cyrilzakka/clinical-trials huggingface dataset:
Effects of Acute Intake of Flavanols on Cerebral Oxygenation and Cognition in Young Male Adults

The study evaluates the impact of one acute dose of cocoa flavanols on brain oxygenation during a hypercapnia challenge, as well as impact on cognitive performance in young healthy males. It further assesses the impact of flavanols on peripheral vascular function, as measured by brachial Flow-mediated dilation (FMD). All participants received a high-flavanol cocoa intervention (185.5 mg of flavanols (-)-epicatechin and (+)- catechin) and a low-flavanol cocoa intervention (\< 4 mg of flavanols). It is hypothesized that the high-flavanol intervention increases cerebral oxygenation during hypercapnia and vascular function in comparison to the low-flavanol intervention.

Cocoa flavanols have been shown to be protective against vascular disease in humans, as evidenced by improvements in peripheral endothelial function (as measured by brachial Flow-mediated dilatation, FMD). There is also emerging evidence suggesting that flavanol-rich diets protect against cognitive aging, but mechanisms remain elusive. In this study the investigators suggest that such mechanisms might be associated with benefits within the brain vasculature. The aim of the present study was therefore to determine whether intake of flavanols enhances cerebral oxygenation in frontal cortical areas of the brain during a hypercapnia challenge (which is a well-established biomarker of vascular reactivity in the brain) to a greater extent than a low-flavanol intervention in young healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-45 years old

Exclusion Criteria:

* smokers
* hypertensive
* with history of cerebrovascular, cardiovascular or respiratory disease
* allergies or intolerances to ingredients present in cocoa powders
* taking long-term medication (e.g., hyperlipidaemia)
* on antibiotics for the previous 3 months before enrollment
* suffering from blood-clotting disorders
* known infections at the time of the study
* on a weight-reducing regimen
Comparison of Criteria for the Designation of a Contact Person in ICU Patients and Close Friends and Relatives

In the vast majority of cases, the person of trust (or contact person) is not designated by the patient (emergency, severe disease situations, coma, sedation, etc.). The healthcare team thus identifies a person who 1) may not be the person the patient would have designated and 2) may not be the most suitable to take on this responsibility. Though the first point is not easy, the main difficulty for the clinician is to know if he is dealing with the "right person for the job", meaning a person who is able to take on the responsibility of the contact person. This is a heavy responsibility in terms of the information given, of passing on this information to relatives and friends, of consulting the doctors, of help or support in medical decisions, etc. This responsibility may also be difficult for one person alone to take on and it may be helpful to share it between several friends or relatives. In a princeps study (QUENOT, 2015), it was shown that the process used by the healthcare team to designate a contact person was based on criteria such as knowledge of the wishes and values of the patient, the strength of the relationship with the patient, and the person of trust designated before admission to the ICU. However, we do not know what criteria are used by the patients themselves or those used by their close friends and relatives. This study will make it possible to determine and to measure the possible differences between the criteria used by the ICU healthcare team (REPERE I), those used by patients (REPERE III) and finally, those used by close friends and relatives (REPERE II).

In order to do this, 300 persons (150 patients and 150 relatives/friends) will complete questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Patients and their friends/relatives who have been given information on the study
* Patients admitted to the ICU according to the criteria defined by decree n° 2002-465 of the law of 5 April 2002 relative to the rights of patients and the quality of the healthcare system;
* Patients unable to designate a person of trust on admission;
* Patients able to designate a person of trust on discharge from the ICU.

Exclusion Criteria:

* Refusal to participate;
* Age \< 18 years;
* Patient/relative under ward of court;
* Patient/relative presenting a major cognitive disorder ruling out a reliable interview;
* Patient and/or relative who cannot be interviewed or who cannot provide information ;
* Absence of family and/or close friends.
Transdermal Vagal Stimulation for POTS

Some patients experience high heart rates and symptoms of light-headedness, fatigue, headache during standing despite well maintained blood pressure.

These patient are disabled and can't be in upright position for a longer time. The purpose of this study is to test whether electrical stimulation of a nerve through a skin of the ear may improve heart rate response and reduce disabling symptoms.

