use investigational devices independently and respond to alarms after training and run-in phase
* Using a blood glucose (BG)-meter or real-time continuous glucose monitoring device that can be downloaded via Accu-Chek® Smart Pix or willingness to use a compatible meter that will be provided for the duration of the study

Exclusion Criteria:

* Prior insulin pump use
* Relevantly impaired hypoglycemia awareness
* History of \>1 hospitalization due to severe hypoglycemia within the previous 3 months
* History of \>1 hospitalization due diabetic ketoacidosis within the last 3 months
* Significant manifestation of diabetes-related late complications
* Pregnant or planning to become pregnant or breastfeeding
* Known allergic reactions to plaster adhesive
* Chronic use (therapy lasting for more than 3 months) of steroids in adrenal suppressive doses, immunosuppressive medication, or chemotherapy
* Serious or unstable chronic medical or psychological condition(s)
* Addiction to alcohol or other substance(s) of abuse as determined by the investigator
* Psychological condition rendering the participant unable to understand the nature and the scope of the study
* Plans for relocation or extensive travel
* Participation in another clinical study within 4 weeks prior to the screening visit
* Dependency on Sponsor or Investigator (e.g. co-worker or family member)
Effect of Different Administration Routes of Dexmedetomidine Combined with Ultrasound-Guided Fascia Iliaca Block on Emergence Agitation After Hip Replacement Surgery

To examine the impact of various administration routes of dexmedetomidine in conjunction with ultrasound-guided fascia iliaca block (FIB) on emergence agitation (EA) during the postoperative recovery period after hip replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 65 years, with no restriction on gender
2. diagnosis of hip joint disease necessitating hip arthroplasty
3. ASA grade I-II
4. no significant cardiopulmonary, hepatic, or renal dysfunction prior to the operation
5. no history of psychiatric disorders or long-term use of sedative medications prior to the operation
6. signing of an informed consent form to voluntarily participate in the study.

Exclusion Criteria:

1. patients allergic to or with contraindications to ropivacaine or dexmedetomidine
2. patients exhibiting symptoms of agitation or delirium prior to the procedure
3. patients with severe central or peripheral nervous system disorders
4. patients with coagulation disorders or receiving anticoagulant therapy
5. pregnant or breastfeeding women
6. patients who received other medications or treatments prior to the procedure that might affect the study results
7. patients unable to cooperate with the study or intolerant to ultrasound-guided iliofascial block
Prevalence of Pathogens in Cerebrospinal Fluid Obtained From Emergency Department Patients

Of all emergency room patients, persons presenting with encephalitis/meningitis syndrome of a potentially infectious nature are among those of greatest concern. Routine clinical and laboratory evaluation of such patients involves screening for known infectious disease agents, selection of which is nonstandardized. Progress in diagnostic technologies, especially molecular techniques based on genetic characteristics of potential pathogens, has greatly expanded the investigators capacity to evaluate specimens from patients for a much wider range of potential pathogens (bacterial, viral, fungal and parasitic agents). Use of Polymerase Chain Reaction (PCR) technology offers the possibility of identifying causative agents for the approximately 50% of all such presentations which go un-diagnosed. The investigators propose a study involving a collaboration between the EMERGEncy ID NET, a network of 10 geographically diverse university-affiliated urban emergency departments (coordinated by Olive View-UCLA Medical Center) and the Centers for Disease Control and Prevention (CDC), to use these new technologies to address this issue.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 3 months old
* Receiving a Lumbar Puncture in the emergency department as part of their standard care.

Exclusion Criteria:

* No CSF available
Medication Reconciliation in an Emergency Department: How to Prioritize Patients ?

Medication reconciliation has proven its efficiency in improving patients' care, especially for emergency patients.

This study aimed to identify risk factors of unintended medication discrepancies (UMD) in an emergency department. Secondary objectives were to identify the number and type of UMD, correction rate of UMD and the impact of emergency department organisation on UMD.

Emergency patients are at high risk of medication errors, for different reasons: emergency admission, patients who don't know their at-home treatment (polymedicated, cognitive disorders, etc) and who don't have their medical prescriptions available.

Medication reconciliation has proven its efficiency in improving patients' care, especially for emergency patients. However, prioritization is essential to ensure a better efficiency of pharmaceutical resources.

In our center, a pharmacy resident has been assigned to medication reconciliation in the emergency department since November 2017, in collaboration with a clinical pharmacist. Every morning, 3 to 4 patients benefit from medication reconciliation (patients who will be transfered to another unit within our hospital).

The main objective was to identify risk factors of unintended medication discrepancies (UMD) in order to prioritize patients who will benefit from this newly implemented activity.

Secondary objectives were to identify the number and type of UMD, correction rate of UMD and the impact of emergency department organisation on UMD.

All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018 were included. Were not included patients with a medication reconciliation performed but transfered to another hospital right after the emergency department visit.