Background Postural Tachycardia Syndrome (POTS) is a syndrome characterized by disabling symptoms of inadequate cerebral perfusion on assuming the upright posture, including light-headedness, fatigue, palpitations, altered mentation, headache, nausea, presyncope, and occasionally syncope.

POTS is characterized by an excessive increase in heart rate and exaggerated increase in plasma catecholamine levels on standing in the absence of a blood pressure fall. These disabling symptoms persist for more than six months.

Objective The objective of this study is to study the effect of vagal stimulation on heart rate modulation during supine and upright posture as a treatment modality for patients with POTS.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking patients who qualify with the criteria of idiopathic postural tachycardia syndrome will be studied. The criteria are:

  1. an increase of heart rate of 30 beats/minute or an upright heart rate of \>= 120 bpm, and
  2. chronic problems of symptoms during upright posture for at least 6 month.
* Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.
* The age limit is 18-75 years.

Exclusion Criteria:

* Patients that have other major medical problems, such as cancer or heart disease are excluded because the influence of that diagnosis on the symptoms is not known.
* Pregnancy.
Trial of the Use of Antenatal Corticosteroids in Developing Countries

Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.

One of the United Nations Millennium Summit goals is to reduce the deaths of children \<5 years by two-thirds for 2015 (UN, 2000). Given that 38% of all under-five deaths worldwide occur in the first four weeks of life, the goal seems unattainable unless a significant fraction of the neonatal deaths are prevented (Darmstadt et al., 2005). Thus, the provision of health care during the perinatal period in developing countries is a top priority. Preterm birth is a major cause of neonatal mortality, currently responsible for 28% of the deaths overall. As the contribution of preterm birth to neonatal deaths is well above 50% (MacDorman et al., 2005) in middle and high income countries, it is expected that as low income countries improve their development, the relative importance of this cause will increase. One of the most powerful perinatal interventions to reduce neonatal mortality is the administration of antenatal corticosteroids to pregnant women at high risk of preterm birth.

The primary objective will be to evaluate whether a cluster-level multifaceted intervention, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, reduces neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six African, Asian, and Latin American countries.

Eligibility Criteria:
This is an intent-to-treat design and thus all pregnancy outcomes of women who deliver in the study clusters and provide consent will be collected. Cluster-level inclusion criteria include

* At least 250 deliveries per year.
* Birth attendants within the health cluster will be consented to participate

Participant-level inclusion criteria include all pregnant women living in and delivering in the study cluster who:

* Are between 24 and 36 weeks GA;
* Present with signs of preterm labor, amniotic fluid leakage, hemorrhage, or hypertension;
* Provide consent for injection or present to a facility where it is standard of care.

Exclusion Criteria:

* There will not be any specific exclusion criteria for clusters or participants.
Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status

This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor receptor 2 negative (HER2-neg), regardless of hormone status.

This is a worldwide, multicenter, non-interventional, retrospective study. The study will consist of 2 components. The first component involves local lab rescoring of qualified historical HER2 fixed tissue immunohistochemistry (IHC) stained slides (preferably using Ventana 4B5 assay) at sites (post-training) for mBC patients previously identified as HER2-neg, and independent central retesting of HER2 status using Ventana 4B5 assay for any enrolled patients with available archived tissue samples at designated central laboratories. Local lab rescoring and independent central retesting/local lab retesting will be conducted blinded of historical HER2 IHC scores.

The second component involves linking the rescored IHC status to the patient medical record either through registry databases or patient chart review. Such information will be used to describe the patient demographics, histopathological features, clinical presentation, and treatment patterns following mBC diagnosis, and clinical outcomes in real-world settings for all patients with HER2 scores of 0, \>0 and \< 1+, and 1+2+/ISH- (HER2 low). The clinicopathological and other relevant BC biomarker information will also be examined based on historical biomarker testing results and/or new testing conducted as part of this study.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women:

   1. ≥ 18 years of age when consent provided for future sample and clinical data use - applicable for all countries participating in the study except Japan
   2. ≥ 20 years of age when consent provided for future sample and clinical data use - applicable for Japan only
2. Must have a histological or cytological confirmed diagnosis of unresectable or/and mBC between 01 January 2015 and 31 December 2017
3. Must have provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use. If the patient is deceased, a waiver may be accepted
4. Diagnosed as HER2-neg (HER2 IHC 0, 1+, 2+/ISH-), regardless of hormone status
5. Progressed on any systemic anti-cancer therapy (eg, endocrine therapy, chemotherapy, CDK4/6i, targeted therapies other than anti-HER2, or immunotherapy) in the metastatic setting
6. Must have historical HER2 fixed tissue IHC stained slides (preferably stained using Ventana 4B5 assay) in acceptable quality for accurate rescoring.

Exclusion Criteria:

1. Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin
2. Patients with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified.
Turkish Translation, Validity and Reliability of the Back Pain and Body Posture Assessment Questionnaire

The Adult Back Pain and Body Posture Assessment Instrument (BackPDE-Y), whose validity and reliability is planned, will be applied. This assessment scale will be translated into Turkish by two native Turkish speakers, one who is fluent in English.

220 people aged between 20-65 are planned to be included in the study. The data obtained from the study will be analyzed with appropriate statistical methods.

In addition, a previously valid and reliable Musculoskeletal System Health Inquiry (MIS-SS) questionnaire, which evaluates the musculoskeletal problems of individuals included in the Study, will be applied. It will be evaluated whether the results of the data obtained from the Back Pain and Body Posture Assessment Instrument for Adults (BackPDE-Y), which we have validated in Turkish, and the results of the data obtained from the Musculoskeletal Health Questionnaire (CIS-SS) questionnaire are consistent with each other.

Eligibility Criteria:
Inclusion Criteria:

18-65 years old Willingness to participate in the study The mother tongue is Turkish, Being able to read and write, - It is between the ages of 18-65.

Exclusion Criteria:

Those with a known or concomitant diagnosis of dementia Not wanting to participate in the study Patients with psychotic disorders, depression with psychotic symptoms, bipolar depression Having a psychiatric illness with a serious psychiatric illness that may prevent the individual from understanding and completing the questionnaire
Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis

It has previously been found that there is no correlation between degree of hydronephrosis and presence of reflux; however this is oftentimes the criteria physicians use to obtain a VCUG.

Investigators conducted a previous retrospective study to evaluate other possible findings on ultrasound that may better predict reflux. Investigators found that if a postnatal ultrasound showed any of the three findings of hydroureter, duplication or dysmorphic kidney, then the odds ratio of detecting reflux was 8.07 (95%CI 3.86, 16.87). The purpose of this study is to perform a randomized prospective study to validate this retrospective study. Investigators hypothesis is that patients with hydronephrosis alone will be more likely to have negative VCUG studies; hence obtaining a VCUG for this indication may not be warranted.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of antenatal hydronephrosis who have a post-natal ultrasound demonstrating hydronephrosis alone and no other abnormalities

Exclusion Criteria:

* Patients with a post-natal ultrasound demonstrating bilateral hydronephrosis
* Patients with a history of posterior urethral valve or when a valve is suspected
* Patients who have hydronephrosis on ultrasound as well as other findings including duplication, hydroureter, dysmorphic kidneys, or bladder abnormalities
Electronic Tool for Interaction Between Patients and Health Professionals

This project's overall objective is to contribute to knowledge and innovation needed to advance ICT-arenas for timely, secure and seamless collaboration between chronically ill patients and appropriate levels of care. The investigators will expand an Internet solution that has successfully supported online patient-provider communication into a device- independent mobile, multifunctional ICT platform, called Connect 2.0, to support individually tailored collaborative care between patients and care providers on the continuum of primary-specialist care. The results will contribute to Norway's Collaboration Reform. Integrating theories from health and ICT related sciences, the project is organized into five work packages that focus on two of VERDIKTs research themes: social networking and mobile internet. We will summarize (1) the current state of collaborative health care models and their utilization of ICT research and innovations; explore challenges related to (2) information exchange between devices, platforms and systems; (3) human-computer interaction, (4) data security and confidentiality; and (5) factors related to successful adoption and implementation of Connect 2.0 patient-provider collaborative care. Finally the investigators will explore how Connect 2.0 impacts interactions, communication and organizational processes in collaborative "real world" care.