This was a retrospective, monocentric, observational study. Number of patients required was 200. Variables collected were:

* demographics (age, sex, lifestyle, comorbidities),
* emergency care variables (date and time of medical care beginning, ambulance arrival, adressing type, medical prescriptions availability, main diagnosis, date and hour of medical prescriptions in the emergency department, prescriber (pharmacy/doctor), destination unit of patients)
* organizational variables (number of daily emergency visits, number of patients hospitalized within the emergency department),
* medical notes information on at-home treatment (number of missing information, of incorrect information, number of prescriptions in at-home treatment)
* medication reconciliation variables (date of medication reconciliation, number of sources of information needed, number of actual prescriptions in at-home treatment, number of intended medication discrepancies, number and type of UMD, time needed for medication reconciliation).

Eligibility Criteria:
Inclusion Criteria:

* All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018

Exclusion Criteria:

* Patients transfered to another hospital right after the emergency department visit
Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes Taking Twice-Daily Exenatide or Once-Weekly Exenatide

The purpose of this substudy is to obtain CGM data from individuals taking exenatide. The CGM measurements gathered before starting and during treatment with exenatide IR and/or exenatide LAR will help determine the characteristics of glucose control during treatment.


Eligibility Criteria:
Inclusion Criteria:

* participant in Amylin Protocol 2993LAR-105
* at least 16 years of age
* type 2 diabetes being treated with stable regiment of metformin, SU, TZD, combination of metformin/SU, combination metformin/TZD, combination SU/TZD
* A1c 7.1 - 11
* fasting glucose less than 280 at screening
* BMI 25 - 45
* stable body weight 6 months prior to screening
* not pregnant and willing to practice birth control
* physical exam \& ECG not clinically significant
* lab values judged not to be clinically significant
* able to understand \& sign consent form

Exclusion Criteria:

* clinically significant medical condition as judged by investigator
* drug or alcohol abuse
* previous use of exenatide or any GLP-1 analog
* has used any investigational drug in the past 30 days prior to screening
* is currently using: alpha-glucosidase inhibitor, insulin, drugs that affect GI motility, use of systemic corticosteroids, use of medications with addictive potential, prescription or OTC weight-loss medications
* has donated blood within 60 days of screening, or is planning to donate during the study
* has had major surgery or blood transfusion within 2 months of screening
* has had a surgical procedure that may impact gastric emptying
* has any allergies or hypersensitivity to any component of study treatment
* is an immediate family member of personnel affiliated with the study at the investigative site
* is employed by Amylin, Lilly or Alkermes
Reduction of Starvation Time Prior to Gastroscopy

The primary objective is to investigate whether intake of approximately 200 ml of sugary fluid 2 hours before the scheduled gastroscopy of the abdomen can reduce the discomfort of fasting period for patients without reducing the quality of the study.

Current standard for fasting and fluid intake before gastroscopy is completely fasting 6 hours before the study. Studies in patients in general anesthesia has been found that it does not increase the risk of aspiration of stomach content during the operation by allowing the patient to drink up to 2 hours prior to anesthesia induction. There are no studies that have examined the quality gastroscopy using this fasting procedure. Some studies show that intake of sugary liquids do not have significant effect on gastric emptying.

There are not deemed to be ethical problems with this study, as it seeks to show that a more lenient standard procedure in endoscopy is as safe as the established. The study is considered safe.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Sufficient knowledge of Danish to understand the written information
* legally competent patients

Exclusion Criteria:

* Patients with a history of pyloric stenosis (narrowing of the transition from stomach to the duodenum)
* Incapacitated patients
* Patients with daily vomiting.
Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients

The purpose of this study is to compare two types of group counseling for cancer patients: Meaning-Centered counseling and Supportive counseling. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" group counseling is intended to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" group counseling is intended to help you cope with cancer by giving you a place to express your feelings and get support from other cancer patients. The purpose of this study is to compare the benefits of these two types of counseling approaches for cancer patients.

To conduct a randomized controlled trial comparing the efficacy of Meaning-Centered Group Psychotherapy (MCGP) versus a standardized Supportive Group Psychotherapy (SGP) in reducing psychological distress (depression and anxiety), end-of-life despair (hopelessness, desire for hastened death, and suicidal ideation), and improving spiritual well-being and overall quality of life in a sample patients with advanced cancer.

To assess the relative impact of Meaning-Centered Group Psychotherapy on different aspects of spiritual well-being (e.g., a sense of meaning and purpose versus spirituality linked to religious faith).

To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy (e.g., potential mediating and moderating influences such as illness severity, religion and religiosity, level of education, race/ethnicity, level of pre-intervention social support, presence of pain and physical symptom burden).

Eligibility Criteria:
Inclusion Criteria:

* \> or = to 21 years of age.
* All patients with stage IV solid tumor cancers; or Stage III solid tumor cancers(excluding breast and prostate cancer) who are receiving ambulatory care at Memorial Sloan-Kettering Cancer Center.
* Able to communicate with an English speaking therapist
* Able to comprehend English to complete study assessments

Exclusion Criteria:

* Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a group-format intervention (i.e., acute psychiatric symptoms which require individual treatment).
* Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient, in the investigator's judgment, to preclude meaningful informed consent and/or data collection. The Mini Mental State Examination (MMSE) will be used as a cognitive screening tool. Patients with MMSE scores below 20 will be excluded.
* Karnofsky Performance Rating Scale score below 50 or physical limitations or illness severity sufficient to preclude participation in outpatient group psychotherapy.