Specifically this study will:

1. Summarize the current state of collaborative health care models and their utilization of ICT research and innovations.
2. Explore challenges and propose solutions for adapting a mobile multifunctional ICT platform (Connect 2.0) into the technical and organizational infrastructures of collaborative health care.
3. Through user-centred design methods address challenges related to human computer interaction and usability of Connect 2.0.
4. Explore challenges and feasible solutions that safeguard data security and confidentiality when connecting an Internet solution with a protected health net while ensuring safe and efficient data transfer through heterogeneous networks.
5. Explore factors related to successful adoption and implementation of Connect 2.0 in real world collaborative care. Based on the above: explore impacts of a test version of Connect 2.0 on interactions, communication and organizational processes.

The work expands partnerships between the Centre for research-based innovation (SFI) consortium (7 business / research partners) called Tromsø Telemedicine Laboratory (TTL), the Norwegian Telemedicine Center (NST), the Center for Shared Decision Making and Nursing Research (CSDM) at Oslo University Hospital, the Department of Computer Science, University of Oslo, the University Hospital of Northern Norway (UNN), Balsfjord Municipality, the Biomedical Information Research Center at the Marshfield Clinic Research Foundation, and the Department of Biomedical informatics at Columbia University in New York.


Eligibility Criteria:
Inclusion Criteria:

* Chronic illness
* Receive municipal health services
* Internet access at home

Exclusion Criteria:

-
A Study to Evaluate the Safety and Efficacy of SYB Filler(SF-01) in the Correction of Nasolabial Folds

The objective of this clinical trial is to verify the safety and efficacy of SYB Filler (SF-01) in the temporary improvement of Nasolabial Folds.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS)
2. Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study.

Exclusion Criteria:

1. Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening
2. Administered Vitamin E or non-steroidal anti-inflammatory drugs or Collagen within 1 week of the date of the screening, or who require these during the period of the study
3. History of bleeding disorder in past or present
4. Received deep-peeling, skin regeneration, plastic surgery (including botulinum toxin injection), wrinkle improvement or acne scar treatment in the facial area within 24 weeks of the date of the screening
5. Administered an hyaluronic acid filler within 24 weeks of the date of the screening
Augmented Care at Worksite for Diabetes Prevention

The purpose of the study was to evaluate the impact of augmented care at the worksite through a lifestyle intervention for diabetes prevention among employees with prediabetes who were slower to respond to a standard diabetes prevention intervention.

Employees at the Ohio State University (OSU) with prediabetes participated in a standard lifestyle intervention (Group Lifestyle Balance) for diabetes prevention. Participants who did not achieve \>2.5% weight loss at week 5 of the intervention were stratified to the augmented intervention (Group Lifestyle Balance Plus) at week 5. The impact of the augmented intervention compared to the standard intervention was determined at 4, 12 and 18 months from baseline to determine if implementing early enhanced training helped participants achieve and maintain weight loss similar to those who received the standard intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Benefits-eligible Ohio State University (OSU) employee
2. Intend to be employed by OSU through the length of the follow-up phase
3. Body mass index: \>24 kg/m\^2 non-Asians; \>22 kg/m\^2 Asians
4. Fasting blood glucose of 100-125 mg/dL or an A1c of 5.7-6.4%
5. Blood glucose of 110-199 (if non-fasting in previous 2 hours)

Exclusion Criteria:

1. Blood glucose level of ≥ 200 mg/dL
2. Conditions that would limit adoption of light/moderate physical activity (i.e., cardiac event, severe chronic obstructive pulmonary disease, advanced arthritis, poorly controlled hypertension)
3. Chronic use of medications that affect blood glucose levels (i.e., corticosteroids)
4. Concurrent participation in a structured weight loss program or counseling for bariatric surgery
5. Pregnant or breastfeeding
6. Score of ≥ 10 on the Patient Health Questionnaire-8 indicating moderate to severe depressive symptoms
7. Score of ≥ 27 on the Binge Eating Scale indicating the potential for binge eating
8. Unwilling to accept randomization
9. Planning to move from the area or changing employment.